SLEEP SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag, Fresenius Medical Care Australia Pty Ltd, CON-759
Product name
SLEEP SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag
Sponsor name
Fresenius Medical Care Australia Pty Ltd
Batches
(Product code F00002202)
Consent start
Consent no.
CON-759
Standard
Section 6, subsections 8(2), 9(3A), 9(6), 9(8) 11(5); and paragraphs 8(1)(a), 8(1)(d), 8(1)(h), 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 (TGO 91)
Non-compliance with standard
The carton labels for the SLEEP SAFE BALANCE 1.5%, 2.3% 4.25% (92934,
92937 92943) products and the STAY SAFE BALANCE 4.25% (AUST R
92959) product do not include the Australian approved name for the active
ingredient 'Sodium bicarbonate', medicine name is more conspicuous on the side
panel rather than the main panel, do not include the name of the medicine and
the name of the dosage form as per the ARTG, do not include the storage
conditions in the required format (92943 and 92959 only), a
machine readable code is not included, space for a dispensing label is not
included, includes the active ingredients for the combined product rather than
the two separate components, the text size for the active ingredients 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,
and the units of measurement for volume are not in accordance with the required
AAN format (eg. mL is mentioned as ml). The carton labels for the STAY SAFE
BALANCE 1.5% 2.3% (92945 92956) products includes the medicine
name more conspicuous on the side panel rather than the main panel, do not
include the name of the medicine and the name of the dosage form as per the
ARTG, space for a dispensing label is not included, includes the active
ingredients for the combined product rather than the two separate components,
the text size for the active ingredients does not meet the requirements, and do
not include the statement 'Use in one patient on one occasion only. Contains no
antimicrobial preservative' or words to this effect. The bag labels for the
SLEEP SAFE BALANCE 1.5%, 2.3% 4.25% (92934, 92937 92943)
products and the STAY SAFE BALANCE 4.25% (92959) product do not include
the Australian approved name for the active ingredient 'Sodium bicarbonate', do
not include the storage conditions in the required format (92943 and AUST
R 92959 only), do not include the name of the dosage form as per the ARTG, do
not include the statement 'Use in one patient on one occasion only. Contains no
antimicrobial preservative' or words to this effect, and the units of
measurement for volume are not in accordance with the required AAN format (eg.
mL is mentioned as ml). The bag labels for the STAY SAFE BALANCE 1.5% 2.3% (AUST
R 92945 92956) products do not include the name of the dosage form as per
the ARTG, and do not include the statement 'Use in one patient on one occasion
only. Contains no antimicrobial preservative' or words to this effect.
Conditions imposed
The labels to which this consent applies are those provided as part of the
application.
Therapeutic product type
Prescription medicines