【medical-news】欧洲医药评价署推荐对Ketek限制使用并对其加强警告

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European Medicines Agency Recommends Restricted Use And Strengthened Warnings For Ketek
Main Category: Respiratory / Asthma News
Article Date: 30 Mar 2007 - 11:00 PDT

The European Medicines Agency (EMEA) has recommended restrictions on the use of Ketek (telithromycin) in three of its four approed indications. For the treatment of bronchitis, sinusitis and tonsillitis/pharyngitis, Ketek should only be used for infections caused by bacterial strains that are suspected or proen to be resistant to or cannot be treated with macrolide or beta-lactam antibiotics.

No such restrictions are recommended for the remaining indication, the treatment of community-acquired pneumonia.

The Agency's Committee for Medicinal Products for Human Use (CHMP) also recommended the contraindication of the use of Ketek in patients with myasthenia grais and strengthened warnings on transient loss of consciousness and effects on ision.

The CHMP has been carrying out a comprehensie reiew of the safety and effectieness of Ketek since January 2006, following reports of seere lier injuries in patients taking telithromycin. As part of this reiew seeral updates relating to the safety of Ketek were made to the Product Information during 2006. These included strengthening the warnings on serious lier reactions and contraindicating the use of the medicine in patients with a preious history of serious lier disorders. In January 2007, the Committee requested updated information from the marketing authorisation holder for Ketek, to allow a comprehensie assessment of the benefits and risks in each of the medicine's approed indications.

Finalising the reiew at its 19-22 March 2007 meeting, the Committee concluded that the effectieness of Ketek has been demonstrated in the approed indications. Howeer, its use is associated with a greater risk of certain side effects, some of which may be serious. These include a worsening of myasthenia grais (which can be life-threatening), transient loss of consciousness, and temporary isual disturbances. Seere problems with the lier hae been reported rarely, but do not occur more frequently than with other releant antibiotic medicines.

The Committee concluded that the benefits of Ketek continue to outweigh its risks in the treatment for bronchitis, sinusitis and tonsillitis/pharyngitis, if used in accordance with the updated product information.

Prescribers are adised to consider the official guidance on the appropriate use of the antibiotics and the local prealence of resistance.

1. More information about the recommendations for Ketek is aailable in a separate question and answer document: Link here (pdf).

2. The European Commission is currently conducting the procedures laid down in Community legislation with a iew to issuing a decision to update the product information for Ketek.

3. The updated product information, for which the Commission decision is pending, is aailable here (pdf).

4. In the European Union, telithromycin is authorised as Ketek and Leiax. The marketing authorisation holder is Aentis Pharma S.A. It is marketed only as Ketek. The European public assessment report for Ketek is published on the EMEA website and can be found here.

5. Ketek is marketed in the European Union/European Economic Area in Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Sloenia, Spain, Sweden and the United Kingdom.

6. The EMEA's statement on the safety of Ketek from January 2006 can be found here (pdf).

www.emea.europa.eu

European Medicines Agency Recommends Restricted Use And Strengthened Warnings For Ketek
欧洲医药评价署推荐对Ketek限制使用并对其加强警告

Main Category: Respiratory / Asthma News
主要类别：呼吸/哮喘新闻

Article Date: 30 Mar 2007 - 11:00 PDT
文章出版日期：2007年3月30日11：00

The European Medicines Agency (EMEA) has recommended restrictions on the use of Ketek (telithromycin) in three of its four approed indications. For the treatment of bronchitis, sinusitis and tonsillitis/pharyngitis, Ketek should only be used for infections caused by bacterial strains that are suspected or proen to be resistant to or cannot be treated with macrolide or beta-lactam antibiotics.
欧洲医药评价署（European Medicines Ealuation Agency，EMEA）已经推荐在Ketek已被批准的四项用药指征中的三项内限制使用Ketek（泰利霉素）。对于治疗支气管炎、鼻窦炎和扁桃体炎/咽炎，Ketek将只能用于由那些可疑或者已经证实对大环内酯或β-内酰胺类抗生素耐药或不能用大环内酯或β-内酰胺类抗生素治疗的细菌系列引起的感染。

No such restrictions are recommended for the remaining indication, the treatment of community-acquired pneumonia.
对余下的适应症没有推荐这样的限制，例如：社区获得性肺炎的治疗。

The Agency's Committee for Medicinal Products for Human Use (CHMP) also recommended the contraindication of the use of Ketek in patients with myasthenia grais and strengthened warnings on transient loss of consciousness and effects on ision.
这个人类使用药物产品评价署的委员会（The Agency's Committee for Medicinal Products for Human Use ，CHMP）还推荐了Ketek在重症肌无力患者中的使用禁忌症并加强警告暂时性意识丧失和视觉影响。
The CHMP has been carrying out a comprehensie reiew of the safety and effectieness of Ketek since January 2006, following reports of seere lier injuries in patients taking telithromycin. As part of this reiew seeral updates relating to the safety of Ketek were made to the Product Information during 2006. These included strengthening the warnings on serious lier reactions and contraindicating the use of the medicine in patients with a preious history of serious lier disorders. In January 2007, the Committee requested updated information from the marketing authorisation holder for Ketek, to allow a comprehensie assessment of the benefits and risks in each of the medicine's approed indications.
这个人类使用药物产品评价署的委员会已经对Ketek自二零零六年一月以来的安全行和有效性进行了广泛的回顾，下述追踪报道服用泰利霉素的患者出现严重肝损害。回顾中的部分综述在二零零六年期间对Ketek的安全行和其产品信息做了几次更新。这些包括加强注意严重肝脏反应并对以前有严重肝脏功能障碍的患者禁止使用该药物。在二零零七年一月，该委员会请求更新Ketek市场授权拥有者更新信息以便综合评估该药物每一项已经被批准的用药指征的有利性和风险度。

Finalising the reiew at its 19-22 March 2007 meeting, the Committee concluded that the effectieness of Ketek has been demonstrated in the approed indications. Howeer, its use is associated with a greater risk of certain side effects, some of which may be serious. These include a worsening of myasthenia grais (which can be life-threatening), transient loss of consciousness, and temporary isual disturbances. Seere problems with the lier hae been reported rarely, but do not occur more frequently than with other releant antibiotic medicines.
该委员会在二零零七年三月十九日至二十二日的会议上最终回顾得出结论：Ketek已被证实在其已被批准的用药指征中是有效的。然而，Ketek使用相关的某些副作用带来了极大的风险，有些甚至非常严重。
这些副作用包括使重症肌无力患者病情恶化、暂时性意识丧失和一过性视觉障碍。对肝脏的严重副反应少有报道，但是其发生率并不比其他有关抗生素药物更加频繁。
The Committee concluded that the benefits of Ketek continue to outweigh its risks in the treatment for bronchitis, sinusitis and tonsillitis/pharyngitis, if used in accordance with the updated product information.
该委员会推断如果按照最近更新的药物产品信息使用Ketek，那么该药物对支气管炎、鼻窦炎和扁桃体炎/咽炎治疗的有效性仍将超过其风险性。
Prescribers are adised to consider the official guidance on the appropriate use of the antibiotics and the local prealence of resistance.
建议处方医师考虑官方对合理使用抗生素和地区流行性耐药性的指南。
1. More information about the recommendations for Ketek is aailable in a separate question and answer document: Link here (pdf).
1.  有关对Ketek使用的推荐意见的更多信息以一独立的问答文件提供，其链接为这里(pdf)。

2. The European Commission is currently conducting the procedures laid down in Community legislation with a iew to issuing a decision to update the product information for Ketek.
2.欧洲委员会目前正在执行一项程序旨在制定公共立法来监督发布Ketek产品信息更新的决定。

3. The updated product information, for which the Commission decision is pending, is aailable here (pdf).
该委员会产品信息更新的决定尚待定，这里可见（pdf）。

4. In the European Union, telithromycin is authorised as Ketek and Leiax. The marketing authorisation holder is Aentis Pharma S.A. It is marketed only as Ketek. The European public assessment report for Ketek is published on the EMEA website and can be found here.
4.在欧共体，Ketek和Leiax是已被授权的泰利霉素。该药物的市场授权拥有者是Aentis Pharma S.A。该公司仅将Ketek推向市场。欧洲公共评估Ketek的报道出版刊登在欧洲医药评价署的网站上，并在此也可以找到。（Here）

