多西他赛[泰索帝仿制药]DOCETAXEL ONE-VIAL 160mg/16ml

药店国别： 产地国家：美国 处方药：是 所属类别： 160毫克/16毫升/瓶 1瓶 包装规格： 160毫克/16毫升/瓶 1瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：PFIZER INC. 原产地英文商品名：DOCETAXEL(TAXOTERE GENERIC) 160mg/16ml/Vial 原产地英文药品名：DOCETAXEL 中文参考商品译名：多西他赛(泰索帝仿制药) 160毫克/16毫升/瓶 中文参考药品译名：多西他赛

简介

  部份中文多西他赛处方资料(仅供参考) 英文名称:DOCETAXEL 中文药名：多西他赛 药物类别：其他抗肿瘤药 药品介绍 DOCETAXEL(DOCETAXEL[泰索帝仿制药])注射液，用于静脉注射最初的美国批准：1996年警告：有毒死亡，肝毒性，新生儿，过敏反应和流体保留请参阅完整的警告信息以获得完整的警告治疗相关死亡率随着肝功能异常，高剂量和NSCLC患者以及以100mg/m 2接受多西紫杉醇的铂类治疗而增加。 如果胆红素> ULN，或AST和/或ALT>1.5×ULN伴随碱性磷酸酶>2.5×ULN，则不应给予。LFT升高会增加严重或危及生命的并发症的风险。在每个治疗周期之前获得LFT。如果中性粒细胞计数<1500个细胞/mm，则不应给予3.频繁血细胞计数以监测中性粒细胞减少症。 在接受地塞米松预先给药的患者中报告了严重的超敏反应，包括非常罕见的致命过敏反应。严重反应需要立即停用多西紫杉醇注射液并进行适当的治疗。如果对多西紫杉醇或用聚山梨醇酯80配制的药物的严重超敏反应史，则禁忌。尽管使用地塞米松，仍可能发生严重的液体潴留。 DOCETAXEL(DOCETAXEL[泰索帝仿制药])注射液，用于静脉注射最初的美国批准：1996年警告：有毒死亡，肝毒性，新生儿，过敏反应和流体保留请参阅完整的警告信息以获得完整的警告治疗相关死亡率随着肝功能异常，高剂量和NSCLC患者以及以100mg/m 2接受多西紫杉醇的铂类治疗而增加。 如果胆红素> ULN，或AST和/或ALT>1.5×ULN伴随碱性磷酸酶>2.5×ULN，则不应给予。LFT升高会增加严重或危及生命的并发症的风险。在每个治疗周期之前获得LFT。如果中性粒细胞计数<1500个细胞/mm，则不应给予3.频繁血细胞计数以监测中性粒细胞减少症。 在接受地塞米松预先给药的患者中报告了严重的超敏反应，包括非常罕见的致命过敏反应。严重反应需要立即停用多西紫杉醇注射液并进行适当的治疗。如果对多西紫杉醇或用聚山梨醇酯80配制的药物的严重超敏反应史，则禁忌。尽管使用地塞米松，仍可能发生严重的液体潴留。 作用机制 多西紫杉醇是一种抗肿瘤剂，通过破坏有丝分裂和间期细胞功能所必需的细胞中的微管网络起作用。多西紫杉醇与游离微管蛋白结合并促进微管蛋白组装成稳定的微管，同时抑制它们的分解。这导致产生没有正常功能的微管束和微管的稳定化，这导致细胞中有丝分裂的抑制。多西紫杉醇与微管的结合不会改变结合微管中的原丝数量，这一特征与目前临床使用的大多数纺锤体毒物不同。 