Fasturtec 1.5mg powder and solvent for solution for infusion vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Rasburicase

Tilgængelig fra:

Sanofi

ATC-kode:

V03AF07

INN (International Name):

Rasburicase

Dosering:

1.5mg

Lægemiddelform:

Powder and solvent for solution for infusion

Indgivelsesvej:

Intravenous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 10010400; GTIN: 5000283109532

Indlægsseddel

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 hos-
pital 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 chemothera-
py 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 reac-
tions, such as severe anaphylaxis including anaphylactic shock
(sudden life-threatening or fatal allergic reactions).
TELL YOUR DOCTOR IMMEDIATELY if you notice any of the following
as you may need to stop treatm

Produktets egenskaber

OBJECT 1
FASTURTEC 1.5 MG/ML POWDER AND SOLVENT FOR
CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 04-Nov-2016 | SANOFI
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.
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
exact duration should be based upon
adequate monitoring of uric acid levels in plasma and c