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Direct Healthcare Professional Communication on the correction made to the Prenoxad Injection following a historic error in the drug product labelling.
Naloxone Hydrochloride, Prenoxad Injection, label correction
Dear Healthcare Professional,
Summary:
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 an 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.
Information on the safety concern:
· As there is no change in the product formulation, there are no implications as regards to clinical effect
· There is no change in the way the product is intended to be used, as clinical titration will ensure the patient receives enough naloxone.
· The dosing schedule remains unchanged.
· The PIL will be updated to reflect the correct drug product strength.
Further information:
· Prenoxad injection is to be reformulated to contain 1mg/mL naloxone hydrochloride, and the labelling of batches after reformulation will reflect this. While this is being undertaken, the information in the PIL/Labelling will not match that in the SmPC.
Prenoxad Injection is intended for emergency use in the home or other non-medical setting by appropriate individuals or in a health facility setting for the complete or partial reversal of respiratory depression induced by natural and synthetic opioids, including methadone, diamorphine (diacetylmorphine (INN)) and certain other opioids such as dextropropoxyphene and certain mixed agonist/antagonist analgesics: nalbuphine and pentazocine.
For this reason Prenoxad Injection should be carried by persons at risk of such events.
It may also be used for the diagnosis of suspected acute opioid overdose.1
The Prenoxad injection SmPC/PIL can be accessed via the following links:
SmPC: https://www.medicines.org.uk/emc/medicine/27616
PIL: link will be provided once revised PIL is approved
Call for reporting:
As a reminder, there is a need to report any suspected adverse reactions to the MHRA via the Yellow Card Scheme Website: http://www.mhra.gov.uk/yellowcard.
Pharmacovigilance department in Aurum Pharmaceuticals Ltd (an entity of Martindale Pharma):
Email:
Please contact Martindale Pharma Medical Information at for all medical enquiries.
References:
1. Prenoxad SmPC : - https://www.medicines.org.uk/emc/medicine/27616
2. Prenoxad PIL:_ link will be provided once revised PIL is approved
Note: Following approval of this letter by the MHRA, this letter will be published on the company website as well.
Macarthys Laboratories Ltd TA Martindale Pharma. Registered office: Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom. Registered in England No. 620024 VAT registration No. 701 7252 70