1.5 mg / ml powder and concentrate for solution for infusion . 
rasburikas

1. What Fasturtec is and what it is used for

Fasturtec contains the active substance rasburikas. 
Rasburikas are used to treat or prevent high levels of uric acid in the blood of adults, children, and adolescents (aged 0-17 years). High levels of uric acid may occur in connection with chemotherapy for diseases that affect the blood cells(hematological diseases).

With chemotherapy, cancer cells are destroyed, which leads to large amounts of uric acid in the bloodstream. 
Fasturtec makes it easier for uric acid to be removed from the body via the kidneys.

2. What you need to know before using Fasturtec

Do not use Fasturtec:

  • if you are allergic (hypersensitive) to rasburikas, another urikas, or any of the other ingredients of this medicine (listed in section 6)
  • if you have had hemolytic anemia (a disease caused by an abnormal breakdown of red blood cells ).

Warnings and cautions

Talk to your doctor, nurse, or pharmacist if you have any kind of allergy. 
Tell your doctor if you have ever had an allergic reaction to any medicine; Fasturtec can cause allergic 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 breathing or swallowing
  • skin rash, itching, or hives ( hives ) on the skin

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

It is not known if the risk of having an allergic reaction is greater if treatment with Fasturtec is repeated.

Should blood disorders occur where red blood cells are broken down abnormally ( hemolysis ) or at abnormal levels of blood pigments (methemoglobinemia), your doctor will immediately and permanently discontinue treatment with Fasturtec.

Other medicines and Fasturtec

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

Pregnancy and breastfeeding

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

Driving and using machines

There is no information available on driving ability and the use of machines.

Fasturtec contains sodium

This medicine contains up to 10.5 mg sodium (the main ingredient in cooking/table salt) per vial. This corresponds to 0.53% of the recommended maximum daily intake of sodium for an adult.

3. How to use Fasturtec

Fasturtec will be given to you before your treatment or at the beginning of your treatment with chemotherapy.

Fasturtec is injected slowly into a blood vessel, which usually takes about 30 minutes.

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

Given once daily, for up to 7 days. 
During treatment with Fasturtec, your doctor will take blood samples to check your uric acid levels and decide how long you should be treated. 
Your doctor may also check your blood to check that you are not developing any blood diseases.

If you take more Fasturtec then you should

If this happens, your doctor will closely monitor the effects on your red blood cells and treat any symptoms that may occur.

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

4. Possible side effects

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

If you suddenly notice:

  • swelling of the face, lips, tongue, or other body parts
  • shortness of breath, wheezing, or difficulty breathing
  • rash, itching, or hives

Tell your doctor, nurse, or pharmacist immediately as this may be a sign of a severe allergic reaction (anaphylactic shock ). These are rare (may affect up to 1 in 1,000 people).

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

  • diarrhea
  • vomiting
  • nausea
  • headache
  • fever

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

  • allergic reactions, mainly rash and hives.

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

  • severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock (frequency unknown) which may be fatal
  • low blood pressure ( hypotension )
  • wheezing or difficulty breathing ( bronchospasm )
  • blood diseases such as a disease that affects red blood cells and causes them to be broken down abnormally ( hemolysis ), destroyed ( hemolytic anemia ), or abnormal levels of blood pigments (methemoglobinemia).
  • seizures (convulsions)

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

  • runny or stuffy nose, sneezing, pressure over the face, or pain ( rhinitis ).

No known frequency (frequency can not be calculated from available data)

  • involuntary muscle movements (involuntary muscle contraction)

If you notice any of these side effects, talk to your doctor, nurse, or pharmacist.

5. How to store Fasturtec

Keep out of sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month. 
Store in a refrigerator (2 ° C-8 ° C) 
Do not freeze. 
Store in the original package. Sensitive to light.

Do not use this medicine if you notice that the solution is a discolored solution and/or contains particles.

6. Contents of the packaging and other information

Content declaration

  • The active substance is rasburikas 1.5 mg/ml. Rasburikas is made from a genetically modified microorganism called Saccharomyces cerevisiae.
  • The other ingredients in the powder are alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
  • The other ingredients in the solvent are poloxamer 188 and water for injections.

What the medicine looks like and the contents of the pack

Fasturtec is supplied as a powder for concentrate for solution for infusion (powder for sterile concentrate) with a solvent. 
The powder is white to off-white crushed or whole grains. 
The diluent is clear and colorless.

One pack contains 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml of diluent . The powder is delivered in a 3 ml clear glass vial with a rubber stopper and the diluent in a 2 ml clear glass ampoule.

One pack contains 1 vial of 7.5 mg rasburikase and 1 ampoule of 5 ml of diluent . The powder is supplied in a 10 ml clear glass vial with a rubber stopper and the diluent in a 5 ml clear glass ampoule.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

sanofi-aventis groupe 
54, rue La Boétie 
F-75008 Paris 
France

Manufacturer

Sanofi Srl

Via Valcanello, 4 
03012 Anagni (FR) 
Italy

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Sanofi AB

Tel: +46 (0) 8 634 50 00

Muhammad Nadeem

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