其 他 安 全 警 示
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| Australia: Safety Alert: Potential contamination of some saline products with Ralstonia pickettii (English only) |
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Therapeutic Goods Administration (TGA) is aware of Ralstonia pickettii cases in patients across multiple states and territories. TGA is working closely with state and territory health departments to investigate the possible role of therapeutic goods.
On 24 Nov 2023, TGA took the precautionary measure of initiating a nationwide quarantine for some Interpharma saline products to minimise possible risk to patients. This decision was made after the investigation identified that some batches of these products were likely to have been used in a cluster of patients who tested positive for R. pickettii.
The link between these cases and the Interpharma products has not yet been confirmed and therefore the goods have not been recalled from the market at this time.
As at 28 Nov 2023, the quarantine affects 3 products on the Australian Register of Therapeutic Goods (ARTG). These are:
- Sodium Chloride 0.9% 10 ml ampoules (AUST R 235989) (batch numbers: 2304400, 301530, 2301531, 2207874)
- Sodium Chloride 0.9% 30 ml ampoules (ARTG entries 370471 and 370408) (all batches)
The sponsor of these products, Interpharma Pty Ltd, is working with TGA as part of the investigation.
R. pickettii is a bacteria commonly found in the natural environment. It rarely causes infection in humans but may cause infection in people with weakened immune systems.
TGA will publish updates as new information becomes available.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/safety-alert-potential-contamination-some-saline-products-ralstonia-pickettii
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Nov 29, 2023
Issued at HKT 16:00
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