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1 Indications And Usage Fetroja Is A Cephalosporin Antibacterial Indicated In Patients 18 Years Of Age Or Older Who Have Limited Or No Alternative Treatment Options, For The Treatment Of Complicated Urinary Tract Infections (Cuti), Including Pyelonephritis Caused By Susceptible Gram-Negative Microorganisms. ( 1.1 ) Approval Of This Indication Is Based On Limited Clinical Safety And Efficacy Data For Fetroja. ( 1.1 , 14 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Fetroja And Other Antibacterial Drugs, Fetroja Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. ( 1.2 ) 1.1 Complicated Urinary Tract Infections (Cuti), Including Pyelonephritis Fetroja ® Is Indicated In Patients 18 Years Of Age Or Older Who Have Limited Or No Alternative Treatment Options For The Treatment Of Complicated Urinary Tract Infections (Cutis), Including Pyelonephritis Caused By The Following Susceptible Gram-Negative Microorganisms: Escherichia Coli , Klebsiella Pneumoniae , Proteus Mirabilis , Pseudomonas Aeruginosa , And Enterobacter Cloacae Complex. Approval Of This Indication Is Based On Limited Clinical Safety And Efficacy Data For Fetroja [See Clinical Studies (14.1) ]. 1.2 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Fetroja And Other Antibacterial Drugs, Fetroja Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.
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