A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rebif Online, Description, Chemistry, Ingredients - Interferon beta-1a
Rebif Online, Description, Chemistry, Ingredients - Interferon beta-1a
DESCRIPTION
Rebif® (interferon beta-1a) is a purified 166
amino acid glycoprotein with a molecular weight of approximately 22,500 daltons.
It is produced by recombinant DNA technology using genetically engineered Chinese
Hamster Ovary cells into which the human interferon beta gene has been introduced.
The amino acid sequence of Rebif® is identical to that of natural
fibroblast derived human interferon beta. Natural interferon beta and interferon
beta-1a (Rebif®) are glycosylated with each containing a single
N-linked complex carbohydrate moiety.
Using a reference standard calibrated against the World Health
Organization natural interferon beta standard (Second International Standard
for Interferon, Human Fibroblast GB 23 902 531), Rebif® has a
specific activity of approximately 270 million international units (MIU) of
antiviral activity per mg of interferon beta-1a determined specifically by an
in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis
virus. Rebif® 22 mcg and 44 mcg contains approximately 6 MIU
or 12 MIU, respectively, of antiviral activity using this method.
Rebif® (interferon beta-1a) is formulated as
a sterile solution in a prefilled syringe intended for subcutaneous (sc) injection.
Each 0.5 ml (0.5 cc) of Rebif® contains either 22 mcg or 44 mcg
of interferon beta-1a, 2 or 4 mg albumin (human) USP, 27.3 mg mannitol USP,
0.4 mg sodium acetate, Water for Injection USP.
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