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PIPTAZ MEDICIANZ/ PIPTAZ MEDSURGE (Medsurge Pharma Pty Ltd)

Product name
PIPTAZ MEDICIANZ/ PIPTAZ MEDSURGE
Date registered
Evaluation commenced
Decision date
Approval time
155 (255 working days)
Active ingredients
piperacillin sodium, tazobactam sodium
Registration type
New generic medicine
Indication

[PIPTAZ MEDSURGE/PIPTAZ MEDICIANZ] is indicated in the treatment of serious bacterial infections caused by susceptible strains of β-lactamase producing organisms in the conditions listed below:

  1. Lower respiratory tract infections
  2. Urinary tract infections (complicated and uncomplicated)
  3. Intra-abdominal infections
  4. Skin and skin structure infections
  5. Bacterial septicaemia
  6. Gynaecological infections

Children under the age of 12 years

In hospitalised children aged 2 to 12 years, piperacillin/tazobactam 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 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 β-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.

Therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the β-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.

In serious infections, presumptive therapy with piperacillin/tazobactam may be initiated before susceptibility test results are available.

Note: For associated bacteraemia due to extended-beta-lactamase (ESBL) producing organisms, see Section 5.1 – Pharmacodynamic properties.

Combination therapy with piperacillin/tazobactam 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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