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

monrol europe s.r.l. - sodium pertechnetate (99m tc) 8,3 gbq - 33,9 gbq; sodium molybdate (99 mo) 10 gbq - 40 gbq - radionuclide generator - 10-40 gbq - molybdate sodium (mo-99); technetium tc 99m sodium pertechnetate (tc-99m) - technetium (99mtc) pertechnetate

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

monrol europe s.r.l. - lutetium (lu-177) chloride 40 gbq/ml - radiopharmaceutical precursor, solution - other therapeutic radiopharmaceuticals

Israel - English - Ministry of Health

hila pharma, israel - sodium (99mtc) pertechnetate; sodium molybdate - radio-pharma generator - sodium (99mtc) pertechnetate 8.3 - 33.9 gbq; sodium molybdate 10 - 40 gbq - this medicinal product is for diagnostic use only.the eluate from the radionuclide generator is indicated for:• labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling withsuch solution.• thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease.• salivary gland scintigraphy diagnosis of chronic sialadenitis (e g sjögren syndrom) as well as to assess salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radio iodine therapy).

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.

United States - English - NLM (National Library of Medicine)

allergan, inc. - fosfomycin tromethamine (unii: 7fxw6u30gy) (fosfomycin - unii:2n81my12te) - fosfomycin 3 g - monurol is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of escherichia coli and enterococcus faecalis . monurol is not indicated for the treatment of pyelonephritis or perinephric abscess. if persistence or reappearance of bacteriuria occurs after treatment with monurol, other therapeutic agents should be selected. (see precautions   and clinical studies   sections.) monurol is contraindicated in patients with known hypersensitivity to the drug.

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.

Canada - English - Health Canada

paladin labs inc. - fosfomycin (fosfomycin tromethamine) - powder for solution - 3g - fosfomycin (fosfomycin tromethamine) 3g - urinary anti-infectives