European Union — Reteplase (Rapilysin®) has been marketed in 15 European Union countries since 1996 for thrombolytic therapy of acute myo-cardial infarction for use within 12 hours of onset of symptoms. The European Medicines Evaluation Agency (EMEA) has received 4 reports concerning a precipitation of reteplase suspected to be due to an incompatibility with heparin when combined in intravenous solution.

As a similar risk for other incompatibilities may also exist, no other medication should be added to the reteplase injection solution. As an urgent measure, the prescribing and patient information has been modified accordingly.

Reference: EMEA Public Statement, EMEA/39890/99, 23 December 1999.