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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->凝血酶抑制剂
处方药:处方药
包装规格: 75毫克 120胶囊
计价单位:
   
生产厂家中文参考译名:
GlaxoSmithkline
生产厂家英文名:
GlaxoSmithkline
该药品相关信息网址1:
http://www.tafinlar.com/
该药品相关信息网址2:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381159.htm
原产地英文商品名:
Tafinlar 75mg 120caps
原产地英文药品名:
DABRAFENIB
中文参考商品译名:
Tafinlar 75毫克 120胶囊
中文参考药品译名:
达拉菲尼胶囊
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
unresectable or metastatic melanoma
临床试验期:

中文适应病症参考翻译1:
有不能切除或转移黑色素瘤
药品信息:
英文药名:Tafinlar(dabrafenib) 中文药名:达拉菲尼胶囊 生产厂家:GlaxoSmithKline 药品介绍: 葛兰素史克(GSK)29日宣布,黑色素瘤新药Tafinlar(dabrafenib) 获得了FDA的批准。 Tafinlar为BRAF抑制剂,作为一种单药口服胶囊,适用于携带BRAF V600E突变的手术不可切除性黑色素瘤或转移性黑色素瘤成人患者。 FDA药物评价和研究中心血液学和肿瘤产品室主任Richard Pazdur,M.D.说:“我们对一种疾病的生物途径的认识进步已允许发展第三和第四个药物Tafinlar和Mekinist,在过去两年FDA已批准为治疗转移黑色素瘤。” FDA的装置和放射性卫生中心体外诊断装置和放射学卫生室主任Alberto Gutierrez,Ph.D.说:“Tafinlar和Mekinist与对BRAF突变检测的第二个诊断伴侣共同批准证实和诊断伴侣检测和靶向癌的分子驱动物发展产品的医药承诺”。 TAFINLAR(dabrafenib)胶囊为口服使用 Initial U.S. Approval:2013 适应证和用途 TAFINLAR是一种激酶抑制剂适用于有不能切除或转移黑色素瘤与用FDA-批准测试检测BRAF V600E 突变患者的治疗。 使用限制:TAFINLAR不适用于有野生型BRAF黑色素瘤患者的治疗。 剂量和给药方法 (1)开始用TAFINLAR治疗前确证在肿瘤标本中存在BRAF V600E突变。 (2)推荐剂量是150 mg口服每天2次在进餐前至少1小时或后至少2小时服用。 剂型和规格 胶囊:50mg,75mg. 禁忌证 无。 警告和注意事项 (1)新原发性皮肤恶性病:开始治疗前,用治疗时每3个月和终止TAFINLAR 后直至6个月进行皮肤学评价。 (2)在BRAF野生型黑色素瘤中促肿瘤:用BRAF抑制剂可能发生细胞增殖增加。 (3)严重发热性药物反应:不用TAFINLAR如发热≥101.3°F或发生并发发热。 (4)高血糖:预先存在糖尿病或高血糖患者中监视血清糖水平。 (5)葡萄膜炎和虹膜炎:常规监视患者视力症状。 (6)葡萄糖-6磷酸脱氢酶缺乏:严密监视溶血性贫血。 (7)胚胎胎儿毒性:可能致胎儿危害。忠告生殖潜力女性对胎儿潜在风险。TAFINLAR可能使激素避孕药疗效较低和应使用另外避孕方法。 不良反应 对TAFINLAR最常见不良反应(≥20%)是角化过度,头痛,发热,关节炎,乳头状瘤,脱发,和掌跖红肿疼痛综合征。 为报告怀疑不良反应,联系GlaxoSmithKline电话1-888-825-5249或FDA电话1-800-FDA-1088或www.fda.gov/medwatch. 药物相互作用 (1)不建议同时给予CYP3A4或CYP2C8的强抑制剂。 (2)不建议同时给予强CYP3A4或CYP2C8诱导剂。 (3)增加胃pH药物可能减低dabrafenib浓度。 (4)与药物是CYP3A4,CYP2C8,CYP2C9,CYP2C19,或CYP2B6的敏感底物同时使用可能导致这些药物疗效丧失。 在特殊人群中使用 (1)哺乳母亲:终止药物或哺乳. (2)有生殖潜能女性和男性:忠告女性患者治疗期间和终止治疗后4周使用高效避孕。忠告男性患者对受损的精子发生的潜能。 Generic Name: dabrafenib Date of Approval: May 29, 2013 Company: GlaxoSmithKline Treatment for: Advanced Melanoma FDA Approves Tafinlar The U.S. Food and Drug Administration (FDA) has approved Tafinlar (dabrafenib), a kinase inhibitor indicated as a single-agent oral treatment for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) in adult patients with BRAF V600E mutation. Tafinlar is not indicated for the treatment of patients with wild-type BRAF melanoma. The mutation must be detected by an FDA-approved test, such as the companion diagnostic assay from bioMérieux S.A., THxID™-BRAF. Tafinlar Medication Guide Read the Medication Guide that comes with Tafinlar before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about Tafinlar? Tafinlar may cause serious side effects, including: Risk of new cancers. Tafinlar may cause new cancers, including cutaneous squamous cell carcinoma (cuSCC) that can spread to other parts of the body. Talk with your healthcare provider about your risk for developing skin cancers. Check your skin and tell your healthcare provider right away about any skin changes including: •a new wart •a skin sore or reddish bump that bleeds or does not heal •a change in size or color of a mole Your healthcare provider should check your skin before you start taking Tafinlar, and every two months while taking Tafinlar to look for any new skin cancers. Your healthcare provider may continue to check your skin for six months after you stop taking Tafinlar. See Tafinlar side effects for more information about side effects. What is Tafinlar? Tafinlar is a prescription medicine used to treat a type of skin cancer called melanoma: •that has spread to other parts of the body or cannot be removed by surgery, and •that has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure that Tafinlar is right for you. Tafinlar is not used to treat people with a type of skin cancer called wild-type BRAF melanoma. It is not known if Tafinlar is safe and effective in children. What should I tell my healthcare provider before taking Tafinlar? Before you start taking Tafinlar, tell your healthcare provider if you: •have liver or kidney problems •have diabetes •plan to have surgery, dental, or other medical procedures •have a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme •have any other medical conditions •are pregnant or plan to become