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
Leukine Online, Description, Chemistry, Ingredients - Sargramostim
Leukine Online, Description, Chemistry, Ingredients - Sargramostim
DESCRIPTION
Leukine®(sargramostim) is a recombinant
human granulocyte-macrophage
colony stimulating factor
(rhu GM-CSF) produced by recombinant
DNA technology in a yeast
(S. cerevisiae) expression
system. GM-CSF is a hematopoietic growth factor
which stimulates proliferation
and differentiation
of hematopoietic progenitor cells. Leukine is a glycoprotein
of 127 amino acids characterized by 3 primary
molecular species having
molecular masses of 19,500, 16,800 and 15,500 daltons. The amino
acid sequence
of Leukine differs from the natural human
GM-CSF by a substitution
of leucine at position
23, and the carbohydrate moiety
may be different from the native
protein. Sargramostim has been selected as the proper name for yeast-derived
rhu GM-CSF.
The Leukine Liquid presentation
is formulated as a sterile,
preserved (1.1% benzyl
alcohol) injectable
solution (500 mcg/mL)
in a vial. Lyophilized Leukine is a sterile,
white, preservative-free, powder
(250 mcg) that requires reconstitution with 1 mL Sterile Water for
Injection, USP or 1 mL Bacteriostatic Water for Injection, USP.
Leukine Liquid and reconstituted lyophilized Leukine are clear
colorless liquids suitable for subcutaneous
injection or intravenous
infusion. Leukine Liquid contains 500 mcg
(2.8 x 106 IU/mL) sargramostim and 1.1% benzyl alcohol
in a 1 mL solution. The vial
of lyophilized Leukine contains 250 mcg
(1.4 x 106 IU/vial) sargramostim. The Leukine liquid
vial and reconstituted lyophilized Leukine vial
also contain 40 mg/mL mannitol, USP; 10 mg/mL sucrose, NF; and 1.2
mg/mL tromethamine, USP as excipients. Biological potency
is expressed in International Units (IU) as tested against the WHO
First International Reference Standard. The specific
activity of Leukine
is approximately 5.6 x 106 IU/mg.
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