Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
interferon beta-1b
Bayer AG
L03AB08
interferon beta-1b
Immunostimulants,
Multiple Sclerosis
Betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Revision: 36
Authorised
1995-11-30
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER BETAFERON 250 MICROGRAM/ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION interferon beta-1b READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Betaferon is and what it is used for 2. What you need to know before you use Betaferon 3. How to use Betaferon 4. Possible side effects 5. How to store Betaferon 6. Contents of the pack and other information Annex – self injection procedure 1. WHAT BETAFERON IS AND WHAT IT IS USED FOR WHAT BETAFERON IS Betaferon is a type of medicine known as interferon used to treat multiple sclerosis. Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections. HOW BETAFERON WORKS MULTIPLE SCLEROSIS (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called _myelin_ ) around the nerves of the CNS and stops the nerves from working properly. This is called demyelination. The exact cause of MS is unknown. An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS. THE DAMAGE TO THE CNS can occur within an MS attack _(relapse)_ . It can cause disability temporarily, such as difficulty walking. Symptoms may disappear completely or partly. Interferon beta-1b has been shown to change the response of the immune system and to help to reduce Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1._ _ NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/ml, powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Recombinant interferon beta-1b * 250 microgram (8.0 million IU) per ml when reconstituted. Betaferon contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial. For the full list of excipients, see section 6.1. * produced by genetic engineering from a strain of _Escherichia coli_ . 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Sterile white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betaferon is indicated for the treatment of • patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). • patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years. • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease. Posology _ _ _Adults _ The recommended dose of Betaferon is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day. _Paediatric population _ No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults. There is no information on the use of Betaferon in children under 12 years of age. Therefo Przeczytaj cały dokument