药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201932719520225.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文ELOCTATE处方资料(仅供参考)
【英文名称】ELOCTATE
【中文名称】阿立哌唑
【适用证】
ELOCTATE,抗血友病因子(重组),Fc融合蛋白,是一种重组DNA衍生的抗血友病因子,适用于成人和患有血友病A(先天性因子VIII缺乏症)的儿童,用于:
按需治疗和控制出血事件
围手术期出血管理
常规预防,以减少出血发作的频率。
【用法用量】
仅用于重建后静脉注射。
每个ELOCTATE小瓶用国际单位(IU或单位)中的重组因子VIII的量标记。一
单位每公斤体重将使因子VIII水平提高2%(IU / dL)。 (2.1)
对于按需治疗和控制出血事件和围手术期处理,使用以下公式计算剂量:
因子VIII的估计增量(IU / dL或正常%)= [总剂量(IU)/体重(kg)]×2(IU / dL / IU / kg)
OR
所需剂量(IU)=体重(kg)x所需因子VIII上升(IU / dL或正常%)x 0.5(IU / kg / IU / dL)
常规预防:每4天50 IU / kg。根据患者反应调整剂量,剂量范围为25-65 IU / kg,间隔3-5天。
对于6岁以下儿童的常规预防:每周两次50 IU / kg。根据患者反应调整剂量,剂量范围为25-65 IU / kg,间隔3-5天。可能需要更高频率或更高剂量,最高可达80 IU / kg。 (2.1)
【注意事项】
不要用于对ELOCTATE有过危及生命的过敏反应(包括过敏反应)的患者。
【INDICATIONS AND USAGE】
ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes.
【DOSAGE AND ADMINISTRATION】
For intravenous use after reconstitution only.
Each vial of ELOCTATE is labeled with the amount of recombinant Factor VIII in international units (IU or unit). One
unit per kilogram body weight will raise the Factor VIII level by 2% (IU/dL). (2.1)
For on-demand treatment and control of bleeding episodes and perioperative management, calculate dose using the following formulas:
Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg)
OR
Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
For routine prophylaxis: 50 IU/kg every 4 days. Adjust dose based on patient response with dosing in the range of 25- 65 IU/kg at 3-5 day intervals.
For routine prophylaxis in children less than 6 years of age: 50 IU/kg twice weekly. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required. (2.1)
【CONTRAINDICATIONS】
Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE. (4)
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201932719520225.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |