英文药名: Tnkase(Tenectelplase Injection) 中文药名: 替奈替普酶注射液 药品生产厂家: Boehringer Ingelheim 药品介绍； 替奈替普酶是第一个被FDA已批准的清除血栓的药物，该药仅须注射1次，5秒钟内吸收，可简化急性 心脏病 的治疗。它的主要成分是TNK酶，1次注射后能迅速清除血栓。 在美国，每年有1，100，000人发生心脏病突发事件，其中约半数人死亡。这主要是由于心脏相应的血管发生阻塞，若在胸闷心悸等症状发生后立即扩张阻塞的血管，则会降低死亡率。 Tenecteplase的主要副作用是颅内出血及中风。 急性心肌梗死(AMI)是病变的冠状动脉并发粥样斑块破裂出血、血管腔内血栓形成，使冠脉闭塞而至引起心肌严重缺血、坏死。现代医学治疗MAI是建立在心梗的发病机制上，即通过静脉注入纤维蛋白溶解药，使内源性纤溶酶原转变为纤溶酶从而由纤溶酶水解形成的纤维蛋白来溶解血块，使冠脉再通。快速冠脉溶栓可限制梗死范围扩大，减少左室功能不良，提高生存率，这一方法已被临床广泛接受。 替特普酶的推荐剂量须依患者体重而定且不得超过50mg，其中体重wt60Ks的应接受30mg、体重≥90Kg的应接受50mg药物治疗。对体重在60～69、70～79和80～89Kg的患者，替特普酶的推荐剂量分别为35、40和45mg。 替特普酶为粉针剂，规格是每瓶含药52.5mg。作50mg计（过量5％），使用时以10ml无菌注射水溶解成5mg／ml液，然后再依患者体重进行冲击性给药。 Generic Name for TNKASE Tenecteplase 50mg/vial; lyophilized pwd for IV inj after reconstitution. Legal Classification: Rx Pharmacological Class for TNKASE Tissue plasminogen activator (tPA). Manufacturer of TNKASE Genentech, Inc. Indications for TNKASE To reduce mortality associated with acute myocardial infarction (AMI). Adult dose for TNKASE Start treatment soon after onset of AMI symptoms. Give as single IV bolus over 5 seconds. <60kg: 30mg; ≥60kg–<70kg: 35mg; ≥70kg–<80kg: 40mg; ≥80kg–<90kg: 45mg; ≥90kg: 50kg. Max: 50mg. Children's dosing for TNKASE Not recommended. Contraindications for TNKASE Active internal bleeding. History of cerebrovascular accident. Intracranial or intraspinal surgery or trauma within 2 months. Intracranial neoplasm, arteriovenous malformation, or aneurysm. Bleeding diathesis. Severe uncontrolled hypertension. Warnings/Precautions for TNKASE Avoid noncompressible arterial puncture, internal jugular and subclavian venous puncture, IM injections and nonessential handling of patient during treatment. Increased bleeding risk at puncture sites; minimize arterial and venous punctures. Increased risk of complications with recent major surgery, cerebrovascular disease, GI or GU bleeding, recent trauma, hypertension (systolic BP ≥180mm Hg and/or diastolic BP ≥110mm Hg), left heart thrombus, acute pericarditis, endocarditis, hemostatic defects, hepatic dysfunction, pregnancy, hemorrhagic ophthalmic conditions, septic thrombophlebitis, elderly. Pregnancy (Cat.C). Nursing mothers. Interactions for TNKASE Increased bleeding risk with heparin, vitamin K antagonists, aspirin, dipyridamole, GP IIb/IIIa inhibitors. May interfere with coagulation tests. Adverse Reactions for TNKASE Bleeding, hypersensitivity reactions, cardiogenic shock, arrhythmias, AV block, pulmonary edema, heart failure, cardiac arrest, recurrent MI, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thromboembolism, electromechanical dissociation, nausea, vomiting, hypotension, fever; cholesterol embolism. How is TNKASE supplied? Vial—1 (w. diluent, supplies) Indication and Safety Information Indication: For use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms. Safety Information: TNKase therapy is contraindicated in the following conditions due to an increased risk of bleeding: active internal bleeding, history of cerebrovascular accident, intracranial or intraspinal surgery or trauma within 2 months, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, and severe uncontrolled hypertension. All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, particularly in elderly patients. In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or percutaneous coronary intervention (PCI) as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate. 通用名称为TNKASE Tenecteplase 50mg/vial;冻干静脉注射重组后PWD。 法律分类： 接收 类药物为TNKASE 组织型纤溶酶原激活物（tPA）。 制造商的TNKASE Genentech公司 主治为TNKASE 为了减少急性心肌梗死（AMI）的死亡率相关。 成人剂量为TNKASE 开始治疗急性心肌梗死症状出现后不久。作为单一的静脉推注给予5秒以上。 <60公斤：30毫克;≥60千克<70千克：35mg;≥70公斤<80公斤：40毫克;≥80千克<90千克：45mg;≥90公斤：50KG。马克斯：50毫克。 儿童剂量为TNKASE 不推荐。 禁忌症为TNKASE 积极的内部出血。脑血管意外史。 2个月内，颅内或椎管内手术或外伤。颅内肿瘤，动静脉畸形或动脉瘤。出血素质。严重的未控制的高血压。 为TNKASE警告/注意事项 避免不可压缩动脉穿刺，颈内静脉和锁骨下静脉穿刺，肌肉注射和病人在治疗过程中的不必要的处理。增加穿刺点出血的危险性，减少动脉和静脉穿刺。最近的主要手术并发症的风险增加，脑血管病，胃肠道或顾出血，近期外伤，高血压（收缩压≥180毫米汞柱和/或舒张压≥110毫米汞柱），左心血栓，急性心包炎，心内膜炎，止血缺陷，肝功能不全，妊娠，出血眼科条件，化脓性血栓性静脉炎，老人。怀孕（Cat.C）。哺乳的母亲。 为TNKASE的相互作用 增加出血的危险，与肝素，维生素K拮抗剂，阿司匹林，潘生丁，GP IIb / IIIa抑制剂。可能会干扰凝血试验。 TNKASE的不良反应 出血，过敏反应，心源性休克，心律失常，房室传导阻滞，肺水肿，心衰，心脏骤停，反复发作的心肌梗死，心肌破裂，心包填塞，心包炎，心包积液，二尖瓣关闭不全，血栓栓塞，机电解离，恶心，呕吐，低血压，发热;胆固醇栓塞。 如何TNKASE提供？ 样品瓶- 1（瓦特稀释剂，耗材）