gabapentin



Generic Name: clozapine (KLOE za peen)



Generic Name: amphotericin B (am foe TER i sin)



1. Name Of The Medicinal Product

Furadantin® tablets 100mg

Nitrofurantoin 100mg tablets

2. Qualitative And Quantitative Composition

Furadantin tablets contain 100mg Nitrofurantoin Ph Eur.

3. Pharmaceutical Form

Furadantin tablets are yellow and pentagonal. Each tablet has a break line on one face and the tablet strength on the opposite face.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections, when due to susceptible strains of Escherichia co/i, Enterococci, Staphylococci, Citrobacter, Kiebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days

Severe Chronic Recurrence: 100mg four times day for seven days

Long Term Suppression: 50mg - 100mg once a day.

Pophylaxis: 50mg four times daily for the duration of procedure and 3 days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days.

Suppressive: 1mg/kg, once a day.

For children under 25kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (Section 4.8).

4.3 Contraindications

Patients suffering from renal dysfunction with a creatinine clearance of less than 60ml/minute or elevated serum creatinine.

In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the new-born infant, due to immature erythrocyte enzyme systems.

Patients with known hypersensitivity to Nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy, which may become severe or irreversible, has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesiae).

Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary condition of patients receiving long-term therapy is warranted (especially in the elderly).

Patients should be monitored closely for signs of hepatitis (particularly in long-term use). Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (If tested for reducing substances)

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine

4.6 Pregnancy And Lactation

Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for specific indication, only after careful assessment.

Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells. Caution should be exercised while breast-feeding an infant known or suspected to have an erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

4.8 Undesirable Effects

Respiratory

If any of the following respiratory reactions occur the drug should be discontinued.

Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.

Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.

Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely. Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

Neurological

Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

Gastrointestinal

Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritis have occurred.

Lupus-like syndrome associated with pulmonary reactions to Nitrofurantoin has been reported.

Exfoliative dermatitis and erythema multiforme (including Stevens- Johnson Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur.

However, these are limited to the genitourinary tract because suppression of normal bacterial flora does not occur elsewhere in the body.

4.9 Overdose

Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furadantin is a broad-spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin. Most strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.

5.2 Pharmacokinetic Properties

Orally administered Nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations at therapeutic dosages are usually low with an elimination half-life of about 30 minutes.

Maximum urinary excretion usually occurs 2-4 hours after administration of Nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained.

5.3 Preclinical Safety Data

Carcinogenic effect of Nitrofurantoin in animal studies was observed. However, human data and extensive use of Nitrofurantoin over 50 years do not support such observation.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Furadantin tablets also contain lactose, maize starch, talc, alginic acid and magnesium stearate and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

The tablets are packaged in light-proof and moisture-resistant containers. Storage temperatures must not exceed 25°C.

6.5 Nature And Contents Of Container

Furadantin tablets are supplied in packs of 30 and 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Used as directed by physician. A Patient Information Leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom.

8. Marketing Authorisation Number(S)

PL 12762/0051 (100mg tablets)

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000.

10. Date Of Revision Of The Text

13/08/2010



Famciclovir 125mg, 250mg, 500mg, 750mg film-coated tablets

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 famciclovir is and what it is used for 2. Before you use famciclovir 3. How to use famciclovir 4. Possible side effects 5. How to store famciclovir 6. Further information What Famciclovir Is And What It Is Used For

Famciclovir belongs to a group of medicines called antiviral agents. These are medicines used in the treatment of infections caused by viruses.

Famciclovir is used in patients with a normal immune system to treat attacks of genital herpes. Genital herpes is a viral infection which is normally spread by sexual contact. It causes blisters and burning around your genitals, which may be painful.

It is also sometimes used to prevent further episodes of genital herpes in patients with a normal immune system.

Famciclovir is used in the treatment of shingles in both patients with a normal immune system and in patients with a weakened immune system. Shingles is caused by a virus called herpes zoster or varicella zoster.

It is used in the treatment of herpes zoster infections of the eye in patients with a normal immune system.

Famciclovir is used in patients with a weakened immune system for the treatment of infections caused by herpes simplex virus, such as genital herpes or fever blisters (herpes labialis).

Before You Use Famciclovir Do not use famciclovir if you are allergic (hypersensitive) to famciclovir, penciclovir or any of the other ingredients of famciclovir. Take special care with famciclovir if you have kidney problems. You should talk with your doctor before you begin treatment with famciclovir, as it may be necessary to adjust your dosage.

As genital herpes is a sexually transmitted disease, you should avoid sexual activity if you have any symptoms of herpes, even if you have started treatment, to reduce the risk of spreading the disease to your partner. You should also take appropriate steps for protected intercourse if you are on long-term treatment with famciclovir for the same reason. Patients should therefore take appropriate steps for protected intercourse (i.e. use condoms).

Consult your doctor if one of the above-mentioned warnings applies to you, or has applied to you in the past.

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.

If you are taking other medicines at the same time as famciclovir, these medicines may interfere with each other. This might be harmful. The effects of the medicines could be increased or diminished and side effects could occur more easily.

In particular this applies to:

probenecid, a medicine against viruses and gout some painkillers such as acetylsalicylic acid and ibuprofen Using famciclovir with food and drink

Famciclovir can be taken with or without food. Swallow the tablets with water.

Pregnancy and breast-feeding

Pregnancy

It is not known if it is safe to use famciclovir during pregnancy. Famciclovir must not be used during pregnancy, unless it is absolutely necessary and only in accordance with your doctor's instructions.

Breast-feeding

There is limited experience with famciclovir in breast-feeding women. Therefore, it should not be used during breast-feeding unless you are directly instructed to do so by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

In rare instances, use of famciclovir may have side effects, such as dizziness, drowsiness and confusion.

If you experience any such side effects then do not drive or operate machinery.

How To Use Famciclovir

Always use famciclovir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Treatment with famciclovir should start as soon as possible after the symptoms of eruption/rash appear.

You should keep taking the medicine even if there is no improvement, as it may take several days for the medicine to work.

