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  药店国别: 欧洲共同体药房
产地国家: 欧洲共同体国家
所属类别: 泌尿生殖系统及泌乳药物->勃起功能障碍症
处方药:处方药
包装规格: 100毫克/片 4片/盒
计价单位:
   
生产厂家英文名:
A.MENARINI IND.FARM.RIUN.Srl
该药品相关信息网址1:
https://www.stendra.com/?utm_campaign=stendra_dtc&utm_medium=banner&utm_source=google_branded&gclid=CNPBhfKH374CFQ9lfgodUwUASw
原产地英文商品名:
Spedra 100mg 4 Tablets
原产地英文药品名:
AVANAFIL
中文参考商品译名:
Spedra 100毫克/片 4片/盒
中文参考药品译名:
阿伐那菲
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Erectile Dysfunction
临床试验期:
完成
中文适应病症参考翻译1:
勃起功能障碍
药品信息:
STENDRA的完整处方资料 适应证和用途 STENDRA是一种磷酸二酯酶5型(PDE5)抑制剂适用于治疗勃起障碍(1) 剂量和给药方法 (1)对大多数患者,开始剂量是100 mg在性活动前约30分钟服用,按需要的基础(2.1) (2)服用STENDRA一天不超过1次(2.1). (3)根据疗效和/或耐受性剂量可增加至200 mg或减低至50 mg。试验提供疗效的最低剂量(2.1) (4)STENDRA可与食物或不与食物服用(2.2) (5)不要与强一种中度CYP3A4抑制剂,在24消失期间剂量不要超过50 mg(2.3). (7)在用稳定α-阻断剂治疗患者,推荐的STENDRA起始剂量是50 mg(2.3). 剂型和规格 片:50 mg,100 mg,200 mg (3) 禁忌证 (1)禁忌给予STENDRA至用任何形式有机有机硝酸盐患者(4.1) (2)对STENDRA片任何组分超敏性(4.2) 警告和注意事项 (1)如由于心血管状态或任何其它理由性活动是不可取的患者不应使用STENDRA(5.1) (2)STENDRA使用与α-阻断剂,其它抗高血压药,或大量饮酒(大于3单位)可能导致低血压(2.3, 5.6, 5.7) (3)如勃起持续大于4小时患者应寻求紧急治疗(5.3) (4)如一只或双眼发生突然丧失视力,可能是非动脉炎性缺血性视神经病变(NAION)体征,患者应停止STENDRA和求医。在有NAION史患者患者讨论增加NAION风险(5.4) (5)在突然间的或丧失听力事件中患者应停止服用STENDRA和立即寻求医学关注(5.5) 不良反应 最常见不良反应(大于或等于2%)包括头痛,脸红,鼻充血,鼻咽炎,和背痛(6.1) 报告怀疑不良反应,联系VIVUS电话(1-866-330-1871)或FDA电话1-800-FDA-1088或www.fda.gov/medwatch. 药物相互作用 (1)STENDRA可加强硝酸盐类,α-阻断剂,抗高血压药,和酒的降压作用(7.1) (2)CYP3A4抑制剂(如,酮康唑[ketoconazole], 利托那韦[ritonavir], 红霉素[erythromycin])增加STENDRA 暴露(7.2) 特殊人群中使用 (1)在严重肾受损患者不要使用(8.6) (2)在有严重肝受损患者中不要使用(8.7) Stendra is an oral medication that is taken approximately 30 minutes before sexual activity. It should not be taken more than once daily. Stendra is considered a phosphodiesterase type 5 (PDE5) inhibitor. As with other PDE5 inhibitors, Stendra should not be used by men who also take nitrates because the combination can cause a sudden drop in blood pressure. Stendra's safety and efficacy were established in 3 double-blind, placebo-controlled clinical studies. A total of 1267 patients were randomly assigned to receive Stendra for up to 12 weeks at doses of 50-, 100-,or 200-mg, or a placebo as needed about 30 minutes before sexual activity. At the start of the studies and every 4 weeks thereafter, patients completed questionnaires to evaluate erectile function, vaginal penetration, and successful intercourse. Results showed patients taking Stendra experienced statistically significant improvement in all 3 end points for all 3 doses of Stendra studied. To further evaluate Stendra's safety, a subset of patients from 2 of the studies were enrolled in another trial to receive up to an additional 40 weeks of treatment. Patients were initially given Stendra at the 100-mg dose, but could have their dose increased to 200 mg or decreased to 50 mg on the basis of their individual response to treatment. Results showed that the adverse effects commonly reported in patients using Stendra did not worsen over time. The most common adverse effects reported in > 2% of patients in clinical studies included headache, flushing, nasal congestion, nasopharyngitis, and back pain. In rare instances, men taking PDE5 inhibitors (including Stendra) reported a sudden decrease or loss of vision. Stendra may interact with certain protease inhibitors, antifungals, and antibiotics. It should not be used in combination with other medications for ED.
更新日期: 2014-04-24
附件:
20146318312830.pdf    

20146318282312.pdf    

 
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