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  药店国别: 意大利药房
产地国家: 意大利
所属类别: 抗癌药物->治疗肠癌药物
处方药:处方药
包装规格: 150毫克/片 60片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
罗氏
生产厂家英文名:
Roche spa
该药品相关信息网址1:
http://www.xeloda.com/
该药品相关信息网址2:
www.rxlist.com/xeloda-drug.htm
该药品相关信息网址3:
http://www.medilexicon.com/drugs/xeloda_717.php
原产地英文商品名:
XELODA 150mg/Tablet 60Tablets/bottle
原产地英文药品名:
CAPECITABINE
中文参考商品译名:
希罗达 150毫克/片 60片/瓶
中文参考药品译名:
卡培他滨
原产地国家批准上市年份:
1998/04/30
英文适应病症1:
Metastatic colorectal carcinoma
英文适应病症2:
Colorectal carcinoma
英文适应病症3:
Metastatic breast cancer
英文适应病症4:
Breast cancer
英文适应病症5:
Cancer
临床试验期:
完成
中文适应病症参考翻译1:
转移性结肠直肠癌
中文适应病症参考翻译2:
结肠直肠癌
中文适应病症参考翻译3:
转移性乳腺癌
中文适应病症参考翻译4:
乳腺癌
中文适应病症参考翻译5:
癌症
药品信息:

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 详细处方信息以本药内容附件PDF文件(201252220364833.pdf)的“原文Priscribing Information”为准
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部分中文愛美力处方资料(仅供参考)

希罗达是胃肠道肿瘤患者的新希望,用于联合化疗治疗晚期或转移性结直肠癌、晚期或转移性胃癌
希罗达也适用于紫杉醇和化疗方案治疗无效的晚期原发性或转移性乳腺癌的进一步治疗
【分类】:乙类
【治疗分类】:化学治疗
【活性成分】:卡培他滨
【适 应 证】:希罗达适用于紫杉醇和包括有蒽环类抗生素化疗方案治疗无效的晚期原发性或转移性乳腺癌的进一步治疗。  
【推荐剂量】:每日2,500mg/m2,连用两周,休息一周。每日总剂量分早晚两次于饭后半小时用水吞服。如病情继续恶化或产生不能耐受的毒性时应停止治疗。
希罗达所引起的毒性有时需要做对症处理或对剂量进行调整(停药或减量)。一旦减量,以后不能再增加剂量。以下是对毒性进行剂量调整时的推荐剂量(根据加拿大国家癌症研究所制定的常见毒性标准)。
1级。
2级。
第一次出现:停止治疗,直到恢复至0-1级水平时,按维持剂量的100%进行下一疗程治疗。
第二次出现:停止治疗,直到恢复至0-1级水平时,按维持剂量的75%进行下一疗程治疗。
第三次出现:停止治疗,直到恢复至0-1级水平时,按维持剂量的50%进行下一疗程治疗。
第四次出现:永久停止治疗。
3级:
第一次出现:停止治疗,直到恢复至0-1级水平时,按维持剂量的75%进行下一疗程治疗。
第二次出现:停止治疗,直到恢复至0-1级水平时,按维持剂量的50%进行下一疗程治疗。
第三次出现:永久停止治疗。
4级:
永久停止治疗。
如停药后需继续治疗,则应考虑到病人的最大益处,且在毒性症状恢复至0-1级水平时以推荐剂量的50%进行使用。
【特殊人群的剂量调整】:
肝功能不全:对肝转移引起的轻度至中度肝功能不全的病人所进行的希罗达药代动力学研究表明,无需对这类病人做剂量调整。
肾功能不全:尚未对肾功能不全者(指血清肌酐)进行希罗达药代动力学研究。
儿童:尚未在儿童中进行希罗达的疗效与安全性研究。 老年人:无须作剂量调整。但在老年人(65岁以上)比年轻人更易对卡培他滨产生毒性,故应对其进行密切监测。
【禁 忌 症】:有希罗达严重副反应或对氟脲嘧啶(卡培他滨的代谢产物)有过敏史者禁用。
【预防措施】:
需限制剂量的毒性包括:腹泻、腹痛、恶心、胃炎及手足综合征。近半数接受希罗达治疗者会诱发腹泻,对发生脱水的严重腹泻者应严密监测并给予补液治疗。每日腹泻4-6次或者夜间腹泻者为2级腹泻,每日腹泻7-9次或大便失禁和吸收障碍者为3级腹泻,每日腹泻10次以上或有肉眼血便和需静脉补液者为4级腹泻。如发生2、3或4级腹泻,则应停用希罗达,直到腹泻停止或腹泻次数减少到1级时再恢复使用。3级或4级腹泻后再使用希罗达应减少用量。几乎近一半使用希罗达的病人发生手足综合征,但多为1-2级,3级综合征者不多见。多数副反应可以消失,尽管需要暂时停止用药或减少用量,但无须长期停止治疗。
【妊娠及哺乳妇女】:
尚未在妊娠妇女中进行希罗达临床研究,但必须要考虑到如果在这类病人中使用希罗达,可能会引起胎儿损伤。动物实验表明卡培他滨能导致胎儿死亡或畸形。这些发现预示卡培他滨衍生物也具有这种作用,因此不能在妊娠妇女中使用希罗达。如在妊娠期间使用希罗达,或在使用希罗达期间发生妊娠时,必须考虑到该药对胎儿损伤或致畸的潜在危险性。生育期妇女使用希罗达时必须采取避孕措施。
尽管尚不知希罗达是否能分泌于奶液中,但由于许多药物能在奶液中分泌而有对哺乳的婴儿造成严重副反应的潜在危险性,因此建议使用希罗达的妇女停止授乳。
【副反应】:
希罗达的副反应较少,以下情况可能与之有关:
消化系统:希罗达最常见的副反应为可逆性胃肠道反应,如腹泻、恶心、呕吐、腹痛、胃炎等。
严重的(3-4级)副反应相对少见。
皮肤:在几乎一半使用希罗达的病人中发生手足综合征:表现为麻木、感觉迟钝、感觉异常、麻刺感、无痛感或疼痛感,皮肤肿胀或红斑,脱屑、水泡或严重的疼痛。皮炎和脱发较常见,但严重者很少见。
一般不良反应:常有疲乏但严重者极少见。其他常见的副反应为粘膜炎、发热、虚弱、嗜睡等,但均不严重。
神经系统:头痛、感觉异常、味觉障碍、眩晕、失眠等较常见,但严重者少见。
心血管系统:下肢水肿较轻且不常见。尚未见其他心血管系统副作用。
血液系统:中性粒细胞减少且少见也不严重,贫血极少见也不严重。
其他:厌食及脱水常见,但重者极少见。
【相互作用】:
联合用药:希罗达与大量药物合用,如抗组胺药,NSAIDs,吗啡,扑热息痛,阿斯匹林,止吐药,H2受体拮抗剂等,未见具有临床意义的副作用。
蛋白结合:卡培他滨与血清蛋白结合率较低(64%)通过置换与能蛋白紧密结合的药物发生相互作用的可能性尚无法预测。
与细胞色素P450酶间的相互作用:在体外实验中,未发现卡培他滨对人类肝微粒体P450酶产生影响。
【药物过量】:
希罗达的临床试验中,未发现由于药物过量而引起的副反应。但动物实验(对猴类以25,679mg/m2/天的积极治疗)以及对人以最大耐受剂量(3,514mg/m2/天)治疗中,药物过量的表现为恶心、呕吐、腹泻、胃肠激惹、肠胃出血和骨髓抑制等。处理方法应包括使用利尿剂脱水治疗,必要时透析治疗。
【保存方式】:药品应置於摄氏 15 ~ 25 度干燥处所;如发生变质或过期,不可再食用。

