英文药名:Abraxane I.V. Infusion(Paclitaxel)
中文药名:紫杉醇静脉注射/输液
生产厂家:大鹏药业有限公司
アブラキサン点滴静注用 100mg
治疗类别名称
抗肿瘤药
商標名
Abraxane I.V. Infusion
構造式
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
分子式
C47H51NO14
分子量
853.91
操作注意事项
1.保存记录
因为它是适用于特定的生物制品,如果您已施用这种药物,这种药物制造的迹象的患者(批号)的名称和地址,使用日期,使用药物名称(商品名称),或者序列号,记录和地址等,保存至少20年。
2. 被存储在一个盒子里,将小瓶包装开封后。
适应病症
乳腺癌,肺癌,非小细胞肺癌,不能切除的胰腺癌
用法与用量
※※乳腺癌,所述的方法是胃癌,非小细胞肺癌的一个B法,是在不可切除胰腺癌使用C方法。
A法:
在每日一次260mg/平方米(体表面积)30分钟的静脉内滴注,然后停药至少20天。此为一疗程,重复给药。此外,根据该状态的患者用药。
B法:
每天一次100毫克/米2(体表面积)分配在一段30分钟滴注,随后停药至少六天。连续3周每周给药一次,这为一疗程,重复给药。此外,根据该状态的患者用药。
※※C法:
与吉西他滨组合,每天一次125毫克/米2(体表面积)分配在一段30分钟滴注,随后停药至少六天。连续3周给药每周一次四周之后是停药。此为一疗程,重复给药。此外,根据该状态的患者用药。
药效药理
1. 抗肿瘤作用
皮下移植到裸鼠(MX-1)和人胰腺来源的细胞系(ASPC-1),肿瘤消退效果或肿瘤生长的抑制作用人乳腺癌组织观察。
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,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。
包装规格
静脉注射
100毫克:1瓶
制造厂商
大鹏药业有限公司
提携
Abraxis BioScience
米国
提示:以上部份处方资料仅供参考,使用时请仔细阅读原文[附件]:http://www.info.pmda.go.jp/go/pack/4240409D1023_1_10/
ABRAXANE® I.V. Infusion 100mg Application
Submitted for Approval of Additional Indications in Japan
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Toru Usami, hereafter Taiho) announced today that it has filed an application to the Japanese Ministry of Health, Labour and Welfare for the approval of additional indications of ABRAXANE® I.V. Infusion 100 mg, an antineoplastic for injectable suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound, launched on September 24, 2010). This application consists of additional indications for gastric cancer and non-small cell lung cancer.
ABRAXANE® was approved for the treatment of breast cancer in July 2010 in Japan. With its innovative, patented nanotechnology platform - nab® technology, ABRAXANE® leverages the natural transport properties of albumin to deliver more cytotoxic drug to the tumor. ABRAXANE® features improved efficacy and safety for breast cancer treatment as well as easier administration compared to solvent-based paclitaxel.
Taiho is confident that ABRAXANE® will continue to offer better treatment options for cancer patients and medical professionals, and will sustain its development in the oncology field.
About ABRAXANE®
ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Celgene's proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. Its technology eliminates the need for steroids and other pre-medication for preventing hypersensitivity reactions, which is required for solvent-based paclitaxel. In addition, ABRAXANE® shortens the infusion period, thereby relieving the burden on patients and potentially improving the efficiency of outpatient chemotherapy.
The U.S. Food and Drug Administration approved ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE® is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma and pancreatic. ABRAXANE® was originally developed by Abraxis BioScience, a wholly-owned subsidiary of Celgene Corporation.