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作者: 一夜清香 时间: 2011-6-10 01:35
标题: 关于“适今可”
 <a href="http://www.accessdata.fda.gov/cms_ia/importalert_165.html#main">http://www.accessdata.fda.gov/cms_ia/importalert_165.html#main</a> 
 
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public). 
 Import Alert # 61-06

ublished Date: 10/02/2009 Type: DWPE Import Alert Name: "Detention Without Physical Examination of Skin Cap Spray, Shampoo And Cream"
 Reason for Alert: Skin Cap, an over the counter (OTC) drug for psoriasis was found by FDA analysis to contain prescription levels of a potent medication, the topical steroid, clobetasol propionate, which can cause serious side effects if used incorrectly or unknowingly. Users would be unaware of the presence of this ingredient, as it is not declared on the labeling for the products. Side effects from long term use of potent topical steroids can include stretch marks, thinning skin, and tiny dilated blood vessels. Use of large amounts, overuse or long term use of potent topical steroids can also cause more serious side effects. 
Skin Cap is an over the counter (OTC) drug sold in various forms (spray, cream, shampoo) that is manufactured by Cheminova International Laboratories, Madrid, Spain, and is available through several U.S. distributors.

soriasis is a chronic skin disorder that can be painful and disabling. It is characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce six times faster than normal skin cells. 
According to Cheminova International, the active ingredient in Skin Cap is zinc pyrithione (ZnP). ZnP is the same active ingredient found in some dandruff shampoos, for which there is no history as an effective psoriasis treatment. Zinc pyrithione (ZnP) has never been found safe and effective for the treatment of psoriasis. ZnP is acceptable as an OTC product for the treatment of seborrheic dermatitis and dandruff only. 
FDA has attempted to inspect the manufacturer and ***contract manufacturer*** to determine compliance with regard to ingredients used in the production of all their products. The firms have not permitted FDA inspections, therefore, we are unable to assure manufacturing operations are in compliance and that the use of clobetasol propionate has not extended to other products manufactured/repacked by these firms.

roducts from these facilities may contain a undeclared prescription strength corticosteroid (clobetasol propionate), although the labeling bears the active ingredient zinc pyrithione.
 Guidance: All products manufactured by Cheminova and all products repacked for Cheminova by Aerosoles Preval may be detained without physical examination based on the refusal of Cheminova Internacionale and Aerosoles Preval to permit FDA inspection of their Madrid, Spain facilities. 
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605. 
When a shipment of product is detained without physical examination, and the importer submits samples to a private laboratory for analysis, if private laboratory analysis DOES NOT INDICATE the presence of clobetasol proprionate, please contact Robert Eshelman of CDER's Division of Labeling and Non Prescription Compliance.

roduct Description: All drug products
 Charge: "This article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]." 
OASIS charge code - UNAPPROVED 
"The products appear to be adulterated as the firm has a history of contamination which may indicate the methods used in, or the facilities or controls used for, its manufacture, do not conform to or are not operated in conformity with current good manufacturing practice [501(a)(2)(B)]." 
OASIS charge code - DRUG GMPS

作者: 一夜清香 时间: 2011-6-10 01:37
 谷歌翻译 
  
 (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public). （注：此进口警报代表了问题该机构目前的指导，FDA的现场工作人员关于制造商（s）和/或产品（s），它不创造或赋予或任何人的任何权利，不能*作的。约束FDA或公众）。 
 Import Alert # 61-06 进口警报＃61-06

