英文药名：Lymphoseek(technetium Tc 99m tilmanocept injection)

中文药名：锝替马诺噻注射剂

生产厂家：Navidea生物制药
药品说明
Lymphoseek（99m锝tilmanocept）于2013年被批准用于确定乳腺癌和黑色素瘤前哨淋巴结
美国首次批准：2013
适应症和用法
Lymphoseek是放射性诊断剂表明有或无闪烁照相成像：
使用手持式γ计数器来定位的淋巴结在实体瘤患者的量这个过程是术中处理的一个组件引流原发肿瘤部位淋巴绘图。
引导使用手持γ计数器患者口腔临床节点负鳞状细胞癌，乳腺癌或黑素瘤前哨淋巴结活检。
用法用量
Lymphoseek是提供一个工具包，并且必须由放射性标记以99m锝，并与在使用前提供的稀释液稀释来制备。
使用Lymphoseek准备和处理过程中无菌技术和辐射安全防范措施。确定总注射体积站点的数目和要注射的制备Lymphoseek之前每个病人。
Lymphoseek的推荐剂量为18.5活度（0.5毫居里）给予至少15分钟发起术淋巴绘图或前哨淋巴结活检手术前：12小时Lymphoseek注射内完成这些过程。
施用推荐的路线是皮内，皮下，乳晕​​，或肿瘤周围。
6小时及其制剂中使用放射性标记Lymphoseek。
剂型和规格
试剂盒制备Lymphoseek的包含五个Tilmanocept粉末各含有250微克tilmanocept和五个稀释剂含4.5毫升的无菌缓冲盐水Lymphoseek小瓶小瓶中。与99m锝和稀释放射性标记后，Lymphoseek包含大约92.5活度（2.5毫居里）和在0.5mL至5ml总体积的注射250微克的99m锝tilmanocept。
禁忌
无。
警告和注意事项
过敏症：询问患者以前反应的药物，尤其是右旋糖酐或修改葡聚糖的形式。观察对过敏的症状和体征以下Lymphoseek注射。有急救设备和训练有素的人员立即可用。
不良反应
最常见的不良反应（发生率<1％）是注射部位的刺激和/或疼痛。
包装规格
Lymphoseek：250微克/瓶*（5瓶冻干粉（NDC52579-1695-1）+5瓶稀释剂（NDC52579-1649-1））注射剂/套件

Lymphoseek® (technetium Tc 99m tilmanocept) injection is a first-in-class mannose receptor (CD206) binding radiopharmaceutical agent developed for use in external lymph node imaging (lymphoscintigraphy), intra-operative lymphatic mapping (ILM) and sentinel lymph node biopsy.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

LYMPHOSEEK Rx
Generic Name and Formulations:
Technetium Tc 99m tilmanocept 250mcg; pwd for SC, intradermal, or peritumoral inj after reconstitution. After radiolabeling (with technetium Tc 99m + dilution); contains approx. 92.5 MBq (2.5 mCi) and 250mcg of technetium Tc 99m tilmanocept in 0.5–5mL total volume.
Company:
Navidea Biopharmaceuticals
Indications for LYMPHOSEEK:
Using a hand-held gamma counter: for lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma; for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity.
Adult:
See full labeling. Determine the planned injection technique and the number of injections per patient prior to preparing dose. May be administered as a single injection or multiple injections. Give 18.5MBq (0.5mCi) as a radioactivity dose and 50mcg as a mass dose, at least 15mins before initiating intraoperative lymphatic mapping; do not delay mapping >15hrs after injection. Total injection volume per patient: 0.1mL in single syringe; 0.5mL in single or in multiple syringes (0.1–0.25mL each); or 1mL in multiple syringes (0.2–0.5mL each). Route of administration: Breast cancer: intradermal, SC, subareolar, peritumoral; Melanoma: intradermal or SC.
Children:
<18yrs: not established.
Warnings/Precautions:
Previous hypersensitivity to dextran or other modified forms. Have resuscitation equipment available. Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. In females of reproductive potential: administer within 10 days following the onset of menses or perform a pregnancy test within 48hrs prior to the administration. Pregnancy (Cat. C). Nursing mothers (discard milk for at least 4hrs after administration).
Interactions:
Co-injection (mixture) with local anesthetics: not recommended.
Pharmacological Class:
Radioactive diagnostic agent.
Adverse Reactions:
Injection site irritation and/or pain.
How Supplied:
Kit—1 (5 vials + 5 diluents; supplies)