Специфическая профилактика гриппа у детей с 6-месячного возраста, подростков и взрослых без ограничения возраста. Вакцина особенно показана лицам с высоким риском возникновения осложнений в случае заболевания гриппом:
Старше 60 лет, детям дошкольного возраста, школьникам
Взрослым и детям, часто болеющим ОРЗ, страдающим хроническими соматическими заболеваниями, в т.ч. болезнями и пороками развития ЦНС, сердечно-сосудистой системы и бронхо-легочной системы, бронхиальной астмой, хроническими заболеваниями почек, сахарным диабетом, болезнями обмена веществ, аутоиммунными заболеваниями, аллергическими заболеваниями (кроме аллергии к куриному белку), хронической анемией, врожденным или приобретенным иммунодефицитом, ВИЧ-инфицированным Вакцина также показана лицам, по роду профессии имеющим высокий риск заболевания гриппом или заражения им других лиц, в т.ч.:
Медработникам, работникам образовательных учреждений, сферы социального обслуживания, транспорта, торговли, полиции, военнослужащим
Противопоказания
Аллергические реакции на куриный белок и компоненты вакцины
Аллергические реакции на ранее вводимые гриппозные вакцины
Острые лихорадочные состояния или обострение хронического заболевания (вакцинацию проводят после выздоровления или в период ремиссии)
Нетяжелые ОРВИ, острые кишечные заболевания (вакцинацию проводят после нормализации температуры)
Инструкция
Состав
1 доза (0.5 мл) гемагглютинин антигенов вирусов гриппа типа А (H1N1)* 5 мкг типа А (H3N2)* 5 мкг типа B* 5 мкг азоксимера бромид 500 мкг. Вспомогательные вещества: фосфатно-солевой буферный раствор - до 0.
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
Гриппол плюс - противогриппозная трехвалентная инактивированная полимер-субъединичная вакцина. Представляет собой протективные антигены (гемагглютинин и нейраминидаза), выделенные из очищенных вирусов гриппа типа А и В, выращенных на куриных эмбрионах, связанные с водорастворимым высокомолекулярным иммуноадъювантом N-оксидированным производным поли-1,4-этиленпиперазина (азоксимера бромид). Антигенный состав вакцины изменяется каждый год в соответствии с эпидемической ситуацией и рекомендациями ВОЗ. Вакцина вызывает формирование высокого уровня специфического иммунитета против гриппа. Защитный эффект после вакцинации, как правило, наступает через 8-12 дней и сохраняется до 12 месяцев, в т.ч. у пожилых лиц. Защитные титры антител к вирусам гриппа после вакцинации лиц разного возраста определяются у 75-95% вакцинированных. Включение в вакцинный препарат иммуномодулятора азоксимера бромида, обладающего широким спектром иммунофармакологического действия, обеспечивает увеличение иммуногенности и стабильности антигенов, позволяет повысить иммунологическую память, существенно снизить прививочную дозу антигенов, повысить устойчивость организма к другим инфекциям за счет коррекции иммунного статуса.
Показания к применению
Специфическая профилактика гриппа у детей с 6-месячного возраста, подростков и взрослых без ограничения возраста. Вакцина особенно показана лицам с высоким риском возникновения осложнений в случае заболевания гриппом:
Старше 60 лет, детям дошкольного возраста, школьникам
Взрослым и детям, часто болеющим ОРЗ, страдающим хроническими соматическими заболеваниями, в т.ч. болезнями и пороками развития ЦНС, сердечно-сосудистой системы и бронхо-легочной системы, бронхиальной астмой, хроническими заболеваниями почек, сахарным диабетом, болезнями обмена веществ, аутоиммунными заболеваниями, аллергическими заболеваниями (кроме аллергии к куриному белку), хронической анемией, врожденным или приобретенным иммунодефицитом, ВИЧ-инфицированным Вакцина также показана лицам, по роду профессии имеющим высокий риск заболевания гриппом или заражения им других лиц, в т.ч.:
Медработникам, работникам образовательных учреждений, сферы социального обслуживания, транспорта, торговли, полиции, военнослужащим
Противопоказания
Аллергические реакции на куриный белок и компоненты вакцины
Аллергические реакции на ранее вводимые гриппозные вакцины
Острые лихорадочные состояния или обострение хронического заболевания (вакцинацию проводят после выздоровления или в период ремиссии)
Нетяжелые ОРВИ, острые кишечные заболевания (вакцинацию проводят после нормализации температуры)
Применение при беременности и в период грудного вскармливания
Доклинические исследования показали, что вакцина гриппозная инактивированная полимер-субъединичная не обладает эмбриотоксическим и тератогенным действием. Решение о вакцинации беременных врач принимает индивидуально с учетом риска заражения гриппом и возможных осложнений гриппозной инфекции. Наиболее безопасна вакцинация во II и III триместрах беременности. Грудное вскармливание не является противопоказанием для вакцинации.