5. Ketek is marketed in the European Union/European Economic Area in Austria, Belgium, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Sloenia, Spain, Sweden and the United Kingdom.
5. Ketek被推向欧共体/在奥地利、比利时、塞浦路斯、芬兰、法国、德国、希腊、爱尔兰、意大利、卢森堡公国、马耳他、挪威、葡萄牙、斯洛文尼亚、西班牙、瑞典和英国等欧洲经济特区的市场。

6. The EMEA's statement on the safety of Ketek from January 2006 can be found here (pdf).
6.欧洲医药评价署对Ketek二零零六年以来的安全性声明可以在这里找到。（here）

www.emea.europa.eu
网站链接地址为www.emea.europa.eu

新闻来源：http://www.medicalnewstoday.com/medicalnews.php?newsid=66667&nfid=crss

编译投稿：
（1007字）

欧洲医药评价署推荐对Ketek限制使用并对其加强警告

主要类别：呼吸/哮喘新闻
文章出版日期：2007年3月30日11：00

欧洲医药评价署（European Medicines Ealuation Agency，EMEA）已经推荐：在Ketek已被批准的四项用药指征中的三项内限制使用Ketek（泰利霉素）。对于治疗支气管炎、鼻窦炎和扁桃体炎/咽炎等疾病，Ketek将只能用于由那些可疑或者已经证实对大环内酯或β-内酰胺类抗生素耐药或不能用大环内酯或β-内酰胺类抗生素治疗的细菌系列引起的感染。
但对余下的适应症没有推荐这样的限制，例如：社区获得性肺炎的治疗。
这个人类使用药物产品评价署的委员会（The Agency's Committee for Medicinal Products for Human Use ，CHMP）还推荐了Ketek在重症肌无力患者中的使用禁忌症并加强警告暂时性意识丧失和一过性视觉影响。
这个人类使用药物产品评价署的委员会已经对Ketek自二零零六年一月以来的安全行和有效性进行了广泛的回顾，下述追踪报道服用泰利霉素的患者出现严重肝损害。回顾中的部分综述在二零零六年期间对Ketek的安全行和其产品信息做了几次更新。这些包括加强注意严重肝脏反应并对以前有严重肝脏功能障碍的患者禁止使用该药物。在二零零七年一月，该委员会请求更新Ketek市场授权拥有者更新信息以便综合评估该药物每一项已经被批准的用药指征的有利性和风险度。
该委员会在二零零七年三月十九日至二十二日的会议上最终回顾得出结论：Ketek已被证实在其已被批准的用药指征中是有效的。然而，Ketek使用相关的某些副作用带来了极大的风险，有些甚至非常严重。
这些副作用包括使重症肌无力患者病情恶化、暂时性意识丧失和一过性视觉障碍。对肝脏的严重副反应少有报道，但是其发生率并不比其他有关抗生素药物更加频繁。
该委员会推断如果按照最近更新的药物产品信息使用Ketek，那么该药物对支气管炎、鼻窦炎和扁桃体炎/咽炎治疗的有效性仍将超过其风险性。
1.  建议处方医师考虑官方对合理使用抗生素和地区流行性耐药性的指南。
1.有关对Ketek使用的推荐意见的更多信息以一独立的问答文件提供，其链接为这里(pdf)。
2.欧洲委员会目前正在执行一项程序旨在制定公共立法来监督发布Ketek产品信息更新的决定。
3.该委员会产品信息更新的决定尚待定，这里可见（pdf）。
4.在欧共体，Ketek和Leiax是已被授权的泰利霉素。该药物的市场授权拥有者是Aentis Pharma S.A。该公司仅将Ketek推向市场。欧洲公共评估Ketek的报道出版刊登在欧洲医药评价署的网站上，并在此也可以找到。（Here）
5. Ketek被推向欧共体/在奥地利、比利时、塞浦路斯、芬兰、法国、德国、希腊、爱尔兰、意大利、卢森堡公国、马耳他、挪威、葡萄牙、斯洛文尼亚、西班牙、瑞典和英国等欧洲经济特区的市场。
6.欧洲医药评价署对Ketek二零零六年以来的安全性声明可以在这里找到。（here）

网站链接地址为www.emea.europa.eu