双酒石酸长春瑞滨注射剂Navelbine

双酒石酸长春瑞滨注射剂Navelbine

药店国别:

产地国家:日本

处方药:是

所属类别: 40毫克/4毫升/瓶

包装规格: 40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:Kyowa Hakko Kirin

原产地英文商品名:Navelbine Injection(ナベルビン注)40mg/4ml/Vial

原产地英文药品名:Vinorelbine ditartrate

中文参考商品译名:NAVELBINE(ナベルビン注)40毫克/4毫升/瓶

中文参考药品译名:双酒石酸长春瑞滨

曾用名:

简介:部份中文长春瑞滨资料(仅供参考)药品英文名Vinorelbine药品别名异长春花碱、长春瑞宾、去甲长春花碱、盖港、诺维本、Navelbine、NVB、Ditartrate

药物剂型注射剂:

10mg(1ml),40mg(4ml)),50mg(5ml)。

药理作用:

与前述的长春花生物碱相似,本品的作用系通过阻滞微管蛋白聚合形成微管和诱导微管解聚,使细胞停止于细胞分裂中期,系抗有丝分裂的细胞周期特异性药物。动物实验表明NVB对多种肿瘤有抑制作用,具有广谱的抗肿瘤活性。药动学仅静脉给药,组织吸收迅速,且在组织中的浓度明显高于VDS和VCR,在肺内浓度差别最大,分别高于VDS和VCR3.4和14.8倍,而在脂肪组织中、胃肠道组织中仅有微小差别。半衰期长,平均为40h。NVB的代谢主要发生在细胞外,大多由粪便排出,且持续3~5周。

适应症:

1.非小细胞肺癌:是目前单药治疗最有效的药物之一,单药有效率高达30%。

2.乳腺癌:是较为有效的药物之一,与其他有效药物联合治疗,总有效率超过60%,完全缓解率达20%左右。

3.晚期卵巢癌:用于治疗强烈化疗后复发或进展的晚期卵巢癌,耐受性较好。

4.其他:如恶性淋巴瘤、头颈部癌、小细胞肺癌、食管癌等。

剂量与用法:

静脉给药:25~30mg/m2(低于20mg/m2时疗效下降或无效)溶于生理盐水10~20ml,静脉注射,或以生理盐水125~150ml稀释,快速静脉滴入(15~20min),每周1次,2次为1个疗程。

禁忌症:

在进行包括肝脏的放疗时禁用本品。

注意事项:

1.本品局部刺激性强,注射时应特别注意,药物注射完毕时应沿原静脉输入大量生理盐水,以减轻局部血管的刺激性。必要时先给予深静脉置管。

2.使用时避免药物溅到皮肤或眼球内,一旦发生这种情况应立即进行冲洗。

不良反应:

1.骨髓抑制:为其主要剂量限制毒性。主要是白细胞减少,尤其是粒细胞减少,3、4度白细胞下降占11%~15%。可有贫血,血小板下降少见。

2.胃肠道反应:恶心、呕吐等,均较轻。

3.神经毒性:较VCR轻,有感觉异常、便秘,偶有腱反射消失,有致麻痹性肠梗阻的报道。

4.呼吸道毒性:本品可引起呼吸困难和气管痉挛,常于注药后数min或几小时内发生。

5.局部刺激:与其他长春花生物碱类药物相同,具有很强的局部刺激性,常用剂量(30mg/m2)时,注射部位静脉炎发生率为18%。

6.其他:脱发、转氨酶升高、下颌痛等。

用法用量:

25~30mg/m2,静脉注射,每周1次,2次为1个疗程专家点评NVB是目前治疗转移性及复发性乳腺癌、非小细胞肺癌最有效的药物之一,NVB与其他药物联合治疗晚期或复发性卵巢癌、食管癌、头颈部癌、淋巴瘤等也取得较好疗效,故临床应用日趋广泛。

双酒石酸长春瑞滨注射剂英文版说明书:

Navelbine Injection 10(Vinorelbine ditartrate)Navelbine Injection 10(ナベルビン注10)Brand name : Navelbine Injection 10 Active ingredient: Vinorelbine ditartrate Dosage form: injection Print on wrapping:Effects of this medicineThis medicine exerts an anti-tumor effect by stopping the function of microtubules that play an important role in cell division.It is usually used for the treatment of non-small cell lung cancer, and inoperable or recurrent breast cancer.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 decrease in bone marrow function, infections, liver disorder, history of interstitial pneumonia or pulmonary fibrosis, neurological or muscular diseases or history of these conditions, ischemic heart disease or history of this condition, or a tendency for constipation.•If you are 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 <>•Non-small cell lung cancer: In general, for adults, this medicine is administered intravenously once a week.Inoperable or recurrent breast cancer: In general, this medicine is administered intravenously once a week for 2 consecutive weeks, then discontinued in the third week.In any case, the dosage intervals depend on concomitant medicines or symptoms/conditions. Ask your doctor about your dosing schedule.Precautions while taking this medicine• Possible adverse reactions to this medicineThe most commonly reported adverse reactions include bone marrow depression, loss of appetite, general malaise, alopecia, nausea, fever, vomiting, phlebitis, stomatitis, constipation, diarrhea, paresthesia/reduced tendon reflexes, and allergy-like symptoms. 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.•general malaise, bruise, dizziness [myelosuppression (leukopenia, anemia, and thrombocytopenia)]•fever, headache, breathing difficulty [interstitial pneumonia, pulmonary edema]•wheezing, crowing sound when breathing, sudden shortness of breath [bronchospasm]•intense abdominal pain, abdominal bloating, no output of stool [paralytic ileus]•general malaise, breathing difficulty, feeling of tight chest [cardiac failure, myocardial infarction, angina pectoris]•rash, breathing difficulty, decreased blood pressure [shock, anaphylaxis]•fever, cough, chest pain, breathing difficulty [pulmonary embolism]•convulsion, impaired consciousness, loss of appetite [syndrome of inappropriate antidiuretic hormone secretion]•general swelling, fatigability, difficulty in urination [acute renal failure]•sudden intense pain in low back and back, fever, nausea/vomiting [acute pancreatitis]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.Kyowa Hakko Kirin Co.,LtdInjectionRevised: 2/2015The 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.http://www.info.pmda.go.jp/go/pack/4240407A1028_1_17/

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