获取国外Hypaque-76药品价格，使用等信息，最快 24 小时回馈
Hypaque-76
Hypaque-76
无菌水注射液
排泄性泌尿外科
主动脉造影
心血管造影（脑室造影，肺
血管造影，选择性冠状动脉造影）
周围血管造影（Peripheral Arteriography）
和周边静脉造影）
静脉数字动脉造影
增强计算对比度
断层扫描头成像
增强计算对比度
体层摄影术
选择性肾动脉造影
选择性内脏动脉造影
中央静脉造影
肾脏造影
| 不用于鞘内使用 |
在本页面
- 描述
- 临床药理学
- 适应症和用法
- 禁忌症
- 警告事项
- 预防措施
- 病人咨询信息
- 药物相互作用
- 不良反应/副作用
- 过量
- 剂量和给药
- 供应/存储和处理方式
Hypaque-76说明
泛影葡糖胺和泛影酸钠的品牌Hypaque-76是一种水溶性，不透射线的诊断介质。它以76％无菌水溶液的形式提供，提供66％（w / v）的泛影葡糖胺和10％（w / v）的泛影酸钠。它是含有37％（w / v）有机键合碘的三碘代苯甲酸衍生物。每毫升含370毫克碘和3.68毫克（0.16 mEq）钠。它由不透射线的碘化阴离子，泛影酸盐和不透射线的阳离子葡甲胺和钠组成。阴离子的有机结合碘使内部结构不透明，从而可以进行X射线可视化和荧光透视。
该溶液对血液具有高渗性，重量克分子渗透压浓度为2016 mosm / kg（由VPO确定）。在37℃下的粘度为9cp。使用Na 2 CO 3与HCl或NaOH将pH调节为6.0至7.7。泛氮酸的pKa为3.4。添加了0.01％的乙二胺四乙酸钙二钠作为螯合稳定剂。溶液澄清，无色至浅黄色。
泛影葡糖胺是1-脱氧-1-（甲基氨基）-D-葡萄糖醇3，5-二乙酰氨基-2,4,6-三碘苯甲酸酯（盐），具有以下结构式：
泛影酸钠是3,5-二乙酰氨基-2,4,6-三碘苯甲酸单钠，具有以下结构式：
Hypaque-76-临床药理学
造影剂的血管内注射使造影剂的流动路径中的那些血管变得不透明，从而可以对人体内部结构进行射线照相可视化，直到发生明显的血液稀释为止。
在生理pH值下，水溶性造影剂会完全分解为不透射线的阴离子和增溶阳离子。当在组织液中循环时，该化合物保持离子化。然而，它不被代谢而是在尿中不变地排泄，每个泛影酸分子都“义务”于其钠或葡甲胺部分。
静脉注射后，不透射线的诊断剂立即在循环血浆中稀释。约10分钟时细胞外区室达到平衡。因此，在10分钟时的血浆浓度与校正至体型的剂量密切相关。
静脉内注射不透射线造影剂的药代动力学通常最好用两室模型来描述，该模型具有用于药物分配的快速α相和用于药物消除的慢β相。在肾功能正常的患者中，泛影酸盐的α和β半衰期分别为30分钟和120分钟。但是在肾功能不全的患者中，β期的消除半衰期可以延长到几天。
可注射的不透射线的诊断剂通过肝脏或肾脏排泄。这两个排泄途径并不互斥，但排泄的主要途径似乎受造影剂对血清白蛋白亲和力的控制。泛影酸钠的0％至10％与血清蛋白结合。
泛影酸盐通过肾小球滤过主要通过肾脏排泄。在任何时间段内肾脏排泄的量取决于过滤后的负荷；即血浆造影剂浓度与肾小球滤过率的乘积。血浆浓度取决于给药剂量和体型。肾小球滤过率随身体大小，性别，年龄，循环动力学，药物的利尿作用和肾功能而变化。肾功能正常的患者在10分钟内会出现泛影葡糖胺和泛影酸钠的最大尿液浓度，排泄剂量的12％。以给药剂量的百分比表示的泛影葡糖胺和泛影酸钠的累积尿排泄平均值在60分钟时为38％，在3小时时为45％，在24小时时为94％至100％。
小于1个月的婴儿和尿路梗阻患者的造影剂尿排泄延迟。泛影石酸钠盐中的尿碘浓度高于葡甲胺盐中的尿碘浓度。
肝和小肠为泛影酸盐的排泄提供了主要的替代途径。在没有严重肾脏疾病的患者中，粪便恢复少于给药剂量的2％。在严重肾功能不全的患者中，这些造影剂通过胆囊排入小肠的排泄量急剧增加。在48小时内，粪便中已回收到高达20％的剂量。
唾液是可注射的不透射线诊断剂的次要分泌途径。在肾功能正常的患者中，少量的造影剂会原样分泌。然而，在尿毒症患者中，在唾液中已检测到在给药前或体内脱碘导致的少量游离碘化物。
泛影酸盐通过简单的扩散越过人类的胎盘屏障，似乎被动地进入胎儿组织。分娩前24小时静脉内注射泛影酸钠和泛影葡胺对胎儿无明显伤害。但是，分娩后4至6天检测到小肠和结肠的新生儿乳浊异常。包括放射在内的程序涉及与胎儿暴露有关的一定风险。 （请参阅预防措施，一般，怀孕类别C。）
可注射的不透射线的诊断剂在人乳中原样排泄。 （请参阅预防措施，一般，护理母亲。）
CT检查
Hypaque-76通过增强放射线照相效率来增强计算机断层扫描脑部扫描。组织密度可视化的增强程度直接与给药剂量中的碘含量有关。快速注射剂量后，碘血峰值立即出现。这些水平在五到十分钟内迅速下降。这可以通过在血管和细胞外液区室中的稀释来解释，这导致血浆浓度最初急剧下降。约十分钟即可达到细胞外区室的平衡；此后，下降变为指数。在达到峰值血碘水平后，经常会出现最大程度的对比度增强。最大对比度增强的延迟范围可能从五分钟到四十分钟不等，这取决于达到的碘峰值水平和病变的细胞类型。这种滞后现象表明，放射线造影对比度的增强至少部分取决于病变内和血池外碘的积累，尽管其发生的机理尚不清楚。非肿瘤性病变（如动静脉畸形和动脉瘤）的影像学增强可能取决于循环血池中的碘含量。
在脑部扫描中，由于存在血脑屏障，泛影葡胺和泛影酸钠注射液品牌Hypaque-76不会在正常脑组织中积聚。正常大脑中X射线吸收的增加是由于血池中存在造影剂。诸如在脑的恶性肿瘤中发生的血脑屏障的破坏允许造影剂在间质肿瘤组织内积累。相邻的正常脑组织不含造影剂。
在非神经组织中（在人体计算机断层扫描过程中），泛影酸盐从血管迅速扩散到血管外空间。由于不存在屏障，因此X射线吸收的增加与血流，造影剂的浓度以及间质性肿瘤组织对造影剂的提取有关。因此，对比增强是由于正常组织和异常组织之间的血管外扩散相对差异，与大脑中的差异很大。
正常和异常组织中泛影酸盐的药代动力学已显示出可变性。造影剂给药后，动脉内给药而非静脉内给药后，对比度增强似乎是最大的。最大的增强可以通过在注射后立即进行的一系列连续的两到三秒扫描（在30到90秒内）来检测，即动态计算机断层扫描。
类固醇治疗的效果
在某些疾病中，接受类固醇治疗的患者的抗炎和抗水肿作用干扰了CT组织增强的预期分布。
Hypaque-76的适应症和用法
Hypaque-76适用于排泄性尿路造影，主动脉造影，心血管造影（心室造影，肺部血管造影，选择性冠状动脉造影），外周血管造影（外周动脉造影和外周静脉造影），静脉数字动脉造影，计算机断层摄影头成像的对比度增强，计算机断层造影的对比度增强身体成像，选择性肾动脉造影，选择性内脏动脉造影，中央静脉造影和肾静脉造影。
除了以下一般禁忌症，警告，注意事项和不良反应之外，在特定过程下，这些类别中还有其他列表。
禁忌症—一般
Hypaque-76在建议的使用中没有绝对的禁忌症（请参阅一般警告和注意事项）。
不要使用Hypaque-76进行脊髓造影或检查可能与蛛网膜下腔相通的背囊或鼻窦。蛛网膜下腔中即使是少量也可能引起抽搐并导致死亡。 （另见主动脉造影，警告。 ）硬膜外注射也是禁忌的。
Hypaque-76不应直接注射到颈动脉，椎动脉或脊椎动脉中。
Hypaque-76禁用于对泛氮盐类过敏的患者。
尿道造影术是无尿患者的禁忌症。
脱水无尿症患者禁用尿路造影和大剂量血管手术。 （另请参见注意事项—常规。）
警告—一般
严重不良事件-鞘内注射无效
由于未鞘内使用碘化造影剂而在鞘内意外给药，已报道了严重的不良反应。这些严重的不良反应包括：死亡，惊厥，脑出血，昏迷，麻痹，蛛网膜炎，急性肾功能衰竭，心脏骤停，癫痫发作，横纹肌溶解症，体温过高和脑水肿。必须特别注意以确保不鞘内给药该药物。
含碘碘化造影剂在体外比非离子型造影剂更能抑制血液凝结。尽管如此，还是要谨慎避免血液与含有离子造影剂的注射器长时间接触。
在使用离子和非离子造影剂的血管造影过程中，已经报道了导致心肌梗塞和中风的严重，很少致命的血栓栓塞事件。因此，特别是在血管造影过程中，细致的血管内给药技术是必要的，以最大程度地减少血栓栓塞事件。许多因素，包括手术时间，导管和注射器的材料，潜在的疾病状态以及伴随的药物治疗，都可能导致血栓栓塞事件的发展。由于这些原因，建议采用细致的血管造影技术，包括密切注意导丝和导管的操作，使用歧管系统和/或三通旋塞阀，频繁用肝素盐溶液冲洗导管并最大程度地缩短手术时间。据报道，使用塑料注射器代替玻璃注射器可减少但不能消除体外凝结的可能性。
排泄性尿路造影对多发性骨髓瘤患者有潜在的危害。在这些患者中，某些具有治疗抵抗力的无尿尿症会导致进行性尿毒症，肾衰竭并最终导致死亡。尽管造影剂和脱水均未单独证明是骨髓瘤患者无尿的原因，但据推测两者的组合可能是病因。骨髓病患者排泄性尿路造影的风险不是该手术的禁忌证；但是，它们需要特殊的预防措施。不建议在准备这些患者进行检查时进行部分脱水，因为这可能会使肾小管中的骨髓瘤蛋白沉淀。在开始泌尿造影术之前，应考虑多发于40岁以上人群的骨髓瘤。
当通过静脉内或动脉内注射该材料时，造影剂可促进镰状细胞病纯合子个体的镰状化。
应谨慎对待已知或怀疑患有嗜铬细胞瘤的患者使用不透射线的材料。如果医生认为此类程序可能带来的好处大于考虑的风险，则可以执行该程序；但是，不透射线介质的注入量应保持在绝对最低限度。在整个手术过程中均应评估血压，并应有治疗高血压危机的措施。
在甲状腺功能亢进症或具有甲状腺功能正常的患者中，在血管内使用碘化不透射线的诊断剂后发生甲状腺风暴的最新报道表明，在此类患者中应先使用泛影石酸盐来评估这种额外的风险。
