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KERYDINTM (tavaborole)局部溶液,5%
2014-12-29 11:55:49 来源: 作者: 【 】 浏览:427次 评论:0
KERYDINTM (tavaborole)局部溶液,5% 
美国初始批准:2014 
适应证和用途
KERYDIN是一种oxaborole抗真菌药适用为由于红色毛癣菌[Trichophyton rubrum]或须癣毛癣菌[Trichophyton mentagrophytes]趾甲甲真菌病的局部治疗。 (1) 
剂量和给药方法
⑴应用KERYDIN至受影响的趾甲每天1次共48周. (2) 
⑵KERYDIN应被应用至正在治疗的整个趾甲表面和每个趾甲的尖下。(2) 
⑶只为局部使用。 (2) 
⑷不为口,眼,或阴道内使用。(2) 
剂型和规格
溶液,5%。 (3) 
 

Kerydin (tavaborole) Topical Solution
Company:  Anacor Pharmaceuticals, Inc.
Application No.:  204427
Approval Date: 7/07/2014

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KERYDIN Rx
Generic Name and Formulations:
Tavaborole 5%; topical soln; contains alcohol.

Company:
Sandoz
Indications for KERYDIN:
Treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Adult:
Apply to affected toenail(s) once daily for 48 weeks. Ensure complete application to entire toenail surface and under the tip of each toenail being treated.

Children:
Not established.

Pharmacological Class:
Oxaborole antifungal.

Warnings/Precautions:
Not for oral, ophthalmic, or intravaginal use. Product is flammable. Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions:
Ingrown toenail, application site reactions (eg, exfoliation, erythema, dermatitis).

How Supplied:
Bottle (10mL)—1 (w. dropper)


 
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