Страна: Тайвань
Язык: китайский
Источник: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ROXITHROMYCIN
賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)
J01FA06
膜衣錠
ROXITHROMYCIN (0812500600) 150.000MG
鋁箔盒裝
製 劑
須由醫師處方使用
SANOFI-AVENTIS FRANCE 1-13, BOULEVARD ROMAIN ROLLAND 75014 PARIS-FRANCE FR
roxithromycin
對RULID具感受性菌所引起之各種中度感染症
註銷日期: 2018/07/03; 註銷理由: 自請註銷; 有效日期: 2019/09/30; 英文品名: RULID 150MG FILM COATED TABLET
已註銷
2014-08-20
3 Tissue distribution is good, especially in lung tissue, tonsils and prostate tissue, 6 and 12 hours after repeated doses of roxithromycin. • Roxithromycin is 96% bound to plasma proteins. The drug mainly binds to alpha-1-acid glycoprotein. This binding is saturable and decreases when roxithromycin concentrations exceed 4mg/l. • Very limited amounts of roxithromycin, i.e. less than 0.05 % of the administered dose, are excreted in breast milk. _METABOLISM_: Roxithromycin is relatively poorly metabolized; more than half of the drug is excreted unchanged. Three metabolites have been identified in the urine and feces: descladinose roxithromycin is the main metabolite, and N-mono and N-didemethyl roxithromycin are minor metabolites. The proportions of roxthromycin and its three metabolites are similar in the urine and feces. _EXERETION_: Roxithromycin is mainly excreted by the fecal route. Seventy-two hours after oral administration of 14 C-radiolabeled roxithromycin, urinary excretion of radioactivity accounts for only 12% of the total amount eliminated in the urine and the feces. PHARMACEUTICAL PARTICULARS– LIST OF EXCIPIENTS Hydroxypropylcellulose, polyoxyethylene-polyoxypropylene glycol (Pluronic ® F68), povidone, anhydrous colloidal silica (Aerosil ® 200), magnesium stearate, talc, maize starch. SHELF LIFE: 3 years. STORAGE CONDITIONS: Store at a temperature not exceeding 25 ° C . NATURE AND CONTENTS OF OUTER PACKAGING: 10 coated tablets in (PVC/aluminum) blister packs. MANUFACTURE: AVENTIS INTERCONTINENTAL 56, Route de Choisy au Bac, F-60200 Compiegne, France ref. France SmPC_18-02-10 Прочитать полный документ