Molgramostim (rHuGM-CSF)

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Description

Molgramostim is a recombinant human granulocyte macrophage colony stimulating factor (rHuGM-CSF), produced by recombinant DNA technology using E.coli. It is a 127 amino acid protein, non-glycosylated, and has a molecular weight of approximately 14.5kD.

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Indications

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 and white lyophilized powder to be reconstituted with a diluent (Sterile Water for Injection) for injection, presented in vials.

• Strength: 100μg, 300μg and 400μg
• Reference: Current EP/CP
• 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, Disodium Phosphate and Monobasic Potassium Phosphate.

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Shelf life and storage conditions

• Drug Product: Storage at 2-8°C for 36 months
• Drug Substance (Concentrated solution): Storage at?or?below -65°C for 12 months