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普来纳西注射混悬液(Plenaxis injectable suspension 100mg)

产地国家:德国

处方药:是

所属类别: 100毫克/瓶 1瓶/盒

包装规格: 100毫克/瓶 1瓶/盒

计价单位:盒

生产厂家英文名:Praecis

原产地英文商品名:Plenaxis injection 100mg/vials 1vials/bottle, cold chain product (storage at 2-8 degrees) extra charge for packaging

原产地英文药品名:abarelix

中文参考商品译名:普来纳西注射混悬液  100毫克/瓶 1瓶/盒 冷链产品(储存在2-8度),需要额外的包装费用

中文参考药品译名:阿巴瑞克

简介

部份中文普来纳西处方资料(仅供参考)

英文药名: Plenaxis(abarelix for injectable suspension)

中文药名: 普来纳西(阿巴瑞克注射混悬液)

生产厂家:Praecis制药

药品介绍:2003年11月25日,Praecis制药公司宣布,FDA已批准其开发的Plenaxis(abarelix注射用混悬液)上市,这是目前得到批准的第一种可存储的促性腺激素释放激素拮抗剂配方, Plenaxis是第一个促性腺素释放激素(GnRH)拮抗剂,为长效混悬剂配方。

用于不适宜用LHRH激动剂治疗和拒绝手术切除的晚期症状性前列腺癌(PCA),并具有一种以上下述3种情况即

1)因转移而出现神经损伤的风险

;2)因局部侵犯或转移病而出现的尿道或膀胱出口阻塞和

3)因骨骼转移而出现的需要持续用麻醉镇痛药的严重骨痛的男性病人治标性治疗。促性腺激素释放激素拮抗剂。

Plenaxis是叫做促性腺素释放激素拮抗剂(gonadotropin-releasing hormone[GnRH] antagonist)的一类药物,它是涉及多数前列腺癌生长的一个关键因素。对81名男子所作的试验,证明Plenaxis有降低晚期、征候的前列腺癌男子睾丸素(testosterone)生产的效果。试验表明,这些患者可以通过至少12周的治疗避免手术去势。他们中的某些还从使用此产品中获得其他益处,包括减少疼痛和缓解泌尿问题。但是,在临床试验中,81名患者中有三人发生了严重的过敏反应,其中一人还失去了知觉。

它将根据药品申报者(sponsor)同意并执行的自愿风险管理计划(voluntary risk management program[RMP])被上市。由于与该药使用相关的严重的和潜在性威胁生命的过敏反应(allergic reactions)的风险增加,根据该计划,药品申报者将把Plenaxis的使用限于没有其他可选择疗法的晚期前列腺癌患者。患前列腺癌的男子中,大约5%-10%有晚期、征候的(symptomatic)疾病,这将使他们成为使用Plenaxis的候选人(candidates)。

英文版说明书

(Gonadotropin-releasing hormone antagonist) is a synthetic peptide that competes with the neurohormone GnRH for its receptor, thus decreasing or blocking GnRH action. As a result endogenous pituitary output of FSH and LH is shut down.GnRH antagonists are also derivatives of the natural GnRH decapeptide with multiple amino acid substitutions. These substitutions modify the agent so that it blocks the receptor and decreases FSH and LH secretions within hours. In contrast to GnRH agonists, antagonists have no flare effect, thus their therapeutic effect is immediately apparent. However, their action is short-lived and daily injections are necessary to maintain their effect. Typically endogenous FSH and LH activity returns about 40 hours after cessation of GnRH antagonist administration, although with a higher dose the return to normal pituitary function will be postponed for longer. Unlike the GnRH agonists, long acting or depot forms of the agent are not currently available, thus GnRH antagonists are not used in the long term therapy of patients with cancer where hormone levels need to be kept low for a long time. As of 2006, Histrelin (as Supprelin-LA) is awaiting approval for use as a 12-month depot injection.The main application of GnRH antagonists is currently short term use in the prevention of endogenous ovulation in patients who undergo exogenous stimulation with FSH in the preparation for IVF. Typically they are administered in the mid- to late follicular phase in stimulated cycles prior to the administration of hCG. Because they decrease luteal competence, patients are usually given some form of luteal support after egg retrieva l.GnRH antagonists for long term use are under investigation (i.e. abarelix), their advantage over GnRH agonist would be that they lack the initial flare stimulation and induce quickly a hypogonadal situation.

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。
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