Product Labelling Change
HPS Pharmacies wish to advise that Phebra has changed the labelling and formulation of Calcium Gluconate Injection as follows:
Calcium Gluconate Injection
Calcium gluconate 931mg/10mL
The following changes have been made:
- The original labelling was ‘Calcium Gluconate Injection 2.2 mmol of calcium in 10 mL’. The new labelling states ‘Calcium Gluconate Injection – calcium gluconate monohydrate 931 mg in 10 mL solution for injection’. The outer carton packaging and vials do still specify the concentration of calcium in mmol. However, this is not as prominent which may pose a safety risk; and
- The formulation has changed to improve stability. The concentration of calcium gluconate is now 931mg/10mL (previously 953mg/10mL) and the concentration of calcium saccharate is now 46mg/10mL (previously 30mg/10mL). However, there is no change to the overall calcium ion concentration of 2.2mmol calcium ions in 10mL. The new formulation is considered equivalent to the old formulation.
This packaging change (shown below) has occurred in order to align with the new labelling requirements in Therapeutic Goods Order No. 91. Other products are also expected to have labelling changes due to this updated order.
For further information, consult the updated Product Information.
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.
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