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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenograstim* (rHuG-CSF) 33.6 million International Units (equivalent to 263 micrograms) per mL after reconstitution
*Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
Excipients known to have a recognised action or effect: phenylalanine
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion.
- White powder
- _Solvent: _clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
THERAPEUTIC INDICATIONS
Reduction in the duration of neutropenia in patients (with non myeloid malignancy) undergoing myeloablative
therapy followed by bone marrow transplantation (BMT) in patients considered to be at increased risk of
prolonged severe neutropenia.
Reduction of duration of severe neutropenia and its associated complications in patients undergoing established
cytotoxic chemotherapy associated with a significant incidence of febrile neutropenia.
Mobilisation of peripheral blood progenitor cells (PBPCs).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should only be given in collaboration with an experienced oncology and/or haematology centre.
GRANOCYTE can be administered by sub-cutaneous injection or by intravenous infusion. Particular handling of the
product or instructions for preparation are given in sections 6.6.
•
The recommended dose of GRANOCYTE is 150 µg (19.2 MIU) per m² per day, therapeutically equivalent to 5 µg
(0.64 MIU) per kg per day for:
- Peripheral stem cells or bone marrow transplantation
- established cytotoxic chemotherapy,
- PBPC mobilisation after chemotherapy.
GRANOCYTE 34 mi
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