Ülke: Ermenistan
Dil: İngilizce
Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clarithromycin
Aesica Queenborough Limited
J01FA09 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ և թողարկման ձև
clarithromycin
500mg (5/1x5/) in blister, (14/1x14/) in blister
tablets modified-release film-coated
500mg (5/1x5/) in blister, (14/1x14/) in blister
Prescription
Registered
2020-10-21
SUMMARY OF PRODUCT CHARACTERISTIC CLARITHROMYCIN 1. NAME OF THE MEDICINAL PRODUCT Klacid ® SR 500 mg, Modified-Release Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clarithromycin 500 mg, modified-Release Tablets: One tablet contains 500 mg Clarithromycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clarithromycin 500 mg,Modified-Release Film-coated tablets 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Clarithromycin is indicated for treatment of infections due to susceptible organisms in adults and children 12 years and older: • Lower respiratory tract infections (e.g., bronchitis, pneumonia) (see section 4.4 and 5.1 regarding Sensitivity Testing); • Upper respiratory tract infections (e.g., pharyngitis, sinusitis) • Skin and soft tissue infections (e.g., folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing) Consideration should be given to national official guidance on the appropriate use of antibacterial agents. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Dosage and Administration _Adults _ The usual recommended dosage of clarithromycin tablets with a modified action in adults and children 12 years and older - 500 mg once a day with meals. In more severe infections, the dosage can be increased to 1000 mg once a day (500 mg 2 times). The usual duration of therapy - from 5 to 14 days, except for the treatment of community-acquired pneumonia and sinusitis, which require therapy for 6-14 days. Klacid ® SR tablets not crush or chew, they must be swallowed whole. _Impaired renal function _ In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the usual recommended dose is 250 mg once daily. Because the modified-release tablet cannot be split, instead immediate-release tablets should be used. In more severe infections, the recommended dose is one 500 mg modified-release tablet once daily. No dose adjustment is required for patients with moderate renal impairment (creatinine clearance 30 Belgenin tamamını okuyun