Public Statement on Metalyse (Tenecteplase) - importance of correct product handling: syringe-vial assembly
News
The European Medicines Evaluation Agency (EMEA) has been informed by Boehringer Ingelheim International GmbH, the Marketing Authorisation Holder (MAH) for Metalyse, of four cases involving Metalyse which suggest that the instructions for use of the product may not have been followed appropriately.
The active substance of Metalyse is tenecteplase, an antithrombotic medicinal product. Metalyse is indicated for the thrombolytic treatment of acute myocardial infarction.
The EMEA wishes to draw users' attention to the instructions for use detailed in the pictogram on the inner lid of the folding box - in particular to steps two, three and four. The vial and pre-filled syringe must be firmly connected by pressing down the syringe until a “click” is noticed. Failure to complete these steps correctly can cause the solvent to leak leading to an insufficient volume in the vial.
Users should check carefully there is no leakage of fluid as this could result in a patient receiving the incorrect dose.
Boehringer Ingelheim International GmbH is currently in the process of re-emphasising these crucial steps in the instructions for use and handling in the Summary of Product Characteristics (SPC) and in the instructions for use detailed in the pictogram on the inner lid of the folding box. Furthermore, the MAH has brought this problem to the attention of health care providers.
If you experience the problem described in this statement, please contact Boehringer Ingelheim International GmbH and/or the National Health Authorities in your country.
The EMEA thought it necessary to provide this information to the public. The SPC and labelling text will be updated in line with this information and will shortly be available in the European Public Assessment Report for Metalyse on the EMEA website.
The current instructions for use and handling in the SPC and the instructions for use detailed in the pictogram on the inner lid of the folding box are attached for convenience.