药品信息:
友情提示:此款药品要求冷冻,但可以在冰箱冷藏温度下保存1年,室内常温下6个月。所以运输没有问题。我们会用常用的冷藏箱(Stereo Foam Box)放入足够的冰袋(Blue Ice)来进行运输。
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201262719050230.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文ChiRhoStim处方资料(仅供参考)
[通用名称]human secretin for injection,注射用人胰泌素
[商品名]ChiRhoStim
[化学结构]其氨基酸排列顺序为:H is-Ser-Asp-G ly-Thr-Phe-Thr-Ser-G lu-Leu-Ser-Arg-Leu-Arg-G lu-G ly-A la-Arg-Leu-G ln-Arg-Leu-Leu-G ln-G ly-Leu-Val-NH2相对分子质量:3039.44,分子式:C130H220N44O39
[药理作用]本品最主要的药理作用是增加胰液的分泌体积和其中碳酸氢盐的含量。在猫体上进行合成人胰泌素(sHS)、合成猪胰泌素(sPS)和猪胰泌素生物衍生物(bPS)的生物等效性研究,证实sHS和sPS在刺激胰外分泌胰液和碳酸氢盐上有相同的药理活性。sHS和sPS的活性0.2μg与bPS 1CU相当,即生物活性约为5.0 CU·μg-1。
[作用机制]胰泌素是十二指肠上端黏膜接触胃酸、脂肪酸或氨基酸后正常分泌的一种激素,由肠黏膜的肠色素细胞分泌,其受体已证实存在于胰脏、胃、肝、结肠和其他组织。
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分类名称 一级分类:其他用药 二级分类:诊断用药 三级分类:器官功能检查诊断剂 药品英文名 Secretin 药品别名 肠促胰液素、促胰液素、肠促胰液肽、分泌素、SecreFlo.、SEC 药物剂型 注射剂:每支含胰泌素16mg,L-半胱氨酸盐酸盐15mg。 药理作用 本品为含27个氨基酸的多肽类激素,与天然猪胰泌素具有相同的氨基酸序列。本品的主要作用是增加胰液的分泌和胰液中碳酸氢盐的含量。本品的活性标准单位以临床单位(clinicalunits,CU)表示,本品的效能相当于5000CU/mg的肽,等同于3000CU/mg的生物合成猪胰泌素。本品为纯肽类制剂,其含量用mg表示,胰泌素mg与生物活性之间的换算关系为:0.2mg=1CU。 药动学 12名健康受试者静注本品0.4mg/kg后,大多数志愿者的血浆胰泌素浓度在60~90min内降至正常基线水平,血浆清除速率为(487±136)ml/min,表观分布容积为2L。 适应证 本品主要用于胰泌素刺激试验。1.刺激胰腺分泌,包括碳酸氢盐的分泌,用来帮助诊断胰腺分泌功能障碍。2.刺激胃泌素分泌,以诊断胃泌素瘤。刺激胰腺分泌,以在内窥镜逆行性胆管造影术(endoscopic retrograde cholangio pancreatography,ERCP)检查中区别十二指肠乳头胆道口壶腹及副壶腹。 禁忌证 1.急性胰腺炎患者禁用,直到急性发作期结束。2.妊娠毒性分级为C级,动物试验未发现生殖毒性,尚不知孕妇用药是否影响胎儿或生殖能力,故本品不宜给孕妇使用,除非必需。3.儿童用药的安全性和疗效尚不清楚,不推荐儿童使用。 注意事项 1.尚不知本品是否经人乳汁分泌,哺乳期妇女慎用。2.迷走神经切断术患者、正在使用抗胆碱药的患者、炎性肠病患者可对本品的刺激呈低反应性,但该反应并不代表有胰脏疾病。3.对胰泌素的刺激产生超过正常体积的胰液分泌,有可能掩盖并发的胰脏病,这种情况偶尔会在酒精性肝病或其他肝病患者身上发生。4.临床研究显示,老年人与成年人使用相同剂量,其安全性、药理作用、诊断效果无差别,但不能排除个别患者敏感性增加。5.本品溶解后立即注射,剩余的溶解液弃掉。6.-20℃冷冻保存。 不良反应 偶见轻度不良反应。尽管在临床观察中未发现皮肤试验过敏或用药后过敏,但仍有引起过敏反应的可能,故用药前应先做皮试,皮试剂量为0.2mg(0.1ml),皮试后1min无过敏反应症状方可用药,尤其有特异性变态反应或哮喘病史的患者,对严重过敏反应应立即采取适当解救措施。尚无长期动物试验研究本品的致癌作用、致畸形作用和致突变作用,小鼠和兔给药20mg/kg无致死。 用法用量 1.胰泌素刺激试验以辅助诊断胰腺分泌功能障碍:患者禁食12~15h,在透视控制下,将不透过射线的双腔管的近侧管开口经口放入胃窦,远侧管开口置于法特乳头外,双管间断给予20~40mmHg负压,当十二指肠内容物pH>6.0时收集十二指肠内基础样品10min。静注本品0.2mg(1ml)试验过敏反应,1min后如无过敏反应,1min内静注本品0.2mg/kg,收集十二指肠液共60ml,每15min分段收集共收集4部分,每次收集完后注射空气清洁十二指肠肠道。将每份液体冷却并对其体积及碳酸氢盐浓度进行分析,如果任何一个样品的碳酸氢盐浓度<80mEq/L,均说明胰腺分泌功能与慢性胰腺炎密切相关。 2.刺激胃泌素分泌以诊断胃泌素瘤:患者至少禁食12h,抽取2份血浆样品测定血浆胃泌素浓度作为基础水平浓度,然后静注本品0.2mg(0.1ml)皮试,如未发生过敏,则1min内静注0.4mg/kg,分别于给药后1min、2min、5min、10min、30min取血浆样品测定胃泌素浓度,若任何一个给药后血浆中的胃泌素浓度比基础水平浓度增加110pg/ml,则胃泌素瘤可能性很大。3.刺激胰腺分泌以在内窥镜逆行插管中区别法特壶腹和副乳头:胰腺分裂患者区别法特壶腹和副乳头时,1min内静注本品0.2mg/kg,看是否有胰液分泌物从乳头流出,有利于区分及套管插入术。将本品16mg溶于8ml生理盐水中,浓度为2mg/ml,强烈振摇使溶解,供注射用。 药物相应作用 合用抗胆碱药可使患者敏感性增强产生假阳性结果。
