Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clarithromycin
KRKA d.d.
J01FA09
clarithromycin
500mg
tablets film-coated
(14/2x7/) in blister
Prescription
Registered
2023-11-25
1. NAME OF THE MEDICINAL PRODUCT Fromilid ® 250 mg film-coated tablets Fromilid ® 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg or 500 mg clarithromycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The 250 mg and 500 mg tablets are slightly brownish yellow, oval and biconvex, covered with film coating. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fromilid film-coated tablets are indicated for the treatment of the following bacterial infections in adults and children 12 years and older, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1): - Bacterial pharyngitis - Mild to moderate community acquired pneumonia - Acute bacterial sinusitis (adequately diagnosed) - Acute exacerbation of chronic bronchitis - Skin infections and soft tissue infections of mild to moderate severity - In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated ulcers (see section 4.2) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage of Fromilid film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician. Patients with respiratory tract/skin and soft tissue infections: _Adults and adolescents (12 years and older) _ The usual recommended dosage of clarithromycin in adults is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration of therapy is 6 to 14 days. _Children younger than 12 years: _ The use of clarithromycin tablets has not been studied in children under 12 years. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 year Citiți documentul complet