מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
G & A Licensing Limited
500 Milligram
Modified-release Tablets
2010-11-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid LA 500mg Modified release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Clarithromycin 500mg. Excipients: Contains lactose. For fill list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. _Product imported from UK._ 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. 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: Use Klacid Paediatric Suspension. Patients with renal impairment: Klacid LA should not be used in patients with renal impairment (creatinine clearance less than 30 ml/min). Klacid immediate-release tablets should be used in this patient population _(see section 4.3)._ IRISH MEDICINES BOARD _______________________________________________ קרא את המסמך השלם