EXTRANEAL 7.5% w/v icodextrin dialysis solution twin bag with drainage bag AHB9849, Baxter Healthcare Pty Ltd, CON-566
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-566
Standard
Paragraphs 8(1)(n), 9(3)(a), 9(3)(b), 9(6), 10(8)(b), 10(8)(e) and 10(8)(f) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
8(1)(n) the labels do not contain a machine readable code 9(3)(a) and (b) the
labels do not have each active and quantity together on separate lines 9(6) the
text size requirements are not met 10(8)(b), (e) and (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