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  药店国别: 美国药房
产地国家: 美国
所属类别: 影响血液及造血系统药物->抗贫血药物
处方药:处方药
包装规格: 40000单位/毫升/瓶 4瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
强生
生产厂家英文名:
Johnson& Johnson
该药品相关信息网址1:
http://www.procrit.com/
该药品相关信息网址2:
http://www.drugs.com/procrit.html
该药品相关信息网址3:
http://www.rxlist.com/procrit-drug.htm
原产地英文商品名:
PROCRIT 40000U/ml/Vial 4Vials/box
原产地英文药品名:
EPOETIN ALFA
中文参考商品译名:
PROCRIT 40000单位/毫升/瓶 4瓶/盒
中文参考药品译名:
阿法依泊汀
原产地国家批准上市年份:
1989/06/01
英文适应病症1:
anemia
英文适应病症2:
Anemia in patients with end-stage renal disease
英文适应病症3:
Received AZT treatment of anemia in HIV-infected patients
英文适应病症4:
Received AZT treatment of anemia in HIV-infected patients
临床试验期:
完成
中文适应病症参考翻译1:
贫血症
中文适应病症参考翻译2:
肾病终末期病人的贫血
中文适应病症参考翻译3:
接受叠氮胸苷治疗的艾滋病毒感染病人的贫血
中文适应病症参考翻译4:
癌症化疗引起的贫血
药品信息:

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 详细处方信息以本药内容附件PDF文件(201142900193937.pdf)的“原文Priscribing Information”为准
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部分中文阿法依泊汀处方资料(仅供参考)

Epogen - 简介
促红细胞生成素.

Epogen实际上是一种生物制剂而不是药物,因为它最初是人体中自然产生的一种物质——由肾制造的一种荷尔蒙,用于刺激红血球的再生。

Epogen - 介绍
Epogen是1976年芝加哥大学的尤金·哥得沃森(Eugene Goldwasser)发现的,他在若干个研究室中进行了基础研究,认为人体的肾必须能够制造出这样一种物质。哥得沃森和芝加哥大学都没有将这种荷尔蒙申请专利,也没有试图去合成它。而哥伦比亚大学的一项国家卫生研究所资助的研究发明了一种技术用于制造生物制剂,该大学很快将这项技术申请了专利。一家刚设立的小生物技术公司Amgen公司从哥伦比亚大学那里经过授权获得了这项技术,并开始大规模开发商业化合成促红细胞生成素分子的技术。Amgen公司现在已经成为制药业巨人,它每年通过医疗保险向肾衰竭病人销售Epogen能够赚得20亿美元的收入。因此,与紫杉醇(Taxol)的例子一样,公众需要为Epogen两次付费——第一次付费是支持了发现这种药物的研究工作,第二次通过医疗保险为购买药物付费。哥得沃森则没有因为他的基础性研究获得一分钱。

一种分子结构与Epogen亳无二致的药物Procrit由强生公司(Johnson& Johnson)推向了市场,就像它是一种不同的物质一样。这种毫无必要的复制品是Amgen和强生公司之间一笔交易的结果。因为我们知道,贫血症不仅仅出现在肾衰竭的情况下,它还可能出现在其他病状下。特别是,它很可能是癌症治疗中病人衰弱后出现的一种并发症。在Amgen公司从Epogen上获得巨额利润之前,Amgen出于公司资金流动的需求将它授权给了强生公司。强生公司在美国销售Epogen,只能针对除肾衰竭之外的其它病症(主要是癌症),在欧洲则没有限制用途。强生公司付给Amgen数百万美元,并保证在未来支付专利使用费。强生公司的分部Ortho将这种药物取名为Procrit进行推广。Procrit每年在全球的销售额大约是30亿美元,这其中的一小部分付给了Amgen。而Amgen需要将它所有关于Epogen销售收入的1%付给哥伦比亚大学。为了不被强生公司击败,Amgen现在获得了另一种疗效更长的相同药物的批准,名字为Aranesp,它希望能用这种药与Procrit展开竞争,同时又不会违背最初的交易合同。这些药物虽然名字不同,但实际上都是同一种药物。

