Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
interferon beta-1b
BAYER CO. (MALAYSIA) SDN. BHD.
interferon beta-1b
15units Units
BAYER AG
Reference: CCPI Version 16 , D3 Betaferon-CCDS 16_clean_08 Feb23.doc 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Betaferon is used for 2. How Betaferon works 3. Before you use Betaferon 4. How to use Betaferon 5. While you are using it 6. Side effects 7. Storage and Disposal of Betaferon 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BETAFERON IS USED FOR Betaferon is indicated for patients with ► a single clinical event suggestive of multiple sclerosis (MS) (‘Clinically Isolated Syndrome’) ► relapsing forms of multiple sclerosis (MS) and ► secondary progressive multiple sclerosis (MS) with active disease, evidenced by relapses or pronounced neurological deterioration within the last two years. In patients with a single clinical event suggestive of multiple sclerosis (‘Clinically Isolated Syndrome’), Betaferon is indicated to delay progression to definite multiple sclerosis. In relapsing-remitting multiple sclerosis Betaferon is indicated for the reduction of frequency and degree of severity of clinical relapses in ambulatory patients (i.e. patients who are able to walk unaided), characterized by at least two attacks of neurological dysfunction over the preceding two year period, followed by complete or incomplete recovery. In secondary progressive multiple sclerosis Betaferon is indicated for the reduction of frequency and severity of clinical relapses and for slowing the progression of disease. Usage of Betaferon Injection in children and adolescents 12 years and above HOW BETAFERON WORKS Multiple sclerosis (MS) is a disease of the central nervous system (CNS) (i.e. brain and spinal cord) but its exact cause 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. Interferon beta-1b has been shown to modify the immune system response. BEFORE YOU USE Betaferon - _When you must not use it _ _ _ BEFORE YOU USE BETAFERON DO NOT USE BET Read the complete document
Reference : Betaferon / Powder and solvent for solution for injection / aCCDS / Version 16 / 31 Jan2022 BETAFERON ® 250 microgram/ml Powder and solvent for solution for injection 1. NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/mL powder and solvent for solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with powder for solution for injection contains 300 microgram recombinant Interferon beta-1b. When reconstituted, 1 mL solution for injection contains 250 microgram recombinant Interferon beta-1b. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Betaferon is indicated for patients with ► a single clinical event suggestive of multiple sclerosis (MS) (‘Clinically Isolated Syndrome’) ► relapsing forms of multiple sclerosis (MS) and ► secondary progressive multiple sclerosis (MS) with active disease, evidenced by relapses or pronounced neurological deterioration within the last two years. In patients with a single clinical event suggestive of multiple sclerosis (‘Clinically Isolated Syndrome’), Betaferon is indicated to delay progression to definite multiple sclerosis. In relapsing-remitting multiple sclerosis Betaferon is indicated for the reduction of frequency and degree of severity of clinical relapses in ambulatory patients (i.e. patients who are able to walk unaided), characterized by at least two attacks of neurological dysfunction over the preceding two year period, followed by complete or incomplete recovery. In secondary progressive multiple sclerosis Betaferon is indicated for the reduction of frequency and severity of clinical relapses and for slowing the progression of disease. Usage of Betaferon Injection in children and adolescents 12 years and above. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Method of administration: Subcutaneous injection _ADULTS _ The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease. The recommended dos Read the complete document