Cufence 盐酸曲恩汀胶囊
通用名称盐酸曲恩汀胶囊
trientine hydrochloride
品牌名称Cufence
产地|公司日本(Japan) |
Tsumura(Tsumura)
技术状态
成分|含量
包装|存储1片/盒
2度-8度（冰箱冷藏，禁止冷冻）
微信客服
Xirou_Canada
微信ID
(8:00-15:00)
服务时间
使用说明书
（免责声明：本说明书仅供参考，不作为治疗的依据，不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议，药物是否适合您，请专业医生（或药剂师）决定。）
等待内容更新
中文说明
（免责声明：本说明书仅供参考，不作为治疗的依据，不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议，药物是否适合您，请专业医生（或药剂师）决定。）
2019年5月29日，人用药品委员会（CHMP）采纳了积极的意见，建议授予用于治疗威尔森氏病的药品Cufence的上市许可。 Cufence于2003年10月24日被指定为孤儿药品。该药品的申请人是Univar BV。
Cufence将作为200毫克硬胶囊（trientine碱）提供。 Cufence的活性物质是trientine dihydrochloride，一种铜螯合剂（ATC代码：A16AX），通过形成稳定的复合物从体内清除铜，然后通过尿液排泄消除。曲恩汀还可以抑制铜从肠道吸收。
Cufence的好处是能够降低威尔森氏病患者血清和组织铜水平过高，从而导致神经系统异常和肝功能障碍。 Cufence最常见的副作用是恶心，偶尔会出现皮疹。在治疗开始时可能发生神经功能恶化。
完整的适应症是：“成人，青少年和5岁或5岁以上儿童，对于不能接受D-青霉胺治疗的患者，治疗威尔森氏病有效。”
建议Cufence由具有威尔森氏病管理经验的专科医师发起。
外文说明
（免责声明：本说明书仅供参考，不作为治疗的依据，不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议，药物是否适合您，请专业医生（或药剂师）决定。）
On 29 May 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cufence, intended for the treatment of Wilson’s disease. Cufence was designated as an orphan medicinal product on 24 October 2003. The applicant for this medicinal product is Univar BV.
Cufence will be available as 200 mg hard capsules (trientine base). The active substance of Cufence is trientine dihydrochloride, a copper-chelating agent (ATC code: A16AX) that removes copper from the body by forming a stable complex that is then eliminated through urinary excretion. Trientine may also inhibit copper absorption from the intestinal tract.
The benefits with Cufence are its ability to decrease the excessively high serum and tissue copper levels in patients with Wilson’s disease, which lead to neurological abnormalities and hepatic dysfunction. The most common side effects of Cufence are nausea and occasionally skin rash. Neurological deterioration can occur at the start of the treatment.
The full indication is: “Cufence is indicated for the treatment of Wilson’s disease in patients intolerant to D-penicillamine therapy, in adults, adolescents and children aged 5 years or older.”
It is proposed that Cufence be initiated by specialist physicians with experience in the management of Wilson’s disease.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