Keep taking the tablets until you have used the whole pack, unless your doctor has given you other instructions. Use lower dosage strength tablets, where these are available.

Adults

Recurrent genital herpes infection in patients with a normal immune system: 250mg twice daily.

In the treatment of genital herpes, you should start taking famciclovir as soon as possible after the occurrence of the first symptoms (pain, burning sensation, blisters).

First outbreak of genital herpes in patients with a normal immune system: 250mg three times daily.

In the treatment of genital herpes, you should start taking famciclovir as soon as possible after the occurrence of the first symptoms (pain, burning sensation, blisters).

Prevention of further recurrences of genital herpes in patients with a normal immune system: one 250mg tablet twice daily.

Prevention of recurring outbreak of genital herpes in HIV patients: 500mg twice daily.

Genital herpes infection in patients with a weakened immune system: 500mg twice daily.

In the treatment of genital herpes, you should start taking famciclovir as soon as possible after the occurrence of the first symptoms (pain, burning sensation, blisters).

Fever blisters in patients with a weakened immune system: 500mg twice daily.

In the treatment of a fever blister (herpes labialis), you should start taking famciclovir as soon as possible after the occurrence of the first symptoms of the infection (pain, burning sensation, blisters).

Shingles in patients with a normal immune system: 500mg three times daily.

In the treatment of shingles (herpes zoster), you should start taking famciclovir as soon as possible (within 48 hours) after the occurrence of the first symptoms of the infection (rash).

Herpes zoster infection of the eye in patients with a normal immune system: 500mg three times daily or 750mg twice daily* for 7 days.

* Only relevant for the 750mg strength.

Shingles in patients with a weakened immune system: 500mg three times daily.

In the treatment of shingles (herpes zoster), you should start taking famciclovir as soon as possible (within 48 hours) after the occurrence of the first symptoms of the infection (rash).

Patients with kidney problems

Depending on how severely the function of your kidneys is affected, your doctor may reduce the dose of famciclovir you must take.

Elderly patients

Your doctor may adjust your dosage of famciclovir according to your kidney function.

Children

Famciclovir is not recommended for use in children below 18 years of age due to lack of data on safety and efficacy.

Duration of treatment

Treatment of genital herpes in patients with a normal immune system: 5 days.

Treatment of genital herpes in patients with a weakened immune system: 7 days.

Prevention of recurrence of genital herpes in patients with a normal immune system: 6-12 months. You should only take famciclovir for as long as your doctor has told you.

Shingles in patients with a normal immune system: 7 days.

Shingles in patients with a weakened immune system: 10 days.

Fever blisters in patients with a weakened immune system: 7 days.

If you use more famciclovir than you should

Contact your doctor or pharmacist if you have taken more famciclovir than stated in this leaflet, or more than the doctor has prescribed.

Rarely, acute kidney failure has occurred in patients with existing kidney disease when the dose of famciclovir was not adjusted accordingly.

If you forget to use famciclovir

If you forget to take the medicine, take it as soon as you remember, or skip the forgotten tablet if it is time for your next dose. Then continue taking the tablets as normal.

Do not take a double dose to make up for a forgotten dose. If you have forgotten several doses, you should contact your doctor.

If you stop using famciclovir

Do not stop taking famciclovir without consulting your doctor first.

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

Possible Side Effects

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

The following side effects may occur:

Common side effects (occur in 1 to 10 users in 100)

Headache Nausea, diarrhoea, vomiting, abdominal pain, constipation Increased sweating Itching

Rare side effects (occur in 1 to 10 users in 10,000)

Confusion (mainly in elderly patients)

Very rare effects (occur in less than 1 user in 10,000)

Blood disorders (shortage of blood cells, called blood platelets that help blood to clot) accompanied by bruises and proneness to bleeding (so-called thrombocytopenia) Hallucinations (seeing and hearing things that are not really there) Dizziness, fatigue (tiredness), drowsiness (primarily in elderly patients) Yellowing of the skin and eyes (jaundice) Abnormal liver function tests Severe skin reactions, such as serious allergic reactions (hypersensitivity) with (high) temperature, dark red patches on the skin, joint pains and/or eye infections (so-called Stevens-Johnson syndrome), acute severe (hypersensitivity) reactions associated with fever and blisters on the skin, shedding of skin (so-called toxic epidermal necrolysis) or rash with reddish (weeping) irregular patches (so-called erythema multiforme); rash, nettle rash

Not known (cannot be estimated from the available data)

Fever

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 Famciclovir

Keep out of the reach and sight of children.

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use famciclovir after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 Famciclovir Tablets contain

The active substance is famciclovir.

125mg tablet: each tablet contains 125mg of famciclovir.

250mg tablet: each tablet contains 250mg of famciclovir.

500mg tablet: each tablet contains 500mg of famciclovir.

750mg tablet: each tablet contains 750mg of famciclovir.

The other ingredients are:

Tablet core: Starch Pregelatinised, Sodium Laurilsulfate, Cellulose, Microcrystalline, Croscarmellose Sodium, Silica Colloidal Anhydrous, Stearic acid.

Film-coating:

Hypromellose (E464), Titanium Dioxide (E171), Macrogol 4000, Macrogol 6000.

What Famciclovir Tablets look like and contents of the pack

125mg film-coated tablets: white, round, biconvex, film-coated tablets with diameter of 7.6mm approximately.

250mg film-coated tablets: white, round, biconvex, film-coated tablets, scored on one side with diameter of 10.6mm approximately.

500mg film-coated tablets: white, oval, film-coated tablets, scored on both sides with dimensions of 18.2 x 8.6mm approximately.

750mg film-coated tablets: white, oval, film-coated tablets with dimensions of 20.5 x 9.8mm approximately.

250mg and 500mg film-coated tablets: The tablet can be divided into equal halves. Use lower strength tablets where these are available.

