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		药店国别: 美国药房产地国家: 美国所属类别: 抗癌药物->治疗黑色素瘤药物处方药:处方药包装规格: 1毫克/片 30片/盒计价单位:

生产厂家英文名:
GSK
该药品相关信息网址1:
http://www.mekinist.com/
该药品相关信息网址2:
http://www.rxlist.com/mekinist-drug.htm

原产地英文商品名:
Mekinist 1mg 30 tablets
原产地英文药品名:
TRAMETINIB
中文参考商品译名:
Mekinist 1毫克/片 30片/盒
中文参考药品译名:
曲美替尼

原产地国家批准上市年份:
0000/00/00
英文适应病症1:
不可切除的或转移黑色素瘤

临床试验期:
完成
中文适应病症参考翻译1:
Unresectable or metastatic melanoma

药品信息:
英文药名：Mekinist(trametinib) 中文药名：曲美替尼片药品介绍葛兰素史克（GSK）29日宣布，黑色素瘤新药Mekinist(trametinib)均获得了FDA的批准。Mekinist为首个MEK抑制剂，作为一种单药口服片剂，适用于携带BRAF V600E或V600K突变的手术不可切除性黑色素瘤或转移性黑色素瘤。 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”。批准日期：2013年5月29日；公司: GlaxoSmithKline 作用机制 Trametinib 是一种有丝分裂原-激活的胞外信号调控激酶1(MEK1)和MEK2激活以及MEK1和MEK2激酶活性的可逆性抑制。MEK蛋白胞外信号-相关激酶 (ERK)通路的上游调节物，促进细胞增殖作用。BRAF V600E突变导致BRAF通路的结构性激活其中包括MEK1和MEK2。Trametinib抑制BRAF V600突变-阳性黑色素瘤细胞在体外和体内生长。适应证和用途 MEKINIST是一种适用于治疗有不可切除的或转移黑色素瘤当用FDA批准测试检验有BRAF V600E或V600K突变患者。使用限制：MEKINIST不适用于治疗以前曾接受BRAF抑制剂治疗患者。剂量和给药方法（1）开始用MEKINIST治疗前确证在肿瘤标本存在BRAF V600E或V600K突变。（2）推荐剂量是2mg口服每天1次服用至少1小时前或进餐后至少2小时。注：(BRAF是一个人基因使一种被称为B-Raf的蛋白。基因还称为原-癌基因B-Raf和v-Raf鼠类肉瘤病毒原癌基因同源B1, 而这个蛋白更以前被称为丝氨酸/苏氨酸蛋白激酶B-Raf) 剂型和规格片：0.5mg，1mg，和2mg。禁忌证无。警告和注意事项（1）心肌病：一个月治疗后再评估LVEF，和其后约每2至3个月评价。（2）视网膜色素上皮脱落(RPED)：对任何视觉障碍进行眼科评价。如被诊断RPED不给MEKINIST和如3个月后无改善终止。（3）视网膜静脉阻塞(RVO)：终止MEKINIST. （4）间质性肺疾病(ILD)：不给MEKINIST对新或进展性不能解释的肺症状或发现，例如咳嗽，呼吸困难，缺氧，或浸润。为治疗-相关ILD或肺炎永远终止MEKINIST。（5）严重皮肤毒性：监视皮肤毒性和继发感染。对不能耐受2级，或3或4级皮疹尽管MEKINIST的中止在3周内未改善终止。（6）胚胎胎儿毒性：可能致胎儿危害。忠告有生殖潜能女性对胎儿潜在风险。不良反应对MEKINIST最常见不良反应(≥20%)包括皮疹，腹泻，和淋巴水肿。特殊人群中使用（1）哺乳母亲：终止药物或哺乳。（2）女性和男性的生殖潜能：忠告女性患者对妊娠计划和预防。可能损害生育能力。 The English name of the drug: Mekinist (trametinib) Chinese drug name: qumei erlotinib tablets Drug Description GlaxoSmithKline (GSK) 29 announced melanoma drug Mekinist (trametinib) have received FDA approval. Mekinist led by a MEK inhibitor, as a single-agent oral tablet for carrying BRAF V600E mutation or V600K surgical unresectable melanoma or metastatic melanoma. FDA Center for Drug Evaluation and Research, director of hematology and oncology products Richard Pazdur, MD, said: "We have a way of biological understanding of the disease advances have allowed the development of the third and fourth drugs Tafinlar and Mekinist, in the past two years, FDA has been approved for the treatment of metastatic melanoma. " Alberto Gutierrez FDA devices and radiological health centers in vitro diagnostic devices and radiological health director, Ph.D., said: "Tafinlar and Mekinist with BRAF mutation detection on the second diagnostic companion diagnostic partner jointly approved and confirmed by the detection and targeting physical development of molecular cancer medicine commitment to drive product. " Approval Date: May 29, 2013; Company: GlaxoSmithKline Mechanism Trametinib is a mitogen - activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 activation and reversible inhibition of MEK1 and MEK2 kinase activity. MEK protein extracellular signal - Raw related kinase (ERK) pathway modulators, promote cell proliferation. BRAF V600E BRAF mutations which result in the activation pathway structural include MEK1 and MEK2. Trametinib inhibition of BRAF V600 mutation - positive melanoma cells grown in vitro and in vivo. Indications and Usage MEKINIST is a suitable treatment of unresectable or metastatic melanoma when tested by FDA approved test or V600K have BRAF V600E mutation patients. Restrictions: MEKINIST does not apply to the treatment of previously treated patients who had BRAF inhibitors. Dosage and Administration (1) started treatment before MEKINIST confirmed the presence of BRAF V600E mutations in tumor specimens or V600K. (2) the recommended dose is 2mg taken orally 1 hour before or after at least one meal at least two hours a day. Note: (BRAF gene makes a person is called a B-Raf protein gene is also known as the original - oncogene B-Raf and v-Raf murine sarcoma viral oncogene homolog B1, and this protein is more. formerly known as serine / threonine protein kinase B-Raf) Formulations and specifications Tablets: 0.5mg, 1mg, and 2mg. Contraindications None. Warnings and Precautions (1) cardiomyopathy: One month after treatment to assess LVEF, and thereafter about every 2-3 months evaluation. (2) the retinal pigment epithelium (RPED): Any visual impairment ophthalmologic evaluation. As was diagnosed RPED not give MEKINIST as three months and no improvement after termination. (3) retinal vein occlusion (RVO): Termination MEKINIST. (4) interstitial lung disease (ILD): do not give MEKINIST new or progressive unexplained pulmonary symptoms or discovered, such as coughing, dyspnea, hypoxia, or infiltration. For the treatment of - or pneumonia-related ILD never terminate MEKINIST. (5) severe skin toxicity: skin toxicity and secondary infection surveillance. Can not tolerate 2, or 3 or 4 rash despite MEKINIST abort termination does not improve within 3 weeks. (6) embryo fetal toxicity: may cause fetal harm. Advice reproductive potential of female potential risk to the fetus. Adverse reactions For MEKINIST most common adverse reactions (≥ 20%) included rash, diarrhea, and lymphedema. Use in Specific Populations (1) Nursing Mothers: discontinue the drug or breastfeeding. (2) female and male reproductive potential: women with advice on pregnancy planning and prevention. May impair fertility.

更新日期: 2014-07-06

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