EMEA issues Metalyse warning

Published: 18-Apr-2002


The European Medicines Evaluation Agency (EMEA) has publicised a warning made by German pharmaceutical company Boehringer Ingelheim International that users of its product Metalyse have been administering the drug incorrectly.

The product is dispensed using a vial and pre-filled syringe to administer the medicine. Patients have apparently not been pressing the syringe as deeply into the vial as they should.

According to the EMEA statement: 'Failure to complete these steps correctly can cause the solvent to leak, leading to an insufficient volume in the vial', and the subsequent administering of an incorrect dose. BI is currently redrafting its instructions for users, said the agency, which stressed that patients should check carefully for any leak.

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