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DIANEAL 1mmol Calcium in 2.5% Glucose Peritoneal dialysis solution standard single bag AHB8258, Baxter HealthcarePty Ltd, CON-568

Product name
DIANEAL 1mmol Calcium in 2.5% Glucose Peritoneal dialysis solution standard single bag AHB8258
Sponsor name
Baxter HealthcarePty Ltd
Consent start
Consent no.
CON-568
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
- 8(1)(b) and (n) the label refers to the previous AAN for glucose (monohydrate) and does not contain a machine readable code; - 9(3)(a) and (b) the label does not include the name of the medicine and the name of the actives and their quantities as a cohesive unit that is not separated by text or graphics; - 9(6) the label does not meet text size requirements - 10(8)(b), (e) and (f) the label provides an approximate osmolality value rather than milliosmoles per litre, does not include the statement 'Not to be used for Intravenous infusion' (has 'For intraperitoneal administration only' instead) and does not contain the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' (includes 'single dose' and 'sterile').
Therapeutic product type
Prescription medicines

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