Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
Clonmel Healthcare Ltd
125/31.25 Milligram
Powder for Oral Suspension
1999-09-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clavamel Paediatric125 mg/31.25 mg per 5 ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125 mg of amoxicillin and potassium clavulanate equivalent to 31.25 mg of clavulanic acid. Excipients: Each 5ml of reconsituted oral suspension contains 12.5mg of Aspartame (E951) 0.0009mg of Ethanol < 0.0002mg Sulphites (including Sulphur Dioxide E220) 1.63mg Gum Arabic E414 (may contain small amounts of Galactose) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension Clear, glass bottles, containing a white to off-white powder for reconstitution with water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clavamel 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 Clavamel 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) • Read the complete document