ИНФЛЮВАК представляет собой трехвалентную инактивированную г... Инструкция
Показания к применению
Профилактика гриппа у взрослых и детей старше 6 мес. Вакцинация рекомендуется всем лицам и, прежде всего, следующим категориям населения, подвергающимся повышенному риску в случае сочетания гриппа с уже имеющимися заболеваниями: Пациенты старше 65 лет вне зависимости от состояния их здоровья. Больные с заболеваниями органов дыхания, включая бронхиальную ...
Гиперчувствительность к куриному белку или какому-либо другому компоненту вакцины. Сильные температурные или аллергические реакции после предыдущей вакцинации субъединичными гриппозными вакцинами.
Инструкция
Состав
В одной дозе сусп. д/в/м и п/к введения (0,5 мл) содержатся ГА и НА следующих вирусных штаммов: А/Калифорния 7/2009/H1N1/NYMC X-181, производный от А/Калифорния 7/2009/H1N1, А/Виктория 210/2009/H3N2/NYMC X-187, подобный А/Перт 16/2009/H3N2, B/Брисбен 60/2008. Вспомогательные вещества: калия хлорид, калия дигидрофосфат, натрия фосфата дигидрат, натрия хлорид, кальция хлорида дигидрат, магния хлорида гексагидрат, вода для инъекций.
Описание
Отпуск иммунобиологического лекарственного препарата ОСУЩЕСТВЛЯЕТСЯ ПО РЕЦЕПТУ ВРАЧА и ПРИ НАЛИЧИИ У ПОКУПАТЕЛЯ ТЕРМОКОНТЕЙНЕРА, в который помещается лекарственный препарат, доставка данного лекарственного препарата в медицинскую организацию при условии хранения в специальном термоконтейнере не должна превышать срок 48 часов после его приобретения.
Фармакологические свойства
ИНФЛЮВАК представляет собой трехвалентную инактивированную гриппозную вакцину, состоящую из поверхностных антигенов (гемагглютинин (ГА), нейраминидаза (НА)) вирусов гриппа типа А и В, выращенных на куриных эмбрионах. Антигенный состав гриппозной вакцины ежегодно обновляется согласно рекомендациям Всемирной организации здравоохранения. Вакцина развивает специфический иммунитет к вирусам гриппа типа А и В, полностью формируемый, как правило, через 14 суток после прививки и сохраняющийся до 1 года.
Показания к применению
Профилактика гриппа у взрослых и детей старше 6 мес. Вакцинация рекомендуется всем лицам и, прежде всего, следующим категориям населения, подвергающимся повышенному риску в случае сочетания гриппа с уже имеющимися заболеваниями: Пациенты старше 65 лет вне зависимости от состояния их здоровья. Больные с заболеваниями органов дыхания, включая бронхиальную астму. Больные с сердечно-сосудистыми заболеваниями любой этиологии. Больные с хронической почечной недостаточностью. Больные с хроническими нарушениями метаболизма, включая сахарный диабет. Больные с иммунодефицитными заболеваниями и больные, получающие иммунодепрессанты, цитостатики, лучевую терапию или кортикостероиды в высоких дозах. Дети и подростки в возрасте от 6 мес до 18 лет, в течение длительного времени получающие препараты, содержащие ацетилсалициловую кислоту, и, следовательно, подверженные повышенному риску развития синдрома Рейе вследствие гриппозной инфекции.
Противопоказания
Гиперчувствительность к куриному белку или какому-либо другому компоненту вакцины. Сильные температурные или аллергические реакции после предыдущей вакцинации субъединичными гриппозными вакцинами.
Применение при беременности и в период грудного вскармливания
Со стороны кровеносной и лимфатической системы: редко - тромбоцитопения. Со стороны иммунной системы: в редких случаях возможны аллергические реакции, в очень редких случаях – анафилактический шок. Со стороны нервной системы: часто - головная боль, редко - парестезии, судороги, энцефаломиелит, неврит, синдром Гийена-Барре. Однако убедительного подтверждения связи этих реакций с вакцинацией не получено. Со стороны сосудистой системы: очень редко - васкулит с транзиторным нарушением функции почек. Общие расстройства: часто - утомляемость, невралгия, не требующие лечения и проходящие через 1–2 дня. Местные реакции: покраснение, припухлость, болезненность, уплотнение, экхимозы. Системные реакции: повышение температуры, недомогание, дрожь, потливость, болезненность в мышцах и суставах.
Способ применения и дозы
Иммунизацию проводят ежегодно в осенний период. Вакцину вводят внутримышечно или глубоко подкожно. Категорически запрещается вводить препарат внутривенно! Доза для взрослых и подростков (с 14 лет): 0,5 мл. Вакцина вводится однократно. Доза для детей с 6 мес. до 3 лет: 0,25 мл. Доза для детей от 3 до 14 лет: 0,5 мл. Вакцина вводится однократно. Детям, ранее не болевшим гриппом и ранее не вакцинированным, рекомендуется вводить вакцину двукратно с интервалом 4 нед. Больным с иммунодефицитом рекомендуется вводить вакцину двукратно с интервалом 4 нед.
Побочное действие
Инфлювак можно применять одновременно с другими вакцинами. При этом вакцины следует вводить в разные участки тела разными шприцами. Возможно усиление побочных эффектов. Если пациент получает иммуносупрессивную терапию, иммунный ответ может быть снижен. После вакцинации возможно получение ложно-положительных результатов серологических тестов при иммуноферментном анализе (ИФА), которые обусловлены выработкой IgM после вакцинации.
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