In use product safety assessment report for intravenous paracetamol in paediatrics

Varinder Rai, Regional Medicines Information Manager, London Medicines Information ServicePublished

In May 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety update to healthcare professionals in the UK highlighting the risk of accidental overdose of intravenous paracetamol in neonates, infants and children. Recently concerns have been raised within the NHS on intravenous paracetamol products and the potential risk of confusion between the two volumes (50mL and 100mL) available from single manufacturers.

This UKMi Product Safety assessment reviews practical in-use safety considerations associated with the use of intravenous paracetamol products in paediatrics. It also focuses on factors to consider in relation to safely picking the correct product prior to administration.Potential next steps and mitigation actions are suggested.

UKMi Product Safety assessments are produced using the validated UKMi product assessment tool.

NOTE: The content of this resource has not been updated since the publication date. Some information may be out of date and links to other documents or website may not work.

Perfalgan 10 mg/ml, solution for infusion: For business reasons, UK MA Withdrawal and cease to distribution is planned in the UK no later than 30 June 2020.