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FOSATIL (Pharmacor Pty Ltd)

Product name
FOSATIL
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
fosfomycin trometamol
Registration type
New generic medicine
Indication

[Trade Name] is indicated only for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females above 12 years of age caused by the following susceptible pathogens: Escherichia coli or, Enterococcus faecalis.

[Trade Name] is not indicated for the treatment of pyelonephritis or perinephric abscess or where resistance is likely (previous treatment failure, infection due to non-susceptible organism).

Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to [Trade Name]. However, therapy may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Consideration should be given to the relevant clinical guidelines on the appropriate use of antibacterial agents.