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  药店国别: 美国药房
产地国家: 美国
所属类别: 造影剂->MRI T2加权造影剂
处方药:处方药
包装规格: 5毫升/瓶 1瓶
计价单位:
   
生产厂家中文参考译名:
安斯泰来制药美国公司
生产厂家英文名:
Astellas
该药品相关信息网址1:
http://www.lexiscan.com/
原产地英文商品名:
LEXISCAN injection 5ml/vial 1 vial
原产地英文药品名:
REGADENOSON
中文参考商品译名:
LEXISCAN 5毫升/瓶 1瓶
中文参考药品译名:
REGADENOSON
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
stress agent indicated for radionuclide myocardial perfusion imaging (MPI)
临床试验期:
完成
中文适应病症参考翻译1:
放射性核素心肌灌注
药品信息:
制造商: 安斯泰来制药美国公司 药理分类: 应激剂(甘酸A2A腺苷受体激动剂) 活性成分(补): Regadenoson 0.4mg/5mL;溶液为四损伤;不含防腐剂。 指示(补): 放射性核素心肌灌注显像患者无法(MPI)的接受适当的运动负荷。 药理作用: 心脏压力测试进行可视化冠脉血流量,以确定冠状动脉疾病的程度。许多患者在跑步机上运动,以引起冠状动脉血流量的增加,但有些是无法行使足够的执行测试。对于这些患者,通过药物暂时增加冠状动脉血流量,可用于模拟在冠脉血流量的增加运动引起。 临床试验: Regadenoson比较两个不同的随机,双盲研究腺苷在2015年谁是表示接受药物负荷心肌灌注显像患者。 1871年例谁图像为主要疗效评价每收到一个初始有效应力扫描使用腺苷。经过初步检查,病人被随机分为regadenoson或腺苷并接受后,中位数为7天进行第二次测试。在这两项研究,结果表明,使用的regadenoson腺苷类似评估的可逆灌注异常程度。 法律分类: 接收 成人: ≥18yrs:为5mL(为0.4mg)快速静脉注射超过10秒;立即​​用生理盐水冲洗跟进(5毫升),然后放射性10-20秒钟后。使用周围静脉和22克或更大的针或导管。 儿童: “18yrs:不推荐。 禁忌(补): 第二或第三度房室传导阻滞或窦房结功能障碍,除非节奏。 警告/注意事项: 有足够的设备和训练有素的复苏的人员。 SA和房室传导阻滞,可能抑制水杨酸/影音节点。低血压。植物神经功能紊乱。左冠状动脉主干狭窄。狭窄的心脏瓣膜疾病。心包炎。心包积液。脑血管狭窄颈动脉供血不足的疾病。低血容量。哮喘。慢性阻塞性肺病。妊娠(Cat.C)。哺乳母亲:暂停治疗后10小时护理。 互动(补): 由甲基黄嘌呤拮抗(如咖啡因,茶碱,避免了12个小时前);可以使用氨茶碱治疗严重的不利影响。可能会增强了达莫(≥2日停牌前使用)。 不良反应(补): 呼吸困难,头痛,面部潮红,胸部疼痛/不适,头晕,心绞痛,恶心,低血压,节奏/传导异常,支气管,呼吸妥协。 如何提供: 单用小瓶(5毫升)-1 一次性使用预填充注射器(5毫升)-1 Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. IMPORTANT SAFETY INFORMATION Do not administer Lexiscan to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker. Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischemia induced by pharmacologic stress agents. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan. Adenosine receptor agonists, including Lexiscan, can depress the SA and AV nodes and may cause first-, second-, or third-degree AV block, or sinus bradycardia requiring intervention. In postmarketing experience, heart block (including third degree), and asystole within minutes of Lexiscan administration have occurred. Adenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. In postmarketing experience, syncope, transient ischemic attacks, and seizures have been observed. In clinical trials, decreased systolic blood pressure (>35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (>25 mm Hg) was observed in 4% of patients within 45 minutes of Lexiscan administration. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. Adenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. When it occurred in clinical trials, increased blood pressure was observed within minutes of Lexiscan administration, and in most cases, resolved within 10 to 15 minutes. In some cases, blood pressure increases were observed 45 minutes following Lexiscan administration. In postmarketing experience, cases of potentially clinically significant hypertension have been reported, particularly in patients with underlying hypertension and when low-level exercise was included in the MPI. Adenosine receptor agonists, including Lexiscan, may cause bronchoconstriction and respiratory compromise. For patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD), or asthma, appropriate bronchodilator therapy and resuscitative measures should be available prior to Lexiscan administration. Lexiscan overdosage may result in serious reactions. Aminophylline was used as a reversal agent in 3% of patients. The most common adverse reactions (≥5%) to Lexiscan are dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia, and feeling hot. Most adverse reactions began soon after dosing, and generally resolved within approximately 15 minutes, except for headache, which resolved in most patients within 30 minutes. In postmarketing experience, abdominal pain in association with nausea, vomiting, or myalgias, and diarrhea, fecal incontinence, musculoskeletal pain, and tremor have occurred. Intravenous Adenoscan is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. IMPORTANT SAFETY INFORMATION Adenoscan is contraindicated in patients with second- or third-degree AV block, unless these patients have a functioning artificial pacemaker, sinus node disease, and known or suspected bronchoconstrictive or bronchospastic lung disease. Fatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and nonfatal myocardial infarction have been reported coincident with Adenoscan infusion. Patients with unstable angina may be at greater risk. Appropriate resuscitative measures should be available. Adenoscan is a potent peripheral vasodilator and can cause significant hypotension. The risk of hypotension may be higher in patients with cardiac or cerebrovascular insufficiency. Adenoscan exerts a direct depressant effect on the SA and AV nodes and has the potential to cause first-, second- or third-degree AV block, or sinus bradycardia. Increases in systolic and diastolic pressure have been observed. Adenosine receptor agonists, including Adenoscan, may cause bronchoconstriction and respiratory compromise. Atrial fibrillation has been reported in patients with Adenoscan infusion and may last from a few seconds to hours, however, patients spontaneously converted to normal sinus rhythm. Most common adverse reactions (≥5%) to Adenoscan are flushing, chest discomfort, dyspnea, headache, discomfort of the throat, neck, or jaw, gastrointestinal discomfort, and lightheadedness/dizziness. Side effects with Adenoscan usually resolve quickly when the infusion is discontinued, although delayed or persistent effects have been observed.
更新日期: 2014-09-11
附件:
201492123081727.pdf    

 
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