英文药名:Dovobet Ointment(Calcipotriol Hydrate)
中文药名:卡泊三醇/克霉唑倍他米松软膏
日文药名:ドボベット軟膏
生产厂家:利奥制药 给药说明 商品名称:Dovobet Ointment 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 包装规格 乳膏:15g/支 30g/支
Compounding external preparation of steroid and active form of vitamin D3 Japan's first Is a combination drug containing betamethasone dipropionate acid ester adrenal cortex hormone (hereinafter, steroid) is Calcipotriol hydrate is an active vitamin D3 derivative, Dobobetto ® ointment, LEO Pharma A / S (Denmark) at it has been developed. Both ingredients of Dobobetto ® ointment has been applied clinically in Japan as psoriasis vulgaris treatment agent. It is a blend external preparation of betamethasone dipropionate acid ester adrenocorticotropic hormone (hereinafter "steroid") is the calcipotriol hydrate is an active form of vitamin D3, 8 last year, Dobobetto (R) ointment welfare Leo Pharma It is the thing you have been making approval to the Department of Labor. A skin disease of chronic and intractable, there are reports of 1-2 per 1,000 prevalence in Japan psoriasis. Topical therapies such as steroids and active vitamin D3, phototherapy, oral therapy is also, there is the treatment of psoriasis, treatment with biologics are now provided in severe cases in recent years. However, treatment with topical agents such as steroids and active vitamin D3 has been performed mainly for mild to moderate, which account for the majority of patients, not only a single agent, both drugs combined, mixed preparation has been . The topical agent used in the treatment of psoriasis, ease of administration as well as the usefulness of higher was required. This agent, at a blending external preparation of steroid and active form of vitamin D3 in Japan's first quickly improved the skin symptoms of psoriasis in the application of once a day, efficacy and safety have been confirmed in domestic clinical trials, This time, we get the approval as Efficacy psoriasis vulgaris. Since for the external preparation of the existing use in psoriasis vulgaris treatment, it is possible to provide ease of administration and high utility, as it can offer a choice of a new treatment highly satisfactory for patients with psoriasis vulgaris I am considered. LEO Pharma A / S, which is the parent company of Leo Pharma Dobobetto (R) ointment, was developed (: Danish Barerappu, President and Chief Executive Officer Head Office "LEO Pharma" Gitte · P · Abo, below), 2001 Since it was launched in Denmark, it is approved in the world 97 countries, including the United States as a topical agent for psoriasis vulgaris in, and it is universal worldwide as one of the first drug of choice of psoriasis vulgaris treatment.
<Product Overview "Dobobetto (R) ointment" of> Product Name: Dobobetto (R) ointment Generic name: calcipotriol hydrate / betamethasone dipropionate acid ester Composition: 1g during, and containing calcipotriol hydrate 52.2μg (50.0μg as calcipotriol), and betamethasone dipropionate acid ester 0.643mg Indications: Psoriasis Vulgaris Dosage and Administration: usually, once a day, I applied an appropriate amount to the affected area. That the use of more than 90g a week is not done: Precautions related to the dosage and administration. Packing: tube 15g × 1,15g × 10,30g × 1 July 4, 2014: Approved Date Sale: Kyowa Hakko Kirin Co., Ltd. Manufacture and sale of: Leo Pharma Co., Ltd.
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