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.
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.
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to firstname.lastname@example.org.
Medicines safety update - important information for health professionals
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.