用于心脏导管检查和血管造影的造影剂可能会引起循环淋巴细胞的细胞损伤。对人类的染色体损伤包括抑制有丝分裂，微核数量增加和染色体畸变。损害似乎与造影剂本身有关，而不是与X射线辐射有关。应当指出，这些试剂尚未在动物或实验室系统中进行充分测试。
肾功能严重受损的患者以及合并有肾脏和肝病的患者应谨慎进行泌尿造影。
皮下外渗引起短暂的刺痛，主要是由于高渗性蜂窝织炎。如果渗出的体积很小，则不良反应的可能性很小。但是，如果外渗广泛，尤其是在血管化较差的区域（例如，脚或手的背部），尤其是在存在血管疾病的情况下，可能会出现皮肤脱落。注射无菌水以稀释或添加散布剂以加速吸收尚未成功，可能会加重病情。
选择性脊柱动脉造影术或提供脊柱分支的躯干动脉造影术可引起轻度至严重的肌肉痉挛。但是，即使是76％的小剂量，也可能发生严重的神经系统后遗症，包括永久性麻痹。
在蛛网膜下腔出血的患者中，已经报道了对比剂给药与临床恶化（包括惊厥和死亡）之间的罕见关联。因此，在这些患者中应谨慎使用血管内碘化造影剂。
注意事项—一般
涉及使用不透射线诊断剂的诊断程序应在经过必要培训且完全了解要执行的特定程序的人员指导下进行。应该有适当的设施来应对手术的任何并发症，以及对造影剂本身的严重反应进行紧急治疗。肠胃外施用不透射线的药剂后，由于发生了严重的延迟反应，因此应至少有30至60分钟的时间提供合格的人员和急救设施（请参阅“不良反应－一般”）。
应始终考虑反应的可能性，包括严重的，危及生命的，致命的，过敏性的或心血管反应（请参阅不良反应）。极为重要的是，要事先认真计划行动方案，以便立即处理严重的反应，并且在发生任何反应时，应有足够的适当人员。
应始终考虑易感患者发生特发性反应的可能性（请参阅“不良反应－概述”）。易感人群包括具有对造影剂先前反应史的患者，对碘本身具有已知敏感性的患者以及具有已知临床超敏性的患者：支气管哮喘，花粉症和食物过敏。
严重的特异反应的发生促使人们使用了几种预测试方法。但是，不能依靠预测试来预测严重的反应，它本身可能对患者有害。建议在注射任何造影剂之前进行透彻的病史（着重于变态反应和超敏反应）在预测潜在不良反应方面比预先测试更为准确。
过敏或超敏反应的阳性历史并不随意禁忌使用造影剂，在这种情况下，诊断程序被认为是必不可少的，但应谨慎行事（请参阅“不良反应－一般”）。应考虑使用抗组胺药或皮质类固醇进行预防用药，以避免或最小化此类患者可能出现的过敏反应。最近的报道表明，这种预处理不能预防严重的威胁生命的反应，但可以降低其发生率和严重性。
血管造影和CT程序的准备脱水是不必要的，并且可能是危险的，可导致婴儿，幼儿，老年人，既往有肾功能不全的患者，晚期血管疾病的患者和糖尿病患者的急性肾衰竭。这些患者的脱水似乎通过泌尿道造影剂的渗透性利尿作用而得到增强。排尿的通宵液体限制可能是不希望的，并且在使用相对较高（76％）的浓度时被认为是不必要的。
尽管氮质血症不是禁忌症，但对于患有严重尿毒症的晚期肾功能不全的患者，应谨慎使用该介质。 （另请参见“专家作文，注意事项”。 ）
据报道，患有糖尿病肾病的糖尿病患者和排尿造影后的易感非糖尿病患者（通常是患有肾脏疾病的老年患者）都患有急性肾衰竭。因此，在这些患者中进行射线照相之前，应仔细考虑潜在的风险。 （另请参见《专家制图，注意事项—准备脱水》。 ）
手术后立即在肾移植受者中谨慎使用排尿泌尿造影。
由于循环渗透负荷的短暂增加，对于充血性心力衰竭患者，应谨慎注射尿路造影剂。手术后应观察此类患者数小时，以发现延迟的血流动力学障碍。
在某些情况下，对于年幼或不合作的儿童以及某些成年患者，可能需要进行全身麻醉。然而，据报道这些患者发生不良反应的可能性更高，这可能归因于患者无法识别不良症状或麻醉的降压作用，这可能会降低心排血量并增加暴露于暴露的时间。造影剂。
静脉注射离子型对比剂时，癫痫发作很少见（约0.01％）。但是，在脑转移患者中用于CT的剂量较高时，发生率可能更高（1％至10％）。在这些患者中，建议在注射前立即使用小剂量的小剂量地西parent预防性使用高剂量的CT疗法。
除了已经描述的一般预防措施外，排尿造影，血管造影和其他用途也具有与所采用的特定技术相关的危害。 （请参阅“个别指示和使用”部分。）
给患者的信息
应当指导接受注射不透射线诊断剂的患者：
- 如果他们怀孕，请告知医生（请参阅临床药理学）。
- 如果他们是糖尿病患者或患有多发性骨髓瘤，嗜铬细胞瘤，纯合镰状细胞病或已知的甲状腺疾病，请告知医生（请参阅“警告-概述”）。
- 如果他们对任何药物，食物过敏，或者对先前用于X射线检查的染料注射有任何反应，请告知医生（请参阅“预防措施－一般”）。
- 在服用该药物之前，应先告知医生他们目前正在服用的任何其他药物，包括非处方药。
药物相互作用
