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Direct Healthcare Professional Communication (DHPC) on melphalan hydrochloride, Melphalan AqVida 90 mg/ml concentrate for solution for infusion: potential risk of overdose due to higher concentration

Active substance: melphalan hydrochloride

AqVida GmbH in agreement with the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Melphalan AqVida RTD 90 mg/ml is a one-vial melphalan formulation as a concentrate

for solution for infusion with a concentration of 90 mg/ml. Alkeran and other melphalan formulations have a final concentration of 5 mg/ml after reconstitution. Due to the 18-fold higher concentration, the introduction of this new product bears a

potential risk of overdose.

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