您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8353 处方药 7980 非处方药 267 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国际免费电话:
QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 瑞士药房
产地国家: 瑞士
所属类别: 抗癌药物->治疗白血病药物
处方药:处方药
包装规格: 1000毫克/40毫升 1瓶/盒
计价单位:
   
生产厂家中文参考译名:
罗氏
生产厂家英文名:
Roche
该药品相关信息网址1:
http://www.drugs.com/pro/gazyva.html
原产地英文商品名:
GAZYVARO 1000 mg/40ml 1vial/box
原产地英文药品名:
Obinutuzumab
中文参考商品译名:
Gazyvaro 1000毫克/40毫升 1瓶/盒
中文参考药品译名:
Obinutuzumab
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Leukemia
临床试验期:

中文适应病症参考翻译1:
白血病
药品信息:
新型白血病药物Gazyvaro(obinutuzumab)注射剂首个突破性获欧盟批准 新生物制品 批准日期:2014年5月23日;公司:瑞士罗氏 作用机制 Obinutuzumab是一种单克隆抗体靶向前B-和成熟B-淋巴细胞的表面上表达的CD20抗原。Upon 结合至CD20,obinutuzumab介导B-细胞溶解通过(1) 参与免疫效应细胞,(2)通过直接地激活细胞内死亡信号通路和/或(3)激活补体级联反应。免疫效应细胞机制包括抗体-依赖细胞毒性和抗体-依赖细胞吞噬作用。 适应证和用途 Gazyvaro(obinutuzumab)是一种针对CD20溶细胞抗体和适用于与苯丁酸氮芥[chlorambucil]联用,为有既往未治疗过慢性淋巴性白血病患者的治疗。 剂量和给药方法 (1)用糖皮质激素,对乙酰氨基酚[acetaminophen]和抗组织胺预先给药。 (2)为静脉输注稀释和给药。不要静脉推注或丸注。 (3)对6个疗程推荐剂量(28天疗程): 1)在疗程1第1天100 mg 2)在疗程1第2天900 mg 3)在疗程1第8和15天1000mg 4)在疗程2-6第1天1000mg 剂型和规格 1000mg/40mL(25mg/mL)单次使用小瓶. 禁忌证 无。 警告和注意事项 (1)输注反应:患者用糖皮质激素,对乙酰氨基酚和抗组织胺预先给药。输注期间严密监视. 对反应中断或终止输注。 (2)肿瘤溶解综合征:预料肿瘤溶解综合征;用抗高尿酸血症药物预先给药和充分水化尤其是对有高肿瘤负荷和/或高循环淋巴细胞计数患者。纠正电解质异常,提供支持性医护和监视肾功能和液体平衡。 (3)中性粒细胞减少:对感染监视。 (4)血小板减少:监视血细胞计数和出血。出血的处理可能需要血液制品支持。 (5)免疫接种:不要给活病毒疫苗GAZYVA给予前或期间。 不良事件 最常见不良事件(发生率 ≥10%)是:输注反应,中性粒细胞减少,血小板减少,贫血,发热,咳嗽,和肌肉骨骼疾病。 http://www.ema.europa.eu. 罗氏Gazyvaro(obinutuzumab)在欧洲获批用于治疗慢性淋巴细胞白血病(CLL) 罗氏(Roche)5月23日宣布,抗癌药物Gazyvaro(obinutuzumab)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Gazyvaro联合苯丁酸氮芥(chlorambucil)用于因一些并存病(comorbidities)导致不适合某种特定化疗(全剂量氟达拉滨)的初治慢性淋巴细胞白血病(CLL)成人患者的治疗。欧盟委员会(EC)预计将在未来几个月内做出最终审查决定。 CHMP的积极意见,主要基于III期CLL11研究的数据。数据表明,与苯丁酸氮芥单药疗法及美罗华(MabThera,通用名:rituximab,利妥昔单抗)+苯丁酸氮芥组合疗法相比,Gazyvaro+苯丁酸氮芥组合疗法显著延长了患者的疾病无进展生存期(PFS),同时也增加了缓解深度(以微小残留病(MRD)评价)。此外,与与苯丁酸氮芥单药疗法相比,Gazyvaro+苯丁酸氮芥组合疗法也增加了初治CLL患者的总生存期(OS)。 关于Gazyvaro(obinutuzumab): obinutuzumab在美国的商品名为Gazyva,已获FDA批准,联合苯丁酸氮芥(chlorambucil)化疗,用于既往未经治疗的慢性淋巴细胞白血病(CLL)患者。Gazyva的获批,将减少生物仿制药对罗氏重磅药物美罗华(Rituxan,通用名:rituximab,利妥昔单抗)的冲击。 obinutuzumab又名GA101,是首个糖基化的II型抗CD20单克隆抗体,靶向B细胞表面的CD20分子,能够直接诱导B细胞死亡。obinutuzumab旨在增强抗体依赖性细胞毒性作用(Antibody-Dependent Cellular Cytotoxicity,ADCC)及直接的细胞死亡诱导作用(Direct Cell Death induction)。 The new leukemia drug Gazyvaro (obinutuzumab) injections first breakthrough eligible for EU approval New biological products Approval Date: May 23, 2014; Company: Roche Mechanism Obinutuzumab is a monoclonal antibody targeted to the front B- B- lymphocytes and mature CD20 antigen expressed on the surface. Upon binding to CD20, obinutuzumab B- cytolysis mediated by (1) involved in immune effector cells, (2) by direct activation of intracellular death signaling and / or (3) activate the complement cascade. Immune effector cell mechanisms, including antibody - dependent cellular cytotoxicity and antibody - dependent cellular phagocytosis. Indications and Usage Gazyvaro (obinutuzumab) is a cytolytic antibodies against CD20 and applies to chlorambucil [chlorambucil] MS, as has previously not been treated with chronic lymphatic leukemia patients. Dosage and Administration (1) The use of corticosteroids, paracetamol [acetaminophen] and antihistamine pretreatment. (2) dilution and intravenous infusion administration. Do intravenous bolus injection or pill. (3) The recommended dose for six courses (28 days of treatment):    1) In