Fasturtec

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

rasburicase

Saadav alates:

Sanofi Winthrop Industrie

ATC kood:

V03AF07

INN (Rahvusvaheline Nimetus):

rasburicase

Terapeutiline rühm:

All other therapeutic products

Terapeutiline ala:

Hyperuricemia

Näidustused:

Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.

Toote kokkuvõte:

Revision: 30

Volitamisolek:

Authorised

Loa andmise kuupäev:

2001-02-23

Infovoldik

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
FASTURTEC 1.5 MG/ML POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION
FOR INFUSION
rasburicase
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or hospital
pharmacist.
-
If you get any side effects, please talk to your doctor, nurse or
hospital pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fasturtec is and what it is used for
2.
What you need to know before you are given Fasturtec
3.
How to use Fasturtec
4.
Possible side effects
5.
How to store Fasturtec
6.
Contents of the pack and other information
1.
WHAT FASTURTEC IS AND WHAT IT IS USED FOR
Fasturtec contains the active ingredient rasburicase.
Rasburicase is used to treat or prevent high blood levels of uric acid
from occurring in adults, children
and adolescents (aged 0 to 17 years) with disorders of the blood cells
(haematological diseases) who
are about to receive or are receiving chemotherapy treatment.
When chemotherapy is given, cancer cells are destroyed, releasing
large amounts of uric acid into the
bloodstream.
Fasturtec works by allowing uric acid to more easily be removed from
the body by the kidneys.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FASTURTEC
DO NOT USE FASTURTEC IF YOU
:
-
are
ALLERGIC
(hypersensitive) to rasburicase, other uricases or any of the other
ingredients of this
medicine (listed in section 6).
-
have a history of
HAEMOLYTIC ANAEMIA
(an illness caused by red blood cells being abnormally
broken down).
WARNING AND PRECAUTIONS
Talk to your doctor, nurse or hospital pharmacist if you have a
history of any kind of allergy.
Tell your doctor if you have ever had any allergic type reactions due
to other medicines; Fasturtec can
cause allergic-type reactions, such as severe anaphylaxis including
anaphylactic

Toote omadused

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fasturtec
_ _
1.5 mg/ml powder and solvent for concentrate for solution for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fasturtec is a recombinant urate-oxidase enzyme produced by
genetically modified
_Saccharomyces _
_cerevisiae _
strain. Rasburicase is a tetrameric protein with identical subunits of
a molecular mass of
about 34 kDa.
After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg
rasburicase.
1 mg corresponds to 18.2 EAU*.
*One enzyme activity unit (EAU) corresponds to the enzyme activity
that converts 1 µmol of uric acid
into allantoin per minute under the operating conditions described:
+30 °C ± 1 °C TEA pH 8.9 buffer.
Excipient(s) with known effect:
Each 1.5 mg/ml vial contains 0.091 mmol of sodium, which is 2.1 mg of
sodium and 7.5 mg/5 ml vial
contains 0.457 mmol of sodium, which is 10.5 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion (powder
for sterile concentrate).
The powder is an entire or broken white to off white pellet.
The solvent is a colourless and clear liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent
acute renal failure, in adults,
children and adolescents (aged 0 to 17 years) with haematological
malignancy with a high tumour
burden and at risk of a rapid tumour lysis or shrinkage at initiation
of chemotherapy.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fasturtec is to be used immediately prior to and during the initiation
of chemotherapy only, as at the
present, there is insufficient data to recommend multiple treatment
courses.
The recommended dose for Fasturtec is 0.20 mg/kg/day. Fasturtec is
administered as a once daily
30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml
(0.9%) solution (see section
6.6).
The duration of treatment with Fasturtec
_ _
may be up to 7 days, the