APROTININ Solution for injection

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.

List of Excipients

Sodium chloride
Water for injections

Pack sizes and marketing

Clear glass vials of 50ml.

Marketing Authorization Holder
Authorization Dates

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

1st April 2003

Marketing authorization number: