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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In the US, Isopto Carbachol (carbachol ophthalmic) is a member of the drug class ophthalmic glaucoma agents and is used to treat Glaucoma, Intraocular Hypertension and Production of Miosis.

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Boots Pharmacy Anaesthetic Throat Spray


Boots Pharmacy Anaesthetic Throat Spray

(Lidocaine Hydrochloride)

Specifically to:

Relieve severe sore throat pain

20 ml e

Read all of this carton for full instructions.

A local anaesthetic spray to provide direct and soothing relief from the pain of severe sore throats.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you have asthma, or difficulty breathing If you are under 12 years of age Talk to your pharmacist or doctor: If you are receiving any medical treatment If you have a high fever, headache, feel sick or are being sick as well as having a sore throat If you are pregnant or breastfeeding

This spray may cause your tongue to become numb. You must take care when eating or drinking hot foods or drinks.

How to use this medicine

Use at the back of the throat only.

Do not breathe in when you use the spray, or get the spray in your eyes.

To spray: Swing the nozzle through 90° and press.

Before first use or after storing the spray for a long time: Press the spray 3 times away from the face into a sink.

Adults and children of 12 years and over
Three sprays at the back of the throat every 3 hours, if you need to.
Don’t use more than 6 times in any 24 hours.

Do not use for children under 12 years.

Do not use more than the amount recommended above.

If you use too much:

Talk to a doctor straight away. Take your medicine with you.

If symptoms do not go away, talk to your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop using the spray.

See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the side of the carton.

Active ingredient

This liquid contains Lidocaine Hydrochloride 2% w/v.

Also contains: purified water, ethanol (30 vol %), sorbitol (E420), sodium citrate, saccharin, quinoline yellow (E104), patent blue V (E131), flavours (peppermint, levomenthol, aniseed).

PL00014/0430

P

Text prepared 10/07

Manufactured for the Marketing Authorisation holder Boots Pharmacy Nottingham NG2 3AA

by

The Boots Company PLC Nottingham NG2 3AA

Contains approximately 150 sprays.

If you need more advice ask your pharmacist.

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1. Name Of The Medicinal Product

Diprobase Cream

2. Qualitative And Quantitative Composition

No pharmacologically active components.

3. Pharmaceutical Form

Cream

4. Clinical Particulars 4.1 Therapeutic Indications

Diprobase Cream is an emollient, moisturising and protective cream for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Diprobase Cream is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.

4.2 Posology And Method Of Administration

Adults and Children:

The cream should be applied to the dry skin areas as often as is required and rubbed well into the skin.

4.3 Contraindications

There are no absolute contraindications to the use of the cream other than hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

None stated.

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

Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.

4.9 Overdose

None stated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Diprobase Cream contains no active ingredients and has no pharmacological action. The ingredients provide emollient, moisturising action on dry or chapped skin.

5.2 Pharmacokinetic Properties

Not applicable due to topical administration and direct action on the skin.

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 SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Chlorocresol

Macrogol Cetostearyl Ether (Cetomacrogol)

Cetostearyl alcohol

Liquid paraffin

White soft paraffin

Phosphoric acid

Sodium dihydrogen phosphate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

15, 50 and 100gm aluminium tubes - 60 months

500gm pump presentations – 36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

50, 100 and 15gm aluminium epoxy lined membrane tubes with plastic caps.

500gm polypropylene piston pack with polyethylene cap and daplen pump, disc and tube or PVC cap, polypropylene pump, polyolefin disc and HDPE tube or

500gm polypropylene jar (container) with a polypropylene dispenser head and cover, the pump system consists of a polyethylene follower plate, a polypropylene pump cylinder, a polyethylene piston with a glass and a polypropylene valve.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU, UK

8. Marketing Authorisation Number(S)

PL 00025/0575

9. Date Of First Authorisation/Renewal Of The Authorisation

12 April 1996 / 12 April 2001

10. Date Of Revision Of The Text

21 March 2011

11 LEGAL CATEGORY

GSL

© Merck Sharp & Dohme Limited 2011. All rights reserved.

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1. Name Of The Medicinal Product

Potaba®(Potassium para-aminobenzoate)

2. Qualitative And Quantitative Composition

Capsules: white/white gelatin capsule shell containing the active ingredient 500mg of potassium para-aminobenzoate powder.

3. Pharmaceutical Form

Capsules: White/white size zero gelatin capsules containing 500mg potassium para-aminobenzoate with Potaba 51 on the shell.

4. Clinical Particulars 4.1 Therapeutic Indications

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Scleroderma

4.2 Posology And Method Of Administration

Potaba capsules should be taken orally; six capsules four times daily with food.

Children: not recommended.

4.3 Contraindications

Potaba should not be given to patients taking sulphonamides as it will inactivate this medication.

4.4 Special Warnings And Precautions For Use

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Potaba treatment should be given cautiously to patients with renal impairment and treatment discontinued if a hypersensitivity reaction occurs.

Potaba should not be taken by patients on sulphonamides; Potaba may cause inactivation of this medication.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

With the exception of sulphonamides, no interactions with other medicaments have been established.

4.6 Pregnancy And Lactation

No information is available on this, therefore it is not recommended.

4.7 Effects On Ability To Drive And Use Machines

There is no evidence that Potaba has any effect on ability to drive or use machines.

4.8 Undesirable Effects

Treatment with Potaba should be interrupted during periods of low food intake,(e.g. during fasting, anorexia, nausea).This is to avoid the possible development of hypoglycaemia.

No serious adverse effects have been reported in patients treated with Potaba.

4.9 Overdose

No particular problems are expected following overdosage with Potaba. Symptomatic and supportive therapy should be given as appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

P.Aminobenzoate is considered a member of the Vitamin B complex. Small amounts are found in cereal, eggs, milk and meats. Detectable amounts are normally present in human blood, spinal fluid, urine and sweat. The pharmacological action of this chemical has not been clearly established, but it has been suggested that the antifibrosis activity of Potaba is brought about by the drug increasing oxygen uptake at the tissue level. Fibrosis is believed to occur from either too much serotonin or too little monoamine oxidase activity over a period of time. The activity of monoamine oxidase is dependant on an adequate oxygen supply. By increasing oxygen supply at tissue level Potaba enhances monoamine oxidase activity thereby preventing or bringing about regression of fibrosis.

5.2 Pharmacokinetic Properties

Potaba is rapidly absorbed and metabolised as food. Excretion is through renal function.

5.3 Preclinical Safety Data

N/A

6. Pharmaceutical Particulars 6.1 List Of Excipients

None

6.2 Incompatibilities

Sulphonamides.

6.3 Shelf Life

Capsules: three years from date of manufacture.

6.4 Special Precautions For Storage

Store below 25?C.

6.5 Nature And Contents Of Container

.

White polypropylene tube with tamper-evident polyethylene cap. A filla may be inserted to reduce ullage.

Containers of 240 x 500mg capsules.

6.6 Special Precautions For Disposal And Other Handling 7. Marketing Authorisation Holder

Glenwood Laboratories Ltd. ,

Jenkins Dale,

Chatham

Kent ME4 5RD

8. Marketing Authorisation Number(S)

Potaba Capsules: 00245/5001R

9. Date Of First Authorisation/Renewal Of The Authorisation

March 1998

10. Date Of Revision Of The Text

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