albunorm20%, 200g / l, solution for infusion


1. Name Of The Medicinal Product

Albunorm 20%, 200 g/l, solution for infusion

2. Qualitative And Quantitative Composition

Albunorm 20% is a solution containing 200 g/l of total protein of which at least 96% is human albumin.

A bottle of 50 ml contains 10 g of human albumin.

A bottle of 100 ml contains 20 g of human albumin.

Excipients:

Sodium (144-160 mmol/l)

Potassium (< 10 mmol/l)

Albunorm 20% is a hyperoncotic solution.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

The solution is a clear, slightly viscous liquid; it is yellow, amber or green.

4. Clinical Particulars 4.1 Therapeutic Indications

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.

4.2 Posology And Method Of Administration

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient?s individual requirements.

Posology

The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:

arterial blood pressure and pulse rate

central venous pressure

pulmonary artery wedge pressure

urine output

electrolyte

haematocrit/haemoglobin

Method of administration

Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride).

The infusion rate should be adjusted according to the individual circumstances and the indication.

In plasma exchange the infusion-rate should be adjusted to the rate of removal.

4.3 Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.

Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:

Decompensated cardiac insufficiency

Hypertension

Oesophageal varices

Pulmonary oedema

Haemorrhagic diathesis

Severe anaemia

Renal and post-renal anuria

In a post-hoc follow-up study of critically ill patients with traumatic brain injury, fluid resuscitation with albumin was associated with higher mortality rates than was resuscitation with saline. While the mechanisms underlying this observed difference in mortality are not clear, caution is advised in the use of albumin in patients with severe traumatic brain injury.

The colloid-osmotic effect of human albumin 200 or 250 g/l is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

200-250 g/l human albumin solutions are relatively low in electrolytes compared to 40-50 g/l human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patients circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.

Data on the use of Albunorm 20% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks.

This medicinal product contains 7.2 –8 mmol / 14.4 –16 mmol sodium per one bottle of 50 ml /100 ml albumin solution, this has to be taken into consideration by patients on a controlled sodium diet.

This medicine contains maximum 1mmol potassium per one bottle of 100 ml albumin solution, this has to be taken into consideration for patients with reduced kidney function or patients on a controlled potassium diet.

Standard measure to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time that Albunorm 20% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interactions of human albumin with other medicinal products are known.

4.6 Pregnancy And Lactation

The safety of Albunorm 20% for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.

No animal reproduction studies have been conducted with Albunorm 20%.

However, human albumin is a normal constituent of human blood.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Mild reactions such as flush, urticaria, fever, and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In case of severe reactions, the infusion should be stopped and an appropriate treatment should be initiated.

The following adverse reactions have been observed for human albumin solutions during the postmarketing phase and can therefore also be expected for Albunorm 20%.

System Organ Class

Reactions

(frequency not known)*

Immune system disorders

anaphylactic shock

anaphylactic reaction

hypersensitivity

Psychiatric disorders

confusional state

Nervous system disorders

headache

Cardiac disorders

tachycardia

Vascular disorders

hypotension

hypertension

flushing

Respiratory, thoracic and mediastinal disorders

dyspnoea

Gastrointestinal disorders

nausea

Skin and subcutaneous tissue disorders

urticaria

angioneurotic oedema

rash erythematosus

hyperhidrosis

General disorders and administration site conditions

pyrexia

chills

* cannot be estimated from the available data

For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient?s haemodynamic parameters carefully monitored.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: blood substitutes and plasma protein fractions,

ATC code: B05AA01

Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver.

Physico-chemical data:

Human albumin 200 or 250 g/l has a corresponding hyperoncotic effect.

The most important physiological function of albumin results from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins.

5.2 Pharmacokinetic Properties

Under normal conditions the total exchangeable albumin pool is 4-5 g/kg body weight, of which 40-45% is present intravascularly and 55-60% in the extravascular space. Increased capillary permeability will alter albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.

Under normal conditions, the average half-life of albumin is about 19 days. The balance between synthesis and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and due to lysosome proteases.

In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In some patients the plasma volume can remain increased for some hours. However, in critically ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.

5.3 Preclinical Safety Data

Human albumin is a normal constituent of human plasma and acts like physiological albumin.

In animals, single-dose toxicity testing is of little relevance and does not permit the evaluation of toxic or lethal doses or of a dose-effect-relationship. Repeated-dose toxicity testing is impracticable due to the development of antibodies to heterologous protein in animal models.

To date, human albumin has not been reported to be associated with embryo-fetal toxicity, oncogenic or mutagenic potential.

No signs of acute toxicity have been described in animal models.

6. Pharmaceutical Particulars 6.1 List Of Excipients

N-acetyl-DL-tryptophan

0.080 mmol/g protein

 

 

Caprylic acid

0.080 mmol/g protein

 

 

Water for injections

ad 1000 ml

 

 

Electrolytes

 

 

 

 

Sodium

144-160 mmol/l

 

 

Potassium

< 10 mmol/l

 

 

6.2 Incompatibilities

Human albumin solution must not be mixed with other medicinal products, whole blood, packed red cells and water for injections.

6.3 Shelf Life

2 years

After the vial has been opened, the content should be used immediately.

6.4 Special Precautions For Storage

Do not store above +25 °C.

Store in the original container in order to protect from light.

Do not freeze.

6.5 Nature And Contents Of Container

- 50 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack size of 1 or 10.

- 100 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack size of 1 or 10.

Not all pack sizes may be marketed in all countries.

6.6 Special Precautions For Disposal And Other Handling

The solution can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5 % glucose or 0.9 % sodium chloride).

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If large volumes are administered, the product should be warmed to room or body temperature before use.

Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated.

Once the container has been opened the content should be used immediately.

Any unused product should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester

M2 1AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 10673/0031

9. Date Of First Authorisation/Renewal Of The Authorisation

23/02/2009

10. Date Of Revision Of The Text

07/07/2009


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Lipobase


1. Name Of The Medicinal Product

Lipobase.

2. Qualitative And Quantitative Composition

Lipobase contains no active ingredient.

3. Pharmaceutical Form

Cream.

4. Clinical Particulars 4.1 Therapeutic Indications

For use where it is desired by the physician to reduce gradually the topical dosage of Locoid Lipocream. It may also be used where a continuously alternating application of the active product and the base is required e.g. in prophylactic therapy. Application of the Lipobase is also recommended where it is felt by the physician that the use of a bland emollient base is preferable to the cessation of therapy with the active product. Lipobase may also be used as a diluent for the active product in those cases where dilution is regarded as necessary by the prescriber. Lipobase may also be used other than in conjunction with a topical corticosteroid for its emollient action, and for the treatment of mild skin lesions such as pruritus or dry, scaly skin, where topical corticosteroid is not warranted.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Lipobase may be used either by replacing an application of the active product or alternating the application of the active product and the base, gradually diminishing the application of the active product until therapy ceases, or by the application of the product for its emollient action.

4.3 Contraindications

None stated.

4.4 Special Warnings And Precautions For Use

A small number of people may be hypersensitive (allergic) to the constituents of Lipobase.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Methyl parahydroxybenzoate may cause allergic skin reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

None stated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The product acts topically as an emollient cream.

5.2 Pharmacokinetic Properties

Topical administration with no pharmacologically active constituents.

5.3 Preclinical Safety Data

No relevant preclinical safety data has been generated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Cetostearyl alcohol

Macrogol cetostearyl ether

Light liquid paraffin

White soft paraffin

Methyl parahydroxybenzoate

Sodium citrate, anhydrous

Citric acid, anhydrous

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

30g, 50g, 100g and 200g packs, 3 years.

200g and 500g packs, 2 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Collapsible aluminium tube with plastic screw cap containing 30 g, 50 g, 100 g or 200 g; and pump dispenser containing 200 g or 500 g.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Astellas Pharma Ltd

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL0166/0125

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation granted 19 February 1985

Renewal granted 23 January 2001.

10. Date Of Revision Of The Text

7th February 2007

11. Legal category

P


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Zinc and Castor Oil Ointment BP (Thornton &amp; Ross Ltd)


1. Name Of The Medicinal Product

Zinc and Castor Oil Ointment BP or Zinc and Castor Oil Cream BP.

2. Qualitative And Quantitative Composition

Zinc oxide BP

7.5% w/w.

Virgin castor oil BP

50.0% w/w.

3. Pharmaceutical Form

Ointment.

4. Clinical Particulars 4.1 Therapeutic Indications

For relief of the symptoms of nappy rash and as a protective water resistant cream for dry, chapped skin.

4.2 Posology And Method Of Administration

Topical. Applied directly to the skin.

Recommended doses and dosage schedules.

As required, up to four times daily or at each nappy change. The product is suitable for use by adults, children and the elderly.

4.3 Contraindications

Known hypersensitivity to any of the ingredients listed

4.4 Special Warnings And Precautions For Use

For external use only.

Keep all medicines out of reach and sight of children.

Zinc and Castor Oil Ointment BP contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Zinc and Castor Oil Ointment BP

or

Zinc and Castor Oil Cream BP contains Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Zinc and Castor Oil Cream BP

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

May mask x-ray pictures under certain circumstances.

4.6 Pregnancy And Lactation

No information is available on the safety of the product when used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

Overdosage is unlikely. If accidentally ingested treatment should be symptomatic. Oral ingestion of large quantities of castor oil may cause nausea, vomiting, colic and diarrhoea.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

D02A B-L Mollients and Protectives

Zinc oxide has a mild antiseptic action, and is useful for relieving the symptoms of nappy rash and other minor skin irritations.

Castor oil acts in the formulation as an emollient and helps alleviate dry, hard and chapped skin.

The formulation as a whole acts to provide a mildly antiseptic water resistant emollient barrier for dry skin conditions and nappy rash.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

No data of relevance, which is additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Cetostearyl Alcohol BP, Beeswax White Lump BP (E901) and Arachis Oil BP.

6.2 Incompatibilities

None known.

6.3 Shelf Life

30g:

36 months unopened.

50g:

36 months unopened.

60g:

36 months unopened.

100g:

36 months unopened.

200g:

36 months unopened.

500g:

36 months unopened.

5000g:

36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

30g:

White glass jar and metal cap with liner.

50g:

White glass jar and metal cap with liner.

60g:

White glass jar and metal cap with liner.

100g:

Styrene crystal jar and polypropylene cap.

200g:

Styrene crystal jar and metal cap with liner.

500g:

Polypropylene jar with lid.

5000g:

High density polythene bucket and lid.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd.,

Linthwaite Laboratories

Huddersfield

HD7 5QH

England

8. Marketing Authorisation Number(S)

PL 12965/0038

9. Date Of First Authorisation/Renewal Of The Authorisation

25.08.1993 / 28.10.1998, 06.07.2000 27/10/2005

10. Date Of Revision Of The Text

27/10/2005

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable


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Boots Epsom Salts B.P.


1. Name Of The Medicinal Product

Epsom Salts (Magnesium Sulphate BP)

Boots Epsom Salts B.P.

2. Qualitative And Quantitative Composition

Magnesium Sulphate 100%

3. Pharmaceutical Form

Powder for oral solution

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of occasional constipation.

4.2 Posology And Method Of Administration

Adults and children over 12 years: 1 to 4g to be taken in warm water, once daily.

Children under 12 years. Not recommended.

4.3 Contraindications

Intestinal obstruction.

4.4 Special Warnings And Precautions For Use

To be used with caution in elderly or debilitated patients and in those with renal insufficiency.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

This product may interact with tetracyclines, digoxin, vitamins and iron and may potentiate tubocurarine during anaesthesia.

4.6 Pregnancy And Lactation

The use of magnesium containing salts in the first trimester of pregnancy should be avoided.

They should only be used after medical advice if the benefits exceed potentially unknown risks of foetal exposure to magnesium. No adverse effects are anticipated in breast fed infants.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Prolonged excessive use of this product may cause alkalosis and hypermagnesaemia.

