South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

triomed (pty) ltd - capsule - each capsule contains cefaclor (monohydrate) equivalent to 250,0 mg cefaclor

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

triomed (pty) ltd - capsule - each capsule contains cefaclor (monohydrate) equivalent to 500,0 mg cefaclor

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

alphapharm pty ltd - cefaclor monohydrate, quantity: 52.45 mg/ml (equivalent: cefaclor, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; erythrosine; sucrose; pregelatinised starch; flavour - keflor is indicated for the treatment of the following types of infections caused by or likely to be caused susceptible organisms: lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory infections, including pharyngitis, tonsillitis and otitis media. skin and skin structure infections. urinary tract infections, including pyelonephritis and cystitis. note: 1. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. keflor appears to be effective as phenoxymethul penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor.

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

alphapharm pty ltd - cefaclor monohydrate, quantity: 26.22 mg/ml (equivalent: cefaclor, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; erythrosine; sucrose; pregelatinised starch; flavour - keflor is indicated for the treatment of the following types of infections caused by or likely to be caused susceptible organisms: lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory infections, including pharyngitis, tonsillitis and otitis media. skin and skin structure infections. urinary tract infections, including pyelonephritis and cystitis. note: 1. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. keflor appears to be effective as phenoxymethul penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - cefaclor monohydrate 26.86 mg/ml equivalent to cefaclor 25 mg/ml - granules for oral suspension - 125 mg/5ml - active: cefaclor monohydrate 26.86 mg/ml equivalent to cefaclor 25 mg/ml excipient: dimeticone erythrosine methylcellulose sodium laurilsulfate starch strawberry flavour 052312 ap0551 sucrose xanthan gum - cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated micro-organisms: lower respiratory infections, including pneumonia caused by s. pneumoniae, h. influenzae (including both ampicillin-sensitive and ampicillin-resistant strains), and s. pyogenes (group a beta- haemolytic streptococci), m.catarrhalis, acute bronchitis, and acute exacerbations of chronic bronchitis. upper respiratory infections, including pharyngitis and tonsillitis caused by s. pyogenes (group a beta-haemolytic streptococci) and m. catarrhalis. otitis media caused by s. pneumoniae, h. influenzae (including both ampicillin-sensitive and ampicillin-resistant strains) staphylococci, and s. pyogenes (group a beta-haemolytic streptococci), and m. catarrhalis. skin and soft-tissue infections caused by staphylococcus aureus (including ?-lactamase producing strains), s. pyogenes (group a beta-haemolytic streptococci) and staphylococcus epidermidis (including ?-lactamase produc

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

alphapharm pty ltd - cefaclor monohydrate, quantity: 393.4 mg (equivalent: cefaclor, qty 375 mg) - tablet, modified release - excipient ingredients: mannitol; hypromellose; hyprolose; methacrylic acid copolymer; stearic acid; magnesium stearate; propylene glycol; purified talc; colour - indications as 16 december 1997: keflor cd is indicated for the treatment of the following types of infections caused by susceptible organisms, in adults and children aged 12 years or older: acute bronchitis and acute exacerbations of chronic bronchitis; upper respiratory infections, including pharyngitis, tonsillitis and acute bacterial sinusitis: community-acquired pneumonia of mild to moderate severity (excluding atypical pneumonia); symptomatic lower urinary tract infections, including cystisis; skin and skin structure infections. note 1. penicillin in the usual drug of choice in the treatment and prevention of streptoccocal infections, including the prophylaxis of rheumatic fever. keflor cd is generally effective in the eradication of streptococci from the oropharynx; however, substantial data establishing the efficacy of keflor cd in the subsequent prevention of rheumatic fever are not available. 2. bacteriological studies to determine the causative organism and its susceptibility to cefaclor should be

Israel - English - Ministry of Health

biotis ltd - prucalopride as succinate - film coated tablets - prucalopride as succinate 1 mg - prucalopride - prucalopride - resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief

Israel - English - Ministry of Health

biotis ltd - prucalopride as succinate - film coated tablets - prucalopride as succinate 2 mg - prucalopride - prucalopride - resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland - prucalopride succinate - constipation - other drugs for constipation - resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

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

alphapharm pty ltd - cefaclor monohydrate -