Correction made to Prenoxad Injection (naloxone) following a historic error in the drug product labelling -

Correction made to Prenoxad Injection (naloxone) following a historic error in the drug product labelling
Information type: Safety alerts
Source: Martindale Pharma
Specialities: Emergency medicine and urgent care
Summary
Due to an historic error, Prenoxad labelled as 1mg/mL naloxone hydrochloride actually contained 0.91 mg/mL naloxone hydrochloride. A reformulation of 1mg/ml has been made to address this issue. The way the product is intended to be used and the dosing schedule remain unchanged.
UKMi comment
The MHRA has directed that the product be reformulated to contain 1 mg/mL naloxone hydrochloride. 'New formulation' will appear on the packaging to differentiate between product that has already been released to market and the reformulated product. There are no additional safety concerns due to this reformulation, and the old formulation may still be used in the meantime. However please note that while this change is being undertaken, the information in the PIL/Labelling will not match that in the SPC.
Related links: Communication to patients, carers and community workers who have been supplied with the product Communication to Non-medical practitioners involved in treatment services, Wholesalers and other direct purchasing groups