البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
Interferon alfa-2b
Merck Sharp & Dohme (Australia) Pty Ltd
Interferon alfa-2b
Registered
INTRON A _Interferon alfa-2b_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET 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 body's immune system response. INTRON A is used to treat patients with the following conditions: • Hairy cell leukaemia • Kaposi's sarcoma in AIDS • Chronic myelogenous leukaemia • Multiple myeloma • Follicular non-Hodgkin's lymphoma • Malignant melanoma • Chronic hepatitis B • Chronic hepatitis C Your doctor, however, may prescribe INTRON A for another purpose. 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. DO NOT USE INTRON A IF YOU ARE PREGNANT OR BREASTFEEDING UNLESS YOUR DOCTOR SAYS SO. ASK YOUR DOCTOR ABOUT THE RISKS AND BENEFITS INVOLVED. IF YOU ARE A WOMAN OF CHILDBEARING AGE MAKE SURE YOU DO NOT BECOME PREGNANT WHILE USING INTRON A. DO NOT USE INTRON A IF 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: 1. IF اقرأ الوثيقة كاملة
Page 1 PRODUCT INFORMATION INTRON A NAME OF THE MEDICINE Interferon alfa-2b (rbe) DESCRIPTION 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 protein. INTRON A Injectable (HSA-free) Solution INTRON A HSA-free Injectable Solution is a clear, colourless solution and is available in single dose vials. Each single dose vial of INTRON A HSA-free Injectable Solution contains, 10 million IU/1 mL, 18 million IU/3 mL or 25 million IU/2.5 mL of recombinant interferon alfa- 2b. The vials also contain sodium phosphate dibasic, sodium phosphate monobasic, disodium edetate, sodium chloride, polysorbate 80, water for injections and m-cresol. PHARMACOLOGY Interferons are a family of naturally occurring, small protein molecules produced and secreted by cells in response to viral infections or various synthetic and biological inducers. Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface. Preliminary studies to characterise these membrane receptors and to determine the subsequent fate of the human interferon-receptor complex have been carried out using 125 I- labelled recombinant interferon alfa-2b. Human interferon receptors, as isolated from human lymphoblastoid (Daudi) cells, appear to be highly asymmetric membrane proteins. They exhibit selectivity for human but not murine interferons, suggesting species specificity. Studies with other interferons have demonstrated species specificity. The results of several studies suggest that, once bound to the cell membrane, the interferon initiates a complex sequence of اقرأ الوثيقة كاملة