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SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL, Fresenius Kabi Australia Pty Ltd, CON-881
Product name
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL
Sponsor name
Fresenius Kabi Australia Pty Ltd
Batches
10QE6318
Consent start
Consent no.
CON-881
Duration
The consent is effective from 28 October 2021 until the batch number 10QE6318 has expired (30 April 2023) or until the batch is depleted, whichever is sooner.
Standard
Paragraphs 8(1)(i), 8(1)(n), 10(2)(a), 10(2)(f), 10(6)(b) and 10(6)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform with the requirements of the paragraphs 8(1)(i),
8(1)(n), 10(2)(a), 10(2)(f), 10(6)(b) and 10(6)(c) of Therapeutic Goods Order
No. 91 - Standard for labels of prescription and related medicines the
requirements of in that The name and contact details of the Australian sponsor
or distributor are not included; There is no machine-readable code on the
primary pack label; The quantity of each excipient in the stated volume of fill
of the injection in the container is not listed; The statements use in one
patient on one occasion only. Contains no antimicrobial preservative are not
included; There is no statement specifying the injection is hypertonic; The
statement of energy equivalent is not stated in kilojoules.
Conditions imposed
1. Supply and use of this batch are restricted to the circumstances proposed in
the application (use in compounding facilities only).
2. The affected batch will be labelled with the 'English neutral label'.
3. The AUST R will be over-stickered on the carton.
4. The receiving manufacturers will be advised of the situation and will be
instructed to keep the bags in the cartons labelled with the AUST R number
until required for use.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines