替吉奥配合颗粒TS-1 combination granule T20说明书

药店国别： 产地国家：日本 处方药：是 所属类别： 0.2克/袋 56袋 包装规格： 0.2克/袋 56袋 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：TAIHO Pharmaceutical Co.,LTD 原产地英文商品名：TS-1 combination granule T20(ティーエスワン配合顆粒T20)0.2g/sachets 56sachets 原产地英文药品名：Tegafur/Gimeracil/Oteracil Potassium 中文参考商品译名：TS-1(替吉奥)配合颗粒 T20(ティーエスワン配合顆粒T20)0.2克/袋 56袋 中文参考药品译名：替加氟/吉莫斯特/氧嗪酸钾 曾用名： 简介： 部分中文TS-1 combination资料(仅供参考)テガフール構造式通用名：替加氟通用名：(欧洲名)替加氟化学名：5-氟-1 - [(2RS) - 四氢呋喃-2-基]尿嘧啶分子式：C8H9FN2O3分子量：200.17熔点：166〜171℃性状它是一种白色结晶粉末。微溶于甲醇，微溶于水或乙醇(95)。它可溶于稀氢氧化钠TS中。甲醇溶液(1→50)示出了没有旋光性。水晶多态性观察。ギメラシル组件名称替加氟ギメラシル構造式通用名称：吉莫斯特通用名：(欧洲名)吉莫斯特化学名称：5-氯-2,4-二羟基吡啶分子式：C5H4ClNO2分子量：145.54熔点：约262℃(分解)性状它是一种白色结晶粉末。氢氧化钠试剂或N，N-二甲基甲酰胺是容易微溶，稍少溶于甲醇，微溶于乙醇(99.5)，极微溶于水。组件名称：吉莫斯特オテラシルカリウム構造式通用名：奥替拉西钾通用名：(欧洲名)氧嗪酸钾化学名称：磷酸二氢钾-1,2,3,4-四氢-2,4-二氧代-1,3,5-三嗪-6-羧酸乙酯分子式：C4H2KN3O4分子量：195.17熔点：300℃以上性状它是一种白色结晶粉末。 pH为8.0，微溶于磷酸盐缓冲溶液或水，和几乎不溶于乙醇(99.5)，或丙酮物理和化学知识其他成分名奥替拉西钾审批条件根据其提交的实施计划，相对于相应的上市后监测(专项调查和上市后的临床试验)的因素在本剂的血药浓度变化进行与信息及其程度的安全性等进行数据的收集，它迅速提交结果。可以为进一步澄清这种药物的疗效和安全性为目的对大肠癌进行随机对照试验以足够的样本大小。效力与该试剂和含铂的抗癌剂用于非小细胞肺癌和，安全性和为了阐明的组合疗法，标准抗癌药物联合用于非小细胞肺癌的未治疗的病例的临床定位组合作为比较对照组治疗，III期随机比较中进行的测试，其中存活和主要终点。 【作用与用途】 本品为氟尿嘧啶衍生物，在体外无抗肿瘤作用，在体内主要经肝脏转变为氟尿嘧啶而起作用。其作用与氟尿嘧啶相同，化疗指数为氟尿嘧啶的2倍，本品可通过血脑屏障。主要用于胃癌、胆道癌、直肠癌、结肠癌、胰腺癌、肝癌、乳腺癌、肺癌及头颈部癌。 【剂量与用法】 成人满足初始剂量(一次量)上的体表面积至下一参考量，早餐后和晚餐后每天两次，每天连续28天口服给予，和其余为其后14天。重复这个管理为一疗程。包装规格ティーエスワン配合顆粒T20　スティック包装(0.2g)：56包(28包×2) 英文版说明书 Dosage form: white granulesSheet listed: (Table) TS-1 blended granules T20 20mg / 0.2g wrapped TC451, (back) TS-1 T20 20mgEffects of this medicineIt is converted into fluorouracil (anti-cancer agent) in the body, to enhance the antitumor effect by increasing the concentration, reducing the gastrointestinal toxicity (side effects).Normally, gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, inoperable or recurrent breast cancer, pancreatic cancer, it will be used in the treatment of biliary tract cancer.Please tell your doctor and pharmacist before certainly responsible for the following people to use.• Before using this medicine, itch, there is the fact that out allergy symptoms such as rash. Bone marrow suppression (less such as the number of white blood cells), kidney failure, liver failure, infection, diabetes, interstitial pneumonia or history, heart disease or history, the digestive tract is ulcers or bleeding.• you are using a fluoropyrimidine drugs (there is a possibility that the expression of serious side effects strengthen action to each other).• was changed from the medicine of fluoropyrimidine to this medicine (washout period prior to taking this medicine is required).• If you are pregnant or breastfeeding.• you are using other drugs (you can strengthen the effect on each other, so there is also likely to weaken, please be aware of the drug being used in the other, including the-counter drugs).Dosage regimen (proper use of this medicine)• Your dosage regimen is (your doctor)• For adults, take in less than 1.25m2 as tegafur to match the first body surface area 40mg, 50mg is less than 1.25~1.5m2, after dinner and after breakfast twice a day on the basis of the 60mg in 1.5m2 more than 28 consecutive days , it will rest for 14 days thereafter. Repeat this as one course, but it should be adjusted according to the state. Increase or decrease the amount of stage once 40mg, 50mg, 60mg, has been with the 75mg, 1 times 75mg is a limit, a minimum amount has been once 40mg. This medicine contains 20mg as tegafur in 1 package. Please Strictly follow the dosing instructions given by your doctor.