4.9 Overdose

Excessive amounts of this medicine may cause diarrhoea and dehydration. Hypermagnesaemia and hypercalcaemia may also occur, particularly if there is impaired renal function. Treatment consists of supportive and symptomatic measures with appropriate correction of fluid and electrolyte balance.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Never undertaken by Abdine Limited. This product was granted a 'Licence as of Right' some 25 years ago.

6. Pharmaceutical Particulars 6.1 List Of Excipients

None.

6.2 Incompatibilities

None are recognised.

6.3 Shelf Life

As packaged for sale: Three years

As reconstituted for use: One day

After first opening the container: One month

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

A spirally wound, varnished, cardboard tub with a press-fit lid or polypropylene jar and cap containing 100g, 150g, 200g, 250g, 300g or 500g.

6.6 Special Precautions For Disposal And Other Handling

Take from 1 to 4g in warm water.

7. Marketing Authorisation Holder

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside PR9 9AL

8. Marketing Authorisation Number(S)

PL 03105/0068

9. Date Of First Authorisation/Renewal Of The Authorisation

12 February 1999

10. Date Of Revision Of The Text

29th November 2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)


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Ventolin Solution for IV Infusion


Ventolin Solution for Intravenous Infusion

1 mg/ml

salbutamol sulphate

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1 What Ventolin Infusion is and what it is used for 2 Before you use Ventolin Infusion 3 How to use Ventolin Infusion 4 Possible side effects 5 How to store Ventolin Infusion 6 Further information What Ventolin Infusion is and what it is used for

Ventolin Solution for Intravenous Infusion (called ‘Ventolin Infusion’ in this leaflet) contains a medicine called salbutamol. This belongs to a group of medicines called ‘beta-agonists’. It acts on special receptor sites in the lungs and in the uterus (in women) to:

help the airways in your lungs to stay open. This makes it easier for air to get in and out. It helps to relieve chest tightness, wheezing and cough relax the muscles in the walls of the uterus.

This may stop the contractions associated with labour.

Ventolin Infusion is used: to treat severe breathing problems in people with asthma and similar conditions to stop premature labour. Before you use Ventolin Infusion Do not use Ventolin Infusion if: you are allergic (hypersensitive) to salbutamol sulphate or any of the other ingredients of Ventolin Infusion (listed in Section 6). Take special care with Ventolin Infusion

Check with your doctor, nurse or pharmacist before taking your medicine if:

you have high blood pressure you are diabetic you have an overactive thyroid gland you have a history of heart problems such as an irregular or fast heartbeat or angina. Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular tell your doctor, nurse or pharmacist if you are taking:

medicines for an irregular or fast heartbeat other medicines for your asthma.

Ventolin Infusion should not be administered in the same syringe or infusion as any other medication.

Using Ventolin with food and drink

You can use Ventolin Infusion at any time of day, with or without food.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

Ventolin is not likely to affect you being able to drive or use any tools or machines.

How to use Ventolin Infusion

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

The Ventolin Infusion will be diluted before it is given to you. Your doctor or nurse will find information about how to dilute the medicine in the Summary of Product Characteristics (SPC).

To treat severe breathing problems The usual dose is 3 to 20 micrograms of salbutamol per minute for as long as required. Higher doses may be used in patients with ‘respiratory failure’. To treat premature labour The usual dose is 10 to 45 micrograms of salbutamol per minute until contractions stop. If your labour continues despite this treatment then the infusion should be stopped.

Ventolin Solution for Intravenous Infusion is not suitable for treating children.

If you receive more Ventolin Infusion than you should

Ventolin Infusion will always be given under carefully controlled conditions. However, if you think that you have been given more than you should tell your doctor or nurse as soon as possible.

The following effects may happen:

your heart beating faster than usual you feel shaky.

These effects usually wear off in a few hours.

If you stop taking Ventolin Infusion

Do not stop taking Ventolin without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

Possible side effects

Like all medicines, Ventolin Infusion can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking Ventolin and see a doctor straight away. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse.

Talk to your doctor as soon as possible if: you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while you may feel your heartbeat is uneven or it gives an extra beat these affect less than 1 in 10 people.

If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.

Tell your doctor if you have any of the following side effects which may also happen with this medicine:

Very common (affects more than 1 in 10 people)

feeling shaky.

Common (affects less than 1 in 10 people)

headache muscle cramps.

Uncommon (affects less than 1 in 100 people)

patients receiving Ventolin Infusion for the treatment of premature labour: cough, wheezing, chest pain or shortness of breath, which may be signs of pulmonary oedema (fluid in the lungs). Tell your doctor immediately.

Rare (affects less than 1 in 1,000 people)

low level of potassium in your blood increased blood flow to your extremities (peripheral dilatation).

Very rare (affects less than 1 in 10,000 people)

changes in sleep patterns and changes in behaviour, such as restlessness and excitability. The following side effects can also happen but the frequency of these are not known: in the treatment of premature labour feeling sick and being sick (nausea and vomiting) chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if this occurs. Do not stop using this medicine unless told to do so a condition known as lactic acidosis which may cause stomach pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat or thirst.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

If you think this medicine is not working well enough for you

If your medicine does not seem to be working as well as usual, talk to your doctor as soon as possible. Your chest problem may be getting worse and you may need a different medicine.

Do not take extra Ventolin unless your doctor tells you to.

How to store Ventolin Infusion Keep out of the reach and sight of children. Do not store above 30°C. Keep the ampoules in the outer carton to protect from light. Use the medicine within 24 hours of mixing with infusion fluids. Do not use Ventolin Infusion after the expiry date, which is stated on the ampoule label and carton after ‘EXP’. The expiry date refers to the last day of that month. If you are told to stop taking this medicine return any unused Ventolin Infusion to your pharmacist to be destroyed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

Further information What Ventolin Infusion contains The active substance is salbutamol sulphate. The other ingredients are water, salt (sodium chloride) and sulphuric acid. What Ventolin Infusion looks like and contents of the pack

Ventolin Infusion comes in a 5 ml glass ampoule.

Each 5 ml ampoule contains 5 mg of salbutamol sulphate in sterile normal saline adjusted to pH 3.5.

Each carton contains 10 ampoules.

Marketing Authorisation Holder Glaxo Wellcome UK Limited trading as: Allen & Hanburys Stockley Park West Uxbridge Middlesex UB11 1BT Manufacturer GlaxoSmithKline Manufacturing S.p.A. San Polo di Torrile Parma Italy

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Ventolin Infusion

Reference number 10949/0087

This is a service provided by the Royal National Institute of Blind People.

Leaflet date: January 2008

Ventolin is a trademark of the GlaxoSmithKline group of companies

© 2008 GlaxoSmithKline group of companies

10000000060960


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Zinacef


ZINACEF 1.5 g, 750 mg and 250 mg

cefuroxime sodium powder for injection

Please read this leaflet carefully before starting to take your medicine. Keep it safe, as you may want to read it again. This leaflet contains important information about Zinacef injection. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is Zinacef?

Zinacef contains cefuroxime, which is an antibiotic belonging to the cephalosporin class. Antibiotics are used to kill the bacteria or “germs” which cause infections.

What Zinacef contains

Each vial contains:

The active ingredient - cefuroxime 250 mg or 750 mg or 1.5 g (as sodium salt).

Other ingredients - none.

Zinacef is supplied in single vials of cefuroxime 250 mg, 750 mg or 1.5 g.

Product licence holder and manufacturer Product licence held by Glaxo Operations UK Ltd. trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Manufactured by GlaxoSmithKline Manufacturing S.p.A. Verona Italy What Zinacef does

This medicine is used to treat infections of the airways; ear, nose and throat; urinary tract; bones and joints; pelvis; blood and wounds; gonorrhoea and meningitis.

Your doctor has decided to give you Zinacef because you have an infection or to protect you from infection before an operation or during dialysis. Sometimes Zinacef is used at the same time as other antibiotics and the correct dose is checked by blood tests.

Before having Zinacef Make sure your doctor knows: if you think you may be pregnant if you are breast-feeding if you have been told that you are allergic to Zinacef, cefuroxime or other antibiotics e.g. penicillin if you have been told that your kidneys are not working as well as they should be if you are taking a diuretic such as furosemide if you are taking an aminoglycoside type antibiotic or any other antibiotics. You and your doctor should also know that: if your urine is tested for sugar, Zinacef does not normally cause a false positive result as occurs with some other cephalosporin antibiotics if you have any blood tests, Zinacef can cause changes to the results.

Like other medicines used to treat meningitis, Zinacef may take a while to clear the body of all the meningitis infection. Because of this, hearing loss caused by meningitis has occurred in a few patients after using Zinacef to treat the disease.

Dosage and administration

The correct dose of Zinacef will be decided by your doctor and depends on the type of infection and your weight and age. Zinacef will usually be given by a doctor or nurse either directly into a vein or into a muscle. In some cases, it may be added to a “drip” intravenous infusion. Zinacef is made up by adding the following amount of sterile water or other recommended diluting solution.

Vial Size 250mg Intramuscular injection (suspension): 1ml Intravenous injection (solution): 2ml Intravenous infusion (solution): - Vial Size 750mg Intramuscular injection (suspension): 3ml Intravenous injection (solution): 6ml Intravenous infusion (solution): - Vial Size 1.5g Intramuscular injection (suspension): - Intravenous injection (solution): 15ml Intravenous infusion (solution): - Vial Size 1.5g infusion Intramuscular injection (suspension): - Intravenous injection (solution): - Intravenous infusion (solution): 50ml

The usual adult dose is from 750 mg to 1.5 g three times a day: bigger or more frequent doses are sometimes needed. The duration of treatment depends on the type of infection. In special cases, just one 1.5 g dose is sufficient.

To treat pneumonia in adults, the usual dose of Zinacef is 1.5 g, twice a day for 2 to 3 days, followed by a 7 day course of the oral form of Zinacef, called Zinnat (cefuroxime axetil).

To treat a sudden worsening of chronic bronchitis, the usual dose of Zinacef is 750 mg, twice a day for 2 to 3 days, followed by a 5 to 7 day course of Zinnat.

The duration of your treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment.

For infants and children, the dose is based on body weight and is usually between 30 mg to 100 mg per kilogram daily divided into three or four separate doses. For newborn children the dose is as for infants and children, but is divided into 2 or 3 doses.

The daily dose depends on whether it is a simple or complicated infection and on whether other antibiotics are being used at the same time.

For patients with kidney problems the dose of Zinacef will be reduced.

Your medication will usually be given to you by a health professional. However if you think you may have missed a dose or have received too much medicine please tell your doctor or nurse.

Zinacef Side Effects

Along with its needed effects, a medicine may cause unwanted effects. Most people given Zinacef find it causes no problems.

A few people can be allergic to antibiotics, if any of the following rare side effects appear soon after having your injection, tell your doctor immediately:

sudden wheeziness, chest tightness, pain or collapse, as these may be symptoms of an acute allergic reaction to your medicine. The more common side effects of Zinacef that could happen to between in 1 in 10 and 1 in 100 people taking it include: changes to “blood counts” or tests used to measure the functioning of organs in the body such as the liver pain or inflammation at the site of injection (thrombophlebitis). Uncommon side effects that could happen to between 1 in 100 and 1 in 1,000 people taking Zinacef include: skin lumps or hives skin rash (red spots), itchiness diarrhoea or vomiting. Rare side effects that could happen to between 1 in 1,000 and 1 in 10,000 people include: as with other antibiotics after long courses of treatment, thrush in the vagina or mouth can occur easy bruising (thrombocytopenia) fever. Very rare side effects that could happen to less 1 in 10,000 taking Zinacef include: swelling of eyelids, face or lips severe diarrhoea from colitis (lower end of the bowel inflamed) kidney inflammation blistering or peeling skin.

If you feel unwell or have any unusual discomfort you do not understand, tell the doctor as soon as possible.

Storage

If you keep the vials at home, keep them away from heat and light which could spoil them. As with all medicines, keep Zinacef vials safely away from children. Store any unopened vials at room temperature below 25°C (77°F). Store reconstituted vials in a fridge at 2-8°C for no longer than 24 hours. Do not autoclave (a method of sterilization often used in hospitals).

What to do with any unused medication

If you are at home and your doctor stops your treatment, return any unused Zinacef vials to a pharmacist for disposal. Only keep your medication if your doctor tells you to. Do not use the unopened vials after the expiry date on the label or carton.

Further information

Remember this medicine is for you. Only a doctor can prescribe it for you.

This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

You may be able to find out more about prescribed medicines from books in public libraries.

Leaflet last updated 3 May 2006

The information provided applies only to Zinacef

Zinacef and Zinnat are registered trademarks of the GlaxoSmithKline group of companies

© 2006 GlaxoSmithKline group of companies


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Myozyme 50 mg powder for concentrate for solution for infusion


Myozyme 50 mg powder for concentrate for solution for infusion

Alglucosidase alfa

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Myozyme is and what it is used for 2. Before you use Myozyme 3. How to use Myozyme 4. Possible side effects 5. How to store Myozyme 6. Further information What Myozyme Is And What It Is Used For

Myozyme is used to treat patients who have a confirmed diagnosis of Pompe disease.

People with Pompe disease have low levels of an enzyme called ?-glucosidase. This enzyme helps the body control levels of glycogen (a type of carbohydrate). Glycogen provides the body with energy, but in Pompe disease the levels can get too high.

Myozyme is an artificial enzyme called alglucosidase alfa – this can replace the natural enzyme which is lacking in Pompe disease.

In patients with late-onset Pompe disease a positive effect was observed over an 18 month period on lung function and walking ability. The evidence on the effect of Myozyme in severely affected patients with late onset Pompe disease is limited.

Before You Use Myozyme Do not use Myozyme

If you are allergic (hypersensitive) to alglucosidase alfa or any of the other ingredients of Myozyme.

Take special care with Myozyme

If you are treated with Myozyme, you may experience a reaction while you are being given the medicine or during the next 2 hours. This is known as an infusion-associated reaction and can sometimes be very severe. If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or antipyretics.

Different groups of patients using Myozyme

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

There is no experience of the use of Myozyme in pregnant women. Myozyme should not be used during pregnancy unless clearly necessary. It is recommended to stop breast-feeding when Myozyme is used. Ask your doctor or pharmacist for advice before taking any medicine.

How To Use Myozyme Instructions for proper use

Myozyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given.

Myozyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Pompe disease.

The recommended dosage of Myozyme is 20 mg/kg body weight given once every 2 weeks.

If you use more Myozyme than you should

There are no cases of overdose reported.

If you forget to use Myozyme

If you have missed an infusion, please contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Myozyme can cause side effects, although not everybody gets them.

Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related effects”). Some of these infusion related side effects became serious. Should you experience any reaction like this, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or antipyretics.

Hives Rash Paleness Redness of the skin (Facial) flushing Increased or high blood pressure Bluish discolouration of the skin Fever or increased body temperature Chills Cough Increased breathing rate Increased or decreased heart rate Vomiting Agitation Tremor Swelling around the eyes Abnormal breathing sounds Difficulty in breathing (including shortness of breath) Headache Cold extremities (e.g. hands, feet) Tingling Pain or local reaction at the site of the drip Dizziness Irritability Itchy skin Retching Low blood pressure Bronchospasm Low level of oxygen in the blood Swelling of the face, swelling of the throat or severe combined swelling of the face, throat and tongue due to a severe allergic reaction Swelling of the arms and legs Feeling hot Increased sweating Eyes tearing Mottled skin Nausea Restlessness Wheezing Heart stopping Chest discomfort Chest pain (not in the heart) Throat tightness Diarrhoea Fatigue Muscle pain Muscle spasms

Life threatening reactions, including very severe generalised allergic reactions and anaphylactic shock, have been reported in some patients.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Myozyme

Keep out of the reach and sight of children

Store in a refrigerator (2°C – 8°C).

Do not use after the expiry date stated on the labelling after the letters ‘EXP’.

It is recommended that Myozyme is used immediately after it has been mixed with sterile water. However it can be kept for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Myozyme contains The active substance is alglucosidase alfa 50 mg. One vial contains 50 mg of alglucosidase alfa. After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml. The other ingredients are mannitol, sodium phosphate monobasic monohydrate sodium phosphate dibasic heptahydrate polysorbate 80 What Myozyme looks like and contents of the pack

Myozyme, 50 mg, is presented as a powder for concentrate for solution for infusion (in a vial- pack: sizes of 1, 10 or 25). Not all pack sizes may be marketed.

Myozyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless to pale yellow solution, which may contain particles. The reconstituted solution must be further diluted.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden The Netherlands

Manufacturer

Genzyme Ltd. 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom/Ireland Genzyme Therapeutics Ltd United Kingdom Tel:+44 1865 405200

This leaflet was last approved in 10/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site :http://www.emea.europa.eu/. There are also links to other websites about rare diseases and treatments.


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Cerezyme 200 U Powder for concentrate for solution for infusion


Cerezyme 200 U powder for concentrate for solution for infusion

Imiglucerase

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Cerezyme is and what it is used for. 2. Before you use Cerezyme. 3. How to use Cerezyme. 4. Possible side effects. 5. How to store Cerezyme. 6. Further Information What Cerezyme Is And What It Is Used For

Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of platelets - a type of blood cell), spleen or liver enlargement or bone disease.

People with Gaucher disease have low levels of an enzyme called acid ?-glucosidase. This enzyme helps the body control levels of glucosylceramide. Glucosylceramide is a natural substance in the body, made of sugar and fat. In Gaucher disease glucosylceramide levels can get too high.

Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme acid ?- glucosidase which is lacking or not active enough in patients with Gaucher disease.

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Before You Use Cerezyme Do not use Cerezyme If you are allergic (hypersensitive) to imiglucerase, or if you are allergic to any of the other ingredients of Cerezyme. Take special care with Cerezyme If you are treated with Cerezyme, you may experience an allergic reaction while you are being given the medicine or shortly after. If you experience a reaction like this, you should tell your doctor immediately. Your doctor may test if you have an allergic reaction to imiglucerase. Some patients with Gaucher disease have high blood pressure in the lungs (pulmonary hypertension). The cause can be unknown, or it can be due to heart, lung or liver problems. It can occur whether the patient is treated with Cerezyme or not. But, if you suffer with any shortness of breath you should tell your doctor. Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you may be pregnant. Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.

How To Use Cerezyme

Instructions for proper use

Cerezyme is given through a drip into a vein (by intravenous infusion).

It is supplied as a powder which will be mixed with sterile water before it is given.

Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.

Your dose will be specific to you. Your doctor will work out your dose based on how severe your symptoms are, and other factors. The recommended dose of Cerezyme is 60 units/kg body weight given once every 2 weeks.

Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.

Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose. This might be every 6 to 12 months.

There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease. Therefore no special dosage regimen can be recommended.

The ICGG Gaucher Registry

You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”.

The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works. This should lead to an improvement in the safe and effective use of Cerezyme. Your patient data will be registered anonymously–nobody will know it is information about you.

If you use more Cerezyme than you should

There are no cases of overdose of Cerezyme reported.

If you forget to use Cerezyme

If you have missed an infusion, please contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Cerezyme can cause side effects, although not everybody gets them.

If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.

Common side effects (occurring in more than 1 in 100 patients) are:

breathlessness hives/ localised swelling of the skin or lining of the mouth or throat itching rash

Uncommon side effects (occurring in more than 1 in 1000 patients) are:

dizziness headache a sensation of tingling, pricking, burning or numbness of the skin increased heart rate bluish skin flushing fall in blood pressure vomiting nausea abdominal cramping diarrhoea pain in the joints infusion site discomfort infusion site burning infusion site swelling injection site sterile abcess chest discomfort fever rigors fatigue backache

Some side effects were seen primarily while patients were being given the medicine or shortly after. These have included itching, flushing, hives/localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin, fall in blood pressure and backache. If you experience any of these symptoms, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Cerezyme

Keep out of the reach and sight of children.

Unopened vials:

Store in a refrigerator (2°C – 8°C)

Do not use Cerezyme after the expiry date printed on the labelling after the letters “EXP”. The expiry date refers to the last date of that month.

Diluted solution:

It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.

The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Cerezyme contains The active substance is imiglucerase. Imiglucerase is a modified form of the human enzyme acid ?-glucosidase produced by recombinant DNA technology. One vial contains 200 units of imiglucerase. After reconstitution, the solution contains 40 units of imiglucerase per ml. Other ingredients are: Mannitol Sodium citrate Citric acid monohydrate Polysorbate 80 Important information about some of the ingredients of Cerezyme

This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution. To be taken into consideration by patients on a controlled sodium diet.

What Cerezyme looks like and contents of the pack

Cerezyme, 200 U, is presented as a powder for concentrate for solution for infusion (in a vial-pack size of 1 or 25). Not all pack sizes may be marketed.

Cerezyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden The Netherlands

Manufacturer

Genzyme Ltd. 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom/Ireland Genzyme Therapeutics Ltd. United Kingdom Tel:+44 1865 405200

This leaflet was last approved in: 06/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/. There are also links to other websites about rare diseases and treatments.


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Noradrenaline (Norepinephrine) 1:1000 or Levophed


1. Name Of The Medicinal Product

Noradrenaline (Norepinephrine) 1:1000 or Levophed

concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Noradrenaline Tartrate 2 mg/ml

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate for solution for infusion

4. Clinical Particulars 4.1 Therapeutic Indications

Norepinephrine 1:1000 is recommended for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.

4.2 Posology And Method Of Administration

Route of Administration:

For intravenous use.

Route and method of infusion:

Norepinephrine 1:1000 should be administered in a diluted solution via a central venous catheter.

The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter.

Dilution instructions:

Norepinephrine 1:1000 should be diluted either with dextrose 5%, or with isotonic dextrose saline.

Adults:

Either add 2 ml of Norepinephrine 1:1000 to 48 ml 5% dextrose for administration by syringe pump, or add 20 ml of Norepinephrine 1:1000 to 480 ml 5% dextrose for administration by drip counter.

In both cases the final concentration of the infusion solution is 80 mg/litre norepinephrine tartrate, which is equivalent to 40 mg/litre norepinephrine base. If other dilutions are used check the calculation carefully before starting treatment.

Initial rate of infusion:

The initial rate of infusion should be between 10 ml/hour and 20 ml/hour (0.16 ml/min to 0.33 ml/min). This is equivalent to 0.8 mg/hr to 1.6 mg/hr norepinephrine tartrate (or 0.4 mg/hr to 0.8 mg/hr norepinephrine base).

Titration of dose:

Once an infusion of norepinephrine has been established the dose should be titrated according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain normotension. The aim should be to establish a low normal systolic blood pressure (100-120 mm Hg) or to achieve an adequate mean arterial blood pressure (greater than 80 mm Hg).

Duration of Treatment and Monitoring:

Norepinephrine should be continued for as long as vasoactive drug support is indicated. The patient should be monitored carefully for the duration of norepinephrine therapy.

Elderly.

As for adults but see Precautions.

Children:

Not recommended.

4.3 Contraindications

The use of pressor amines during cyclopropane or halothane anaesthesia may cause serious cardiac arrhythmias. Because of the possibility of increasing the risk of ventricular fibrillation, norepinephrine should be used with caution in patients receiving these or any other cardiac sensitising agent or who exhibit profound hypoxia or hypercarbia.

Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because norepinephrine may increase the ischemia and extend the area of infarction. Similar caution should be observed in patients with hypotension following myocardial infarction and in patients with Prinzmetal's variant angina.

4.4 Special Warnings And Precautions For Use

Norepinephrine should be used only in conjunction with appropriate blood volume replacement. When infusing norepinephrine, the blood pressure and rate of flow should be checked frequently to avoid hypertension. Extravasation of the solution may cause local tissue necrosis. The infusion site should be checked frequently. If extravasation occurs, the area should be infiltrated with phentolamine without delay.

