Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter
2024.05.27
Active substance: disodium folinate
In the updated DHPC medac GmbH informs about changes for additionally usable filter material and the pore size of the filter. Healthcare professionals are requested to use particle filters made of PVDF or PES (pore size ≤ 5.0 μm) for infusions and bolus injections until further notice.
DHPC - 2024.05.15
With the DHPC of 2024-05-15 the company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion. The root cause of the particles is an interaction between the primary packaging material and the active substance. Healthcare professionals are therefore requested to use particle filters for infusions and bolus injections until further notice.