Страна: Вірменія
мова: англійська
Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefixime (cefixime trihydrate)
Alkaloid AD Skopje
J01DD08
cefixime (cefixime trihydrate)
400mg
tablets film-coated
(5/1x5/) in blister, (7/1x7/) in blister, (10/2x5/) in blister
Prescription
Registered
2022-11-03
PANCEF 400 mg film-coated tablets Summary of Product Characteristics 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PANCEF 400 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg cefixime (in a form of cefixime trihydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM * Film-coated tablets. White to slightly cream, oblong, biconvex, film coated tablets with bisection line on one side of the tablet. The tablet can be divided into two equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pancef is indicated for the treatment of infections caused by microorganisms susceptible to cefixime, as follows: acute upper respiratory tract infections (pharyngo-tonsillitis, sinusitis); otitis media acuta; lower respiratory tract infections (acute bronchitis, acute exacerbation of chronic bronchitis, tracheobronchitis, pneumonia); uncomplicated and complicated urinary tract infections, including acute pyelonephritis; uncomplicated gonorrhea (cervical/urethral); Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ ADULTS AND CHILDREN (WEIGHING MORE THAN 50 KG OR OLDER THAN 10 YЕАRS OF AGE). The recommended dosage is 400 mg daily, administered as single oral dose or divided in two equal oral doses of 200 mg every 12 hours. PANCEF 400 mg film-coated tablets Summary of Product Characteristics 2 For the treatment of uncomplicated cervical/urethral gonococcal infection, a single one day oral dose of 400 mg is recommended. For the treatment of lower urinary infections in women a single dose of 400 mg or 3 day treatment is recommended. OLDER PEOPLE Older people may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in in cases with severe renal impairment (See “Dosage in patients with renal Impairment”). DOSAGE IN PATIENTS WITH RENA Прочитайте повний документ