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  药店国别: 以色列药房
产地国家: 以色列
所属类别: 皮肤科药物->治疗银屑病药物
处方药:处方药
包装规格: 15克/管
计价单位:
  点击放大  
生产厂家中文参考译名:
Schering-Plough Lab (Israel).
生产厂家英文名:
Schering-Plough Lab (Israel).
该药品相关信息网址1:
www.taclonex.com/
该药品相关信息网址2:
www.drugs.com/taclonex.html
该药品相关信息网址3:
www.rxlist.com/taclonex-drug.htm
原产地英文商品名:
Triderm Cream 15G/TUBE
原产地英文药品名:
BETAMETHASONE DIPROPIONATE/CALCIPOTRIENE HYDRATE
中文参考商品译名:
Triderm软膏 15克/管
中文参考药品译名:
二丙酸倍他米松/水合钙泊三醇
原产地国家批准上市年份:
2006/01/09
英文适应病症1:
Psoriasis
临床试验期:
完成
中文适应病症参考翻译1:
银屑病
药品信息:

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 详细处方信息以本药内容附件PDF文件(20126718395315.PDF)的“原文Priscribing Information”为准
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 部分中文Taclonex处方资料(仅供参考)

银屑病Taclonex上市
    2006年1月10日Warner Chilcott公司和LEO制药公司宣布FDA批准了Taclonex的新药上市申请。  
    该项申请是在2005年3月提交的。Taclonex为局部用膏剂,含有0.005%钙泊三醇(calcipotriene)和0.064%二丙酸倍他米松,用于治疗成人寻常性银屑病。Taclonex在除美国以外的其他国家的商品名为Dovobet或Daivobet。  
    Warner Chilcott公司在1月1日从百时美施贵宝公司收购了Dovonex (0.005%钙泊三醇)美国销售权。Dovonex是美国使用最广泛的非甾体局部用银屑病治疗药物。Taclonex中除了钙泊三醇外还包含了糖皮质激素二丙酸倍他米松。Warner Chilcott公司希望在2006年上半年可以上市Taclonex。

药品名称
商品名称:Taclonex
通用名称:钙泊三醇倍他米松软膏
英文名称:Calcipotriol Betamethasone Ointment

适应症
主要用于适合局部治疗的稳定性斑块状银屑病。

用法用量
每天用于患病皮肤一次。推荐4周为一个疗程。一个疗程结束后,在医学监测下可重复进行此疗程。每天最大剂量不超过15g,每周最大剂量不超过100g,治疗面积不应超过体面积的30%。
任何疑问,请遵医嘱!

不良反应
迄今为止,超过2500名患者参加了本品临床试验,结果显示大约10%的患者出现轻度的不良反应。根据临床试验及售后适用结果提示药物常见的不良反应(发生率>1/100和<1/10)为瘙痒症、皮疹、皮肤烧灼感。少见的不良反应(发生率>1/1000和<1/100)为皮肤疼痛或者刺激感,皮炎、红斑、银屑病加重,毛囊炎,应用部位色素沉着。罕见的不良反应(>1/10000和<1/1000)为脓疱型银屑病。

注意事项
(1)下列情况患者禁用:不能使用于钙代谢失调的病患,禁用于点状、脱落性脓疱型之干癣,也禁用于肾功能不全或严重肝疾病患者。
(2)本品不可使用于脸部,使用后应将手部清洗干净以避免接触脸部。
(3)本品尚未有使用于头皮、并用其他局部或全身性银屑病(牛皮癣)或光疗法的经验。使用治疗期间,医师可建议病人避免过度暴露于日光下。
(4)同药袋放置于室温之阴凉干燥处避光储存,请勿放在孩童可以取得之处。
(5)使用期间如需服用其它药品,请主动告诉您的医师或药师。

