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Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion
Fasturtec® 1.5 mg/ml powder and solvent for concentrate for solution for infusion
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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.
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:
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.
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
No information on the ability to drive and use machines is available.
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 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.
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):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Frequency not known (frequency cannot be estimated from the available data)
If you notice any of these, tell your doctor, nurse or hospital pharmacist.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
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
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in November 2022.