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Avigan 法匹拉韦片

通用名称法匹拉韦片 Favipiravir
品牌名称Avigan
产地|公司日本(Japan) | 富山化学(Toyama)
技术状态
成分|含量200mg
包装|存储100片/盒 室温
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通用中文 法匹拉韦片 通用外文 Favipiravir
品牌中文 品牌外文 Avigan
其他名称
公司 富山化学(Toyama) 产地 日本(Japan)
含量 200mg 包装 100片/盒
剂型给药 片剂 口服 储存 室温
适用范围 流感 流感病毒.新的或复兴的流感病毒感染(只要其他抗流感病毒药物无效或效果不足
通用中文 法匹拉韦片
通用外文 Favipiravir
品牌中文
品牌外文 Avigan
其他名称
公司 富山化学(Toyama)
产地 日本(Japan)
含量 200mg
包装 100片/盒
剂型给药 片剂 口服
储存 室温
适用范围 流感 流感病毒.新的或复兴的流感病毒感染(只要其他抗流感病毒药物无效或效果不足

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。)
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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。)

新型抗病毒强效口服药

Avigan(Favipiravir)-法匹拉韦片-埃博拉新药

-アビガン錠(ファビピラビル(T-705))
药物分类名称
抗流感病毒剂
商標名
AVIGAN
一般名:ファビピラビル(Favipiravir)
化学名:6-Fluoro-3-hydroxypyrazine-2-carboxamide
構造式:
分子式:C5H4FN3O2
分子量:157.10
性状:
它是一种白色至浅黄色粉末。它微溶于乙腈或甲醇,不易溶于水或乙醇(99.5)。
熔点:187-193℃
批准条件
制定药品风险管理计划,适当实施。
2.
由于在使用该药物的实际使用条件下必须充分考虑其有效性和安全性,应进行适当的上市后监督等。
3.
不要生产/销售,除非卫生,劳工和福利部长要求。
4.
制造和销售时,实行严格的分销管理和适当的安全措施,不被用于普通流感病毒感染。
5.
只有当这种药物的管理被认为适合的情况下才能进行治疗,其有效性和风险将事先向患者或其家人提供文件,并且仅在获得书面知情同意书后才予以管理采取适当措施。
药效药理
1.
体外抗病毒活性
甲型和乙型流感病毒实验室菌株的EC50值为0.014〜0.55μg/ mL,显示出抗病毒活性。
季戊型流感A和B病毒(金刚烷(金刚烷胺和金刚乙胺),奥司他韦和扎那米韦耐药菌株)的EC 50值分别为0.03〜0.94μg/ mL和0.09〜0.83μg/ mL。
包括猪A型和禽类来源的包括高致病性菌株的A型(包括H5N1,H7N9菌株)的甲型流感病毒(包括金刚烷,奥司他韦和扎那米韦)的EC 50值为0.06至3.53 μg/ mL。
对金刚烷,奥司他韦和扎那米韦耐药的甲型和乙型流感病毒的EC 50值为0.09〜0.47μg/ mL,无交叉耐药。
2.
动物模型中的治疗效果
在流感病毒A(H7N9),A(H1N1)pdm09和A(H3N2)的小鼠感染模型中,通过口服60mg/kg/天或更少的静脉内病毒载量降低5天。
在具有流感病毒A(H3N2)和A(H5N1)的小鼠感染模型中,通过30mg/kg /天的口服施用5天显示出治疗效果。
另外,在严重联合免疫缺陷小鼠的流感病毒A(H3N2)感染模型中,通过口服30mg/kg/天显示治疗效果14天。
3.
作用机序
据认为,其在细胞中被代谢成三磷酸核糖基(Fabipiravir RTP),Fabipiravir RTP选择性抑制涉及流感病毒复制的RNA聚合酶。 Fabipiravir RTP(1000μmol/ L)对人类DNA聚合酶α,β和γ没有抑制α,β抑制为9.1〜13.5%,γ为11.7〜41.2% 显示动作。 此外,Fabipyruville RTP对人RNA聚合酶II的抑制作用(IC 50值)为905μmol/ L。
4.
耐性
在Fabipiravir针对氟维地那韦的情况下,甲型流感病毒甲型流感病毒的易感性没有发生变化,并没有选择抗性病毒。 在包括国际联合III期试验的临床试验中,尚未获得关于该耐药性流感病毒的出现状况的资料。
适应病症
新的或复兴的流感病毒感染(只要其他抗流感病毒药物无效或效果不足)
用法与用量
成年人,在第一天每天两次1600mg,第二天至第五天每天600mg,每天两次口服。 总行政期为5天。
包装
アビガン錠200mg:100錠(PTP)
製造販売
富山化学工業株式会社




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。)
Anti-influenza virus drugs "Abigan ® Tablets 200mg" Notice of manufacturing and marketing approval in Japan of
Toyama Chemical Co., Ltd. of the Fujifilm Group (Head Office: Shinjuku-ku,Tokyo, President: Sugata Ekitsukasa, below, Toyama Chemical), this time, tablet type of new anti-influenza virus drugs "Abigan ® Tablets 200mg" (generic name : Fabipirabiru, Research Code: T-705, I'll let you know since we acquired the manufacturing and marketing approval of the following "Abigan").
Influenza viruses replicate genes in infected cells, to expand the infection to other cells by the proliferation and release. Currently, neuraminidase inhibitors are used to treat, whose is the release inhibiting to the prevent the spread of infection, "Abigan" is, of preventing proliferation by inhibiting gene replication in cells of the virus it is a drug with a new mechanism (RNA polymerase inhibitor). From these characteristics of the drug, avian influenza virus A (H5N1) and A (H7N9) antiviral effects are expected for such, in the experimental animal level already effect is confirmed.
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"Abigan" is based on the current situation surrounding the recent influenza, new or re-emerging influenza virus infection occurs, and in case other anti-influenza drugs such as neuraminidase inhibitors is invalid or effect insufficient, new mechanism that it should be in usable condition to "Abigan" with it is determined that there is a meaning, it became approved for the first time in the world in the country.
"Abigan" is new or re-emerging influenza virus infection occurs, this drug when it determines that when used for countermeasures against the influenza virus countries are drugs administered to the patient will be considered. Therefore, it is not intended to immediately sell for squid, do the production and supply, etc. In response to the request from the Minister of Health, Labour and Welfare.
Toyama Chemical, We take the expectations of society for "Abigan" very seriously, and in case there was a production request from the Minister of Health, Labour and Welfare, so that it can respond promptly while sufficiently attention to distribution management and safety measures, stable supply system I will continue to build.
Toyama Chemical Fujifilm Group aims to "contribute to the development of the world's health care through new drug development" that as research and development-oriented company.
<Product Overview "Abigan">
Brand Name Abigan ® Tablets 200mg
Generic name Fabipirabiru
Efficacy new or re-emerging influenza virus infection (However, other anti-influenza virus drugs limited to those of the invalid or insufficient effect.)
DOSAGE AND ADMINISTRATION usually, the first day as Fabipirabiru in adults is 2 times once 1600mg 1 day from the second day fifth day administered orally once 600mg 2 times a day. The total administration period to five days.
Manufacturing and marketing approval date March 24, 2014