据报道，在一些肝功能不全的患者中，曾接受口服胆囊造影剂和泌尿造影剂后出现了肾脏毒性。因此，对于任何最近接受过胆囊造影剂的患有已知或疑似肝胆疾病的患者，应推迟使用血管内泌尿道造影剂。
在造影剂中添加正性肌力药可能会产生悖论性的抑郁反应，这可能对缺血性心肌有害。
盐酸苯海拉明与Hypaque-76在同一注射器中混合时可能引起沉淀。
在某些情况下（pH，温度，浓度，时间），泛影酸盐溶液与盐酸异丙嗪，盐酸苯海拉明，马来酸溴苯那敏或盐酸番木瓜碱溶液不相容。
在使用前，请勿长时间（例如，数小时或更长时间）用Hypaque-76预填充塑料注射器。
药物/实验室测试的相互作用
如果指示了可能受造影剂影响的这些研究中的任何一项，则建议在给予造影剂之前或之后两天或更长时间进行这些研究。
泛影酸盐会干扰几种实验室的尿液和血液测试。
验血混凝：泛影酸盐显着抑制凝血的所有阶段。血纤蛋白原浓度和因子V，VII和VIII降低。凝血酶原时间和凝血活酶时间增加。
血小板凝集：高浓度的血浆泛影素会抑制血小板凝集。
血清钙：腹泻盐可能会降低血清钙水平。但是，血清钙的这种消耗也可能是在某些造影剂的制备中添加了螯合剂（乙二胺四乙酸二钠）的结果。
红细胞计数：暂时减少红细胞计数。 net 99m-RBC标记干扰。
白细胞计数：减少。
尿素氮（BUN）：暂时增加（请参阅临床药理学）。
血清肌酐：短暂增加。
尿液检查尿液中排出的造影剂可能会干扰某些实验室测定，例如蛋白尿，比重，重量克分子渗透压摩尔浓度或细菌培养。
甲状腺功能检查结合蛋白质的碘（PBI）和总血清有机碘：尿路造影后，两种检查均出现短暂增加。 PBI和放射性碘吸收研究的结果取决于碘的估计，在使用碘化尿路造影剂后长达16天之内，它们无法准确反映甲状腺功能。但是，不依赖于碘估算的甲状腺功能测试（例如T 3树脂摄取或游离甲状腺素测定）不会受到影响。
致癌，诱变，生育力受损
为了评估致癌潜力，诱变作用或Hypaque-76是否可影响雄性或雌性的生育力，尚未在动物中进行长期研究。
怀孕类别C
Hypaque-76尚未进行动物繁殖研究。还不知道Hypaque-76在施予孕妇时是否会造成胎儿伤害或会影响生殖能力。仅当明确需要时，才应将Hypaque-76给予孕妇。
人工与分娩
尚不清楚在分娩或分娩时使用这些造影剂是否会对胎儿造成直接或延迟的不良影响，延长分娩时间或增加需要分娩钳子或进行其他产科干预或新生儿复苏的可能性。
护理母亲
泛影酸盐在人乳中原样排泄。由于潜在的不良反应，尽管尚未确定哺乳婴儿会发生严重的不良反应，但是当将这些造影剂施用于哺乳期妇女时应格外小心。
儿科用
婴儿和幼儿在进行排尿泌尿系统造影或其他任何操作之前，不应有任何液体限制（请参阅“注意事项—概述”）。儿科剂量的指导原则在《剂量和管理-常规》中介绍。
不良反应-一般
伴随血管内使用泛影酸盐的不良反应约95％为轻度至中度。然而，已经发生了威胁生命的反应和死亡，其中大多数是心血管原因。
对可注射造影剂的不良反应分为两类：化学毒性反应和特异反应。
化学毒性反应是由造影剂的理化性质，剂量和注射速度引起的。造影剂灌注的所有血液动力学紊乱和对器官或血管的伤害都包括在此类别中。
特异反应包括所有其他反应。它们在20至40岁的患者中更常见。特异反应可能取决于也可能不取决于注射剂量，注射速度，注射方式和射线照相程序。特异反应可分为轻度，中度和重度。次要反应是自限性的，持续时间短。严重的反应危及生命，治疗是紧急和强制性的。
有过敏史的患者对造影剂产生不良反应的报道率是普通人群的两倍。有造影剂先前反应史的患者比其他患者的敏感性高三倍。但是，对造影剂的敏感性似乎不会随着反复检查而增加。
对注射用造影剂的大多数不良反应会在注射开始后的一到三分钟内出现，但可能会延迟反应。
不良反应按器官系统分组，并按出现的递减顺序和大致的发生率在下面列出。无论频率如何，在其他反应之前都列出了更为严重的反应。
每100位病人大于1
整体身体：报告的死亡发生率从每百万的6.6例（0.00066％）到每10,000例患者中的1例（0.01％）。大多数死亡发生在注射期间或5至10分钟后，主要特征是心脏骤停，心血管疾病是主要的加重因素。
尿路造影后出现低血压性塌陷和休克的个别报道在文献中被发现。据估计，电击的发生率是每20,000名患者中有1名（0.005％）。
心血管系统：最常见的对泛影酸盐的不良反应是血管舒张（温暖的感觉）。估计的发病率为49％。
消化系统：恶心6％，呕吐3％。
神经系统：感觉异常6％，头晕5％。
呼吸系统：鼻炎1％，咳嗽增加2％。
皮肤和附属物：荨麻疹1％。
据估计，大约有12％的泌尿科造影患者出现注射部位的疼痛。疼痛通常是由于外溢。
经静脉造影的患者中，估计超过1％的患者在静脉穿刺部位上方出现疼痛性红斑热肿胀。
特殊感觉：口味变态11％。
泌尿生殖系统：排泄性尿路造影后，估计有23％的患者发生近端肾小管的渗透性肾病。
每100名病人少于1名
