The Italian Medicines Agency (AIFA) is making available an Important Safety Information Notice concerning Bendamustine Accord 25 mg/mL concentrate for solution for infusion to inform healthcare professionals about the risk of medication errors resulting from the concentration of this formulation compared with other authorised bendamustine-containing medicinal products.

Bendamustine Accord 25 mg/mL has a concentration that is ten times higher than that of other bendamustine-containing medicinal products. Errors during the preparation and dilution of the product may result in the administration of an incorrect dose, leading to overdose, serious adverse reactions and potentially fatal outcomes.

Healthcare professionals are advised to exercise particular caution during the preparation and dilution of the medicinal product. It should be noted that no reconstitution is required and that the product must be diluted exclusively with 9 mg/mL (0.9%) sodium chloride solution for injection to a final volume of approximately 500 mL, in accordance with the instructions provided in the Summary of Product Characteristics (SmPC). 

Further information is provided in the related document.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure continuous monitoring of drug safety and the protection of patient health.