禁忌
对药物的活性成份及任一辅料过敏者。

怀孕及哺乳期妇女用药
孕妇:尚无足够的数据支持本品可以用于孕妇。动物试验提示糖皮质激素可致生殖毒性。但一些流行病学研究结果并没有显示怀孕期间使用皮质类固醇的妇女产出先天性畸形婴儿。孕妇使用本品的安全性尚不明确。因而,在孕期妇女,只有当利益大于弊端时才可使用本品。
哺乳期妇女:倍他米松可以进入乳汁,但在治疗剂量内对婴儿没有不良影响,数据显示钙泊三醇不在乳汁中分泌。给哺乳期妇女使用本品应该注意,在哺乳期,患者不能将本品涂敷在乳房上。

儿童用药
儿童及18岁以下的青少年不能使用本品。

老年用药
尚不明确。临床试验中有部分老年患者参加。
 
药物相互作用
应避免与其他的甾体类药物同时使用。

规格
卡泊三醇&倍他米松软膏0.005%/0.064% X 60grams

INDICATIONS AND USAGE
Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment is approved for use on the skin to treat psoriasis vulgaris (plaque psoriasis) in adults 18 years of age and older and should be applied to affected areas once daily for up to 4 weeks. Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension is approved to treat moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older and should be applied to affected areas on the scalp once a day for 2 weeks or until cleared. If the affected area is not cleared, Taclonex Scalp® Topical Suspension may be continued for up to 8 weeks. Do not exceed the recommended weekly dose of 100 grams for either product. Neither product is recommended for use on children.

IMPORTANT SAFETY INFORMATION ABOUT TACLONEX® OINTMENT AND TACLONEX SCALP® TOPICAL SUSPENSION
FOR TOPICAL USE ONLY. Do not use Taclonex® Ointment or Taclonex Scalp® Topical Suspension on your face, under your arms, or on your groin. Do not get either product in your eyes, mouth, or vaginal area. Do not swallow Taclonex® Ointment or Taclonex Scalp® Topical Suspension.

You should not use Taclonex® Ointment or Taclonex Scalp® Topical Suspension if you are allergic to any of their ingredients, have thin skin (atrophy) at the treatment site, have known or suspected calcium metabolism disorders (too much or too little calcium in your blood or urine), have erythrodermic, exfoliative, or pustular psoriasis, or have severe kidney or severe liver disease. Avoid excessive exposure to either natural or artificial sunlight if you apply Taclonex® Ointment to exposed portions of your body or use Taclonex Scalp® Topical Suspension. Tell your doctor if you have a skin infection, are getting phototherapy treatments for your psoriasis, are pregnant, or planning to become pregnant, or are breastfeeding. Also tell your doctor about other medicines you are taking, especially other corticosteroids, products containing calcipotriene, or medicines for your psoriasis.

Taclonex® Ointment and Taclonex Scalp® Topical Suspension may cause serious side effects if you use too much, use it for too long, or use it with other medicines that contain corticosteroids or calcipotriene. Taclonex® Ointment and Taclonex Scalp® Topical Suspension contain the same medicine to treat psoriasis vulgaris. If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medicines. Taclonex® Ointment and Taclonex Scalp® Topical Suspension can pass through your skin. Serious side effects may include too much calcium in your blood or urine or adrenal gland problems. Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex® Ointment or Taclonex Scalp® Topical Suspension.

The most common side effects of Taclonex® Ointment are itching and rash. Other less common side effects with Taclonex® Ointment include redness of the skin, inflamed hair pores (folliculitis), psoriasis, skin irritation, skin burning, change of skin color (at the site of application), rash with pus-filled papules, thinning of the skin, and swollen fine blood vessels (this makes your skin appear red at the site of application).

The most common side effects of Taclonex Scalp® Topical Suspension are inflamed hair pores (folliculitis) and burning sensation of the skin. Other side effects include itching, worsening of psoriasis, redness of the skin, and skin pain or irritation.

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 详细处方信息以本药内容附件PDF文件(20126718395315.PDF)的“原文Priscribing Information”为准
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更新日期: 2013-04-21
附件:






20126718395315.PDF    

 
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