下面列出了其他不常见的无伴随发生率的反应，按器官系统分组。
整个身体：疟疾复发，尿毒症，高肌酐和BUN（请参阅预防措施，一般，药物/实验室测试相互作用），血小板减少症，白细胞减少症和贫血。
心血管系统：脑血肿，血液动力学异常，窦性心动过缓，短暂性心电图异常，心室纤颤，瘀点，胸痛和心脏骤停。
消化系统：腮腺和上颌下腺严重的单侧或双侧肿胀。
神经系统：抽搐，瘫痪和昏迷。 （请参阅预防措施－常规。）
呼吸系统：哮喘，呼吸困难，喉头水肿，肺水肿和支气管痉挛。
皮肤和附属物：外渗坏死，荨麻疹伴或不伴瘙痒，皮肤粘膜水肿和血管神经性水肿。
特殊感觉：双眼刺激，流泪，瘙痒，结膜软化，感染和结膜炎。
泌尿生殖系统：肾功能衰竭，疼痛。
过量
当泛影酸钠的剂量水平高于含45 g碘的水平时，不良反应的发生率会增加。在短时间内（例如30分钟）以等于80 gI或90 gI的总剂量给药时，出现系统性不耐受的临床体征（主要与高渗作用有关），表现为震颤，易怒和心动过速。在其他方面健康的成年人中，超过这些最大耐受剂量水平，呼吸困难和肺水肿的发生率和严重性将会增加。
据报道，在尿路造影中有4例婴儿用药过量。注射后19小时内有3名婴儿死亡。过量的范围从略高于推荐的儿科剂量到超过19 g / kg的剂量。注射造影剂后10分钟至数小时之间出现剂量过量的症状。不良反应危及生命，主要影响肺和心血管系统。症状包括：紫osis，心动过缓，酸中毒，肺出血，抽搐，昏迷和心脏骤停。所有婴儿的肾脏均显示不佳，所有组织和脉管系统均弥漫性浑浊。尸检发现急性肺损伤和/或皮下组织水肿。过量注射不透射线造影剂的治疗旨在支持所有重要功能，并迅速采取对症治疗。
小鼠中的泛影酸盐的急性静脉内LD 50相当于5.3 gI / kg至8.0 gI / kg的碘含量，似乎与注射速度成正比。
泛影酸盐可透析。
剂量和用法-一般
患者的准备随放射线医生的喜好和所执行放射线检查程序的类型而异。所使用的特定射线照相程序将取决于患者的状态和诊断指征。个体剂量应根据年龄，体型和检查指征量身定制。 （有关具体剂量和用法，请参见“个体适应症”）。
血管内使用的不透射线的诊断剂溶液在注射时应处于体温，使用前可能需要加热。万一发生结晶，可通过将小瓶放在40°C至50°C的水浴中并轻轻摇动2至3分钟或直至固体重新溶解来澄清溶液。如果颗粒仍然存在，请不要使用该样品瓶，而要丢弃它。该溶液可以高压灭菌一次。
溶液应在室温下保存，并避免强光照射，并且应丢弃容器中剩余的未使用部分。
造影剂的稀释和撤除应在无菌条件下用无菌注射器完成。
给药前应目视检查肠胃外药品是否有颗粒物和变色。避免用手套粉或棉纤维污染导管，注射器，针头和造影剂。
小儿用药
可注射的不透射线的诊断剂的儿科剂量通常以重量为基础确定，应针对每位患者单独计算。 （请参阅“个别指示和使用”部分。）
药物不相容性
泛影酸盐在体外与某些抗组胺药和许多其他药物不相容。 It is believed that one of the chief causes of in vitro incompatibility is an alteration of pH. Turbidity of solutions of intravascular contrast medium occurs between pH 2.5 and 4.1. Another cause is chemical interaction; therefore, other pharmaceuticals should not be mixed with contrast agents in the same syringe.
INDIVIDUAL INDICATIONS AND USAGE
THE FOLLOWING SECTIONS FOR INDIVIDUAL INDICATIONS AND USAGE CONTAIN CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, AND DOSAGE AND ADMINISTRATION SECTIONS RELATED TO THE SPECIFIC PROCEDURES . HOWEVER, IT SHOULD BE UNDERSTOOD THAT THE INFORMATION IN THE GENERAL SECTIONS IS ALSO LIKELY TO APPLY TO ALL OF THESE SPECIFIC USES.
Hydration: With the possible exception of urography, patients should be fully hydrated prior to the following procedures.
