NANOGEN | Solution for injection FICOCYTE (Filgrastim 30 MU)

NANOGEN | Solution for injection FICOCYTE (Filgrastim 30 MU)

NANOGEN | Solution for injection FICOCYTE (Filgrastim 30 MU)

NANOGEN | Solution for injection FICOCYTE (Filgrastim 30 MU)

NANOGEN | Solution for injection FICOCYTE (Filgrastim 30 MU)

FICOCYTE

FICOCYTE

COMPOSITION
Each prefilled syringe of 0.5 mL contains:
Filgrastim   30 MU
DESCRIPTION
Filgrastim (recombinant methionyl human granulocyte - colony stimulating factor or rHu G - CSF ) is produced by recombinant DNA technology in Escherichia coli. 
Pharmacotherapeutic group: Agents/Cytokine  Haematopoietic
INDICATION
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 myelo dysplastic 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 (PBPC) . 
In patients 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 are inappropriate.
The safety and efficacy of FICOCYTE are similar in adults and children receiving cytotoxic chemotherapy.
CONTRAINDICATION
FICOCYTE should not be administered to patients: 
  • 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, SHELF LIFE, PACKING UNITS
Storage: 
Store at 2oC - 8oC. Do not freeze. Protect from light. The solution for injection should be inspected visually for particulate matters and discoloration before administration. 
Shelf life: 
24 months from manufacturing date. 
Packing units: 
Box of 01 prefilled syringe of FICOCYTE 30 MU solution for injection (0.5 mL).

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