MONUROL 3G GRANULES

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

FOSFOMYCIN TROMETAMOL

Commercializzato da:

EP PLUS GROUP SDN. BHD.

INN (Nome Internazionale):

FOSFOMYCIN TROMETAMOL

Confezione:

1Units Units

Prodotto da:

ZAMBON SWITZERLAND LTD

Foglio illustrativo

Not applicable

Scheda tecnica

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