BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Direct Healthcare Professional Communication (DHPC) Gliolan® (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non high-grade glioma

Active substance: 5-Aminolävulinsäure, 5-ALA

medac GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that it is basically unknown for how long useful fluorescence persists in tumour cells beyond the defined window of lucid contrast. If the surgery is delayed by more than 12 hours, surgery should be re-scheduled for the next day or later. Another dose of this medicine can be taken 2 – 4 hours before anaesthesia.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 470KB, File is accessible