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Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

5 March 2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule is not safe to be used for either the epidural or intrathecal routes.

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule is an unregistered product (sourced from overseas) that has been approved for use as an alternative product during the current shortage of DBL Morphine Sulfate 30 mg/1 mL injection BP ampoule.

DBL Morphine Sulfate 30 mg/1 mL injection BP ampoule is the only registered morphine 30 mg injection product marketed in Australia and is not expected to be available again until 30 May 2019.

In the meantime, the TGA has granted approval under Section 19A of the Therapeutic Goods Act 1989 to Link Medical Products to supply the alternative product, Morphine Sulfate Injection BP 30 mg in 1 mL ampoule, for the following indication:

  • For the relief of severe pain not responsive to non-opioid analgesics.

While Morphine Sulfate Injection BP 30 mg in 1 mL ampoule is a suitable alternative in most situations, there are critical formulation differences between it and the registered product that have potential patient safety implications.

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule contains preservative (unlike the DBL morphine product) which means it can only be administered intravenously, intramuscularly or subcutaneously.

Although DBL Morphine Sulfate 30 mg/1 mL injection has not been approved for use by the epidural or intrathecal routes, and references only intravenous, intramuscular and subcutaneous routes in its Product Information, the TGA is aware that there is some off-label use via the other two routes.

Below is a picture of the labelling for the Section 19A-approved product which includes an oversticker with a warning about this issue.

Information for consumers

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

Information for health professionals

Link Medical Products has distributed a Dear Health Care Professional Letter (pdf,179kb) which provides further information about this issue.

During the shortage, health professionals who would have used DBL Morphine Sulfate 30 mg/1 mL injection BP ampoule for the epidural or intrathecal routes should consider using other strengths of DBL Morphine products.

Link Medical Products can be contacted on 1800 181 060. Information about this Section 19A approval has been published in the TGA's online Section 19A database.

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.