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  药店国别: 印度药房
产地国家: 印度
所属类别: 抗癌药物->治疗骨髓瘤药物
处方药:处方药
包装规格: 20毫克/片 14片
计价单位:
   
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis India
该药品相关信息网址1:
https://www.novartisoncology.com/news/product-portfolio/jakavi
该药品相关信息网址2:
https://www.medicines.org.uk/emc/medicine/26991
原产地英文商品名:
Jakavi 20mg 14 tablets
原产地英文药品名:
Ruxolitinib Phosphate
中文参考商品译名:
Jakavi 20毫克/片 14片
中文参考药品译名:
磷酸鲁索替尼
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
intermediate or high-risk myelofibrosis
英文适应病症2:
primary myelofibrosis
英文适应病症3:
post-polycythemia vera myelofibrosis
英文适应病症4:
post-essential thrombocythemia myelofibrosis
临床试验期:

中文适应病症参考翻译1:
中或高风险性骨髓纤维化
中文适应病症参考翻译2:
原发性骨髓纤维化
中文适应病症参考翻译3:
真性红细胞增多后症骨髓纤维化
中文适应病症参考翻译4:
后原发性血小板骨髓纤维化
药品信息:
简介: 英文药名:JAKAVI(RUXOLITINIB PHOSPHATE Tablets) 中文药名:磷酸鲁索替尼 生产厂家:诺华制药 药品介绍: JAKAVI(Ruxolitinib) 有效成分:Ruxolitinib 生产厂家:瑞士诺华 适合病症:原发性骨髓纤维化症 批准上市时间:2014年 药品形状:片剂 有效成分量:5mg/15mg/20mg / 片 包装容量:28片/ 60片/瓶 欧洲药品管理局人用药品委员会建议批准Jakavi来治疗患骨髓纤维化这一血液疾病的患者的脾肿大。Jakavi的用法为每日两次。欧洲药品管理局通常会接受委员会的建议。 骨髓纤维化会导致贫血、乏力、疼痛和脾肿大。它会导致异常血细胞在骨髓内堆积,形成厚厚的瘢痕组织,减缓健康血细胞的产生。为了代偿这一不足,其他器官,包括肝脏和脾脏开始产生血细胞。这是一种罕见的疾病,诺华公司说,在欧盟,每10万人中有不足1人患此疾病。该瑞士制药商表示,研究表明,骨髓纤维化患者的平均存活期大约是5.7年。 Jakavi® Jakavi (ruxolitinib) Jakavi® (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis1. Myelofibrosis Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. Since the abnormal marrow can no longer produce enough normal blood cells, the spleen often becomes enlarged when it takes responsibility for blood cell creation2. Patients may also suffer debilitating symptoms, including fatigue/weakness, shortness of breath, fever/night sweats, itchy skin, bone/joint pain, abdominal pain and/or weight loss, and have a poor quality of life and shortened survival2,3,4. Jakavi directly targets the underlying mechanism of disease, significantly reducing the size of the spleen in patients with myelofibrosis and relieving symptoms regardless of JAK mutational status, disease subtype, or any prior treatment, including hydroxyurea1. Polycythemia Vera (PV) PV is a rare and incurable blood cancer associated with an overproduction of blood cells in the bone marrow that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack5. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease6. This is typically defined as hematocrit levels greater than 45%, elevated white blood cell count and/or platelet count, and may be accompanied by debilitating symptoms and/or an enlarged spleen6,7,8. Jakavi has shown to improve two key measures of disease control, including hematocrit control without use of phlebotomy and spleen size reduction, and improved PV-related symptoms in adult patients with PV who are resistant to or intolerant of hydroxyurea9. This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative. Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States. Jakavi is marketed in the United States by Incyte Corporation as Jakafi® for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea and for the treatment of patients with intermediate or high-risk myelofibrosis. The safety and efficacy profile of Jakavi has not yet been established outside the approved indications.
更新日期: 2015-09-24
附件:
201681620263029.pdf    

 
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