Rebif solution for injection in pre-filled pen 44mcg/0.5ml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Interferon beta-1a

Disponível em:

MERCK PTE. LTD.

Código ATC:

L03AB07

Dosagem:

44 mcg/0.5mL

Forma farmacêutica:

INJECTION, SOLUTION

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Merck Serono S.A.

Data de autorização:

2014-03-13

Folheto informativo - Bula

1. 
NAME OF THE MEDICINAL PRODUCT 

Rebif 44 micrograms solution for injection in pre-filled pen 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each Rebif 44 micrograms solution for injection in pre-filled pen
contains 44 micrograms (12 MIU*) of interferon beta-1a** in 0.5 ml 
solution. 

* 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 pen. 
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: 22mcg and 44mcg. 

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