Shortage of DBL GENTAMICIN 10mg/1mL (as sulfate) injection BP ampoule and alternative supply arrangement under Section 19A of the Therapeutic Goods Act

LINK Healthcare has advised that, due to a shortage of Australian registered DBL GENTAMICIN 10mg/1mL (as sulfate) injection BP ampoule (AUST R 16339), LINK has arranged the supply of an alternative product REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules, registered and marketed in Germany.
 
REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules, is NOT registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 March 2021.
 
REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules is registered in Germany and the packaging displays text in the German language. This product will have a secondary label attached, containing the translation of important information including: active ingredient, strength (10 mg) and dosage form (2 mL) identified in English, with the addition of an overlabel on the package.
 
The Australian Product Information for gentamicin injection is available at https://www.ebs.tga.gov.au/.
 
For further information please contact LINK Healthcare Customer Service on 1800 181 060 or via email at customerservice@linkhealthcare.com.au.
 

 
Last updated 10:52 22.01.2021