英文药名：ADVATE Antihemophilic Factor (Recombinant),Plasma/Albumin-Free Method〔rurioctocog alfa (genetical recombination)〕

中文药名：注射用重组人凝血因子VIII/血浆/白蛋白组

生产厂家：百特 Baxter
药品介绍
ADVATE是一种全长重组FVIII产品（重组人类凝血因子VIII注射剂），未添加任何血液添加剂，适用于A型血友病患者出血的治疗和预防，不适用于血管性血友病(von Willebrand disease，vWD)的治疗。目前该药已获全球59个国家批准上市
治疗类别名称
重组凝血因子VIII
欧文商標名
ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method
一般名：
ルリオクトコグ アルファ(遺伝子組換え)
〔rurioctocog alfa (genetical recombination)JAN 〕
本質3)～5)：
ヒト肝細胞のmRNAに由来するヒト第VIII因子cDNAの発現により、チャイニーズハムスター卵巣細胞で産生される2,332個のアミノ酸残基(C12257H17863N3220O3552S83：分子量269,812.82)からなる糖たん白質(分子量：300,000-350,000)
操作注意事项
保存记录
但不是代理指定生物制品，因为它是一种血液产品更换药物，给药或处方这种药物，药品名（商品名），序列号，给药或一天配制和施用或制剂时要被存储在至少20年的事情接收病人的名字，记录地址等。
药效药理
药物是活化血液凝固因子IX，磷脂通过激活凝血因子X具有钙有助于固有凝固。
适应症
对凝血因子VIII缺乏症患者中，补充血液凝血因子VIII在血浆中，以抑制出血倾向。
剂量和给药方法
溶解药物在所附的溶液5mL，静脉内注射或输注缓慢。速度不超过10ml/min时注入。剂量通常施用到每体重1千克剂量为10〜30个国际单位，并增加或酌情根据症状减少。
包装规格
ADVATE Antihemophilic Factor 静脉250：250国际单位×1瓶 附着溶液（日本药典注射用水5mL）
ADVATE Antihemophilic Factor 静脉500：500国际单位×1瓶 附着溶液（日本药典注射用水5mL）
ADVATE Antihemophilic Factor 静脉注射1000：1000国际单位×1瓶 附着溶液（日本药典注射用水5mL）
ADVATE Antihemophilic Factor 静脉注射1500：1500国际单位×1瓶 附着溶液（日本药典注射用水5mL）
ADVATE Antihemophilic Factor 静脉注射2000：2000国际单位×1瓶 附着溶液（日本药典注射用水5mL）

制造商（进口商）
日本百特有限公司

注：以上部份中文资料仅供参考，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/6343432D4036_1_01/6343432D4036_1_01?view=body
www.oneyao.net  www.120ty.net
Other Description (handling of ancillary equipment, etc.)
Baxter is a registered trademark of Baxter International Inc.
Advate / Adobeito is a registered trademark of Bakusuaruta, Incorporated
ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications
ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.
Your healthcare provider may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).
ADVATE is not used to treat von Willebrand disease.
DETAILED IMPORTANT RISK INFORMATION
You should not use ADVATE if you:
•Are allergic to mice or hamsters.
•Are allergic to any ingredients in ADVATE.
Tell your healthcare provider if you are pregnant or breastfeeding because ADVATE may not be right for you.
You should tell your healthcare provider if you:
•Have or have had any medical problems.
•Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
•Have any allergies, including allergies to mice or hamsters.
•Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).
Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
You can have an allergic reaction to ADVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.
Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91ca765f-fe58-4dee-a7eb-c8d3de9f115a