适应症和用法 多西紫杉醇注射液是一种微管抑制剂，适用于：乳腺癌(BC)：化疗失败后局部晚期或转移性BC的单一药物;并用阿霉素和环磷酰胺作为可操作淋巴结阳性BC的辅助治疗。非小细胞肺癌(NSCLC)：铂类治疗失败后局部晚期或转移性NSCLC的单一药物;顺铂治疗无法切除，局部晚期或转移性未治疗的NSCLC。激素难治性前列腺癌(HRPC)：与雄激素非依赖性(激素难治)转移性前列腺癌的泼尼松。胃腺癌(GC)：用顺铂和氟尿嘧啶治疗未经治疗的晚期胃癌，包括胃食管连接。头颈癌鳞状细胞癌(SCCHN)：顺铂和氟尿嘧啶用于局部晚期SCCHN的诱导治疗。 剂量和给药 在配备有管理可能的并发症(例如，过敏反应)的设施中施用。每3周静脉内施用1小时。不建议使用PVC设备。对于One-vial配方，仅使用21号针头从小瓶中取出多西紫杉醇注射液。BC：局部晚期或转移：60mg/m 2至100mg/m 2单一药剂。BC佐剂：阿霉素50mg/m 2后1小时给药75mg/m2，每3周给予环磷酰胺500mg/m 2，共6个周期。NSCLC：铂类治疗失败后：75mg/m 2单剂。NSCLC：未接受化疗：75mg/m 2，然后顺铂75 mg/m2。HRPC：75mg/m 2，每天两次，连续使用5 mg泼尼松。GC：75mg/m 2，接着顺铂75mg/m 2(仅在第1天)，然后每天使用氟尿嘧啶750mg/m 2作为24小时静脉输注(第1天至第5天)，从结束时开始顺铂输注。SCCHN：75mg/m 2，然后静脉注射顺铂75mg/m 2(第1天)，然后每天750mg/m 2氟尿嘧啶作为24小时静脉输注(第1天至第5天)，从顺铂结束开始输液;持续4个周期。SCCHN：75mg/m 2，然后静脉注射顺铂100mg/m 2(第1天)，然后每天1000mg/m2氟尿嘧啶作为24小时静脉内输注(第1至4天);持续3个周期对于所有患者：预先用口服皮质类固醇激素治疗根据需要调整剂量剂量形式和强度用于多西紫杉醇注射液的稀释液80mg/2mL 80mg20mg/0.5mL用多西紫杉醇注射液稀释液20mg一瓶多西紫杉醇注射液：单剂量和多剂量小瓶160mg/8mL，80mg/4mL和20mg/1mL 禁忌症 对多西紫杉醇或聚山梨醇酯过敏80。中性粒细胞计数<1500个细胞/mm 3。 警告和注意事项 急性髓性白血病：接受多西紫杉醇，多柔比星和环磷酰胺治疗的患者，监测延迟性骨髓增生异常或髓样白血病。皮肤反应：可能发生反应，包括四肢红斑伴水肿，随后脱屑。严重的皮肤毒性可能需要调整剂量。神经系统反应：可能发生反应，包括感觉异常，感觉迟钝和疼痛。严重的神经感觉症状需要调整剂量或持续停药。眼部疾病：已报道囊样黄斑水肿(CME)，需要停止治疗。虚弱：可能发生严重的虚弱，可能需要停止治疗。酒精含量：多西紫杉醇注射液中的酒精含量可能会影响中枢神经系统。这可能包括在输注后立即损害患者驾驶或使用机器的能力。怀孕：给孕妇服用可能会导致胎儿受伤。应建议有生育能力的女性在接受多西他赛注射液时不要怀孕。 不良反应 所有多西紫杉醇适应症的最常见不良反应是感染，中性粒细胞减少症

