This information is being sent in agreement with the MHRA.
The Marketing Authorisation Holder would like to inform you of the following:
A correction has been made to the labelling of Prenoxad injection that addresses a historic error in how the product has been labelled.
The active substance in Prenoxad is naloxone hydrochloride.
The labelling now shows the strength as 0.91mg/ml from the previous 1mg/ml
There is no change in the product content or in the formulation of the product.
The change is in the way the drug product strength is presented in the product information.
The way the product is intended to be used and the dosing schedule remain unchanged.
There are no additional safety concerns due to this labelling error correction.
For more information, read the full letters: