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  药店国别: 美国药房
产地国家: 美国
所属类别: 骨科药物->类风湿关节炎
处方药:处方药
包装规格: 11毫克 30片/瓶
计价单位:
  点击放大  
生产厂家英文名:
Pfizer Laboratories Div Pfizer Inc
该药品相关信息网址1:
https://www.xeljanz.com/?src_code=XELW10031358
该药品相关信息网址2:
https://www.rxlist.com/xeljanz-drug.htm
原产地英文商品名:
XELJANZ XR 11mg 30tabs/bottle
原产地英文药品名:
tofacitinib
中文参考商品译名:
XELJANZ XR 11毫克 30片/瓶
中文参考药品译名:
托法替尼
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Severe active rheumatoid arthritis
临床试验期:
完成
中文适应病症参考翻译1:
严重活动性类风湿性关节炎
药品信息:
适应症和用途 ● XELJANZ,一种Janus激酶(JAKs)的抑制剂,适用于治疗中度至严重活动性类风湿性关节炎成年患者对氨甲喋呤已反应不佳或不能耐受。可用作单药治疗或与氨甲喋呤或其他非生物制品疾病修饰抗风湿药物(DMARDs)联用。 ● XELJANZ不应与生物制品DMARD或强免疫抑制剂例如硫唑嘌呤[zathioprine]和环孢菌素[cyclosporine]联用。 (1.1) 剂量和给药方法 类风湿性关节炎 XELJANZ的推荐剂量是5 mg每天2次。 剂型和规格 ● 片:5 mg (3) 禁忌症 无 (4) 警告和注意事项 ● 严重感染 –在活动性感染期间不要给XELJANZ,包括局部感染。如发生严重感染,中断XELJANZ直至感染控制。(5.1) ● 用XELJANZ治疗患者中曾报道淋巴瘤和其他恶性病。(5.2) ● 胃肠道穿孔 – 患者可能增加风险谨慎使用。(5.3) ● 实验室监视 – 建议由于淋巴细胞,嗜中性,血红蛋白,肝酶和脂质潜在变化。(5.4) ● 免疫接种 – 活疫苗不应与XELJANZ同时给予。 (5. 5) ● 严重肝受损–不建议(5.6) 不良反应 最常报道不良反应在对照临床试验头3个月期间(发生大于或等于2%单药治疗或与DMARDs联用用XELJANZ治疗患者)是上呼吸道感染,头痛,腹泻和鼻咽炎。(6.1) 为报告怀疑不良反应,联系Pfizer,Inc电话1-800-438-1985或FDA电话1-800-FDA-1088或www.fda.gov/medwatch. 药物相互作用 ● 细胞色素P450 3A4 (CYP3A4)的强抑制剂(如,酮康唑[ketoconazole]):减低剂量至5 mg每天1次。(2.1) ● 一种或更多同时药物导致CYP3A4的中度抑制和CYP2C19的强抑制作用(如,氟康唑[fluconazole]):减低剂量至5 mg每天1次。 (2.1) ● 强CYP诱导剂(如,利福平[rifampin]):可能导致临床反应丢失或减低。 (2.2) 特殊人群中使用 中度和严重肾受损和中度肝受损:减低剂量至5 mg每天1次。 (8.6,8.7) Indications and Usage ● XELJANZ, one kind of Janus kinase (JAKs) inhibitor , for the treatment of moderate to severe active rheumatoid arthritis in adult patients on methotrexate had a poor response or intolerance . Can be used as monotherapy or in combination with methotrexate or other non- biological products disease -modifying antirheumatic drugs (DMARDs) combined. ● XELJANZ DMARD or biological products should not be strong immunosuppressants such as azathioprine [zathioprine] and cyclosporine [cyclosporine] combined. ( 1.1 ) Dosage and Administration Rheumatoid Arthritis The recommended dose is XELJANZ 5 mg 2 times a day . Formulations and specifications ● tablets : 5 mg (3) Contraindications No ( 4 ) Warnings and Precautions ● severe infection - during active infection not to XELJANZ, including local infection. In the event of a serious infection , interrupted XELJANZ until the infection control . ( 5.1 ) ● XELJANZ treatment of patients with lymphoma have been reported and other malignant diseases. ( 5.2 ) ● gastrointestinal perforation - patients may increase the risk of caution. ( 5.3 ) ● Laboratory Monitoring - recommended due to lymphocytes, neutrophils , hemoglobin, potential changes in liver enzymes and lipids . ( 5.4 ) ● Immunization - Live vaccines should not be given simultaneously with XELJANZ . ( 5.5 ) ● severe liver damage - not recommended ( 5.6 ) Adverse reactions The most frequently reported adverse reactions in the three -month period , controlled clinical trial head ( greater than or equal to 2% occurrence monotherapy or in combination with DMARDs patients treated with XELJANZ ) were upper respiratory tract infection , headache, diarrhea and nasopharyngitis . ( 6.1 ) To report suspected adverse reactions, contact Pfizer, Inc Phone 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov / medwatch. Drug Interactions ● cytochrome P450 3A4 (CYP3A4) is a strong inhibitor ( eg , ketoconazole [ketoconazole]): reduce dose to 5 mg 1 time per day. ( 2.1 ) ● one or more drugs at the same time cause moderate inhibition of CYP3A4 and CYP2C19 strong inhibition ( eg , fluconazole [fluconazole]): reduce dose to 5 mg 1 time per day. ( 2.1 ) ● strong CYP inducers ( eg , rifampicin [rifampin]): clinical response may lead to loss or reduced. ( 2.2 ) Use in Specific Populations Moderate and severe renal impairment and moderate hepatic impairment : reduce dose to 5 mg 1 time per day. ( 8.6,8.7 )
更新日期: 2019-6-19
附件:
201961916184812.pdf    

 
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