替加氟/吉莫斯特/氧嗪酸钾S-1Meiji Combination Capsules T20说明书

药店国别： 产地国家：日本 处方药：是 所属类别： 20毫克/胶囊 56胶囊/盒 包装规格： 20毫克/胶囊 56胶囊/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：Meiji Seika Pharma Co 原产地英文商品名：S-1Meiji Combination(エスワンメイジ配合カプセルT20)20mg/capsule 56capsule/box 原产地英文药品名：Tegafur/Gimeracil/Oteracil Potassium 中文参考商品译名：S-1Meiji配合胶囊(エスワンメイジ配合カプセルT20)20毫克/胶囊 56胶囊/盒 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S-1Meiji Combination]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 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。 英文版说明书 Combination T20Effects of this medicineThis medicine is biotransformed into fluorouracil (anticancer drug) in the body, enhances antitumor activity by increased concentration and relieves gastrointestinal toxicities (side effects).It is usually used to treat gastric cancer.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: marrow depression (including leukopenia), renal or hepatic disorder, infectious disease, diabetes mellitus, current/history of interstitial pneumonia, current/history of cardiac disease, gastrointestinal ulcers or bleeding.If you are transferring the medicine from fluoropyrimidine-group anti-cancer medicine to this medicine.•If you are pregnant, potentially 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 <>•For adults: In general, take this medicine twice a day after breakfast and dinner for 28 consecutive days, followed by 14-day rest. This is repeated as one course but it may change according to the condition. Initial standard dose of tegafur is determined based on body surface area (BSA) as follows: 40 mg per dose for patients with a BSA less than 1.25 m2; 50 mg per dose for patients with a BSA 1.25 m2 to less than 1.5 m2; 60 mg per dose for patients with a BSA equal to or greater than 1.5 m2. The dosage may be adjusted to 40 mg, 50 mg, 60 mg or 75 mg for single dose. The maximum single dose should not exceed 75 mg, with the minimum dose of 40 mg. This preparation contains 20 mg of tegafur in a capsule. Strictly follow the instructions.•You should never take any fluorinated pyrimidine medicine together with this medicine.•Take memos about your medication status, health condition, and any symptoms you have noticed, and show those memos to your doctor or pharmacist at visits.•If you miss a dose, skip the missed dose and follow your regular dosing schedule. 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•During the treatment, laboratory tests (hematological, liver and renal function test, etc.) are performed regularly at least once every 2 weeks to detect asymptomatic adverse reactions as early as possible. Be sure to keep your visiting schedule.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include loss of appetite, nausea, vomiting, diarrhea, general malaise, stomatitis, pigmentation, rash and lacrimation. 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.•prolonged bleeding, general malaise, fever, sore throat [marrow depression]•yellowing of the skin, general malaise, yellowing of the white of eyes, loss of appetite [serious liver disorder]•diarrhea, severe abdominal pain [serious enteritis]•respiratory distress, fever, dry cough [interstitial pneumonia]•bloody stool, black stool, vomiting of blood, abdominal pain [serious stomatitis, gastrointestinal ulcer/bleeding/perforation]•severe stomatitis, red rash, hyperemia of the eyelid and eyes [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome]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 reach of children. Store away from direct sunlight, heat and moisture.•Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.Meiji Seika Pharma Co., Ltd.InternalPublished: 12/2013The 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.