Fasturtec

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Rasburicase 7.5mg

Disponibil de la:

sanofi-aventis new zealand limited

INN (nume internaţional):

Rasburicase 7.5 mg

Dozare:

7.5 mg

Forma farmaceutică:

Powder for infusion

Compoziție:

Active: Rasburicase 7.5mg Excipient: Alanine Dibasic sodium phosphate dihydrate Dibasic sodium phosphate dodecahydrate Mannitol Monobasic sodium phosphate Poloxamer 188 Water for injection

Unități în pachet:

Ampoule, glass, diluent, 1 dose unit

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Sanofi Chimie

Indicații terapeutice:

The treatment and prophylaxis of acute hyperuricaemia, in patients with haematological malignancy at risk of a rapid tumour lysis.

Rezumat produs:

Package - Contents - Shelf Life: Ampoule, glass, diluent - 1 dose units - 48 months from date of manufacture stored at or below 25°C - Combination pack, 1 vial powder + 1 ampoule - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, powder - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorizare:

2010-08-26

Prospect

FASTURTEC®
1
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 recommende

Caracteristicilor produsului

New Zealand Data Sheet
Fasturtec - rasburicase
fasturtec-ccdsv6-dsv4-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
FASTURTEC (POWDER FOR INFUSION)
Fasturtec 1.5mg powder for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
After reconstitution, 1 mL of Fasturtec powder for infusion contains:
1.5 mg rasburicase rys.
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.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for infusion.
Fasturtec is a sterile powder supplied in a stoppered clear glass
vial, accompanied by a solvent in
a clear glass ampoule. 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
Rasburicase is indicated for the treatment and prophylaxis of acute
hyperuricaemia, in patients
with haematological malignancy at risk of a rapid tumour lysis.
New Zealand Data Sheet
Fasturtec - rasburicase
fasturtec-ccdsv6-dsv4-20jun22
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Rasburicase is to be used immediately prior to and during the
initiation of chemotherapy only, as
at present, there is insufficient data to recommend multiple treatment
courses.
In patients who are not hyperuricemic at baseline, chemotherapy
regimens should be started
within 24 hours of first administration of rasburicase. In patients
who are hyperuricemic at
baseline, chemotherapy regimens should be started within 48 hours of
first administration of
rasburicase.
_CHILDREN AND ADULTS _
The recommended dose for rasburicase is 0.20 mg/kg/day. Rasburicase is
administered as a once
daily 30 minute intrave