Famciclovir Tablets are available in blister packs of:

125mg: 10 tablets



Pronunciation: floo-TIK-a-sone



Pronunciation: FLOO-droe-KOR-ti-sone



Definition of Fibromatosis:

1. A condition characterised by the occurrence of multiple fibromas, with a relatively large distribution.

2. Abnormal hyperplasia of fibrous tissue.

Drugs associated with Fibromatosis

The following drugs and medications are in some way related to, or used in the treatment of Fibromatosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Fibromatosis Dupuytren's contracture (1 drug)



Generic Name: iron supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Beef,Iron & Wine Bifera Elite Iron Femiron Feosol Fergon Ferrex 150 Hemocyte

In Canada

Fer-In-Sol Palafer Pms-Ferrous Sulfate

Available Dosage Forms:

Tablet, Chewable Liquid Tablet Capsule Solution Tablet, Enteric Coated Tablet, Extended Release Suspension Syrup Capsule, Extended Release Elixir Capsule, Liquid Filled Uses For Fer-In-Sol

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

Bleeding problems Burns Hemodialysis Intestinal diseases Stomach problems Stomach removal Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

Increased need for iron supplements should be determined by your health care professional.

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Iron is found in the diet in two forms—heme iron, which is well absorbed, and nonheme iron, which is poorly absorbed. The best dietary source of absorbable (heme) iron is lean red meat. Chicken, turkey, and fish are also sources of iron, but they contain less than red meat. Cereals, beans, and some vegetables contain poorly absorbed (nonheme) iron. Foods rich in vitamin C (e.g., citrus fruits and fresh vegetables), eaten with small amounts of heme iron-containing foods, such as meat, may increase the amount of nonheme iron absorbed from cereals, beans, and other vegetables. Some foods (e.g., milk, eggs, spinach, fiber-containing, coffee, tea) may decrease the amount of nonheme iron absorbed from foods. Additional iron may be added to food from cooking in iron pots.

The daily amount of iron needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for iron are generally defined as follows (Note that the RDA and RNI are expressed as an actual amount of iron, which is referred to as “elemental”' iron. The product form [e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate] has a different strength):

Persons U.S.



fos-a-PRE-pi-tant dye-MEG-loo-meen

Commonly used brand name(s)

In the U.S.

Emend

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Fosaprepitant

Uses For fosaprepitant

Fosaprepitant is used with other medicines to prevent nausea and vomiting caused by cancer treatment (chemotherapy). It acts in the brain to prevent nausea.

fosaprepitant is available only with your doctor's prescription.

Before Using fosaprepitant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fosaprepitant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fosaprepitant or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fosaprepitant in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fosaprepitant in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving fosaprepitant, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fosaprepitant with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Astemizole Cisapride Pimozide Terfenadine

Using fosaprepitant with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Etoposide Ifosfamide Imatinib Irinotecan Paclitaxel Vinblastine Vincristine

Using fosaprepitant with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam Desogestrel Dexamethasone Dienogest Diltiazem Drospirenone Estradiol Cypionate Estradiol Valerate Ethinyl Estradiol Ethynodiol Diacetate Etonogestrel Ketoconazole Levonorgestrel Medroxyprogesterone Acetate Mestranol Midazolam Norelgestromin Norethindrone Norgestimate Norgestrel Rifampin Tolbutamide Triazolam Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of fosaprepitant

A nurse or other trained health professional will give you fosaprepitant in a hospital or clinic. fosaprepitant is given through a needle placed in one of your veins.

fosaprepitant is usually given on the first day of your chemotherapy as part of a three-day regimen along with other medicines. Fosaprepitant is not for long-term use, but you may need to use fosaprepitant again if you have more chemotherapy in the future.

fosaprepitant comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using fosaprepitant

It is very important that your doctor check your progress at regular visits to make sure fosaprepitant is working properly and to check for unwanted effects.

You should not receive fosaprepitant if you are also using cisapride (Propulsid®) or pimozide (Orap®). Fosaprepitant may cause serious or life-threatening problems if used together with these medicines.

fosaprepitant may cause serious allergic reactions. Tell your doctor or nurse right away if you have itching; hives; a rash; shortness of breath; trouble with breathing; trouble with swallowing; warmth or redness in your face, neck, arms, or upper chest; or any swelling of your hands, face, or mouth while you are receiving fosaprepitant.

If you are also taking a blood thinner called warfarin (Coumadin®, Jantoven®), your doctor will need to check your blood after using fosaprepitant.

Birth control pills may not work as well while you are using fosaprepitant. To keep from getting pregnant, use another form of birth control together with your pills during treatment and for one month after your last treatment. Other forms include condoms, diaphragms, and contraceptive foams or jellies.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

