SPECTRILA Powder for concentrate for solution for infusion

Active ingredients: Asparaginase

Product name and form

Spectrila 10,000 U powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White powder.

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.

Active Ingredient
Description

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

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/15/1072/001
EU/1/15/1072/002

14 January 2016