英文药名：TAXOL INJECTION（Paclitaxel） 中文药名：紫杉醇注射液 生产厂家：施贵宝有限公司 タキソール注射液30mg／タキソール注射液100mg 类别名称 抗肿瘤药 欧文商標名 TAXOL INJECTION 一般名： パクリタキセル（Paclitaxel） 化学名： (－)-(1S,2S,3R,4S,5R,7S,8S,10R,13S)-4,10-Diacetoxy-2-benzoyloxy-5,20-epoxy-1,7-dihydroxy-9-oxotax-11-en-13-yl(2R,3S)-3-benzoylamino-2-hydroxy-3-phenylpropionate 構造式： 分子式： C47H51NO14 分子量： 853.91 融点： 220～223℃ 性状： 紫杉醇是淡黄白色粉末白色。易溶于苄醇，微溶于乙腈或甲醇，乙醇（99.5）微溶，并且几乎不溶于水。 操作注意事项 1.在这种药物与输液混合，尽快使用可以。 2.打开包装也省去把小瓶在一个盒子里的东西后。 3.制备过程中最好是戴上手套。如果化学附着到皮肤尽可能彻底冲洗立即用大量自来水。 适应病症 卵巢癌，非小细胞肺癌，乳腺癌，胃癌，子宫内膜癌，头颈癌复发或远处转移，食道癌具有复发或远处转移，血管肉瘤，逐行或复发宫颈癌，复发或难治生殖细胞肿瘤（睾丸肿瘤，卵巢肿瘤，性腺外肿瘤） 用法用量 *非小细胞肺癌并用的方法，子宫内膜癌。 乳腺癌的使用方法A或B方法。 使用与A法或卡铂组合C法的卵巢癌。 胃癌使用方法A或E法。 在使用中与其他抗肿瘤剂组合的一种方法，复发或难治性生殖细胞肿瘤。 头颈部癌复发或远处转移，有复发或远处转移食管癌，血管肉瘤将使用B法。 宫颈癌进展或复发联合顺铂，使用D方法。 A法： 成人，每天一次210毫克/平方米（体表面积）分配的时间内滴注3小时，随后停药至少3周。以此为1冷的，重复的管理。 B法： 成人，分配在1小时内静脉滴注每天一次100毫克/米2（体表面积），施用一次为连续6周出现周，随后停药至少两周。以此为1冷的，重复的管理。 C法： 成人，为分配在1小时内静脉点滴，每天一次80毫克/米2（体表面积），连续三周给药每周一次。以此为1冷的，重复的管理。 D法： 成人，为每日一次135mg/平方米（体表面积）的静脉滴注超过24小时，然后停药至少3周。以此为1冷的，重复的管理。 ＊E法： 成人，分配在1小时内静脉点滴，每天一次80毫克/米2（体表面积），连续三周给药，每周一次，随后停药至少两周。以此为1冷的，重复的管理。 应当指出的是，剂量是根据患者的病情减轻。 药效药理 1.抗肿瘤作用 小鼠移植人卵巢癌（A2780），非小细胞肺癌（LX-1，L2987，H2981），乳腺癌（MCF-7，MX-1），胃癌（MKN-1，MKN-45，MKN-74，ST-4），相对于子宫内膜癌（EC-1-JCK），肿瘤消退效果或肿瘤生长抑制效果已经观察到。 在体外，对顺铂（CDDP）人卵巢癌细胞培养KF1以及该耐顺铂株KFrb灵敏度的测试中，肿瘤生长的抑制效果已经观察到。 此外，在考虑由顺铂抗性株（A2780卵巢癌），紫杉醇没有显示交叉耐药性。 2. 作用机序 引起的稳定化以及通过促进微管蛋白聚合过度微管形成的，通过有丝分裂纺锤体的功能失效发挥抑制对细胞分裂的抗肿瘤活性。 此外，检查染色体的使用紫杉醇治疗培养癌细胞（HeLa细胞），随着时间的推移G2 + M期的动力学增加并观察到细胞的细胞，最下列药物加入18和27小时G1期降低细胞是G2 + M期，它表现出染色体四倍体。从这个结果，紫杉醇被认为阻止在G2 + M期的细胞周期。 包装规格 紫杉醇注射液 30毫克    5mL（含30毫克的紫杉醇）1瓶 100毫克   16.7mL（含100毫克的紫杉醇）1瓶 制造商 施贵宝有限公司 注：以上中文资料不够完整，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/4240406A1031_1_19/ TAXOL INJECTION（Paclitaxel） TAXOL INJECTION 100mg（タキソール注射液100mg）  Brand name : TAXOL INJECTION 100mg 　Active ingredient: Paclitaxel 　Dosage form: injection 　Print on wrapping: TAXOL INJECTION 30mg（タキソール注射液30mg）  Brand name : TAXOL INJECTION 30mg 　Active ingredient: Paclitaxel 　Dosage form: injection 　Print on wrapping: Effects of this medicine This medicine enters the cells and suppresses growth of malignant cells to destroy them. It is usually used to treat ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, uterine corpus cancer, recurrent/distant metastatic head and neck cancer, recurrent/distant metastatic esophageal cancer, angiosarcoma, progressive/recurrent uterine cervical cancer and recurrent/refractory germ cell tumor (testicular/ovarian/extragonadal tumor). 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, infections 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>> •For non-small cell lung cancer and uterine corpus cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks. For breast cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks, or administer for 1 hour once a week for 6 weeks in a row as 1 course with a drug cessation period of at least 2 weeks and repeat the course. For ovarian cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks, or administer for 1 hour once a week for 3 weeks in a row as 1 course and repeat the course. For gastric cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks, or administer for 1 hour once a week for 3 weeks in a row as 1 course with a drug cessation period of at least 2 weeks and repeat the course. For recurrent/refractory germ cell tumor: In general, repeat the cycle of administering