Fasturtec1.5 mg/ml powder and solvent for concentrate forsolution for infusion

Fasturtec contains the active ingredient rasburicase.
Rasburicase is used to treat or prevent high blood levels of uric acid from occurring in patients 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.

Do not use Fasturtec if you:

• are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of Fasturtec
• have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally broken down).

Take special care with Fasturtec 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 as Fasturtec can cause allergic-type reactions, including severe cases.

It is not known whether the chance of developing an allergic reaction is increased if treatment with Fasturtec is repeated.

In case of disorders of the blood in which red blood cells are abnormally broken down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia), your doctor will immediately and permanently discontinue treatment with Fasturtec.

Using other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast feeding

Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

No information on the ability to drive and use machines is available.

Fasturtec is to be given to you before or during the start of your course of chemotherapy.

Fasturtec is injected slowly into a vein, which should take about 30 minutes.

Your dose will be calculated according to your body weight.
The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.

It will be given once a day, for up to 7 days.
During treatment with Fasturtec, your doctor will carry out blood tests to check the levels of uric acid and decide how long you will be treated for.
Your doctor may also test your blood to make sure that you do not develop any blood disorders.

If you use more Fasturtec than you should

If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any symptoms that follow.

If you have any further questions on the use of this product, ask your doctor, nurse or hospital pharmacist.

Like all medicines, Fasturtec can cause side effects, although not everybody gets them. Fasturtec will be administered at the same time as other medicines that may also cause side effects.

If you suddenly notice:

• a swelling of the face, lips, tongue or other part of your body
• a shortness of breath, wheezing or breathing problems
• a rash, itching or hives tell your doctor, nurse or hospital pharmacist immediately as these may be signs of a serious allergic reaction (anaphylaxis). These are rare (affecting between 1 in 1,000 and 1 in 10,000 patients).

Common side effects (affecting between 1 in 10 and 1 in 100 patients):

• high fever
• allergic reactions, mainly rashes and urticaria.

Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 patients):

• severe allergic reaction, such as low blood pressure (hypotension) and wheezing or difficulty in breathing (bronchospasm)
• severe diarrhoea
• severe vomiting
• severe nausea
• severe headache
• blood disorders such as a disorder of the blood in which red blood cells are abnormally broken down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia).

Rare (affecting between 1 in 1,000 and 1 in 10,000 patients):

• runny or blocked nose, sneezing, facial pressure or pain (rhinitis).

If you notice any of these, tell your doctor, nurse or hospital pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or hospital pharmacist.

Keep out of the reach and sight of children.

Do not use Fasturtec after the expiry date which is stated on the carton.
Store in a refrigerator (2 °C ? 8 °C).
Do not freeze.
Store in the original package in order to protect from light.
Do not use Fasturtec if you notice that the solution is unclear and/or contains particles.

What Fasturtec contains

• The active substance is rasburicase 1.5 mg/ml. Rasburicase is produced by genetechnology in a microorganism named Saccharomyces cerevisiae.
• The other ingredients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
• The other ingredients of the solvent are: poloxamer 188, water for injection.

What Fasturtec looks like and contents of the pack

Fasturtec is provided as a powder for concentrate for solution for infusion (powder for sterile concentrate) with a solvent.
The powder is an entire or broken white to off white pellet.
The solvent is a colourless and clear liquid.

Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent. The powder is supplied in 3 ml clear glass vial with a rubber stopper and the solvent in a 2 ml clear glass ampoule.

Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent. The powder is supplied in 10 ml clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

sanofi-aventis
174, avenue de France
F-75013 Paris
France

Manufacturers

Glaxo Wellcome Production
1, rue de l?Abbaye
F-76960 Notre Dame de Bondeville
France

Gruppo Lepetit s.r.l.
Località Valcanello
03012 Anagni (FR)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien

sanofi-aventis Bulgaria EOOD . 359 02 970 53 00 Magyarország sanofi-aventis zrt., Magyarország Tel. 36 1 505 0050

eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022

Danmark sanofi-aventis Denmark AS Tlf 45 45 16 70 00 Nederland sanofi-aventis Netherlands B.V. Tel 31 0182 557 755

Deutschland Sanofi-Aventis Deutschland GmbH Tel 49 0180 2 222010 Norge sanofi-aventis Norge AS Tlf 47 67 10 71 00

Eesti sanofi-aventis Estonia OÜ Tel 372 627 34 88 Österreich sanofi-aventis GmbH Tel 43 1 80 185 0

sanofi-aventis AEBE 30 210 900 16 00 Polska sanofi-aventis Sp. z o.o. Tel. 48 22 280 00 00

España sanofi-aventis, S.A. Tel 34 93 485 94 00 Portugal sanofi-aventis - Produtos Farmacêuticos, S.A. Tel 351 21 35 89 400

România sanofi-aventis România S.R.L. Tel 40 0 21 317 31 36 France sanofi-aventis France Tél 0 800 222 555 Appel depuis létranger 33 1 57 63 23 23

Ireland sanofi-aventis Ireland Ltd. Tel 353 0 1 403 56 00 Slovenija sanofi-aventis d.o.o. Tel 386 1 560 48 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel 421 2 57 103 777

Italia sanofi-aventis S.p.A. Tel 39 02 393 91 SuomiFinland sanofi-aventis Oy PuhTel 358 0 201 200 300

sanofi-aventis Cyprus Ltd. 357 22 871600 Sverige sanofi-aventis AB Tel 46 08 634 50 00

Latvija sanofi-aventis Latvia SIA Tel 371 67 33 24 51 United Kingdom sanofi-aventis Tel 44 0 1483 505 515

Lietuva

UAB sanofi-aventis Lietuva
Tel: +370 5 2755224

This leaflet was last approved in {MM/YYYY}

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The following information is intended for medical or healthcare professionals only: See section 3 ?How to use Fasturtec? and practical information on preparation and handling given below.

Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule). Reconstitution results in a solution with a concentration of 1.5 mg/ml to be further diluted with sodium chloride 9 mg/ml (0.9%).

Reconstitution of the solution:
Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Do not shake.
Inspect visually prior to use. Only clear and colourless solutions without particles should be used. For single-use only, any unused solution should be discarded.
The solvent contains no preservative. Therefore the reconstituted solution should be diluted under controlled and validated aseptic conditions.

Dilution before infusion:
The required volume of the reconstituted solution depends on the patient's body weight. The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration. The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ml (0.9%) solution to make a total volume of 50 ml. The concentration of rasburicase in the final solution for infusion depends on the patient's body weight.

The reconstituted solution contains no preservative. Therefore the diluted solution should be infused immediately.

Infusion:
The final solution should be infused over 30 minutes.

Sample handling:
If it is necessary to monitor a patient?s uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte. Blood must be collected into pre-chilled tubes containing heparin anticoagulant. Samples must be immersed in an ice/water bath. Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4 °C). Finally, plasma must be maintained in an ice/water bath and analysed for uric acid within 4 hours.