Roteas是成人使用的抗凝药物（一种防止血液凝结的药物）：

        预防非瓣膜性心房颤动（心脏上腔不规则的快速收缩）患者的中风（由脑部血块引起）和全身性栓塞（其他器官的血块）。它用于有一个或多个危险因素的患者，例如以前有中风，高血压，糖尿病，心力衰竭或75岁或以上；

        用于治疗深静脉血栓形成（DVT，通常是腿部深静脉血栓）和肺栓塞（供应肺部的血管凝块），并防止DVT和肺栓塞再次发生。

    Roteas含有活性物质edoxaban。

    这种药物与Lixiana相同，后者已获得欧盟（EU）的授权。生产Lixiana的公司已同意将其科学数据用于Roteas（“知情同意”）。

    Roteas可作为片剂（15、30和60 mg）提供，并且只能通过处方获得。通常的剂量是每天一次60毫克。继续治疗，而获益大于出血的风险，这取决于所治疗的疾病和任何现有的风险因素。对于肾功能中度或重度降低，体重低的患者，或同时服用某些药物（称为P-gp抑制剂）的患者，应将其剂量减半。在Roteas和其他抗凝药物之间切换的患者可能还需要调整剂量。有关更多信息，请参见包装手册。

Roteas中的活性物质edoxaban是“ Xa因子抑制剂”。这意味着它可以阻断凝血酶Xa的酶Xa。凝血酶对于凝血是必不可少的。通过阻断Xa因子，该药物可降低血液中凝血酶的水平，从而有助于治疗血凝块并降低其在动脉和静脉中形成并导致DVT，肺栓塞，中风或其他器官损害的风险。

事实证明，Roteas在预防房颤患者的中风和全身性栓塞方面与标准抗凝华法林一样有效。在一项主要研究中对效果进行了研究，该研究涉及超过21,000名患者，平均持续2.5年。有效性的主要指标是每年患者中风或全身栓塞的发生率。首次全身性栓塞或中风发生在182例接受标准剂量Roteas的患者中，其中232例接受了华法林的患者，分别对应于这些事件的年发生率分别约为1.2％和1.5％。当使用另一种推荐的中风类型定义时，在143名接受Roteas（0.9％）的患者和157名华法林（1％）的患者中发现了因血块引起的栓塞或中风。肾功能下降的患者有比肾功能正常的患者更好的结果的趋势。

    在治疗和预防DVT或肺栓塞患者的血凝块中，一项涉及8200多例患者的研究还发现，罗泰茶与华法林同样有效。有效性的主要衡量标准是研究期间发生另一次DVT或肺栓塞的患者人数。接受依多沙班治疗的4,118例患者中有130例（3.2％）发生了进一步发作，接受华法令治疗的4,122例患者中有146例（3.5％）进一步发作。

    Roteas最常见的副作用（最多可能影响十分之一的人）是皮肤和软组织，鼻子（鼻）和阴道的出血。出血可发生在任何部位，并且可能是严重的甚至是致命的。其他常见的副作用是贫血（红细胞水平低），皮疹和肝功能检查的异常结果。有关Roteas报告的所有副作用的完整列表，请参阅包装手册。

    Rotea绝对不能用于活动性出血，患有会影响血液凝结的肝病，严重的无法控制的高血压或患有严重出血风险的患者。也不得将其用于孕妇或哺乳期妇女或与其他抗凝剂一起使用。有关限制的完整列表，请参见包装手册。

    FDA的人类用药用产品委员会（CHMP）决定，Roteas的好处远大于其风险，并建议将其批准在欧盟使用。已显示该药物在降低房颤患者的卒中发生率和预防DVT进一步发作或肺栓塞方面至少与华法林一样有效。

    在安全性方面，与华法林相比，整体出血严重风险（如脑部出血）的风险降低了，尽管在华法林治疗得到良好管理的情况下差异可能较小。尽管粘膜（鼻腔，内脏和阴道等体腔内衬的组织）出血的风险更大，但委员会认为可以采取适当措施加以控制。

    营销Roteas的公司将为医生开药处方提供教育材料，并为患者提供警示卡，解释用药出血的风险以及如何管理。它还将研究该药物对房颤和良好肾功能患者的作用。

    产品特性摘要和包装手册中还包括了医疗专业人员和患者应遵循的有关安全有效使用Roteas的建议和预防措施。

    欧盟委员会于2017年4月20日授予了在整个欧盟范围内有效的Roteas营销许可。

    有关使用Roteas进行治疗的更多信息，请阅读包装手册（也是EPAR的一部分）或与您的医生或药剂师联系。

Roteas is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:

· to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as having had a previous stroke, high blood pressure, diabetes, heart failure or being 75 years old or over;

· to treat deep-vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occurring.

Roteas contains the active substance edoxaban.

This medicine is the same as Lixiana, which is already authorised in the European Union (EU). The company that makes Lixiana has agreed that its scientific data can be used for Roteas (‘informed consent’).

Roteas is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription. The usual dose is 60 mg once a day. Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors. Doses should be halved in patients with moderately or severely reduced kidney function, or low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body. Dose adjustments may also need to be made in patients who are switched between Roteas and other anticoagulant medicines. For further information, see the package leaflet.

The active substance in Roteas, edoxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is essential for blood clotting. By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.

Roteas has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years. The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year. A first systemic embolism or stroke occurred in 182 patients given standard doses of Roteas and in 232 of those given warfarin, corresponding to annual rates for these events of around 1.2% and 1.5% respectively. When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 143 patients given Roteas (0.9%) and 157 given warfarin (1%). There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.

In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Roteas was also found to be as effective as warfarin, in a study involving over 8,200 patients. The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period. Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).

The most common side effects with Roteas (which may affect up to 1 in 10 people) are bleeding from skin and soft tissues, nose (epistaxis) and the vagina. Bleeding can occur at any site and can be severe or even fatal. Other common side effects are anaemia (low levels of red blood cells), rash and abnormal results in tests of liver function. For the full list of all side effects reported with Roteas, see the package leaflet.

Roteas must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding. It must also not be used in pregnant or breastfeeding women or together with another anticoagulant. For the full list of restrictions, see the package leaflet.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Roteas’s benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism.

With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed. Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Committee considered that the risk could be managed with appropriate measures.

The company that markets Roteas will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them. It will also carry out a study of the effects of the medicine in patients with atrial fibrillation and good kidney function.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Roteas have also been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Roteas on 20. April 2017

For more information about treatment with Roteas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.