Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
INTERFERON BETA 1A
MERCK SERONO LTD
L03AB07
SOLUTION FOR INJECTION
INTERFERON BETA 1A 44 MCG/ML
S.C
Required
MERCK EUROPE B.V., THE NETHERLANDS
INTERFERON BETA-1A
INTERFERON BETA-1A
Rebif (interferone beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. Efficacy of Rebif in chronic progressive multiple sclerosis has not been established.
2023-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only PRE-FILLED SYRINGE CARTRIDGE FOR INSERTION INTO AN ELECTRONIC SYRINGE THE ACTIVE INGREDIENT: Interferon beta-1a Each pre-filled syringe of REBIF® 22 MCG including a needle, contains: 22 micrograms (6 million International Units [IU]) interferon beta-1a in 0.5 mL. The preparation contains 2.5 mg benzyl alcohol. Each pre-filled syringe of REBIF® 44 MCG including a needle, contains: 44 micrograms (12 million International Units [IU]) interferon beta-1a in 0.5 mL. The preparation contains 2.5 mg benzyl alcohol. Each cartridge of REBIF® 22 MCG inserted into an appropriate syringe, contains: 66 micrograms (18 million International Units [IU]) interferon beta-1a in 1.5 mL. The preparation contains 7.5 mg benzyl alcohol. Each cartridge of REBIF® 44 MCG inserted into an appropriate syringe, contains: 132 micrograms (36 million International Units [IU]) interferon beta-1a in 1.5 mL. The preparation contains 7.5 mg benzyl alcohol. Inactive ingredients: see section 6 and section 2 under “Important information about some of the ingredients of the medicine”. • READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. • Keep this leaflet at hand; you may need to read it again. • If you have further questions, refer to the doctor or pharmacist. • This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. • Use the medicine properly. • Consult the pharmacist if you need further information. Refer to the doctor if the signs of the disease (symptoms) worsen or are not improving. • If you experience any side effects, refer to your doctor. This includes any possible side effect not included in this leaflet. See section 4. 1. WHAT IS THE MEDICINE INTENDED FOR Rebif ( Aqra d-dokument sħiħ
PRESCRIBING INFORMATION REBIF ® 22MCG REBIF ® 44MCG 1. NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in pre-filled syringe Rebif 44 micrograms/0.5 mL solution for injection in pre-filled syringe Rebif 22 micrograms/0.5 mL solution for injection in cartridge Rebif 44 micrograms/0.5 mL solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION REBIF 22 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**. 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. REBIF 44 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of interferon beta-1a**. 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. REBIF 22 MICROGRAMS SOLUTION FOR INJECTION IN CARTRIDGE Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 44 micrograms/mL. 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. REBIF 44 MICROGRAMS SOLUTION FOR INJECTION IN CARTRIDGE Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 88 micrograms/mL. 2 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. * 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. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 2 Aqra d-dokument sħiħ