Вакцина для профилактики гепатита А. Обеспечивает защиту про... Инструкция
Показания к применению
профилактика гепатита А с 12-месячного возраста.
Противопоказания
Гиперчувствительность к какому-либо компоненту вакцины; — симптомы гиперчувствительности на предыдущее введение вакцины Хаврикс; . Острые инфекционные и неинфекционные заболевания, обострение хронических заболеваний являются временными противопоказаниями для проведения прививок; при нетяжелых ОРВИ, острых кишечных заболеваниях прививки проводят сразу ...
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
Вакцина для профилактики гепатита А. Обеспечивает защиту против гепатита А, формируя специфический иммунитет путем индукции выработки антител против вируса гепатита А (ВГА), а также путем активации клеточных механизмов иммунитета. Двукратная прививка с интервалом 6-12 месяцев обеспечивает длительное сохранение иммунитета. При изучении кинетики иммунного ответа, в специальных исследованиях было установлено, что после введения одной дозы Хаврикс; достигается ранняя и быстрая сероконверсия. При этом уже через 13 дней после введения вакцины число лиц с защитным титром антител (> 20 мМе/мл) составляло 79%. С увеличением срока с момента введения препарата этот показатель значительно нарастал. Для обеспечения длительной защиты вводят вторую (ревакцинирующую) дозу в период между 6-12 месяцев после введения 1-й дозы. Повторная прививка, проведенная через 12-60 месяцев лицам, ранее однократно привитым, обеспечивает адекватный иммунный ответ. На основании имеющихся данных, можно заключить, что лицам с не измененным иммунным статусом после проведения курса вакцинации, состоящего из введения вакцинирующей и ревакцинируюшей доз, нет необходимости проводить повторную ревакцинацию.
Показания к применению
профилактика гепатита А с 12-месячного возраста.
Противопоказания
Гиперчувствительность к какому-либо компоненту вакцины; — симптомы гиперчувствительности на предыдущее введение вакцины Хаврикс; . Острые инфекционные и неинфекционные заболевания, обострение хронических заболеваний являются временными противопоказаниями для проведения прививок; при нетяжелых ОРВИ, острых кишечных заболеваниях прививки проводят сразу после нормализации температуры.
Применение при беременности и в период грудного вскармливания
В связи с отсутствием адекватных данных применение вакцины Хаврикс; при беременности и в период лактации не рекомендуется, несмотря на минимальный риск воздействия инактивированных вакцин на плод и ребенка.
Способ применения и дозы
Хаврикс; нельзя вводить в/в! Вакцина Хаврикс; предназначена для в/м введения. Перед введением вакцину следует обследовать визуально на предмет выявления инородных частиц и изменения внешнего вида. Непосредственно перед введением вакцины флакон или шприц нужно энергично встряхнуть до получения слегка мутноватой суспензии белого цвета. Если в вакцине обнаружены какие-либо отклонения от нормы, то такая упаковка с вакциной подлежит уничтожению. Взрослым и детям старшего возраста вакцину следует вводить в область дельтовидной мышцы, а детям 12-24 мес - в переднелатеральную область бедра. Вакцину не следует вводить в ягодичную мышцу, а также п/к, поскольку при таких путях введения образование антител к вирусу гепатита А может не достигнуть оптимального уровня. Схема вакцинации: Разовая доза при первичной вакцинации для взрослых и подростков в возрасте старше 16 лет составляет 1 мл, для детей и подростков в возрасте до 16 лет – 0.5 мл. Оптимальный срок введения ревакцинирующей дозы составляет 6-12 месяцев после введения вакцинирующей дозы, что обеспечивает длительную защиту привитых. Если ревакцинация не проведена в срок от 6 до 12 мес, при необходимости защиты от заражения гепатитом А, ревакцинацию проводят в срок до 60 мес после введения первой дозы.
