APROTININ Solution for injection Ref.[6212] Active ingredients: Aprotinin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, the Netherlands

Product name and form

Aprotinin 10,000 KIU/ml Injection BP.

Pharmaceutical Form
Solution for Injection.

Qualitative and quantitative composition

Each 50ml vial contains aprotinin solution corresponding to 500,000 Kallikrein Inactivator Units, KIU (= 277.8 European Pharmacopoeia, E.P. units) aprotinin in 0.9% sodium chloride solution.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Aprotinin	Aprotinin is a broad spectrum protease inhibitor which has antifibrinolytic properties. By forming reversible stoichiometric enzyme-inhibitor complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein, thus inhibiting fibrinolysis.

List of Excipients
Sodium chloride Water for injections

Pack sizes and marketing

Clear glass vials of 50ml.

Marketing authorization holder

Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, the Netherlands

Marketing authorization dates and numbers

PL40621/0020

1^st April 2003

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