塞替派粉末溶液输注TEPADINA powder solution 15MG

药店国别： 产地国家：德国 处方药：是 所属类别： 15毫克/瓶 包装规格： 15毫克/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：ADIENNE S.r.l. S.U. 原产地英文商品名：TEPADINA powder solution infusion 15MG/VIAL 原产地英文药品名：THIOTEPA 中文参考商品译名：TEPADINA粉末溶液输注 15毫克/瓶 中文参考药品译名：塞替派 曾用名： 简介：部份中文塞替派处方资料(仅供参考)中文通用名称：塞替派英文通用名称：Thiotepa其它名称：二胺硫磷、硫替哌、三胺硫磷、三乙撑硫代磷酰胺、三乙烯硫化磷酰胺、室安的宝、息安的宝、Ledertepa、NSC-6396、Onco Tuitepa、Oncotiotepa、Phosphorothionic Triethenamide、TESPA、Tespamin、Thiofosyl、Thiophosphamide、Thiophosphoramide、Thioplex、Thiotepa Lederle、Thio-TERA、Tifosyl、Tiofosamid、Tiotepum、Triethylenethiophosphoramide、TSPA临床应用主要用于治疗乳腺癌、卵巢癌、膀胱癌(局部灌注)及癌性体腔积液(腔内注射)等，也曾用于治疗原发性肝癌、子宫颈癌、黑色素瘤、胃肠道肿瘤等。 药理: 1.药效学 本药为多功能烷化剂类抗肿瘤药，属非特异性细胞周期药物。本药在结构上具有乙撑亚胺基，在生理条件下，可形成不稳定的亚乙基亚胺基，与DNA的碱基发生交叉联结，使碱基烷基化，从而干扰DNA和RNA的功能，达到抗肿瘤的目的。体外实验显示，本药可引起染色体畸变，动物实验(小鼠)表明本药有致癌性。 2.药动学 本药不易经消化道吸收。快速静脉注射给药(低于5分钟)后5分钟内血药浓度达峰值;膀胱灌注或腔内注射后25分钟内在血循环中可检测出本药。在体内广泛分布于各组织，血浆蛋白结合率为10%(主要白蛋白、脂蛋白结合)。可透过血-脑脊液屏障，脑脊液中的药物浓度为血浆浓度的60%-100%。主要在肝脏经细胞色素P450氧化代谢为替派(tepa)。本药半衰期α相为6分钟，β相为10分钟，注射后1-4小时血药浓度下降90%。大部分药物于24-48小时内以代谢物形式经尿液排出(原形不足1%)。 注意事项: 1.禁忌症(1)对本药过敏者。(2)有严重肝、肾功能不全者。(3)严重骨髓抑制者。(4)孕妇。 2.慎用(1)有骨髓抑制或肿瘤已浸润至骨髓者。(2)肝、肾功能不全者。(3)感染患者。(4)有泌尿系统结石史和痛风史者。 3.药物对妊娠的影响 本药可能有致畸性，不推荐孕妇使用，特别是妊娠初期应避免使用。 4.药物对哺乳的影响 尚不清楚本药能否分泌入人类乳汁，哺乳妇女用药时应权衡利弊。 5.药物对检验值或诊断的影响 可致血尿酸水平增加。 6.用药前后及用药时应当检查或监测 用药期间及停药后3周内应定期检查血常规、血小板计数及肝、肾功能。 不良反应: 1.血液系统 骨髓抑制为本药剂量限制性毒性，多于用药后1-6周出现，部分患者在疗程结束后才出现，停药后大多可恢复，部分患者骨髓抑制持续时间较长。 2.胃肠道 可有食欲减退、恶心及呕吐等胃肠道反应。 3.其它 少见过敏反应，个别患者有发热、疲乏、脱发及皮疹。尚可见头痛头晕、注射部位疼痛、出血性膀胱炎、女性闭经和男性精子形成异常。 药物相互作用: ·药物-药物相互作用1.本药与尿激酶同时应用治疗膀胱癌时，尿激酶可增加本药在肿瘤组织中的浓度。 2.本药可抑制假胆碱酯酶的活性，而延长琥珀胆碱的作用时间。 3.使用本药时接种活疫苗(如轮状病毒疫苗)，将增加活疫苗感染的风险。 给药说明: 1.本药稀释后如有浑浊，则不能使用。 2.为防止高尿酸血症，治疗时可大量补液、碱化尿液，必要时服用别嘌醇等抗尿酸药。 3.在放疗的同时使用本药，应适当调整剂量。 4.国外资料提示，当白细胞计数低于3×10×E9/L或血小板计数低于150×10×E9/L时，应停用本药。 5.药物过量时尚无特效解毒药。 用法与用量: 成人·常规剂量·静脉注射 每次10mg(或0.2mg/kg)，每日1次，连用5日后改为每周3次，一个疗程总量为300mg。1.5-2月后可重复下一疗程。·肌内注射 同静脉注射。·动脉注射：每次10-20mg，用法同静脉注射。·腔内注射(胸腹腔或心包腔)：每次10-30mg，每周1-2次。·膀胱灌注 每次50-100mg，溶于生理盐水50-100mL中，通过导尿管将本药注入膀胱，每周1次，4周后改为每月1次，10次为一疗程。·瘤内注射 每次5-10mg，可注射一处或多处。制剂与规格塞替派注射液 1mL:10mg。贮法：遮光、密闭、在冷处保存。注射用塞替派 (1)5mg。(2)10mg。贮法：遮光、密闭、在冷处保存。 塞替派粉末溶液输注英文版说明书: TEPADINA 100 mg powder for concentrate for solution for infusionTEPADINA® 15mg/TEPADINA® 100 mgSummary for the publicWhat is Tepadina?Tepadina is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance thiotepa.What is Tepadina used for?Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways:as a ‘conditioning’ (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells). This type of transplant is used in patients who need to replace their blood-making cells because they have a blood disease such as a cancer of the blood (including leukaemia) or diseases causing low red blood cell counts (including thalassaemia or sickle-cell anaemia);during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.Tepadina can be used for transplantation of cells from a donor and for transplantation of cells derived from the patient’s own body.Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 January 2007.The medicine can only be obtained with a prescription.How is Tepadina used?Tepadina treatment must be supervised by a doctor who has experience in treatments given before transplantation. It must be given as an infusion into a large vein lasting two to four hours.The dose of Tepadina depends on the type of blood disease or solid tumour that the patient has and the type of transplantation to be carried out. The dose also depends on the patient’s body surface area (calculated using the height and weight of the patient). In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation. In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation. For further information, see the Summary of Product Characteristics (also part of the EPAR).How does Tepadina work?The active substance in Tepadina, thiotepa, belongs to a group of medicines called ‘alkylating agents’. These substances are ‘cytotoxic’. This means that they kill cells, especially cells that multiply rapidly, such as cancer or progenitor (or ‘stem’) cells (cells that can develop into different types of cell). Tepadina is used with other medicines before transplantation to destroy the abnormal cells and the patient’s existing blood-making cells. This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection.Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.How has Tepadina been studied?Because thiotepa has been used for many years in the EU, the company presented data from the published literature. This included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumours, who were having a transplant of blood-making cells. The studies looked at the number of patients with successful transplantations, how long it took for the diseases to come back and how long the patients survived.What benefit has Tepadina shown during the studies?The published studies showed that thiotepa used in combination with other chemotherapy medicines is beneficial to adults and children being treated for blood diseases and solid tumours. It helps to destroy the patient’s existing blood-making cells, resulting in the successful transplantation of new cells, improved survival and a reduced risk of the diseases coming back.What is the risk associated with Tepadina?The most common side effects seen with Tepadina when used with other medicines are infections, cytopenia (low number of cells in the blood), graft-versus-host disease (when the transplanted cells attack the body), disorders of the gut, haemorrhagic cystitis (bleeding and inflammation in the bladder) and mucosal inflammation (inflammation of the moist body surfaces). For the full list of all side effects reported with Tepadina in adults and children, see the Package Leaflet.Tepadina should not be used in people who may be hypersensitive (allergic) to thiotepa or any of the other ingredients. It must not be used in women who are pregnant or breast-feeding. It must also not be used together with the vaccine against yellow fever or vaccines containing live viruses or bacteria.Why has Tepadina been approved?The Committee for Medicinal Products for Human Use (CHMP) noted that the active substance in Tepadina, thiotepa, has a well established used. This means that it has been used for many years and that there was sufficient information on its effectiveness and safety. The Committee decided that, based on available published information, Tepadina’s benefits are greater than its risks and recommended that it be given marketing authorisation.Other information about Tepadina:The European Commission granted a marketing authorisation valid throughout the European Union for Tepadina to Adienne S.r.l. on 15 March 2010. The marketing authorisation is valid for five years, after which it can be renewed.