It has been suggested that phentolamine may be added directly to the infusion flask to act as an antidote against sloughing without affecting the vasopressor activity of norepinephrine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Norepinephrine should be used with extreme caution in patients receiving monoamine oxidase inhibitors or tricyclic antidepressants because severe, prolonged hypertension may result. The elderly may be especially sensitive to the effects of norepinephrine.

4.6 Pregnancy And Lactation

Norepinephrine may impair placental perfusion and induce foetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to foetal asphyxia in late pregnancy. These possible risks to the foetus should therefore be weighed against the potential benefit to the mother.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Hypertension may occur, which may be associated with bradycardia as well as headache and peripheral ischemia, including gangrene of the extremities. Cardiac arrhythmias may arise when norepinephrine is used in conjunction with cardiac sensitising agents, and may be more likely in patients with hypoxia or hypercarbia. Prolonged administration may result in plasma volume depletion.

4.9 Overdose

Overdosage may result in severe hypertension, reflex bradycardia, marked increase in peripheral resistance and decreased cardiac output. These may be accompanied by violent headache, photophobia, retrosternal pain, pallor, intense sweating and vomiting. In the event of overdosage, treatment should be withdrawn and appropriate corrective treatment initiated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents, ATC code: C01CA03

The vascular effects of norepinephrine in the doses usually used clinically result from the simultaneous stimulation of alpha and beta adrenergic receptors in the heart and vascular system. Except in the heart, its action is predominantly on the alpha receptors. This results in an increase in the force (and in the absence of vagal inhibition) in the rate of myocardial contraction. Peripheral resistance increases and diastolic and systolic pressures are raised.

5.2 Pharmacokinetic Properties

Up to 16% of an intravenous dose is excreted unchanged in the urine with methylated and deaminated metabolites in free and conjugated forms.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium Chloride

Water for Injections.

This medicinal product contains sodium

? 2 ml container contains 0.29 mmol (or 6.7 mg) sodium per container.

? 4 ml container contains 0.58 mmol (or 13.3 mg) sodium per container.

? 20 ml container contains 2.9 mmol (or 67 mg) sodium per container.

To be taken into consideration by patients on a controlled sodium diet.

6.2 Incompatibilities

Infusion solutions containing norepinephrine tartrate have been reported to be incompatible with the following substances: alkalis and oxidising agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton.

6.5 Nature And Contents Of Container

2ml, 4ml and 20ml ampoules packed in boxes of 5.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Hospira Enterprises BV.

Randstad 22-11, 1316 BN Almere,

The Netherlands

8. Marketing Authorisation Number(S)

PL 23061/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

1 July 2005

10. Date Of Revision Of The Text

October 2010


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Intratect


INTRATECT 50 g/l solution for infusion

Human normal immunoglobulin for intravenous administration

Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What INTRATECT is and what it is used for
2. Before you use INTRATECT
3. How to use INTRATECT
4. Possible side effects
5. How to store INTRATECT
6. Further information

What Intratect Is And What It Is Used For

INTRATECT is an extract of human blood which contains antibodies (the body’s own defensive substances) to diseases, available in the form of an infusion solution. The solution is ready for infusion into a vein (a “drip”).

INTRATECT is immunoglobulin (antibodies) from blood donated by a broad spectrum of the population and is likely to contain antibodies to most common infectious diseases. Adequate doses of INTRATECT can restore normal values when blood levels of Immunoglobulin G are low.

INTRATECT is used in patients who do not have sufficient antibodies (replacement therapy) in cases of:

Patients born with lack of antibodies (primary immunodeficiency syndromes) such as: congenital agammaglobulinemia or hypogammaglobulinemia common variable immunodeficiency severe combined immunodeficiencies Wiskott Aldrich syndrome Patients with blood diseases that cause recurrent infections and a lack of antibody production such as: myeloma chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia children born with AIDS and frequent infections

INTRATECT is also used to treat inflammatory disorders (immunomodulation) such as:

Guillain-Barr? syndrome (a disease that damages the nerves in the whole body) Kawasaki disease (a disease in children which causes inflammations of several organs of the body and where the arteries in the heart become enlarged) Idiopathic thrombocytopenic purpura (ITP, where a patient has reduced blood platelets) when the patient will have surgery in the near future or is at risk of bleeding

INTRATECT is also used against infection after bone marrow transplantation.

Before You Use Intratect You should not be given INTRATECT if you are allergic (hypersensitive) to human immunoglobulin or any of the other ingredients of INTRATECT (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. have an immunoglobulin A deficiency, especially if you have antibodies against immunoglobulin A in your blood Take special care with INTRATECT (and talk to your doctor) if you suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia) have not received this medicine before or if there has been a long interval (e.g. several weeks) since you last received it (you will need to be closely monitored during your infusion and for an hour after your infusion has stopped) have been given INTRATECT recently (you will need to be observed during the infusion and for at least 20 minutes after your infusion) have had a reaction to other antibodies (in rare cases you may be at risk of allergic reactions) have or have had a kidney disorder have received medicines that may harm your kidneys (if your kidney function worsens, you may need to stop treatment with INTRATECT)

Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume (hypovolaemia), if your blood is thicker than normal (high blood viscosity), if you have been bed-ridden or immobile for some time (immobilisation) or if you have problems with your blood vessels (vascular diseases) or other risks for thrombotic events (blood clots).

Please note - reactions

You will be carefully observed during the infusion period with INTRATECT to make sure that you do not suffer a reaction. Your doctor will make sure that the rate at which INTRATECT is infused is suitable for you.

If you notice any of the following signs of a reaction, i.e. sudden wheeziness, difficulty in breathing, fast pulse, swelling of the eyelids, face, lips, throat or tongue, rash or itching (especially affecting your whole body) during the infusion of INTRATECT, tell your doctor immediately. The rate of infusion can be slowed or the infusion can be stopped altogether.

Information on transmission of infectious agents

INTRATECT is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, it is important to prevent infections being passed on to patients. Blood donors are tested for viruses and infections. Manufacturers of these products also process the blood or plasma to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are given, the possibility of passing on infection cannot be totally excluded.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.

The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

INTRATECT can reduce the effectiveness of some vaccines such as:

measles rubella mumps chicken pox

You may have to wait up to 3 months before you can have some vaccines and up to a year before you can have a measles vaccine.

Effects on blood tests

INTRATECT can affect blood tests. If you have a blood test after receiving INTRATECT, please inform the person taking your blood or your doctor that you have received INTRATECT.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

Your doctor will decide if INTRATECT may be used during pregnancy and breast-feeding.

Driving and using machines

INTRATECT has no known effects on your ability to drive or use machines.

How To Use Intratect

INTRATECT is intended for intravenous administration (infusion into a vein). It is given to you by a doctor or nurse. The dose will depend on your condition and your body weight. Your doctor will know the right amount to give you.

At the beginning of your infusion you will receive INTRATECT at a slow rate. Your doctor may then gradually increase the infusion rate.

The infusion rate and its frequency is dependant on the reason you are being given INTRATECT.

For replacement therapy in patients with a weak immune system (immunodeficiency) and for children with AIDS, the infusion is given every 2 or 3-4 weeks.

To treat inflammatory disorders (immunomodulation) the infusion may be given as followed:

Idiopathic Thrombocytopenic Purpura:

for the treatment of an acute episode an infusion is given on day 1, which may be repeated once in 3 days.

Alternatively a lower dosage may be given daily for 2 to 5 days.

Guillain Barr? syndrome: the infusion is given for 3 to 7 days.

Kawasaki disease: the infusion should be administered over 2 to 5 days or as a single dose.

For bone marrow transplantation to treat infection and prevent rejection, the infusion is given every week for up to 3 months. Where there is lack of antibody production, the infusion is given every month until there are normal levels of antibodies.

If you miss an infusion

INTRATECT will be given to you in hospital by a doctor or nurse so you are unlikely to miss an infusion. However, tell your doctor if you think you have missed an infusion.

If you receive more INTRATECT than you should

An overdose can lead to fluid overload and increased thickness of the blood, especially in elderly patients or patients with reduced kidney function. If you think you have been given too much INTRATECT, tell your doctor, who will decide if the infusion should be stopped and an alternative treatment given. If you have any further questions on the use of this product, ask your doctor or nurse.

Possible Side-Effects

Like all medicines, INTRATECT can have side-effects, although not everybody gets them.

If you notice any of the following effects, tell your doctor immediately:

rash, itching, wheezing, difficulty in breathing, swelling of the eyelids, face, lips, throat or tongue, extremely low blood pressure, fast pulse

This can be an allergic or a serious allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

Tell your doctor straight away if you notice any of the following very rare effects:

severe chest pain or chest pressure (heart attack, cardiac infarct) weakness, paralysis or numbness on one side of the body, loss of vision in one or both eyes, speech difficulties (stroke) cough, chest pain, rapid breathing, rapid heart rate (pulmonary embolism) swelling, pain, redness of the leg (deep vein thrombosis)

Occasionally, the following may occur:

chills headache fever vomiting feeling sick (nausea) joint pain low blood pressure mild lower back pain

Rarely, the following may occur:

a sudden fall in blood pressure temporary meningitis (inflammation of the brain lining) decrease in the number of red blood cells due to a breakdown of these cells in the blood vessels (haemolytic anaemia) eczema-like symptoms (temporary skin reactions) an increase in the serum creatinine (a waste product) and/or sudden kidney failure

Other reported side effects:

severe chest pain or chest pressure (angina pectoris) (very rare) shivering or trembling (rigors) (very rare) decreased blood pressure (very rare) back pain (very rare) difficulty in breathing (dyspnoe) (very rare)

If a side effect occurs, the infusion rate will be decreased or stopped.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Intratect

Keep out of the reach and sight of children.

Your pharmacist or doctor knows how to store INTRATECT.

It should be kept in the outer carton to protect it from light.

Do not store above 25°C. Do not freeze.

Further Information What INTRATECT contains: The active substance of INTRATECT is human immunoglobulin for intravenous administration. INTRATECT contains 50 g/l human plasma proteins of which at least 96 % is immunoglobulin G (IgG). The IgG subclass distribution is approx. 57 % IgG1, 37 % IgG2, 3 % IgG3 and 3 % IgG4. The maximum immunoglobulin A (IgA) content is 2 mg/ml. The other ingredients are: glycine and water for injections. What INTRATECT looks like and the contents of the pack:

INTRATECT is a solution for infusion. The solution is clear to faintly opalescent (milky colours like an opal) and colourless to pale yellow.

Pack containing 1 vial with 1 g in 20 ml of solution

Pack containing 1 vial with 2.5 g in 50 ml of solution

Pack containing 1 vial with 5 g in 100 ml of solution

Pack containing 1 vial with 10 g in 200 ml of solution

Marketing Authorisation Holder and Manufacturer: Biotest Pharma GmbH Landsteinerstrasse 5 63303 Dreieich Germany Tel.:+ 49 6103 801-0 Fax:+ 49 6103 801-150 and -727 e-mail:[email protected]de

PL 04500/0005

This leaflet was approved in October 2008


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Nitronal


1. Name Of The Medicinal Product

Nitronal®

2. Qualitative And Quantitative Composition

Glyceryl trinitrate 1 mg/ml.

3. Pharmaceutical Form

Solution for infusion.

4. Clinical Particulars 4.1 Therapeutic Indications

(1) Unresponsive congestive heart failure, including that secondary to acute myocardial infarction.

(2) Refractory unstable angina pectoris and coronary insufficiency, including Prinzmetal's angina.

(3) Control of hypertensive episodes and / or myocardial ischaemia during and after cardiac surgery. For the induction of controlled hypotension for surgery.

4.2 Posology And Method Of Administration

For intravenous use. Nitronal® should be administered by means of a micro-drip set infusion pump or similar device which permits maintenance of constant infusion rate.

Adults and the elderly - the dose should be titrated against the individual clinical response.

