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  药店国别: 德国药房
产地国家: 德国
所属类别: 影响血液及造血系统药物->溶栓抗凝药物
处方药:处方药
包装规格: 20毫克/片 30片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
JANSSEN PHARMS
生产厂家英文名:
JANSSEN PHARMS
该药品相关信息网址1:
http://www.xarelto.com/en/index.php
该药品相关信息网址2:
http://www.netdoctor.co.uk/medicines/xarelto/100005185.html
原产地英文商品名:
XARELTO FILM COATED TAB 20mg/tab 30tabs/box
原产地英文药品名:
RIVAROXABAN
中文参考商品译名:
拜瑞妥薄膜衣片 20毫克/片 30片/盒
中文参考药品译名:
利伐沙班
中文参考化合物名称:
5-氯-氮-((5S)-2-氧-3-[-4-(3-氧-4-吗啉基)苯基]-1,3-唑烷-5-基-2-噻吩-羧酰胺
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Anticoagulant
英文适应病症2:
Prevention of venous thromboembolism
临床试验期:
完成
中文适应病症参考翻译1:
抗凝血
中文适应病症参考翻译2:
预防静脉血栓形成
药品信息:

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 详细处方信息以本药内容附件PDF文件(20115423370019.pdf、20115423371117.pdf)的“原文Priscribing Information”为准
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部分中文利伐沙班处方资料(仅供参考)

FDA肯定拜耳和强生合作推出的抗凝药Xarelto
    FDA顾问团建议批准拜耳和强生出品的抗凝药Xarelto,但该药存在可能导致出血和肝损害方面的问题。
    FDA心血管及肾脏疾病顾问委员会(CRAC)就该药的疗效进行了投票,议题为药物用于接受过膝盖及髋部手术的患者之后是否利大于弊,投票结果为15票赞成,2票反对。因为FDA先前曾表示对该药的风险有所疑虑,这次投票结果让一些观察家大为惊讶。
    CRAC审阅了该药在主要临床实验中获取的数据,参加这一系列实验的受试者人数达12000人。其中,大多数数据都在比较Xarelto和目前的标准疗法Lovenox(注射剂,赛诺菲-安万特出品)的疗效。
    数据显示,靶向作用于Xa凝血因子的Xarelto在防止凝血形成方面效果较好,同时会增加出血的风险,但几率极小。CRAC建议该药能通过批准,但也指出对它的不良反应不能掉以轻心。
    其中投了反对票的一位专家表示,Xarelto获得批准之后,可能很多医生会用来作为长期用药而对它潜在的不良反应一无所知,这实在令人忧虑。
    FDA于5月28日决定是否批准Xarelto上市销售。该药已在欧洲和加拿大通过批准,用于接受过膝盖和髋部手术的患者,以防止凝血,但拜耳和强生正继续对药物进行研究,检测其用于治疗更大疾患如中风和急性冠脉综合征方面的效果,拓宽药物的开发前景。

【商 品 名】拜瑞妥
   
【通 用 名】利伐沙班片
   
【英 文 名】Xarelto
   
【成 份】利伐沙班Rivaroxaban,其化学名称:5-氯-氮-((5S)-2-氧-3-[-4-(3-氧-4-吗啉基)苯基]-1,3-唑烷-5-基-2-噻吩-羧酰胺。
   
【性 状】本品为红色薄膜衣片.
   
【适 应 症】用于择期髋关节或膝关节置换手术成年患者,以预防静脉血栓形成(VTE).
   
【用法用量】推荐剂量为口服利伐沙班10mg,每日1次.如伤口已止血,首次用药时间应于手术后6-10小时之间进行.治疗疗程长短依据每个患者发
生静脉血栓栓塞事件的风险而定,即由患者所接受的骨科手术类型而定.
   
【剂 型】片剂
   
【有 效 期】三年
   
【贮 藏】常温(10-30°C)密封保存.

Xarelto (rivaroxaban)
Main use:Preventing blood clots following hip or knee replacement
Active ingredient:Rivaroxaban
Manufacturer:Bayer
 
How does it work?
Xarelto tablets contain the active ingredient rivaroxaban, which as a type of medicine called an anti-thrombotic. It is used to stop blood clots forming within the blood vessels following hip or knee replacement surgery.

Blood clots usually only form to stop bleeding that has occurred as a result of injury to tissue in the body. After hip or knee replacement surgery there is a risk of blood clots forming in the blood vessels. This risk is increased by being immobile for long periods of time following the surgery, as a result of slowed blood flow in the leg and pelvic veins. A clot that forms in the veins of the leg is called a deep vein thrombosis. These dangerous blood clots can travel to the lungs, causing a serious condition called a pulmonary embolism.

The blood clotting process is complicated. When blood begins to clot, a cascade of chemicals is activated within the body, resulting in the formation of an enzyme called thrombin. Thrombin is central to the complete process of blood clotting. It causes a protein called fibrinogen to be converted into another called fibrin. Fibrin binds blood cells called platelets together, and this forms the blood clot.

Rivaroxaban works by binding to a blood clotting called factor Xa, which prevents the formation of thrombin. This stops the formation of fibrin, the essential component of blood clots.

What is it used for?
Preventing dangerous blood clots in the veins (venous thromboembolism) in adults who have undergone elective total hip or knee replacement surgery.

