Вакцина против гепатита B. Способствует выработке иммунитета... Инструкция
Показания к применению
Специфическая профилактика вирусного гепатита В у детей, подростков и взрослых. В соответствии с Национальным календарем профилактических прививок и календарем профилактических прививок по эпидемическим показаниям, вакцинация против вирусного гепатита В всех групп населения, не привитых ранее. Вакцинация против вирусного гепатита В в группах риска, ...
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 против гепатита B. Способствует выработке иммунитета против вируса гепатита В. Представляет собой очищенный основной поверхностный антиген вируса гепатита B (HBsAg), полученный с помощью технологии рекомбинантной ДНК и адсорбированный на гидроксид алюминияе. Антиген продуцируется культурой дрожжевых клеток (Saccharomyces cerevisiae), полученных методом генной инженерии и имеющих ген, кодирующий основной поверхностный антиген вируса гепатита В. От дрожжевых клеток HBsAg очищен с помощью нескольких последовательно применяемых физико-химических методов.HBsAg спонтанно трансформируется в сферические частицы диаметром 20 нм, содержащие негликозилированные HBsAg полипептиды и липидную матрицу, состоящую главным образом из фосфолипидов. Исследования показали наличие у этих частиц свойств, характерных для природного HBsAg. Профилактическая эффективность в группах риска составляет от 95% до 100% у новорожденных, детей и взрослых из группы риска. Энджерикс В вызывает образование специфических HBs-антител, которые в титре 10 МЕ/л защищают от гепатита В. У новорожденных от HBsAg позитивных матерей, иммунизированных по схеме 0, 1, 2, 12 мес или 0, 1, 6 мес без одновременного или последующего назначения иммуноглобулина против HBV (HBIg) при рождении, профилактическая эффективность вакцинации составляет 95%, тогда как одновременное назначение вакцины и HBIg при рождении повышает эффективность профилактики до 98%. Профилактическая эффективность у здоровых лиц при применении схемы вакцинации 0, 1, 6 мес у более 96% вакцинированных определяется защитный уровень антител через 7 мес после введения первой дозы. Если вакцинация проводится по схеме 0, 1, 2, 12 месяцев, то 15% и 89% вакцинированных имеют защитный уровень антител через 1 месяц после первой дозы и 1 месяц после третьей дозы соответственно. Через 1 месяц после четвертой дозы защитный титр антител определяется у 95.8% вакцинированных. В случае, когда вакцинация проводится по схеме 0, 7, 21 день, через 1 и 5 недель после третьей дозы у 65.2% и 76% вакцинированных определяется защитный титр антител соответственно. Через 1 месяц после четвертой дозы, введенной через год после иммунизации, защитный уровень антител определяется у 98.6% вакцинированных. В результате всеобщей вакцинации детей в возрасте от 6 до 14 лет против гепатита В наблюдалось значительное снижение частоты развития гепатоцеллюлярной карциномы, а также персистенции антигена гепатита В, который является важным фактором развития рака печени.
Показания к применению
Специфическая профилактика вирусного гепатита В у детей, подростков и взрослых. В соответствии с Национальным календарем профилактических прививок и календарем профилактических прививок по эпидемическим показаниям, вакцинация против вирусного гепатита В всех групп населения, не привитых ранее. Вакцинация против вирусного гепатита В в группах риска, в т.ч.:
Персонал медицинских и стоматологических учреждений, включая сотрудников клинических и серологических лабораторий,
Пациенты, которым проводится или планируются переливание крови и ее компонентов, плановые хирургические вмешательства, инвазивные лечебные и диагностические процедуры, трасплантация органов,
Лица, у которых повышенный риск заболевания связан с их сексуальным поведением,
Лица, употребляющие инъекционные наркотики,
Лица, направляющиеся в регионы, эндемичные по гепатиту В,
Лица, проживавшие в эндемичных по гепатиту В регионах,
Больные серповидно-клеточной анемией,
Пациенты с хроническим заболеванием печени, или лица, относящиеся к группе риска развития заболеваний печени (в т.ч. пациенты с хроническим гепатитом С и носители вируса гепатита С, злоупотребляющие алкоголем),
Лица, имеющие тесный контакт с больными острым или хроническим гепатитом В, а также, в соответствии с календарем профилактических прививок по эпидемическим показаниям:
Дети домов ребенка, детских домов и интернатов,
