Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Oncaspar 750 U/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear, colourless solution. |
One ml of solution contains 750 Units (U)** of pegaspargase*.
One vial of 5 ml solution contains 3,750 Units.
* The active substance is a covalent conjugate of Escherichia coli-derived L-asparaginase with monomethoxypolyethylene glycol
** One unit is defined as the quantity of enzyme required to liberate 1 μmol ammonia per minute at pH 7.3 and 37°C
The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see section 5.1.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegaspargase |
Pegaspargase is a covalent conjugate of Escherichia coli-derived L-asparaginase with monomethoxypolyethylene glycol. The mechanism of action of L-asparaginase is the enzymatic cleavage of the amino acid L-asparagine into aspartic acid and ammonia. Depletion of L-asparagine in blood results in inhibition of protein-synthesis, DNA-synthesis and RNA-synthesis, especially in leukaemic blasts which are not able to synthesise L-asparagine, thus undergoing apoptosis. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate monohydrate |
5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap.
Pack size of 1.
Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
EU/1/15/1070/001
Date of first authorisation: 14 January 2016
| Drug | Countries | |
|---|---|---|
| ONCASPAR | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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