Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fasturtec

Document Subject

Generated Narrative: MedicinalProductDefinition mp111cffde6ab225ef6f9090cd3d257fe8

identifier: http://ema.europa.eu/identifier/EU/1/00/170/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-111cffde6ab225ef6f9090cd3d257fe8

identifier: http://ema.europa.eu/identifier/EU/1/00/170/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - fasturtec

Attesters

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

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.

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 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 treatment:

• swelling of the face, lips, tongue or throat
• coughing or wheezing
• difficulty in breathing or swallowing
• rash, itching or hives (nettle-type rash) on the skin

These may be the first signs that a severe allergic reaction is happening. Your treatment with Fasturtec may need to be stopped, and you may need further treatment. 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.

Other medicines and Fasturtec
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 contains sodium This medicine contains up to 10.5 mg sodium, (main component of cooking/table salt) per vial. This is equivalent to 0.53% of the recommended maximum daily dietary intake of sodium for an adult.

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 are given more Fasturtec than you should be 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 medicine, ask your doctor, nurse or hospital pharmacist.

Like all medicines, this medicine 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 (may affect up to 1 in 1,000 people).

Very common side effects (may affect more than 1 in 10 people):

• diarrhoea
• vomiting
• nausea
• headache
• fever

Common side effects (may affect up to 1 in 10 people):

• allergic reactions, mainly rashes and urticaria.

Uncommon side effects (may affect up to 1 in 100 people):

• severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock (frequency not known) which may be fatal
• low blood pressure (hypotension)
• wheezing or difficulty in breathing (bronchospasm)
• blood disorders such as a disorder of the blood in which red blood cells are abnormally broken down (haemolysis), destroyed (haemolytic anaemia), or abnormal blood pigment levels (methaemoglobinaemia)

fits (convulsion).

Rare (may affect up to 1 in 1,000 people):

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

Frequency not known (frequency cannot be estimated from the available data)

• involuntary muscle movements (muscle contraction involuntary).

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

Reporting of side effects If you get any side effects, talk to your doctor, nurse or hospital pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 this medicine 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 gene technology 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 2 ml or 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 Winthrop Industrie 82 avenue Raspail 94250 Gentilly France

Manufacturers

Sanofi S.r.l. Via Valcanello, 4 03012 Anagni (FR) Italy

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

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g sanofi-aventis zrt. Tel.: +36 1 505 0Danmark Sanofi- A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: + 39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 Nederland Sanofi B.V. Tel: +31 (0)20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis
: +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia sanofi S.r.l. Tel: 800536Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: