EXTRANEAL 7.5 % w/v icodextrin dialysis solution twin bag with drainage bag AHB9849, Baxter Healthcare Pty Ltd, CON-554
Product name
EXTRANEAL 7.5 % w/v icodextrin dialysis solution twin bag with drainage bag AHB9849
Sponsor name
Baxter Healthcare Pty Ltd
Consent start
Consent no.
CON-554
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not comply with the requirements of the Therapeutic Goods Order
91 with respect to the following paragraph 8(1)(n) - the labels do not contain a
machine readable codeparagraphs 9(3)(a) and 9(3)(b) - the labels do not have
each active and quantity together on separate lines subsection 9(6) - the text
size requirements are not met paragraphs 10(8)(b), 10(8)(e) and 10(8)(f) - the
labels include approximate osmolality, do not include the statement 'Not to be
used for intravenous infusion' (has 'for intraperitoneal administration only')
and do not include the statements 'Use in one patient on one occasion only.
Contains no antimicrobial preservative' (includes 'Single dose' and 'Sterile').
Therapeutic product type
Prescription medicines