(Approval lapsed) REFOBACIN (gentamicin) 10mg (10 mg/2mL) ampoules

For the treatment of serious infections cause by susceptible strains of the following pathogens:

Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus species (coagulase positive and coagulase negative).

Gentamicin solution for injection may be used for the treatment of the following conditions when caused by susceptible organisms:

• Septicaemia,
• Respiratory tract infections,
• Infected wounds, bone and soft tissue infections including peritonitis, septic abortion and burns complicated by sepsis
• Urinary tract infections (recurrent, complicated). Gentamicin injection is not routinely indicated in the initial treatment of uncomplicated urinary tract infections unless the organism is resistant to other less toxic antibacterials.

Gentamicin solution for injection may be considered as initial therapy in suspected or confirmed gram negative infections. If anaerobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regime. The decision to continue therapy with gentamicin should be based on the results of susceptibility tests, the severity of the infection, and the important additional considerations outlined in the SPECIAL WARNINGS AND PRECAUTIONS FOR USE section of the Australian PI. If the causative organisms are resistant to gentamicin and the patient is not responding favourably, other appropriate therapy should be instituted.