Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Jazz Pharmaceuticals Ireland Ltd, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland
Enrylaze 10 mg/0.5 mL solution for injection/infusion.
| Pharmaceutical Form |
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Solution for injection/infusion. Clear to opalescent, colourless to slightly yellow solution with a pH of 7.0 ± 0.5 and an osmolality: 290–350 mOsmol/Kg. |
One vial contains 0.5 mL solution of 10 mg of recombinant crisantaspase*
The amino acid sequence is identical to native L-asparaginase from Erwinia chrysanthemi (also known as crisantaspase).
An in-vitro activity assay demonstrated that 1 mg of recombinant crisantaspase approximates 1 000 U of native crisantaspase, consistent with the in-vivo comparisons from clinical trials. Serum asparaginase activity (SAA) exposures (Cmax, concentration at 48h & 72h and AUC) have been shown to be comparable for 25 mg/m² recombinant crisantaspase and 25 000 U/m² native crisantaspase, when administered intravenously or intramuscularly in healthy subjects.
* recombinant Erwinia chrysanthemi L-asparaginase produced in Pseudomonas fluorescens by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Asparaginase |
Asparaginase hydrolyses asparagine to aspartic acid and ammonia. In contrast to normal cells, lymphoblastic tumour cells have a very limited capacity for synthesising asparagine because of a significantly reduced expression of asparagine synthetase. Therefore, they require asparagine which diffuses from the extracellular environment. As a result of asparaginase-induced asparagine depletion in serum, protein synthesis in lymphoblastic tumour cells is disturbed while sparing most normal cells. |
| List of Excipients |
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Trehalose dihydrate |
2 mL Type 1 clear borosilicate glass vial sealed with a halobutyl rubber stopper and aluminium overseal and a violet plastic cap.
Pack size: 3 vials.
Jazz Pharmaceuticals Ireland Ltd, 5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland
EU/1/23/1747/001
| Drug | Countries | |
|---|---|---|
| ENRYLAZE | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania |
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