英文版说明书

Docetaxel For InjectionDactinomycin For Injection USPCompositions:Each vial contains Docetaxel 20/80/120 mgPharmacological classification & ATC Classification:L01CD02 - docetaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.Pharmacology:Docetaxel disrupts the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. It binds to the free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly, resulting in inhibition of mitosis.Distribution: Rapidly distributed throughout body tissues. Protein-binding: >95%Metabolism: Extensively hepatic.Excretion: Faeces (as metabolites), urine; 11 hr (elimination half-life).Indications: Docetaxel is primarily indicated in:Breast cancerHead and neck cancerProstate cancerNon-small cell lung cancerGastric adenocarcinomaDosage & administration:IntravenousBreast cancerAdult: As a single agent: Initially, 60-100 mg/m2 BSA by infusion once every 3 wk. In combination therapy: 75 mg/m2once every 3 wk.Hepatic impairment: ALT and/or AST >1.5 times the upper limit of normal (ULN), and alkaline phosphatase >2.5 times the ULN: Reduce dose from 100 mg/m2 to 75 mg/m2. Avoid in severe impairment.IntravenousHead and neck cancerAdult: 75 mg/m2 BSA once every 3 week. For gastric adenocarcinoma: Dose is given before cisplatin and fluorouracil. For head and neck cancer: Treatment is given for 3 cycles followed by chemoradiotherapy or 4 wk followed by radiotherapy alone. For prostatic cancer: May be given with oral prednisolone 5 mg bid continuously during treatment.Hepatic impairment: ALT and/or AST >1.5 times the upper limit of normal (ULN), and alkaline phosphatase >2.5 times the ULN: Reduce dose from 100 mg/m2 to 75 mg/m2. Avoid in severe impairment.IntravenousProstate cancerAdult: 75 mg/m2 BSA once every 3 week. For gastric adenocarcinoma: Dose is given before cisplatin and fluorouracil. For head and neck cancer: Treatment is given for 3 cycles followed by chemoradiotherapy or 4 wk followed by radiotherapy alone. For prostatic cancer: May be given with oral prednisolone 5 mg bid continuously during treatment.Hepatic impairment: ALT and/or AST >1.5 times the upper limit of normal (ULN), and alkaline phosphatase >2.5 times the ULN: Reduce dose from 100 mg/m2 to 75 mg/m2. Avoid in severe impairment.IntravenousNon-small cell lung cancerAdult: 75 mg/m2 BSA once every 3 week. For gastric adenocarcinoma: Dose is given before cisplatin and fluorouracil. For head and neck cancer: Treatment is given for 3 cycles followed by chemoradiotherapy or 4 wk followed by radiotherapy alone. For prostatic cancer: May be given with oral prednisolone 5 mg bid continuously during treatment.Hepatic impairment: ALT and/or AST >1.5 times the upper limit of normal (ULN), and alkaline phosphatase >2.5 times the ULN: Reduce dose from 100 mg/m2 to 75 mg/m2. Avoid in severe impairment.IntravenousGastric adenocarcinomaAdult: 75 mg/m2 BSA once every 3 week. For gastric adenocarcinoma: Dose is given before cisplatin and fluorouracil. For head and neck cancer: Treatment is given for 3 cycles followed by chemoradiotherapy or 4 wk followed by radiotherapy alone. For prostatic cancer: May be given with oral prednisolone 5 mg bid continuously during treatment.Hepatic impairment: ALT and/or AST >1.5 times the upper limit of normal (ULN), and alkaline phosphatase >2.5 times the ULN: Reduce dose from 100 mg/m2 to 75 mg/m2. Avoid in severe impairment.Special Populations:Reduce initial dose by 25% in monotherapy of patients with moderate hepatic impairment.Contraindications:Previous severe hypersensitivity reaction to docetaxel, the solvent or polysorbate 80. Severe neutropenia; pregnancy, severe liver impairment.Side Effects: :Erythematous patches, eruptions, scleroderma, onycholysis, alopoecia, nausea, vomiting, diarrhoea, stomatitis; increases in hepatic transaminases, bilirubin and alkaline phosphatase; mucositis, asthenia, arthralgia, myalgia, paroxysmal atrial tachycardia, atrial flutter, dysrrhythmia, hypertension and heart failure.Potentially Fatal: Neutropenia; fluid retention syndrome; anaemia.Precautions:Lactation. Hepatic impairment. Monitor liver blood function and blood counts regularly. Premedication with oral dexamethsaone at 16 mg daily for 3 days, starting one day before docetaxel treatment is recommended.Drug Interactions:Co-admin of drugs that induce, inhibit, or metabolised by cytochrome P-450 isoenzyme may affect the metabolism of docetaxel.Potentially Fatal: Caution should be exercised during concomitant therapy with ciclosporin, terfenadine,ketoconazole, erythromycin and troleandomycin.Click to view more docetaxel Drug InteractionsPregnancy & Lactation:Category D :There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).Storage:Intravenous: Store at 2-25°C.