专家制图
Diatrizoate salts are used in small, medium, and large dose urography. Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures. Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction (see CLINICAL PHARMACOLOGY).
Nephrotomography and "Adequate" or High Dose UrographyHypaque-76 solution may be used for excretory urography in selected patients. It may be used when prior urography has failed to provide diagnostic contrast and for preliminary excretory tract study to detect obstruction in azotemic patients or to avoid retrograde instrumentation. It may also be used as a high dosage medium to intensify and prolong the nephrographic effect when the prime purpose is examination of the renal parenchyma, especially with tomography. When combined with the urea "washout" technique, Hypaque-76 provides the necessary increased pyelographic contrast and diuresis required for screening or special examination of patients with suspected renal hypertension.
Contraindication
Urography is contraindicated in patients with anuria.
预防措施
Although azotemia is not considered a contraindication, care is required in patients with advanced renal failure. The usual preparatory dehydration should be omitted, and urinary output should be observed for one to two days in these patients. Adequate visualization may be difficult or impossible to attain in patients with severely impaired renal and/or hepatic function. Use with extreme caution in patients with concomitant hepatorenal disease.
When Hypaque-76 is used with a urea "washout" procedure, the patient should also be observed for a few hours to detect signs of undue dehydration caused by increased diuresis induced by both the medium and the urea. Ingestion of water may be required for rehydration.
In myelomatosis, urography should only be performed with caution. If a weak protein-binding agent such as a diatrizoate is used for the procedure, it is essential to omit preparatory dehydration, administer fluids, and attempt to alkalinize the urine.
Preparatory Dehydration: Preparatory dehydration is dangerous in infants, young children, the elderly, and azotemic patients (especially those with polyuria, oliguria, diabetes, advanced vascular disease, or preexisting dehydration). The undesirable dehydration in these patients may be accentuated by the osmotic diuretic action of the medium.
Dehydration may improve image quality in patients with adequate renal function particularly if a low dose is used. Dehydration, however, will not improve contrast quality in patients with substantial renal insufficiencies and will increase risk of contrast induced renal damage. Dehydration in these patients is therefore contraindicated.
不良反应
Side effects following this relatively high dose urography are usually mild and transitory and do not appear to occur more frequently or severely than those induced by "standard dose" urography. Nausea, facial flushing, and emesis are not uncommon reactions. (See also ADVERSE REACTIONS—General.)
剂量和给药
The usual intravenous dose for adults is 20 mL, with a range of 20 mL to 40 mL. Children require less in proportion to weight: Under 6 months of age—4 mL; 6 to 12 months—6 mL; 1 to 2 years—8 mL; 2 to 5 years—10 mL; 5 to 7 years—12 mL; 8 to 10 years—14 mL; 11 to 15 years—16 mL.
ANGIOGRAPHY—General
Diatrizoate salts are used for radiographic studies throughout the cardiovascular system.
Intravascular radiopaque diagnostic agents of high concentration are not recommended for cerebral or spinal angiography (see CONTRAINDICATIONS—General), and contrast agents with the lowest compatible viscosity and higher concentration of iodine (310 mg/mL to 480 mg/mL of bound iodine) must be used for angiocardiography. Contrast media approaching serum ionic content and osmolality have less potential for deleterious effects on the myocardium (see PRECAUTIONS—General, Drug Interactions).
Addition of chelating agents may contribute to toxicity in coronary angiography, and the sodium content of angiographic agents used in coronary arteriography is of crucial importance.
AORTOGRAPHY
Hypaque-76 solution may be injected by commonly accepted techniques, such as translumbar, retrograde catheter, retrograde pressure injection (by cannula) or antegrade (brachial) catheter, for examination of the aorta and its major branches.
警告事项During aortography by the translumbar technique, extreme care is advised to avoid inadvertent intrathecal injection since the injection of even small amounts (5 mL to 7 mL) of the contrast medium may cause convulsions, permanent sequelae, or fatality. Should the accident occur, the patient should be placed upright to confine the hyperbaric solution to a low level, anesthesia may be required to control convulsions, and if there is evidence of a large dose having been administered, a careful cerebrospinal fluid exchange-washout should be considered.
Pheochromocytoma: Administration of angiographic media to patients known or suspected to have pheochromocytoma can cause dangerous changes in blood pressure. A minimum dose should be injected. The blood pressure should be carefully monitored and measures for controlling major fluctuations should be available.
预防措施The presence of a vigorous pulsatile flow should be established before using a catheter or pressure injection technique. A small "pilot" dose (about 2 mL) should be administered to locate the exact site of needle or catheter tip to help prevent injection of the main dose into a branch of the aorta or intramurally. In the translumbar technique, severe pain during injection may indicate intramural placement and abdominal or back pain afterwards may indicate hemorrhage from the injection site. Following catheter procedures, gentle pressure hemostasis for 5 to 10 minutes is advised, followed by observation for 30 to 60 minutes and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.
Under conditions of slowed aortic circulation there is an increased likelihood of aortography causing muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortic-iliac or even femoral artery bed obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, injection of vasopressors to increase contrast, and low injection sites (L2-3). In these patients the concentration, dose, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully evaluated.
不良反应The only adverse reaction expected is a mild burning or painful sensation on injection. Unusual reactions can occur, as in angiocardiography. An abrupt hypertensive episode can occur following entry of the medium into the renal artery in patients with pheochromocytoma. Mesenteric necrosis, acute pancreatitis, renal shutdown (usually transitory), and neurologic complications have been reported following inadvertent injection of a large part of the aortic dose into a branch of the aorta. Entry of the large aortic dose into the renal artery can cause, even in the absence of symptoms, albuminuria, cylindruria, hematuria, and an elevated BUN. Rapid and complete return of function usually follows.
