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  药店国别: 美国药房
产地国家: 美国
所属类别: 皮肤科药物->牛皮癣
处方药:处方药
包装规格: 15毫克/瓶 4瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
安斯泰来
生产厂家英文名:
ASTELLAS
该药品相关信息网址1:
http://www.amevive.com/
该药品相关信息网址2:
http://www.drugs.com/cdi/amevive.html
该药品相关信息网址3:
http://www.rxlist.com/amevive-drug.htm
原产地英文商品名:
AMEVIVE 15mg/Vial 4Vials/box
原产地英文药品名:
ALEFACEPT
中文参考商品译名:
AMEVIVE 15毫克/瓶 4瓶/盒
中文参考药品译名:
阿法赛特
原产地国家批准上市年份:
2003/01/30
英文适应病症1:
Psoriasis
临床试验期:
完成
中文适应病症参考翻译1:
牛皮癣
药品信息:

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 详细处方信息以本药内容附件PDF文件(20124918032119.PDF,200952701395411.pdf)的“原文Priscribing Information”为准
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部分中文阿法赛特处方资料(仅供参考)

Alefacept,Amevive阿法赛特(人源L FA-3/IgG1融合蛋白)
    美国食品及药物管理局FDA批准了又一种牛皮癣新药Amevive,属名为alefacept,用于治疗中度及严重噬斑型牛皮癣成人患者。

  Amevive的作用机制是减少与牛皮癣有关的免疫性反应,后者会增加皮肤感染甚至发生恶性病变的危险。FDA是根据最近完成的两项双盲随机临床治疗结果做出上述批准的。这两项研究总共涉及到1,060例慢性噬斑型牛皮癣成人患者,结果表明Amevive组患者的病变皮肤面积、病变程度以及与此有关的炎症反应都要比对照组得到更为显著的改善。可能发生的副作用包括咽喉痛、眩晕、咳嗽、恶心以及肌肉酸痛等。鉴于目前还不大清楚该药对妊娠的影响,有关专家建议孕妇应当与AME-VIVE药厂(Biogen公司)取得联系,以便后者监测可能对胎儿发生的任何副作用。此外专家们还提醒说,患者在接受 Amevive治疗期间还需要定期检查白细胞数。

    Biogen公司的人源L FA-3/IgG1融合蛋白alefacept(AmeviveTM)能够与T-细胞结合,抑制T-细胞激活和产生,导致T-细胞选择性的凋亡,该药已经在美国和欧洲完成了治疗牛皮癣的III 期临床试验。1000名中重度牛皮癣患者参加的试验数据表明,在每周静脉注射该药后,71%的患者牛皮癣面积和严重程度得分(PASI)改善了50%以上,40%的患者PASI改善了75%以上。现在该药在美国和欧洲申请治疗中重度慢性噬斑性牛皮癣。

Alefacept injection
Brand names for this medication
Amevive

What is this medicine?
ALEFACEPT (a la FA cept) is used to treat adult patients with moderate or severe chronic plaque psoriasis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?
They need to know if you have any of the following conditions:
• cancer
• fever or infection
• immune system problems
• an unusual or allergic reaction to alefacept, any human or hamster proteins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?
This medicine is for injection into a muscle or infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?
Do not take this medicine with any of the following medications:
• medicines that suppress the immune system
• phototherapy like methoxsalen, porfimer, and aminolevulinic acid

This medicine may also interact with the following medications:
• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?
Visit your doctor or health care professional for checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need to have regular blood checks. The side effects of the medicine can continue after you finish your treatment. Promptly report any side effects.

This medicine may increase your risk of getting an infection. Stay away from people who are sick. See your doctor if you get an infection.

Do not become pregnant while taking this medicine and for 8 weeks after stopping the medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or tightness
• dark urine
• severe stomach pain
• signs of infection like fever, chills, or sore throat
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
• cough
• dizziness
• headache
• muscle ache or pain
• nausea
• pain at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.

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 详细处方信息以本药内容附件PDF文件(20124918032119.PDF,200952701395411.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-4-10
附件:


20124918032119.PDF    

200952701395411.pdf    

 
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