ublished Date: 10/02/2009 发表日期：10/02/2009 Type: DWPE 类型：DWPE Import Alert Name:进口警报名称： "Detention Without Physical Examination of Skin Cap Spray, Shampoo And Cream" “没有皮肤第喷雾，洗发水和霜体格检查拘留” 
 Reason for Alert:原因快讯： Skin Cap, an over the counter (OTC) drug for psoriasis was found by FDA analysis to contain prescription levels of a potent medication, the topical steroid, clobetasol propionate, which can cause serious side effects if used incorrectly or unknowingly.皮帽子，在柜台交易（OTC）药物治疗牛皮癣的分析，发现了美国FDA遏制处方用药水平的一种有效的，外用类固醇，丙酸氯倍他索，这可能会导致严重的副作用，如果使用不当或浑然不觉。 Users would be unaware of the presence of this ingredient, as it is not declared on the labeling for the products.用户将这种成分的存在浑然不知，因为它不是在为产品标签声明。 Side effects from long term use of potent topical steroids can include stretch marks, thinning skin, and tiny dilated blood vessels.从长期烈性长期使用外用类固醇的副作用包括妊娠纹，皮肤变薄，扩张血管和微小的。 Use of large amounts, overuse or long term use of potent topical steroids can also cause more serious side effects.大量的使用，过度使用或长期外用类固醇的烈性长期使用也可能导致更严重的副作用。 
Skin Cap is an over the counter (OTC) drug sold in various forms (spray, cream, shampoo) that is manufactured by Cheminova International Laboratories, Madrid, Spain, and is available through several US distributors.皮肤Cap是在柜台（场外交易）在（喷雾，面霜，洗发水），是国际实验室制造的Cheminova，马德里，西班牙，美国多家分销商，通过提供各种形式的销售毒品的。

soriasis is a chronic skin disorder that can be painful and disabling.牛皮癣是一种慢性皮肤疾病，可以是痛苦和丧失能力。 It is characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce six times faster than normal skin cells.它的特点是发炎，红色，鳞片的皮肤时引起的影响细胞繁殖快六倍比正常皮肤细胞病变。 
According to Cheminova International, the active ingredient in Skin Cap is zinc pyrithione (ZnP).据Cheminova国际，第活性成分在皮肤是锌吡硫（ZnP）。 ZnP is the same active ingredient found in some dandruff shampoos, for which there is no history as an effective psoriasis treatment. ZnP是相同的活性成分在一些头皮屑洗发水，其中有一个是没有找到有效的治疗牛皮癣的历史。 Zinc pyrithione (ZnP) has never been found safe and effective for the treatment of psoriasis.吡硫锌（ZnP）从来没有被发现，为安全有效的治疗牛皮癣。 ZnP is acceptable as an OTC product for the treatment of seborrheic dermatitis and dandruff only. ZnP已成为一种对脂溢性皮炎和头皮屑的唯一治疗场外交易的产品可以接受的。 
FDA has attempted to inspect the manufacturer and ***contract manufacturer*** to determine compliance with regard to ingredients used in the production of all their products. FDA已经试图检查制造商和合约制造商*** ***以确定有关在其所有产品的生产用原料的规定。 The firms have not permitted FDA inspections, therefore, we are unable to assure manufacturing operations are in compliance and that the use of clobetasol propionate has not extended to other products manufactured/repacked by these firms.该公司没有允许美国FDA检查，因此，我们无法保证在生产*作符合并指出，丙酸氯倍他索还没有扩展到制造/由这些公司重新包装等产品。

roducts from these facilities may contain a undeclared prescription strength corticosteroid (clobetasol propionate), although the labeling bears the active ingredient zinc pyrithione.这些设施的产品可能含有未申报的处方强度皮质激素（丙酸氯倍他索），虽然标签熊吡硫锌的活性成分。 
 Guidance:指导意见： All products manufactured by Cheminova and all products repacked for Cheminova by Aerosoles Preval may be detained without physical examination based on the refusal of Cheminova Internacionale and Aerosoles Preval to permit FDA inspection of their Madrid, Spain facilities.由Cheminova和Cheminova重新包装的Aerosoles普雷瓦尔所有产品生产的所有产品可能被拘留，不因Cheminova Internacionale基础和Aerosoles普雷瓦尔拒绝允许美国FDA的马德里，西班牙设施检查身体检查。 
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605.如有问题或问题有关的科学，科学政策，样品采集，分析，制备，或分析方法，请与科学部在现场（301）827-7605。 
When a shipment of product is detained without physical examination, and the importer submits samples to a private laboratory for analysis, if private laboratory analysis DOES NOT INDICATE the presence of clobetasol proprionate, please contact Robert Eshelman of CDER's Division of Labeling and Non Prescription Compliance.当产品出货拘留，没有体检，与进口商提交的样本，以一个私人实验室进行分析，如果私人化验分析并不能表明氯倍他索proprionate存在，请联系CDER的的标签和非处方合规部罗伯特埃什尔尔曼。

