HPS Pharmacies wish to advise 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 – 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)
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|
Information about this section 19A approval has been published in the TGA’s online Section 19A database.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Link Medical Products on 1800 181 060 for further information or to arrange supply, or your pharmacist at HPS Pharmacies.