REBIF 44 PRE-FILLED SYRINGE 44 mcg/0.5 ml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

INTERFERON BETA-1A

Disponível em:

MERCK PTE. LTD.

Código ATC:

Pending

Dosagem:

44 mcg/0.5 ml

Forma farmacêutica:

INJECTION

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Merck Serono S.p.A

Data de autorização:

1999-10-27

Folheto informativo - Bula

1. 
NAME OF THE MEDICINAL PRODUCT 

Rebif 44 micrograms solution for injection in pre-filled syringe 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each pre-filled syringe (0.5ml) contains 44 micrograms (12 MIU*)
of interferon beta-1a**. 

* Million International Units, measured by cytopathic effect
(CPE) bioassay against the in-house IFN 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: 2.5 mg benzyl alcohol 
For a 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  
x 
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 relapsing multiple sclerosis (see section 5.1) 
x 
patients with 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 two strengths: 22 mcg and 44 mcg.  

When first starting treatment with Rebif, in order
to allow tachyphylaxis to develop thus reducing adverse reactions
it is 
recommended that patients be started at 8.8 micrograms dose
subcutaneously and the dose be increased over a 4 we