Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
AMOXICILLIN CLAVULANIC ACID
Pinewood Laboratories Ltd,
500/125 Milligram
Tablets
2002-02-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pinaclav 500mg/125mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets Yellowish-white or light yellow oblong-formed, biconvex tablet with ‘625’ on one side and an engraved line on the other side. 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): • 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 Pinaclav 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 of alternative presentations of Pinaclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) sho Belgenin tamamını okuyun