通用名称

Indocyanine green

儿科标签批准日期

2018/11/21 0:00:00

特定指示/秒

Visualization of vessels, blood flow and tissue perfusion before, during, and after various surgical procedures, including minimally invasive surgeries and visualization of extrahepatic biliary ducts

标签更改摘要

- Use for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients one month and older. - Pediatric use for visualization of vessels, blood flow and tissue perfusion is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro and reconstructive procedures, and by clinical trials in adults. - Use for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 to 17 years. - Pediatric use for visualization of extrahepatic biliary ducts is supported by clinical trials in adults in addition to clinical use in pediatric patients. - Use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients less 12 years of age. - Safety and efficacy of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumors has not been established in pediatric patients. - Information on dosing. - New indication and a new route of administration.

治疗类别

Radioactive Diagnostic Agent

立法类型

PREA Only

产品说明书链接