How do I take it?
Treatment with this medicine should be started six to ten hours after the surgery, though this may be delayed if there are any complications with bleeding after surgery.
The tablets are usually taken once daily for 14 days following a knee replacement and for 35 days following a hip replacement. Do not stop taking this medicine until you have been advised to by your doctor.
The tablets can be taken with or without food.

Warning!
As this medicine prevents blood clotting, the most common side effects associated with treatment involve bruising or bleeding. Not all people will experience side effects. However, you should let your doctor know straight away if you notice any sign of bruising or bleeding while you are taking this medicine. This includes any signs of blood in your urine, or any sign of bleeding from the stomach or intestine, for example vomiting blood and/or passing black/tarry/bloodstained stools.

Use with caution in
Moderate to severely decreased kidney function.
Liver disorders such as cirrhosis of the liver.
People with an increased tendency to bleed, for example due to blood clotting disorders such as haemophilia, or the conditions listed below.
People with low numbers of blood cells called platelets in their blood (thrombocytopenia).
People with active or recent ulcerative diseases of the intestines, eg peptic ulcers or ulcerative colitis.
People with uncontrolled very high blood pressure (hypertension).
People who have recently had brain, spinal or eye surgery.
People who have recently had bleeding inside the skull or brain (intracranial or intracerebral haemorrhage).
People who have a problem with the blood vessels at the back of the eye (retinopathy).
People with abnormalities of the blood vessels in the brain or spinal cord.
People having spinal or epidural anaesthesia or injection into the spine.
People who have an indwelling catheter in their spine for pain relief after the surgery.
People taking medicines that may increase the risk of bleeding, for example anticoagulants such as warfarin, antiplatelets such as aspirin or clopidogrel, or non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac or ibuprofen (see end of factsheet for more examples).

Not to be used in
People with active severe or dangerous bleeding.
People with liver disease associated with blood clotting problems and an increased risk of bleeding.
Pregnancy.
Breastfeeding.
This medicine is not recommended for people having surgery for a hip fracture.
This medicine is not recommended for children and adolescents less than 18 years of age, as its safety and efficacy have not been established in this age group.
Xarelto tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
The safety of this medicine during pregnancy has not been established. The manufacturer states that this medicine should not be used during pregnancy because of the risk of bleeding and potential risk of harm to a developing baby.
Women who could get pregnant should use an effective contraception method whilst taking this medicine to avoid getting pregnant. Seek medical advice from your doctor.
It is not known if rivaroxaban passes into breast milk. This medicine should therefore not be used during breastfeeding. Mothers will need to either stop breastfeeding while taking this medicine, or not take this medicine. Seek medical advice from your doctor.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)
Bleeding after the operation (see warning section above).
Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
Nausea.
Fever.

Uncommon (affect between 1 in 100 and 1 in 1000 people)
Dizziness.
Headache.
Increased heart rate (tachycardia).
Blood clots which form a solid swelling (haematoma).
Bleeding in the gut.
Bleeding from the rectum.
Blood in the urine.
Low blood pressure.
Nose bleeds (epistaxis).
Anaemia.
Alteration in results of liver function tests.
Disturbances of the gut, such as constipation, diarrhoea, abdominal pain, indigestion, dry mouth and vomiting.
Skin reactions such as itching, rash.
Elevated levels of creatinine and urea in the blood.
Excessive fluid retention in the body tissues, resulting in swelling (oedema).
Feeling weak or fatigued.
Weeping of a surgical wound.

Rare (affect between 1 in 1000 and 1 in 10,000 people)
Fainting.
Abnormal liver function.
Nettle-type rash (urticaria).
Generally feeling unwell.
Allergic dermatitis.

Unknown frequency
Hypersensitivity reactions such as rash, itching, hives or swelling of the lips and face.
Major bleeding (haemorrhage), eg in the abdomen or inside the skull.
Kidney failure.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

The medicines listed below increase the blood level of rivaroxaban, which could increase the risk of bleeding. Rivaroxaban is not recommended for people taking these medicines:
antifungal medicines such as ketoconazole, itraconazole, posaconazole and voriconazole (fluconazole has less of an effect and can be used with caution).
HIV protease inhibitors such as atazanavir, nelfinavir, ritonavir, saquinavir and indinavir.

There may also be an increased risk of bleeding if any of the following medicines that are used to prevent blood clotting are used in combination with rivaroxaban:
acenocoumarol
aspirin
bivalirudin
clopidogrel
dabigatran
danaparoid
dipyridamole
fondaparinux
heparins or low-molecular weight heparins
lepirudin
phenindione
thrombolytic agents (clot-busters), eg alteplase, streptokinase
glycoprotein IIb/IIIa receptor antagonists, eg abciximab, eptifibatide and tirofiban
warfarin.

There may be an increased risk of bleeding if non-steroidal anti-inflammatory drugs used to relieve pain and inflammation (NSAIDs, eg diclofenac, ibuprofen, naproxen) are taken in combination with this medicine.

The following medicines may reduce the amount of rivaroxaban in the blood, which could make it less effective at preventing blood clots:
carbamazepine
phenytoin
rifampicin
the herbal remedy St.John’s wort (Hypericum perforatum).

Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain rivaroxaban as the active ingredient.

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 详细处方信息以本药内容附件PDF文件(20115423370019.pdf、20115423371117.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2013-03-24
附件:






20115423371117.pdf    

20115423370019.pdf    

 
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