fosaprepitant Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Black, tarry stools blurred vision chills confusion cough decreased urination difficult or labored breathing dizziness dry mouth fainting fever increase in heart rate lightheadedness lower back or side pain nervousness pain, swelling, or redness at the injection site painful or difficult urination pale skin pounding in the ears rapid breathing shortness of breath slow or fast heartbeat sore throat sunken eyes tenderness, swelling, warmth, or skin discoloration at the injection site thirst tightness in the chest ulcers, sores, or white spots in mouth unusual bleeding or bruising unusual tiredness or weakness wheezing wrinkled skin Less common Hard lump at the injection site Rare Blood in the urine changes in patterns and rhythms of speech changes in skin color chest pain or discomfort coma convulsions fast, slow, irregular, pounding, or racing heartbeat or pulse general feeling of discomfort or illness headache increased sweating increased thirst lightheadedness, dizziness, or fainting muscle pain or cramps nausea or vomiting pain, tenderness, or swelling of the foot or leg slurred speech swelling swelling of the face, ankles, or hands trouble with speaking troubled breathing with exertion wheezing Incidence not known Difficulty with swallowing hives or welts itching large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Acid or sour stomach belching burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings continuing ringing or buzzing or other unexplained noise in ears diarrhea difficulty having a bowel movement (stool) dizziness feeling of indigestion hair loss or thinning of the hair hearing loss hiccups indigestion lack or loss of strength loss of appetite pain in the chest below the breastbone stomach discomfort, upset, or pain swelling or inflammation of the mouth weight loss Less common Feeling of warmth pain or discomfort in chest, upper stomach, or throat redness of the face, neck, arms, and occasionally, upper chest sudden sweating unusually warm skin Rare Abdominal or stomach distension or pain abnormal dreams blemishes on the skin bumps on the skin burning, dry, or itching eyes change in taste change in walking and balance clumsiness or unsteadiness confusion about identity, place, and time difficulty with moving discharge, excessive tearing excess air or gas in the stomach extreme thirst false or unusual sense of well-being flushed, dry skin frequent urination fruit-like breath odor full feeling heartburn increased hunger increased sensitivity of the skin to sunlight increased urination increased volume of pale, dilute urine joint pain muscle aching or cramping muscle stiffness or weakness oily skin passing gas pimples redness or other discoloration of the skin redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid severe constipation severe sunburn sleepiness sleeplessness sweating swollen joints trouble performing routine tasks trouble sleeping unable to sleep unexplained weight loss unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness weight gain white patches in the mouth or throat or on the tongue white patches with diaper rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: fosaprepitant Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More fosaprepitant Intravenous resources Fosaprepitant Intravenous Side Effects (in more detail) Fosaprepitant Intravenous Use in Pregnancy & Breastfeeding Fosaprepitant Intravenous Drug Interactions Fosaprepitant Intravenous Support Group 0 Reviews for Fosaprepitant Intravenous - Add your own review/rating Compare fosaprepitant Intravenous with other medications Nausea/Vomiting, Chemotherapy Induced



1. Name Of The Medicinal Product

Furosemide 20mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 20mg furosemide.

For excipients, see 6.1

3. Pharmaceutical Form

Tablet.

Appearance: A white, circular, flat bevelled edge tablet with 'F' scoreline 20' embossed on one face and plain on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

In the treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome.

In the treatment of peripheral oedema due to mild to moderate hypertension (alone, or in combination with other antihypertensive agents in the treatment of more severe cases).

Management of oliguria due to acute or chronic renal insufficiency.

4.2 Posology And Method Of Administration

Adults: The usual initial daily dose is 40mg. This may require adjustment until the effective dose is achieved. In mild cases 20mg daily or 40mg on alternate days may be sufficient, whereas in cases of resistant oedema daily doses of 80mg and above may be used.

In patients with chronic renal insufficiency, an initial daily dose of 250mg is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250mg at four to six hourly intervals up to a maximum daily dose of 1,500 mg in 24 hours. In exceptional cases up to 2,000 mg in 24 hours may be given.

Children: The oral dose for children ranges from 1-3mg/kg body weight daily, up to a maximum total dose of 40mg per day.

Elderly: The usual adult dose, but caution is advised as furosemide is excreted more slowly in the elderly.

Method of administration: Oral – the tablets should be swallowed with water.

4.3 Contraindications

Furosemide is contra-indicated in the presence of anuria, electrolyte deficiency, precoma associated with hepatic cirrhosis, digitalis intoxication, porphyria and hypersensitivity to furosemide or sulphonamides.

4.4 Special Warnings And Precautions For Use

Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy. Regular monitoring of fluid and electrolyte balance is recommended.

Use with caution in patients with impaired hepatic or renal function, diabetes mellitus or adrenal disease.

Use with care in elderly patients or those with prostatic hypertrophy or impairment of micturition.

Latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.

Hypotension may occur if ACE inhibitors are added to furosemide therapy. The dose of furosemide should be reduced or the drug stopped before initiating the ACE inhibitor.

Use with caution in patients with a history of gout. Discontinue furosemide if bone marrow depression occurs.

This product contains lactose. Patients with rare herditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Furosemide may enhance the toxicity of cardiac glycosides by electrolyte disturbance particularly potassium and magnesium.

The action of antihypertensive agents such as methyldopa may be enhanced by furosemide. The nephrotoxic effect of cephaloridine and the aminoglycoside antibiotics may be increased by furosemide.

The action of diuretics such as furosemide may be antagonised by certain non-steroidal anti-inflammatory agents.

The renal clearance of lithium is decreased by furosemide, resulting in increased and possibly toxic serum levels. Concomitant administration should be avoided unless plasma levels can be monitored.

Concurrent administration of glucocorticoids may cause sodium retention and exacerbate potassium loss.

Furosemide decreases the effects of some drugs (e.g. antidiabetics and pressor amines) and may potentiate the effects of others (e.g. salicylates, theophylline, and curare type muscle relaxants).

Resultant hypokalaemia may potentiate cardiac toxicity of certain drugs such as antihistamines and antiarrythmics. It may also antagonise the action of antiarrhythmics such as lidocaine, mexiletine and tocainide.

4.6 Pregnancy And Lactation

Furosemide has been given after the first trimester of pregnancy for oedema, hypertension and toxaemia of pregnancy without causing foetal or new-born adverse effects. However, it should only be given during pregnancy if strictly indicated and for short-term treatment.

As it may inhibit lactation and passes into breast milk, furosemide should be used with caution in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Reduced mental alertness and rarely dizziness and blurred vision have been reported. Patients so affected should not drive or operate machines.

4.8 Undesirable Effects

Furosemide is generally well tolerated. Fluid and electrolyte imbalance is the most common side effect. Uncommonly nausea, diarrhoea, blurred vision, dizziness, headache, pancreatitis, photosensitivity, vasculitis and interstitial nephritis have occurred very rarely. The incidence of allergic reactions such as skin rashes is very low, but when these occur treatment should be withdrawn.

A transient rise in creatinine may occur as may hypotension and liver dysfunction. Muscle spasm and paraesthesia have also been reported. Hyperuricaemia may be induced and precipitate gout in some patients.

Temporary increase in plasma cholesterol and triglyceride concentrations may occur. Latent diabetes may become manifest and the insulin requirements of diabetic patients may increase.

Bone marrow depression is a rare complication and treatment should be withdrawn. The haemopoeitic status should therefore be regularly monitored.

Calcium depletion may occur and nephrocalcinosis has been reported in premature infants.

Tinnitus and deafness have occurred, usually with large parenteral doses and rapid administration and in renal impairment.

4.9 Overdose

In cases of overdosage there is a danger of dehydration and electrolyte depletion due to excessive diuresis. Treatment should be aimed at fluid replacement and correction of electrolyte imbalance. Gastric lavage may be useful if ingestion is recent.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furosemide is one of the high ceiling diuretics, a term used to denote a group of diuretics that have a distinctive action on renal tubular function. The peak diuresis is far greater than that observed with other agents.

The main site of action is the thick ascending loop of Henle where they inhibit electrolyte re-absorption. It increases renal blood flow without increasing the filtration rate. Such a change in renal haemodynamics reduces fluid and electrolyte re-absorption in the proximal tubule and may augment the initial diuretic response.

Furosemide is an inhibitor of carbonic anhydrase but this activity is too weak to contribute to a proximal diuresis except when massive doses are employed. Furosemide enhances the excretion of both calcium and magnesium to an extent approximately proportional to the increase in sodium excretion. Unlike the thiazides, high ceiling diuretics do not increase calcium re-absorption in the distal tubule. The calciuric action of these agents is the basis for their use in symptomatic hypercalcaemia.

5.2 Pharmacokinetic Properties

Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. Bioavailability is about 65%. It has a biphasic half-life in plasma with a terminal elimination phase up to about 2 hours but this is prolonged in neonates, and in patients with hepatic and renal insufficiency.

It is extensively bound to plasma proteins but is rapidly secreted by the organic acid transport system of the proximal tubule. In this manner it gains access to the tubular fluid and eventually to its site of action more distally.

It is mainly excreted in the urine largely unchanged, but also in the form of glucuronide and free amine metabolites. Variable amounts are also excreted in the bile. Furosemide crosses the placental barrier and is excreted in milk. Non renal elimination is considerably increased in renal failure. The clearance of furosemide is not increased by haemodialysis.

5.3 Preclinical Safety Data

Not relevant

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose monohydrate

Magnesium stearate (E470b)

Sodium starch glycollate

Maize starch.

Starch paste 15%

6.2 Incompatibilities

Not Applicable

6.3 Shelf Life

Tablet container: 5 Years

Blister: 2 Years

6.4 Special Precautions For Storage

Tablet containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.

Blister packs: Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Tablet container and cap (polypropylene container with low density polyethylene cap)

Pack sizes: 28, 56, 100, 250, 500 and 1000 tablets.

Blister (250 (?m white opaque PVC and 20 (?m hard temper aluminium foil).

Pack sizes: 28 and 56 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Aurobindo Pharma Limited

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 20532/0039

9. Date Of First Authorisation/Renewal Of The Authorisation

28/10/2005

10. Date Of Revision Of The Text

30/11/2007



Generic Name: sodium fluoride



Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

Alpha-E Aqua Gem-E Aquasol E D-Alpha Gems E-400 E-600 E-Gems Formula E 400 Gamma E-Gems Gamma E Plus Key-E Natural Vitamin Blend E-400IU Nutr-E-Sol

Available Dosage Forms:

Liquid Solution Tablet Capsule, Liquid Filled Tablet, Chewable Powder for Solution Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Formula E 400

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

Intestine disease Liver disease Pancreas disease Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

                                                  Persons U.S. Canada mg



Flecainide Acetate 50mg and 100mg tablets

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 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. Index 1 What Flecainide Acetate tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information What Flecainide Acetate tablets are and what they are used for

Flecainide Acetate tablets belong to a group of medicines called anti-arrhythmics. They work by regulating the heart rate.

Flecainide Acetate tablets may be used to treat the following conditions when other drugs are not effective: irregular beats of the upper heart chambers (atria) including Wolff-Parkinson-White Syndrome irregular beats of the lower heart chambers (ventricles). Before you take

Do not take Flecainide Acetate tablets and tell your doctor if you:

are allergic (hypersensitive) to flecainide acetate or any of the other ingredients (see section 6) suffer from conduction problems of the heart, such as a slow or fast heart beat or heart block suffer from heart failure have severely low blood pressure have had a heart attack (myocardial infarction) are in shock due to heart problems (cardiogenic shock) have rapid and irregular heart beat (atrial fibrillation) are taking disopyramide (medicine to treat irregular heart rhythms).

Take special care with Flecainide Acetate tablets and tell your doctor if you:

suffer from low or high levels of potassium in the blood have liver or kidney disease have a pacemaker have any heart disease or an enlarged heart have rapid or irregular heart beats after heart surgery have been told you have disturbances in heart rhythm known as sick sinus syndrome. Taking other medicines

Before taking Flecainide Acetate tablets, tell your doctor if you are taking or have recently taken the following medicines, or are taking any non-prescribed medicines:

verapamil or beta blockers (e.g. propranolol to treat heart diseases) laxatives (to treat constipation) diuretics (‘water tablets’) steroids (e.g. betamethasone, hydrocortisone or prednisolone) sodium channel blockers (e.g. lidocaine to treat irregular heartbeat (arrhythmia) or as a local anaesthetic) phenytoin, phenobarbital or carbamazepine (to treat epilepsy) digoxin (to treat heart conditions) amiodarone, quinidine or disopyramide (to treat irregular heart rhythms) cimetidine (to treat stomach ulcers) fluoxetine or tricyclic antidepressants (e.g. amitriptyline to treat depression) terfenadine or astemizole (to treat allergic reactions) quinine or halfantrine (to treat or prevent malaria) Pregnancy and breast-feeding

Your doctor will only prescribe Flecainide Acetate tablets if it is absolutely necessary. Breast feeding is not recommended whilst taking Flecainide Acetate tablets. Check with your doctor if you are unsure.

Driving and using machines

Flecainide Acetate tablets may cause dizziness or affect your vision. Make sure you are not affected before you drive or operate machinery.

