通用名称

Sulfur Hexafluoride Lipid-Type A Microspheres

儿科标签批准日期

2019/11/13 0:00:00

特定指示/秒

Use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms

标签更改摘要

- Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. - Safety and effectiveness in pediatric patients are based on adequate and well-controlled studies in adults and are supported by a clinical study in 12 pediatric patients with extrapolation of efficacy to younger pediatric patients. - No new adverse reactions were reported in the pediatric study - Safety of intravenous use of Lumason was based on evaluation of published literature involving the use of Lumason in over 1400 pediatric patients (0 to 17 years). - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.

治疗类别

Radioactive Diagnostic Agent

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

9 YEARS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic

研究设计

Open-Label,Trad PK

登记的患者

13

患者分析

N/A

中心的数量

2

国家数量

1

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

N/A