Лица, занятые в производстве иммунобиологических препаратов из донорской и плацентарной крови,
Студенты медицинских институтов и учащиеся средних медицинских учебных заведений (в первую очередь выпускники). В областях с умеренной или высокой частотой заболеваемостью гепатитом В, где имеется риск инфицирования для всей популяции, помимо всех вышеперечисленных групп вакцинация необходима и для всех детей, включая новорожденных, а также подростков и молодежи
Способ применения и дозы
В/м (взрослым и детям старшего возраста вакцину вводят в область дельтовидной мышцы, детям до 2 лет - в передне-боковую поверхность бедра), взрослым и детям с 16 лет - 1 мл Энджерикса В (20 мкг поверхностного антигена вируса гепатита В), новорожденным и детям до 15 лет - 0.5 мл (10 мкг поверхностного антигена вируса гепатита В). Рекомендуется следующая схема иммунизации: 1 доза Энджерикса В - в выбранную дату, 2 доза - через 1 мес и 3 доза - через 6 мес после введения 1 дозы. Ревакцинация - 1 доза каждые 5 лет. Для групп риска (новорожденные, матери которых инфицированы гепатитом B, пациенты, лица, отправляющиеся в регионы с высоким уровнем заболеваемости гепатитом В): 1 доза Энджерикса В - в выбранный день, 2 и 3 дозы - через 1 мес и через 2 мес после введения 1 дозы. Ревакцинация Энджериксом В - спустя 1 год после 3 дозы первичной иммунизации. Перед введением Энджерикса В вакцину следует хорошо взболтать, поскольку при хранении может образоваться небольшое количество осадка (белого цвета с прозрачной бесцветной надосадочной жидкостью).
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Способствует выработке иммунитета против вируса гепатита В. Представляет собой очищенный основной поверхностный антиген вируса гепатита B (HBsAg), полученный с помощью технологии рекомбинантной ДНК и адсорбированный на гидроксид алюминияе. Антиген продуцируется культурой дрожжевых клеток (Saccharomyces cerevisiae), полученных методом генной инженерии и имеющих ген, кодирующий основной поверхностный антиген вируса гепатита В. От дрожжевых клеток HBsAg очищен с помощью нескольких последовательно применяемых физико-химических методов.HBsAg спонтанно трансформируется в сферические частицы диаметром 20 нм, содержащие негликозилированные HBsAg полипептиды и липидную матрицу, состоящую главным образом из фосфолипидов. Исследования показали наличие у этих частиц свойств, характерных для природного HBsAg. Профилактическая эффективность в группах риска составляет от 95% до 100% у новорожденных, детей и взрослых из группы риска. Энджерикс В вызывает образование специфических HBs-антител, которые в титре 10 МЕ/л защищают от гепатита В. У новорожденных от HBsAg позитивных матерей, иммунизированных по схеме 0, 1, 2, 12 мес или 0, 1, 6 мес без одновременного или последующего назначения иммуноглобулина против HBV (HBIg) при рождении, профилактическая эффективность вакцинации составляет 95%, тогда как одновременное назначение вакцины и HBIg при рождении повышает эффективность профилактики до 98%. Профилактическая эффективность у здоровых лиц при применении схемы вакцинации 0, 1, 6 мес у более 96% вакцинированных определяется защитный уровень антител через 7 мес после введения первой дозы. Если вакцинация проводится по схеме 0, 1, 2, 12 месяцев, то 15% и 89% вакцинированных имеют защитный уровень антител через 1 месяц после первой дозы и 1 месяц после третьей дозы соответственно. Через 1 месяц после четвертой дозы защитный титр антител определяется у 95.8% вакцинированных. В случае, когда вакцинация проводится по схеме 0, 7, 21 день, через 1 и 5 недель после третьей дозы у 65.2% и 76% вакцинированных определяется защитный титр антител соответственно. Через 1 месяц после четвертой дозы, введенной через год после иммунизации, защитный уровень антител определяется у 98.6% вакцинированных. В результате всеобщей вакцинации детей в возрасте от 6 до 14 лет против гепатита В наблюдалось значительное снижение частоты развития гепатоцеллюлярной карциномы, а также персистенции антигена гепатита В, который является важным фактором развития рака печени."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Специфическая профилактика вирусного гепатита В у детей, подростков и взрослых. В соответствии с Национальным календарем профилактических прививок и календарем профилактических прививок по эпидемическим показаниям, вакцинация против вирусного гепатита В всех групп населения, не привитых ранее. Вакцинация против вирусного гепатита В в группах риска, в т.