部份中文帕拉米韦处方资料（仅供参考）
商品名：Rapiacta Intravenous Drip Infusion
英文名：Peramivir Hydrate
中文名：帕拉米韦冻干粉注射剂
生产商：塩野义制薬
药品介绍
帕拉米韦(Peramivir)由日本盐野义公司研制开发，于1999年获日本厚生省批准上市，商品名为:Rapiacta，用于成人病患的治疗。2010年10月，日本批准了该药物的儿科用药。
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
药用类别名称
抗流感病毒剂
批准日期：2012年6月
欧文商標名
RAPIACTA for Intravenous Drip Infusion Bag 300mg
RAPIACTA for Intravenous Drip Infusion Vial 150mg
一般的名称
ペラミビル水和物
（Peramivir Hydrate）（JAN）
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
性状
白色～微黄褐色白色粉末。
不易溶于水，不易溶于甲醇或乙醇（99.5），极难溶于N，N-二甲基甲酰胺。
化学構造式
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］
批准条件
关于国内外关于流感病毒对本制剂的耐药性化的调查结果和信息，应随时向监管机构报告。
药效药理
作用机制
选择性地抑制人A型和B型流感病毒的神经酰胺酶。流感病毒的神经酰胺酶具有唾液酸切割活性，通过切割糖链末端的唾液酸，使子代病毒能够从感染细胞的表面游离。青霉素通过抑制神经酰胺酶抑制子代病毒从感染细胞表面游离的步骤，防止病毒扩散到另一个细胞，结果显示病毒增殖抑制作用。
药理作用
流感病毒对神经酰胺酶的抑制作用
对人A型及B型流感病毒的神经酰胺酶显示出抑制活性，其50%抑制浓度A型为0.54～11nmol/L，B型为6.8～17nmol/L（in vitro试验）。
对流感病毒感染小鼠的治疗效果
在人A型及B型流感病毒感染小鼠致死模型中，通过单次静脉内给药维拉米韦，发现存在剂量依赖性的生存数增加，其50%有效量A型为0.4～1.5mg/kg，B型为0.1～1.0mg/kg。
耐受性
在以成人患者为对象的国内第Ⅱ期试验及以儿童患者为对象的国内第Ⅲ期试验中，在本制剂给药前后，对本制剂的敏感性降低了3倍以上的菌株只有A型少数例。另外，在以成人患者为对象的国际共同第Ⅲ期试验中，在感染了与这些敏感性降低株相同的亚型且表现出相同程度敏感性的株的患者中确认了治疗效果。另外，在in vitro耐药性病毒分离试验中，有报告显示出与类药交叉耐药性的耐药性株的出现，但未报告本制剂特有的耐药性株。
适应症
〈成人〉
通常，用15分钟以上单次点滴静注300mg作为培拉米韦。对于因并发症等有可能加重的患者，每天1次600mg，用15分钟以上单次点滴静脉注射，但根据症状可以连日反复给药。另外，根据年龄、症状适当减量。
〈小儿〉
通常，作为培拉米韦，每天1次用15分钟以上单次滴注10mg/kg，但根据症状可以连日反复给药。给药量的上限为每剂量600mg。
包装
〈点滴静注液袋〉
300毫克
1袋〔60mL×1］
〈点滴静注液〉
小瓶150毫克
10瓶[15mL×10］
制造和销售
盐野义制药株式会社
提携
BIOCRYST PHARMACEUTICALS, INC.
注：以上中文不够完整，使用者以原处方资料为准。
完整说明附件：
https://www.info.pmda.go.jp/go/pack/6250405A1032_1_13/?view=frame&style=XML&lang=ja
------------------------------------------------------- 
January 26, 2010 -- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President: Isao Teshirogi; hereafter “Shionogi”) today announced that it will launch a novel anti-viral drug for influenza, “RAPIACTA 300mg Bag for Intravenous Drip Infusion” and “RAPIACTA 150mg Vial for Intravenous Drip Infusion” (generic name:  peramivir), on January 27, 2010.
RAPIACTA is a novel  anti-viral drug for influenza (neuraminidase inhibitor), licensed from US-based  BioCryst Pharmaceuticals, Inc.
and it has been developed by Shionogi in Japan*. On January 13, 2010,  Shionogi received the world's first marketing and manufacturing approval for both single dose administration for adult uncomplicated  seasonal influenza infection as well as single or multiple dose administration for adult patients at high-risk.
Shionogi has also completed a clinical study in pediatric patients with uncomplicated  seasonal influenza and will file an additional application for the pediatric use of  RAPIACTA within this fiscal year.
* The phase III multi-national Asian study for RAPIACTA was conducted in Japan, Taiwan and Korea.
This drug is expected to be sufficiently effective and to improve compliance against  seasonal influenza virus infection with a single-dose administration as an outpatient.
It is also widely available for the case of severe and life-threatening influenza or the difficult case to be administered orally.
Shionogi believes that  RAPIACTA represents an important therapeutic advance for patients with influenza.
Shionogi will make efforts to monitor all patients who receive  RAPIACTA during the specific period of time after launch and to delineate its clinical utilization and safety in order to keep health care professionals informed promptly of the proper use of the product.
Recognizing that novel anti-influenza drugs are needed for the H1N1 influenza pandemic, Shionogi is expected to secure an adequate supply for about 700,000 people for this fiscal year (until March 2010) as a result of its maximum efforts, and it will also make efforts to ensure the manufacturing system for stable supply in the next fiscal year.
Shionogi, as a leading company of anti-infective drugs, is committed to directing its resources into research and development and also into educational activities to contribute to the treatment of infectious diseases, especially of bacterial and viral origin.
RAPIACTA for Intravenous Drip Infusion Product Overview Product Name: RAPIACTA 300mg bag for intravenous drip infusion  RAPIACTA 150mg vial for intravenous drip infusion
Generic Name: PeramivirIndication: Infection with influenza A or B virus strainForm and Content: 300mg of peramivir in one bag (60mL) for intravenous drip infusion 150mg of  peramivir in one vial (15mL) for intravenous drip infusionDosage and Administration: In general, a single dose of 300mg of peramivir is to be administrated to adult patients as intravenous drip infusion over longer than 15 minutes. Forpatients at high-risk, a single dose of 600mg of peramivir is to be administrated as intravenous drip infusion over longer than 15 minutes one time daily, but multiple daily doses are also a treatment option depending on the condition of the patient. The dosage should be adjusted according to the age or medical condition of the patient.
Approval Date: January 13, 2010