2000年，美国FDA批准CSL Bering公司的Helixate FS在美国及欧盟用于甲型血友病的治疗。Helixate FS是基因重组凝血因子Ⅷ，应用Helixate FS旨在减少出血发作次数及关节损伤风险。还适用于控制或预防甲型血友病**患者的出血发作。

HELIXATE（抗血友病因子，重组）板
[杰特贝林有限责任公司]

（抗血友病因子[重组]，与蔗糖配方）对于静脉注射使用，冻干粉重组时

最初美国批准：1993

最近的重大变化

适应症和用途
 
适应症
helixate FS是一种抗血友病因子（重组）表示：

控制和预防出血，在A型血友病的成人和儿童（0-16岁）
在成人和儿童A型血友病的围手术期的管理
常规的预防措施，以减少儿童血友病患者出血发作的频率和关节损伤的风险与没有预先存在的关节损伤。
 
剂量和用法
仅用于静脉使用

每小瓶含Helixate财政司司长在国际单位的重组第八因子标示量（国际单位）
控制和预防出血和围手术期管理：

剂量（单位）=体重（公斤）×所需的第八凝血因子上升（IU / dL或正常％）×0.5（IU / dL的IU /每公斤）。
重组后的产品的静脉注射的频率取决于出血事件的类型和主治医生的建议。
对于常规预防儿童在没有预先存在的关节损伤，推荐剂量为25 IU /公斤，每隔一天。
 
剂型和优势
helixate FS粉是250，500，1000，2000和3000 IU单用小瓶。
 
禁忌
不要使用那些表现立即危及生命的过敏性反应，包括过敏性休克，在产品或者其组成部分，包括鼠标或仓鼠蛋白的患者。
 
注意事项：
过敏性休克和严重的过敏反应是可能的。如果出现症状，应停止使用，治疗与Helixate FS和应寻求紧急治疗。患者可能发展到小鼠或仓鼠蛋白，它是目前在产品中的微量过敏。
已发现患者在接受第八凝血因子产品的开发活动中和抗体。如果没有达到预期的血浆因子Ⅷ活性水平，如果没有预期的剂量，法第八因子抑制剂浓度应执行的措施控制出血。
 
不良反应
在临床试验中观察到的最常见的不良反应（频率≥4％的患者）抑制剂在以前未经治疗和微创治疗的患者（PUP的台胞证），皮肤相关的过敏反应（如皮疹，瘙痒），荨麻疹，注射部位形成反应（例如，发炎，疼痛），中央静脉通路装置（CVAD）行相关感染。
 
在特殊人群中使用
怀孕：没有人或动物的数据。如果确实需要，只能使用。
儿科使用：高等教育第八凝血因子的清除已与成人相比，儿童（4.4-16岁）。可能需要调整剂量。
日期：12/2010

Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Monograph title
ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION
Common brand name(s)
Advate, Helixate, Kogenate, Recombinate
Uses
This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop.This medication should not be used to treat von Willebrand disease.

How to use
This medication is given by injection into a vein, usually over 5 to 10 minutes or as directed by your doctor. The medication may need to be given more slowly over a longer time depending on your dose and how you respond to it.After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If you have any questions, ask your health care professional.If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use immediately according to the product instructions.The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely.Tell your doctor if your condition does not improve or if it worsens.

Missed dose
It is important to follow the dosing schedule as directed by your doctor. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

Precautions
Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Side effects
Flushing of the face, headache, nausea, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, and chills may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes
Do not share this medication with others.Laboratory blood tests (e.g., factor VIII levels) should be performed frequently to determine your dosage and to check how well this medication is working. Consult your doctor for more details.

Medical alert
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Storage
Store the medication according to the manufacturer's instructions. Ask your pharmacist if you have any questions. Do not freeze this product or store it in the bathroom. Protect the product from light. After mixing, use the product within the time frame stated in the manufacturer's instructions and throw away any unused portion. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.
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注：以下产品不同规格和不同的价格，购买时请以电话为准！
原产地英文商品名:
Helixate FS 250IU VIAL
原产地英文药品名:
Antihemophilic Factor (Recombinant) Formulated with Sucrose
原产地英文化合物名称:
Human Recomb FVIII Factor
中文参考商品译名:
Helixate FS 250国际单位/瓶
中文参考药品译名:
人基因重组抗血友病（FVIII）因子
中文参考化合物名称:
人基因重组凝血第八因子
生产厂家中文参考译名:
CSL Behring美国公司
生产厂家英文名:
CSL Behring USA

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原产地英文商品名:
Helixate FS 500IU VIAL
原产地英文药品名:
Antihemophilic Factor (Recombinant) Formulated with Sucrose
原产地英文化合物名称:
Human Recomb FVIII Factor
中文参考商品译名:
Helixate FS 500国际单位/瓶
中文参考药品译名:
人基因重组抗血友病（FVIII）因子
中文参考化合物名称:
人基因重组凝血第八因子
生产厂家中文参考译名:
CSL Behring美国公司
生产厂家英文名:
CSL Behring USA
---------------------------------------------------------------
原产地英文商品名:
Helixate FS 1000IU VIAL
原产地英文药品名:
Antihemophilic Factor (Recombinant) Formulated with Sucrose
原产地英文化合物名称:
Human Recomb FVIII Factor
中文参考商品译名:
Helixate FS 1000国际单位/瓶
中文参考药品译名:
人基因重组抗血友病（FVIII）因子
中文参考化合物名称:
人基因重组凝血第八因子
生产厂家中文参考译名:
CSL Behring美国公司
生产厂家英文名:
CSL Behring USA
---------------------------------------------------------------
原产地英文商品名:
Helixate FS 2000IU VIAL
原产地英文药品名:
Antihemophilic Factor (Recombinant) Formulated with Sucrose
原产地英文化合物名称:
Human Recomb FVIII Factor
中文参考商品译名:
Helixate FS 2000国际单位/瓶
中文参考药品译名:
人基因重组抗血友病（FVIII）因子
中文参考化合物名称:
人基因重组凝血第八因子
生产厂家中文参考译名:
CSL Behring美国公司
生产厂家英文名:
CSL Behring USA