部份中文西那卡塞处方资料(仅供参考) 通用名称:盐酸西那卡塞片 商品名称:锐克钙 商品名称:Sensipar,Mimpara,Regpara; 英文名称:Cinacalcet Hydrochloride Tablet 成份 化学名称:N-((1R)-1-(1-萘基)乙基)-3-(3-(三氟甲基)苯基)丙-1-胺盐酸盐; 分子式: C22H22F3N.HCl ; 分子量:393.87 适应症 该药主要用于治疗肾病透析患者的继发性甲状旁腺机能亢进,或者甲状旁腺癌所致的高钙血症。 用法用量 该药应整片吞服,初始剂量为30mg/天,进食时服用。随后根据患者反应情况,每2~4周调整一次剂量(按60mg/天、90mg/天、120mg/天和180mg/天顺序依次递增),直至患者PTH水平达到美国肾脏基金会临床指南推荐的标准(150~300pg/ml),该药可单独应用或与维生素D醇和磷酸盐结合剂合用。 包装规格 片 12.5毫克 100片(PTP)
25毫克 100片(PTP) 75毫克 100片(PTP)
厂家:协和发酵麒麟 完整处方资料附件:http://www.info.pmda.go.jp/go/pack/3999023F1022_2_08/ 国外上市情况 盐酸西那卡塞由美国NPS Pharmaceuticals 公司研发的拟钙剂,2004年3月8日FDA批准Amgen公司(NPS制药公司该产品的许可权受让人)生产的盐酸西那卡塞上市,商品名为Sensipar;2008年1月,协和麒麟公司生产的盐酸西那卡塞在日本上市,商品名为REGPARA,规格为12.5mg、25mg、75mg(以西那卡塞计)。 Release of Calcium Receptor Agonist "Regpara®Tablets 12.5mg,25 mg, 75 mg/100tablets" Kyowa Hakko Kirin Co., Ltd. (Headquarters: Tokyo, Representative Director: Chen Yu Hui, hereinafter referred to as "Kyowa Hakko Kirin") today announced that it will release 12.5 mg of Calpium Receptor agonist " : Cinacalcet hydrochloride) "will be released. "REGPARA® tablet (hereinafter referred to as" REGPARA® ") is a drug that inhibits the secretion of parathyroid hormone (PTH) by acting on the calcium receptor of the parathyroid gland, and in January 2008 it underwent maintenance dialysis It is on sale as a treatment for secondary hyperparathyroidism. Moreover, in February 2014, the indication of "hypercalcemia in parathyroid cancer, hypercalcemia in primary hyperparathyroidism with parathyroidectomy or postoperative recurrence" and additional usage and dosage Acquired approval. "Regalapar® tablet 12.5mg" to be released this time was approved on February 10, 2015 as a low dose standard and listed on the drug price standard on May 29 of the same year. Seven years have passed since the start of domestic sales of REGPARA®, and many patients use it, but the reactivity and tolerability of this drug differs for each patient. By "REGPARA ® tablets 12.5 mg", it is expected that fine-grained dose adjustment will be possible in the future. The Kyowa Hakko Kirin Group pursues progress in life science and technology and contributes to the health and abundance of the people of the world by creating new value. . Product overview of "REGPARA®tablets" Product name REGPARA ® tablets 12.5 mg, 25 mg, 75 mg Common name Cinacalcet hydrochloride Indication 1. Secondary hyperparathyroidism under maintenance dialysis 2. Hypercalcemia in the following diseases · Parathyroid carcinoma · Primary hyperparathyroidism with or without parathyroidectomy or postoperative recurrence Packing REGPARA ® tablets 12.5 mg, 25 mg, 75 mg / 100 tablets Approval acquisition date February 10, 2015 Drug price criteria Listed date May 29, 2015 --------------------------------------- 产地国家: 日本 原产地英文商品名: REGPARA 12.5mg/tablet 100tablets/bottle 原产地英文药品名: Cinacalcet Hydrochloride 中文参考商品译名: 锐克钙 12.5毫克/片 100片/盒 中文参考药品译名: 盐酸西那卡塞 中文参考化合物名称: N-((1R)-1-(1-萘基)乙基)-3-(3-(三氟甲基)苯基)丙-1-胺盐酸盐 生产厂家中文名: 协和麒麟公司 生产厂家英文名: Kyowa Hakko Kirin --------------------------------------- 产地国家: 日本 原产地英文商品名: REGPARA 25mg/tablet 100tablets/bottle 原产地英文药品名: Cinacalcet Hydrochloride 中文参考商品译名: 锐克钙 25毫克/片 100片/盒 中文参考药品译名: 盐酸西那卡塞 中文参考化合物名称: N-((1R)-1-(1-萘基)乙基)-3-(3-(三氟甲基)苯基)丙-1-胺盐酸盐 生产厂家中文名: 协和麒麟公司 生产厂家英文名: Kyowa Hakko Kirin --------------------------------------- 产地国家: 日本 原产地英文商品名: REGPARA 75mg/tablet 100tablets/bottle 原产地英文药品名: Cinacalcet Hydrochloride 中文参考商品译名: 锐克钙 75毫克/片 100片/盒 中文参考药品译名: 盐酸西那卡塞 中文参考化合物名称: N-((1R)-1-(1-萘基)乙基)-3-(3-(三氟甲基)苯基)丙-1-胺盐酸盐 生产厂家中文名: 协和麒麟公司 生产厂家英文名: Kyowa Hakko Kirin
|