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

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