ERTAPENEM-AFT (AFT Pharmaceuticals Pty Ltd)

Ertapenem-AFT is indicated for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis, see Section 4.4 Special Warnings and Precautions for Use) caused by susceptible strains of microorganisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics.

Ertapenem-AFT is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and postsurgical gynaecological infections.

Ertapenem-AFT is also indicated for the treatment of diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens which are suspected or proven to be resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with Ertapenem-AFT may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy should be adjusted accordingly.