DBL AMIKACIN 500mg/2mL (as sulfate) injection vial, Pfizer Australia Pty Ltd, CON-1224
Product name
DBL AMIKACIN 500mg/2mL (as sulfate) injection vial
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1224
Standard
Paragraph 9(1)(a), subparagraph 10(3)(a)(i), paragraph 10(3)(b), paragraph 9(1)(e) and paragraph 10(4)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply with the above requirements of the TGO 91 because
the product will be supplied with the UK label which has the following
differences: - The name of the product is expressed as Amikacin in place of DBM
Amikacin Injection - The carton doesn't state the quantity of the medicine (5
vials) - The name and quantity of each excipient is not included on the carton
or vial - There is no 'Contains no antimicrobial preservative' statement - The
vial does not contain the correct sponsor details, only including Hospira when
the sponsor is Pfizer.
Conditions imposed
1. The Dear Healthcare Provider (DHCP) letter is identical to that provided to
the Therapeutic Goods Administration on 15 March 2024 will be supplied with
each affected batch describing the differences in the labels and requesting
the package leaflet be disposed and directing user to the Australian PI on
the TGA website.
2. The carton label will include over-stickers with the following information:
* The Australian Sponsor details on the carton
* The number for the medicine
* Signal Heading as required by the Therapeutic Goods (Poisons
Standard'”February 2024) Instrument 2024
* Schedule 1 of the TGO 91 required information '“ 'Contains Sulfites'
* A direction to not administer the product undiluted
Therapeutic product type
Prescription medicines