Tests

Your doctor will monitor your progress on a regular basis with ECG (electrocardiogram) and blood tests, and may alter the dose if necessary.

If you see another doctor or go into hospital, let them know what medicines you are taking.

How to take

Always take Flecainide Acetate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Treament may be started in hospital.

Swallow these tablets whole with water on an empty stomach or one hour before food.

Doses: Adults and adolescents (13-17 years of age) treatment of irregular beats of the upper heart chambers (atria) : starting dose is 50mg twice a day up to a maximum dose of 300mg per day. treatment of irregular heart beats of the lower heart chambers (ventricular) : starting dose is 100mg twice a day up to a maximum dose of 400mg per day. Children under 12 years of age - not recommended Elderly patients or those fitted with pacemakers, with kidney or liver problems or taking amiodarone or cimetidine - a lower dose of flecainide may be given. If you take more Flecainide Acetate tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once.

If you forget to take Flecainide Acetate tablets

If you forget to take a dose take it as soon as you remember, unless it is nearly time to take the next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

Possible side effects

Like all medicines, Flecainide Acetate tablets can cause side effects, although not everybody gets them.

Stop taking Flecainide Acetate tablets and contact your doctor at once if the following allergic reaction happens: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common (occurs in more than 1 in 10 users): dizziness, giddiness, light headedness, headache, double or blurred vision

Common (occurs in less than 1 in 10 users): signs of your heart condition getting worse or development of new heart symptoms, a change in heart beat pattern (especially in patients with existing heart problems)

Uncommon (occurs in less than 1 in 100 users): changes in the numbers and types of your blood cells, difficulty breathing, feeling or being sick

Rare (occurs in less than 1 in 1,000 users): affects on your immune system which may be associated with inflammation, hallucinations, depression, confusion, memory loss, nervousness, anxiety, disturbances of movement, convulsions, ‘pins and needles’ or numbness, problems with co-ordination, raised liver enzyme levels or jaundice (yellow skin and/or whites of the eyes)

Very rare (occurs in less than 1 in 10,000 users): particles in the front of the eye (corneal deposits), lung disease (pneumonitis), sensitivity of the skin to light, flushing or increased sweating, allergic skin reactions (which may be itchy), dry mouth, impairment of taste, joint and muscle pain, impotence.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Do not store the tablets above 25°C and store in the original packaging.

Do not use Flecainide Acetate tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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 Flecainide Acetate tablets contain The active substance (the ingredient that makes the tablets work) is flecainide acetate. Each tablets contains either 50mg or 100mg of the active ingredient. The other ingredients are croscarmellose sodium, magnesium stearate, maize starch, pregelatinised maize starch, microcrystalline cellulose (E460). What Flecainide Acetate tablets look like and contents of the pack

Flecainide Acetate tablets are white, uncoated tablets.

Pack sizes are 60 tablets

Marketing Authorisation Holder and Manufacturer Actavis Barnstaple EX32 8NS UK

Date of last revision: July 2008.

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis Barnstaple EX32 8NS UK

50134525



fure-a-ZOL-i-done

Available Dosage Forms:

Suspension Tablet

Therapeutic Class: Antibiotic

Chemical Class: Nitrofuran

Uses For furazolidone

Furazolidone is used to treat bacterial and protozoal infections. It works by killing bacteria and protozoa (tiny, one-celled animals). Some protozoa are parasites that can cause many different kinds of infections in the body.

Furazolidone is taken by mouth. It works inside the intestinal tract to treat cholera, colitis, and/or diarrhea caused by bacteria, and giardiasis. furazolidone is sometimes given with other medicines for bacterial infections.

Furazolidone may cause some serious side effects when taken with certain foods, beverages, or other medicines. Check with your health care professional for a list of products that should be avoided.

Furazolidone is available only with your doctor's prescription.

Before Using furazolidone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For furazolidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to furazolidone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because furazolidone may cause anemia, use in infants up to 1 month of age is not recommended.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of furazolidone in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking furazolidone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using furazolidone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amitriptyline Apraclonidine Atomoxetine Benzphetamine Brimonidine Citalopram Clovoxamine Cyclobenzaprine Cyproheptadine Dexmethylphenidate Dextroamphetamine Diethylpropion Escitalopram Femoxetine Fluoxetine Fluvoxamine Guanadrel Guanethidine Isocarboxazid Levomethadyl Maprotiline Mazindol Methamphetamine Methyldopa Methylphenidate Milnacipran Morphine Morphine Sulfate Liposome Nefazodone Nefopam Opipramol Paroxetine Phendimetrazine Phenmetrazine Phentermine Phenylalanine Pseudoephedrine Reserpine Sertraline Sibutramine Tapentadol Tetrabenazine Tranylcypromine Venlafaxine Zimeldine

Using furazolidone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Albuterol Altretamine Amphetamine Arformoterol Avocado Bambuterol Bitolterol Bitter Orange Broxaterol Clenbuterol Difenoxin Diphenoxylate Droperidol Ephedrine Ethchlorvynol Fenoterol Fentanyl Formoterol Guarana Hexoprenaline Hydromorphone Indacaterol Isoetharine Kava Levalbuterol Licorice Lisdexamfetamine Ma Huang Mate Meperidine Metaraminol Norepinephrine Oxycodone Phenylephrine Phenylpropanolamine Pirbuterol Procaterol Reboxetine Rimiterol Ritodrine Salmeterol St John's Wort Terbutaline Tulobuterol Tyrosine

Using furazolidone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ginseng Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using furazolidone with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using furazolidone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use furazolidone, or give you special instructions about the use of food, alcohol, or tobacco.

Tyramine Containing Food Other Medical Problems

The presence of other medical problems may affect the use of furazolidone. Make sure you tell your doctor if you have any other medical problems, especially:

Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)—Patients with G6PD-deficiency may develop mild anemia while taking furazolidone Proper Use of furazolidone

Do not give furazolidone to infants up to 1 month of age, unless otherwise directed by your doctor. furazolidone may cause anemia in these patients.

