Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
PCO Manufacturing
500 Milligram
Modified-release Tablets
2004-05-07
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 of clarithromycin. Excipients: also contains lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified Release Tablets. _Product imported from Greece, Spain, the Netherlands and the UK:_ Yellow, ovaloid tablets, plain on both sides. 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, acute and chronic 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 500mg modified-release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500mg modified-release tablets daily. 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 may be used in this patient population. _(See 4.3 Contra-_ _indications)._ 4.3 CONTRAINDICATIONS Clarithromycin is contraindicated in patients wit Belgenin tamamını okuyun