您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8473 处方药 8099 非处方药 268 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国内客服电话:
国际免费电话:


QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->化疗药物
处方药:保健药品
包装规格: 150毫克
计价单位:
   
该药品相关信息网址1:
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a694011.html
原产地英文商品名:
Granisetron Hydrochloride 150mg
原产地英文药品名:
Granisetron Hydrochloride
中文参考商品译名:
盐酸格拉司琼 150毫克
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy or radiation)
临床试验期:
完成
中文适应病症参考翻译1:
止吐药,用于化、放疗所致的恶心和呕吐
药品信息:
盐酸格拉司琼 性质、用途与生产工艺 盐酸格拉司琼概述 盐酸格拉司琼最初是由英国 Beecham公司开发于80年代中期。1991年,由合并后的Smithkline-Beecham(SB)公司首次将3mg注射剂Kytri1在南非推上市。迄今,包括1mg口服片剂、1mg注射剂,盐酸格拉司琼已在美、英、法、日、德、意等全世界四十多个国家和地区上市。Smithkline-Beecham(SB)公司在和葛兰素公司合并是又将该品转给了罗氏公司。 国外研究资料表明, 盐酸格拉司琼具有高度的受体选择性。其与5-HT3受体的亲和力是与其它受体如5-HT1、5-HT2、多巴胺D1、D1,组胺H1、苯二氮卓及阿片受体的亲和性的4000—10000倍,而恩丹西酮的这种差异仅1000倍。对顺铂致雪貂呕吐的预防试验, 盐酸格拉司琼三个剂量组:2×0.005、2×0.05及2×0.5mg/kg( iv)的止吐率分别为93%、96%和100%,而恩丹西酮2×2.5mg/kg的止吐率为89%,表明盐酸格拉司琼抗呕吐活性强于恩丹西酮至少5倍。毒性研究认为, 盐酸格拉司琼在小剂量时能达到很好的止吐作用, 副作用很小。大剂量时心血管系统出现异常。由于盐酸格拉司琼的临床推荐剂量很小(3mg/d),仅为动物试验所用的最低剂量(<1mg/kg= 的l/25,因此,临床应用是很安全的。药代动力学研究表明, 盐酸格拉司琼在病人体内的半衰期( t1/2)为9h,健康人为4h;老年人t 1/2为7.7h,青年人为4.9h。盐酸格拉司琼主要在肝脏代谢,以7-羟基盐酸格拉司琼和其他代谢产物形式通过粪便和尿液排出体外。肝功受损或肝转移癌的血浆清除率减少,肾功能不全时清除力为正常时的1/4。口服观察到很高的首过代谢,绝对生物利用度为60%。 国内市场分析 1993年,我国批准进口了英国 SB公司的康泉( Kytri1)注射剂(3mg/3mI),注册证号: X930279,并在临床试用。1994年,中美天津史克制药有限公司采用进口原料加工方式生产盐酸格拉司琼 3mg注射剂,并取得卫生部批文:(94)卫药准字J-10号(四类),商品名“凯瑞特”。目前国内已有多个厂家的产品上市,制剂厂家更是多达几十家见附件一。 我国人口众多,每年新发现的恶性肿瘤患者人数已逾160万,化疗、放疗引起的恶心呕吐一直是令医生和患者烦恼的严重副作用之一,对新型止吐剂有着迫切的需求。目前司琼类的药物已经占据了止吐药的大部分市场。主要包括恩丹西酮(枢复灵)、 盐酸格拉司琼(康泉)和托烷司琼(呕必停,Tropisetron),其中,枢复灵和康泉已积累了大量临床应用经验,医生反映良好,对改善我国的化疗呕吐治疗起到了积极的作用。随着产品的国产化,价格下降,以及人们收入水平的提高,止吐药的市场一定会大幅度提高。在这种情况下,作为第二个上市的司琼类药物盐酸格拉司琼肯定会有良好的市场前景。 说明书 【性状】无色或几乎无色的澄明液体。 【药理毒理】本品是一种高选择性的5-HT3受体拮抗剂,对因放疗、化疗及手术引起的恶心和呕吐具有良好的预防和治疗作用。放疗、化疗及外科手术等因素可引起肠嗜铬细胞释放5-HT,5-HT可激活中枢或迷走神经的5-HT3受体而引起呕吐反射。本品控制恶心和呕吐的机理,是通过拮抗中枢化学感受区及外周迷走神经末梢的5-HT3受体,抑制恶心、呕吐的发生。本品选择性高,无锥体外系反应、过度镇静等副作用。 【适应症】放于放射治疗、细胞毒素类药物引起的恶心和呕吐。 【用法用量】静脉滴注。成人推荐用量通常为3mg,于化疗前30分钟静脉给药。大多数病人只需给药一次,对恶心和呕吐的防预作用便可超过24小时,必要时可增加给药次数1-2次,但每日最高剂量不超过9mg。输注时间不少于5分钟。 【药代动力学】健康受试者静注本品20或40μg/kg后,平均血浆浓度峰值为13.7 和42.8μg/L,血浆消除半衰期约3.1-5.9小时。本品在体内分布广泛,血清蛋白结合率约为65%,大部分迅速代谢,主要代谢途径N-去烷基化及芳香环氧化后被共轭化。本品通过粪便和尿液排泄。 化学性质 白色或微黄白色结晶性粉末,无臭。易溶于水,较难溶于甲醇,极难溶于乙醇,几不溶于乙醚。熔点290-292℃。急性毒性LD50、雌小鼠,雄、雌大鼠(mg/kg):17,25,14,16静脉注射。 用途 为外周及中枢神经系统中5-羟色胺3(5-HT3)的选择性拮抗剂。用于细胞毒药物或放疗引起的恶心和呕吐。 用途 解痉药。止吐药,用于化、放疗所致的恶心和呕吐。 用途 用作解痉药 生产方法 化合物(I)和化合物(Ⅱ)反应,即得格拉司琼。用氯化氢-乙醇酸化,得到盐酸格拉司琼。 