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Ergometrine maleate injection (500 microgram/mL) ampoule

Alternative product approved to address expected shortage

21 January 2021

Health professionals are advised that the Therapeutic Goods Administration (TGA) has authorised the supply of an alternative product to address an expected shortage of ergometrine maleate injection (500 microgram/mL).

Ergometrine is administered during obstetric procedures following the delivery of the placenta to promote involution of the uterus in order to treat haemorrhage.

DBL Ergometrine Injection (AUST R 58866) is the only registered ergometrine-only injection product marketed in Australia and is expected to be in shortage from 12 February 2021 until 18 June 2021. Updated information provided by the sponsor is available at ergometrine maleate - medicine shortage information.

The alternative product, Ergonovine maleate injection USP (0.25 mg/mL) ampoule, is usually only supplied overseas but has been approved under section 19A of the Therapeutic Goods Act 1989 for use during the shortage of DBL Ergometrine Injection (ergometrine maleate injection ampoule), AUST R58866.

It is important to note that the alternative product

  • uses a different name to identify the active ingredient
  • is a different concentration to the Australian registered medicine.

This table compares the Australian registered product to the overseas product:

Australian registered product
DBL Ergometrine Injection (AUST R: 58866)

Overseas product
Ergonovine maleate injection USP (0.25 mg/mL)

Name of active ingredient Ergometrine maleate Ergonovine maleate
Concentration 500 micrograms per millilitre 250 micrograms per millilitre
Ampoule volume 1 millilitre 1 millilitre

Health professionals should take care when using Ergonovine maleate injection USP (0.25 mg/mL) ampoule to ensure the correct dosage is used.

Information for health professionals

Link Medical Products has distributed a Dear Health Care Professional Letter that provides further information. Health professionals should contact Link Medical Products on 1800 181 060 for further information or to arrange supply.

Information about this section 19A approval has been published in the TGA's online Section 19A database.

Due to the difference in concentration, health professionals are reminded to take care when using Ergonovine maleate injection USP (0.25 mg/mL) ampoule to ensure the correct dosage is used, as detailed above.

Information for consumers

This medicine is only used in hospitals. If you have any questions or concerns about this issue, talk to your health professional.