Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Profind Wholesale Ltd.
500 Milligram
Modified-release Tablets
2009-08-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid LA 500mg Modified release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg clarithromycin Excipients: Contains lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified Release Tablet _Product imported from the UK and Hungary:_ Yellow, ovaloid modified release tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid LA is indicated for treatment of infections caused by susceptible organisms. Indications include: • Lower respiratory tract infections for example bronchitis and pneumonia. • Upper respiratory tract infections for example sinusitis and pharyngitis. • Skin and soft tissue infections for example folliculitis, cellulitis and erysipelas. As with other antibiotics, it is recommended that guidelines on the prevalence of local resistance, and associated medical practice regarding the prescription of antibiotics, be consulted before prescribing Klacid LA. Klacid LA is indicated in adults and children 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _The usual recommended dosage of Klacid LA in adults is one 500 mg modified-release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500 mg modified-release tablets taken as one dose daily. Dose must be taken at the same time every day. Tablets must be swallowed whole. The usual duration of treatment is 6 to 14 days. _Children older than 12 years: _As for adults. _Children younger than 12 years: _Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Use of Klacid LA is not recommended for children younger than 12 years. Therefore children und Soma hati kamili