Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
INTERFERON BETA 1B
BAYER ISRAEL LTD
L03AB08
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
INTERFERON BETA 1B 0.3 MG/VIAL
S.C
Required
BAYER AG, GERMANY
INTERFERON BETA-1B
INTERFERON BETA-1B
Use in ambulatory patients with relapsing-remitting multiple sclerosis (RRMS) and relapsing progressive M.S. to reduce the frequency of clinical exacerbations. Treatment of secondary progressive (SP) form of multiple sclerosis. Treatment of patients who have experienced 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, including the prescence of MRI abnormalities characteristic of M.S. and if they are determined to be at high risk of developing clinically definite multiple sclerosis.
2020-12-31
FILE NAME Betaferon-ENG-D23-F.docx PRODUCT Betaferon JOB NO. SO23000468 LANGUAGE English ARTWORK Patient Leaflet DOCUMENT HISTORY VER. DATE CHANGE DESCRIPTION BY 27-Jun-23 11:22 Last save _OUR EXPERTISE. YOUR SUCCESS._ 2 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor's prescription only BETAFERON POWDER AND SOLVENT FOR SOLUTION FOR SUBCUTANEOUS INJECTION ACTIVE INGREDIENT AND QUANTITY: interferon beta-1b 0.3 mg/vial After reconstitution, 1 ml contains 250 micrograms (8.0 million international units) interferon beta- 1b. Inactive ingredients and allergens – see section 2 ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. ESSENTIAL INFORMATION ABOUT THE MEDICINE This section presents a summary of the most essential information from the leaflet about treatment with Betaferon. • Before injection, prepare the Betaferon solution by using the vial that contains Betaferon powder and the pre-filled syringe that contains a solvent. This will be prepared by your doctor or nurse, or by you after you have received appropriate training. • Detailed instructions regarding preparation of the Betaferon solution and self-injection under the skin are provided in the Annex “Self -injection instructions .” • Routinely change the site of injection. See section 2 ‘Special warnings about using this medicine’ and follow the instructions in the Annex, in part II ‘Rotating injection sites’. 1) WHAT IS THIS MEDICINE INTENDED FOR? • For treatment of ambulatory patients suffering from multiple sclerosis Đọc toàn bộ tài liệu
1. NAME OF THE MEDICINAL PRODUCT BETAFERON 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 Use in ambulatory patients with relapsing-remitting multiple sclerosis (RRMS) and relapsing progressive M.S. to reduce the frequency of clinical exacerbations. Treatment of secondary progressive (SP) form of multiple sclerosis. Treatment of patients who have experienced 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, including the presence of MRI abnormalities characteristic of M.S. and if they are determined to be at high risk of developing clinically definite multiple sclerosis. 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. Therefore Betaferon should not be u Đọc toàn bộ tài liệu