Fasturtec

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Rasburicase

Fáanlegur frá:

Sanofi-Aventis Australia Pty Ltd

Tegund:

Medicine Registered

Upplýsingar fylgiseðill

FASTURTEC
®

_rasburicase_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fasturtec.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you using
Fasturtec against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FASTURTEC IS
USED FOR
Fasturtec contains rasburicase rys,
which is a recombinant urate-oxidase
enzyme. Fasturtec is used to prevent
or to decrease the high levels of uric
acid in your blood that can occur as a
result of chemotherapy for cancers of
the blood, such as leukemia or
lymphoma. Normal amounts of uric
acid in the blood are removed by the
kidneys. If there are high levels of
uric acid in the blood, your kidneys
may not be able to remove the
excess, and may be damaged.
Fasturtec converts uric acid into a
substance called allantoin, which is
easier for your kidneys to remove.
Your doctor may have prescribed
Fasturtec for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Fasturtec is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
FASTURTEC
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN FASTURTEC
IF YOU HAVE ANY OF THE FOLLOWING
CONDITIONS;
•
G6PD (glucose-6-phosphate
dehydrogenase) deficiency
•
Any condition that causes
haemolytic anaemia
DO NOT USE FASTURTEC IF YOU HAVE AN
ALLERGY TO IT, OTHER URICASES OR ANY
OF THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic reaction to
Fasturtec may include skin rash,
itchiness, shortness of breath, or
difficulty breathing.
DO NOT USE FASTURTEC IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
Fasturtec is not recommended

Vara einkenni

 
Fasturtec*  PI 
#63323v3.0 
Page _1 _
PRODUCT INFORMATION 
FASTURTEC 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Rasburicase rys for injection 
CAS NUMBER 
134774-45-1_ _
DESCRIPTION 
Fasturtec is a sterile  powder supplied in a stoppered clear glass
vial, accompanied by a 
solvent in a clear glass ampoule. 
The excipients contained in the Fasturtec 1.5 mg and 7.5 mg
vials are: alanine, mannitol, 
sodium phosphate-dibasic dihydrate, disodium phosphate-monobasic,
sodium 
phosphate-dibasic dodecahydrate.  The solvent contains poloxamer
and water for 
injections. 
1 mg of rasburicase corresponds to 18.2
EAU.  One enzyme activity unit (EAU) 
corresponds to the enzyme activity that converts 1µmol of uric acid
into allantoin per minute 
under the operating conditions described: +30ºC ± 1ºC TEA pH 8.9
buffer. 
PHARMACOLOGY 
PHARMACOLOGICAL ACTION 
Rasburicase is a recombinant urate-oxidase enzyme produced
by a genetically modified 
_Saccharomyces cerevisiae _
strain.  _  _Rasburicase is a tetrameric protein with identical 
sub-units of a molecular mass of about 34 kDa.  In humans, uric
acid is the final step in the 
catabolic pathway of purines.  The acute
increase in plasma levels of uric acid subsequent 
to the lysis of large numbers of malignant cells and during
cytoreductive chemotherapy may 
lead to degradation of renal function and renal failure which results
from the precipitation of 
crystals of uric acid in renal tubules.  Rasburicase is a
potent uricolytic agent that catalyses 
enzymatic oxidation of uric acid into allantoin,
a water soluble product, more easily excreted 
by the kidney in the urine.  The enzymatic oxidation of uric acid
leads to stoichiometric 
formation of hydrogen peroxide.  The increase of hydrogen peroxide
over ambient levels 
can be eliminated by endogenous antioxidants and the only
increased risk for haemolysis is 
in G6PD deficient and inherited anaemia patients.  
In h