Molgramostim (rHuGM-CSF)
l
Description
Molgramostim is a human
granulocyte macrophage colony-stimulating factor
(GM-CSF), produced by recombinant DNA technology
from E.coli. It is 127 amino acid protein,
non-glycosylated, and has
a molecular weight of
approximately 14.5kD.
The amino acid sequence is identical
to the natural, except for the addition of an
N-terminal methionine.
l
Indication
1.
In patients receiving myelosuppressive
therapy ( cancer chemotherapy ) to reduce the
severity of neutropenia, thereby reducing the risk
of infection and allowing better adherence to the
chemotherapeutic regimen;
2.
In patients undergoing autologous or
syngeneic bone marrow transplantation to accelerate
myeloid recovery (Molgramostim does not improve
overall survival or increase time to relapse);
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Pharmaceutical particulars
Sterile, white and preservative-free lyophilized
powder to be reconstituted with a diluent (Sterile
Water for Injection) for injection, presented in
vials.
Dosage: 75μg/vial, 150μg/vial, 300μg/vial and
400μg/vial
Reference: Current European
Pharmacopoeia and Internal Requirements
Specific activity: ≥1.0×107IU/mg
Purity
(HPLC,
SDS-PAGE):
≥98%
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Composition
Active
ingredients: Molgramostim (rHuGM-CSF)
Inactive ingredients: Mannitol, Macrogol 4000, Human
Albumin, Dibasic Sodium phosphate
and
Monobasic Potassium Phosphate.
l Shelf
life and storage conditions
| Finished
formulation |
Store
at 2-8℃
for 3 years |
| API
(Concentrated solution) |
Store
at -70℃
for 12 months |
+32 1658 9045
+32 1650 9045
