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DIANEAL 1mmol Calcium in 2.5% Glucose Peritoneal dialysis solution standard single bag AHB8258, Baxter HealthcarePty Ltd, CON-550
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-550
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products that do not conform to the requirements of paragraphs 9(3)(a) and
9(3)(b) of Therapeutic Goods Order 91 with respect to the following paragraphs
8(1)(b) and 8(1)(n) - the label refers to the previous Australian Approved Name
(AAN) for glucose (monohydrate) and does not contain a machine readable
code;paragraphs 9(3)(a) and 9(3)(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; subsection 9(6) - the label does not
meet text size requirementsparagraphs 10(8)(b), 10(8)(e) and 10(8)(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