REBIF

Krajina: Indonézia

Jazyk: indonézština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktívna zložka:

INTERFERON BETA-1A

Dostupné z:

MERCK TBK - Indonesia

INN (Medzinárodný Name):

INTERFERON BETA-1A

Dávkovanie:

22 MCG

Forma lieku:

INJEKSI

Počet v balení:

DUS, 3 PRE-FILLED SYRINGE @ 22 MCG (0,5 ML)

Výrobca:

MERCK SERONO S.P.A. - Italy

Dátum Autorizácia:

2021-08-04

Súhrn charakteristických

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