Who is XELODA for?
XELODA is used to treat:
Cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body. This is called metastatic colorectal cancer (mCRC). XELODA is used as a single medicine to treat mCRC. In medical studies, people lived longer when they took other cancer medicines at the same time that they took 5-fluorouracil (5-FU) and leucovorin. In medical studies, XELODA used as a single medicine was no worse than 5-FU and leucovorin taken together. XELODA did not improve survival compared with these 2 medicines.
Cancer of the colon after surgery.
Breast cancer that has spread to other parts of the body. This is called metastatic breast cancer (mBC). For this kind of breast cancer, XELODA is taken together with another medicine called docetaxel.
Breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines. These medicines include paclitaxel and anthracycline-containing medicine such as doxorubicin.

What is the most important safety information I should know about XELODA?
It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN®). XELODA may increase the effect of this medicine. This could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots. He or she will change the dose of the blood thinner, if needed.

Who should not take XELODA?
Do not take XELODA if:
You are nursing a baby. XELODA may pass through your breast milk and to the baby and harm the baby
You are allergic to the chemotherapy medicines 5-FU and capecitabine or to any of the ingredients in XELODA
Your body doesn't have enough of the enzyme DPD (dihydropyrimidine dehydrogenase)

What should I tell my doctor before taking XELODA?
Tell your doctor if you:
Are pregnant or think you may be pregnant. XELODA may harm your unborn child. Men and women should use effective birth control while taking XELODA
Take a blood thinner, such as warfarin
Take phenytoin (DILANTIN®)
Have kidney, liver, or heart problems
Take folic acid, a B complex vitamin, or a multivitamin containing folic acid

Stop taking XELODA immediately and contact your doctor right away if you have any of these serious common side effects or any other side effects that worry you:
Diarrhea* — at least 4 more bowel movements each day than is normal for you or if you wake up because you need to have a bowel movement
Throwing up (vomiting)* — more than once in 24 hours
Feeling sick to your stomach (nausea)* — if you don't feel like eating and if the amount of food you eat each day is much less than usual
Pain, redness, swelling, or sores in your mouth (stomatitis)*
Hand-and-foot syndrome — pain, swelling, or redness of your hands or feet that prevents normal activity
Fever or infection — a temperature of 100.5°F or higher or other signs of infection
If you do have any of the side effects listed above, or if you have other side effects that worry you, your doctor can change your dose of XELODA or stop your XELODA treatment for a while. This may help to reduce the side effects and stop them from getting worse.

What are the other common side effects of XELODA?
Constipation*
Loss of appetite*
Stomach area pain* or upset stomach
Too much water loss from the body (dehydration)*
Rash or dry, itchy, discolored skin
Nail problems
Hair loss
Tiredness or weakness
Dizziness or headache
Pain, including chest, back, joint, or muscle pain
Trouble sleeping
Problems with your sense of taste

*This side effect is more common in patients 80 years and older.

You may have different side effects if you take XELODA with docetaxel. Please talk with your doctor about possible side effects that may be caused by taking XELODA with other medicines.

Please be sure to talk with your doctor if you have any questions about your cancer or treatment.

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 详细处方信息以本药内容附件PDF文件(201252220364833.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2015-04-12
附件:
201252220364833.pdf    

 
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