醋酸亮丙瑞林注射器（LEUPLIN PRO FOR INJECTION KIT 22.5mg）

产地国家：日本 处方药：是 所属类别： 22.5毫克/套件 包装规格： 22.5毫克/套件 计价单位：套件 生产厂家英文名：Takeda 原产地英文商品名：LEUPLIN PRO(リュープリンPRO注射用キット)22.5mg/KIT 原产地英文药品名：Leuprorelin Acetate 中文参考商品译名：LEUPLIN PRO(リュープリンPRO注射用キット)22.5毫克/套件 中文参考药品译名：醋酸亮丙瑞林

简介

部份中文醋酸亮丙瑞林处方资料（仅供参考） 商品名：LEUPLIN PRO FOR INJECTION KIT 英文名：Leuprorelin Acetate 中文名：醋酸亮丙瑞林 生产商：武田薬品リュープリンPRO注射用キット22.5mg 性状：醋酸利普林是一种白色带淡黄色白色粉末。 很易溶于水或醋酸 (100), 易溶于甲醇, 微溶于乙醇 (99.5)。它是吸湿湿的。 药理学： 1.作用机制当反复给药lh-h或高活性lh-r衍生物的赖普拉乙酸盐, 第一次给药后的短暂垂体后, 促性腺激素刺激作用 (急性作用) 观察到, 在脑垂体刺激生产和释放促性腺激素降低。 此外, 睾丸和卵巢促性腺激素反应性降低, 睾酮和雌二醇的产生能力降低 (慢性作用)。利普林醋酸盐的lh释放活性约为lh-rh的100倍, 其垂体性腺功能抑制效果强于lh-rh。醋酸卢普罗林是一种活性很强的lh-rh 衍生物, 垂体腺体的抑制作用强, 乙酸利普兰酯与lh-rh相比对蛋白水解酶具有很高的抵抗力, 由于lh-rh受体的高亲和力。此外, 由于目前的製剂是一种缓释製剂, 它通过在血液中释放利普伦林醋酸酯, 在任何时候都表现出性腺功能的抑制作用, 从而导致有效睾丸和卵巢的反应性减少。 2.促性腺激素浓度的抑制作用(1) 前列腺癌患者经皮下注射24週一次血清睾酮浓度降低到以下持续去势, 观察药物去势。(2) 绝经前乳腺癌患者经皮下给药一次, 24週一次, 一般降低到低于更年期水准, 认识到卵巢功能的抑制作用, 通常排卵抑制, 月经停止。 适应症：前列腺癌，绝经期前乳腺癌 用法与用量：通常情况下, 成人在24周内作为醋酸溶苯硫醚, 在皮下给药一次, 为22.5毫克。在给药过程中, 通过将柱塞杆按在针头上, 悬浮液总量被转移到粉末部分, 同时注意不要抽打, 使用充分悬浮。 临床结果： 前列腺癌对于前列腺癌治疗患者 (抗肿瘤作用的患者通过使用11.25毫克的雷普林sr注射试剂盒是稳定的), (共4次)11.25毫克在24周皮下注射一次 (共两次) 或作为磷酸酯的利帕拉乙酸盐。作为一个主要的评价专案, 患者在开始给药后48周内保持血清睾酮浓度的比例(100ng/dl或以下)是100%在22.5毫克给药组(81/81例), 11.25毫克管理组98.7%(78/ 79), 两组[95%置信区间]之间的差异为1.3%[-3.4%, 6.8%], 并且满足预先设定的非隐性标准(95%置信区间的下限超过10%)。 绝经前乳腺癌对于绝经后乳腺癌术后患者, 皮下给予1次(共2次)或11.25毫克(共4次) (与每组他莫西芬20mg day联合使用), 作为每24週一次22.5毫克的lprorylacetic醋酸盐。是一个主要的评价专案, 患者在绝经水准48周后服用后抑制血清雌二醇浓度的比例 (30pgsm或以下), 在22.5mg管理组 (81/83 例), 11.25毫克给药组(81。 /84), 两组[95%置信区间] 之间的差异为 1.2%[-5.2%, 7.8%], 满足预先设定的非隐性标准 (95% 置信区间的下限大于10%)。 包装：1套件

英文版说明书

manufacturing and marketing approval prostate cancer and premenopausal breast cancer therapeutic agent of the "Leuplin ®PRO injection kit 22.5mg" in JapanOn September 28, 2015, the Company announced today its "Leuplin® PR Injection Kit 22.5 mg" (hereinafter referred to as "Injection Kit"), asustained 24-week product of "Leuprin®" (generic name: leuprorelin acetate, for the "24-week sustained formulation"), let you know that it has acquired a manufacturing and marketing approval from the Ministry of Health, Labor and welfare as prostate cancer and premenopausal breast cancer therapeutic agent.Leuplin is an LH-RH agonist (luteinizing hormone releasing hormone derivative) injectable formulation created by the Company, which acts continuously on the pituitary gland and decreases the reactivity of the pituitary gland, thereby producing sex hormone Suppress. This drug is, as a therapeutic agent for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, the United States, Europe, has been used in Asia and the like.We repeated innovation of pharmaceutical technology and developed this drug which was administered once daily at the time of first approval in the United States (1985) as a sustained release formulation by original microcapsule formulation technology, and 1 It has made it possible to maintain a stable blood concentration over a long period of time by administration. Currently, sales in Japan are 4 weeks sustained preparation of this drug and 12 weeks sustained preparation.The approval acquisition of the 24-week sustained preparation in Japan this time, our company examined the efficacy, safety, pharmacokinetics and hormonal dynamics etc. of this drug for prostate cancer and premenopausal breast cancer in Japan, 2 It is based on the results of one multicenter, randomized, open-label clinical phase III trial. As the premenopausal breast cancer therapeutic agent, it will be approved as the world's first 24-week sustained-release preparation.We expect that we can respond to the needs of prostate cancer · premenopausal breast cancer patients and medical personnel by delivering this drug.Outline of sustained preparation for 24 weeksproduct nameLeuplin® PRO injection kit 22.5 mgcommon nameLeuprorelin acetateIndication○ Prostate cancer○ premenopausal breast cancerDosage regimenUsually, adults receive 22.5 mg subcutaneously as leuprorelin acetate once every 24 weeks.Upon administration, the plunger rod is pushed with the injection needle facing upward, and the total amount of the suspension liquidMove it to the powder part, use it while sufficiently suspending it, taking care not to foam.