(1) Unresponsive congestive heart failure. The normal dose range is 10-100 micrograms / minute administered as a continuous intravenous infusion with frequent monitoring of blood pressure and heart rate. The infusion should be started at the lower rate and increased cautiously until the desired clinical response is achieved. Other haemodynamic measurements are extremely important in monitoring response to the drug: These may include pulmonary capillary wedge pressure, cardiac output and precordial electrocardiogram depending on the clinical picture.

(2) Refractory unstable angina pectoris. An initial infusion rate of 10-15 micrograms / minute is recommended; this may be increased cautiously in increments of 5-10 micrograms until either relief of angina is achieved, headache prevents further increase in dose, or the mean arterial pressure falls by more than 20 mm Hg.

(3) Use in surgery. An initial infusion rate of 25 micrograms / minute is recommended; this should be increased gradually until the desired systolic arterial pressure is attained. The usual dose is 25-200 micrograms / minute.

Children - Not recommended for use in children.

4.3 Contraindications

Hypersensitivity to nitrates. Hypotensive shock, severe anaemia, cerebral haemorrhage, arterial hypoxaemia, uncorrected hypovolaemia and angina caused by hypertrophic obstructive cardiomyopathy. Concomitant administration of sildenafil (section 4.5).

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients with severe liver or renal disease, hypothermia, hypothyroidism.

Nitronal® should not be given by bolus injection.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Glyceryl trinitrate may potentiate the action of other hypotensive drugs, and the hypotensive and anticholinergic effects of tricyclic anti-depressants; it may also slow the metabolism of morphine-like analgesics.

The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil. A severe and possibly dangerous fall in blood pressure may occur. This can result in collapse, unconsciousness and may be fatal. Such use is therefore contra-indicated (section 4.3).

4.6 Pregnancy And Lactation

This product should not be used in pregnancy or in women who are breast feeding infants unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

No information available.

4.8 Undesirable Effects

Nitronal® is generally well tolerated because a minimum dose is administered in unit time. Headache, dizziness, flushing, hypotension and tachycardia may be encountered, particularly if the infusion is administered too rapidly. Nausea, diaphoresis, restlessness, retrosternal discomfort, abdominal pain and paradoxical bradycardia have been reported. These symptoms should be readily reversible on reducing the rate of infusion or, if necessary, discontinuing treatment.

4.9 Overdose

Signs and symptoms: Vomiting, restlessness, hypotension, syncope, cyanosis, coldness of the skin, impairment of respiration, bradycardia, psychosis and methaemoglobinaemia may occur.

Treatment: The symptoms may be readily reversed by discontinuing treatment; if hypotension persists, raising the foot of the bed and the use of vasoconstrictors such as intravenous methoxamine or phenylephrine are recommended. Methaemoglobinaemia should be treated by intravenous methylene blue. Oxygen and assisted respiration may be required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Glyceryl trinitrate exerts a spasmolytic action on smooth muscle, particularly in the vascular system. The predominant effect is an increase in venous capacitance resulting in marked diminution of both the left ventricular filling pressure and volume (preload). There is also a reduction in afterload due to moderate dilation of the arteriolar resistance vessels. These haemodynamic changes lower the myocardial oxygen demand. By direct action and through the reduction of myocardial wall tension glyceryl trinitrate also lowers the resistance to flow in the coronary collateral channels and allows re-distribution of blood flow to ischaemic areas of the myocardium.

Administration of Nitronal® by intravenous infusion to patients with congestive heart failure results in a marked improvement in haemodynamics, reduction of elevated left ventricular filling pressure and systolic wall tension, and an increase in the depressed cardiac output. It reduces the imbalance that exists between myocardial oxygen demand and delivery, thereby diminishing myocardial ischaemia and controlling ischaemia-induced ventricular arrhythmias.

5.2 Pharmacokinetic Properties

It is important that the dose of Nitronal® be titrated against the individual clinical response.

After intravenous administration, glyceryl trinitrate is widely distributed in the body with an estimated apparent volume of distribution of approximately 200 litres, and is rapidly metabolised to dinitrate and mononitrate with an estimated half life of 1 to 4 minutes, resulting in plasma levels of less than 1 microgram / ml.

5.3 Preclinical Safety Data

None, of relevance to the prescriber, which are not given elsewhere in this document.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glucose, water for injections, hydrochloric acid.

6.2 Incompatibilities

Glyceryl trinitrate is adsorbed onto administration systems composed of polyvinyl chloride, - see 6.6.

6.3 Shelf Life

Ampoules: 4 years

Vial: 2 years

The diluted solution should be administered as soon as possible; it is stable for up to 24 hours in the recommended infusion system.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original container.

6.5 Nature And Contents Of Container

Cartons of 10 ampoules or single vials.

Amber glass ampoule (containing 5ml or 25ml).

Clear glass vial (containing 50ml).

6.6 Special Precautions For Disposal And Other Handling

Nitronal® need not be diluted before use but can be diluted with Dextrose Injection BP, Sodium Chloride and Dextrose Injection BP, 0.9% Sodium Chloride Injection BP or other protein-free infusion solution, if required.

The solution, whether or not diluted, should be infused slowly (see dosage section) and not given by bolus injection.

To ensure a constant infusion rate of glyceryl trinitrate it is recommended that Nitronal® be administered by means of a syringe pump or polyethylene infusion bag with a counter, or with a glass or rigid polyethylene syringe and polyethylene tubing. Systems made of polyvinyl chloride may absorb up to 50% of the glyceryl trinitrate from the solution, thus reducing the efficacy of the infusion. If the recommended type of system is unavailable, a 1:10 dilution of Nitronal® should be used and the infusion rate modified according to the haemodynamic response of the patient, until the required parameters are attained.

7. Marketing Authorisation Holder

Merck Serono Limited

Bedfont Cross, Stanwell Road

Feltham, Middlesex

TW14 8NX

United Kingdom

8. Marketing Authorisation Number(S)

PL 11648 / 0093

9. Date Of First Authorisation/Renewal Of The Authorisation

24 June 2010

10. Date Of Revision Of The Text

1st August 2010

Legal Category

POM


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Fabrazyme 5 mg, powder for concentrate for solution for infusion


Fabrazyme 5 mg powder for concentrate for solution for infusion

Agalsidase beta

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Fabrazyme is and what it is used for 2. Before you use Fabrazyme 3. How to use Fabrazyme 4. Possible side effects 5. How to store Fabrazyme 6. Further information What Fabrazyme Is And What It Is Used For

Fabrazyme is used as enzyme replacement therapy in Fabry disease, where the level of ?-galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs.

Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.

Before You Use Fabrazyme Do not use Fabrazyme

If you have experienced an allergic anaphylactic reaction to agalsidase beta or if you are allergic (hypersensitive) to any of the other ingredients of Fabrazyme.

Take special care with Fabrazyme

If you are treated with Fabrazyme, you may develop infusion associated reactions. An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (See 4 “Possible Side Effects”). If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent such reactions from occurring.

Different groups of patients using Fabrazyme

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Using other medicines

There are no known interactions with other medicinal products. Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamicin due to a theoretical risk of decreased agalsidase beta activity. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Fabrazyme with food and drink

Interactions with food and drink are unlikely.

Pregnancy and breast-feeding

Use of Fabrazyme during pregnancy is not recommended. There is no experience with the use of Fabrazyme in pregnant women. Fabrazyme may get into breast milk. Use of Fabrazyme during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking this medicine.

How To Use Fabrazyme

Fabrazyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals)

Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.

The recommended dose of Fabrazyme for adults and children 8 – 16 years is 1 mg/kg body weight, once every 2 weeks. No changes in dose are necessary for patients with kidney disease.

If you use more Fabrazyme than you should

There are no cases of overdose of Fabrazyme reported. Doses up to 3 mg/kg body weight have shown to be safe.

If you forget to use Fabrazyme

If you have missed an infusion of Fabrazyme, please contact your doctor.

Possible Side Effects

Like all medicines, Fabrazyme can cause side effects, although not everybody gets them.

In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after. If you experience any serious side effect or side effects not listed, please tell your doctor immediately.

In clinical trials the following side effects were reported:

Very common (occurring in more than 1 in 10 patients):

chills fever headache abnormal touch feeling (pins and needles) nausea vomiting feeling cold

Common (occurring in 1 in 100 to 1 in 10 patients):

chest pain difficulty in breathing pallor itching abnormal tear secretion feeling weak tinnitus nasal congestion diarrhoea redness muscle pain increased blood pressure sudden swelling of the face or throat oedema in extremities vertigo stomach discomfort muscle spasms sleepiness increased heart beat abdominal pain back pain rash low heart rate lethargy syncope cough abdominal discomfort swelling face joint pain decreased blood pressure chest discomfort face oedema exacerbated difficulty in breathing muscle tightness fatigue flushing pain throat tightness dizziness palpitations decreased sensitivity to pain burning sensation wheezing urticaria pain at the extremities nasopharyngitis hot flush feeling hot hyperthermia decreased mouth sensitivity musculoskeletal stiffness

Uncommon (occurring in 1 in 1000 to 1 in 100 patients):

tremor red eyes ear pain throat pain fast breathing itchy rash feeling hot and cold difficulty swallowing infusion site pain infusion site reaction itching eyes ear swelling bronchospasm runny nose heart burn skin discomfort musculoskeletal pain rhinitis influenza-like illness malaise low heart rate due to conduction disturbances increased sensitivity to pain upper respiratory tract congestion red rash (mottled purplish) skin discoloration coldness of the extremities injection site blood clotting skin discoloration oedema

Unknown frequency

Serious allergic reactions serious inflammation of the vessels lower blood oxygen levels

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Fabrazyme

Keep out of the reach and sight of children.

Unopened vials

Store in a refrigerator (2 °C – 8 °C).

Do not use Fabrazyme after the expiry date which is stated on the labelling after the letters ‘EXP’.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Fabrazyme contains The active substance is agalsidase beta, one vial contains 5 mg. Other ingredients are: Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate. What Fabrazyme looks like and contents of the pack

Fabrazyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted. Package sizes: 1, 5 and 10 vials per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Genzyme Europe B.V. Gooimeer 10 NL-1411DD Naarden The Netherlands

Manufacturer

Genzyme Ltd. 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom/Ireland Genzyme Therapeutics Ltd. United Kingdom Tel: +44 1865 405200

This leaflet was last approved in 01/2010

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments.


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Pabrinex Intravenous High Potency Injection


1. Name Of The Medicinal Product

Pabrinex Intravenous High Potency, Solution for injection

2. Qualitative And Quantitative Composition

Each presentation (carton) contains either 5ml or 10ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.

Each No 1 ampoule contains: 5ml ampoule 10ml ampoule Thiamine Hydrochloride BP 250mg 500mg Riboflavin (as Phosphate Sodium BP) 4mg 8mg Pyridoxine Hydrochloride BP 50mg 100mg Each No 2 ampoule contains: 5ml ampoule 10ml ampoule Ascorbic Acid BP 500mg 1000mg Nicotinamide BP 160mg 320mg Anhydrous Glucose BP 1000mg 2000mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars 4.1 Therapeutic Indications

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy; after acute infections, post-operatively and in psychiatric states. Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

4.2 Posology And Method Of Administration

Pabrinex is also available as an Intramuscular High Potency Injection. Therefore before administration, ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAVENOUS injection.

1) The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50ml to 100ml physiological saline or glucose 5% and infused over 30 minutes (see “Special Precautions for Storage” section).

2) For a combined injection volume of not more than 10ml (e.g. the contents of one 5ml ampoule number 1 and one 5ml ampoule number 2) the contents of the ampoules are drawn up into a syringe to mix them just before use, then injected slowly, over a period of 10 minutes, into a vein.

Adults:

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy    

10ml solution from Ampoule

Number 1

PLUS

10ml solution from Ampoule

Number 2

OR

   

15ml solution from Ampoule

Number 1

PLUS

15ml solution from Ampoule

Number 2

2 to 3 pairs of 5ml ampoules* (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.

* or equivalent volume of 5ml and/or 10ml ampoules

    Psychosis following narcosis or E.C.T; toxicity from acute infections    

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes twice daily for up to 7 days.

    Haemodialysis    

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes once every two weeks at the end of dialysis.

