Please Note: Alternative supply arrangements under Section 19A of the Therapeutic Goods Act 1989 for registered medicine Baxter Sodium Chloride 0.9% Intravenous Infusion- ARTG 48520 (1000mL).
The above Australian registered medicine is in shortage due to an unexpected increase in consumer demand. Aborns Pharmaceuticals Pty Ltd has been able to arrange for supply of the following alternative product, registered and marketed in France, on a temporary basis:
Sodium Chloride 0.9% Bioluz, Solution for Infusion in Dual Access PVC Bag 1000ml (France). This product is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 30 April 2025 for the following indications:
- for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.
The s19A approved product is identical in active ingredient and strength to the Australian registered product. It is registered and marketed in France and therefore, all the labelling is in the French language. The name of the medicine and strength is identifiable in the English language to Australian Healthcare Professionals. The package leaflet is in the French language. The s19A medicine is in the form of solution for infusion bag with dual access, equipped with a collection site and an infusion site.
The key differences between the Australian registered products and the France registered products are outlined in the table below:
Specifications:
- Product: Sodium Chloride IV 0.9% Dual PVC 1000ml
- Size: 1000ml
- UOM: Box of 50
- Image is a sample of product
Warning: Always read the label and follow directions for use.
Please refer to the attached documents.
