GRANOCYTE 34
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
LENOGRASTIM
Available from:
Chugai Pharma UK Ltd
Dosage:
34 million IU/ML
Pharmaceutical form:
Pdr+Solv for soln for inf/inj
Authorization date:
2009-09-01
Summary of Product characteristics
License
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 coll
Read the complete document
