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PIPERACILLIN TAZOBACTAM KABI (Fresenius Kabi Australia Pty Ltd)

Product name
PIPERACILLIN TAZOBACTAM KABI
Date registered
Evaluation commenced
Decision date
Approval time
151 working days (255)
Active ingredients
piperacillin sodium; tazobactam sodium
Registration type
New generic medicine
Indication

PIPERACILLIN TAZOBACTAM KABI (powder for injection) is indicated in the treatment of serious bacterial infections caused by susceptible strains of Beta-lactamase producing organisms in the conditions listed below:

  • Lower respiratory tract infections.
  • Urinary tract infections (complicated and uncomplicated).
  • Intra-abdominal infections.
  • Skin and skin structure infections.
  • Bacterial septicaemia.
  • Gynaecological infections.
Children under the age of 12 years

In hospitalised children aged 2 to 12 years, PIPERACILLIN TAZOBACTAM KABI is indicated for the treatment of serious intra-abdominal infections. It has not been evaluated in this indication for paediatric patients below the age of 2 years.

While PIPERACILLIN TAZOBACTAM KABI is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and Beta-lactamase producing piperacillin-resistant organisms. Appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to PIPERACILLIN TAZOBACTAM KABI. Therapy with PIPERACILLIN TAZOBACTAM KABI however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the Beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.

In serious infections, presumptive therapy with PIPERACILLIN TAZOBACTAM KABI may be initiated before susceptibility test results are available.

Combination therapy with PIPERACILLIN TAZOBACTAM KABI and aminoglycosides may be used in the treatment of serious infections caused by Pseudomonas aeruginosa. Both drugs should be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

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