甲磺酸伊马替尼胶囊(GLIVEC 400mg capsules )

产地国家:德国

处方药:是

所属类别: 400毫克/胶囊 30胶囊/盒

包装规格: 400毫克/胶囊 30胶囊/盒

计价单位:盒

生产厂家英文名:Novartis

原产地英文商品名:GLIVEC 400mg/cap 30caps/box

原产地英文药品名:IMATINIB MESYLATE

中文参考商品译名:格列卫 400毫克/胶囊 30胶囊/盒

中文参考药品译名:甲磺酸伊马替尼

简介:

部份中文GLIVEC处方资料(仅供参考)

药品名称:imatinib mesylate

商 品 名:GLIVEC

通用名称:甲磺酸伊马替尼胶囊

剂型:胶囊剂

主要成份:本品主要成份为甲磺酸伊马替尼

性状:本品为胶囊,内容物为白色至类白色粉末。

适应症:用于治疗慢性髓性白血病(CML)急变期、加速期或α-干扰素治疗失败后的慢性期患者。用于治疗不能切除和/或发生转移的恶性胃肠道间质肿瘤(GIST)的成人患者。

用法用量:一开始治疗就应由对慢性粒细胞白血病有治疗经验的医师进行。对急变期和加速期患者甲磺酸伊马替尼的推荐剂量为600mg/日,对干扰素治疗失败的慢性期患者为400mg/日,均为每日一次口服,宜在进餐时服药,并饮一大杯水,只要有效,就应持续服用。如果血象许可,没有严重药物不良反应,在下列情况下剂量可考虑从400mg/日增加到600mg/日,或从600mg/日增加到800mg/日(400mg,口服,分2次服用):疾病进展、治疗至少3个月后未能获得满意的血液学反应,已取得的血液学反应重新消失。

贮藏:阴凉,干燥保存在30°C以下。

有效期:25℃保存,15℃~30℃之间也可接受,有效期36个月。

生产企业:诺华制药有限公司

英文版说明书:

Based on the striking results of phase II clinical trials, Glivec was filed for registration and received approval from the European Union (EU) (May 31, 2002), the Food and Drug Administration (FDA) in the United States (February 1, 2002), and other countries for the treatment of adult patients with c-Kit (CD117)–positive unresectable and/or metastatic malignant GISTs. On December 19th, 2008, Glivec was also approved for adjuvant treatment for patients in the United States. Glivec is approved for GIST in many different countries, although it is probably approved in fewer countries for adjuvant use.Glivec is known by several different names:•Gleevec in the U.S.•Glivec outside the U.S.•Imatinib Mesylate (the generic name).•STI571 when it was in clinical trials (STI stands for Signal Transduction Inhibitor).Glivec is a pill that is taken either once or twice daily, depending on the dose.Glivec is different from traditional chemotherapy in that it is very selective. Traditional chemotherapy kills all cells that are dividing quickly. This is what causes so many of the side effects of traditional chemotherapy. In addition to the cancer cells, this type of chemotherapy also kills many of the body’s normal cells. Glivec is much more selective and as a result has fewer side effects. It was designed to block the activity of a mutant type of enzyme (an enzyme is a specific type of protein) that causes Chronic Myeloid Leukemia (CML). This enzyme is called Bcr/Abl. In addition to blocking Bcr/Abl, Gleevec also blocks several other enzymes. These are:•KIT•Platelet Derived Growth Factor Receptors (PDGFR-alpha and PDGFR-beta)•Various forms of the Abl enzymesThe KIT receptor belongs to a class of receptors called the tyrosine kinase family. It is estimated that the human genome will reveal more than 400 tyrosine kinases. Because Glivec selectively blocks only a few of these tyrosine kinases, it is both effective and has fewer side effects than traditional chemotherapy.For normal signal transduction to occur in the KIT receptor, a chemical called ATP (adenosine triphosphate) must bind to a site in the kinase domain of the receptor. Glivec prevents signal transduction of KIT by binding to this ATP binding site. This prevents the transfer of phosphate groups from ATP and blocks signal transduction in normal and mutated forms of KIT.Glivec is introduced in a tablet form•Glivec 400mg and 100mg tablets have replaced the 100mg capsules to make therapy more convenient for all patients.•It is important for you to understand that you will receive exactly the same medicine in the new Glivec tablets that you have come to know.

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