Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Sanofi-aventis groupe, 54, rue La Boétie, F-75008 Paris, France
Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
| Pharmaceutical Form |
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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. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Rasburicase |
Rasburicase is a highly potent uricolytic agent that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, easily excreted by the kidneys in the urine. |
| List of Excipients |
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Powder: Alanine Solvent: Poloxamer 188 |
Fasturtec is supplied as a 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 (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent. The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
Not all pack sizes may be marketed.
Sanofi-aventis groupe, 54, rue La Boétie, F-75008 Paris, France
EU/1/00/170/001-002
Date of first authorisation: 23 February 2001
Date of latest renewal: 9 February 2006
| Drug | Countries | |
|---|---|---|
| FASTURTEC | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom |
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