多西他赛,多西他赛注射剂(DOCETAXEL INTRAVENOUS INFUSION)

药店国别:

产地国家:日本

处方药:

所属类别: 80毫克/4毫升/瓶

包装规格: 80毫克/4毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:TOWA PHARMACEUTICAL CO

原产地英文商品名:DOCETAXEL INTRAVENOUS INFUSION(ドセタキセル点滴静注)80MG//4mL/VIAL

原产地英文药品名:DOCETAXEL

中文参考商品译名:DOCETAXEL(ドセタキセル点滴静注)80毫克/4毫升/瓶

中文参考药品译名:多西他赛

曾用名:

简介

部份多西他赛中文处方资料(仅供参考)

药品英文名:Docetaxel

药品别名:多西他赛、紫杉特尔、泰索帝、艾素、Taxotere

药物剂型注射剂(粉):20mg,80mg。

药理作用

本品作用机制与紫杉醇相同,稳定微管作用比紫杉醇大2倍。

药代动力学

本品符合三室药代动力学模型,A、B、C阶段半衰期分别是4min、36min和11.1h。按100mg/m2静脉滴注1h测定其平均峰浓度为3.7μg/ml。本品95%以上与血浆蛋白结合,主要从粪便及尿液中排泄,48h内粪便排出约60%,大部分为代谢产物,极少为原形。

适应证

1.卵巢癌、乳腺癌、非小细胞肺癌。

2.其他实体瘤:如头颈部癌、小细胞肺癌、黑色素瘤、胃癌、胰腺癌等。

禁忌证:对本品过敏者、妊娠、哺乳期妇女禁用。

注意事项

1.治疗过程中应不断检测全血细胞计数,中性粒细胞≤1.5×109/L时禁用本品。对于发生严重中性粒细胞减少(<0.5×109/L,持续7天或以上)的患者,在下一疗程中应减少使用剂量。

2.用药前须预防性给予地塞米松等药物。

3.开始给药的前10min内速度宜慢。用药过程中应严密监测,准备好抢救措发生严重过敏反应者应停止使用本品。

4.避光,2~8℃条件下保存。药物溶解后在室温中可保存8h,2~8℃条件下可保存24h。

5.禁用PVC增塑的设备稀释或盛装药液。

不良反应

1.骨髓抑制:主要剂量限制性毒性是中性粒细胞减少,最低点发生于治疗后第8天。也可见血小板下降及贫血。

2.过敏反应:表现为潮红、皮疹、胸部紧缩感、背痛、呼吸困难、药物热和寒战。大多发生于开始输液后的几min。

3.皮肤反应:较常见,表现为局限于手、足、双臂、面部或胸部的凸起皮疹,可伴瘙痒,少数情况下发生脱皮。

4.液体潴留:未行预防用药者发生率为61%,包括水肿、胸腔积液、心包积液、腹水和体重增加等,停药后可消失。预防性口服地塞米松可减少液体潴留及过敏反应的发生率及严重性。

5.胃肠道反应:恶心、呕吐、腹泻、口腔黏膜炎,多为轻度到中度。

6.神经系统:较常见,如感觉迟钝、烧灼感等,多不严重。

7.肝功损害:AST、ALT、胆红素和碱性磷酸酶升高。

8.其他:低血压、脱发、乏力、肌痛、色素沉着、局部刺激、静脉炎。

有报道用药期间出现心动过速、房颤、心律失常、高血压或心力衰竭等。

用法用量

1.75mg/m2加入5%葡萄糖或生理盐水250ml,静脉滴注1h,每3周重复一次,联合用药时剂量酌减。

2.每周疗法:35~40g/m2,每周1次,连用6周停2周。

注:为预防液体潴留和过敏反应的发生,从使用本品前1天开始口服地塞米松,每天16mg,连续5天。

生产厂商:DOCETAXEL INTRAVENOUS INFUSION(Docetaxel)DOCETAXEL INTRAVENOUS INFUSION 80mg/4mL "TOWA"(ドセタキセル点滴静注80mg/4mL「トーワ」)

英文版说明

Brand name:DOCETAXEL INTRAVENOUS INFUSION 80mg/4mL "TOWA" Active ingredient: Docetaxel Dosage form: Injection Print on wrapping:Effects of this medicineThis medicine suppresses growth of cancer cells by inhibiting the function of microtubules required for cell division.It is usually used to treat cancers of the breast, lung, stomach, head and neck, ovary, esophagus, uterine corpus and prostate.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 bone marrow suppression (fever, subcutaneous bleeding), infectious disease, interstitial pneumonia or pulmonary fibrosis.If you have hepatic disorder, kidney disorder, edema or alcohol hypersensitivity.•If you are pregnant, possibly 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 <<to be written by a healthcare professional>>•In general, for adults, inject by intravenous infusion once a day at the interval of every 3 to 4 weeks.•The treatment duration depends on your symptoms.Precautions while taking this medicine• Possible adverse reactions to this medicineThe most commonly reported adverse reactions include loss of appetite, nausea, vomiting, diarrhea, stomatitis, alopecia, numbness, general malaise and fever. 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.•feeling weaker than usual and feverish, subcutaneous bleeding, anemia [bone marrow depression]•breathing difficulty, decreased blood pressure, rash [shock symptoms, anaphylaxis]•general malaise, loss of appetite, yellowness of the skin/white of the eyes [jaundice, hepatic failure, hepatic dysfunction]•edema, small amount of urinary output, general malaise [acute renal failure]•fever, cough, breathing difficulty [interstitial pneumonia, pulmonary fibrosis]•shortness of breath, cough, general edema [heart failure]•dizziness, headache, bleeding tendency (nasal bleeding, bleeding gums, subcutaneous bleeding) [disseminated intravascular coagulation]•abdominal pain, hematemesis, melena [intestinal perforation, gastrointestinal bleeding, ischemic colitis, colitis]•stoppage of defecation, abdominal pain, loss of appetite [ileus]•breathing difficulty suddenly occurring in adults [acute respiratory distress syndrome]•severe pain in the upper abdomen or lower back, fever [acute pancreatitis]•fever, loss of appetite, red rash [mucocutaneous ocular syndrome, toxic epidermal necrosis, erythema multiforme]•breathing difficulty, nausea, edema [cardiac tamponade, pulmonary edema, edema/body fluid retention]•acute precordial pressure, anginal pain, cold sweat [myocardial infarction, venous thromboembolism]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.The 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

 

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