--------------------------------- Secretin injection Brand names for this medication ChiRhoStim, SecreFlo
What is this medicine? SECRETIN (si KREE tin) is used as an aid in the diagnosis of certain disorders of the pancreas, stomach, and intestines.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine? They need to know if you have any of these conditions: • eczema • history of allergies • liver disease • lung or breathing disease, like asthma • pancreatitis • an unusual or allergic reaction to secretin, other medicines, foods, dyes, or preservatives • pregnant or trying to get pregnant • breast-feeding
How should I use this medicine? This medicine is for injection into a vein. It is usually given by a healthcare professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
What if I miss a dose? This does not apply.
What may interact with this medicine? • atropine • antihistamines for allergy, cough and cold • certain medicines for bladder problems like oxybutynin, tolterodine • certain medicines for stomach problems like dicyclomine, hyoscyamine • ipratropium • certain medicines for travel sickness like scopolamine • certain medicines for Parkinson's disease like benztropine, trihexyphenidyl
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine? Your condition will be closely monitored while you are receiving this medicine.
The effects of the injection only last for a few minutes or less. Follow all instructions of your health care provider for before and after your test.
What side effects may I notice from receiving this medicine? Side effects that you should report to your doctor or health care professional as soon as possible: • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue • breathing problems • dizziness • feeling faint or lightheaded, falls • palpitations • slow, irregular heartbeat
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): • abdominal cramps or discomfort • flushing • headache • nausea • sweating
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine? This drug is given in a hospital or clinic and will not be stored at home.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201262719050230.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |