STAY SAFE BALANCE 4.25% glucose 1.25mmol/L calcium peritoneal dialysis solution bag, Fresenius Medical Care Australia Pty Ltd, CON-1409
Product name
STAY SAFE BALANCE 4.25% glucose 1.25mmol/L calcium peritoneal dialysis solution bag
Sponsor name
Fresenius Medical Care Australia Pty Ltd
Consent start
Consent no.
CON-1409
Duration
The consent is effective from 15 September 2025 until 30 September 2026.
Standard
Section 6; Subsections 8(2), 9(3A), 9(6), 9(8) and 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(a), 9(1)(d), 10(8)(f) and 11(1)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because the labels: • do not state the active
ingredients in accordance with their Australian Approved Name (AAN). • the
medicine name is more prominent on the side panel rather than the main label. •
do not include the medicine name and dosage form as per the ARTG. • do not
include the storage conditions in the required format. • do not state the name
and contact details of the Australian sponsor or distributor. • do not include a
machine readable code. • do not include space for a dispensing label. • list the
name and quantity of active ingredients for the combined product and not that of
individual components. • are printed with active ingredients in a text size that
does not meet the requirements. • do not include the statement “Use in one
patient on one occasion only. Contains no antimicrobial preservative” or words
to this effect. • do not express the units for volume in accordance with the
required AAN format.
Conditions imposed
The sponsor will apply an over sticker that includes the Registration number
(AUST R) for the goods along with the sponsor contact details. A letter will be
supplied with each affected batch.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines