Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
AMOXICILLIN CLAVULANIC ACID
Pinewood Laboratories Ltd,
per 5ml
Powder for Oral Suspension
2002-02-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pinaclav 125mg/31.25mg per 5ml, Powder for Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of suspension contains 125mg of amoxicillin as amoxicillin trihydrate and 31.25mg of clavulanic acid as potassium clavulanate. Excipients: also includes Aspartame (E951) 2.5mg per 5ml; Sucrose 0.1mg per 5ml; Sodium 2mmol per 5ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. White to light yellow homogenous powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pinaclav 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 Pinaclav 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 Pinaclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of Lue koko asiakirja