Please Note: Alternative supply arrangements under Section 19A of the Therapeutic Goods Act 1989 for registered medicines Baxter 0.9% Sodium Chloride Intravenous Infusion - ARTG 48515 (100mL) and ARTG 48520 (1000mL).
The above Australian registered medicines are in shortage due to unexpected increase in consumer demand.
Aborns Pharmaceuticals Pty Ltd has been able to arrange supply of Sodium Chloride 0.9% solution for infusion bag 100mL and 1000mL (Lavoisier, France) as alternative products on a temporary basis. These products are 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:
Indicated 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.
Sodium Chloride 0.9% solution for infusion bag 100mL and 1000mL (Lavoisier, France) are identical in active ingredient and strength to the Australian registered products. They are 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. The package leaflet is in the French language.
Specifications:
- Product: Sodium Chloride IV 0.9% Dual PP 100ml (10022742)
- Size: 100mL
- Sterility: Sterile
- Colour: Colourless
- Storage Conditions: Store below 25ºC
- Unit of Measurement: Box of 50
Image is a sample of the product
WARNING ALWAYS READ THE LABEL BEFORE USE
Please refer to the attached documents here.
Please Note: Alternative supply arrangements under Section 19A of the Therapeutic Goods Act 1989 for registered medicines Baxter 0.9% Sodium Chloride Intravenous Infusion - ARTG 48515 (100mL) and ARTG...
