Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INTERFERON BETA-1A
MERCK TBK - Indonesia
INTERFERON BETA-1A
22 MCG
INJEKSI
DUS, 3 PRE-FILLED SYRINGE @ 22 MCG (0,5 ML)
MERCK SERONO S.P.A. - Italy
2021-08-04
Page 1 of 9 REBIF INTERFERON BETA 1-A 1. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 5.1 List of Excipients. 2. 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. 3. CLINICAL PARTICULARS 3.1 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 4.1 Pharmacodynamic properties_). Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (_see_ _section 4.1 Pharmacodynamic properties_). 3.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. For patients initiating treatment with Rebif, Rebif 22 micrograms is available in a pack that corresponds to the patient needs for the first month of therapy. Posology When first starting treatment with Rebif, it is recommended that the dose be gradually increased in order to allow tachyphylaxis to develop thus reducing the risk of adverse reactions. It is recommended that 20% of the total dose be administered during the first 2 weeks of therapy, 50 % of the total dose be administered in weeks 3 and 4, and the full dose from the 5th week onwards. Relapsing multiple sclerosis Rebif 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. Paediatric population No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, a paediatric retrospective cohort study collected safety data with Rebif from med Izlasiet visu dokumentu