FICOCYTE (Filgratism)

Each prefilled syringe of 0.5 mL contains:

Active ingredients: Filgrastim...............30 MU

Excipients: Sodium hydroxide, Glacial acetic acid, Sorbitol as Sorbitol Syrup, Polysorbate 80, Water for Injections,

Filgrastim (recombinant human granulocyte - colony stimulating factor, rHu G-CSF ) is produced by r-DNA technology in E.coli.

Filgrastim is supplied as an injectable solution in prefilled syringes. Injectable solution is sterile, clear and colorless.

INDICATIONS

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Mobilisation of peripheral blood progenitor cells (PBPCs).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5x10⁹/L, and a history of severe or recurrent infections, long term administration of FICOCYTE is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events .
Treatment of persistent neutropenia (ANC≤1.0 x10⁹/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options to manage neutropenia are inappropriate.
The safety and efficacy of FICOCYTE are similar in adults and children receiving cytotoxic chemotherapy.

Hypersensitivity to the active substance or to any of the excipients . FICOCYTE should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
With severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics.

Storage: Store at 2^oC - 8^oC. Do not freeze. Protect from light.

Shelf life: 24 months from manufacturing date.

Packing units: Box of 01 prefilled syringe of solution for injection FICOCYTE 30 MU (0.5 mL)