Additional procedural reactions include injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, accidental selective filling of the right renal artery during the translumbar procedure in the presence of preexistent renal disease, and retroperitoneal hemorrhage from the translumbar approach.
Dosage and AdministrationAdult: The usual adult dose as a single injection is 15 mL to 40 mL, repeated if indicated, to a total of 160 mL.
Pediatric: The usual single pediatric dose ranges from 0.3 mL/kg to 0.9 mL/kg. The total dose should not exceed 1 mL/kg.
ANGIOCARDIOGRAPHY
Pharmacology-Hemodynamic ChangesDue to its physical characteristics (chiefly tonicity and viscosity) and the volume administered, Hypaque-76 may cause a number of transitory hemodynamic changes. When the medium is ejected from the left ventricle or introduced at the root of the ascending aorta, a brief (three seconds) hypertensive response is usually induced, followed immediately by a decrease in aortic and peripheral blood pressures below normal levels, lasting for at least two minutes. This hypotensive phase may be followed by a 15- to 20-minute period of fluctuating blood pressure.
Clinical doses (up to 1 mL per kg) injected into the vena cava or right heart outflow tract usually cause an irregular rise in right ventricular blood pressure, a slight increase in pulmonary artery blood pressure, and delayed signs of peripheral hypotension.
Other changes reported clinically include an increase in cardiac output and atrial pressure, a decrease in myocardial contractile force, and at the peak of postinjection hypotension, a marked rise in aortic and carotid blood flow, and elevation of central venous pressure. At dosage levels used in angiocardiography, the hematocrit and hemoglobin level may fall about 10 to 15 percent and serum osmolality may rise 10 to 12 percent. Blood carbon dioxide, pH, and BUN levels may fall. These changes commence immediately after injection, reach a maximum in two to five minutes, and return to normal values in 10 to 15 minutes. However, after the initial rise, plasma volume may decrease and continue to fall below control levels, even beyond 30 minutes, probably due to diuresis. If repeat injections are made in rapid succession these changes are likely to be more pronounced. (See also Dosage and Administration.) Hypaque-76 is not metabolized. It is eliminated unchanged, rapidly and completely in the urine by glomerular filtration.
预防措施
During administration of large doses of Hypaque-76 continuous monitoring of vital signs is desirable. Caution is advised in the administration of large doses to patients with incipient heart failure because of the possibility of aggravation of the preexisting condition. Hypotension should be corrected promptly since it may induce serious arrhythmias.
Because of the hemodynamic changes which may occur on injection into the right heart outflow tract, special care, especially regarding dosage, should be observed in patients with right ventricular failure, pulmonary hypertension, or obliterated pulmonary vascular beds.
Precautions in Infants
Apnea, bradycardia and other arrhythmias, cerebral effects (lethargy and depression), and a tendency to acidosis are more likely to occur in cyanotic infants. It is desirable that vital signs be monitored on an intensive care basis afterwards to detect delayed adverse effects (arrhythmia, electrolyte and hemodynamic disturbances). Infants are more likely than adults to respond with convulsions, particularly after repeated injections. Unlike in the adult, the amount of the total dosage in young infants is of particular importance. (See Dosage and Administration.)
不良反应
See ADVERSE REACTIONS—General.
剂量和给药
The individual dose is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults. The size of each individual dose is a more important consideration than the total dosage used. When large individual doses are administered, as for contrast in the cardiac chambers and thoracic aorta, it has been suggested that 20 minutes be permitted to elapse between each injection to allow for subsidence of hemodynamic disturbances.
Ventriculography
Adult: The usual adult dose in a single injection is 45 mL, with a range of 40 mL to 50 mL. This may be repeated as necessary. However, when combined with selective coronary arteriography, the total dose should not exceed 225 mL.
Pediatric: The usual single pediatric dose is 0.2 mL/kg to 0.3 mL/kg. The total dose should not exceed 50 mL.
Pulmonary Angiography or Arch Study Used Alone
Adult: The usual single adult dose is 30 mL, with a range of 10 mL to 56 mL.
Pediatric: The pediatric dose ranges from 0.3 mL/kg to 0.9 mL/kg. The total dose should not exceed 1 mL/kg.
Combined Angiocardiographic ProceduresMultiple Procedures
With continuing advances in radiologic techniques and the development of more sophisticated equipment as well as more versatile and reliable radiopaque media, it is possible to examine multiple vascular systems and target organs during a single radiographic examination of the patient.
Multiple procedures of selective angiography require multiple injections of the contrast medium into several specific target organs and result in a greater dosage. Large doses of Hypaque-76 were well tolerated in multiple injections and multiple procedures of angiography.
See general sections for Contraindications, Warnings, Precautions, Adverse Reactions, and Dosage and Administration recommendations as well as those sections pertinent to the specific procedures.
Adult: The maximum total dose for multiple procedures in adult use should not exceed 225 mL.
Pediatric: When multiple procedures are required in pediatric use, the total dose administered should be maintained below 4 mL/kg, or especially in young infants below 3 mL/kg.
Selective Coronary Arteriography
Adult: The usual single adult dose for right or left coronary arteriography is 8 mL (range 4 mL to 10 mL) repeated as required up to a total dose of 120 mL for coronary arteriography alone.
