去纤苷钠_Defitelio_去纤苷钠冻干粉注射剂defibrotide说明书
[caption id="attachment_40256" align="alignleft" width="300"] Defitelio 200mg/2.5ml(defibrotide sodium 去纤苷钠冻干粉注射剂)[/caption]
药店国别:
产地国家:美国
处 方 药:是
所属类别:200毫克/2.5毫升(80毫克/毫升)/瓶 10瓶/盒
包装规格:200毫克/2.5毫升(80毫克/毫升)/瓶 10瓶/盒
计价单位:盒
生产厂家中文参考译名:爵士制药公司
生产厂家英文名:Jazz Pharmaceuticals plc
原产地英文商品名:DEFITELIO 200mg/2.5mL(80mg/mL)/vial 10vial/Box
原产地英文药品名:defibrotide-sodium
中文参考商品译名:Defitelio 200毫克/2.5毫升(80毫克/毫升)/瓶 10瓶/盒
中文参考药品译名:去纤维钠
简介:
近日,美国FDA批准Jazz制药的 Defitelio(defibrotide sodium,中文译名:去纤苷钠)治疗经血液或骨髓造血干细胞移植 (HSCT)后肝小静脉闭塞(VOD)并伴有肾或肺异常的成人和儿童患者。这是FDA第一个治疗严重肝VOD的批准,这种病稀有且危及生命
FDA 的药物评价和研究中心血液学和肿瘤学产品办公室主任Richard Pazdur, M.D.,说:'Defitelio的批准填补了巨大需求,病人接受化疗和HSCT后会有罕见的但经常致命的并发症,Defitelio针对此适应症
批准日期:2016年3月30日 公司:爵士制药公司
DEFITELIO(去纤维钠[defibrotide-sodium])注射液,为静脉使用
作用机制:
去纤维钠的作用机制尚未完全阐明。在体外,去纤维钠增强纤溶酶水解纤维蛋白凝块的酶活性。研究评价去纤维钠对内皮细胞(ECs)药理学效应是主要地在人微血管内皮细胞系中进行。在体外,去纤维钠增加组织纤溶酶原激活剂(t-PA)和血栓调节蛋白表达,和减低von Willebrand因子(vWF)和纤溶酶原激活剂抑制剂-1(PAI-1)表达,因此减低EC活化和增加EC-介导的纤维蛋白溶解。去纤维钠保护ECs免受化疗,肿瘤坏死因子-α(TNF-α),血清饥饿,和灌注所致损伤。
适应症和用途:
DEFITELIO是适用为有肝小静脉闭塞病(VOD),也称为肝窦阻塞综合征(SOS),造血干细胞移植(HSCT)后有肾或肺功能失调成年和儿童患者的治疗。
剂量和给药方法:
给予DEFITELIO 6.25 mg/kg每6小时给予作为2-小时静脉输注。
治疗共最小21天。如21天后VOD的体征和症状没有解决。继续治疗直至解决。
剂型和规格:
注射液:200mg/2.5mL(80mg/mL)在一个单次-患者-使用小瓶。
禁忌症:
⑴同时给药与全身抗凝剂或纤维蛋白溶解疗法。
⑵对DEFITELIO或对任何赋形剂已知超敏性。
警告和注意事项:
⑴出血:监视患者对出血。如发生显著出血不给或终止DEFITELIO。
⑵超敏性反应:如发生严重或危及生命过敏反应,终止DEFITELIO,按照标准医护治疗,和监视直至体征和症状解决。
不良反应:
用DEFITELIO治疗最常见不良反应(发生率 ≥10%和独立的因果关系)为低血压,腹泻,呕吐,恶心和鼻出血。
药物相互作用:
DEFITELIO可能增强抗血栓形成/纤溶蛋白溶解药物的活性。
供应/贮存和处置:
DEFITELIO(去纤维钠)注射液是在一个单次-患者-使用,透明玻璃小瓶作为一个清澈,浅黄色至棕色,无菌,无防腐剂溶液为静脉输注供应。每小瓶(NDC 68727-800-01)含200mg/2.5mL(在一个浓度80mg/mL)的去纤维钠。
DEFITELIO(去纤维钠)注射液的每个纸箱(NDC 68727-800-02)含10个小瓶。
贮存DEFITELIO(去纤维钠)注射液在20°C-25°C(68°F-77°F);外出允许15°C至30°C(59°F至 86°F)间(见USP控制室温)。
DEFITELIO(defibrotide sodium) injection, for intravenous use
Initial U.S. Approval: 2016
Defitelio® (defibrotide sodium) is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
IMPORTANT SAFETY INFORMATION
Contraindications
Defitelio is contraindicated in the following conditions:
Concomitant administration with systemic anticoagulant or fibrinolytic therapy
Known hypersensitivity to Defitelio or to any of its excipients
Warnings and Precautions
Hemorrhage
Defitelio may increase the risk of bleeding in patients with VOD after HSCT. Do not initiate Defitelio in patients with active bleeding. Monitor patients on Defitelio for signs of bleeding. If bleeding occurs, withhold or discontinue Defitelio.
Concomitant systemic anticoagulant or fibrinolytic therapy may increase the risk of bleeding and should be discontinued prior to Defitelio treatment. Consider delaying Defitelio administration until the effects of the anticoagulant have abated.
Hypersensitivity Reactions
Hypersensitivity reactions including rash, urticaria, and angioedema have occurred in less than 2% of patients treated with Defitelio. One case of an anaphylactic reaction was reported in a patient who had previously received Defitelio. Monitor patients for hypersensitivity reactions, especially if there is a history of previous exposure. If a severe hypersensitivity reaction occurs, discontinue Defitelio, treat according to the standard of care, and monitor until symptoms resolve.
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10% and independent of causality) with Defitelio treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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