NEUPOGEN PRE-FILLED SYRINGE 48 mu0.5 ml

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

FILGRASTIM

Fáanlegur frá:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

ATC númer:

L03AA02

Skammtar:

48 mu/0.5 ml

Lyfjaform:

INJECTION

Samsetning:

FILGRASTIM 48 mu/0.5 ml

Stjórnsýsluleið:

INTRAVENOUS, SUBCUTANEOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

Amgen Manufacturing Limited

Leyfisstaða:

ACTIVE

Leyfisdagur:

1999-03-01

Upplýsingar fylgiseðill

 
1 
NEULASTIM®                          
Pegfilgrastim                        

1. 
DESCRIPTION 
1.1 
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG 
Hematopoietic growth factor 
Pharmacotherapeutic group: Cytokines, ATC Code: L03AA13 

1.2 
TYPE OF DOSAGE FORM 
Solution for injection in pre-filled syringe. 

1.3 
ROUTE OF ADMINISTRATION 
Subcutaneous injection. 

1.4 
STERILE / RADIOACTIVE STATEMENT 
Sterile. 

1.5 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
6 mg of pegfilgrastim in 0.6 ml (10 mg/ml*) solution for injection. 
* Based on protein only. The concentration is 20mg/ml if the PEG moiety is included. 
Pegfilgrastim  is  composed  of  filgrastim  (recombinant  methionyl  human  G-CSF)  with  a  20  kDa 
polyethylene glycol (PEG) molecule covalently bound to the N-terminal methionine residue.  
Filgrastim is produced by recombinant DNA technology in E. coli (K12). 
Excipients: Sodium acetate** Sorbitol, Polysorbate 20, Water for injections.  
**Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide. 

2. 
CLINICAL

PARTICULARS 
2.1 
THERAPEUTIC INDICATION(S) 
Reduction  in  the  duration  of  neutropenia  and  the  incidence  of  febrile  neutropenia  in  patients 
treated  with  cytotoxic  chemotherapy  for  malignancy  (with  the  exception  of  chronic  myeloid 
leukemia and myelodysplastic syndromes).  

2.2 
DOSAGE AND ADMINISTRATION 
Adults (≥ 18 years): One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended 
for  each  chemotherapy  cycle,  administered  as  a  subcutaneous  injection  approximately  24  hours 
following cytotoxic chemotherapy. 
Neulastim  therapy  should  be  initiated  and  supervised  by  physicians  experienced �

Vara einkenni

1
NEUPOGEN
®
Filgrastim
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Haematopoietic growth factor (Cytokines)
ATC code:
L03AA02
1.2
TYPE OF DOSAGE FORM
_Single-use vials _
Neupogen vial of 1.0 ml or 1.6 ml solution for injection.
_Single-use pre-filled syringes _
Neupogen solution for injection in pre-filled syringe of 0.5 ml.
1.3
ROUTE OF ADMINISTRATION
Intravenous infusion or subcutaneous injection.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
filgrastim (recombinant-methionyl human granulocyte-colony stimulating
factor,
r-metHuG-CSF, from
_E. coli_
K12).
Filgrastim is a highly purified 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.
_Vials _
1 vial of Neupogen of 1.0 ml injection solution contains 30 MU (= 300

g) of filgrastim.
1 vial of Neupogen of 1.6 ml injection solution contains 48 MU (= 480

g) of filgrastim.
_Pre-filled syringes _
1 pre-filled syringe of Neupogen of 0.5 ml contains 30 MU (= 300

g) of filgrastim.
1 pre-filled syringe of Neupogen of 0.5 ml contains 48 MU (= 480

g) of filgrastim.
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 _
Neupogen 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 leukaemia and myelodysplastic syndromes)
and for the reduction in the
duration of neutropenia and its clinical sequelae in patients
undergoing myeloablative therapy
2
followed by bone marrow transplantation considered to be at increased
risk of prolonged severe
neutropenia (see section 2.5.3 Paediatric Use).
_Perip