紫杉醇注射液(TAXOL INJECTION 30mg)

产地国家:日本

处方药:是

所属类别: 30毫克/5毫升/瓶

包装规格: 30毫克/5毫升/瓶

计价单位:瓶

生产厂家英文名:Bristol-Myers

原产地英文商品名:TAXOL INJECTION(タキソール注射液)30mg/5mL/vial

原产地英文药品名:Paclitaxe

中文参考商品译名:Taxol注射剂(タキソール注射液)30毫克/5毫升/瓶

中文参考药品译名:紫杉醇

简介:

部份中文紫杉醇处文资料(仅供参考)

通用名:紫杉醇注射液

英文名:Paclitaxel Injection

商品标:Taxol

作用类别:药理毒理本品是新型抗微管药物,通过促进微管蛋白聚合抑制解聚,保持微管蛋白稳定,抑制细胞有丝分裂。体外实验证明紫杉醇具有显著的放射增敏作用,可能是使细胞中止于对放疗敏感的G2和M期。药代动力学静脉给予紫杉醇,药物血浆浓度呈双相曲线。本品蛋白结合率89%~98%,紫杉醇在肝脏代谢。紫杉醇主要在肝脏代谢,随胆汁进入肠道,经粪便排出体外(90%)。经肾清除只占总清除的1%~8%,肾功能不全者一般紫杉醇在肝肾功能不全的病人体内代谢尚不明确。

适应症:卵巢癌和乳腺癌及NSCLC的一线和二线治疗。头颈癌、食管癌,精原细胞瘤,复发非何金氏淋巴瘤等。

用法和用量:为了预防发生过敏反应,在紫杉醇治疗前12小时口服地塞米松10mg,治疗前,6小时再囗服地塞米松10mg,治疗前30~60分钟给予苯海拉明肌注20mg,静注西咪替丁300mg或雷尼替丁50mg。单药剂量为135~200mg/m2,在G-CSF支持下,剂量可达250mg/m2。将紫杉醇用生理盐水或5%葡萄糖盐水稀释,静滴3小时。联合用药剂量为135~175mg/m2,3~4周重复。

不良反应

1、过敏反应:发生率为39%,其中严重过敏反应发生率为2%。多数为1型变态反应,表现为支气管痉挛性呼吸困难,荨麻疹和低血压。几乎所有的反应发生在用药后最初的10分钟。

2、骨髓抑制:为主要剂量限制性毒性,表现为中性粒细胞减少,血小板降低少见,一般发生在用药后8~10日。严重中性粒细胞发生率为47%,严重的血小板降低发生率为5%。贫血较常见。

3、神经毒性:周围神经病变发生率为62%,最常见的表现为轻度麻木和感觉异常,严重的神经毒性发生率为6%。

4、心血管毒性:可有低血压和无症状的短时间心动过缓。肌肉关节疼痛:发生率为55%,发生于四肢关节,发生率和严重程度呈剂量依赖性。

5、胃肠道反应:恶心,呕吐,腹泻和黏膜炎发生率分别为59%,43%和39%,一般为轻和中度。

6、肝脏毒性:为ALT,AST和AKP升高。

7、脱发:发生率为80%。

8、局部反应:输注药物的静脉和药物外渗局部的炎症。

禁忌:对聚氧乙基代蓖麻油过敏者。禁用于中性白细胞低于1500/MM者。

注意事项:治疗前应用地塞米松,苯海拉明和H2受体拮抗剂进行预处理。未稀释的浓缩药液不要接触聚氯乙烯塑料器械或设备,且不能进行静脉滴注。稀释的药液应储藏在瓶内或塑料袋,采用聚氯乙烯给药设备滴注。给药期间应注意有无过敏反应及生命特征的变化。孕妇及哺乳期妇女用药紫杉醇在动物实验中证实影响胚胎生长,故孕妇禁用。育龄妇女,治疗期不宜怀孕。

药物相互作用:药代动力学资料证明顺铂后给予本品,本品清除率大约降低30%,骨髓毒性较为严重。同时应用酮康唑影响本品的代谢。药物过量尚无相应的解毒药。用药过量最主要的,可预测的并发症包括骨髓抑制,外周神经毒性及黏膜炎。

贮藏:遮光,密闭25℃以下保存。

英文版说明书:

TAXOL INJECTION(Paclitaxel)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 medicineThis 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 medicineThe 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 SquibbInjectionRevised: 9/2015The 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.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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