FASTURTEC Powder and solvent for concentrate for solution for infusion Ref.[8536] Active ingredients: Rasburicase

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Sanofi-aventis groupe, 54, rue La Boétie, F-75008 Paris, France

Product name and form

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

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.

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.

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

Powder:

Alanine
Mannitol
Disodium phosphate dodecahydrate
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate

Solvent:

Poloxamer 188
Water for injection

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/00/170/001-002

Date of first authorisation: 23 February 2001
Date of latest renewal: 9 February 2006

Drugs

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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