部分中文碘海醇处方资料（仅供参考）
商品名称：Gadovist
英文名称：Gadobutrol
通用名称：钆特醇注射器
剂    型：造影剂
生产厂家：拜耳药品
药品介绍
Gadovist是一种新型的强效磁共振成像对比剂，被批准用于人体多个部位的对比增强磁共振成像（CE-MRI）诊断，包括脑、脊髓、血管、肝和肾。加乐显含1.0mol/L浓度的钆布醇，为市场上其他含钆对比剂浓度的两倍。此外，加乐显含有高浓度的离子态T1-弛豫效能。鉴于其高浓度和高弛豫效能，加乐显在所有含钆对比剂中显示了每毫升最高的短T1效能。这使得加乐显拥有优异的图像质量，并具备使用剂量更小的实用优点。
ガドビスト静注1.0mol/Lシリンジ5mL／ ガドビスト静注1.0mol/Lシリンジ7.5mL／ ガドビスト静注1.0mol/Lシリンジ10mL
药效分类
环状非离子性核磁共振造影
批准日期：2018年5月
商標名
Gadovist IV Inj.1.0mol/L
構造式
一般名
ガドブトロール（Gadobutrol）JAN
化学名
［10-［（1RS,2SR）-2,3-Dihydroxy-1-（hydroxymethyl）propyl］-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato（3-）］gadolinium
分子式
C18H31GdN4O9
分子量
604.71
性状
本品是白色的结晶体的粉末。
本品极易溶于水，所以很难溶进乙醇(99.5)。
批准条件
在制定医药品风险管理计划的基础上，适当实施。
药效药理
由于本剂中的锗离子(gd3 +)显示有常磁性，因此在核磁共振现象中，能够促进氢原子核的缓和，缩短缓和时间。因此，特别是在t1强调mr图像上，对比度增加。
适应症
核共振成像下的阴影
脑与脊髓
躯体干部和四肢造影
用法与用量
通常，把0.1 ml的正式药品注入静脉
临床成绩
1.脑·脊髓影
(1)国内第ii/iii相单盲测试
在一例适用于具有转移性脑肿瘤或有嫌疑的造影核磁共振成像的患者151中，针对造影mri检测出的病变数量(每参加测试的3名读影医生的平均值)，显示了该产品对0.1mmol/kg的加德特利多尔0.2mmol/kg的不劣性。
(参照表1)
(2)日本第3 iii相非盲测试
对于患有脑脊髓病变或疑似核磁共振成像(mri)的患者，采用0.1mmol/kg的mri检查的造影效果，边缘明了度，内部结构的评分，记录了检测病变的数量。结果显示，与非造影核磁共振成像(受试者3名读影医生的平均值的平均值)相比较，在非造影核磁共振成像与造影mri的结合中，检测病变数量的不劣性得到验证，其他评价项目更有明显优势。
(参照表2)
(3)国外第3 iii相非盲测试
对于患有脑脊髓病变或疑似核磁共振成像(mri)的患者，采用0.1mmol/kg的mri检查的造影效果，边缘明了度，内部结构的评分，记录了检测病变的数量。结果显示，与非造影核磁共振成像(受试者3名读影医生的平均值的平均值)相比较，在非造影核磁共振成像与造影mri的结合中，检测病变数量的不劣性得到验证，其他评价项目更有明显优势。(外国数据)
(参照表3)
2.躯壳干部和四肢造影
国际联合iii相比较测试
在功能为适应乳腺、心脏、腹部、肾、骨盆或四肢造影mri检查的患者造影mri中，对病变的造影效果、边缘明了度和内部结构进行了评分。结果(各实验对象3名读影医生的平均值合计后的总得分)、非造影mri和造影mri结合中，显示了对0.1mmol/kg的褐藻糖胺0.1mmol/kg的不劣性。
(参照表4)
包装
注射剤　瓶
2mL×3
制造商(进口)
拜耳药品公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明书附件：https://pharma-navi.bayer.jp/omr/online/product_material/GAD_MPI_201808230_1534740295.pdf
Gadovist (gadolinium-containing magnetic resonance contrast agent) bayer gadolinium-containing Gadovist has been approved by Japan
The German pharmaceutical giant Bayer (Bayer) recently announced that Gadovist (trade name: ", common name: gadobutrol, gadolinium cloth alcohol) injection of Japan approved for magnetic resonance imaging (MRI) diagnosis of the drug is approved by the Japanese first high/high relaxation gadolinium, apply to the multiple points of contrast-enhanced magnetic resonance imaging (MRI) contrast - enhacement MRI, CE - diagnosis, including the brain, spinal cord, blood vessels, liver and kidney, the drug dosage of 0.1 ml/kg body weight.
According to statistics, more than 1.6 million contrast-enhanced magnetic resonance imaging (ce-mri) examinations are performed annually in Japan.
Gadovist's approval was based on data from two key clinical trials conducted in Japan. An open-label phase III study involving 223 patients demonstrated the superiority of gadobutrol enhanced MRI over non-enhanced MRI in the central nervous system (CNS).
Another phase III Asian study demonstrated the non-inferiority of gadobutrol enhanced MRI in other parts of the body (breast, heart, kidney, abdomen, pelvis, lower limbs) compared with that obtained by gadopentetate dimeglumine.
Gadovist is a 1.0 molar concentration of gadolinium butanol aqueous solution of the commodity name, other regions of the commodity known as Gadovist 1.0, the United States commodity known as Gadavist. The drug is an extracellular contrast agent based on gadolinium (Gd) for magnetic resonance imaging (MRI).
Gadovist was first approved in Switzerland in February 1998 and has since been listed in Australia, Canada, the European Union, the United States and other countries. Gadovist has been approved by more than 100 countries around the world.
About Gadovist:Galloxian is a new powerful magnetic resonance imaging contrast agent, which is approved for ce-mri diagnosis of multiple parts of the human body, including brain, spinal cord, blood vessels, liver and kidney. Galexian contains 1.0mol/L concentration of gadolinium-butanol, which is twice the concentration of other gadolinium-containing contrast agents on the market. In addition, galexian contains high concentration of t1-relaxation efficiency of ionic state. In view of its high concentration and high relaxation efficiency, galloxian showed the highest short T1 efficiency per ml among all gadolinium-containing contrast agents. This gives garroxian excellent image quality and the practical advantage of using a smaller dose.