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Water for injection and haemolysis

Medicines Safety Update

24 June 2020

Health professionals are reminded that water for injection can cause haemolysis resulting in patient harm, including death, if large quantities are inadvertently administered intravenously without being rendered isotonic.

Water for injection, which is hypotonic, is indicated for dissolving or diluting injectable therapeutic substances for parenteral administration (where water is a suitable solvent).

It is contraindicated for intravenous administration if it is not adjusted to isotonicity by the addition of suitable solutes.

The TGA is aware of international reports of mix-ups between 1 litre bags of water for injection and other 1 litre bags, including sodium chloride 0.9% and glucose 5%.

As with any therapeutic good, water for injection products should always be used in strict accordance with all instructions for using the product. All registered injection products in Australia with a volume of 100 mL or more are required to include a statement on the label if the injection is hypotonic, hypertonic or isotonic.

Always carefully check the label to ensure there is no confusion between water for injection and other IV bags.


What to report? You don't need to be certain, just suspicious!

The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.

We particularly request reports of:

  • all suspected reactions to new medicines
  • all suspected medicines interactions
  • suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

Reports may be submitted:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

© Commonwealth of Australia 2020

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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at .

Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.

Acting Editor: Dr Grant Pegg

Deputy Editor: Mr Michael Pittman

Contributor: Ms Rosemary Pascoe