替加氟配合口腔崩解片TS-1 combination OD tablet 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/片 56片 包装规格： 20毫克/片 56片 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 OD tablet T20(ティーエスワン配合OD錠T20)20mg/tablet 56tablet 原产地英文药品名：Tegafur/Gimeracil/Oteracil Potassium 中文参考商品译名：TS-1 combination口腔崩解片(ティーエスワン配合OD錠T20)20毫克/片 56片 中文参考药品译名：替加氟/吉莫斯特/氧嗪酸钾 曾用名： 简介： 部分中文替加氟配合口腔崩解片资料(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 配合OD錠T20　PTP包装：56錠(14錠×2×2)、140錠(14錠×2×5)Brandname 　英文版说明书 TS-1 combination OD Tablet T20　Active ingredient: TegafurGimeracilOteracil potassium　Dosage form: Pale blue-green tablet with white central part on one side, φ: 7.5 mm, thickness: 3.5 mm　Print on wrapping: TC41 20mgEffects of this medicineTS-1 is biotransformed into fluorouracil (anticancer drug) in the body, enhances antitumor activity by increased concentration and relieves gastrointestinal toxicities (side effects).Before using this medicine, be sure to tell your doctor and pharmacist•If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you present a condition indicative of bone marrow suppression (including leukopenia).If you have renal or hepatic dysfunction. If you have an infectious disease or diabetes.If you have a current or past history of interstitial pneumonia. If you have a heart disease or a history of heart disease.If you have gastrointestinal ulcers or hemorrhage.•If you are using fluoropyrimidine-group anti-cancer drugs. (TS-1 and these medicines may interact strongly with each other and cause serious side effects.)•If you are transferring the medicine from fluoropyrimidine-group anti-cancer medicine to this medicine. (An appropriate washout period must be provided in consideration of the influence of these prior agents.)•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, TS-1 is usually administered twice daily 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 patient's condition. Initial standard dose of Tegafur is determined based on body surface area (BSA) as follows: 40mg per dose for patients with a BSA less than 1.25 m2., 50 mg per dose for patients with a BSA 1.25 to less than 1.5 m2. and 60 mg per dose for patients with a BSA equal to or greater than 1.5 m2. The dose may be decreased or increased to single dosing level of 40mg, 50mg, 60mg, or 75mg. The maximum single dose should not exceed 75mg, with the minimum dose of 40mg. This medicine contains 20 mg of Tegafur in each tablet. Strictly follow the instruction of your doctor / pharmacist.•Place the tablet in your mouth and wait until it dissolves naturally by saliva, then swallow with saliva. You may also take this medicine with a glass of water or warm water. Do not take the medicine without water while in lying position.•TS-1 must NOT be taken with other fluoropyrimidine-group anti-cancer drugs.•Record your drug consumption, your physical condition and symptoms and show your records to your physician or pharmacist on your next visit.•Proceed with the prescribed schedule of medication starting from the next dose. DO NOT take a double dose to make up for the missed dose.•If you missed a dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.•If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.•Do not change the amount of your dose or your dosing schedule without the instruction of your doctor.Precautions while taking this medicine•During the treatment, laboratory tests (hematological, liver and renal function tests) are performed regularly at least once every 2 weeks to detect asymptomatic side effects as early as possible. Be sure to keep your visiting schedule.Possible adverse reactions to this medicineCommon side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:anorexia, nausea, vomiting, diarrhea, tiredness, stomatitis, pigmentation, rash, lacrimation, etc.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.•bleeding tendency, tiredness, fever, sore throat [bone marrow suppression]•yellowing of the skin, tiredness, yellowing of the whites of the eyes, anorexia [[severe hepatic dysfunction]•diarrhea, severe abdominal pain [severe enteritis]•breathing difficulty, fever, dry cough [interstitial pneumonia]•blood in stool, darkened stool, hematemesis, abdominal pain [gastrointestinal ulcer / gastrointestinal hemorrhage / gastrointestinal perforation]•severe stomatitis, red rash, eyelid or eye redness [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 the medicine out of the reach of babies, infants, and children. Store away from direct sunlight, heat, and humidity.•Discard the remainder. Do not store them. Check with the pharmacy regarding how to discard.TAIHO Pharmaceutical Co.,LTD.InternalPublished: 6/2013The 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.