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：瓶 生产厂家英文名：Nippon Kayaku 原产地英文商品名：Rozeus Intravenous Solution(ロゼウス静注液)40mg/4ml/vial 原产地英文药品名：Vinorelbine Ditartrate 中文参考商品译名：Rozeus(ロゼウス静注液)40毫克/4毫升/瓶 中文参考药品译名：长春瑞滨二酒石酸盐

简介

英文药名：Rozeus Intravenous Solution(Vinorelbine Ditartrate) 中文药名：长春瑞滨二酒石酸盐静脉注射液 生产厂家：日本化药 药品介绍 一般名：ビノレルビン酒石酸塩(Vinorelbine Ditartrate) 化学名：(+)-Methyl(3aR,4R,5S,5aR,10bR,13aR)-4-acetoxy-3a-ethyl-9-[(2R,6R,8S)-4-ethyl-1,3,6,7,8,9-hexahydro-8-methoxycarbonyl-2,6-methano-2H-azecino[4,3-b]indol-8-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate ditartrate 分子式：C45H54N4O8・2C4H6O6 分子量：1079.11 构造式：性状长春瑞滨酒石酸盐是一种白色至浅黄白色粉末。水，甲醇，乙醇(99.5)，或非常易溶于乙酸(100)，并易溶于丙酮，并几乎不溶于乙醚或己烷。还容易溶解于水中非常pH为4以下，在pH7的观察下降迅速溶解度以上。长春瑞滨酒石酸盐是吸湿性。 操作注意事项 稳定性测试Rozeusu静脉注射液10毫克和Rozeusu静脉注射液40毫克正常的市场分布下(低于5℃加速测试使用的是结果的最终包装产品(20±1℃，相对湿度75%，6个月)，以避免结冰这三年内稳定的推测在) 适应症 本品适用于非小细胞肺癌、转移性乳腺癌、难治性淋巴瘤、卵巢癌以及头颈部肿瘤患者、恶性淋巴瘤等。相关的疗效的预防措施 (1) 尚未建立的疗效和安全性的这种药物(没有经验)的术前，术后化疗。 (2) 该试剂的给药是化疗蒽环类抗肿瘤剂和紫杉烷类抗肿瘤剂之后被引导到发作或复发。 (3) 对于组合疗法与其他抗癌剂，包括在第一次化疗，疗效和安全性的药物尚未确定。用法用量在非小细胞肺癌的情况下通常情况下，注射一次20〜25毫克/平方米缓慢静脉注射，每周一班的长春瑞滨成人。此外，想增加或减少取决于患者的年龄和症状。但是，最高剂量一次25毫克/平方米。不可操作或在复发性乳腺癌的情况下一般两周连续给药一次为25mg/m2的每周一班的长春瑞滨成人，3周将是休息。此外，根据患者的年龄，症状用药。 预防措施相关的用法和剂量 1.推迟给药时的给药前的白血细胞的数目小于2000个/mm3，施用在等待恢复至2000个/mm3以上。 2.日本药典生理盐水提前约50毫升这种药物，日光站5%葡萄糖注射液，日本药典用林格氏溶液或乳酸林格氏溶液稀释。施用理想的是从一开始就在10分钟内完成。应当指出的是，由于补液等给药后，在完全冲洗事化学品。包装规格Rozeusu静脉注射液 10毫克：1瓶Rozeusu静脉注射液 40毫克：1瓶** 制造商 日本化药有限公

英文版说明书

Product Name: Rozeusu intravenous solution 10mg 40mgActive ingredient: vinorelbine tartrate (Vinorelbine ditartrate)Dosage form: injectionDescribed sheet:Effects of this medicineIt is possible to suppress the cancer cells that increase, it indicates the action to reduce the tumor.Normal, non-small cell lung cancer, it is used in the treatment of inoperable or recurrent breast cancer.Please tell your doctor and pharmacist before certainly responsible for the following people to use.• Before using this medicine, itch, sometimes had any unusual or allergic reaction such as rash. Bone marrow suppression, history of liver failure, interstitial pneumonia or pulmonary fibrosis, neuromuscular disease or history, ischemic heart disease or a history that, there is a tendency toward constipation. You are suffering from infectious diseases.• pregnancy, or breast-feeding• other you are using, such as medicine (You can strengthen the effect on each other, so there is also likely to weaken, please note, including OTC drugs and food in use to others).Dosage regimen (proper use of this medicine)• Your dosage regimen is (doctor»)• non-small cell lung cancer: I usually injected intravenously once a week.The surgery can not or recurrent breast cancer: usually, once a week, were injected intravenously with 2 consecutive weeks, 3 week and rest period.• You have decided to use period while watching the effect. For specific period of use, please ask your doctor.Notes on life• be asked while taking care of using this medicine (side effects)Loss of appetite as the main side effects, general malaise, hair loss, nausea, fever, vomiting, phlebitis, stomatitis, constipation, diarrhea, paresthesia, tendons reflection attenuation, has been reported, such as allergic-like symptoms. If you notice these symptoms, please consult your doctor or pharmacist.In rare cases symptoms appear, such as the following, there is likely to be early symptoms of side effects indicated in brackets [].In such cases, stop the use, please immediately seek medical care.• anemia symptoms, fever, bleeding tendency [myelosuppression (leukopenia, anemia, such as thrombocytopenia)]• cough from, shortness of breath, fever, body movement when the palpitation, dyspnea, nausea and vomiting [interstitial pneumonia, pulmonary edema]• convulsive shortness of breath, wheezing (whistling sound) [bronchospasm]• severe abdominal pain, belly spring, not de flights, loss of appetite, nausea, vomiting [paralytic ileus]• shortness of breath, swelling, tightness of rapid anterior chest, anginal pain, cold sweat [heart failure, myocardial infarction, angina pectoris]Other side effects does not describe all. If you notice any symptoms of concern other than the above came out, please consult your doctor or pharmacist.