•    During stability studies, batches D210131C and D210131BC of Mitomycin Medac 10 mg showed an out of specification result with regard to visible particles.
•    In case of intravenous administration, if the solution is not filtered, the administered particles could lead to an increased risk of thromboembolic events in the capillary arteries.
•    The risk of thromboembolic events can be effectively prevented by using an appropriate particulate filter (5 µm pore size).
•    Following the discovery of visible particles in batches D210131C and D210131BC, corrective measures were implemented and the new batches in distribution did not show any criticality. However, pending final results and for greater precaution, it is advisable to use the particulate filter even on new batches being distributed.
•    The recommendation applies in case of intravenous use.
•    Filtration is not required for intravesical administration.
•    The ability of medac GmbH to supply mitomycin-based medicines is still guaranteed.