Способ применения и дозы
Вакцинацию проводят ежегодно в осенне-зимний период. Возможна вакцинация в начале эпидемического подъема заболеваемости гриппом. Детям старше 3 лет, подросткам и взрослым вакцину вводят в/м или глубоко п/к в верхнюю треть наружной поверхности плеча (в дельтовидную мышцу), детям младшего возраста - в/м в переднебоковую поверхность бедра. Детям в возрасте от 6 до 35 мес включительно вводят по 0.25 мл двукратно с интервалом 3-4 недели. Детям старше 36 мес и взрослым вакцину вводят однократно в дозе 0.5 мл. Ранее не болевшим гриппом и не вакцинированным детям возможно двукратное введение вакцины с интервалом 3-4 недели. Пациентам с иммунодефицитом и получающим иммуносупрессивную терапию возможно введение вакцины двукратно по 0.5 мл с интервалом 3-4 недели. Правила введения вакцины Перед применением вакцину следует выдержать до комнатной температуры и хорошо встряхнуть. Снять защитную крышку с иглы и удалить воздух из шприца, удерживая его в вертикальном положении иглой вверх и медленно нажимая на поршень. Для иммунизации детей, которым показано введение 0.25 мл (1/2 дозы) вакцины, необходимо удалить половину содержимого шприца, надавив на поршень до специальной риски, отмеченной на корпусе шприца, или до метки красного цвета, нанесенной на край этикетки, и ввести оставшиеся 0.25 мл. Вскрытие ампул и флаконов и процедуру вакцинации осуществляют при строгом соблюдении правил асептики и антисептики: перед вскрытием ампульный нож, шейку ампулы или пробку флакона протирают ватой, смоченной 70% этиловым спиртом, вскрывают ампулу или прокалывают иглой резиновую пробку флакона, набирают вакцину в шприц одноразового применения и удаляют из шприца избыток воздуха. Спиртом протирают кожу в месте инъекции. Препарат во вскрытой ампуле или флаконе хранению не подлежит.
Побочное действие
Вакцина является высокоочищенным препаратом, хорошо переносится детьми и взрослыми. Частота побочных реакций определяется следующим образом: часто (>1/100, меньше1/10), нечасто (>1/1000, меньше1/100), редко (>1/10 000, меньше1/1000), очень редко (меньше1/10 000). Местные реакции: часто - болезненность, гиперемия, уплотнение и отек в месте введения. Общие реакции: часто - недомогание, слабость, субфебрильная температура; нечасто - легкий насморк, боль в горле, головная боль и повышение температуры выше субфебрильной (указанные реакции обычно проходят самостоятельно в течение 1-2 суток); редко - аллергические реакции, в т.ч. немедленного типа. Со стороны нервной системы: очень редко - невралгия, парестезия, неврологические расстройства. Со стороны костно-мышечной системы: очень редко - миалгия. Пациент должен быть проинформирован о необходимости сообщать врачу о любых выраженных или не указанных в инструкции побочных реакциях.
Передозировка
Случаи передозировки вакцины Гриппол плюс не зарегистрированы.
Особые указания
В день прививки вакцинируемые должны быть осмотрены врачом (фельдшером) с обязательной термометрией. При температуре выше 37.0°С вакцинацию не проводят. Не пригоден к применению препарат в ампулах, флаконах, шприцах с нарушенной целостностью или маркировкой, при изменении физических свойств (цвета, прозрачности), при истекшем сроке годности, нарушении требований к условиям хранения. Вакцину запрещается вводить в/в. В кабинетах, где проводится вакцинация, необходимо иметь средства противошоковой терапии. Вакцинированный должен находиться под наблюдением медработника в течение 30 мин после иммунизации. Влияние на способность к вождению автотранспорта и управлению механизмами Гриппол плюс не оказывает влияния на способность к вождению автомобиля или управление машинами и механизмами.
