DIANEAL Low Calcium with 4.25% w/v Glucose Peritoneal Dialysis Solution bag AHB9355/9796/9604 /9358, Baxter HealthcarePty Ltd, CON-568
Product name
DIANEAL Low Calcium with 4.25% w/v Glucose Peritoneal Dialysis Solution bag AHB9355/9796/9604 /9358
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