人促胰液素注射粉末剂CHIRHOSTIM powder Injection 40mcg

药店国别： 产地国家：美国 处方药：是 所属类别： 40微克/瓶 包装规格： 40微克/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：CHIRHOCLIN INC 原产地英文商品名：ChiRhoStim powder Injection 40mcg/vial 原产地英文药品名：SECRETIN ACETATE (HUMAN) 中文参考商品译名：CHIRHOSTIM注射粉末剂 40微克/瓶 中文参考药品译名：人促胰液素

简介

注射人促胰液素human secretin(商品名 ChiRhoStim)获FDA批准上市，用于胰腺癌和胰腺外分泌功能不全的诊断孤儿药productsthat助剂，缩短手术时间和患者的治疗。批准日期：2017年4月26日 公司：ChiRhoClin, Inc.CHIRHOSTIM(人促胰液素[human secretin])注射，静脉内使用最初美国认证：2004年 作用机理 ChiRhoStim的主要动作®是刺激胰腺导管细胞分泌在大体积的流体胰腺确实含有碳酸氢盐。泌是激素并通常从十二指肠在近端肠腔胃酸，脂肪酸和氨基酸的曝光释放。促胰液素是从肠黏膜肠嗜铬细胞释放。促胰液素受体已经鉴定了在胰腺，胃，肝，结肠和其他组织。当促胰液素结合到胰管细胞促胰液素受体它打开囊性纤维化跨膜传导调节因子(CFTR)的通道，导致富碳酸氢盐胰液分泌。促胰液素可通过迷走神经迷走神经通路自从传出刺激迷走神经，因此刺激工作碳酸氢盐分泌和阿托品块胰液素刺激胰腺分泌。 适应症和用法 ChiRhoStim®的适应症是刺激促胰液素类：胰腺分泌，包括盐，碳酸氢盐，以在胰腺外分泌功能不全帮助诊断胃泌素分泌到在胃泌素瘤的诊断助剂胰腺分泌到促进父亲的壶腹的识别和内窥镜逆行胰胆管造影期间所述附件乳头(ERCP) 用法用量 为了避免不正确的刺激试验结果，停止下列药物的时间ChiRhoStim®药之前的推荐量：抗胆碱药：至少5个半衰期。H2受体拮抗剂：至少2天。质子泵抑制剂(PPI)：有关特定的质子泵抑制剂的处方信息。 通过指示推荐的剂量示于表：迹象推荐剂量方案胰腺分泌，包括碳酸氢盐，刺激在的胰腺外分泌功能不全诊断辅助经1分钟0.2微克/ kg通过静脉内注射胃泌素分泌的刺激胃泌素瘤中的辅助诊断经1分钟0.4微克/ kg通过静脉内注射胰腺分泌物的刺激，以促进内镜逆行胰胆管造影过程中的附件乳头壶腹部的标识(ERCP)经1分钟0.2微克/ kg通过静脉内注射确定小瓶的数目进行重构基于所述患者的体重和规定的剂量ChiRhoStim® 必须在给药前0.9%氯化钠注射液进行重构请参阅有关外分泌试验方法的完整信息的完整处方信息 剂型和规格 对于注射：16微克或40微克人促胰液素作为在单剂量小瓶中用于重建的冻干粉末 禁忌症：无 警告和注意事项 海波应对患者分泌刺激试验与迷走神经切断，炎性肠病或接收抗胆碱药：停止抗胆碱药至少五个刺激之前测试的半衰期;考虑诊断辅助额外的测试和临床评估。超响应于促胰液刺激测试：在接收H2受体拮抗剂或质子泵抑制剂错误地暗示胃泌素瘤患者中增加胃泌素分泌;停止共同施用刺激之前测试药物。 患者酒精或其他肝脏疾病掩盖并存胰腺疾病增加胰腺分泌;考虑诊断辅助额外的测试和临床评估。 不良反应 最常见的不良反应(≥2例)有恶心，呕吐，面色潮红和胃部不适。 包装规格/储存与处理 ChiRhoStim®(人促胰液素)，用于注射，作为在单剂量小瓶用于重构的冻干白色粉末无菌

英文版说明书

FDA approved labeling update and 5-year shelf life approvalJuly 25, 2017 -- ChiRhoClin, Inc. is pleased to notify the medical community that ChiRhoStim® (Human Secretin for Injection) has received FDA approval, updating its package insert. There are two significant changes to the package insert. The first change eliminates the need to inject a test dose prior to administering ChiRhoStim®. The second significant change is the removal of the contraindication section. The benefit for patients experiencing an acute pancreatitis episode is that they can be administered ChiRhoStim® for pancreatic eva luation. These two changes to the package labeling may shorten procedure time and patient treatment. In addition, an extended 5-year shelf life of ChiRhoStim® was approved. This shelf life extension of the product stability will provide a steady stream of Secretin for the future.ChiRhoStim® is an orphan drug product that aids in the diagnoses of pancreatic cancer and pancreatic exocrine dysfunction. ChiRhoStim® is approved for pancreatic function testing, facilitating cannulation during ERCP, and Gastrinoma testing. In addition, secretions of the pancreatic fluid after secretin stimulation can be used in situ for imaging modalities such as MRCP, CT, and EUS.Skip Purich, C.O.O., said "These improvements to our product shelf life and updated labeling will assist the medical community in shortening Gastroenterology and Radiology procedure times. As well as not delaying diagnostic testing such as secretin stimulated MRCP (SMRCP) or function testing while a patient is suffering from acute pancreatitis."ChiRhoClin, Inc., a Maryland based family run corporation founded in 1991 by Dr. Edward D. Purich, is a research and development oriented pharmaceutical company focused on developing orphan drug products for the gastrointestinal and radiological community. Our emphasis is to develop orphan drug products that will diagnose and treat pancreatic gastrointestinal diseases and encourage research in the pancreatic area through our small pancreatic grant programChiRhoStim is available as 16mcg and 40mcg strength lyophilized powder in single-dose vials for reconstitution