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Представляет собой протективные антигены (гемагглютинин и нейраминидаза), выделенные из очищенных вирусов гриппа типа А и В, выращенных на куриных эмбрионах, связанные с водорастворимым высокомолекулярным иммуноадъювантом N-оксидированным производным поли-1,4-этиленпиперазина (азоксимера бромид). Антигенный состав вакцины изменяется каждый год в соответствии с эпидемической ситуацией и рекомендациями ВОЗ. Вакцина вызывает формирование высокого уровня специфического иммунитета против гриппа. Защитный эффект после вакцинации, как правило, наступает через 8-12 дней и сохраняется до 12 месяцев, в т.ч. у пожилых лиц. Защитные титры антител к вирусам гриппа после вакцинации лиц разного возраста определяются у 75-95% вакцинированных. Включение в вакцинный препарат иммуномодулятора азоксимера бромида, обладающего широким спектром иммунофармакологического действия, обеспечивает увеличение иммуногенности и стабильности антигенов, позволяет повысить иммунологическую память, существенно снизить прививочную дозу антигенов, повысить устойчивость организма к другим инфекциям за счет коррекции иммунного статуса."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Специфическая профилактика гриппа у детей с 6-месячного возраста, подростков и взрослых без ограничения возраста. Вакцина особенно показана лицам с высоким риском возникновения осложнений в случае заболевания гриппом:"}},{"type":"list","data":{"style":"unordered","items":["Старше 60 лет, детям дошкольного возраста, школьникам","Взрослым и детям, часто болеющим ОРЗ, страдающим хроническими соматическими заболеваниями, в т.ч. болезнями и пороками развития ЦНС, сердечно-сосудистой системы и бронхо-легочной системы, бронхиальной астмой, хроническими заболеваниями почек, сахарным диабетом, болезнями обмена веществ, аутоиммунными заболеваниями, аллергическими заболеваниями (кроме аллергии к куриному белку), хронической анемией, врожденным или приобретенным иммунодефицитом, ВИЧ-инфицированным Вакцина также показана лицам, по роду профессии имеющим высокий риск заболевания гриппом или заражения им других лиц, в т.ч.:","Медработникам, работникам образовательных учреждений, сферы социального обслуживания, транспорта, торговли, полиции, военнослужащим"]}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Аллергические реакции на куриный белок и компоненты вакцины","Аллергические реакции на ранее вводимые гриппозные вакцины","Острые лихорадочные состояния или обострение хронического заболевания (вакцинацию проводят после выздоровления или в период ремиссии)","Нетяжелые ОРВИ, острые кишечные заболевания (вакцинацию проводят после нормализации температуры)"]}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Доклинические исследования показали, что вакцина гриппозная инактивированная полимер-субъединичная не обладает эмбриотоксическим и тератогенным действием. 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Ранее не болевшим гриппом и не вакцинированным детям возможно двукратное введение вакцины с интервалом 3-4 недели. Пациентам с иммунодефицитом и получающим иммуносупрессивную терапию возможно введение вакцины двукратно по 0.5 мл с интервалом 3-4 недели. Правила введения вакцины Перед применением вакцину следует выдержать до комнатной температуры и хорошо встряхнуть. Снять защитную крышку с иглы и удалить воздух из шприца, удерживая его в вертикальном положении иглой вверх и медленно нажимая на поршень. Для иммунизации детей, которым показано введение 0.25 мл (1/2 дозы) вакцины, необходимо удалить половину содержимого шприца, надавив на поршень до специальной риски, отмеченной на корпусе шприца, или до метки красного цвета, нанесенной на край этикетки, и ввести оставшиеся 0.25 мл. Вскрытие ампул и флаконов и процедуру вакцинации осуществляют при строгом соблюдении правил асептики и антисептики: перед вскрытием ампульный нож, шейку ампулы или пробку флакона протирают ватой, смоченной 70% этиловым спиртом, вскрывают ампулу или прокалывают иглой резиновую пробку флакона, набирают вакцину в шприц одноразового применения и удаляют из шприца избыток воздуха. Спиртом протирают кожу в месте инъекции. Препарат во вскрытой ампуле или флаконе хранению не подлежит."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Вакцина является высокоочищенным препаратом, хорошо переносится детьми и взрослыми. Частота побочных реакций определяется следующим образом: часто (\u003e1/100, меньше1/10), нечасто (\u003e1/1000, меньше1/100), редко (\u003e1/10 000, меньше1/1000), очень редко (меньше1/10 000). Местные реакции: часто - болезненность, гиперемия, уплотнение и отек в месте введения. Общие реакции: часто - недомогание, слабость, субфебрильная температура; нечасто - легкий насморк, боль в горле, головная боль и повышение температуры выше субфебрильной (указанные реакции обычно проходят самостоятельно в течение 1-2 суток); редко - аллергические реакции, в т.ч. немедленного типа. Со стороны нервной системы: очень редко - невралгия, парестезия, неврологические расстройства. Со стороны костно-мышечной системы: очень редко - миалгия. Пациент должен быть проинформирован о необходимости сообщать врачу о любых выраженных или не указанных в инструкции побочных реакциях."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Случаи передозировки вакцины Гриппол плюс не зарегистрированы."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В день прививки вакцинируемые должны быть осмотрены врачом (фельдшером) с обязательной термометрией. При температуре выше 37.0°С вакцинацию не проводят. Не пригоден к применению препарат в ампулах, флаконах, шприцах с нарушенной целостностью или маркировкой, при изменении физических свойств (цвета, прозрачности), при истекшем сроке годности, нарушении требований к условиям хранения. Вакцину запрещается вводить в/в. В кабинетах, где проводится вакцинация, необходимо иметь средства противошоковой терапии. Вакцинированный должен находиться под наблюдением медработника в течение 30 мин после иммунизации. Влияние на способность к вождению автотранспорта и управлению механизмами Гриппол плюс не оказывает влияния на способность к вождению автомобиля или управление машинами и механизмами."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Гриппол плюс - противогриппозная трехвалентная инактивированная полимер-субъединичная вакцина. 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