产地国家：美国 处 方 药：是 所属类别：5毫升/瓶 5瓶/盒 包装规格：5毫升/瓶 5瓶/盒 计价单位：盒 生产厂家中文参考译名：Nicox S.A 生产厂家英文名：Nicox S.A 原产地英文商品名：Zerviate 10ml/Vial 5Vial/box 原产地英文药品名：Cetirizine Ophthalmic Solution 中文参考商品译名：Zerviate眼药水0.24% 5毫升/瓶 5瓶/盒 中文参考药品译名：西替利嗪

简介

近日，美国食品药品监督管理局(FDA)批准了ZERVIATE1(Cetirizine Ophthalmic Solution 中文译名：西替利嗪眼用溶液0.24%;以前为AC- 170),这种众所周知的抗组胺药的第一种局部眼用制剂，用于治疗与过敏性结膜炎有关的眼瘙痒。 批准日期：2017年5月30日 公司：Nicox SA ZERVIATE(西替利嗪[cetirizine])滴眼液0.24%，用于局部眼用 这些重点内容不包括安全有效地使用ZERVIATE所需的所有信息。查看ZERVIATE的完整处方信息。美国最初批准：1995年 作用机理 ZERVIATE是一种组胺-1(H1)受体拮抗剂(抗组胺剂)，是肥大细胞中组胺释放的抑制剂。 其作用是通过选择性抑制H 1组胺受体来介导的。 西替利嗪的抗组胺活性已在多种动物和人类模型中得到证明。 体内和离体动物模型显示出可忽略的抗胆碱能和抗5-羟色胺能活性。 体外受体结合研究表明，除H1受体外，对其他受体均无可测的亲和力。 适应症和用途 ZERVIATE(西替利嗪眼用溶液)0.24%是组胺-1(H1)受体拮抗剂，可用于治疗与过敏性结膜炎有关的眼痒。 剂量和给药 建议的剂量是每天每只受影响的眼睛两次滴一滴。 剂量形式和强度 无菌眼用溶液：在1mL溶液中加入2.4mg西替利嗪(0.24%)。 禁忌症 没有。 警告和注意事项 尖端和溶液的污染为了防止污染滴头和溶液，建议患者不要用瓶的滴头触摸眼睑或周围区域。 不良反应 最常见的不良反应(1-7%)是眼部充血，滴眼部位疼痛和视力下降。 包装供应/存储和处理方式 ZERVIATE是一种无菌，缓冲，透明，无色的水溶液，含有0.24%的西替利嗪(相当于0.29%的西替利嗪盐酸盐)，装在白色的低密度聚乙烯多剂量眼科瓶中，该瓶带有低密度的聚乙烯滴管头和白色的聚丙烯瓶盖 。ZERVIATE装在7.5mL的瓶子中，该瓶子包含5mL，10mL的瓶子中包含7.5mL西替利嗪滴眼液，2.40mg[相当于2.85mg西替利嗪盐酸盐在1mL溶液中]。 将5mL装满7.5mL瓶NDC 71776-024-05 存放：存放在15°C至25°C(59°F至77°F)。

英文版说明书

Nicox receives FDA approval of ZERVIATE (cetirizine ophthalmic solution) 0.24% About ZERVIATE ZERVIATE, the brand name approved by the U.S. FDA for cetirizine ophthalmic solution, 0.24% (formerly AC-170), is a novel formulation of cetirizine developed for the first time for topical application in the eye. Cetirizine, the active ingredient in Zyrtec®4, is a second generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation. Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with world-wide exposure representing more than 300 million patient-years Important Information about ZERVIATE INDICATION: ZERVIATE (cetirizine ophthalmic solution) 0.24% is indicated for treatment of ocular itching associated with allergic conjunctivitis. DOSAGE AND ADMINISTRATION: The recommended dose is one drop in each affected eye twice daily (approximately 8 hours apart). IMPORTANT SAFETY INFORMATION The most commonly reported adverse reactions occurred in approximately 1-7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and reduction in visual acuity. About Allergic Conjunctivitis Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the white surface of the eye and the inner surface of the eyelids. It is a common eye disease, especially in children, and may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light. It is estimated that more than 75 million people suffer from allergic conjunctivitis in the U.S.9 and the preva lence ranges from 20% to 40%.