GRAN PRE-FILLED SYRINGE 30 mu/0.5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Filgrastim

Available from:

KYOWA HAKKO KIRIN (SINGAPORE) PTE. LTD.

ATC code:

L03AA02

Dosage:

30 mu/0.5 ml

Pharmaceutical form:

INJECTION, SOLUTION, CONCENTRATE

Administration route:

INTRAVENOUS, SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

F Hoffmann-LA Roche Ltd

Authorization date:

2007-03-23

Patient Information leaflet

GRAN
™
Filgrastim
1. DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Hematopoietic growth factor (Cytokines)
ATC code: L03AA02
1.2 TYPE OF DOSAGE FORM
_Single-use pre-fi lled syringes_
Gran solution for injection in pre-fi lled syringe of 0.5 ml.
1.3 ROUTE OF ADMINISTRATION
Intravenous infusion or subcutaneous injection.
1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ fi lgrastim (recombinant-methionyl human
granulocyte-
colony stimulating factor, r-metHuG-CSF, from E. coli K12).
Filgrastim is a highly purifi ed non-glycosylated protein
comprising 
175 amino acids. Filgrastim is produced in a laboratory strain of 
Escherichia coli bacteria which has been genetically altered by the 
addition of a gene for the granulocyte colony-stimulating factor.
_Pre-fi lled syringes_
1 pre-fi lled syringe of Gran of 0.5 ml contains 30 MU (= 300 μg)
of 
fi lgrastim. Excipients: sodium acetate*, sorbitol, polysorbate 80,
water 
for injection.
*Sodium acetate is formed by titrating glacial acetic acid with
sodium 
hydroxide
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
_Established cytotoxic chemotherapy_
Gran is indicated for 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 leukemia and myelodysplastic syndromes) and for the 
reduction in the duration of neutropenia and its clinical sequelae
in 
patients undergoing myeloablative therapy followed by bone marrow 
transplantation considered to be at increased risk of prolonged
severe 
neutropenia (see section 2.5.3 Pediatric Use).
_Peripheral blood progenitor cell mobilization (PBPC)_
Gran is indicated for the mobilization of autologous peripheral
blood 
progenitor cells alone, or following myelosuppressive chemotherapy 
and the mobilization of peripheral blood progenitor cells in normal 
donors (allogeneic PBPC).
_Severe chronic neutropenia (SCN)_
Long term administrat