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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->凝血酶抑制剂
处方药:处方药
包装规格: 966IU
计价单位:
  点击放大  
生产厂家英文名:
Baxalta Incorporated
该药品相关信息网址1:
https://www.feiba.com/us/hcp/about
该药品相关信息网址2:
https://www.rxlist.com/feiba-vh-drug.htm
原产地英文商品名:
FEIBA NF PDS 966IU vial
原产地英文药品名:
anti-inhibitor coagulant complex
中文参考商品译名:
FEIBA NF PDS 966IU vial
中文参考药品译名:
抗抑制剂凝血剂复合物
原产地国家批准上市年份:
1986/01/31
英文适应病症1:
Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitor
临床试验期:
完成
中文适应病症参考翻译1:
抗抑制剂混凝剂复合物,适用于血友病A和B患者
药品信息:

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详细处方信息以本药内容附件PDF文件(201952714285837.pdf)的“原文Priscribing Information”为准
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部分中文FEIBA 处方资料(仅供参考)

【英文名称】FEIBA

【适用证】

FEIBA是一种抗抑制剂混凝剂复合物,适用于血友病A和B患者,具有以下抑制剂:

•控制和预防出血事件。

•围手术期管理。

•常规预防,以预防或减少出血发作的频率。 在没有因子VIII或因子IX的抑制剂的情况下,FEIBA不适用于治疗由凝血因子缺乏引起的出血事件。(1)

【用法用量】

仅用于重建后静脉注射(2)

•每瓶FEIBA含有标记量的因子VIII抑制剂旁路活性单位。(2)

出血类型;剂量(单位/ kg);频率/持续时间

控制和预防出血; 50-100;由出血事件的类型决定

围手术期管理; 50-100;由外科手术干预的类型决定

常规预防; 85;每隔一天

•最大注射或输注速度不得超过每分钟每公斤体重2个单位。(2.3)

【禁忌】

•对FEIBA或其任何成分的过敏或严重超敏反应的历史,包括激肽生成系统的因素。(4)

•弥散性血管内凝血(DIC)。(4)

•急性血栓形成或栓塞(包括心肌梗塞)。(4)

【使用注意】

•FEIBA可在每日每公斤200单位剂量和血栓形成危险因素患者后引起血栓栓塞事件。 监测接受FEIBA的患者血栓栓塞事件的体征和症状。(5.1)

•可能发生过敏反应和严重的超敏反应。 如果出现症状,请停止使用FEIBA治疗并进行适当的治疗。(5.2)

•FEIBA由人血浆制成,可含有感染因子,例如病毒,变异克雅氏病(vCJD)和理论上的克雅氏病(CJD)剂。(5.3)

【INDICATIONS AND USAGE】

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

•Control and prevention of bleeding episodes.

•Perioperative management.

•Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to factor VIII or factor IX. (1)

【CONTRAINDICATIONS】

•History of anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system. (4)

•Disseminated intravascular coagulation (DIC). (4)

•Acute thrombosis or embolism (including myocardial infarction). (4)

【WARNINGS AND PRECAUTIONS】

•FEIBA can cause thromboembolic events following doses above 200 units per kg per day and in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. (5.1)

•Anaphylaxis and severe hypersensitivity reactions may occur. Should symptoms occur, discontinue treatment with FEIBA and administer appropriate treatment. (5.2)

•FEIBA is made from human plasma and may contain infectious agents, e.g., viruses, the variant Creutzfeldt-Jacob disease (vCJD) and theoretically, Creutzfeldt-Jacob disease (CJD) agent. (5.3)

【DOSAGE AND ADMINISTRATION】

For intravenous use after reconstitution only (2)

•Each vial of FEIBA contains the labeled amount of factor VIII inhibitor bypassing activity in units. (2)

Type of Bleeding ; Dose (unit/kg) ;Frequency/Duration

Control and Prevention of Bleeding; 50 - 100; Determined by the type of bleeding episode

Perioperative Management; 50 - 100; Determined by the type of surgical intervention

Routine Prophylaxis; 85; Every other day

•Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. (2.3)

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详细处方信息以本药内容附件PDF文件(201952714285837.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-5-27
附件:
201952714285837.pdf    

 
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