ч.:"}},{"type":"list","data":{"style":"unordered","items":["Персонал медицинских и стоматологических учреждений, включая сотрудников клинических и серологических лабораторий,","Пациенты, которым проводится или планируются переливание крови и ее компонентов, плановые хирургические вмешательства, инвазивные лечебные и диагностические процедуры, трасплантация органов,","Дети, рожденные матерями-носителями вируса гепатита В,","Лица, у которых повышенный риск заболевания связан с их сексуальным поведением,","Лица, употребляющие инъекционные наркотики,","Лица, направляющиеся в регионы, эндемичные по гепатиту В,","Лица, проживавшие в эндемичных по гепатиту В регионах,","Больные серповидно-клеточной анемией,","Пациенты с хроническим заболеванием печени, или лица, относящиеся к группе риска развития заболеваний печени (в т.ч. пациенты с хроническим гепатитом С и носители вируса гепатита С, злоупотребляющие алкоголем),","Лица, имеющие тесный контакт с больными острым или хроническим гепатитом В, а также, в соответствии с календарем профилактических прививок по эпидемическим показаниям:","Дети домов ребенка, детских домов и интернатов,","Лица, занятые в производстве иммунобиологических препаратов из донорской и плацентарной крови,","Студенты медицинских институтов и учащиеся средних медицинских учебных заведений (в первую очередь выпускники). В областях с умеренной или высокой частотой заболеваемостью гепатитом В, где имеется риск инфицирования для всей популяции, помимо всех вышеперечисленных групп вакцинация необходима и для всех детей, включая новорожденных, а также подростков и молодежи"]}}]},{"id":4,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В/м (взрослым и детям старшего возраста вакцину вводят в область дельтовидной мышцы, детям до 2 лет - в передне-боковую поверхность бедра), взрослым и детям с 16 лет - 1 мл Энджерикса В (20 мкг поверхностного антигена вируса гепатита В), новорожденным и детям до 15 лет - 0.5 мл (10 мкг поверхностного антигена вируса гепатита В). Рекомендуется следующая схема иммунизации: 1 доза Энджерикса В - в выбранную дату, 2 доза - через 1 мес и 3 доза - через 6 мес после введения 1 дозы. Ревакцинация - 1 доза каждые 5 лет. Для групп риска (новорожденные, матери которых инфицированы гепатитом B, пациенты, лица, отправляющиеся в регионы с высоким уровнем заболеваемости гепатитом В): 1 доза Энджерикса В - в выбранный день, 2 и 3 дозы - через 1 мес и через 2 мес после введения 1 дозы. Ревакцинация Энджериксом В - спустя 1 год после 3 дозы первичной иммунизации. Перед введением Энджерикса В вакцину следует хорошо взболтать, поскольку при хранении может образоваться небольшое количество осадка (белого цвета с прозрачной бесцветной надосадочной жидкостью)."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Вакцина против гепатита B. Способствует выработке иммунитета против вируса гепатита В. Представляет собой очищенный основной поверхностный антиген вируса гепатита B (HBsAg), полученный с помощью технологии рекомбинантной ДНК и адсорбированный на гидроксид алюминияе. Антиген продуцируется культурой дрожжевых клеток (Saccharomyces cerevisiae), полученных методом генной инженерии и имеющих ген, кодирующий основной поверхностный антиген вируса гепатита В. От дрожжевых клеток HBsAg очищен с помощью нескольких последовательно применяемых физико-химических методов.HBsAg спонтанно трансформируется в сферические частицы диаметром 20 нм, содержащие негликозилированные HBsAg полипептиды и липидную матрицу, состоящую главным образом из фосфолипидов. Исследования показали наличие у этих частиц свойств, характерных для природного HBsAg. Профилактическая эффективность в группах риска составляет от 95% до 100% у новорожденных, детей и взрослых из группы риска. Энджерикс В вызывает образование специфических HBs-антител, которые в титре 10 МЕ/л защищают от гепатита В. 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В случае, когда вакцинация проводится по схеме 0, 7, 21 день, через 1 и 5 недель после третьей дозы у 65.2% и 76% вакцинированных определяется защитный титр антител соответственно. Через 1 месяц после четвертой дозы, введенной через год после иммунизации, защитный уровень антител определяется у 98.6% вакцинированных. 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