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英文药名：INAVIR DRY POWDER INHALER（Laninamivir Octanoate Hydrate）
中文药名：拉尼娜米韦辛酸酯水合物/干粉吸入器
生产厂家：第一三共制药
药品介绍
商品名：INAVIR
通用名：Laninamivir Octanoate Hydrate（暂译名：拉尼娜米韦辛酸酯水合物）
临床试验代号：CS-8958
原研公司：日本第一三共株式会社
类别名称：长效选择性神经氨酸酶（neuramidinase,NA）抑制剂/抗流感病毒药物
药效药理
拉尼纳米韦辛酸酯水合物是一种前药，被转化为活性代谢物Laninamivir通过水解，显示出抗病毒活性之后。
(1) 体外抗病毒活性
Laninamivir神经氨酸酶A型和B型流感病毒在体外的低浓度（实验室菌株IC50：2.32〜38.8nM，临床分离株的IC 50：1.29〜26.5nM）8，其被抑制）。此外，Laninamivir是磷酸奥司他韦耐药株（IC50：5.62〜48.9nM），以及新的甲型流感（H1N1）病毒（IC50：0.41nM）和高致病性禽流感A（H5N1）病毒（IC50： 0.28〜2.1nM）8也显示出在体外（神经氨酸苷酶抑制活性的抗病毒活性）
(2) 体内抗病毒活性
A型的小鼠感染模型流感病毒，由拉尼成实建筑辛酸酯水合物的单个鼻给药，显著减少在肺病毒滴度在6.6〜660μg/kg的，它是在21〜190μg/kg的显著11的治疗效果，如增加的Na存活数观察到）。此外，在B型流感病毒的雪貂感染模型，拉尼奈美建筑辛酸酯水合物（24μg/kg和240μg/kg）的单一鼻内给药降低病毒滴度在鼻灌洗液12）。
此外，新流感A（H1N1）的病毒的小鼠感染模型中，和图9显著在肺中病毒滴度在拉尼成实建筑辛酸酯水合物700μg单鼻给药降低/公斤观察）。
即使在高致病性禽流感A（H5N1）病毒的三天，拉尼成实建筑辛酸酯水合物的单一鼻内给药，感染后的小鼠感染模型在剂量大于75μg/千克，750μg/肺病毒滴度直至感染的第六后它降低在高于kg的剂量。
(3) 作用机序
新形成的病毒，感染的细胞拉尼成实建筑辛酸酯水合物，选择性抑制神经氨酸酶A型和B型流感病毒的活性代谢物Laninamivir通过抑制从释放，抑制病毒的生长。
(4) 耐性
在临床试验8试验，以研究拉尼成实建筑辛酸针对流感病毒感染酸酯水合物的效果（包括国际合作试验的一项研究中），在流感病毒株分离自患者1917案件Laninamivir活性代谢物应变滴敏感观察。
适应症
治疗和预防A型或B型流感病毒感染
用法用量
治疗中使用
大人
每天一次，每次单独吸入给药40毫克
小孩
如果小于10岁，每天一次，每次单独吸入给药10-20毫克
对于超过10岁，每天一次，每次单独吸入给药20-40毫克
使用的预防
成人和10岁以上年龄较大的儿童
每天一次，每次单独吸入给药20毫克，吸入给药两天。
包装规格
吸入粉：20毫克/2容器（2盒）
存储
在室温下保存
失效日期
包装可以在到期日的显示中使用。
生产厂商
第一三共有限公司
注意事项
这种药物是仅用于“治疗流行性感冒A或B病毒感染”的目的时的好处。
Inavir Dry Powder Inhaler（Laninamivir octanoate hydrate）
Inavir Dry Powder Inhaler 20mg [for prevention]（イナビル吸入粉末剤20mg［予防用］）
Brand name : Inavir Dry Powder Inhaler 20mg [for prevention ]
Active ingredient: Laninamivir octanoate hydrate
Dosage form: Inhaled dry powder
Print on wrapping: 要処方, イナビル吸入粉末剤20mg, 吸入剤, （１）, （２）, 製造番号, 第一三共
Inavir Dry Powder Inhaler 20mg[for treatment]（イナビル吸入粉末剤20mg［治療用］）
Brand name : Inavir Dry Powder Inhaler 20mg[for treatment]
Active ingredient: Laninamivir octanoate hydrate
Dosage form: Inhaled dry powder
Print on wrapping: 要処方, イナビル吸入粉末剤20mg, 吸入剤, （１）, （２）, 製造番号, 第一三共
Effects of this medicine
This medicine selectively inhibits neuraminidase that is on the surface of type A/B influenza virus, prevents release of newly-produced virus from infected cells and suppresses the growth of influenza virus.
It is usually used to treat/prevent type A/B influenza virus infection.
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 have an allergy to dairy products.
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/children aged 10 years or more, inhale a dose of 2 packages once a day. For children aged less than 10 years, inhale a dose of 1 package once a day. This product contains 20 mg of laninamivir octanoate in a package and the medicine is filled in 2 parts of the package. Strictly follow the instructions.
The medicine is only for oral inhalation use. Read the instruction for users (available only in Japanese) thoroughly before using the medicine.
Do not stop inhaling this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
In clinical trial for child patients on this medicine, there have been reports of psychoneurotic symptoms such as abnormal behavior. As for child patients aged under 20, it is important to prevent possible troubles including abnormal behavior resulting in fall accidents. In case that your child aged under 20 is treated at home, please be careful not to leave him/her alone for at least 2 days.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, nausea, gastroenteritis, hives, dizzinessa and fever. 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.
breathing difficulty, hives, decrease of blood pressure, pale face, cold sweat [shock, anaphylaxis]
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
Keep out the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.
DAIICHI SANKYO COMPANY, LIMITED External
Revised: 8/2015
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.
http://www.info.pmda.go.jp/go/pack/6250703G1022_1_12/
http://gigazine.net/news/20101024_flu_inabiru/
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