PRODUCTS > THERAPEUTIC PRODUCTS

Haematopoietic agent (Anemia, neutropenia)

PEGCYTE

DESCRIPTION

Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (Filgrastim) and monomethoxypolyethylene glycol . Filgrastim is a water-soluble 175-amino-acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of Escherichia coli transformed with a genetically engineered plasmid containing the human G-CSF gene. The average molecular weight of pegfilgrastim is approximately 39 kD.

COMPOSITION

Each lyophilized powder vial contains:     Pegfilgrastim 6 mg and a solvent vial of 1 mL

Each glass vial of 1 ml contains:             Pegfilgrastim 6 mg

Each prefilled syringe of 0.5 ml contains: Pegfilgrastim 6 mg

THERAPEUTIC INDICATIONS

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Administration route:

SC  injection

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: Store at 2°C to 8°C. Do not freeze. Protect from light. The solution for injection should be inspected visually for particulates and discolouration before administration.

Shelf life:  24 months from manufacturing date.

Reconstituted solution is stable for 7 days at 2°C -8°C

Packing units:

Box of 01 vial of Pegcyte lyophilized powder + 1 vial of solvent 1 mL.

Box of 01 or 05 vial(s) of Pegcyte solution for injection (1 mL)

Box of 01 or 06 prefilled syringe(s) of Pegcyte solution for injection (0,5 mL)

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