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氮芥外用软膏(VALCHLOR gel)说明书

产地国家:美国

处 方 药:

所属类别:60克/管

包装规格:60克/管

计价单位:

生产厂家中文参考译名:Actelion

生产厂家英文名:Actelion

原产地英文商品名:VALCHLOR gel 0.016% 60g/Tubes

原产地英文药品名:mechlorethamine

中文参考商品译名:Valchlor凝胶 60克/管

中文参考药品译名:氮芥

简介

美国FDA批准氮芥外用制剂VALCHLOR,每天一次凝胶局部施用,治疗患者以阶段IA和IB蕈样肉芽肿型皮肤T细胞淋巴瘤谁收到事先皮肤导向治疗(MF-CTCL)烷基化药物。Valchlor在美国被指定为孤儿药。

处方修改批准日期:2015年8月

公司:Actelion公司美国制药公司

VALCHLOR(氮芥 mechlorethamine)凝胶,局部使用

最初美国批准:1949年

作用机理

氮芥,也称为氮芥,是抑制快速增殖细胞的烷化剂。

适应症和用法

VALCHLOR是在患者中谁收到事先皮肤导向治疗阶段IA和IB蕈样肉芽肿型皮肤T细胞淋巴瘤的局部治疗所表示的烷基化的药物。

用法用量

对于只有局部皮肤使用

每日一次应用的薄膜对皮肤的受灾地区

剂型和规格

凝胶:0.016%w/w的氮芥(相当于0.02%氮芥HCl中)在60克管

禁忌症

严重过敏对氮芥

警告和注意事项

黏膜或眼外伤:VALCHLOR暴露于粘膜,特别是眼睛,可造成粘膜损伤可能是严重的。眼睛受伤可能会导致失明。立即冲洗至少15分钟,然后立即就医咨询。

二次曝光VALCHLOR:比其他病人的个人必须避免与VALCHLOR皮肤接触

皮炎:监测患者发红,肿胀,发炎,瘙痒,水疱,溃疡,和继发皮肤感染。停止治疗或减少剂量频率。

非黑色素瘤皮肤癌:治疗期间和治疗后监测患者。

胚胎 – 胎儿毒性:可引起胎儿造成伤害。告知潜在危险的妇女胎儿易燃凝胶:VALCHLOR是酒精类凝胶。避免引起火灾,火焰,吸烟,直到凝胶已干

不良反应

最常见的不良反应(≥5%)的皮炎,瘙痒,细菌性皮肤感染,皮肤溃疡或起泡,和色素沉着。

特殊人群中使用

哺乳母亲:请停止药物或哺乳

英文版说明书

氮芥外用软膏VALCHLOR(MECHLORETHAMINE HYDROCHLORIDE)GEL

Valchlor (mechlorethamine) gel 0.016% is applied topically once a day to affected areas of the skin. Valchlor is the first and only FDA-approved topical formulation of mechlorethamine.

CURRENT INDICATION

In the US, Valchlor gel 0.016% is indicated for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy.

Regulatory review with the European health authorities is ongoing.

AVAILABLE CLINICAL DATA

The efficacy of Valchlor was assessed in a randomized, multicenter, observer-blind, non-inferiority trial of 260 patients. Patients were stratified based on Stage (IA vs IB and IIA) and then randomized to receive Valchlor gel 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) or Aquaphor®-based mechlorethamine HCl 0.02% ointment (compounded mechlorethamine). Patients had received at least one prior skin-directed therapy. Qualifying prior therapies included topical corticosteroids, phototherapy, Targretin® gel, and topical nitrogen mustard. Patients were not required to be refractory to or intolerant of prior therapies. Treatments were applied topically on a daily basis for 12 months.

60% of the patients on the Valchlor arm and 48% of patients on the comparator arm achieved a response based on the Composite Assessment of Index Lesion Severity (CAILS) score. Valchlor was non-inferior to the comparator based on a CAILS overall response rate ratio of 1.24 (95% CI 0.98, 1.58). Complete responses constituted a minority of the CAILS or Severity Weighted Assessment Tool (SWAT) overall responses. The onset of CAILS overall response for both treatment arms showed a wide range from 1 to 11 months.

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and skin hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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