Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
interferon beta-1a
Merck Europe B.V.
L03AB07
interferon beta-1a
Immunostimulants,
Multiple Sclerosis
Rebif is indicated for the treatment of:patients with a single demyelinating event with an active inflammatory process, 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 multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years.Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.
Revision: 41
Authorised
1998-05-03
151 B. PACKAGE LEAFLET 152 PACKAGE LEAFLET: INFORMATION FOR THE USER REBIF 22 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE interferon beta-1a 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 Rebif is and what it is used for 2. What you need to know before you use Rebif 3. How to use Rebif 4. Possible side effects 5. How to store Rebif 6. Contents of the pack and other information 1. WHAT REBIF IS AND WHAT IT IS USED FOR Rebif belongs to a class of medicines known as interferons. These are natural substances that transmit messages between cells. Interferons are produced by the body and play an essential role in the immune system. Through mechanisms that are not totally understood, interferons help to limit the damage of the central nervous system associated with multiple sclerosis. Rebif is a highly purified soluble protein that is similar to the natural interferon beta that is produced in the human body. Rebif _ _ is used for the treatment of multiple sclerosis. It has been shown to reduce the number and the severity of relapses and to slow the progression of disability. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE REBIF_ _ DO NOT USE REBIF_ _ • if you are allergic to natural or recombinant interferon beta or any of the other ingredients of this medicine (listed in section 6). • if you are severely depressed at present. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Rebif. • Rebif should only be used under the supervision of your Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**. * Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house interferon beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology. Excipient with known effect: Contains 2.5 mg benzyl alcohol per dose of 0.5 mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/L. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rebif is indicated for the treatment of relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1). Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Rebif is available in three strengths: 8.8 micrograms, 22 micrograms and 44 micrograms. For patients initiating treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in a pack that corresponds to the patient needs for the first month of therapy. Posology The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection. A lower dose of 22 micrograms, also given three times per week by subcutaneous injection, is recommended for patients who cannot tolerate the higher dose in view of the treating specialist. When first starting treatment with Rebif, the dose should be gradually escalat Lesen Sie das vollständige Dokument