roduct Description:产品描述： All drug products所有药品 
 Charge:负责人： "This article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an effective new drug application (NDA)[Unapproved New Drug, Section 505(a)]." “这篇文章是受拒予入境根据第801（一）（3），它似乎是在第201条款所指的新的药物（P）的没有一个有效的新药申请（NDA）[未经批准的新药，第505条（a）条]。“ 
OASIS charge code - UNAPPROVED收费代码绿洲 - 未批准 
"The products appear to be adulterated as the firm has a history of contamination which may indicate the methods used in, or the facilities or controls used for, its manufacture, do not conform to or are not operated in conformity with current good manufacturing practice [501(a)(2)(B)]." “这些产品似乎是掺假的企业有污染这可能表明使用的方法或设施或为它的制造使用的控制，历史不符合或不符合现行良好生产*作与实践[ 501（一）（2）（b）条]。“ 
OASIS charge code - DRUG GMPS绿洲收费代码 - 药物绿化总纲图

作者: 一夜清香 时间: 2011-6-10 01:42
 <a href="http://special.fh21.com.cn/skin/changjian/npx/20060316/17315964.shtml">http://special.fh21.com.cn/skin/changjian/npx/20060316/17315964.shtml</a>
 美国食品与药品署正在调查Blue Cap药
 　　美国食品与药品署(FDA)下令一家设在迈阿密的公司Catalysis停止进口Blue Cap药(包括喷剂,软膏和洗液),直到对该药是否含有不明成份的强激素的调查水落石出为止。
　　FDA在2000年7月11日给Catalysis公司的正式函中称,Blue Cap喷剂和软膏中被掺入了不良成分,并且没有获得过在美国作为OTC药物销售的批准,因为含有不明的类固醇激素。其喷剂和软膏都在实验室中已经检出了倍它米松,一种处方型外用强激素。FDA称检出的激素成分是<a>\\\"17-propionate</a> 21-butyrate\\-:special:1:-倍它米松,与今年年初加拿大卫生官员从另一种药品Skin-Cap喷剂中检出的一样。Skin-Cap曾因此被驱逐出了加拿大市场。错用强激素会导致致严重的副作用,并且突然停药会引起其它皮肤病,包括银屑病的恶化。在调查未结束的期间,NPF建议大家不要构买Blue Cap,其它正在使用Blue Cap的患者应与他们的医生商量治疗停药办法。除了在药中加入不明成分的物质,Blue Cap的厂商还不恰当地对该药进行广告宣传。他们称药中包含的活性锌物质。在OTC药物中,这种成分只被批准用来治疗头皮屑和脂溢性皮炎,对银屑病没有效果。

作者: 兖州刘大夫 时间: 2011-6-10 08:12
一度推崇的药，又被推翻了。

作者: lihud81 时间: 2011-6-13 01:49
上面不是说"突然停药会引起其它皮肤病,包括银屑病的恶化" 吗? 那该怎么做?又不能一下子停掉.

作者: 大巧不工 时间: 2011-6-14 22:31
去医院请教怎样停用激素药，按医生的指导进行。

作者: 牛皮癣人 时间: 2011-6-28 08:22
被这药坑得很惨 还是协和的教授专家开的

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