To address the anticipated supply interruption of Pfizer Gentamicin ampoules from Nov 2024 to March 2025, HPS would move Gentamicin Injection 80mg/2mL to Gentamicin Noridem (supplied by Interpharma) effective from 17th June 2024:
Gentamicin Noridem
Gentamicin (as sulfate) 80mg/2mL
ARTG 391250
Gentamicin Noridem is an Australian registered product that also contains gentamicin (as sulfate) 80mg/2mL. This is a suitable alternative in most situations. However, this product contains sodium metabisulfite as a preservative. In susceptible people, this sulfite can cause allergic-type reactions, which may be severe.
In comparison, the Pfizer Gentamicin product does not contain any antimicrobial preservative.
The presence of the preservative in the Noridem product precludes other off-label routes of administration. Aminoglycosides can be administered via inhalation for the treatment of chronic pulmonary infections. However the Noridem product should not be used via this route due to the risk of airway irritation associated with the presence of sodium metabisulfite. Tobramycin, an alternate aminoglycoside is available and certain brands are approved for administration via inhalation. Supply of Tobramycin (Sun) 300 mg/5 mL solution for inhalation ampoule remains available. For more information, please refer to the safety notice produced by NSW Health.
If a sulfite-free gentamicin product is required, the possibility of supply via the Special Access Scheme (SAS) could be explored on a case-by-case basis. The lead time for accessing SAS stock is longer and ongoing availability is not certain.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact your pharmacist
at HPS Pharmacies.
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