Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rifaximin
Alfa Wassermann S.p.A.
rifaximin
200mg
tablets film-coated
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT ALFA NORMIX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _One film-coated tablet contains:_ Rifaximin 200 mg 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of gastrointestinal disorders sustained by Rifaximin-sensitive bacteria such as acute gastrointestinal infections, traveler’s diarrhea, intestinal overgrowth syndrome, hepatic encephalopathy, symptomatic uncomplicated diverticular disease of the colon and chronic bowel inflammation. Prophylaxis of infective complications in colorectal surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years of age: from 1 film-coated tablet every 8 hours to 2 film- coated tablets every 8 - 12 hours (equal to 600 - 1200 mg of Rifaximin) The duration of treatment should not exceed 7 days and should be determined by the clinical response of the patients. In the cases in which repeated courses of treatment are required, each course of treatment should be separated by a wash-out period of 20 to 40 days. The total duration of the intermittent therapy should be determined by the adequacy of the clinical response of the patients. DOSES MAY BE MODIFIED IN QUANTITY AND FREQUENCY, ACCORDING TO THE PHYSICIAN’S ADVICE . Method of administration Orally with a glass of water. Rifaximin can be administered with or without food. Elderly No dosage adjustment is necessary as the safety and efficacy data of ALFA NORMIX showed no differences between the elderly and the younger patients. Hepatic impairment No dosage adjustment is necessary for patients with hepatic insufficiency (see section 5.2). Renal impairment 2 Although dosing change is not anticipated, caution should be used in patients with impaired renal function (see section 5.2). Paediatric Population The safety and efficacy of rifaximin in children younger than 12 years of age have not been established. Currently available data are described in section 5.1, but no dosage reco Прочитать полный документ