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Gentamicin 40 mg/mL Injection (Hospira UK Limited)

Safety advisory - alternative product filling shortage may cause airway irritation if administered via inhalation

1 April 2020

Consumers and health professionals are advised that Gentamicin 40 mg/ml Injection (Hospira UK Limited) may cause constriction or irritation to the airways if used as an inhalation to treat certain infections in the lungs, due to the presence of the preservatives, sodium metabisulfite, methyl hydroxybenzoate and propyl hydroxybenzoate.

Gentamicin 40 mg/ml Injection (Hospira UK Limited) is an unregistered product (sourced from overseas) that has been approved for use as an alternative product during the current shortage of Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule. This product is not expected to be available again until 30 April 2021.

In the meantime, the TGA has granted approval under Section 19A of the Therapeutic Goods Act 1989 to Pfizer Australia Pty Ltd to supply the alternative product, Gentamicin 40 mg/ml Injection (Hospira UK Limited), for the following indications:

Gentamicin 40mg/ml Injection (Hospira UK Limited) is approved for the treatment of infections due to susceptible organisms including Pseudomonas aeruginosa, and species of Proteus, Escherichia, Klebsiella, Enterobacter, Serratia and Staphylococcus (including strains resistant to other antibiotics such as penicillin). In vitro, gentamicin is also active against Salmonella and Shigella. Gentamicin may be used for the treatment of the following conditions when caused by susceptible organisms:

  • Bacteraemia
  • Respiratory tract infections
  • Urinary tract infections
  • Skin and skin structure infections
  • Burns
  • Sepsis

While Gentamicin 40 mg/ml Injection (Hospira UK Limited) is a suitable alternative in most situations, clinicians using this product for off-label use via inhalation may need to take the presence of preservatives into account and the possible effect they may have on a patient's airways.

Although Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule has not been approved for use via inhalation and its Product Information references only intramuscular or intravenous use, the TGA is aware that there is some off-label use via inhalation.

Information for consumers

If you have any questions or concerns about this issue, talk to your health professional

Information for health professionals

During the shortage, health professionals who would have used Pfizer (Perth) Gentamicin 80 mg/2 mL (as sulfate) injection BP ampoule via inhalation for a patient may need to consider other products for the patient's treatment.

If a preservative-free gentamicin product is required, health professionals may wish to request supply via the Special Access Scheme (SAS).

Pfizer Australia Pty Ltd can be contacted on 1800 675 229. Information about this Section 19A approval has been published in the TGA's online Section 19A database.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.