Neulastim Pre-filled Syringe 6mg0.6ml

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Pegfilgrastim

Доступно од:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

АТЦ код:

L03AA13

Дозирање:

6mg

Фармацеутски облик:

INJECTION, SOLUTION

Састав:

Pegfilgrastim 6mg/0.6ml

Пут администрације:

SUBCUTANEOUS

Тип рецептора:

Prescription Only

Произведен од:

Amgen Manufacturing, Limited

Статус ауторизације:

ACTIVE

Датум одобрења:

2006-04-20

Информативни летак

 
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 �

Карактеристике производа

1
NEULASTIM
®
Pegfilgrastim
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Haematopoietic 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 20 mg/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 leukaemia 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 in oncology and/or
haematology.
2
2.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 1.5.
2.4
WARNINGS AND PRECAUTIONS
2.4.1
GENERAL
In order to improve the traceability of granulocyte-colony stimulating
factors (G-CSFs), the trade name
of the administered product should be clearly recorded in the patient
file.
Limited clinical data suggest a comparable effect on time to recovery
of severe neutropenia for
pegfilgrastim to