GRANOCYTE 13
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
LENOGRASTIM
Available from:
Chugai Pharma UK Ltd
Dosage:
13 million IU/ML
Pharmaceutical form:
Pdr+Solv for soln for inf/inj
Authorization date:
2009-09-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lenograstim* (rHuG-CSF) 13.4 million International Units (equivalent to 105 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
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 13 million IU/mL can be us
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