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英文药名: Ventavis(iloprost Nebule)
中文药名: 万他维(吸入用伊洛前列素)
生产厂家: Bayer Corporation
药品介绍
在2006年年初，先灵公司将首次向中国引进一种新的治疗肺动脉高压方面的产品万他维®(Ventavis®)。肺动脉高压是一种非常少见的疾病，目前国内数据显示患病率只有百万分之一到二，在国内还没有有效的治疗手段。因此万他维®将为中国患者提供有效的治疗方案。另外在2006年年中的时候，先灵公司还会有抗肿瘤药方面的产品福达华®(Fludara®)的口服剂型上市。对先灵公司来说，2006年的重点就是提高临床研发的力度，使中国的消费者可以尽早在市场上看到先灵公司的新产品。
万他维®（吸入用伊洛前列素iloprost）是由先灵公司开发的第一个吸入用稳定的前列环素类似物。万他维直接作用于肺血管的前列环素受体，以它独特的肺选择性为肺动脉高压的治疗带来突破。临床研究证实，万他维®可显著改善血流动力学参数，尤其是与预后密切相关的标志物，并且可提高重度患者的运动耐量。
万他维®于2003年9月获得EMEA批准在欧洲各国上市，用于治疗原发性肺动脉高压（即特发性和家族性肺动脉高压）。
2004年12月，万他维®亦被美国FDA批准上市，用于治疗纽约心脏协会 (NYHA)&功能分级为III或IV级的肺动脉高压。
药品说明
商品名:万他维
通用名:吸入用伊洛前列素溶液
英文名:Ventavis
剂型:喷剂
主要成分:伊洛前列素
性状:本品为无色或微黄色的澄清液体，3毫升I型无色玻璃安瓿内含2毫升吸入用伊洛前列素溶液。
适应症:治疗中度原发性肺动脉高压。
用法用量:
成人：每次吸入应从2.5微克开始(吸入装置中口含器所提供的剂量)。可根据不同患者的需要和耐受性逐渐增加伊洛前列素剂量至5.0微克。
根据不同患者的需要和耐受性，每天应吸入伊洛前列素6-9次。
根据口含器与雾化器所需的药物剂量，每次吸入时间大约应为5-10分钟。
肾功能或肝功能不全患者：肝功能异常以及肾功能衰竭需要血液透析的患者，伊洛前列素的清除率是降低的，应考虑减少用药剂量.
儿童以及青少年（18岁以下）：目前还没有在儿童或青少年中应用的经验。除非有资料支持，否则本药不能应用于18岁以下的患者.
雾化器的使用：如果某种雾化器能达到下列标准，则认为它适用于本药溶液的雾化：
液滴的中位空气动力学直径（MMAD）或中位直径（MMD）为3-4m；
口含器输出剂量为：每次吸入伊洛前列素2.5或5ug；
一个剂量为2.5或5ug伊洛前列素的雾化时间：大约为4-10分钟（为了避免全身性副作用，4分钟内输出的伊洛前列素不得超过5ug）。
禁忌:以下患者禁用：
-对伊洛前列素或任何赋形剂过敏。
-出血危险性增加的疾病（如活动性消化性溃疡，外伤，颅内出血或者其他出血），由于本药对血小板的作用可能会使出血的危险性增加。
-患有心脏病的患者，如：严重心律失常、严重冠状动脉性心脏病、不稳定性心绞痛、发病6个月内的心肌梗塞、未予控制和治疗的或未在严密检测下的非代偿性心力衰竭、先天性或获得性心脏瓣膜疾病伴非肺动脉高压所致的有临床意义的心肌功能异常。
-明显的肺水肿伴呼吸困难。
-近3个月发生过脑血管事件（如短暂性脑缺血发作、中风）或其他脑供血障碍。
-妊娠，哺乳妇女。
不良反应:
除了由于吸入用药的局部不良反应如咳嗽加重外，吸入伊洛前列素的不良反应主要与前列环素药理学特性有关。临床试验中最常见的不良反应包括血管扩张，头疼以及咳嗽加重。
The 20 mcg/mL concentration is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Ventavis 10 mcg/mL ampules are still available. Ventavis should be inhaled as your doctor prescribes, usually 6-9 times a day, but not more often than every 2 hours.1
Respironics and I-neb Adaptive Aerosol Delivery (AAD) are trademarks of or belonging to Koninklijke Philips Electronics N.V.
SECOND WIND is a licensed trademark of Pulmonary Rehabilitation Associates.
For more information about Ventavis, please call 1-866-ACTELION (1-866-228-3546).
*What is Ventavis?
Ventavis is a prescription medicine used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. Ventavis may improve your ability to exercise and your symptoms for a short time by lowering your blood pressure and opening up the blood vessels in your lungs.
In the key clinical study, Ventavis showed clinical improvement as defined by 3 specific measurements: ability to exercise as measured by the 6-minute walk test, symptoms (NYHA Functional Class), and decrease in the worsening of PAH symptoms.
Ventavis is a medication you breathe in through a special device called the I-neb Adaptive Aerosol Delivery (AAD) System.
The study showing Ventavis is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors (65%) or connective tissue diseases (23%).
Ventavis has not been studied in children younger than 18 years old.
What is the most important information I should know about Ventavis?
Ventavis may not be right for you. Before taking Ventavis, tell your doctor about all of your medical conditions, including if you have liver or kidney problems; are pregnant, or plan to become pregnant; or are breast-feeding. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines used to treat high blood pressure or heart problems or medicines that lessen blood clotting (warfarin, Coumadin, Jantoven). Ventavis and other medicines may affect each other, causing side effects.
What are the possible side effects of Ventavis?
Ventavis may cause side effects, including feeling dizzy, lightheaded, and faint. If you have any of these side effects, you should stand up slowly when you get out of chairs or bed. Tell your doctor if your fainting gets worse during treatment with Ventavis. Your doctor may need to change your dose or treatment.
Do not drive a car or operate any tools or machines if dizziness or fainting from low blood pressure is a problem for you.
You may have trouble breathing after taking Ventavis, because it may cause the muscles around your airway to tighten (bronchospasm). Get emergency help right away if you have trouble breathing.
The most common side effects of Ventavis include red face (flushing), increased cough, low blood pressure, headaches, nausea, spasm of your jaw muscles that makes it hard to open your mouth, and fainting.
Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Ventavis. For more information, ask your doctor or pharmacist. | 
