Australia - English - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - fosfomycin trometamol, quantity: 5.631 g - granules - excipient ingredients: saccharin; sucrose; flavour - monurol 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.,monurol 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 monurol. 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g;   - oral granules - 3 g - active: fosfomycin trometamol 5.631 g equivalent to fosfomycin 3g   excipient: orange flv pdr fa-01142 (20375254) saccharin sodium sucrose tangerine flv pdr fa-00898 (20375218) - treatment of uncomplicated actue cystitis caused by pathogens susceptible to fosfomycin in adult women and adolescents aged over 12.

Kenya - English - Pharmacy and Poisons Board

fosfomycin trometamol 3gm - granules for oral suspension - fosfomycin trometamol 3gm - fosfomycin

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

zambon uk ltd - fosfomycin trometamol - granules for oral solution - 3gram

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - fosfomycin trometamol - granules for oral solution - other antibacterials; fosfomycin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

zambon sa-nv - fosfomycin trometamol 5631 mg - eq. fosfomycin 3000 mg - granules for oral solution - 3 g - fosfomycin trometamol 5631 mg - fosfomycin

Kenya - English - Pharmacy and Poisons Board

cipla limited cipla house, peninsula business park, ganpatrao - fosfomycin trometamol - powder for oral solution in sachet - each sachet contains 5.631g fosfomycin trometamol… - fosfomycin

Canada - English - Health Canada

jamp pharma corporation - fosfomycin (fosfomycin tromethamine) - powder for solution - 3g - fosfomycin (fosfomycin tromethamine) 3g - urinary anti-infectives

Ireland - English - HPRA (Health Products Regulatory Authority)

zambon s.p.a. - fosfomycin trometamol - granules for oral solution - 3 gram(s) - other antibacterials; fosfomycin

Israel - English - Ministry of Health

rafa laboratories ltd - fosfomycin as trometamol - powder for oral solution - fosfomycin as trometamol 3 g/sachet - fosfomycin - fosfomycin - a single-dose treatment for acute, uncomplicated urinary tract infection and as prophylaxis in diagnostic and surgical transurethral procedures.