Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metronidazole
Takeda Pharma A/S
P01AB01
metronidazole
500mg
tablets film-coated
(20) in glass container
Prescription
Registered
2018-05-29
_1 _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS FOR METRONIDAZOLE NYCOMED FILM-COATED TABLETS 500MG 1. NAME OF THE PRODUCT Metronidazole Nycomed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active substance Metronidazole 500 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets White oval film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inflammatory infections caused by microorganisms susceptible to metronidazole: Protozoal infections: extraintestinal amebiasis, including amebic liver abscess, intestinal amebiasis (amebic dysentery), trichomoniasis. Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgates), bone and joint infections, infections of the central nervous system (CNS), including meningitis, brain abscess, infective endocarditis, pneumonia, empyema and pulmonary abscess, sepsis. Infections caused by Clostridium spp., Peptococcus niger, Peptostreptococcus spp.: intraabdominal infections (peritonitis, liver abscess), pelvic infections (endometritis, tubo-ovarian abscess, vaginal vault infection). Antibiotic-associated pseudomembranous colitis. Gastritis or duodenal ulcer associated with Helicobacter pylori (as combination therapy). Crohn's disease. Prevention of postoperative complications (especially interventions on colon, pararectal surgery, appendectomy, gynecological surgery). _2 _ _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Metronidazole should be used orally, before or after the meal. The drug product should be taken with sufficient amount of water. In intestinal amebiasis Metronidazole Nycomed is used for 7 days 1500 mg per day divided into three doses. In acute amebic dysentery the daily dose for adults is 1500 - 3000 mg divided into three doses. For children 6 - 15 years old the daily dose is 35 - 50 mg/kg divided into 2-3 doses. In liver abscess and other extraintestinal forms of amebiasis the maximum daily exposure is 1500 - 3000 mg divided into 3 d Læs hele dokumentet