البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Interferon alfa-2b 50 MIU/mL
Merck Sharp & Dohme (New Zealand) Limited
Interferon alfa-2b 50 MIU/mL
60 MIU
Solution for injection
Active: Interferon alfa-2b 50 MIU/mL Excipient: Dibasic sodium phosphate Disodium edetate dihydrate Metacresol Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection
Cartridge, glass, 6x0.2mL doses of 10 million IU, 1.2 mL
Prescription
Prescription
MSD International GmbH
INTRON A Redipen is used in the treatment of: · Hairy cell leukaemia in splenectomised or non-splenectomised patients; · Chronic myelogenous leukaemia;
Package - Contents - Shelf Life: Cartridge, glass, 6x0.2mL doses of 10 million IU - 1.2 mL - 15 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). With exposure to temperatures of up to 30 degrees C for up to 2 days 48 hours not refrigerated stored at or below 30°C. In-use, 4 weeks stored as directed between doses.
1998-02-11
KEYTRUDA ® 1 INTRON A ® _interferon alfa-2b _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Intron A. This leaflet answers some common questions about Intron A. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Intron A against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may want to read it again. WHAT INTRON A IS USED FOR Intron A belongs to a group of medicines called interferons. Interferons are a family of naturally occurring, small protein molecules. They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers. Interferons modify the response of the body's immune system to help fight infections, leukaemia and tumours. Your doctor may have prescribed Intron A for another reason. Ask your doctor if you have any questions about why Intron A has been prescribed for you. BEFORE YOU USE INTRON A _WHEN YOU MUST NOT USE IT _ Do not use Intron A if: you are allergic to interferon alfa- 2b or any of the ingredients listed at the end of this leaflet. you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved. you are a woman of childbearing age make sure you do not become pregnant while using Intron A. the packaging is torn or shows signs of tampering. Do not use Intron A after the expiry date (EXP) printed on the pack. If you use it after the expiry date it may have no effect at all, or worse, an unexpected effect. If you are not sure whether you should start using Intron A, talk to your doctor. _BEFORE YOU START TO USE IT _ YOU MUST TELL YOUR DOCTOR IF: you are allergic to any other medicines or any food, dyes or preservativ اقرأ الوثيقة كاملة
_Page 1_ NEW ZEALAND DATA SHEET 1. INTRON A REDIPEN INTRON A Redipen 18 MIU Solution for injection INTRON A Redipen 30 MIU Solution for injection INTRON A Redipen 60 MIU Solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each INTRON A Redipen 18 MIU contains interferon alfa-2b 15 million IU/mL (6 doses of 3 million IU, 0.2 mL per dose) Each INTRON A Redipen 30 MIU contains interferon alfa-2b 25 million IU/mL (6 doses of 5 million IU, 0.2 mL per dose) Each INTRON A Redipen 60 MIU contains interferon alfa-2b 50 million IU/mL (6 doses of 10 million IU, 0.2 mL per dose) INTRON A is a sterile, stable formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. Recombinant interferon alfa-2b is a water soluble protein with a molecular weight of approximately 19,300 daltons. It is obtained from a clone of _E. coli_ which has a genetically engineered plasmid containing an interferon alfa-2 gene from human leucocytes. The activity of INTRON A is expressed in terms of International Units (IU). The specific activity of INTRON A is approximately 2.6 x 10 8 IU/mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM INTRON A Redipen is a preloaded, multi-dose disposable injector and is available in packs of single pens. Each pack also contains 6 needles and 6 swabs. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INTRON A Redipen is used in the treatment of: Hairy cell leukaemia in splenectomised or non-splenectomised patients; Kaposi's sarcoma in patients with acquired immune deficiency syndrome (AIDS); Chronic myelogenous leukaemia; Multiple myeloma; Follicular non-Hodgkin's lymphoma; Malignant melanoma; Chronic hepatitis B in adults; Chronic hepatitis C in adults. _Page 2_ 4.2 DOSE AND METHOD OF ADMINISTRATION Dose HAIRY CELL LEUKAEMIA The recommended dosage of INTRON A is 2 million IU/m 2 administered subcutaneously three times a week (every other day). Higher doses are not recommended. Normalisation of one or more haemato اقرأ الوثيقة كاملة