通用名称:indocyanine green for injection, USP 商品名称:IC-Green®(ICG) 中文药名:吲哚青绿 剂型:针剂,粉针剂,冻干,对于解决方案 IC-GREEN®(吲哚花青绿注射,USP)静脉注射 最初美国批准:1959年 适应症和用法 IC绿化®三碳菁染料,表示: 用于确定心输出量,肝功能和肝血流。 对于眼部血管造影。 用法用量 指标的稀释研究。 在无菌条件下,在IC绿化®粉末应与无菌水溶解为注射液,USP提供,它是制备后使用6小时内的溶液中。稀释曲线通常剂量IC绿化®是:成人5.0毫克,儿童 - 2.5毫克,幼儿 - 1.25毫克。 肝功能研究。 在无菌条件下,在IC绿化®粉末应与无菌水溶解为注射液,USP提供。患者应称量的剂量为0.5毫克/公斤体重的基础上计算的。恰好5毫升无菌注射用水,USP应加入到25毫克小瓶得到5毫克染料每毫升的溶液。 眼科血管造影研究。 剂量高达40毫克集成电路绿化®染料在2mL无菌注射用水,USP应施用。生理盐水的5毫升丸应紧跟染料的注入。 剂型和规格 集成电路绿化®是含有25mg吲哚花青绿的不超过5%的碘化钠的无菌,冻干绿色粉末。 禁忌症 集成电路绿化®包含碘化钠和应谨慎谁有过敏,因为过敏反应的风险的碘化物病史的患者中使用。 警告和注意事项 因过敏反应死亡报告下列心导管检查过程中IC绿化®管理。 集成电路绿化®是在水溶液中不稳定的,并且必须在6小时内使用。 放射性碘摄取研究不应继用集成电路绿化®的至少一个星期进行。 不良反应 最常见的不良反应为过敏性荨麻疹或反应。这些已经报道在患者和无过敏的碘化物的历史。 药物相互作用 含有亚硫酸氢钠的产品减少集成电路绿化®的血液中的吸收峰。 生产商:Akorn公司
IC-GREEN 绿提供增强的脉络膜和其相关的病理的成像,由于其独特的近红外荧光的性质和它的高血浆结合能力。 •红外线激发(805nm)和发射(835nm峰值)IC-绿色波长允许RPE和视网膜下出血与荧光素超强的渗透力。 •IC-GREEN 绿不会从容器那样容易泄漏的FA,因为它是高度结合到血浆蛋白质与FA(98%对45%),并且由于其更高melecular重量(775与337) •IC-绿能产生比较荧光脉络膜循环的最佳成像。 •IC-绿能提供脉络膜循环的最佳成像,使其成为一个很好的辅助FA。 包装: 套件 - 6×25毫克IC-绿色小瓶 - 6×10毫升安培水溶剂
完整资料附件: 1:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe138b13-43e1-4ab2-8882-07ed91bb70ea 2:https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=7961 IC-GREEN ® (indocyanine green for injection, USP) For Intravenous Injection Initial U.S Important Safety Information INDICATIONS AND USAGE For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography. CONTRAINDICATIONS IC-GREEN® contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides. WARNINGS Anaphylactic deaths have been reported following IC-GREEN® administration during cardiac catheterization. PRECAUTIONS General: IC-GREEN® Powder and Solution: IC-GREEN® is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the dilution curves. IC-GREEN® (indocyanine green for injection) powder may cling to the vial or lump together because it is freeze-dried in the vials. Drug Interactions: Heparin preparations containing sodium bisulfite reduce the absorption peak of IC-GREEN® in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis. Drug/Laboratory Test Interactions: Radioactive iodine uptake studies should not be performed for at least a week following the use of IC-GREEN®. Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility. Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal Reproduction studies have not been conducted with IC-GREEN®. It is also not known whether IC-GREEN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IC-GREEN® should be given to a pregnant woman only if clearly indicated. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IC-GREEN® is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. ADVERSE REACTIONS Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treatment with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids should be administered. OVERDOSAGE There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD50 after I.V. administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg in rats and 50 and 80 mg/kg in rabbits.
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