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 详细处方信息以本药内容附件PDF文件（201141219035524.pdf）的“原文Priscribing Information”为准
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部分中文奥洛他定处方资料（仅供参考）

制造商：
爱尔康实验室公司

药理分类：
抗组胺（H1的-阻断剂）

活性成分：
奥洛他定（盐酸）0.6％（665mcg/spray）;水喷鼻剂;含有苯扎氯。

适应症：
季节性过敏性鼻炎。

药理作用：
季节性过敏性鼻炎的描述如拥塞的一系列症状，打喷嚏，鼻子痒，并以季节性pollens.Olopatadine敏感引起的流鼻水是一种抗组胺剂通过与减轻炎症反应的allergens.This鼻腔喷雾制剂干预这些症状该药物可以使病人直接针对炎症的症状面积。

临床试验：
三个随机，双盲，安慰剂对照，平行组，多中心，2个星期的研究是建立在剔除季节性过敏性鼻炎治疗的安全性和奥洛他定喷鼻剂的功效。在这些研究中，1,598个成人和青少年患者，治疗或者奥洛他定为0.4％，0.6％奥洛他定，或安慰剂（车鼻喷剂）。疗效评估由四个独立的鼻部症状评分（鼻塞，流涕，鼻痒，打喷嚏）病人的录音。症状被记录为反射（症状严重程度在过去12小时）或瞬时上0到3（缺席，轻度，中度或重度）的规模（症状在录音时间严重性）。主要疗效终点是从在上午和下午的反射鼻症状总分从基线的总和百分比变化安慰剂的差异，在2周的时间的平均值。在每一个试验中，研究药物（两个在每个鼻孔喷，每天两次）治疗的患者在总的反射鼻症状评分统计学显着降低，而车辆。奥洛他定为0.6％，在这两项研究从基线的变化-3.63和-2.90，分别比安慰剂为-2.67和-1.92。

法律分类：
接收

成人：
2，每个鼻孔喷两次。

儿童：
不推荐。

警告/注意事项：
其它鼻腔疾病：不推荐。避开眼睛。监控鼻腔黏膜的变化。妊娠（Cat.C）。哺乳的母亲。

互动：
Potentiates中枢神经系统抑郁症，酒精，镇静剂等中枢神经系统。

不良反应：
苦味，头痛，鼻衄，咽喉疼痛，后期滴鼻，咳嗽，鼻腔破溃，嗜睡。

如何提供：
鼻腔喷雾泵30.5克（240喷）

FDA批准PATANASE®鼻喷雾剂用于治疗鼻变态反应症
    Alcon公司2008年4月16日宣布美FDA已批准PATANASE®鼻喷雾剂，PATANASE®（盐酸奥罗他定）主要用来缓解12岁以上年龄患者以及老年患者的季节性变应性鼻炎症状。PATANASE®鼻喷雾剂增加了Alcon公司抗过敏反应产品链。
    Alcon公司副总裁兼全球市场和首席营销官Kevin Buehler说，我们期待着医生提供PATANASE®鼻喷雾剂给变态反应患者，迅速缓解患者症状。我们很高兴我们的药物能进入鼻腔市场，同时我们也很有信心把这个新药发展下去以确保我们在局部领域的专营权。
    FDA批准PATANASE®鼻喷雾剂主要是基于多种临床研究、安全性评估、药物的效能以及患者的发病原因。通过为期两周的随机、双盲、缓解变态反应的临床试验，基于总鼻症状得分（TNSS，关于鼻塞、流鼻涕、鼻痒和打喷嚏的综合测评），结果显示，一日用药两次，每次每鼻孔喷两次，与安慰剂相比，使用PATANASE®的患者总鼻症状得分具有明显的降低。此外，对发病的原因也进行了研究，在研究中发现，发生过敏性鼻炎的患者主要是暴露于高密度的花粉中的人群。使用PATANASE®和安慰剂每个鼻孔喷两次随机治疗以后，根据患者在12h内自行报告情况发现，使用PATANASE®喷雾剂治疗后可以维持0.5～12h，与安慰剂相比具有明显的统计学意义。
    医疗研究中心的医学博士Eli Meltzer说，患有季节性变应反应的患者在患病期间使得他们的生活极其不幸，而PATANASE®是既能快速缓解其变态反应症状，又容易携带的非甾体鼻腔喷雾剂。它起效较快，非常适合我们快节奏社会患者较迅速地改善和缓解他们的变态反应症状。
    PATANASE®用于只用于鼻腔给药治疗12岁以上以及老年人的季节性过敏性鼻炎。最常见的不良反应主要有苦涩、头痛、鼻出血、咽喉疼痛、后鼻滴涕、咳嗽和尿路感染。
    季节性变应性鼻炎也称为“花粉热”，是由于机体对致敏花粉过敏而引起的一系列变态反应症状，包括眼结膜充血、打喷嚏、鼻子发痒、鼻漏、流泪和眼痒。根据the American College of Allergy, Asthma & Immunology (ACAAI)统计，美国大约有4000万～5000万的人遭受着变态反应疾病，变态反应疾病不仅麻烦，而且已经关联到各种常见的严重的慢性呼吸系统疾病，如鼻窦炎和哮喘。此外，还可能会干扰人们的日常活动或降低人们的生活质量。

