部份中文利伐沙班处方资料（仅供参考）
商品名：Xarelto Fine Granules
英文名：Rivaroxaban
中文名：利伐沙班细颗粒
生产商：拜耳制药
药品简介
2022年06月24日，日本厚生劳动省（MHLW）已批准Xarelto（rivaroxaban，利伐沙班）：将Xarelto（剂量2.5mg，每日2次）联合阿司匹林（81-100mg，每日1次），用于外周动脉疾病（PAD）患者血运重建后的治疗。
心血管疾病（CVD）包括冠状动脉疾病（CAD）和外周动脉疾病（PAD），约占全球死亡人数的三分之一。尽管在管理方面取得了进步，但CVD仍然给医疗和社会护理带来了巨大负担。
PAD是一种常见的血液循环疾病，动脉狭窄会减少主要流向下肢的血流量，从而增加主要心血管事件的风险。据估计，PAD影响全球2亿多人。虽然通常一开始是无症状的，但PAD症状可能发展到严重程度，需要血管重建以避免截肢。PAD是截肢的首要原因，并导致致死性和非致死性心血管事件的高发生率。截肢是PAD的一种毁灭性并发症，尽管在很大程度上是可以预防的，但与高死亡率相关。
Xarelto是全球适应症最广泛的非维生素K拮抗剂类口服抗凝剂（NOAC），能显著降低冠心病（CAD）和外周动脉疾病（PAD）群体主要不良心脏事件的风险。
イグザレルト細粒分包10mg／イグザレルト細粒分包15mg
药效分类名称
选择性直接作用型第Xa因子抑制剂
批准日期：2015年12月
商品名
Xarelto fine granules 10mg
Xarelto fine granules 15mg
一般的名称
リバーロキサバン（Rivaroxaban）
化学名
5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide
分子式
C19H18ClN3O5S
分子量
435.88
性状
本品为白色～微黄色粉末。
化学構造式
批准条件
〈静脉血栓栓塞的治疗及复发抑制（小儿）〉
制定医药品风险管理计划并妥善实施。
药效药理
1. 作用机序
这种药物是一种选择性和直接Xa因子抑制剂，示出了通过口服给药的效果。内在的和外在的血液凝固级联，该药物以抑制，凝血酶产生和血栓形成的Ⅹa因子被抑制。这种药物不抑制凝血酶，也不具有对血小板有直接的影响。
2. 抗血栓效果
这种药物，小鼠，大鼠或兔的静脉和动脉血栓形成模型中，以剂量依赖性方式的血栓形成被抑制。另外，在兔静脉血栓形成模型中，抑制血栓的后血栓形成的增加。
适应病症
成人
○非瓣膜病性心房颤动患者缺血性脑卒中及全身性栓塞的发病抑制
○静脉血栓栓塞（深部静脉血栓症及肺血栓栓塞症）的治疗及复发抑制
小児
○静脉血栓栓塞的治疗及复发抑制
用法用量
〈非瓣膜病性心房颤动患者缺血性脑卒中及全身性栓塞的发病抑制〉
通常，成人每日1次饭后口服15mg作为利巴罗沙星。另外，对于有肾损伤的患者，根据肾功能的程度，每10mg每日减量1次。
〈静脉血栓栓塞症的治疗及复发抑制〉
成人
通常，成人在深部静脉血栓症或肺血栓栓塞症发病后的初期3周，作为利巴沙星，每天2次饭后口服15mg，之后每天1次饭后口服15mg。
小儿
通常，对于体重30kg以上的儿童，作为利巴沙星，每天1次饭后口服15mg。
包装
細粒剤
细粒分包
10mg：90包〔3包〕×30]



15mg：90包〔3包〕×30]
制造和销售元 (进口)
拜耳药品株式会社
注：以上中文不够完整，使用者以原处方资料为准。
完整说明附件：
https://www.info.pmda.go.jp/go/pack/3339003C1028_1_12/?view=frame&style=XML&lang=ja
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Xarelto Fine Granules（Rivaroxaban）
Xarelto Fine Granules 10mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]（イグザレルト細粒分包10mg［抑制缺血性卒中和全身性栓塞的发生在非瓣膜性房颤患者］）
Brand name : Xarelto Fine Granules 10mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]
　Active ingredient: Rivaroxaban
　Dosage form: white fine granules
　Print on wrapping: white fine granules
Xarelto Fine Granules 15mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]（イグザレルト細粒分包15mg［抑制缺血性卒中和全身性栓塞的发生在非瓣膜性房颤患者］）
Brand name : Xarelto Fine Granules 15mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]
　Active ingredient: Rivaroxaban
　Dosage form: white fine granules
　Print on wrapping: イグザレルト細粒分包15mg,Xarelto Fine Granules (0.75g)
Xarelto Fine Granules 15mg [treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism]（イグザレルト細粒分包15mg［深静脉血栓和肺栓塞的治疗和抑制复发］）
Brand name : Xarelto Fine Granules 15mg [treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism]
　Active ingredient: Rivaroxaban
　Dosage form: white fine granules
　Print on wrapping: イグザレルト細粒分包15mg,Xarelto Fine Granules (0.75g)
Effects of this medicine
This medicine inhibits blood coagulation factor Xa to prevent blood clotting. It improves clotting tendency in the atrium and prevents thromboembolism, a disease caused by blood coagulation in the vessels.
It is usually used to prevent onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have bleeding (intracranial bleeding, gastrointestinal bleeding, etc.), liver disorder, renal disorder, acute bacterial endocarditis, bleeding tendency, prolonged bleeding or low body weight.
If you are at high risk of bleeding (If you have recently had gastrointestinal tract ulcer, intracranial bleeding or cerebrospinal/eye surgery. If you have a history of bronchiectasis or lung bleeding. If you have gastric ulcer, duodenal ulcer, malignant tumor or hypertension).
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 15 mg of the active ingredient at a time, once a day after meals. If you have renal disorder, the dosage may be decreased to 10 mg at a time, once a day. This preparation contains 10 mg of the active ingredient in a tablet. Strictly follow the instructions.
•If you miss a dose, take a missed dose as soon as possible. However, there should be 12 hours or more before the next scheduled dose. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•If you will receive dental treatment, endoscopic examination or surgery, make sure to inform your doctor in advance that you are taking this medicine. If you will receive treatment in other medical institutions or buy other medicines at pharmacies, etc., inform your doctor or pharmacist that you are taking this medicine.
•Pay attention not to get injured since this medicine lead to prolonged bleeding. If bleeding time is prolonged or the injury involves a large area, immediately contact your doctor.
•Avoid taking any food containg hypericum perforatum (St. John's wort), since it may diminish medicinal effects.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nasal bleeding, subcutaneous bleeding, gum bleeding, bloody urine, conjunctival bleeding, anemia, wound bleeding, hemoptysis (coughing up blood), bleeding in the mouth, hemorrhoidal bleeding, retinal bleeding and melena (black stool). If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•nausea, vomiting, headache [bleeding (gastrointestinal bleeding, intracranial bleeding, etc.)]
•nausea, dull, yellowing of the skin and the white of eyes [liver dysfunction, jaundice]
•coughing, bloody phlegm, breathing difficulty, shortness of breath, fever [interstitial lung disease]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
Bayer Yakuhin, Ltd.Internal
Revised: 9/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.