Granisetron Hydrochloride Your doctor has ordered granisetron to prevent nausea and vomiting caused by cancer chemotherapy. The drug will be added to an intravenous fluid that will drip through a needle or catheter placed in your vein for at least 5 minutes, about a half-hour before chemotherapy administration. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how you respond to the medication. Precautions Before administering granisetron, tell your doctor and pharmacist if you are allergic to granisetron or any other drugs. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking granisetron, call your doctor. Administering your medicationReturn to top Before you administer granisetron, look at the solution closely. It should be clear and free of floating material. Gently squeeze the bag or observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks. Use a new solution, but show the damaged one to your health care provider. It is important that you use your medication exactly as directed. Do not change your dosing schedule without talking to your health care provider. Your health care provider may tell you to stop your infusion if you have a mechanical problem (such as a blockage in the tubing, needle, or catheter); if you have to stop an infusion, call your health care provider immediately so your therapy can continue. Side effectsReturn to top Granisetron may cause side effects. Tell your health care provider if any of these symptoms are severe or do not go away: headache dizziness weakness drowsiness stomach pain constipation diarrhea If you experience any of the following symptoms, call your health care provider immediately: chest pain irregular heartbeat trouble breathing fainting spells rash If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088]. Storing your medicationReturn to top Your health care provider probably will give you a several-day supply of granisetron at a time. You will be told to store it at room temperature. Store your medication only as directed. Make sure you understand what you need to store your medication properly. Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury. In case of emergency/overdoseReturn to top In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Signs of infectionReturn to top If you are receiving granisetron in your vein or under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your vein or skin). If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible: tenderness warmth irritation drainage redness swelling
更新日期: 2013-08-22
附件:
201412318212638.pdf    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国内客服电话:     国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com