制造商：
Octapharma公司
药理分类：
复杂的凝血因子
活性成分（补）：
血管性血友病因子/第八因子复合物（人）; 450国际单位vWF水平：完成脉冲和450国际单位的FVIII活动，每为5mL; 900国际单位vWF水平：完成脉冲和900国际单位，每10毫升的FVIII活动，残疾人士，为静脉注射后重建;不含防腐剂;溶剂-洗涤剂处理。
指示（补）：
出血（自发性和外伤引起的）治疗重度血友病的疾病，治疗轻至中度冯为谁去氨加压素是血管性血友病无效或禁忌。
药理作用：
血管性血友病因子（vWF）及凝血第八因子在凝血级联反应是在正常人体血浆中的蛋白。血管性血友病患者的疾病器（VWD）的经验作为一个缺陷或异常的vWF其中，除了其作为调解人的作用，血小板粘附，稳定内源性因子VIII结果失血过多。
Wilate是人血浆源性血管性血友病因子/凝血因子VIII复杂，是缓慢静脉注射管理。这是准备从筛选汇集来自捐助者血浆病毒灭活和经历两个步骤。虽然疾病传播的可能性很低，它仍然是一个理论上的可能性。
有几种类型的血管性血友病，每一个结果在不同的药理特征。因此，疾病的类型可能会影响治疗的最佳剂量和持续时间。例如，与血管性血友病患者可能需要3型比其他类型的患者高剂量。
临床试验：
四前瞻性临床研究，进行评估在血管性血友病患者的出血与控制该产品的有效性。数据是从1068出血治疗70例，其中有37个3型血管性血友病。使用额外的客观标准和主观四点止血效能量表，84％的事件被评为取得成功。在70例，其中45收到要求治疗出血。在成功治疗出血，93％是在3型患者。大部分的发作治疗1-3天，然而，胃肠道出血最多7天经常需要治疗。
法律分类：
接收
成人和儿童：
<5yrs：联系制造商。通过静脉给于2-4mL/min注射。 ≥5yrs：小出血：20〜40国际单位/公斤一次，然后20-30国际单位/ kg，每12-24小时。主要出血：40-60国际单位/公斤一次，然后20〜40国际单位/ kg，每12-24小时。根据监测和vWF的调整：完成脉冲和第八因子活性，流血位置;一般治疗时间为3天（轻微出血）和5-7天（大出血）。见文学活动水平的目标。
警告/注意事项：
不为自发性出血，手术出血的预防，治疗或血友病预防答：应在凝血监督训练的医生。与持续过高的FVIII水平血栓事件的风险;监视器。失效可能表明抗体形成;停止，如果证实。对血源性疾病的传播风险;考虑在注射液对A和B型肝炎疫苗接种监测脉冲;缓慢或停止输液，如果心脏发生率显着增加。妊娠（Cat.C）。哺乳的母亲。
不良反应（补）：
荨麻疹，头晕，过敏性反应，抗体的形成。
如何提供：
洁1（瓦特稀释剂，物资）
最后更新：
2010年4月19日
WILATE
Manufacturer:
Octapharma
Pharmacological Class:
Coagulation factor complex
Active Ingredient(s):
von Willebrand Factor/Factor VIII Complex (human); 450 IU VWF:RCo and 450 IU FVIII activities per 5mL; 900 IU VWF:RCo and 900 IU FVIII activities per 10mL; pwd; for IV injection after reconstitution; preservative-free; solvent-detergent treated.
Indication(s):
Bleeding episodes (spontaneous and trauma induced) in patients with severe von Willebrand disease, and patients with mild to moderate von Willebrand disease for whom desmopressin is ineffective or contraindicated.
Pharmacology:
Von Willebrand Factor (VWF) and Coagulation Factor VIII are proteins involved in the clotting cascade that are found in normal human plasma. Patients with von Willebrand’s disease (VWD) experience excessive bleeding as a result of a deficiency or abnormality of VWF which, in addition to its role as a mediator of platelet adhesion, stabilizes endogenous Factor VIII.
Wilate is a human plasma-derived von Willebrand Factor/Coagulation Factor VIII complex that is administered by slow IV injection. It is prepared from pooled plasma from screened donors and undergoes two viral inactivation steps. While the probability of disease transmission is remote, it remains a theoretical possibility.
There are several types of VWD, each of which results in a different pharmacological profile. Thus, the type of disease may influence the optimal treatment dose and duration. For example, patients with VWD type 3 may require higher doses than patients with other types.
Clinical Trials:
Four prospective clinical studies were conducted to assess the efficacy of this product in the control of bleeding in patients with VWD. Data were obtained from the treatment of 1068 bleeding episodes in 70 patients, 37 of whom had VWD type 3. Using additional objective criteria and a subjective four-point hemostatic efficacy scale, 84% of the episodes were rated as being successful. Of the 70 patients, 45 of them received on demand treatment for bleeding episodes. Of the successfully treated bleeding episodes, 93% were in patients with type 3 disease. Most of the episodes were treated for 1–3 days; however, GI bleeds often required treatment for up to 7 days.
Legal Classification:
Rx
Adults & Children:
<5yrs: contact manufacturer. Give by IV injection at 2–4mL/min. ≥5yrs: Minor bleed: 20–40 IU/kg once, then 20–30 IU/kg every 12–24 hours. Major bleed: 40–60 IU/kg once, then 20–40 IU/kg every 12–24 hours. Monitor and adjust according to VWF:RCo and FVIII activity, and location of bleed; usual treatment duration is 3 days (minor hemorrhage) and 5–7 days (major hemorrhage). See literature for activity level goals.
Warnings/Precautions:
Not for prophylaxis of spontaneous bleeding, prevention of surgical bleeding, or hemophilia A. Treatment should be supervised by physician trained in coagulopathies. Risk of thrombotic events with sustained excessive FVIII levels; monitor. Ineffectiveness may indicate antibody formation; discontinue if confirmed. Risk of transmission of blood-borne diseases; consider vaccination against hepatitis A and B. Monitor pulse during injection; slow or stop infusion if marked increase in heart rate occurs. Pregnancy (Cat.C). Nursing mothers.
Adverse Reaction(s):
Urticaria, dizziness, hypersensitivity reactions, antibody formation.
How Supplied:
Kit—1 (w. diluent, supplies)