intravenous infusion for 3 hour once a day with a drug cessation period of at least 3 weeks. For recurrent/distant metastatic head and neck cancer recurrent/distant metastatic esophageal cancer and angiosarcoma: In general, administer for 1 hour by intravenous infusion once a week for 6 weeks in a row as 1 course with a drug cessation period of at least 2 weeks and repeat the course. For progressive/recurrent uterine cervical cancer: In general, repeat the cycle of administering intravenous infusion for 24 hours once a day with a drug cessation period of at least 3 weeks. •It may be administered over a long period according to your response to the treatment. •Dexamethasone, Ranitidine or Famotidine, and Diphenhydramine will be used before treatment with this medicine in order to prevent hypersensitivity reaction. Precautions while taking this medicine •This medicine contains alcohol which may cause drowsiness or dizziness. Avoid driving a car or operating dangerous machinery after administering this medicine. Possible adverse reactions to this medicine The most commonly reported adverse reactions include peripheral neuropathy, joint pain, muscle pain, nausea/vomiting, loss of hair, fever, rash, nail disorder, taste disorder, dizziness, fatigue, edema, diarrhea, constipation, loss of appetite, stomatitis, nasopharyngitis, weight loss, weight gain, hypertension and interstitial pneumonia. 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. •sudden respiratory distress, chest pain, reduction in blood pressure, fast/slow pulse, hot flush in face, edema, sweating [shock, anaphylactoid symptoms] •fever, chill, sore throat, cough, pain during urination, bleeding tendency, continuous bleeding, anemia [myelosuppression such as leukopenia] •paralysis of limbs, difficulty in buttoning up clothes or manual dexterity task [peripheral neuropathy, paralysis] •persistent cough, breathing difficulty, fever [interstitial pulmonary disease, fibrosis of the lung] •sudden respiratory distress [acute respiratory distress syndrome] •palpitation, shortness of breath, chest pain, breathing difficulty [myocardial infarction, congestive heart failure, cardiac conduction disorder, pulmonary embolism, thrombophlebitis, stroke, pulmonary edema] •hearing loss, ear ringing [hearing impairment, ear ringing] •severe stomachache, hematoma [gastrointestinal necrosis, gastrointestinal perforation, gastrointestinal bleeding, gastrointestinal ulceration] •severe stomachache, diarrhea [serious bowel inflammation] •loss of appetite, nausea/vomiting, severe constipation, stomachache, abdominal distention [intestinal tract obstruction, paralysis of intestine] •jaundice [hepatic function disorder, jaundice] •severe upper abdominal pain [pancreatitis] •inability to pass urine, urine with blood [acute renal failure] •ring-shaped erythema in limbs, fever, diarrhea, burn-like symptoms [oculomucocutaneous syndrome, toxic epidermal necrolysis] •bleeding tendency, continuous bleeding [disseminated intravascular coagulation] •loss of urine volume [tumor lysis syndrome] •unstableness while walking, speech disorder, memory loss, slow movement [leukoencephalopathy (includes reversible posterior leukoencephalopathy 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. Bristol-Myers SquibbInjection Revised: 9/2015 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 treatment.