Побочное действие
Профиль безопасности, представленный ниже, основан на данных, собранных в результате наблюдения более чем 5300 пациентов. Частота встречаемости нежелательных явлений определяется следующим образом: очень часто (≥ 10%), часто (≥ 1% и <10%), иногда (≥ 0.1% и <1%), редко (≥ 0.01% и < 0.1%), очень редко (<0.01%). Данные клинических исследованийИнфекции и инвазии: иногда - инфекции верхних дыхательных путей, ринит. Со стороны обмена веществ и питания: часто — потеря аппетита. Со стороны нервной системы: очень часто - раздражительность, головная боль; часто - сонливость; иногда - головокружение; редко - снижение чувствительности, парестезии. Со стороны пищеварительной системы: часто - диарея, тошнота, рвота. Дерматологические реакции: иногда - сыпь; редко - зуд. Со стороны костио-мышечной системы: иногда - миалгия, скелетно-мышечное напряжение. Общие и местные реакции: очень часто - боль и покраснение в месте введения, утомляемость; часто - недомогание, лихорадка (>37.5°С), припухлость и уплотнение в месте введения; иногда - гриппоподобные симптомы; редко — озноб. Пострегистрационные данныеСо стороны иммунной системы: анафилаксия, аллергические реакции, включая анафилактоидные реакции и симптомы аллергического состояния, напоминающие таковые при сывороточной болезни. Со стороны нервной системы: судороги. Со стороны сердечно-сосудистой системы: васкулит. Аллергические реакции: ангионевротический отек, крапивница, многоформная эритема. Со стороны костно-мышечной системы: артралгия.
Передозировка
При пострегистрационном наблюдении были зарегистрированы случаи передозировки. Нежелательные явления, возникшие в результате передозировки, были сходны с теми, которые наблюдались при введении рекомендованной дозы вакцины.
Особые указания
Хаврикс; не обеспечивает защиту от гепатита, вызываемого другими возбудителями, такими как вирус гепатита В, вирус гепатита С, вирус гепатита Е, а также другими известными возбудителями, поражающими печень. Хаврикс; следует вводить с осторожностью пациентам с тромбоцитопенией или с нарушениями со стороны свертывающей системы крови, поскольку после в/м инъекции у таких пациентов может возникнуть кровотечение. После проведения инъекции таким пациентам следует наложить давящую повязку (но не растирать) не менее чем на 2 мин. Пациентам с тромбоцитопенией или с нарушениями свертывающей системы крови допускается п/к введение вакцины Хаврикс;. У пациентов, находящихся на гемодиализе, а также у пациентов с нарушениями со стороны иммунной системы после однократного введения дозы вакцины Хаврикс; можно не добиться выработки адекватного титра антител против вируса гепатита А. Таким пациентам может потребоваться введение дополнительных доз вакцины. Как и при парентеральном введении любых других вакцин, в прививочном кабинете должно быть все необходимое для купирования возможной анафилактической реакции на вакцину Хаврикс;. Вакцинированный должен находиться под медицинским наблюдением в течение 30 мин после иммунизации. Иммунизация Хаврикс; особо рекомендуется лицам с повышенным риском инфицирования, а также лицам, у которых гепатит А может иметь тяжелое течение, или лицам, заболевание которых гепатитом А в силу их профессиональной принадлежности может привести к возникновению вспышек. К ним относятся:— лица, проживающие на территориях с высоким уровнем заболеваемости гепатитом А;— лица, выезжающие в регионы с высоким уровнем заболеваемости гепатитом А (военнослужащие, путешественники и др.);— лица, контактные в очагах. Постэкспозиционная профилактика Хаврикс; не гарантирует 100% эффективности а зависит от срока, момента контакта с вирусом гепатита А, инфицирующей дозы и прогнозируемого состояния здоровья привитого;— лица, подверженные профессиональному риску заражения: медицинский персонал и персонал по уходу за больными (в особенности в инфекционных, гастроэнтерологических и педиатрических отделениях); персонал детских дошкольных учреждений; работники канализационных и водопроводных служб; персонал пищевой промышленности и предприятий общественного питания;— лица из числа особых групп риска (пациенты с хроническими заболеваниями печени или повышенным риском заболевания печени; больные гемофилией; пациенты с множественными гемотрансфузиями; наркоманы; гомосексуалисты; лица, ведущие беспорядочную половую жизнь). Вакцинация Хаврикс; также показана всем другим группам населения. Влияние на способность к вождению автотранспорта и управлению механизмамиВлияние на способность к концентрации внимания маловероятно.