Furazolidone may be taken with food to lessen the chance of an upset stomach.

To use the oral suspension:

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep taking furazolidone for the full time of treatment, even if you begin to feel better after a few days. If you stop taking furazolidone too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of furazolidone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of furazolidone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (oral suspension or tablets): For cholera or diarrhea caused by bacteria: Adults—100 milligrams (mg) taken four times a day for five to seven days. Children up to 1 month of age—Use is not recommended. Children 1 month of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.25 mg per kilogram (kg) (0.56 mg per pound) of body weight taken four times a day for five to seven days. For giardiasis: Adults—100 mg taken four times a day for seven to ten days. Children up to 1 month of age—Use is not recommended. Children 1 month of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.25 mg to 2 mg per kg (0.56 to 0.90 mg per pound) of body weight taken four times a day for seven to ten days. Missed Dose

If you miss a dose of furazolidone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using furazolidone

It is important that your doctor check your progress at regular visits. This is to check whether or not the infection is cleared up completely.

If your symptoms do not improve within a week, or if they become worse, check with your doctor.

Drinking alcoholic beverages or taking other alcohol-containing preparations (for example, elixirs, cough syrups, tonics, or injections of alcohol) while taking furazolidone may rarely cause problems. These problems include increased side effects such as redness of the face, difficult breathing, fainting, and a feeling of tightness in the chest. These side effects usually go away within 24 hours without treatment. However, these effects may occur if you drink alcoholic beverages for up to 4 days after you stop taking furazolidone. Therefore, you should not drink alcoholic beverages or take other alcohol-containing preparations while you are taking furazolidone and for 4 days after stopping it.

Certain foods, drinks, or other medicines may cause very dangerous reactions, such as severe high blood pressure, when taken with furazolidone. Aged or fermented foods and drinks commonly contain tyramine or other substances that increase blood pressure. To avoid such reactions, the following measures are recommended:

Do not eat foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; yeast or meat extracts; fava or broad bean pods; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; or any overripe fruit. If a list of these foods is not given to you, ask your health care professional to provide one. Do not drink alcoholic beverages or alcohol-free or reduced-alcohol beer and wine. Do not eat or drink large amounts of caffeine-containing food or beverages such as chocolate, coffee, tea, or cola. Do not take any other medicines unless approved or prescribed by your doctor. This includes nonprescription (over-the-counter [OTC]) appetite suppressants (diet pills) or medicine for colds, sinus problems, or hay fever or other allergies. Do not take any of the above-listed foods, drinks, or medicine for at least 2 weeks after you stop taking furazolidone. They may continue to react with furazolidone during that time. Other foods may also contain tyramine or other substances that increase blood pressure. However, these products generally do not cause serious problems when taken with furazolidone, especially if eaten when fresh and in small amounts. These include yogurt, sour cream, cream cheese, cottage cheese, chocolate, and soy sauce. If you have any questions about this, ask your health care professional. Also ask for a list of foods, beverages, or medicines that may cause serious problems when taken with furazolidone. furazolidone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Fever itching joint pain skin rash or redness sore throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Abdominal or stomach pain diarrhea headache nausea or vomiting

furazolidone commonly causes dark yellow to brown discoloration of urine. This side effect does not usually need medical attention.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Generic Name: fluocinolone ophthalmic implant (floo oh SIN oh lone off THAL mik IM plant)



1. Name Of The Medicinal Product

Benzoin Tincture Compound BP or Friars Balsam BP

2. Qualitative And Quantitative Composition

Storax prepared BP 10.0% w/v

Benzoin sumatra crushed BP 10.0% w/v

3. Pharmaceutical Form

Tincture

4. Clinical Particulars 4.1 Therapeutic Indications

1. As an inhalant for relief of the symptoms of colds.

2. As a mild antiseptic dressing.

4.2 Posology And Method Of Administration

1. Through the mouth and nasal passages.

2. Topical.

1. As an inhalant

Adults, children over 3 months of age and the elderly: Add one 5ml spoonful to a pint of hot, but not boiling water.

The dose may be repeated after 4 hours if required.

The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly.

Not suitable for children under 3 months of age.

2. As an antiseptic

Adults, children and the elderly: Apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.

4.3 Contraindications

Contraindicated in patients with known sensitivity to sumatra benzoin or storax.

4.4 Special Warnings And Precautions For Use

Not suitable for children under 3 months when used as an inhalant.

For external use only.

Keep all medicines away from children.

Caution: Highly flammable. Keep away from a naked flame.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use of this product by the indicated routes is not considered likely to cause any undesirable effects in the above conditions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

This product is for external use only. Accidental ingestion is likely to cause a severe burning sensation in the mouth and mucous membranes due to the high alcohol content and the bitter taste of the aloes and balsamic acids. Dilution of the product in the mouth will cause the separation of an unpleasant gummy residue. It is considered unlikely that a significant quantity could be swallowed. However the main effects would be those of alcohol intoxication.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Sumatra benzoin has been used as an ingredient in inhalations used in the treatment of catarrh of the upper respiratory tract for many years. It has also been used topically for its antiseptic and protective properties.

Storax has mild antiseptic action.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Aloes powdered BP, purified water BP, ethanol (96%) BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

25ml: 36 months unopened.

50ml: 36 months unopened.

500ml: 36 months unopened.

2000ml: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container    

25ml:

glass bottle and plastic cap with liner.

50ml:

glass bottle and plastic cap with liner or white 28mm polypropylene cap with Tamper Evident band and EPE/Saranex liner.

500ml:

glass bottle and plastic cap with liner.

2000ml:

glass bottle and plastic cap with liner.

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 12965/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

11/10/93 19/11/98

10. Date Of Revision Of The Text

March 2005

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable



1. Name Of The Medicinal Product

Flebogamma® 5%.

Solution for infusion.

2. Qualitative And Quantitative Composition

Human normal immunoglobulin (IVIg)

The percentage of IgG subclasses is approximately 68.7% IgG1, 25.9% IgG2, 3.7% IgG3 and 1.78% IgG4.

