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RAPIACTA for Intravenous Drip Infusion（帕拉米韦注射液软袋包装）

2014-01-12 03:44:17 作者：新特药房来源：互联网浏览次数：407 文字大小：【大】【中】【小】

简介：帕拉米韦注射液软袋包装英文名称：Peramivir Hydrate商品名称：Rapiacta® （美国），販売名ラピアクタ点滴用バッグ（日本）化学名称：(1S,2S,3R,4R)-3-[(1S)-1-(Acetylamino)-2-ethylbutyl]-4-guanidino-2- ...

关键字：帕拉米韦注射液 Peramivir Hydrate 商标名RAPIACTA Vial 抗流感病毒剂用于治疗A型或B型流感病毒感染

部份中文帕拉米韦/ラピアクタ处方资料（仅供参考）
帕拉米韦注射液软袋及瓶装包装
英文名称：Peramivir Hydrate
商品名称：Rapiacta®（美国），販売名ラピアクタ点滴用バッグ（日本）
化学名称：
(1S,2S,3R,4R)-3-[(1S)-1-(Acetylamino)-2-ethylbutyl]-4-guanidino-2-hydroxycyclopentanecarboxylic acid trihydrate
分子式：C15H28N4O4･3H2O
分子量：382.45
CAS号：1041434-82-5
化学结构式：
规格：
200mg/20ml（美国）注射液300mg/瓶、150mg/瓶（日本盐野义）
适应症：
用于治疗A型或B型流感病毒感染
用法用量：
通常情况下，成人300mg静脉滴注，每日1次，不少于15分钟。
严重并发症的患者， 600mg静脉滴注，每日1次，不少于15分钟。症状严重者，连日反复治疗，根据年龄和症状，适当减量。
国外上市情况：
2009年10月23日，FDA根据美国疾病控制和预防中心的要求，其已针对正在研究中的抗病毒药peramivir发布了一项紧急使用授权（EUA），批准该药可静脉注射用于部分已证实或疑似2009 H1N1型流感感染的住院成人和儿童患者，由BioCryst制药公司研制上市。
盐野义于2007年从美国制药商BioCryst Pharmaceutical处购得在日本及台湾生产和销售权，2010年1月，由日本盐野义公司在日本上市。
产品优势：
帕拉米韦( Peramivir ),又名RWJ-270201或BCX-1812,分子量为328 ku,是一个新颖的环戊烷类抗流感病毒药物,是继扎那米韦(Zanamivir)和奥司米韦(Oseltamivir)研发成功并于1999年上市之后的又一新型流感病毒NA抑制剂。该药物于2000年由澳大利亚国立大学药学院Babu教授领导的课题组在实验室研制成功。国外对帕拉米韦抗病毒的体内外试验和临床试验结果显示,该药物能有效抑制各种流感病毒株的复制和传播过程,具有耐受性好、毒性小等优点。

ラピアクタ点滴静注液バッグ300mg／ラピアクタ点滴静注液バイアル150mg

治疗类别名称
抗流感病毒剂
有效成分：Peramivir Hydrate 帕拉米韦
批准上市时间：2010年10月
欧文商標名
RAPIACTA for Intravenous Drip Infusion
一般的名称：ペラミビル水和物（JAN）
Peramivir Hydrate
化学名：
(1S,2S,3R,4R)-3-[(1S)-1-(Acetylamino)-2-ethylbutyl]-4-guanidino-2-hydroxycyclopentanecarboxylic acid trihydrate
分子式：C15H28N4O4・3H2O
分子量：382.45
化学構造式：

性状：
白细黄棕白色粉末。
微溶于水，在甲醇或乙醇（99.5），N-微溶，几乎在N-二甲基甲非常可溶的。
融点：242.0～243.5℃（分解）
分配係数：log P＝-1.16(P＝0.069)［1-オクタノール/水］
条件批准
1.为了证实药物的安全性和有效性，开展适当的后期制作和销售是基于使用调查。
2.国内外研究成果和有关尊重的抗流感病毒的药物目前的信息，在任何时间，上报监管部门。
药品形状：液体，软袋及瓶装包装
包闭规格
静脉输液袋：300毫克：60毫升×1袋，60毫升×10袋

静脉滴注：150毫克：15毫升×10瓶

制造厂商
盐野义制药有限公司
提携
BIOCRYST PHARMACEUTICAL
日本上市的完整处方资料附件：http://www.info.pmda.go.jp/go/pack/6250405A1032_1_03/
RAPIACTA Vial 150mg for Intravenous Drip Infusion（ラピアクタ点滴静注液バイアル150mg）
Brand name : RAPIACTA Vial 150mg for Intravenous Drip Infusion
　Active ingredient: Peramivir hydrate
　Dosage form: injection
　Print on wrapping:
RAPIACTA Bag 300mg for Intravenous Drip Infusion（ラピアクタ点滴静注液バッグ300mg）
Brand name : RAPIACTA Bag 300mg for Intravenous Drip Infusion
　Active ingredient: Peramivir hydrate
　Dosage form: injection
　Print on wrapping:
Effects of this medicine
This medicine inhibits the release of viruses from cells infected with influenza viruses, thereby showing an inhibitory action against proliferation of viruses.
It is usually used for the treatment of influenza A and B viral infections.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults and children, this medicine is administered once a day by an intravenous drip infusion over a period of 15 minutes or longer.
•It is usually used by a single infusion (only one time). However, according to complications or symptoms it may be used for more than 2 days.
Precautions while taking this medicine
•If you are breastfeeding, avoid it for 2 or 3 days after the treatment.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, nausea and vomiting. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•hypotension, facial pallor, cold sweat [shock]
•fever, sore throat [leukopenia, neutropenia]
•malaise, anorexia, yellowness in skin or in the white of eyes [hepatic function disorder, jaundice]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•[To parental guardians etc.] There have been some reports on the onset of psychoneurotic symptoms such as abnormal behavior in patients treated with the anti-influenza virus drugs including this medicine. Therefore, you should keep the following in mind. There is a risk of occurrence of abnormal behavior in children or minors. In case of recuperation at home after the treatment with this medicine, the parental guardians etc. should make sure that the child or the minor is not left alone for at least 2 days.
Shionogi & Co., Ltd.Injection
Revised: 7/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.