利福昔明FDA批准片剂Ⅲ期临床试验药业上市复发风险安慰剂对照Xifaxan 550mg片剂获得批准用于降低≥18岁患者的肝性脑病(hepatic encephalopathy,HE)复发的风险.此项批准是基于一项在299例患者中进行的双盲,安慰剂对照,国际多中心Ⅲ期临床试验.该试验证明Xifaxan@550mg片剂在统计学上和临床上均可显著降低HE复发风险.中国新药...
XIFAXAN®(rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IMPORTANT SAFETY INFORMATION XIFAXAN is not for everyone. Do not take XIFAXAN...
2016年新批准3.1类肝性脑病新药利福昔明550mg临床批件转让 不用申请一次性进口原研即可开展临床 基本信息 通用名利福昔明片(Rifaximin Tablet) 规格550mg 适应症肝性脑病 注册分类3.1(首仿)已获得临床批件 在注册数2 【疾病介绍】肝性脑病(hepatic encephalopathy,HE)是一种由严重肝病引起的、以代谢紊乱为基础的中枢神...
Healthy adults (single or multiple rifaximin doses of 550 mg): Peak plasma concentrations attained 1 hour after dose; mean peak plasma concentrations range from 2.4–4 ng/mL.IBS with diarrhea (rifaximin 550 mg three times daily for 14 days): Peak plasma concentrations attained 1 hour after ...
PO(Adults):550 mg twice daily. Irritable Bowel Syndrome With Diarrhea PO(Adults):550 mg 3 times daily for 14 days; if recurrence of symptoms, may treat up to an additional 2 times. Availability Availability Availability Tablets:200 mg, 550 mg ...
PO(Adults):550 mg twice daily. Irritable Bowel Syndrome With Diarrhea PO(Adults):550 mg 3 times daily for 14 days; if recurrence of symptoms, may treat up to an additional 2 times. Availability Availability Availability Tablets:200 mg, 550 mg ...
Adults:550 mg P.O. b.i.d. Off-label uses • Hepatic encephalopathy Contraindications • Hypersensitivity to drug, its components, or rifamycin anti-infectives Precautions Use cautiously in: • elderly patients • pregnant or breastfeeding patients ...
Salix制药公司近日宣布了两项随机双盲安慰剂对照多中心的Ⅲ期临床试验(TARGET1和TARGET2)的成功结果,用来评估利福昔明(rifaximin)(Ⅰ)550mg,每天三次用于治疗非便秘型肠易激综合征(non—CIBS))的疗效和安全性.每项试验中经过14天(第1周和第2周)的疗程用(Ⅰ)治疗的患者与安慰剂相比在主要指标即缓解IBS症状超过1...
200 mg, 550 mg oral tablets How should I store Xifaxan? Xifaxan should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Sto...
Patients will be randomized to treatment either with rifaximin alone (550 mg twice daily (bid) continuously for a period of 3 months) or with rifaximin (550 mg bid continuously) in combination with lactulose (30–60 ml daily) for 3 months. An esophagogastroduodenoscopy (EGD) will be ...