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Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Medicine shortage – product supplied under section 19A

22 October 2018

Consumers and health professionals are advised that Prenoxad 1 mg/mL solution for injection in a pre-filled syringe is in shortage as a result of a shipping delay. The interruption in supply began on 18 October 2018 and is expected to be resolved in mid-November 2018.

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.

Prenoxad 1 mg/mL solution for injection is not registered in Australia. It is supplied under section 19A of the Therapeutic Goods Act 1989 to help address a shortage of registered naloxone pre-filled syringe products.

Due to this, information about this shortage does not appear in the TGA’s Medicines Shortages Information Initiative, which only includes information about shortages of registered products.

The sponsor of Prenoxad 1 mg/mL solution for injection, Phebra, has written to health professionals and wholesalers providing information about this shortage.

Information for consumers

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals

If you have any questions or concerns about this issue, contact Phebra on 1800 720 020 or email orders@phebra.com.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.