醋酸舍瑞林缓释植入剂(Zoladex 10.8mg 3-month)

产地国家:美国 处方药:是 所属类别: 10.8毫克 3-month/植入剂 包装规格: 10.8毫克 3-month/植入剂 计价单位:注射器 生产厂家英文名:TERSERA THERAPEUTICS 原产地英文商品名:Zoladex Syringe 10.8 mg 3-month 原产地英文药品名:goserelin acetate 中文参考商品译名:诺雷德 10.8毫克 3-month/注射器 中文参考药品译名:醋酸戈舍瑞林

简介

部份中文醋酸戈舍瑞林处方资料(仅供参考) 英文名:Goserelin Acetate SR Depot 商品名:诺雷得 中文名:醋酸戈舍瑞林缓释植入剂 汉语拼音:Chusuangesheruilin Huanshizhiruji 成分:主要成份为醋酸戈舍瑞林 性 状:白色的粉末。容易溶于乙酸(100),更容易溶于水,不溶于甲醇,不溶于乙醇(95),几乎不溶于乙醛、乙醚。 药理作用:本药是一种合成的、促黄体生成素释放激素的类似物,长期使用可抑制垂体的促黄体生成激素的分泌,从而引起男性血清睾酮和女性血清雌二醇的下降,停药后这一作用是可逆的。男性病人在第一次用药之后21日左右,睾酮浓度可降低到去势后的水平,在每28天用药1次的治疗过程中,睾酮浓度一直保持在去势后的浓度范围内。这种睾酮抑制作用可使大多数病人的前列腺肿瘤消退,症状改善。女性患者在初次用药后21日左右,血清雌二醇浓度受到抑制,并在以后每28天的治疗中维持在绝经后水平。这种抑制与激素依赖性的乳腺癌,子宫内膜异位症相关。 药代动力学 本药具有几乎完全的生物利用度。每4周使用一注射埋植剂,可保持有效血药浓度,而无组织蓄积。诺雷德的蛋白结合能力较差,在肾功能正常的情况下,血浆清除半衰期为2-4小时,肾功能不全病人的半衰期将会延长,但对于每月都使用埋植剂的患者来说,这影响非常小,故没有必要改变这些病人的用量。在肝功能不全的病人中,药代动力学无明显的变化。 毒理研究 在长期重复使用诺雷德的雄性鼠中,曾观察到良性脑垂体肿瘤的发病率上升,这一事实与以前已观察到的行外科去势后的大鼠的情形相似,但尚未发现与人体使用的经验有任何关联。在小鼠实验中,长期重复使用数倍于人类常用剂量的诺雷德后,可发现胰岛细胞及幽门部胃粘膜细胞增生。这些事实与临床的关系尚不清楚。 适应症:前列腺癌闭经前乳腺癌 用法与用量:通常,在成人中,每4周(28日)1次,在成人中,至少在1次左右的时候涂抹1次1筒1袋(含有高温泉水)。 临床成绩:1.前列腺癌在12周的用药期进行的比较临床试验中,通过使用本药剂,在全例中获得了较强的效果,对象病入网改善率为64.2%(34/53),自知症状的综合改善率为63.4%(26/41),有效利用率为66.0%(35/53),为8)。在一般临床试验10人中,也获得了与比较临床试验几乎相同的成绩。在长期注射临床试验11个阶段,在40周的用药期间,对象病入巢改善率为68.6%(35/51),自知症状综合改善率为72.3%(34/47),其使用率为78.8%(41/52)。2.闭经前乳腺癌根据进行、复发乳腺癌患者的治疗效果的判定标准,在国内临床试验4、12、13个阶段中,获得级别效果(30.5%)(18/59),完全奏效率32.1%(18/56),各转移病巢部位的奏效率为软部组织31.3%(10/32)、骨37.0%(10/27)、内脏29.4%(5/17)。另外,手术后辅助治疗中的本剂(3.6 mg / 4周)的有效性,讨论了上市后临床试验(207例)及类似的欧洲的4考试(2659例)和金属アナリシス14)的结果显示,本剂群书剂非群和比较开创无病生存时间明显延长(hr:0.83,95%可信区间0.72 -0.95,p = 0.0074)。并且,关于整个生存时间,没有有效的保留,但允许延长的(hr: 0.85, 95%信赖区间0.70-1.03,p=0.1023)。

英文版说明书

Zoladex (10.8mg goserelin acetate implant)Company: AstraZenecaApproval Status: Approved January 1996Treatment for: prostate cancerAreas: Diabetes / Endocrinology; Urology & Kidneys; Cancer & OncologyGeneral InformationThe original 3.6 mg formulation of Zoladex has been available since 1989 as a monthly implant. The new formation, 10.8 mg goserelin acetate implant given every three months, offers greater convenience to subjects choosing treatment with a luteinizing-hormone-releasing hormone (LHRH) analogue. The 3.6 mg formulation of Zoladex was shown to be as effective as orchiectomy (surgical castration) in controlling the spread of prostate cancer, thus offering men a choice between medical treatment and surgery.The growth of prostate cancer can be stimulated by the male hormone testosterone. Treatment with Zoladex as a subcutaneous injection results in a decline in testosterone, which then reduces stimulation of hormone-responsive prostate tumors.The 3-month formulation of Zoladex is a cylindrical implant with a 1.5 mm diameter that contains 10.8 mg of goserelin. Given by subcutaneous injection, the biodegradable implant slowly dissolves, delivering therapeutic levels of the drug continuously over a period of 12 weeks.Clinical ResultsIn controlled studies of subjects with advanced prostate cancer, the Zoladex 10.8 mg formulation produced pharmacodynamically similar effect in terms of testosterone suppression to that achieved with the 3.6 mg formulation.Side EffectsThe most frequently reported adverse effects in clinical trials with the 10.8 mg formulation were hot flashes and pain.Mechanism of ActionZoladex is an analogue of naturally occurring LHRH. Continuous administration of Zoladex results in a significant decline in testosterone production by the testicles. This reduces testosterone stimulation of prostate cancer growth.Additional InformationThe once-a-month Zoladex 3.6 mg formulation was recently cleared by the FDA for the treatment of advanced breast cancer in premenopausal and perimenopausal women. Since 1993, Zoladex has also been used as a treatment for endometriosis, a noncancerous gynecological condition affecting an estimated five million women in the United States.Prostate cancer is the most common cancer (other than skin cancers) among men in the United States. According to the American Cancer Society, some 244,000 men will be diagnosed with the disease in 1995, and 40,400 men will die of it.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
药品价格查询,专业药品查询网站,药品说明书查询,药品比价 » 醋酸舍瑞林缓释植入剂(Zoladex 10.8mg 3-month)

提供最优质的资源集合

药品说明书 药品比价