Rebif 22mcg0.5ml solution for injection

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

RECOMBINANT HUMAN INTERFERON BETA

Inapatikana kutoka:

MERCK SDN. BHD.

INN (Jina la Kimataifa):

RECOMBINANT HUMAN INTERFERON BETA

Vitengo katika mfuko:

12Units Units; 1Units Units; 3Units Units; 3 Pieces Pieces; 1 Pieces Pieces; 12 Pieces Pieces

Viwandani na:

Merck Serono S.p.A.

Taarifa za kipeperushi

Consumer Medication Information Leaflet (RiMUP)
1
REBIF
®
SOLUTION FOR INJECTION
Interferon Beta-1a (22mcg, 44mcg per 0.5ml)
What is in this leaflet
1.
What Rebif is used for
2.
How Rebif works
3.
Before you use Rebif
4.
How to use Rebif
5.
While you are using Rebif
6.
Side Effects
7.
Storage and Disposal of Rebif
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What Rebif is used for
R
ebif is used in ambulatory people
who have relapsing forms of multiple
sclerosis (MS). It is also approved for
use in those who have experienced a
single clinical event likely to be a first
sign of multiple sclerosis.
How Rebif works
Rebif belongs to a class of medicine
known as interferons. The active
substance of Rebif is interferon beta-
1a, a recombinant human interferon
beta produced in Chinese hamster
ovary cells.
Rebif has been shown to reduce the
number of attacks that occur, decrease
the severity of attacks and increase the
time between attacks.
Treatment with Rebif also delays the
progression in disability and lowers
the number of times people need to be
hospitalised because of attacks.
Before you use Rebif
-
When you must not use it
Do not use if you have an allergy to:

interferon beta

any of the other ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itching or hives on the skin.
Do not use Rebif if:

you are feeling depressed (feeling of
severe sadness and unworthiness) or
have thoughts of suicide.

you are pregnant or intend to
become pregnant as there may be an
increased risk of spontaneous
abortion. Rebif may be considered
during pregnancy if clinically
needed.

you want to have children; you
should discuss this matter with your
doctor.

after the expiry date (EXP) printed
on the pack or if the packaging is torn
or shows signs of tampering.
If it has expired or is

Tabia za bidhaa

1
NAME OF THE MEDICINAL PRODUCT
Rebif 22mcg/0.5ml solution for injection
Rebif 44mcg/0.5ml solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe or prefilled pen (0.5 ml) contains 22 mcg (6 MIU*) or 44mcg (12 MIU*) of
interferon beta-1a**.
Each cartridge (1.5ml) contains 66mcg (18 MIU*) or 132mcg (36 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/0.5ml benzyl alcohol
For a full list of excipients, please see section List of excipients. PHARMACEUTICAL FORM
Solution for injection in pre -filled syringe or pre-filled pen.
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/l.
Solution for injection in cartridge
Clear to opalescent solution, with pH 3.7 to 4.1 and osmolarity 250 to 450 mOsm/l. CLINICAL PARTICULARS Therapeuti c indications
Rebif is indicated for the treatment of
• 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
clinically definite multiple sclerosis.
• patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more
acute exacerbations in the previous two years.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without
ongoing relapse activity. Posology and method of administration
Treatment should be initiated under supervision of physician experienced in the treatment of the disease.
Rebif is available in two strengths: 22 mcg and 44 mcg.
Posology
When first starting treatment with Rebif, in order to allow tachyphylaxis to develop thus reducing
adverse reactions, it is recommended that 8.8 mcg (0.1 ml of the 44 mcg strength or 0.2 ml o