the course of a 100 mg on day 1    2) In the course of a 900 mg on day 2    3) In the course of an 8 and 15 days 1000mg    4) In the course of the first day 2-6 1000mg DOSAGE FORMS AND STRENGTHS 1000mg / 40mL (25mg / mL) single-use vials. Contraindications None. Warnings and Precautions (1) infusion reactions: Patients with glucocorticoids, acetaminophen and an antihistamine pretreatment. Closely monitored during infusion. Infusion interruption or termination of the reaction. (2) tumor lysis syndrome: the expected tumor lysis syndrome; hyperuricemia with anti-drug pretreatment and adequate hydration especially for a high tumor burden and / or high circulating lymphocyte counts in patients. Correction of electrolyte abnormalities, provide supportive care and monitoring of renal function and fluid balance. (3) neutropenia: infection surveillance. (4) thrombocytopenia: Monitor blood counts and bleeding. Treatment of bleeding may require blood products support. (5) Immunization: Do not give live virus vaccines GAZYVA given before or during. Adverse Events The most common adverse events (incidence ≥10%) are: infusion reactions, neutropenia, thrombocytopenia, anemia, fever, cough, and musculoskeletal diseases. http://www.ema.europa.eu. Roche Gazyvaro (obinutuzumab) approved in Europe for the treatment of chronic lymphocytic leukemia (CLL) Roche (Roche) 5, today announced a anticancer drug Gazyvaro (obinutuzumab) won the European Medicines Agency (EMA) Committee for Medicinal Products for human use (CHMP) positive opinion. CHMP recommends approval Gazyvaro joint chlorambucil (chlorambucil) is used because some comorbidities (comorbidities) lead is not suitable for a particular chemotherapy (fludarabine full dose) in previously untreated chronic lymphocytic leukemia (CLL) in adult patients treatment. The European Commission (EC) is expected to make a final review of the decision in the coming months. CHMP positive opinion is based primarily on data CLL11 phase III study. Data show that with chlorambucil monotherapy and rituximab (MabThera, generic name: rituximab, rituximab) + compared to chlorambucil combination therapy, Gazyvaro + chlorambucil combination therapy significantly prolonged progression-free survival in patients with the disease (PFS), also increases the ease depth (with minimal residual disease (MRD) evaluation). In addition, compared with chlorambucil monotherapy, Gazyvaro + chlorambucil combination therapy also increased in patients with previously untreated CLL overall survival (OS). About Gazyvaro (obinutuzumab): obinutuzumab goods in the United States called Gazyva, has been approved by FDA, the joint chlorambucil (chlorambucil) chemotherapy, for the treatment of previously untreated chronic lymphocytic leukemia (CLL) patients. Gazyva approved, will reduce the biosimilars to Roche blockbuster drug rituximab: the impact (Rituxan, generic name rituximab, rituximab) is. obinutuzumab known GA101, the first glycosylation type II anti-CD20 monoclonal antibody targeting the CD20 B cell surface molecules can directly induce B cell death. obinutuzumab designed to enhance the antibody-dependent cytotoxic effect (Antibody-Dependent Cellular Cytotoxicity, ADCC), and direct cell death-inducing effect (Direct Cell Death induction).
更新日期: 2019-1-2
附件:
2014102622153412.pdf    

2014102622151932.pdf    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com