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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);

 

 

l        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%

 

l      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
 

 

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Last modified: 05/19/16