Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: medac Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100, E-mail: contact@medac.de
Spectrila 10,000 U powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White powder. |
Each vial contains 10,000 units of asparaginase*.
One unit (U) is defined as the quantity of enzyme required to liberate one μmol ammonia per minute at pH 7.3 and 37°C.
After reconstitution each ml contains 2,500 units of asparaginase.
* Produced in Escherichia coli cells 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 |
|---|
|
Sucrose |
Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.
Each pack contains either 1 or 5 vials. Not all pack sizes may be marketed.
medac Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100, E-mail: contact@medac.de
EU/1/15/1072/001
EU/1/15/1072/002
14 January 2016
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