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苯甲醇洗液|Ulesfia(benzyl alcohol)

2011-04-26 09:30:24  作者:新特药房  来源:中国新特药网天津分站  浏览次数:239  文字大小:【】【】【
简介: 制造商: Sciele制药公司 药理分类: Pediculicide 活性成分(补): 苯甲醇5%;洗剂。 指示(补): 头虱。 药理作用: 苯甲醇是一种非毒性剂,发挥他们的呼吸气孔的关闭它通过抑制虱子pediculi ...
关键字:苯甲醇洗液

制造商:
Sciele制药公司

药理分类:
Pediculicide

活性成分(补):
苯甲醇5%;洗剂。
指示(补):
头虱。

药理作用:
苯甲醇是一种非毒性剂,发挥他们的呼吸气孔的关闭它通过抑制虱子pediculicidal效果,使车辆阻挠气孔,从而导致窒息死亡的虱子。它没有杀卵活性。

临床试验:
两个多中心,随机,双盲,车辆控制的研究是在6个月的628例年龄和活跃老年人进行头虱建立的安全性和Ulesfia疗效。对于疗效评估,从每个家庭最年轻的受试者参加了队列和随机治疗原发性肝癌的一个星期分开的两个治疗要么Ulesfia或车辆。其他被感染的家庭成员参加了二级处理队列和收到的最年轻的在他们的家庭受到同样的待遇。二级处理队列是只计算为安全参数。

对Ulesfia疗效评定为题材的14天治疗后,最终活虱免费的比例。本学科与活虱子在任何时候第一次治疗后,被认为是治疗失败。在一级处理的研究1和2,76.2%和75%的患者与Ulesfia各县,分别比活虱子4.8%和26.2例,分别,谁收到车辆%免费。

法律分类:
接收

成人和儿童:
<六个月:不推荐。 ≥六个月:取足够量完全饱和的头发干燥头皮和头发。短发:4八盎司;中等长度:824盎司,长头发:2448盎司10分钟后,用清水彻底冲洗。重复后7天。申请后要洗手。

警告/注意事项:
避免接触眼睛。新生儿。妊娠(Cat.B)。哺乳的母亲。

不良反应(补):
对眼有刺激性,应用部位反应(如过敏,麻醉,感觉减退),接触性皮炎,瘙痒。

如何提供:
乳液安士

最后更新:
2009年8月27日

Sciele公司近日表示5%的苯甲醇洗液(benzyl alcohol lotion)已正式在美国上市用于治疗头虱病,商品名为Ulesfia,Ulesfia是首个通过使头虱窒息而杀死头虱的处方药物,没有潜在的神经毒性方面的副作用。Ulesfia可用于6个月在以上人群。

每天全球有600-1200万3-12岁的儿童感染头虱,通过堵塞头虱的呼吸孔而头虱窒息而亡。使公司表示,很高兴能在头虱高发期在美国上市该药。试验表明使用5%的苯甲醇洗液每周两次,每次10分钟可使75%的患者免除头虱。

ULESFIA

Manufacturer:

Sciele Pharma, Inc.

Pharmacological Class:

Pediculicide

Active Ingredient(s):

Benzyl alcohol 5%; lotion.

Indication(s):

Head lice.

Pharmacology:

Benzyl alcohol is a non-neurotoxic agent that exerts its pediculicidal effect by inhibiting lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles, and thus causing asphyxiation and death of the lice. It does not have ovicidal activity.

Clinical Trials:

Two multicenter, randomized, double-blind, vehicle-controlled studies were conducted in 628 patients 6 months of age and older with active head lice infestation to establish the safety and efficacy of Ulesfia. For the evaluation of efficacy, the youngest subject from each household was enrolled in the Primary Treatment Cohort and randomized to either Ulesfia or vehicle for two treatments separated by one week. Other infested household members were enrolled in the Secondary Treatment Cohort and received the same treatment as the youngest subject in their household. The Secondary Treatment Cohort was evaluated only for safety parameters.

The efficacy of Ulesfia was assessed as the proportion of subjects free of live lice 14 days after the final treatment. Subjects with live lice present at any time after the first treatment were considered to be treatment failures. In the Primary Treatment Cohorts of Studies 1 and 2, 76.2% and 75% of patients treated with Ulesfia, respectively, were free of live lice compared to 4.8% and 26.2% of patients, respectively, who received vehicle.

Legal Classification:

Rx

Adults & Children:

<6months: not recommended. ≥6months: Apply sufficient amount to dry hair to completely saturate scalp and hair. Short hair: 4–8oz; Medium length: 8–24oz; Long hair: 24–48oz. After 10 minutes, thoroughly rinse off with water. Repeat after 7 days. Wash hands after application.

Warnings/Precautions:

Avoid contact with eyes. Neonates. Pregnancy (Cat.B). Nursing mothers.

Adverse Reaction(s):

Ocular irritation, application site reactions (eg, irritation, anesthesia, hypoesthesia), contact dermatitis, pruritus.

How Supplied:

Lotion—8oz

责任编辑:admin


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