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药物名称:阿法依泊汀  
药物别名:重组人红细胞生成素,生血素,利血宝,促红素 Recombinant Human Erythropoietin,Epogen,Recormon 
英文名称:Epoetin Alfa 
粉针剂:1500IU、3000IU;倍他依泊汀[基](Epoetin Beta)粉针剂:1000IU、2000IU、5000IU或10000IU。
功用作用:肾病终末期病人的贫血、接受叠氮胸苷治疗的艾滋病毒感染病人的贫血以及癌症化疗引起的贫血。
用法用量:静注或皮下注射,一般开始剂量为50IU~150IU/kg,3次/周。如4周内,网状红细胞计数、细胞压积或血红蛋白水平未见明显增加,可小辐度增加剂量;如在2周内红细胞压积增加超过4%,应减少剂量。以红细胞压积达30%~33%或血红蛋白达100g~120g/L为指标,调节维持量,一般25IU/kg,3次/周。接受长期血透患者,应在每次透析结束时给予本品。腹腔内给药,剂量大于或等于静注剂量。 
注意事项:妊娠C类。治疗期间应监测血压、血管栓塞情况及血清铁量,必要时应补铁。皮下注射倍他依泊汀整体平均反应比阿法依泊汀高出12%(P<0.05)。

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GENERIC NAME: epoetin alfa

BRAND NAME: Epogen, Procrit

DRUG CLASS AND MECHANISM: Epoetin alfa is a man-made, injectable drug for treating anemia. Erythropoietin is a protein that normally is made in the body by the kidney. It causes the bone marrow to produce oxygen-carrying red blood cells. Under normal conditions, when the body senses a decrease in red blood cells or a deficiency in the supply of oxygen, more erythropoietin is produced, and this increases the number of red blood cells. When this natural mechanism is not working, it may become necessary to stimulate the bone marrow to produce red blood cells. The erythropoietin that is used for therapy, called epoetin alfa, is man-made. It is a product of the genetic engineering of ovarian cells of the Chinese hamster and is produced through recombinant DNA technology in bacteria. It does not cure the underlying cause of the anemia, and unless the underlying cause can be reversed, treatment with epoetin alfa must be continued indefinitely. Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. Other colony-stimulating factors include filigrastim (Neupogen) and sargramostim (Leukine). Epogen and Procrit are both epoetin alfa, but they are marketed by two different pharmaceutical companies.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Epoetin alfa is available as a liquid for injection in vials containing from 2,000 to 40,000 units of epoetin alfa.

STORAGE: Epoetin alfa should be stored at 2-8°C (36-46°F). It should not be frozen. Multiple-use vials should be used within 21 days of the first use.

PRESCRIBED FOR: Epoetin alfa is used to treat anemia that is associated with chronic kidney failure in patients who are or will be receiving renal dialysis. It also is used to treat anemia in patients with HIV infection who are receiving zidovudine and in patients with cancer who are receiving chemotherapyand develop anemia. Epoetin alfa may be used to replace transfusions of red blood cells in patients who are anemic and undergoing surgery. Epoetin alfa has not been shown to improve fatigue or quality of life in patients with cancer.

DOSING: Epoetin alfa is administered intravenously or subcutaneously (under the skin) at 50-300 units per kilogram of weight, three times weekly. The dose is tailored to each patient based on targeted hemoglobin levels. Adult patients with cancer receiving chemotherapy may be treated with 40,000 to 60,000 units subcutaneously weekly. Epoetin alfa vials should not be shaken since the drug may be damaged, and bubbles may form that prevent some of the drug from being drawn up into the syringe during injection. Iron stores should be evaluated before therapy and supplemental iron should be administered if needed.

DRUG INTERACTIONS: No clinical studies have been done to demonstrate epoetin alfa drug interactions.

PREGNANCY: There are no studies of epoetin alfa use in pregnant women .

NURSING MOTHERS: It is not known if epoetin alfa is excreted into breast milk.

SIDE EFFECTS: Epoetin alfa is well-tolerated. The most common side effects in patients with kidney failure on dialysis are high blood pressure, headache, joint-pain and clotting at the injection site. Rare cases of stinging at the injection site, skin rash and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration. Allergic reactions, seizures and thrombotic events (e.g., heart attacks, strokes, and pulmonary embolism ) rarely occur.

In HIV-infected patients receiving zidovudine, the most common side effects with epoetin alfa are fever, headache, rash, and nasal or chest congestion. Rare cases of seizures or severe rash have occurred in these patients.

The most common side effects in patients undergoing surgery with anemia are fever, nausea, constipation, skin reactions, vomiting and headaches. Blood clots in veins, referred to as a deep venous thrombosis, also may occur.

Among patients with cancer receiving chemotherapy, the most common side effects of epoetin alfa are fever, diarrhea, tissue swelling, shortness of breath, paresthesia (abnormal sensations like burning or prickling that may occur anywhere in the body), and upper respiratory infection.

Treatment with epoetin alfa may increase the growth of several types of cancer and reduce survival, and, therefore, its use should be restricted to the conditions discussed previously.

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 详细处方信息以本药内容附件PDF文件(201142900193937.pdf)的“原文Priscribing Information”为准
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更新日期: 2011-4-29
附件:




201142900193937.pdf    

 
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