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антиген вируса гепатита А (штамм HM 175) 1440 ед. ИФА. Вспомогательные вещества: алюминия гидроксид 0.5 мг (сорбент), 2-феноксиэтанол 5 мг (консервант), аминокислоты (смесь), натрия гидрофосфат, калия дигидрофосфат, полисорбат 20, калия хлорид, натрия хлорид, неомицина сульфат (следы), вода д/и."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"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."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Вакцина для профилактики гепатита А. Обеспечивает защиту против гепатита А, формируя специфический иммунитет путем индукции выработки антител против вируса гепатита А (ВГА), а также путем активации клеточных механизмов иммунитета. Двукратная прививка с интервалом 6-12 месяцев обеспечивает длительное сохранение иммунитета. При изучении кинетики иммунного ответа, в специальных исследованиях было установлено, что после введения одной дозы Хаврикс; достигается ранняя и быстрая сероконверсия. При этом уже через 13 дней после введения вакцины число лиц с защитным титром антител (\u003e 20 мМе/мл) составляло 79%. С увеличением срока с момента введения препарата этот показатель значительно нарастал. Для обеспечения длительной защиты вводят вторую (ревакцинирующую) дозу в период между 6-12 месяцев после введения 1-й дозы. Повторная прививка, проведенная через 12-60 месяцев лицам, ранее однократно привитым, обеспечивает адекватный иммунный ответ. На основании имеющихся данных, можно заключить, что лицам с не измененным иммунным статусом после проведения курса вакцинации, состоящего из введения вакцинирующей и ревакцинируюшей доз, нет необходимости проводить повторную ревакцинацию."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"профилактика гепатита А с 12-месячного возраста."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к какому-либо компоненту вакцины; — симптомы гиперчувствительности на предыдущее введение вакцины Хаврикс; . Острые инфекционные и неинфекционные заболевания, обострение хронических заболеваний являются временными противопоказаниями для проведения прививок; при нетяжелых ОРВИ, острых кишечных заболеваниях прививки проводят сразу после нормализации температуры."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В связи с отсутствием адекватных данных применение вакцины Хаврикс; при беременности и в период лактации не рекомендуется, несмотря на минимальный риск воздействия инактивированных вакцин на плод и ребенка."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Хаврикс; нельзя вводить в/в! Вакцина Хаврикс; предназначена для в/м введения. Перед введением вакцину следует обследовать визуально на предмет выявления инородных частиц и изменения внешнего вида. Непосредственно перед введением вакцины флакон или шприц нужно энергично встряхнуть до получения слегка мутноватой суспензии белого цвета. Если в вакцине обнаружены какие-либо отклонения от нормы, то такая упаковка с вакциной подлежит уничтожению. Взрослым и детям старшего возраста вакцину следует вводить в область дельтовидной мышцы, а детям 12-24 мес - в переднелатеральную область бедра. Вакцину не следует вводить в ягодичную мышцу, а также п/к, поскольку при таких путях введения образование антител к вирусу гепатита А может не достигнуть оптимального уровня. Схема вакцинации: Разовая доза при первичной вакцинации для взрослых и подростков в возрасте старше 16 лет составляет 1 мл, для детей и подростков в возрасте до 16 лет – 0.5 мл. Оптимальный срок введения ревакцинирующей дозы составляет 6-12 месяцев после введения вакцинирующей дозы, что обеспечивает длительную защиту привитых. Если ревакцинация не проведена в срок от 6 до 12 мес, при необходимости защиты от заражения гепатитом А, ревакцинацию проводят в срок до 60 мес после введения первой дозы."