   

Elderly: as for adults.

Children: Pabrinex Intravenous High Potency is rarely indicated for administration to children, however suitable doses are as follows:

Under 6 years quarter of the adult dose 6 - 10 years third of the adult dose 10 - 14 years half to two thirds of the adult dose 14 years and over as for the adult dose 4.3 Contraindications

Known hypersensitivity to any of the active constituents or to the excipients.

4.4 Special Warnings And Precautions For Use

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential. Initial warning signs of a reaction to Pabrinex are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered. To minimise the risk of such events with Pabrinex Intravenous High Potency, the preferred mode of administration is by infusion over a period of 30 minutes.

This medicine is for injection into a vein only and should not be given by any other route

Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

4.6 Pregnancy And Lactation

No adverse effects have been noted at recommended doses when used as clinically indicated.

However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.

4.8 Undesirable Effects

Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.

4.9 Overdose

In the unlikely event of overdosage, treatment is symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.

ATC code: A11EB

5.2 Pharmacokinetic Properties

Not supplied.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Edetic acid

Sodium hydroxide

Water for Injections

6.2 Incompatibilities

If it is necessary to administer Pabrinex Intravenous High Potency in infusion, it is recommended that Pabrinex IV HP is administered in physiological saline or glucose 5%.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton. Do not freeze.

Storage of diluted Pabrinex Intravenous High Potency

The stability of Pabrinex Intravenous High Potency in intravenous infusion fluids, at room temperature, is as follows:

Intravenous infusion fluid

In the light

Glucose 5%

7 hours

Physiological saline (sodium chloride 0.9%)

7 hours

Glucose 4.3% with sodium chloride 0.18%

4 hours

Glucose 5% with potassium chloride 0.3%

4 hours

Sodium lactate M/6

7 hours

Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. Store diluted solutions at 2°C to 8°C if not used immediately. Do not freeze.

6.5 Nature And Contents Of Container

Pabrinex Intravenous High Potency is supplied in pairs of amber glass ampoules of 5ml or 10ml. Pack sizes contain ten pairs of 5ml or five pairs of 10ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

7. Marketing Authorisation Holder

Archimedes Pharma UK Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

PL 12406/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: October 1993

Date of the latest renewal: October 2003

10. Date Of Revision Of The Text

22 July 2010


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Calcium Chloride BP Sterile Solution (UCB Pharma Limited)


1. Name Of The Medicinal Product

Calcium Chloride BP Sterile Solution

2. Qualitative And Quantitative Composition

Calcium Chloride Dihydrate BP 13.4% w/v

'For excipients, see 6.1'

3. Pharmaceutical Form

Sterile solution for slow intravenous injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Calcium Chloride Sterile Solution is indicated for the treatment of acute hypocalcaemia where there is a requirement for the rapid replacement of calcium, e.g. severe hypocalcaemic tetany or hypoparathyroidism, or where the oral route is inappropriate due to malabsorption.

4.2 Posology And Method Of Administration

Route of Administration: Slow intravenous injection.

Adults

A typical dose is 2.25 to 4.5 mmol of calcium given by slow intravenous injection not exceeding 1 ml per minute and repeated as necessary.

Children

The cause of the hypocalcaemia must be fully assessed before starting therapy including dietary review, measurement of vitamin D and PTH, together with regular serum calcium and phosphate levels. For children with hypocalcaemic tetany a dosage of 0.25 to 0.35 mmol/kg of calcium given by slow intravenous injection may be given, repeated every six to eight hours until a response is seen. For other hypocalcaemia conditions initial doses of 0.5 to 3.5 mmol of calcium may be given to elevate serum calcium concentrations.

Infants

Calcium chloride has been given to infants at doses of under 0.5 mmol of calcium, but calcium gluconate is usually preferred due to the irritancy of calcium chloride.

4.3 Contraindications

Parenteral calcium therapy is contraindicated in patients receiving cardiac glycosides. Unsuitable for the treatment of hypocalcaemia caused by renal insufficiencies.

In cardiac resuscitation, the use of calcium is contraindicated in the presence of ventricular fibrillation.

Ceftriaxone is contraindicated in premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life) and full-term newborns (up to 28 days of age) if they require (or are expected to require) IV calcium treatment, or calcium-containing infusions because of the risk of precipitation of ceftriaxone-calcium (see sections 4.4 and 4.5).

The treatment of asystole and electromechanical dissociation.

Hypersensitivity to any component.

4.4 Special Warnings And Precautions For Use

Calcium chloride can cause gastro-intestinal irritation due to the stimulatory effects of calcium on gastric acid production. However, the effect would be most likely with oral administration.

Close monitoring of serum calcium levels is essential following IV administration of calcium.

Calcium salts should be used with caution in patients with impaired renal function, cardiac disease or sarcoidosis.

Because it is acidifying, calcium chloride should be used cautiously in patients with respiratory acidosis or respiratory failure.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions.

Calcium chloride injection is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, IV administration at that site should be discontinued at once. Local infiltration of the affected area with 1 % procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For interaction between calcium containing products and ceftriaxone, please see sections 4.3 and 4.4 above.

Calcium-containing products may decrease the effectiveness of calcium channel blockers.

Calcium salts reduce the absorption of a number of drugs such as bisphosphonates, fluoride, some fluoroquinolones and tetracyclines; administration should be separated by at least 3 hours.

Calcium chloride infusion reduces the cardiotonic effects of dobutamine.

The effects of digitalis can be increased by increases in blood calcium levels, and the administration of intravenous calcium may result in the development of potentially life-threatening digitalis induced heart arrhythmias.

Thiazide diuretics decrease urinary calcium excretion, and caution is required if such drugs are administered with both calcium chloride and other calcium-containing preparations.

4.6 Pregnancy And Lactation

Calcium chloride has no known effects on the foetus or infant, but as with all drugs it should not be administered during pregnancy or breast feeding unless considered essential.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rapid intravenous injection may cause vasodilation, decreased blood pressure, bradycardia and arrhythmias.

The patient may complain of tingling sensations, a chalky 'calcium' taste and a sense of oppression or 'heat wave'.

Irritation can occur after intravenous injection. Extravasation can cause burning, necrosis and sloughing of tissue, cellulitis and soft tissue calcification.

Hypertension

Venous thrombosis

Hypercalcemia

4.9 Overdose

Excessive administration of calcium salts leads to hypercalcaemia. Too rapid injection of calcium salts may also lead to many of the symptoms of hypercalcaemia as well as chalky taste, hot flushes and peripheral vasodilation. Treatment of hypercalcaemia is by the administration of sodium chloride by intravenous infusion. Cardiac arrhythmia and cardiac arrest may occur.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code:A12 A07

Calcium is an essential electrolyte involved in the function of nervous, muscular and skeletal systems, cell membrane and capillary permeability. The cation is also an important activator in many enzymatic reactions and plays a regulatory role in the release and storage of neurotransmitters and hormones.

5.2 Pharmacokinetic Properties

Intravenously administered calcium will be absorbed directly into the blood system. Serum calcium levels will increase immediately and may return to normal values in thirty minutes to two hours depending on the rate of renal clearance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide

Hydrochloric acid

Water for injections

6.2 Incompatibilities

Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulphates.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

10ml neutral Type 1 glass ampoules in packs of 10.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3 WE

UK

8. Marketing Authorisation Number(S)

PL 00039/5888R

9. Date Of First Authorisation/Renewal Of The Authorisation

18 February 1993, 17 February 2003

10. Date Of Revision Of The Text

January 2010


More




Taxotere 20 mg


Taxotere 20 mg concentrate and solvent for solution for infusion

docetaxel

TAXOTERE 20 mg concentrate and solvent for solution for infusion

docetaxel

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your hospital pharmacist. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist. In this leaflet: 1. What Taxotere is and what it is used for 2. Before you use Taxotere 3. How to use Taxotere 4. Possible side-effects 5. How to store Taxotere 6. Further information What Taxotere Is And What It Is Used For

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. For the treatment of early breast cancer with lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide. For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin. For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone. For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. Before You Use Taxotere

You should not be given TAXOTERE if:

you experienced in the past a severe allergic reaction to it or to polysorbate 80 which is contained in the product. the number of white blood cells is too low. you have a severe liver disease. you are pregnant or breast feeding. Take special care with TAXOTERE:

Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE. In case of white blood cell disturbances, you may experience associated fever or infections.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of TAXOTERE in particular allergic reactions and fluid retention (swelling of the hands,feet, legs or weight gain).

During treatment, you may be given medication to maintain the number of your blood cells.

Taking/using other medicines:

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.

Pregnancy and breast-feeding:

TAXOTERE must NOT be administered if you are pregnant or if you are planning to become pregnant. You must take adequate contraceptive precautions during therapy and for at least three months after TAXOTERE is no longer administered to you. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must NOT breast-feed while you are treated with TAXOTERE.

If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.

Driving and using machines:

There is no reason why you cannot drive between courses of TAXOTERE except if you feel dizzy or are unsure of yourself.

How To Use Taxotere

TAXOTERE will be administered to you by a healthcare professional.

Usual dosage

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m2) and will determine the dose you should receive.

Method and route of administration

TAXOTERE will be given by infusion into one of your veins. The infusion will last approximately one hour during which you will be in the hospital.

Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give him/her results of your blood tests. Such information will allow him/her to decide whether a dose reduction is needed. If you have any further questions on the use of this product, ask your doctor or hospital pharmacist.

Possible Side Effects

Like all other anticancer medicines, TAXOTERE can cause side effects, although not everybody gets them.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur:

flushing, skin reactions, itching chest tightness; difficulty in breathing fever or chills back pain low blood pressure

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of drugs that are received:

Very Common: (experienced in more than 1 in 10 patients)

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets, fever: if this happens you must tell your doctor immediately allergic reactions as described above loss of appetite (anorexia) insomnia feeling of numbness or pins and needles or pain in the joints of muscles headache alteration in sense of taste inflammation of the eye or increased tearing of the eyes swelling caused by faulty lymphatic drainage shortness of breath nasal drainage; inflammation of the throat and nose; cough bleeding from the nose sores in the mouth stomach upsets including nausea, vomiting and diarrhea, constipation abdominal pain indigestion short term hair loss (in most cases normal hair growth should return) redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) change in the color of your nails, which may detach muscle aches and pains; back pain or bone pain change or absence of menstrual period swelling of the hands, feet, legs tiredness; or flu-like symptoms weight gain or loss

Common (experienced in less than 1 in 10 but more than 1 in 100 patients)

oral candidiasis dehydration dizziness hearing impaired decrease in blood pressure; irregular or rapid heart beat heart failure oesophagitis dry mouth difficulty or painful swallowing haemorrhage raised liver enzymes (hence the need for regular blood tests)

Uncommon: (experienced in more than 1 in 1,000 but less than 1 in 100)

fainting at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling inflammation of the colon, small intestine; intestinal perforation

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.

How To Store Taxotere

Keep out of the reach and sight of children.

TAXOTERE should not be used after the expiry date shown on the pack.

Do not store above 25°C or below 2°C.

Store in the original package in order to protect from light.

The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature.

The infusion solution should be used within 4 hours at room temperature.

Further Information What TAXOTERE contains: The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel anhydrous. One vial contains 20 mg docetaxel. The other ingredient is polysorbate 80. What TAXOTERE looks like and contents of the pack:

TAXOTERE 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80.

Each blister carton of TAXOTERE 20 mg concentrate and solvent for solution for infusion contains:

one single-dose TAXOTERE vial and, one single-dose solvent for TAXOTERE vial Marketing Authorisation Holder: Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex France Manufacturer: Aventis Pharma Dagenham Rainham Road South Dagenham Essex RM10 7XS United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom sanofi-aventis Tel:+44 (0) 1483 505 515

This leaflet was last updated in January 2007


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Glucose Injection BP Minijet (International Medication Systems)


1. Name Of The Medicinal Product

Glucose Injection BP Minijet 50%w/v

2. Qualitative And Quantitative Composition

Glucose anhydrous 500 mg in 1ml.

