BeneFIX

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

factor IX (Recombinant); Nonacog alfa

Verfügbar ab:

Pfizer Australia Pty Ltd

Klasse:

Medicine Registered

Gebrauchsinformation

BENEFIX
®

_nonacog alfa (rch) (recombinant coagulation factor IX), 250, 500,
1000, 2000, 3000 IU /vial_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about BeneFIX. It
does not contain all of the available
information. It does not take the
place of talking to your doctor or
hospital pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING BENEFIX, ASK YOUR DOCTOR OR
HOSPITAL PHARMACIST.
Your doctor and hospital pharmacist
have more information.
KEEP THIS LEAFLET WITH YOUR
BENEFIX.
You may need to read it again.
WHAT BENEFIX IS
BeneFIX, nonacog alfa (rch) is a
coagulation factor IX product that is
produced by recombinant
technology. Mammalian cells, which
have the DNA for human coagulation
factor IX put in them, are grown in
large amounts in cell culture
laboratories. These cells make
recombinant human factor IX, which
is released into cell culture media and
then very highly purified. The
recombinant factor IX does not
contain any human blood,
preservatives, or added animal or
human components.
WHAT BENEFIX IS USED
FOR
People with haemophilia B
(Christmas disease) are deficient in
coagulation factor IX. BeneFIX
works by replacing factor IX to
enable blood to clot.
BeneFIX is used for the control and
treatment of bleeding and the
prevention of bleeding in people with
haemophilia B.
BeneFIX has been approved for use
in haemophilia B. Ask your doctor if
you have any questions about why
BeneFIX has been prescribed for
you.
There is no evidence that BeneFIX is
addictive.
BeneFIX is not expected to affect
your ability to drive a car or operate
machinery.
BEFORE YOU USE
BENEFIX
_WHEN YOU MUST NOT USE IT_
DO NOT USE BENEFIX IF YOU ARE
ALLERGIC TO HAMSTER PROTEINS OR ANY
OF THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Signs of allergy include a skin rash,
itching, chest tightness, wheezing,
dizziness, hives, faintness, rapid
heartbeat, blurred vision, shortness of
breath and/or a swollen face. If any
of these signs occur, stop using
BeneFIX and see yo

Fachinformation

 
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Version : pfpbenev10813 
Supersedes: pfpbenev10511 

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PRODUCT INFORMATION 
BENEFIX


nonacog alfa (rch) 
NAME OF THE MEDICINE 
BeneFIX,  nonacog  alfa  (rch),  (recombinant  coagulation  factor  IX),  powder  and  solvent  for 
solution for injection.  (INN= nonacog alfa) 
DESCRIPTION 
BeneFIX, nonacog alfa is a purified protein produced by recombinant DNA technology for use in 
therapy of factor IX deficiency, known as haemophilia B or Christmas disease. Nonacog alfa is a 
glycoprotein with an approximate molecular mass of 55,000 Da consisting of 415 amino acids in 
a single chain. It has a primary amino acid sequence that is identical to the Ala 148 allelic form 
of plasma-derived factor IX, and has structural and functional characteristics similar to those of 
endogenous factor IX. 
BeneFIX is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is 
extensively characterised and shown to be free of infectious
agents. The stored cell banks are free 
of blood or plasma products. The
CHO cell line secretes recombinant factor IX into a
defined cell 
culture medium that does not contain any proteins derived from animal or human sources and the 
recombinant factor IX is purified by a chromatography purification process that does not require 
a monoclonal antibody step and yields a high-purity, active product. A membrane filtration step 
that has the ability to  retain molecules with  apparent  molecular weights  >70,000 (such as large 
proteins  and  viral  particles)  is  included  for  additional  viral  safety.  BeneFIX  is  predominantly  a 
single  component  by  SDS-polyacrylamide  gel  electrophoresis  evaluation.