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EMA 8月2日关于被召回缬沙坦药品审核更新 (翻译稿)
时间:2018-8-4 来源:

Update on review of recalled valsartan medicines

被召回缬沙坦药品审核更新


 

Preliminary assessment of possible risk to patients 

对患者潜在风险的初步评估



EMA is conducting a review of the possible health effects in patients who may have taken valsartan medicines containing N-nitrosodimethylamine (NDMA) an impurity found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.

EMA正对可能服用了含有亚硝基二亚胺NDMA(在浙江意甲比赛直播manbetx所生产的活性成分中发现的一种杂质)的缬沙坦药品的患者进行可能的健康影响的审查。

 

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal tests. It is present in some foods and water supplies but is not expected to cause harm when ingested in very low levels.

基于动物实验,NDMA被归类为可能的人体致癌物质 (可能会引发癌症的物质)。该物质在一些食品和水中都含有,但在摄入很低的量时不应会造成伤害。

 

Following a preliminary evaluation, EMA estimates that there could be one extra case of cancer for every 5,000 patients taking the affected medicines at the highest valsartan dose (320 mg) every day for 7 years. This is based on average levels of this impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals (60 parts per million).

经过初步评估之后,EMA估计以每天最高剂量(320mg)连续7年服用受影响药品, 则每5000名患者中可能会增加一例的癌症案例。 这是基于该杂质在浙江意甲比赛直播manbetx所生产的活性成分中检出的平均水平(百万分之六十)做出的估计。

 

The possible cancer risk has been extrapolated from animal studies and should be considered in the context of the lifetime risk of cancer in the EU (1 in 3) and NDMA exposure from other sources.

可能的致癌风险是从动物研究数据推断而得的,并应结合在欧洲人一生中的患癌风险(每三人中有一人)和其他NDMA的来源而进行考量。

 

This preliminary estimate is based on the assumption that the NDMA present in the active substance is carried over in the final product in the same amount.

本初步预测是基于活性成分中的NDMA将毫无损耗地被转移至制剂产品中的假设。

 

Companies that had used the active substance from Zhejiang Huahai in their valsartan medicines are required to test samples they hold to determine the actual NDMA levels in the final products. Additional checks are being carried out by EU official control laboratories. Once data from all these tests are available, EMA will be able to provide more information on the risk that the impurity may have posed for patients in the EU.

已在其缬沙坦药品中使用了华海活性成分的公司被要求检测其留样以确定最终制剂中NDMA的实际水平。EU的官方实验室也在进行额外的检查。一旦得到所有这些检测数据,EMA将可以提供更多关于该杂质对EU患者可能带来的风险方面的更多信息。

 

It is important to note that there is no immediate risk to patients. Patients taking the affected medicines who have not yet switched to an alternative should not stop taking their medicines without consulting their doctor or pharmacist.

很重要的是对患者并没有立即的风险。正在服用受影响药品且未换成其它替代药品的患者在咨询其医生或药师之前不应停止服药。

 

Valsartan medicines are used for patients with serious or potentially serious conditions of the circulatory system (high blood pressure, a recent heart attack and heart failure). It is therefore not advisable to go without treatment if a treatment has been prescribed.

缬沙坦药品被用于循环系统有严重问题或有潜在严重问题的患者(高血压,最近有过心脏病发作和心力衰竭)。因此, 不建议在治疗方案已经开出的情况下终止治疗。

 

All valsartan medicines containing the active substance fromZhejiang Huahai Pharmaceuticals have been recalled from pharmacies in the EU but several other valsartan medicines not affected by the impurity are available. Patients who want more information about their treatments should contact their doctor or pharmacist. Further information is provided by national medicines authorities.

所有含有浙江华海缬沙坦活性成分的药品均已从EU药房召回,但几个未受该杂质影响的其它缬沙坦药品仍在销售。希望获得更多关于其治疗信息的患者应联系其医生或药师。国家药品监管机构提供更多信息。

 

NDMA was an unexpected impurity believed to have formed as a side product after Zhejiang Huahai introduced changes to its manufacturing process in 2012. No other active substances produced by the company are affected.

NDMA是一种非预期杂质,推测是在浙江华海于2012年对其生产工艺进行变更之后形成的副产物。该公司所生产的其它活性成分不受影响。

 

EMA is working closely with international partners and will provide further information on its website as the review progresses.

EMA正在与国际合作方紧密合作,将在其官网提供进一步的审核进展信息。

 

 

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