Labelling Change for Sodium Bicarbonate 8.4% Injection

HPS Pharmacies wish to advise that Phebra has changed the labelling of Sodium Bicarbonate 8.4% Injection as follows:

Phebra Sodium Bicarbonate 8.4% Vial
Sodium bicarbonate 8.4g/100mL
ARTG 48376

The carton and vial labels have been amended to give more prominence to the mmol concentration of sodium and bicarbonate ions. Phebra confirms that each 100mL vial of Sodium Bicarbonate 8.4% Injection contains 100 mmol of sodium ions and 100 mmol of bicarbonate ions.

To ensure uninterrupted supply, Phebra will continue to supply product from the current batch (batch number 14994) which only expresses the mmol strength within the content on the main panel. Future batches will have the mmol strength displayed more prominently adjacent to the medicine name.

This packaging change has occurred in order to align with the new labelling requirements in Therapeutic Goods Order No. 91.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
 
Should you require further information regarding this matter, please contact Phebra on 1800 720 020 or your pharmacist at HPS Pharmacies.