ERTAPENEM KABI (Fresenius Kabi Australia Pty Ltd)
Product name
ERTAPENEM KABI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
179 working days (255)
Active ingredients
Ertapenem sodium
Registration type
New generic medicine
Indication
ERTAPENEM KABI (powder for injection vial) is indicated:
- for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis) 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.
- as initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections.
- 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.