PERIPHERAL ANGIOGRAPHY
The use of Hypaque-76 is sometimes preferred over less concentrated media in selected cases for femoral and brachio-axillary arteriography in adults.
预防措施Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all.
不良反应Pain or a burning sensation with some spasm may occur, and is more marked in patients with arterial insufficiency. Therefore, the procedure is more satisfactorily performed under general or, for the lower extremity, spinal anesthesia.
Technical complications have included hemorrhage from the puncture site, and brachial plexus palsy following axillary artery injections.
Arterial thrombosis, displacement of arterial plaques, and ipsilateral venous thrombosis are very rare complications.
Dosage and AdministrationArteriography (aorto-iliac runoff and peripheral)
Adult: The single adult dose for femoral arteriography varies from 20 mL to 40 mL, depending on the site of placement, ie, aorta-iliac runoff, iliofemoral, femoral. For the upper limb, 20 mL to 40 mL is usually sufficient. These doses may be repeated up to three times.
VENOGRAPHY
Dosage and AdministrationCentral Venography
Adult: For central venography (inferior or superior vena cava), the total adult dose is 40 mL to 50 mL, repeated up to two times.
Renal Venography
Adult: The usual single adult dose is 20 mL to 40 mL.
Peripheral Venography
Adult: The usual single adult dose is 40 mL with a range of 40 mL to 60 mL.
SELECTIVE RENAL ARTERIOGRAPHY
Dosage and AdministrationAdult: The usual single adult dose is 8 mL, repeated up to three times. The dose ranges from 5 mL to 10 mL.
SELECTIVE VISCERAL ARTERIOGRAPHY
Dosage and AdministrationCeliac Axis: The usual adult dose ranges from 30 mL to 40 mL with subselective arteriography of its branches, eg, hepatic, usual dose of 25 mL with a range of 15 mL to 30 mL; mesenteric, usual dose of 30 mL with a range of 20 mL to 40 mL; splenic, usual dose of 20 mL with a range of 20 mL to 50 mL.
Superior Mesenteric: The usual single adult dose is 30 mL with a range of 20 mL to 40 mL. The maximum total dose should not exceed 175 mL.
INTRAVENOUS DIGITAL ARTERIOGRAPHY
Arteriograms of diagnostic quality can be obtained following the intravenous administration of Hypaque-76 employing digital subtraction and computer imaging enhancement equipment. The intravenous route of administration using these techniques has the advantage of being less invasive than the corresponding selective catheter placement of the medium. The dose is administered into a peripheral vein usually by mechanical injection although sometimes by rapid manual injection. The technique has been used most frequently to visualize the ventricles, the aorta and most of its larger branches including carotid, cerebral, vertebral, renal, celiac, mesenterics, and the major peripheral vessels of the limbs.
预防措施Since the dose is usually administered mechanically under high pressure, rupture of smaller peripheral veins has occurred. It has been suggested that this can be avoided by using an intravenous catheter threaded proximally beyond larger tributaries or in the case of the antecubital vein, into the superior vena cava. Sometimes the femoral vein is used.
Dosage and AdministrationThe usual dose of Hypaque-76 per injection by the intravenous digital technique is 30 mL to 60 mL with a range of 0.5 mL/kg to 1 mL/kg administered as a bolus 7.5 mL/second to 30 mL/second using a pressure injector. The dose and rate of injection will depend primarily on the type of equipment and technique used, with first exposures made on calculated circulation time.
CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
Injectable radiopaque contrast media may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.
Tumors: Radiopaque diagnostic agents may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated.
In calcified lesions, there is less likelihood of enhancement.治疗后，肿瘤可能显示减少或没有增强。
Nonneoplastic Conditions of the Brain: The use of Hypaque-76 may be beneficial in the enhancement of images of lesions not due to neoplasms. Cerebral infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if a contrast medium is used. The use of Hypaque-76 improved the contrast enhancement in approximately 60 percent of cerebral infarctions studied from one week to four weeks from the onset of symptoms.
Sites of active infection also will produce contrast enhancement following contrast medium administration.
Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.
Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast medium administration may be helpful in ruling out the possibility of associated arteriovenous malformation.
The opacification of the inferior vermis following contrast medium administration has resulted in false-positive diagnoses in a number of normal studies.
Dosage and AdministrationThe suggested dose is 50 mL to 125 mL by intravenous administration; scanning may be performed immediately after completion of administration. Doses for children should be proportionately less, depending on age and weight.
CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC BODY IMAGING
Hypaque-76, brand of diatrizoate meglumine and diatrizoate sodium injection, may be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis, and retroperitoneal space.
Enhancement of computed tomography with Hypaque-76 may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions (eg, hepatic abscess delineation prior to percutaneous drainage). In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (eg, tumor extension), or may help to define suspicious lesions seen with unenhanced CT (eg, pancreatic cyst).
Contrast enhancement appears to be greatest within 60 to 90 seconds after bolus administration of the contrast agent. Therefore, utilization of a continuous scanning technique (dynamic CT scanning) may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused mass shows unchanged x-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.
Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological and unenhanced CT findings.
Dosage and AdministrationThe suggested dose is 50 mL to 125 mL by rapid intravenous bolus administration; scanning may be performed immediately after completion of administration. Doses for children should be proportionately less, depending on age and weight.
How is Hypaque-76 Supplied
Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0776-04)
Calibrated bottles of 200 mL, rubber stoppered, with hangers, box of 10 (NDC 0407-0778-02)
由Amersham Health Inc.发行。
新泽西州普林斯顿08540
Printed In USA
HNC-9D
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