Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID
B & S Healthcare
J01CR02
AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID
500/125 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors
Authorised
2009-01-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 500/125 mg Film-Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from Greece:_ White, oval, film-coated tablets with a breakline on one side, ‘A’ on one side of the line and ‘C’ on the other and plain on the other side. _Product imported from Spain:_ White, capsule shaped, film-coated tablets imprinted with 'A/C' on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): ° Acute bacterial sinusitis (adequately diagnosed) ° Acute otitis media ° Acute exacerbations of chronic bronchitis (adequately diagnosed) ° Community acquired pneumonia ° Cystitis ° Pyelonephritis ° Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis. ° Bone and joint infections, in particular osteomyelitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Augmentin that is selected to treat an individual infection should take into account: ° The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) ° The severity and the site of the infection IRISH MEDICINES BOARD _ Preberite celoten dokument