Direct Healthcare Professional Communication (DHPC) on mitomycin of the company Medac: Intravenous administration until further notice only with the use of a particle filter
2021.11.03
Active substance: mitomycine
The Direct Healthcare Professional Communication (DHPC) on restrictions on the use of mitomycin preparations of the company Medac GmbH for intravenous administration has been lifted. The use of a particle filter for intravenous administration is no longer required (see
information letter).
The company Medac GmbH informs that all mitomycin preparations of the company may only be administered intravenously using a particle filter (pore size 5 µm) until further notice. Within the framework of an ongoing stability programme, a result outside the specification was found on some batches with regard to the formation of visible particles. No negative effects are to be expected from the particles during intravesical application.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN