SLEEP SAFE BALANCE 4.25% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag, Fresenius Medical Care Australia Pty Ltd, CON-918

The products do not conform to the requirements of Section 6, subsections 8(2), 9(3A), 9(6), 9(8) and 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(a), 9(1)(d), 10(8)(f) and 11(1)(c) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91), in that the products labels do not state the active ingredients in accordance with their Australian Approved Name, the medicine name is more prominent on the side panel rather than the main label, do not include the medicine name and dosage form as per the ARTG, do not include the storage conditions in the required format, do not state the name and contact details of the Australian sponsor or distributor, do not include a machine readable code, do not include space for a dispensing label, lists the name and quantity of active ingredients for the combined product and not that of individual components, are printed with active ingredients in a text size that does not meet the requirements, do not include the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' or words to this effect and do not express the units for volume in accordance with the required AAN format.