Direct Healthcare Professional Communication (DHPC) on Trisenox® (arsenic trioxide): risk of medication errors due to the introduction of a 2 mg/ml vial replacing the 1 mg/ml glass vial
2020.03.31
Active substance: arsenic trioxide
Teva B.V. (Marketing Authorisation Holder of Trisenox®) in agreement with the European Medicines Agency (EMA) and Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Risk for medication errors exists since Trisenox® (arsenic trioxide) will be replaced by a new presentation containing double concentration. 1 mg/ml single-use 10 ml ampoule (containing 10 mg of arsenic trioxide) will be replaced by 2 mg/ml single-use 6 ml vial (containing 12 mg of arsenic trioxide). The two different concentrations will temporarily coexist on the market.
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