PATIENT INFORMATION
PATANASE® (PAT-uh-nase) (olopatadine hydrochloride) Nasal Spray

For Use in the nose (Intranasal) only.

Read the Patient Information that comes with PATANASE® Nasal Spray carefully before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your health care provider about your medical condition or your treatment.

What is PATANASE® Nasal Spray?
PATANASE® Nasal Spray is a prescription medicine used to provide relief of seasonal allergy symptoms in adults and children 6 years of age and older.

PATANASE® Nasal Spray contains an antihistamine medicine that may help reduce nasal symptoms of seasonal allergic rhinitis.

What should I tell my health care provider before taking PATANASE® Nasal Spray?
Tell your health care provider about all your medical conditions, including if you are:
allergic to any of the ingredients in PATANASE® Nasal Spray. See the end of this leaflet for a complete list of the ingredients in PATANASE® Nasal Spray.
pregnant or planning to become pregnant. It is not known if PATANASE® Nasal Spray will harm your unborn baby.
breast-feeding a baby. It is not known if PATANASE® Nasal Spray passes into your breast milk.

Tell your health care provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. PATANASE® Nasal Spray and other medicines may affect each other, causing side effects.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I use PATANASE® Nasal Spray?
PATANASE® Nasal Spray is for use in the nose only. Do not spray it in your eyes or mouth.
Use PATANASE® Nasal Spray exactly as your health care provider tells you. Do not stop taking PATANASE® Nasal Spray without talking to your health care provider.
This nasal device should be discarded after the labeled number of sprays (240) or after the expiration date on the medicine label or box.
Do not use PATANASE® Nasal Spray after the expiration date on the medicine label and box.

Follow the Patient Instructions for Use below.

What are the possible side effects of PATANASE® Nasal Spray?
Side effects of PATANASE® Nasal Spray include:
bad or bitter taste
headache
nosebleeds
sores in your nose
hole in the nasal septum

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of PATANASE® Nasal Spray. For more information, ask your health care provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I avoid while using PATANASE® Nasal Spray?
PATANASE® Nasal Spray can make you sleepy.

Avoid the following while using PATANASE® Nasal Spray:
operating machinery, driving a motor vehicle, or doing other dangerous activities
using alcohol or other medicines that can also make you sleepy, such as sedatives and tranquilizers

General information about PATANASE® Nasal Spray
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use PATANASE® Nasal Spray for a condition for which it was not prescribed. Do not give PATANASE® Nasal Spray to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about PATANASE® Nasal Spray. If you would like more information about PATANASE® Nasal Spray talk with your health care provider. You can ask your health care provider or pharmacist for information about PATANASE® Nasal Spray that is written for health professionals. What are the ingredients of PATANASE® Nasal Spray?
Active ingredient: olopatadine hydrochloride 665 micrograms per 100 microliter spray.

Inactive ingredients: 0.01% benzalkonium chloride, sodium phosphate, dibasic, edetate disodium, sodium chloride, hydrochloric acid, sodium hydroxide and water.

What should I know about seasonal allergic rhinitis?
"Rhinitis" means inflammation of the lining of the nose. Seasonal allergic rhinitis is sometimes called "hay fever". Seasonal allergic rhinitis can be caused by allergies to pollen. If you have allergic rhinitis, your nose becomes stuffy, runny and itchy. You may also sneeze a lot. You may also have red, itchy, watery eyes and itchy throat, or blocked itchy ears.

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 详细处方信息以本药内容附件PDF文件（201141219035524.pdf）的“原文Priscribing Information”为准
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