The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for paracetamol solution for infusion and the risk of accidental overdosing of neonates, infants and underweight adults (due to medication errors following confusion between mg and ml).
The Danish Health and Medicines Authority has now translated this recommendation into Danish:
Paracetamol solution for infusion and risk of accidental overdosing of neonates, infants and underweight adults
The text is used to prepare new product information.
Furthermore, marketing authorisation holders of paracetamol solution for infusion must implement the new text by submitting variation applications for all relevant products.