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Профиль безопасности, представленный ниже, основан на данных, собранных в результате наблюдения более чем 5300 пациентов. Частота встречаемости нежелательных явлений определяется следующим образом: очень часто (≥ 10%), часто (≥ 1% и \u003c10%), иногда (≥ 0.1% и \u003c1%), редко (≥ 0.01% и \u003c 0.1%), очень редко (\u003c0.01%). Данные клинических исследованийИнфекции и инвазии: иногда - инфекции верхних дыхательных путей, ринит. Со стороны обмена веществ и питания: часто — потеря аппетита. Со стороны нервной системы: очень часто - раздражительность, головная боль; часто - сонливость; иногда - головокружение; редко - снижение чувствительности, парестезии. Со стороны пищеварительной системы: часто - диарея, тошнота, рвота. Дерматологические реакции: иногда - сыпь; редко - зуд. Со стороны костио-мышечной системы: иногда - миалгия, скелетно-мышечное напряжение. Общие и местные реакции: очень часто - боль и покраснение в месте введения, утомляемость; часто - недомогание, лихорадка (\u003e37.5°С), припухлость и уплотнение в месте введения; иногда - гриппоподобные симптомы; редко — озноб. Пострегистрационные данныеСо стороны иммунной системы: анафилаксия, аллергические реакции, включая анафилактоидные реакции и симптомы аллергического состояния, напоминающие таковые при сывороточной болезни. Со стороны нервной системы: судороги. Со стороны сердечно-сосудистой системы: васкулит. Аллергические реакции: ангионевротический отек, крапивница, многоформная эритема. Со стороны костно-мышечной системы: артралгия."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При пострегистрационном наблюдении были зарегистрированы случаи передозировки. Нежелательные явления, возникшие в результате передозировки, были сходны с теми, которые наблюдались при введении рекомендованной дозы вакцины."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Хаврикс; не обеспечивает защиту от гепатита, вызываемого другими возбудителями, такими как вирус гепатита В, вирус гепатита С, вирус гепатита Е, а также другими известными возбудителями, поражающими печень. Хаврикс; следует вводить с осторожностью пациентам с тромбоцитопенией или с нарушениями со стороны свертывающей системы крови, поскольку после в/м инъекции у таких пациентов может возникнуть кровотечение. После проведения инъекции таким пациентам следует наложить давящую повязку (но не растирать) не менее чем на 2 мин. Пациентам с тромбоцитопенией или с нарушениями свертывающей системы крови допускается п/к введение вакцины Хаврикс;. У пациентов, находящихся на гемодиализе, а также у пациентов с нарушениями со стороны иммунной системы после однократного введения дозы вакцины Хаврикс; можно не добиться выработки адекватного титра антител против вируса гепатита А. Таким пациентам может потребоваться введение дополнительных доз вакцины. Как и при парентеральном введении любых других вакцин, в прививочном кабинете должно быть все необходимое для купирования возможной анафилактической реакции на вакцину Хаврикс;. Вакцинированный должен находиться под медицинским наблюдением в течение 30 мин после иммунизации. Иммунизация Хаврикс; особо рекомендуется лицам с повышенным риском инфицирования, а также лицам, у которых гепатит А может иметь тяжелое течение, или лицам, заболевание которых гепатитом А в силу их профессиональной принадлежности может привести к возникновению вспышек. К ним относятся:— лица, проживающие на территориях с высоким уровнем заболеваемости гепатитом А;— лица, выезжающие в регионы с высоким уровнем заболеваемости гепатитом А (военнослужащие, путешественники и др.);— лица, контактные в очагах. Постэкспозиционная профилактика Хаврикс; не гарантирует 100% эффективности а зависит от срока, момента контакта с вирусом гепатита А, инфицирующей дозы и прогнозируемого состояния здоровья привитого;— лица, подверженные профессиональному риску заражения: медицинский персонал и персонал по уходу за больными (в особенности в инфекционных, гастроэнтерологических и педиатрических отделениях); персонал детских дошкольных учреждений; работники канализационных и водопроводных служб; персонал пищевой промышленности и предприятий общественного питания;— лица из числа особых групп риска (пациенты с хроническими заболеваниями печени или повышенным риском заболевания печени; больные гемофилией; пациенты с множественными гемотрансфузиями; наркоманы; гомосексуалисты; лица, ведущие беспорядочную половую жизнь). Вакцинация Хаврикс; также показана всем другим группам населения. 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