pregnant. Tafinlar can harm your unborn baby. ◦Females who are able to become pregnant should use birth control during treatment and for four weeks after stopping Tafinlar. ◦Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking Tafinlar. You should use another effective method of birth control while taking Tafinlar. Talk to your healthcare provider about birth control methods that may be right for you. ◦Tell your healthcare provider right away if you become pregnant during treatment with Tafinlar. •are breastfeeding or plan to breastfeed. It is not known if Tafinlar passes into your breast milk. You and your healthcare provider should decide if you will take Tafinlar or breastfeed. You should not do both. Tafinlar may cause lower sperm counts in men. This could affect the ability to father a child. Talk to your healthcare provider if this is a concern for you. Talk to your healthcare provider about family planning options that might be right for you. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tafinlar and certain other medicines can affect each other, causing side effects. Tafinlar may affect the way other medicines work, and other medicines may affect how Tafinlar works. You can ask your pharmacist for a list of medicines that may interact with Tafinlar. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take Tafinlar? •Take Tafinlar exactly as your healthcare provider tells you. Do not change your dose or stop Tafinlar unless your healthcare provider tells you. •Take Tafinlar two times a day, about 12 hours apart. •Take Tafinlar at least one hour before or two hours after a meal. •Do not open, crush, or break Tafinlar capsules. •If you miss a dose, take it as soon as you remember. If it is within six hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose. If you take too much Tafinlar, call your healthcare provider or go to the nearest hospital emergency room right away. Tafinlar side effects Tafinlar may cause serious side effects, including: •See What is the most important information I should know about Tafinlar? •Fever. Tafinlar can cause fever, including severe fever. In some cases, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Tell your healthcare provider right away if you get a fever while taking Tafinlar. •Blood sugar problems. Some people may develop high blood sugar or worsening diabetes during treatment with Tafinlar. If you are diabetic, your healthcare provider will check your blood sugar levels before and during treatment with Tafinlar. Tell your healthcare provider if you have any of the following symptoms of high blood sugar: ◦increased thirst ◦urinating more often than normal ◦your breath smells like fruit •Eye problems. You should have your eyes examined before and while you are taking Tafinlar. Tell your healthcare provider right away if you get these symptoms during treatment with Tafinlar: ◦eye pain, swelling, or redness ◦blurred vision or other vision changes during treatment with Tafinlar The most common side effects of Tafinlar include: •thickening of the outer layers of the skin •headache •joint aches •warts •hair loss •redness, swelling, peeling, or tenderness of hands or feet Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Tafinlar. For more information about side effects, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to GSK at 1-888-825-575-5249. How should I store Tafinlar? •Store Tafinlar at room temperature, between 68°F to 77°F (20°C to 25°C). •Ask your healthcare provider or pharmacist how to safely throw away Tafinlar that is out of date or no longer needed. Keep Tafinlar and all medicine out of the reach of children. General information about Tafinlar Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tafinlar for a condition for which it was not prescribed. Do not give Tafinlar to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Tafinlar that is written for health professionals. For more information, call GlaxoSmithKline at 1-888-825-5249 or go to www.tafinlar.com. What are the ingredients in Tafinlar? Active ingredient: dabrafenib Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose Capsule shells contain: hypromellose, red iron oxide (E172), titanium dioxide 600 (E171).
更新日期: 2014-12-15
附件:
20151719023236.PDF    

 
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