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VAMIN 18 ELECTROLYTE FREE 500 mL injection bottle, Fresenius Kabi Australia Pty Ltd, CON-932
Product name
VAMIN 18 ELECTROLYTE FREE 500 mL injection bottle
Sponsor name
Fresenius Kabi Australia Pty Ltd
Consent start
Consent no.
CON-932
Duration
The consent is effective from 26 April 2022 until 31 December 2023.
Standard
Paragraphs 8(1)(h), 8(1)(i) and 10(2)(f) of Therapeutic Goods Order 91 (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of Paragraphs 8(1)(h), 8(1)(i)
and 10(2)(f) of Therapeutic Goods Order 91, in that the product labels (carton
and bottle) do not include the storage conditions applicable to the medicine
i.e., ‘Store below 25°C. Do not freeze’; do not include the Australian sponsor
details; and do not include the statement ‘Use in one patient on one occasion
only. Contains no antimicrobial preservative’ or words to that effect.
Conditions imposed
1. A customer letter identical to that provided in the email correspondence to
the TGA dated 21 April 2022 will be supplied with each affected batch.
2. Supply and use of the above referenced batch are restricted to the
circumstances proposed in the application [use in the compounding facility
(Slade Health) only].
3. The AUST R will be over-stickered on the carton as advised in your
application dated 5th April 2022.
4. The labels to which this consent applies are those provided with the
application in the email correspondence dated 5th April 2022.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines