REBIF 22 PRE-FILLED SYRINGE 22 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:

22 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:

1999-04-05

Folheto informativo - Bula

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 (0.5ml) contains 22 micrograms (6 M IU*)
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 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.  
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 escalated in order to allow tachyphylaxis to develop
thus 
reducing adverse reactions, it is recommended that 8.8 mcg (0.1