Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FOSFOMYCIN TROMETAMOL
EP PLUS GROUP SDN. BHD.
FOSFOMYCIN TROMETAMOL
1Units Units
ZAMBON SWITZERLAND LTD
Not applicable Les hele dokumentet
3g Fosfomycin trometamol granules Antibacterial PROPERTIES/EFFECTS ATC-code: J01XX01 _Mechanism of action_ Monurol contains the active substance fosfomycin [mono 2-ammonium-2-hydroxymethyl-1,3- propanediol) (2R-cis) -(3-methyloxyranil) phosphonate] in the form of trometamol salt. Fosfomycin is an antibiotic (derived from phosphonic acid) with a bactericidal effect. This is based on inhibition of bacterial cell wall synthesis, blocking one of the first steps of peptidoglycan synthesis. Fosfomycin is actively transported into the bacterial cell via two different transport systems (the sn-glycerol-3- phosphate and hexose-6 transport systems). PHARMACODYNAMICS The structure of fosfomycin is analogous to that of p-enolpyruvate. This is why it inactivates the enzyme enolpyruvyl transferase and thus the condensation of uridine diphosphate-Nacetylglucosamine with p-enolpyruvate is irreversibly blocked, one of the first steps in the synthesis of the bacterial cell wall. Fosfomycin may also reduce bacterial adhesion to the bladder mucosa, which may be a predisposing factor for recurrent urinary tract infections. The susceptibility breakpoints established by the European Committee on Antimicrobial Susceptibility Testing are as follows (EUCAST breakpoint table version 11, 01.01 2021): Species Susceptible Resistant Enterobacterales ≤ 8 mg/l > 8 mg/l _Prevalence of acquired resistance_ The prevalence of acquired resistance of individual species may vary geographically and over time. Local information about the resistance situation is therefore necessary, particularly in order to ensure appropriate treatment of severe infections. The following table is based on data from surveillance programs and studies. It comprises relevant for the approved indications: Commonly susceptible species - Aerobic Gram-negative microorganisms - _Escherichia coli_ Species in which acquired resistance may be a problem - Aerobic Gram-positive microorganisms - Enterococcus faecalis - Aerobic Gram-negative microorganisms - Klebsiella pneumonia - _Pro Les hele dokumentet