注射皮下剂Lymphoseek(Technetium Tc 99m tilmanocept)

药店国别： 产地国家：美国 处方药：是 所属类别： 250微克/瓶 5瓶+5瓶稀释剂/盒 包装规格： 250微克/瓶 5瓶+5瓶稀释剂/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：Navidea Biopharmaceuticals 原产地英文商品名：Lymphoseek injection Kit 250mcg/Vial 5Vial+5Via of diluent 原产地英文药品名：technetium Tc 99m tilmanocept 中文参考商品译名：Lymphoseek套件 250微克/瓶 5瓶+5瓶稀释剂/盒 中文参考药品译名：锝TC-99N阿普西肽 曾用名： 简介：FDA于2013年3月批准LYMPHOSEEK KIT(TECHNETIUM TC-99M TILMANOCEPT)INJECTABLE INJECTION可用于淋巴结定位,它是一种放射性的诊断显像剂,帮助医师定位正在接受肿瘤引流淋巴结手术切除治疗的乳腺癌或黑色素瘤患者的淋巴结。淋巴结过滤在身体组织内流动的淋巴液。这种液体可以含有癌细胞,并种植到身体其它部位。通过检查出并手术切除肿瘤引流淋巴结,可以帮助医师确定是否癌细胞已经扩散。批准日期：2013年3月13日 公司：美国Navidea生物制药Lymphoseek(锝TC-99N阿普西肽[technetium Tc 99m tilmanocept])注射皮下，乳晕或肿瘤周围使用最初美国批准：2013目前的主要变化适应证和用途 9/2014 作用机理 Lymphoseek(99m锝tilmanocept)是一种放射性诊断试剂。它积累在淋巴组织和选择性结合甘露糖位于巨噬细胞和树突状细胞的表面上的结合受体(CD206)。 99m锝tilmanocept是选自二亚乙基三乙酸(DTPA)和甘露糖的多个单元的大分子，每个共价连接至10kDa的葡聚糖主链。甘露糖充当受体的配体，和DTPA作为螯合剂用于与99m锝标记。适应症和用法Lymphoseek是放射性诊断剂具有或不具有用于闪烁照相成像表示：淋巴映射使用手持γ计数器来定位实体瘤患者的量本程序是术中管理的一个组件引流原发肿瘤部位的淋巴结。引导使用手持γ计数器患者口腔的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供给作为工具包和必须由具有99m锝放射性标记，并与使用前的供给稀释剂稀释来制备。使用Lymphoseek准备和处理过程中无菌操作技术和辐射安全注意事项。确定位点的总注射体积和数目要注射的制备Lymphoseek之前每个病人。Lymphoseek的推荐剂量为18.5活度(0.5 MCI)发起术淋巴映射或前哨淋巴结活检手术前给予至少15分钟：14小时Lymphoseek注射内完成这些过程。施用的推荐路线是皮内，皮下，乳晕​​，或肿瘤周围。6小时及其制剂内使用放射性Lymphoseek。剂型和规格试剂盒的准备Lymphoseek包含每片含250微克tilmanocept和含4.5毫升无菌缓冲液的小瓶Lymphoseek稀释剂5 Tilmanocept 5小瓶粉末。与99m锝和稀释放射性标记后，Lymphoseek包含大约92.5活度(2.5 MCI)和注射0.5毫升〜5毫升总体积250微克99m锝tilmanocept的。 禁忌症 没有。 警告和注意事项 过敏症：询问有关药物，尤其是右旋糖酐右旋糖酐或修饰形式事先反应的患者。请遵守以下Lymphoseek注射过敏的症状和体征。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/储存与处理 为Lymphoseek的准备(99m锝tilmanocept)注射剂包括套件：Tilmanocept粉，250微克(NDC 52579-1695-1)五瓶稀释剂的五瓶为Lymphoseek(NDC 52579-1649-1)处方信息5个标签盾牌二十五个标签产品小瓶和注射器个人存储对于Lymphoseek(99m锝tilmanocept)注射液在USP控制室温20℃原包装的准备商店套件 - 25℃(68oF - 77oF)，游览允许15°C至30°C(59°F至86°F )。在室温下于辐射屏蔽存储放射性标记Lymphoseek。6小时编制内使用放射性Lymphoseek。处理该试剂盒Lymphoseek的准备(99m锝tilmanocept)注射液被批准用于分发由美国核管理委员会许可在10 CFR 35.200或正在通过协议国家颁发同等牌照识别的产品材料使用的人。 注射皮下剂英文版说明书 Lymphoseek Radiopharmaceutical Cleared in U.S. to Map Draining Lymph Nodes for Melanoma, Breast CancerIndications And UsageDosage And AdministrationTable 1. Preparation of Lymphoseek for Administration Planned Number of Injections for a Patient Total Injection Volume Per Patient Reconstituted Vial Volume of Radiolabeled Lymphoseek1 syringe x 0.1 mL 0.1 mL 0.5 mL5 syringes x 0.1 mL or2 syringes x 0.25 mL or 1 syringe x 0.5 mL 0.5 mL 2.5 mL5 syringes x 0.2 mL or4 syringes x 0.25 mL or 2 syringes x 0.5 mL 1 mL 5 mLDosage Forms And StrengthsThe Kit for preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is supplied as five Tilmanocept Powder vials each containing 250 mcg tilmanocept and five DILUENT for Lymphoseek vials each containing 4.5 mL of sterile buffered saline. After radiolabeling with technetium Tc 99m, Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume. Kit for preparation of Lymphoseek contains five Tilmanocept Powder vials each containing 250 mcg tilmanocept and five