Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANIC ACID (IN THE FORM OF POTASSIUM CLAVULANATE)
LTT Pharma Limited
AMOXICILLIN TRIHYDRATE CLAVULANIC ACID (IN THE FORM OF POTASSIUM CLAVULANATE)
875/125 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 875 mg/125 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Augmentin 875/125mg Film Coated tablets contain Amoxicillin trihydrate equivalent to 875mg amoxicillin and potassium clavulanate equivalent to 125mg clavulanic acid For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film coated tablet. _Product imported from Malta_ White to off white oval film coated tablet debossed with the letters AC on both sides and with a score line on one side. The purpose of the score line is to aid swallowing and not to enable the tablet to be divided into two equal halves 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 The age, weight and renal function of the patient as shown below. The use read_full_document