SPECTRILA Powder for concentrate for solution for infusion (2019)
Product Name and Form
Spectrila 10,000 U powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion.
Qualitative and Quantitative Composition
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.
Pack sizes and Marketing
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: email@example.com
14 January 2016