Shortage of DBL GENTAMICIN 10mg/1mL (as sulfate) injection BP ampoule and alternative supply arrangement under Section 19A of the Therapeutic Goods Act
Update 29 September 2022:
After ongoing supply issues, the product BL GENTAMICIN 10mg/1mL (as sulfate) injection BP ampoule (AUST R 16339), previously marketed by Pfizer, is now reported by the Therapeutic Goods Administration (TGA) as discontinued in Australia.
A new replacement product has been approved under Section 19A of the Therapeutic Goods Act 1989, to be supplied by Link Medical Products until 30 November 2022: Gentamicin Injection USP 10mg/mL (20 mg/2mL) (Teligent OU).
Warning: the replacement product Teligent OU contains the antioxidant sodium metabisulfite, which may cause bronchoconstriction if administered by inhalation. For more information, refer to the TGA Safety advisory. ANZCA notes that similar warnings have been issued for another gentamicin injection product at a different concentration – refer to our Safety alert on Gentamicin Injection USP 40 mg/mL (80mg/2mL).
This update supersedes previous advice of 20 November 2020 that the replacement product for DBL GENTAMICIN 10mg/1mL (as sulfate) injection BP ampoule (AUST R 16339) would be REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules.
The Australian Product Information for all currently registered (non-Section 19A) gentamicin injection products is available from the Australian Register of Therapeutic Goods. For information on supply of Gentamicin injection 10mg/1mL products in New Zealand, please refer to Pharmac New Zealand.