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Paracetamol infusion dosage for babies labelled ten times correct amount on patient information leaflet

By Costanza Pearce

04 Mar 2019

An error on the patient information leaflet (PIL) for a paracetamol infusion product lists the maximum dosage for babies as ten times the correct amount, the Medicines & Healthcare products Regulatory Agency (MHRA) has warned in a Class 4 drug alert.

The dosage table on the incorrect PIL gives a maximum volume of paracetamol solution for babies and infants weighing 10kg or less as 75ml rather than 7.5ml, according to the manufacturer Accord Healthcare Limited.

The error applies to the 50ml vial of paracetamol solution for infusion that is not currently marketed but shares a PIL with the 100ml vial.

The affected products are:

Paracetamol 10mg/ml Solution for Infusion

MAH Holders:

Actavis Group PTC ehf, PL 30306/0391

Accord Healthcare Limited, PL 20075/0701

The MHRA said: ‘The 100ml vial is restricted for use in adults, adolescents and children weighing more than 33kg but we cannot rule out the possibility that it is being used for the treatment of term newborn infants, infants, toddlers and children weighing 33kg or less.’

A corrected PIL can be accessed here.

All unexpired batches manufactured by Accord Healthcare Limited or Actavis Group PTC ehf are affected.

Distribution of affected batches will cease once corrected stock becomes available, anticipated in the second quarter of 2019.

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