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  药店国别: 美国药房
产地国家: 美国
所属类别: 生物药物->生化药物
处方药:处方药
包装规格: 900-1300毫克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
CSL Behring
生产厂家英文名:
CSL Behring
该药品相关信息网址1:
http://www.riastap.com/
该药品相关信息网址2:
http://www.drugs.com/riastap.html
该药品相关信息网址3:
http://www.rxlist.com/riastap-drug.htm
原产地英文商品名:
RIASTAP POWDER FOR RECONSTITUTION 900-1300mg/vial
原产地英文药品名:
FIBRINOGEN
中文参考商品译名:
RIASTAP重组粉剂 900-1300毫克/瓶
中文参考药品译名:
纤维蛋白原
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Acute hemorrhagic
英文适应病症2:
Fibrinogen deficiency
临床试验期:
完成
中文适应病症参考翻译1:
急性出血
中文适应病症参考翻译2:
纤维蛋白原缺乏
药品信息:

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 详细处方信息以本药内容附件PDF文件(201152322385829.pdf)的“原文Priscribing Information”为准
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部分中文纤维蛋白原处方资料(仅供参考)

RiaSTAP获得FDA批准用于治疗急性出血症
    致力于开发血浆蛋白生物制剂的CSL Behring公司近日宣布,FDA已批准RiaSTAP上市销售,这是第一种也是唯一一种获准用于患有先天性纤维蛋白原缺乏(包括无纤维蛋白原血症和低纤维蛋白原血症)的患者,以治疗急性出血,但RiaSTAP并不用于治疗异常血纤维蛋白原血症。
    此次该药获准的依据是一项II期开放标签药物动力学及安全性实验结果,该实验的终点是观测药物在发挥止血过程中的最大凝血稳固程度(MCF)。
    实验结果显示,受试者在用药30分钟后体内的血浆纤维蛋白原均达到最高水平,用药1个小时后体内的血浆纤维蛋白原活性均达到最大值。此外,患者用药1个小时之后,MCF也显著增强。
    目前,CSL Behring公司在着手开展RiaSTAP的一项售后实验,继续观察药物的安全性和止血效果。

美国FDA批准纤维蛋白原浓缩液上市RiaSTAP
    美国FDA批准CSL Behring公司的纤维蛋白原浓缩液(fibrinogen concentrate,RiaSTAP)上市,首个和迄今唯一用于治疗先天性纤维蛋白原缺陷(包括纤维蛋白原缺乏血症和低纤维蛋白原血症)患者的急性出血。罕见先天性纤维蛋白原缺乏,但此潜在威胁生命的出血疾病影响约百万分之一的人。本品不适用于异常纤维蛋白原血症。
    2008年3月,本品获准进入罕用阶段,2008年8月进行了优先评价。本品获准上市是基于一项关键的前瞻性开放式II期临床采用最大血块硬度(MCF)作为凝血疗效替代终点进行了药动学和安全性研究。MCF是血块结构完整性的实验室测定,反映了纤维蛋白原形成纤维蛋白血块的潜在效果。
     纤维蛋白原也称为凝血因子I,是形成血块所需蛋白质。血浆中纤维蛋白原浓度决定了形成血块的能力和在体内的活性。纤维蛋白原浓度降低限制了体内形成血块的能力。
     本品是经确保安全的病毒灭活和去除纯化的纤维蛋白原浓缩液。在全球销售100万单位(美国外的商品名为Haemocomlettan)。
     对15例患者药动学研究显示,平均纤维蛋白原血浆抗原浓度和平均血浆活性水平分别在输注后30分钟至1小时达到最大程度,随后逐渐降低。结果还表明,输注本品1小时后平均改善 MCF的效果较基础值显著高(P<0.000 1)。

RiaSTAP获孤儿药地位
    CSL Behring的先天性纤维蛋白原缺乏病治疗药RiaSTAP获得美国FDA批准上市,这还是FDA批准的第一个该类疾病治疗药,公司将获得7年的市场独占期。


RiaSTAP
Generic Name: fibrinogen (fye BRIN oh gen)
Brand Names: RiaSTAP

What is RiaSTAP?
RiaSTAP is a man-made form of a protein that occurs naturally in the body and helps the blood clot.

RiaSTAP is used to treat bleeding episodes in people who have a congenital fibrinogen deficiency.

RiaSTAP may also be used for other purposes not listed in this medication guide.

Important information about RiaSTAP
You should not use RiaSTAP if you have ever had an allergic reaction to fibrinogen, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using RiaSTAP, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject RiaSTAP if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. RiaSTAP comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the RiaSTAP injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling in your one or both legs, and problems with vision, speech, or balance.

RiaSTAP is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Before using RiaSTAP
You should not use RiaSTAP if you have ever had an allergic reaction to fibrinogen, or if you have ever had any other life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using RiaSTAP, tell your doctor if you have a history of stroke or blood clot.

FDA pregnancy category C. It is not known whether RiaSTAP is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

RiaSTAP is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use RiaSTAP?
RiaSTAP is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject RiaSTAP if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You will need to mix RiaSTAP with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix RiaSTAP with any other medicines, or give other medicines through the same IV line.

RiaSTAP contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away. Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your RiaSTAP dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. After mixing RiaSTAP with a diluent, use it right away or store the mixture at room temperature and use it within 24 hours. The mixed medicine should be clear or slightly colored. Do not use the mixed medication if it has changed colors, is cloudy, or has any particles in it.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

To be sure RiaSTAP is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with RiaSTAP. Do not miss any follow-up visits to your doctor.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store the unmixed dry powder in a refrigerator or in a dark cool place. Keep the medicine protected from light and do not allow it to freeze. Throw away any unused vial after the expiration date on the label has passed.

What happens if I miss a dose?
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a RiaSTAP overdose are not known.

What should I avoid while taking RiaSTAP?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using RiaSTAP.

RiaSTAP side effects
Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effect, such as:
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
sudden cough, rapid breathing, fast heart rate;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
pain or swelling in one or both legs.

Less serious side effects may include:
fever
chills;
nausea; or
vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RiaSTAP?
There may be other drugs that can interact with RiaSTAP. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Compare RiaSTAP with other medications
Congenital Fibrinogen Deficiency

Where can I get more information?
Your pharmacist can provide more information about RiaSTAP.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件(201152322385829.pdf)的“原文Priscribing Information”为准
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更新日期: 2011-5-24
附件:




201152322385829.pdf    

 
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