For excipients see 6.1

3. Pharmaceutical Form

Solution for injection.

The clear, colourless solution is contained in a USP Type I glass vial with an elastomeric closure. The container is specially designed for use with the IMS Minijet injector supplied.

4. Clinical Particulars 4.1 Therapeutic Indications

a) As a source of energy in parenteral nutrition.

b) In severe hypoglycaemia due to insulin excess or other causes.

c) For reduction of cerebrospinal pressure and/or cerebral oedema due to delirium tremens or acute alcohol intoxication.

Glucose injection 50% w/v is strongly hypertonic and is used partly because of its dehydrating effects.

4.2 Posology And Method Of Administration

Hypertonic solutions of glucose should be administered via a central vein. The dose is variable and depends upon the indication, clinical condition and size of the individual.

The rate of utilisation of glucose varies considerably from patient to patient. In general, the maximal rate has been estimated at 500-800mg/kg body weight/hour. If the patient's capacity to utilise glucose is exceeded, glycosuria and diuresis will occur.

Adults, elderly, children over 6 years:

Hypoglycaemia: 20-50ml of a 50% w/v solution, repeated as necessary according to the patient's response, by slow intravenous injection, e.g. 3ml/minute. After 25g of glucose has been given, it is advisable to interrupt the injection and evaluate the effect. The exact dose required to relieve hypoglycaemia will vary. After the patient responds, supplemental oral feeding is indicated to avoid relapse, especially after insulin shock therapy.

Acute alcoholism: 50ml of glucose 50% w/v solution should be administered intravenously. Unmodified insulin (20 units) and thiamine hydrochloride (100mg) should be added to the infusion.

4.3 Contraindications

The intravenous use of strongly hypertonic solutions of glucose is contraindicated in patients with anuria, intracranial or intraspinal haemorrhage, or delirium tremens if the patient is already dehydrated.

Known sensitivity to corn or corn products, hyperglycaemic coma, or ischaemic stroke.

4.4 Special Warnings And Precautions For Use

Hypertonic solutions of glucose should be administered via a large central vein to minimise the damage at the site of injection.

Use with caution in patients with diabetes mellitus, severe undernutrition, carbohydrate intolerance, thiamine deficiency, hypophosphataemia, haemodilution, sepsis and trauma. Rapid infusion of hypertonic glucose solution may lead to hyperglycaemia. Patients should be observed for signs of mental confusion or loss of consciousness.

Prolonged use in parenteral nutrition may affect insulin production; blood and urine glucose should be monitored. Fluid and acid-base balance and electrolyte status should also be determined during therapy with dextrose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Intravenous glucose may result in considerable foetal insulin production, with an associated risk of rebound hypoglycaemia in the new-born. Infusion should not exceed 5-10g/hour during labour or Caesarean section.

4.7 Effects On Ability To Drive And Use Machines

This preparation is intended for use only in emergencies.

4.8 Undesirable Effects

Anaphylactoid reactions have been reported in patients with asthma and diabetes mellitus.

Local pain, inflammation, irritation, thrombophlebitis and fever may occur.

Hypokalaemia, hypomagnesaemia or hypophosphataemia may result from the use of hypertonic solutions via the intravenous route.

Prolonged or rapid administration of hyperosmotic (>5%) solutions may lead to dehydration.

The administration of glucose without adequate levels of thiamine (which form the coenzyme systems in its metabolism), may precipitate overt deficiency states, e.g. Wernicke's encephalopathy.

Excess glucose infusion produces increased CO2, which may be important in respiratory failure, and stimulates catecholamine secretion.

4.9 Overdose

The patient becomes hyperglycaemic and glycosuria may occur. This can lead to dehydration, hyperosmolar coma and death.

Treatment: The infusion should be discontinued and the patient evaluated. Insulin may be administered and appropriate supportive measures taken.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Glucose, the natural sugar occurring in the blood, is the principle source of energy for the body. It is readily converted to fat and is also stored in the liver and muscles as glycogen. When a rapid rise in blood sugar is demanded by the body, glycogen is quickly liberated as d-glucose. When the supply of glucose is insufficient, the body mobilises fat stores which are converted to acetate with production of energy by the same oxidative pathways employed in the combustion of glucose.

It may decrease body protein and nitrogen losses. Glucose is also the probable source of glucuronic acid with which many foreign substances and their metabolites combine to form excretion products. It probably provides the basic substances required for the formation of hyalluronates and chondroitin sulphates, the supporting structures of the organism. It can be converted to a pentose essential for the formation of nucleic acids by the cells.

5.2 Pharmacokinetic Properties

Glucose is metabolised to carbon dioxide and water with the release of energy.

5.3 Preclinical Safety Data

Not applicable since glucose has been used in clinical practice for many years and its effects in man are well known.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Water for Injection

6.2 Incompatibilities

Glucose solutions which do not contain electrolytes should not be administered concomitantly with blood through the same infusion set as haemolysis and clumping may occur.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The product is available as 10ml and 50ml.

6.6 Special Precautions For Disposal And Other Handling

The container is specially designed for use with the IMS Minijet injector. Do not use the injection if crystals have separated.

Administrative Data 7. Marketing Authorisation Holder

International Medication Systems (UK) Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 03265/0008R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date first granted: 28 February 1991

Date renewed: 28 February 1996

10. Date Of Revision Of The Text

April 2001

POM


More




Simulect 10mg powder and solvent for solution for injection or infusion


Simulect 10 mg powder and solvent for solution for injection or infusion

Basiliximab

Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Simulect is and what it is used for 2. Before you are given Simulect 3. How Simulect is given to you 4. Possible side effects 5. How to store Simulect 6. Further information What Simulect Is And What It Is Used For

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, adolescents and children who are having a kidney transplant. Immunosuppressants reduce the body’s response to anything that it sees as "foreign" – which includes transplanted organs. The body’s immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs.

You will only be given two doses of Simulect. These will be given in hospital, around the time of your transplant operation. Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely. You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.

Before You Are Given Simulect

Follow your doctor’s instructions carefully. If you are unsure about anything, ask your doctor, nurse or pharmacist.

You must not be given Simulect if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6 under "What Simulect contains". Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past. if you are pregnant or breast-feeding. Take special care with Simulect if you have previously received a transplant that failed after only a short time or, if you have previously been in the operating theatre for a transplantation that in the end was not performed.

In this situation, you may have received Simulect. Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.

Using other medicines

Please tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Older patients (aged 65 years and over)

Simulect can be given to older patients, but the information available is limited. Your doctor may discuss this with you before you are given Simulect.

Children and adolescents (aged 1 to 17 years)

Simulect can be given to children and adolescents. The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.

Pregnancy and breast-feeding

It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant. You must not be given Simulect if you are pregnant. You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect. If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.

You should also tell your doctor if you are breast-feeding. Simulect may harm your baby. You must not breast-feed after being given Simulect or up to 4 months after the second dose.

Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.

Driving and using machines

There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.

How Simulect Is Given To You

You will only be given Simulect if you are receiving a new kidney. Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20–30 minutes or as an intravenous injection using a syringe.

If you have experienced a severe allergic reaction to Simulect or if you had complications after your surgery such as graft loss, the second dose of Simulect should not be given to you.

The first dose is given just before the transplant operation, and the second dose 4 days after the operation.

Usual dose for children and adolescents (aged 1 to 17 years) For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg. For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg. Usual dose for adults

The usual dose for adults is 20 mg in each infusion or injection.

If you are given too much Simulect

An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer. Your doctor will watch out for any effects on your immune system and treat them if necessary.

Possible Side Effects

Like all medicines, Simulect can cause side effects, although not everybody gets them.

Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine.

Sudden severe allergic reactions have been reported in patients treated with Simulect. If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, wheezing or trouble breathing or flu-like symptoms, tell your doctor or nurse immediately.

In children, the most commonly reported side effects were constipation, excessive growth of normal hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections.

In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

How To Store Simulect

Store in a refrigerator (2°C - 8°C).

Keep out of the reach and sight of children.

Further Information What Simulect contains The active substance is basiliximab. Each vial contains 10 mg of basiliximab. The other ingredients are: potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine. What Simulect looks like and contents of the pack

Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab. It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections. 2.5 ml of the sterile water is used to dissolve the powder before it is given to you.

Simulect is also available in vials with 20 mg basiliximab.

Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom Manufacturer Novartis Pharma S.A.S. 26, rue de la Chapelle F-68333 Huningue France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom Novartis Pharmaceuticals UK Ltd. Tel:+44 1276 698370

This leaflet was last approved in 10 / 2008


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velaglucerase alfa


Generic Name: velaglucerase alfa (VEL a GLOO ser ase AL fa)
Brand Names: VPRIV

What is velaglucerase alfa?

Velaglucerase is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people with Type I Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Velaglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, velaglucerase is not a cure for this condition.

Velaglucerase may also be used for purposes not listed in this medication guide.

What is the most important information I should know about velaglucerase alfa? You should not use velaglucerase alfa if you are allergic to it. Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection. Velaglucerase is not a cure for Gaucher disease. What should I discuss with my health care provider before receiving velaglucerase alfa? You should not use velaglucerase alfa if you are allergic to it. FDA pregnancy category B. Velaglucerase alfa is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether velaglucerase alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is velaglucerase alfa given?

Velaglucerase alfa is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Velaglucerase alfa must be given slowly, and the IV infusion can take at least 1 hour to complete.

Velaglucerase alfa is usually given every other week. Follow your doctor's dosing instructions very carefully.

Your doctor may occasionally change your dose to make sure you get the best results.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your velaglucerase alfa injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while receiving velaglucerase alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Velaglucerase alfa side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.

Less serious side effects may include:

headache;

low fever;

dizziness, tired feeling;

nausea, stomach pain;

knee pain, back pain; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Velaglucerase alfa Dosing Information

Usual Adult Dose for Gaucher Disease:

For use in the treatment of type 1 Gaucher disease:
Recommended dose: 60 Units/kg administered as a 60 minute intravenous infusion every other week

Usual Pediatric Dose for Gaucher Disease:

For use in the treatment of type 1 Gaucher disease:
Recommended dose: 60 Units/kg administered as a 60 minute intravenous infusion every other week

What other drugs will affect velaglucerase alfa?

There may be other drugs that can interact with velaglucerase alfa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More velaglucerase alfa resources Velaglucerase alfa Side Effects (in more detail) Velaglucerase alfa Dosage Velaglucerase alfa Use in Pregnancy & Breastfeeding Velaglucerase alfa Support Group 0 Reviews for Velaglucerase alfa - Add your own review/rating velaglucerase alfa Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Velaglucerase alfa MedFacts Consumer Leaflet (Wolters Kluwer) Velaglucerase alfa Professional Patient Advice (Wolters Kluwer) VPRIV Consumer Overview Vpriv Prescribing Information (FDA) Compare velaglucerase alfa with other medications Gaucher Disease Where can I get more information? Your doctor or pharmacist can provide more information about velaglucerase alfa.

See also: velaglucerase alfa side effects (in more detail)


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Nitrocine


1. Name Of The Medicinal Product

Nitrocine 1mg/ml, solution for infusion

2. Qualitative And Quantitative Composition

Ampoules containing 10 mg glyceryl trinitrate in 10 ml, or as glass bottles containing 50 mg glyceryl trinitrate in 50 ml.

For excipients see 6.1.

3. Pharmaceutical Form

Isotonic sterile solution for infusion

4. Clinical Particulars 4.1 Therapeutic Indications

Surgery:

Nitrocine is indicated for:

1. the rapid control of hypertension during cardiac surgery.

2. reducing blood pressure and maintaining controlled hypotension during surgical procedures.

3. controlling myocardial ischaemia during and after cardiovascular surgery.

Unresponsive congestive heart failure:

Nitrocine may be used to treat unresponsive congestive heart failure secondary to acute myocardial infarction.

Unstable angina:

Nitrocine may be used to treat unstable angina, which is refractory to treatment with beta blockers and sublingual nitrates.

4.2 Posology And Method Of Administration

Adults and Elderly

The dose of Nitrocine should be adjusted to meet the individual needs of the patient.

The recommended dosage range is 10 - 200 mcg/min but up to 400 mcg/min may be necessary during some surgical procedures.

Children:

The safety and efficacy of Nitrocine has not yet been established in children.

Surgery:

A starting dose of 25 mcg/min is recommended for the control of hypertension, or to produce hypotension during surgery. This may be increased by increments of 25 mcg/min at 5 minute intervals until the blood pressure is stabilized. Doses between 10 - 200 mcg/min are usually sufficient during surgery, although doses of up to 400 mcg/min have been required in some cases.

The treatment of perioperative myocardial ischaemia may be started with a dose of 15 - 20 mcg/min, with subsequent increments of 10 - 15 mcg/min until the required effect is obtained.

Unresponsive congestive heart failure:

The recommended starting dose is 20 - 25 mcg/min. This may be decreased to 10 mcg/min, or increased in steps of 20-25 mcg/min every 15 - 30 minutes until the desired effect is obtained.

Unstable angina:

An initial dose of 10 mcg/min is recommended with increments of 10mcg/min being made at approximately 30 minute intervals according to the needs of the patient.

Administration

Nitrocine can be administered undiluted by slow intravenous infusion using a syringe pump incorporating a glass or rigid plastic syringe.

Alternatively, Nitrocine may be administered intravenously as an admixture using a suitable vehicle such as Sodium Chloride Injection B.P. or Dextrose Injection B.P.

Prepared admixtures should be given by intravenous infusion or with the aid of a syringe pump to ensure a constant rate of infusion.

During Nitrocine administration there should be close haemodynamic monitoring of the patient.

Example of admixture preparation

To obtain an admixture of GTN at a concentration of 100 mcg/ml, add 50 ml Nitrocine solution (containing 50 mg glyceryl trinitrate) to 450 ml of infusion vehicle to give a final volume of 500 ml.

A dosage of 100 mcg/min. can be obtained by giving 60 ml of the admixture per hour. This is equivalent to a drip rate of 60 paediatric microdrops per minute or 20 standard drops per minute. At this drip rate the admixture provides enough solution for an infusion time of 8 hours 20 minutes.

For full details it is advisable to consult the dosage chart on the package insert.

Bottles of Nitrocine are for single use only and should not be regarded as multi-dose containers.

4.3 Contraindications

Nitrocine should not be used in the following cases:

Known hypersensitivity to nitrates, marked anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia or severe hypotension.

As the safety of Nitrocine during pregnancy and lactation has not yet been established, it should not be used unless considered absolutely essential.

Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.

4.4 Special Warnings And Precautions For Use

Close attention to pulse and blood pressure is necessary during the administration of Nitrocine infusions.

Nitrocine should be used with caution in patients suffering from hypothyroidism, severe liver or renal disease, hypothermia and malnutrition.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent intake of drugs with blood pressure lowering properties e.g. beta blockers, calcium antagonists, vasodilators etc. and/or alcohol may potentiate the hypotensive effect of Nitrocine. The hypotensive effect of nitrates are potentiated by concurrent administration of sildenafil (Viagra®). This might also occur with neuroleptics and tricyclic antidepressants.

4.6 Pregnancy And Lactation

There is no, or inadequate, evidence of safety of the drug in human pregnancy or lactation, but it has been in widespread use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, this product can be used if there is no safer alternative.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In common with other nitrates, headaches and nausea may occur during administration. Other possible adverse reactions include hypotension, tachycardia, retching, diaphoresis, apprehension, restlessness, muscle twitching, retrosternal discomfort, palpitations, dizziness and abdominal pain. Paradoxical bradycardia has also been observed.

4.9 Overdose

Mild overdose usually results in hypotension and tachycardia. If arterial systolic blood pressure drops below 90 mmHg and if heart rate increases 10% above its initial value, the infusion should be discontinued to allow a return to pre-treatment levels. If hypotension persists, or in more severe cases, this may be reversed by elevating the legs and/or treatment with hypertensive agents.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: C01DA 02 – Organic Nitrates

Glyceryl trinitrate reduces the tone of vascular smooth muscle. This action is more marked on the venous capacitance vessels than the arterial vessels. There is a reduction in venous return to the heart and a lowering of elevated filling pressure. This lowering of filling pressure reduces the left ventricular end diastolic volume and preload. The net effect is a lowering of myocardial oxygen consumption.

Systemic vascular resistance, pulmonary vascular pressure and arterial pressure are also reduced by glyceryl trinitrate and there is a net reduction in the afterload.

By reducing the preload and afterload, glyceryl trinitrate reduces the workload on the heart.

Glyceryl trinitrate affects oxygen supply by redistributing blood flow along collateral channels from the epicardial to endocardial regions.

5.2 Pharmacokinetic Properties

As with all commonly used organic nitrates the metabolic degradation of glyceryl trinitrate occurs via denitration and glucuronidation. The less active metabolites resulting from this biotransformation can be recovered from the urine within 24 hours.

Glyceryl trinitrate is eliminated from plasma with a short half-life of about 2-3 minutes. This rapid disappearance from plasma is consistent with the high systemic clearance values for this drug (up to 3270 L/hour)

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glucose

Propylene glycol

Water for injection.

Hydrochloric acid (for pH adjustment)

6.2 Incompatibilities

Nitrocine contains glyceryl trinitrate in isotonic sterile solution and is compatible with commonly employed infusion solutions. No incompatibilities have so far been demonstrated.

Nitrocine is compatible with glass infusion bottles and with rigid infusion packs made of polyethylene. Nitrocine may also be infused slowly using a syringe pump with a glass or plastic syringe.

Nitrocine is incompatible with polyvinylchloride (PVC) and severe losses of glyceryl trinitrate (over 40%) may occur if this material is used. Contact with polyvinylchloride bags should be avoided. Polyurethane also induces a loss of the active ingredient.

6.3 Shelf Life

Glass ampoules 5 years

Glass vials 5 years

For admixture shelf life, refer to section 6.4.

6.4 Special Precautions For Storage

Chemical and physical in-use stability of the admixture has been demonstrated for 24 hours at 25?C in suitable containers.

From a microbiological point of view, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8?C, unless dilution has taken place in controlled and validated aseptic conditions.

6.5 Nature And Contents Of Container

Glass ampoules 10 ml (Type I glass)

Glass, rubber stoppered vials 50 ml (Type II glass)

6.6 Special Precautions For Disposal And Other Handling

Bottles of Nitrocine are for single use only and should not be regarded as multi-dose containers.

Admixtures are prepared by replacing a given volume of infusion vehicle with an equal volume of the product to produce the final infusion solution. For admixture storage, refer to section 6.4.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00039/0747

9. Date Of First Authorisation/Renewal Of The Authorisation

21 January 2009

10. Date Of Revision Of The Text


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Human Albumin Biotest 5%


Human Albumin Biotest 5%, solution for infusion

Human albumin

Read this entire leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Human Albumin Biotest 5% is and what it is used for
2. Before you are given Human Albumin Biotest 5%
3. How you are given Human Albumin Biotest 5%
4. Possible side effects
5. How to store Human Albumin Biotest 5%
6. Further information

What Human Albumin Biotest 5% Is And What It Is Used For

Human Albumin Biotest 5% is a solution for infusion (into a vein). 1000 ml solution contains 50 g human plasma protein of which at least 95% is human albumin.

Human Albumin Biotest 5% is used to restore and maintain circulating blood volume where there is a low blood volume and the use of a colloid, such as albumin, is required.

Before You Are Given Human Albumin Biotest 5% You will not receive Human Albumin Biotest 5% if: you are allergic (hypersensitive) to albumin preparations or to any of the other ingredients (these are listed in section 6 of this leaflet). Special care will be taken with Human Albumin Biotest 5%:

Suspicion of allergic or anaphylactic type reactions requires immediate stopping of the injection. In case of shock, standard medical treatment for shock should be applied.

The infusion will also be stopped if you develop any of the following conditions as a sign of cardiovascular overload (hypervolaemia):

headache dyspnoea (difficulties in breathing) jugular vein congestion (a build up of fluid in a neck vein) increased blood pressure raised venous pressure (increased pressure in the veins) pulmonary oedema (water on the lungs) You should tell your doctor if you suffer from any of the following conditions: Decompensated cardiac insufficiency (heart failure) Hypertension (high blood pressure) Oesophageal varices (enlarged veins in the gullet) Pulmonary oedema (water on the lungs) Haemorrhagic diathesis (tendency to abnormal or spontaneous bleeding) Severe anaemia (reduced red blood cells) Renal and post-renal anuria (decreased or absent urine production)

He/She will take the appropriate precautions. You will also be monitored by your doctor to check your circulatory situation with the electrolyte balance and blood volume.

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time you receive a dose of Human Albumin Biotest 5% the name and batch number of the product are recorded in order to maintain a record of the batches used.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines including any that you may have bought without a prescription from a chemist or supermarket.

Pregnancy and breast-feeding

If you are pregnant, planning a family, or breast-feeding ask your doctor or pharmacist for advice before taking any medicine. If you have already told your doctor then follow any instructions that may have been given to you.

Driving and using machines

Human Albumin Biotest 5% has no known effects on the ability to drive or use machines.

How You Are Given Human Albumin Biotest 5%

Human Albumin Biotest 5% treatment will usually be given in hospital by a doctor or a nurse.

Human albumin can be given directly into a vein.

Dosage and Frequency of Administration

The amount of Human Albumin Biotest 5% you receive depends on your size, the illness, and on fluid or protein losses.

Your doctor will calculate the dose of Human Albumin Biotest 5% and how often you will receive it to obtain the correct levels in your blood.

If you are given more Human Albumin Biotest 5% than you should

This is very unlikely but your doctor will know what to do if this happens.

If you have any further questions on the use of the product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Human Albumin Biotest 5% can cause side effects, although not everybody gets them.

The following side effects have been reported:

flush, urticaria (nettle rash), fever and nausea (feeling sick).

These occur rarely.

Very rarely, severe reactions such as shock may occur. If this happens the infusion will be stopped and the appropriate treatment will be started.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Human Albumin Biotest 5%

Human Albumin Biotest 5% should be kept in the outer carton to protect it from light.

Human Albumin Biotest 5% should not be stored above 25?C.

Do not freeze. Keep out of the reach and sight of children.

Do not use Human Albumin Biotest 5% after the expiry date which is stated on label and outer carton. The expiry date refers to the last day of that month.

The product, once opened, should be used immediately.

Immediately before administration, check that the solution is clear. The product must not be used if any cloudiness or particles are visible.

Medicines should not be disposed of via wastewater or household water. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Human Albumin Biotest 5% contains:

Each vial with 250 ml solution contains 12.5 g of human plasma protein.

It also contains the other ingredients caprylate, N-acetyl-DL-tryptophanate, sodium ions, and water for injections.

What Human Albumin Biotest 5% looks like and contents of the pack

A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

Glass vial with 250 ml

Marketing Authorisation Holder and Manufacturer Biotest Pharma GmbH Landsteinerstra?e 5 63303 Dreieich Germany Tel.: +49 6103 801-0 Fax: +49 6103 801-150 und -727
[email protected]

For any information about this medicine, please contact your local representative of the Marketing Authorisation Holder:

Biotest (UK) Ltd. 28 Monkspath Business Park Highlands Road Shirley Solihull West Midlands B90 4NZ Tel:+44(0)121 733 3393 Fax:+44(0)121 733 3066
[email protected]

PL 04500/0011

POM

This medicinal product is authorised in the Member States of the EU under the following trade names:

Austria: Albiomin 50 g/l
Germany: Albiomin 5% (50 g/l)
Hungary: Human Albumin Biotest 50 g/l
Italy: Albiomin 5% (50 g/l)
Romania: Albiomin 5% (50 g/l)
Spain: Albiomin 5% (50 g/l)
UK: Human Albumin Biotest 5%

This leaflet was last approved in February 2009.


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Human Albumin Biotest 5%


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