Human protein content is 50 g/l of which at least 97% is IgG.

IgA content is lower than 0.05 mg/ml.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion

4. Clinical Particulars 4.1 Therapeutic Indications

Flebogamma® 5% is indicated for:

Replacement therapy in:

Primary immunodeficiency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodeficiency

- severe combined immunodeficiency

- Wiskott Aldrich syndrome

Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Children with congenital AIDS and recurrent infections.

Immunomodulation

Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

Guillain Barr? Syndrome.

Kawasaki disease.

Allogeneic bone marrow transplantation.

4.2 Posology And Method Of Administration

4.2.1. Posology

The dose and dosage regimen is dependent on the indication.

In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.

Replacement therapy in primary immunodeficiency syndromes

The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4-6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4-0.8 g/kg followed by at least 0.2 g/kg every three weeks.

The dose required to achieve a trough level of 6 g/l is of the order of 0.2-0.8 g/kg/month. The dosage interval when steady state has been reached varies from 2-4 weeks.

Trough levels should be measured in order to adjust the dose and dosage interval.

Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections

The recommended dose is 0.2-0.4 g/kg every three to four weeks.

Idiopathic Thrombocytopenic Purpura

For the treatment of an acute episode, 0.8-1 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days. The treatment can be repeated if relapse occurs.

Guillain Barr? syndrome

0.4 g/kg/day for 3 to 7 days.

Experience in children is limited.

Kawasaki Disease

1.6-2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose.

Patients should receive concomitant treatment with acetylsalicylic acid.

Allogeneic Bone Marrow Transplantation

Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.

For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation.

In case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.

The dosage recommendations are summarised in the following table:

Indication

Dose

Frequency

Replacement therapy in primary immunodeficiency

- starting dose:

0.4 – 0.8 g/kg

- thereafter:

0.2 – 0.8 g/kg

 

 

every 2 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l

Replacement therapy in secondary immunodeficiency

0.2 – 0.4 g/kg

every 3 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l

Children with AIDS

0.2 – 0.4 g/kg

every 3 – 4 weeks

Immunomodulation:

   

Idiopathic Thrombocytopenic Purpura

0.8 – 1 g/kg

or

0.4 g/kg/d

on day 1, possibly repeated once within 3 days

 

for 2 – 5 days

Guillain Barr? syndrome

0.4 g/kg/d

for 3 – 7 days

Kawasaki disease

1.6 – 2g/kg

or

2g/kg

in several doses for 2 – 5 days in association with acetylsalicylic acid

in one dose in association with acetylsalicylic acid

Allogeneic bone marrow transplantation:

   

-treatment of infections and prophylaxis of graft versus host disease

0.5 g/kg

every week from day –7 up to 3 months after transplantation

-persistent lack of antibody production

0.5 g/kg

every month until antibody levels return to normal

4.2.2. Method of administration

Flebogamma® 5% should be infused intravenously at an initial rate of 0.6-1.2 ml/kg/hour for the first thirty minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 4.2 ml/kg/hour.

4.3 Contraindications

Hypersensitivity to any of the components.

(See special warnings about excipients, section 4.4.).

Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA.

4.4 Special Warnings And Precautions For Use

Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under “4.2. Posology and method of administration” must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently:

- in case of high rate of infusion,

- in patients with hypo- or agammaglobulinemia with or without IgA deficiency,

- in patients who receive human normal immunoglobulin for the first time, or in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.

True hypersensitivity reactions are rare. They can occur in the very seldom cases of IgA deficiency with anti-IgA antibodies.

Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.

Potential complications can often be avoided by ensuring:

- that patients are not sensitive to human normal immunoglobulin by first injecting the product slowly at an initial rate of 0.6-1.2 ml/kg/hour,

- that patients are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.

There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients. Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with diseases which increase blood viscosity).

Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.

In case of renal impairment, IVIg discontinuation should be considered.

While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. Flebogamma® 5% does not contain sucrose. In patients at risk, the use of IVIg products that do not contain sucrose may be considered.

In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.

In all patients, IVIg administration requires:

- adequate hydration prior to the initiation of the infusion of IVIg

- monitoring of urine output

- monitoring of serum creatinine levels

- avoidance of concomitant use of loop diuretics

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the side effect.

In case of shock, standard medical treatment for shock should be implemented.

Standard measures 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.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV.

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

There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

It is strongly recommended that every time that Flebogamma® 5% 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.

Special warnings about excipients: this medicinal product contains 5 g of sorbitol per 100 ml as excipient. In case of fructose hereditary intolerance this product should not be used.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Live attenuated virus vaccines

Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.

Interference with serological testing

After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test), reticulocyte count and haptoglobin.

4.6 Pregnancy And Lactation

The safety of Flebogamma® 5% for use in human pregnancy has not been established and therefore should only be given with caution to pregnant women and breast feeding mothers. Human immunoglobulins are excreted into the milk.

Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and neonate are to be expected.

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

Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.

Increase in serum creatinine level and/or acute renal failure have been observed.

Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.

For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.

Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors. It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.

The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

5.2 Pharmacokinetic Properties

Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.

Human normal immunoglobulin has a half-life of 46 days (range 33-65 days). This half-life may vary from patient to patient, in particular in primary immunodeficiency.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

- 5% D-sorbitol

- Water for Injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products or intravenous fluids. It should be administered by a separate intravenous line.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Flebogamma® 5% should be stored below 25 °C and protected from light. The contents must not be frozen.

Do not use after expiry date.

6.5 Nature And Contents Of Container

Flebogamma® 5% is supplied in type II glass vials containing 10 ml, 50 ml, 100 ml and 200 ml of solution.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

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

7. Marketing Authorisation Holder

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vall?s

08150 Barcelona - SPAIN

8. Marketing Authorisation Number(S)

PL 12930/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

08/11/2005

10. Date Of Revision Of The Text

15/02/2006





Generic Name: Saquinavir (sa-KWIN-a-veer)



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