Direct Healthcare Professional Communication (DHPC) on Atropinsulfat 100 mg solution for injection: Risk of visible particles in the solution, use of a filter
2024.04.04
Active substance: Atropine sulfate
The company Dr. Franz Köhler Chemie GmbH informs about particle detected during the ongoing stability studies in the medicinal product Atropinsulfat 100 mg solution for injection, 5 x 10 ml and 25 x 10 ml. The root cause of the particle formation is currently suspected to be an interaction between the primary packaging and the components of the solution. Healthcare professionals are therefore requested to use a filter (pore size: 0.2 μm - 0.45 μm; filter material: polyethersulfone (PES), regenerated cellulose (RC) or nylon) when applying.
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