País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANIC ACID
Rowex Ltd
AMOXICILLIN TRIHYDRATE CLAVULANIC ACID
500/125 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoclav Duo 500 mg/125 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as potassium clavulanate). For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oblong, biconvex film-coated tablet with notches on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoclav is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): o Acute bacterial sinusitis (adequately diagnosed) o Acute otitis media o Acute exacerbations of chronic bronchitis (adequately diagnosed) o Community acquired pneumonia o Cystitis o Pyelonephritis o Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis. o 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 Amoclav that is selected to treat an individual infection should take into account: o The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) o The severity and the site of the infection o The age, weight and renal function of the patient as shown below. The use of alternative presentations of Amoclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1). For adults and Leia o documento completo