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Lymphoseek powder for injection
儿科标签批准日期
2021/5/19 0:00:00
特定指示/秒
With or without scintigraphic imaging for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management
标签更改摘要
- Safety and effectiveness of Lymphoseek have been established in pediatric patients 1 month of age and older.
- Use of Lymphoseek for this population is supported by evidence from adequate and well-controlled studies in adults with additional safety and diagnostic data from an open-label, single-arm trial in 23 pediatric patients with either melanoma (5), rhabdomyosarcoma (4), or other solid tumors (14) who received Lymphoseek (18.5 MBq and 50 mcg) and underwent intraoperative lymphatic mapping, with or without additional use of preoperative scintigraphic imaging and/or blue dye.
- Safety and effectiveness of Lymphoseek have not been established in pediatric patients less than 1 month of age.
- Information on dosing, adverse reactions, and clinical study.
治疗类别
Radioactive Diagnostic Agent