Neupogen

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Filgrastim

Disponible des:

Amgen Australia Pty Ltd

clase:

Medicine Registered

Informació per a l'usuari

28 November 2008
CMI FOR NEUPOGEN
®
Page 1 of 8
Neupogen
®
1
NEUPOGEN
®
Filgrastim (rbe)
CONSUMER MEDICINE INFORMATION
A
WHAT IS IN THIS BOOKLET
This booklet answers some common
questions about NEUPOGEN
®
.
Please note that this booklet does
not contain everything there is to
know about NEUPOGEN
®
.  It does
not take the place of talking to your
doctor, nurse or pharmacist.
All medicines have risks and
benefits.  Your doctor has
prescribed NEUPOGEN
®
 after
considering its likely benefit to you,
as well as the potential risks.  IF YOU
HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, TALK TO YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS BOOKLET WITH YOUR
MEDICINE.  You may need to read
this information again.
1.
What NEUPOGEN
®
 is used for
How it works
2.
Before you use NEUPOGEN
®
When you must NOT use
NEUPOGEN
®
Before you start to use
NEUPOGEN
®
Taking other medicines
3.
How to use NEUPOGEN
®
How much to inject
Where to inject
When to inject
How long to use it
4.
Things to do before you
inject
How to prepare your
injection – NEUPOGEN
®
Ready to Use Syringe
How to prepare your
injection – NEUPOGEN
®
 in
a Vial
How to inject
If you forget your injection
If you inject too much
(Overdose)
5.
While you are using
NEUPOGEN
®
Things you must do
Things you must not do
6.
Side effects
7.
After using NEUPOGEN
®
Storage
Disposal
8.
Product description
What it looks like
Ingredients
Supplier
WHAT NEUPOGEN
®
 IS
USED FOR
Your doctor may have prescribed
NEUPOGEN
®
 because:
(1)
YOU ARE RECEIVING
CHEMOTHERAPY FOR CANCER
Unfortunately, some
chemotherapy will reduce the
number of neutrophils in your
body. Although NEUPOGEN
®
is not a treatment for cancer, it
does help the body to make
new neutrophils and this will
reduce your chance of
developing infections that
might require antibiotics and/or
hospital stays. It may even
increase your chance of
receiving your chemotherapy
on time and at the right dose.
(2) YOU ARE RECEIVING A BONE
MARROW OR STEM CELL
TRANSPLANT
Bl

Fitxa tècnica

 
NEUPOGEN
®
 (FILGRASTIM) PRODUCT INFORMATION  
PAGE 1 OF 21 

NAME OF THE DRUG 
NEUPOGEN
®
 is the Amgen Inc. trademark for filgrastim (rbe), a recombinant 
methionyl human granulocyte colony stimulating factor. 
DESCRIPTION 
NEUPOGEN
®
 (filgrastim) is a 175 amino acid protein
manufactured by recombinant 
DNA technology.  NEUPOGEN
®
 is produced by _Escherichia coli_ bacteria into which 
has been inserted the human granulocyte
colony stimulating factor gene.  It has a 
molecular weight of 18,800 daltons.  NEUPOGEN
®
 is unglycosylated and contains an 
N-terminal methionine necessary for expression in _E coli_. 
NEUPOGEN
®
 is a sterile, clear, colourless, preservative-free liquid for parenteral 
administration.  The product is available in single
use prefilled syringes and vials.  
The single use prefilled syringes contain either 300
µg or 480 µg filgrastim at a fill 
volume of 0.5 mL.  The single use vials contain
either 300 µg or 480 µg filgrastim at a 
fill volume of 1.0 mL or 1.6 mL, respectively. 
The specific activity of NEUPOGEN
®
 by in vitro proliferative cell assay is 1 x 
10
8 
IU/mg
when assayed against the WHO international standard for granulocyte 
colony stimulating factor, 88/502.  The clinical significance of this in
vitro potency 
assignment is unknown. 
COMPOSITION 
NEUPOGEN
®
 is formulated in
a 10 mM sodium acetate buffer at pH 4.0, containing 
5% sorbitol and 0.004% polysorbate 80.  The quantitative
composition for each single 
use syringe or vial is: 
SYRINGES 

300 ΜG/0.5 ML  480 ΜG/0.5 ML 
Filgrastim

300 µg 
480 µg 
Acetate

0.295 mg 
0.295 mg 
Sorbitol

25.0 mg 
25.0 mg 
Polysorbate 80

0.004% 
0.004% 
Sodium

0.0175 mg 
0.0175 mg 
Water for Injection USP q.s. ad

0.5 mL 
0.5 mL 

VIALS 

300 ΜG/ML 
480 ΜG/1.6 ML