Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
rasburicase
Sanofi Winthrop Industrie
V03AF07
rasburicase
All other therapeutic products
Hyperuricemia
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Revision: 30
Authorised
2001-02-23
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER FASTURTEC 1.5 MG/ML POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION rasburicase READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or hospital pharmacist. - If you get any side effects, please talk to your doctor, nurse or hospital pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 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 1. WHAT FASTURTEC IS AND WHAT IT IS USED FOR 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FASTURTEC 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 Izlasiet visu dokumentu
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fasturtec _ _ 1.5 mg/ml powder and solvent for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified _Saccharomyces _ _cerevisiae _ strain. Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa. After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase. 1 mg corresponds to 18.2 EAU*. *One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer. Excipient(s) with known effect: Each 1.5 mg/ml vial contains 0.091 mmol of sodium, which is 2.1 mg of sodium and 7.5 mg/5 ml vial contains 0.457 mmol of sodium, which is 10.5 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate). 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 Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Fasturtec is to be used immediately prior to and during the initiation of chemotherapy only, as at the present, there is insufficient data to recommend multiple treatment courses. The recommended dose for Fasturtec is 0.20 mg/kg/day. Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml (0.9%) solution (see section 6.6). The duration of treatment with Fasturtec _ _ may be up to 7 days, the Izlasiet visu dokumentu