• Do not drink together in absolute and medicine of fluoropyrimidine.• and medication status, the body of the state, it is also possible to note the symptoms noticed, let's show it to the doctor or pharmacist at the time of examination.• If you forget to drink, please take one dose to the next dose time. Absolutely Do not take two doses at once.• Please consult your doctor or pharmacist if you took too much of this medicine by mistake.• without the doctor's instructions, please do not change the amount or taking time to drink in their own judgment.Notes on life• During the use of this medicine, in order to find the side effects that do not appear in symptoms, (more than once every two weeks) Routine clinical tests (blood, liver function, such as renal function tests), so is done, visit day please as much as possible observe.That where I am with the after care that is using this medicine (side effects)The main side effects, loss of appetite, nausea, vomiting, diarrhea, dullness, stomatitis, pigmentation, rash, etc. lacrimation has been reported. If you notice these symptoms, please consult your doctor or pharmacist.In rare cases symptoms appear, such as the following, may be the initial symptoms of side effects indicated in brackets [].In such cases, discontinue use, please immediately seek medical care.• bleeding is difficult to stop, dullness, fever, sore throat [bone marrow suppression]• skin yellowing, dullness, white of the eyes become yellow, anorexia [severe liver failure]• diarrhea, severe abdominal pain [severe enteritis]• stuffy, fever, dry cough [interstitial pneumonia]• stool blood is mixed, black stool, and vomit blood, abdominal pain [gastrointestinal ulcers, gastrointestinal bleeding, gastrointestinal perforation]• severe stomatitis, red rash, redness of the eyelid and eye [mucocutaneous ocular syndrome]Other side effects not listed here may occur all. If you notice any symptoms of concern other than the above came out, please consult your doctor or pharmacist.Storage and other information• infants, where it is not out of reach of children, direct sunlight, high temperature, please keep away from moisture.• If the drug is remaining, please discard it. Please consult the pharmacy regarding how to discard.Taiho Pharmaceutical Co., Ltd. oral agentJuly 2010 revisionThe medicine can have side effects as well as the effect (benefit) (risk). It is possible to suppress the side effects as much as possible, it is important to bring out the effect to the fullest. To do so, we must have the cooperation and understanding of patients who are using this medicine.Product Name: TS-1 blended granules T20Active ingredient: tegafur (Tegafur)Gimeracil (Gimeracil)Oteracil potassium (Oteracil potassium)Dosage form: white granules