加载中…FDA 有关肝素钠标准的警示 2009-10-01
(2009-10-17 21:47:39)
标签：
美国fda肝素钠警告健康 |
分类： 医药科技 |
有关肝素钠原料生产企业和制剂使用人员注意 (新的USP标准2009-10-1执行, 对用药的影响)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184674.htm
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
FDA警告: 新的肝素钠USP标准品可能导致效价结果偏低
Adjustments may be needed to achieve desired anticoagulant effect in some patients
为达到对某些病人的治疗效果可能需要进行调整
New Heparin to Ship Starting October 8
新的肝素钠在10-8开始发送
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.
FDA告诫健康专家们这一生产方面的变化, 以期望减少用量来达到同先前一致的溶栓效果.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.
为防止潜在污染, USP接受了新的生产控制手段. 这些改变包括对于标准品效价单位的调整.
Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
在美国的生产厂家标识的效价将按照新的USP标准执行. 这些新的变化包括USP肝素钠效价单位同WHO的国际标准品单位保持一致, WHO的标准品在欧洲已经使用多年. 修订的肝素钠USP标准品的效价会比之前的USP标准品的低10%左右.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
单位效价主要是确定药品对于人体作用的活性, 对于肝素钠而言是其本身溶栓性的能力测试.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug uation and Research.
在美国市场上的肝素钠产品在10月1日开始使用新的USP标准进行控制. 但FDA要求他们在10月8日之后才可以发货, 主要是要给予医院机构有时间了解和调整他们的质量药物方案和给药操作.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
尽管FDA批准的标签不进行改动, 包括推荐剂量, 但还是有必要让健康专家在使用药品时了解新旧产品之间的效价区别.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
在美国的四家厂商, APP_最大的生产厂家; Hospira; BAXTER, 和B. Braun, 都被FDA 要求帮助药学家和健康专家确定新的产品同之前产品的不同.
Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
在美国的处方和OTC药品必须符合USP的公共标准, 如果有标准存在. 修订的肝素钠产品的标准收载在USP个论中.
USP Heparin Information
The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and ot her adverse events in the United States. The monograph was changed to include a test for the contaminant.
个论的修改是针对2007-2008出现的因中国厂商生产过程污染的事故进行的. 标准修改包括针对污染物的测试.
For more information 更多FDA信息如下
FDA Alert to Health Care Professionals
http://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInfo
USP Heparin Information
http://www.usp.org/hottopics/heparin.html
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