DILUENT for Lymphoseek vials containing 4.5 mL of sterile buffered saline. After radiolabeling with technetium Tc 99m and dilution, Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume for injection.ContraindicationsNone. None.Warning and CautionsHypersensitivity: Ask patients about prior reactions to drugs, especially dextran or modified forms of dextran. Observe for hypersensitivity signs and symptoms following Lymphoseek injection. Have resuscitation equipment and trained personnel immediately available. 5.1 Hypersensitivity Reactions Lymphoseek may pose a risk of hypersensitivity reactions due to its chemical similarity to dextran [see Description (11)]. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs). Before administering Lymphoseek, ask patients about prior hypersensitivity reactions to drugs, especially to dextran and modified forms of dextran. Have resuscitation equipment and trained personnel immediately available at the time of Lymphoseek administration. 5.2 Radiation Risks Any radiation-emitting product may increase the risk for cancer, especially in pediatric patients. Adhere to the dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to either patients or health care workers.Adverse ReactionsThe most common adverse reactions (incidence < 1%) are injection site irritation and/or pain. To report SUSPECTED ADVERSE REACTIONS, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or www.lymphoseek.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In open label, single arm clinical trials, 553 patients with either breast cancer, malanoma, or squamous cell carcinoma of the oral cavity, skin, and lip received Lymphoseek. No patients experienced serious adverse reactions. Injection site irritation (4 patients; 0.7%) and pain (1 patient; 0.2%) were reported.Use In Specific Populations8.1 Pregnancy Pregnancy Category C There are no adequate or well-controlled studies of Lymphoseek in pregnant women. Additionally, animal reproduction studies have not been conducted with technetium Tc 99m tilmanocept. However, all radiopharmaceuticals, including Lymphoseek, have a potential to cause fetal harm. Lymphoseek should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers It is not known whether technetium Tc 99m tilmanocept is present in human milk. Based on the half-life of technetium Tc 99m, a nursing woman should pump and discard milk for at least 60 hours (ten half-lives) after administration of Lymphoseek. 8.4 Pediatric Use Safety and effectiveness of Lymphoseek in patients less than 18 years of age have not been established. 8.5 Geriatric Use Of the 553 patients enrolled in clinical studies of breast cancer, melanoma, and squamous cell carcinoma (SCC) of oral cavity, skin, and lip, 179 (32%) were aged 65 or older. Review of the clinical data, including eva luation of the frequency of adverse reactions, has not identified differences in safety or efficacy between elderly patients (65 to 90 years of age) and younger patients (18 to 65 years of age).