Профилактика следующих заболеваний, вызываемых вирусом папилломы человека типов 6, 11, 16 и 18, у детей и подростков в возрасте от 9 до 17 лет и у молодых женщин в возрасте от 18 до 26 лет: рак шейки матки, вульвы и влагалища, генитальные кондиломы (condyloma acuminata). Профилактика предраковых диспластических состояний у детей и подростков в возрасте ...
Повышенная чувствительность к активным компонентам и наполнителям вакцины, введение последующей дозы вакцины при возникновении симптомов повышенной чувствительности. Относительные противопоказания — нарушения свертываемости крови вследствие гемофилии, тромбоцитопении или на фоне приема антикоагулянтов. При необходимости применения вакцины у данной категории ...
Действующее вещество: L1 белки вируса папилломы человека (6, 11, 16, 18 типы). Вспомогательные вещества: алюминий в виде адъюванта алюминия гидроксифосфат-сульфат аморфного, хлорид натрия, L-гистидин, полисорбат, борат натрия, 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
Квадривалентная вакцина против вируса папилломы человека (ВПЧ). Представляет собой стерильную суспензию для в/м введения, приготовленную из смеси высокоочищенных вирусоподобных частиц (ВВЧ) рекомбинантного основного капсидного белка (L1) ВПЧ типов 6, 11, 16 и 18. Белки L1 продуцируются путем раздельной ферментации в рекомбинантных Saccharomyces cerevisiae CANADE 3C-5 (Штамм 1895) и образуют ВВЧ путем самосборки. ВВЧ для каждого типа очищаются и адсорбируются на алюминийсодержащем адъюванте (аморфный гидроксифосфатсульфат алюминия). Проведение полного курса вакцинации приводит к образованию специфических антител к четырем типам ВПЧ - 6, 11, 16 и 18 - в защитном титре более чем у 99% вакцинированных на период не менее 36 месяцев во всех возрастных группах. Вакцина обладает практически 100% эффективностью в предотвращении индуцированных 6, 11, 16 и 18 типами ВПЧ раковых заболеваний половых органов, предраковых эпителиальных дисплазий и генитальных кондилом.
Показания к применению
Профилактика следующих заболеваний, вызываемых вирусом папилломы человека типов 6, 11, 16 и 18, у детей и подростков в возрасте от 9 до 17 лет и у молодых женщин в возрасте от 18 до 26 лет: рак шейки матки, вульвы и влагалища, генитальные кондиломы (condyloma acuminata). Профилактика предраковых диспластических состояний у детей и подростков в возрасте от 9 до 17 лет и у молодых женщин в возрасте от 18 до 26 лет: аденокарцинома шейки матки in situ (AIS), цервикальная внутриэпителиальная неоплазия степени 2 и 3 (СIN 2/3), внутриэпителиальная неоплазия вульвы степени 2 и 3 (VIN 2/3), внутриэпителиальная неоплазия влагалища степени 2 и 3 (VaIN 2/3), цервикальная внутриэпителиальная неоплазия степени 1 (CIN 1).
Противопоказания
Повышенная чувствительность к активным компонентам и наполнителям вакцины, введение последующей дозы вакцины при возникновении симптомов повышенной чувствительности. Относительные противопоказания — нарушения свертываемости крови вследствие гемофилии, тромбоцитопении или на фоне приема антикоагулянтов. При необходимости применения вакцины у данной категории пациентов следует оценить потенциальные преимущества вакцинации и сопряженный с ней риск. При вакцинации в таких случаях необходимо принять меры для снижения риска образования постинъекционной гематомы.
Применение при беременности и в период грудного вскармливания
Адекватных и строго контролируемых исследований безопасности применения Гардасила при беременности не проводилось. Потенциальное воздействие вакцины на репродуктивную функцию у женщин и на плод не изучалось. Данных, свидетельствующих о том, что введение вакцины Гардасил оказывает нежелательное воздействие на фертильность, беременность или на плод, не имеется. Вакцину Гардасил можно вводить женщинам в период лактации (грудного вскармливания).
Способ применения и дозы
Внутримышечно в дельтовидную мышцу или переднелатеральную область бедра. Вакцина не предназначена для внутривенного введения. Для детей и подростков в возрасте от 9 до 17 лет и молодых женщин в возрасте от 18 до 26 лет разовая доза вакцины составляет 0,5 мл. Рекомендуемый курс вакцинации состоит из 3 доз и проводится по схеме: первая доза — в назначенный день, вторая — через 2 месяца после первой, третья — через 6 месяцев после первой. Допускается ускоренная схема вакцинации, при которой вторая доза вводится через 1 месяц после первой прививки, а третья — через 3 месяца после второй прививки. При нарушении интервала между прививками курс вакцинации считается завершенным, если 3 вакцинации проведены в течение 1 года. Вакцина готова к применению, дополнительного разведения или ресуспендирования не требуется. Перед употреблением флакон/шприц с вакциной встряхивают до получения однородной мутной взвеси. Утрата гомогенности, появление включенных частиц и изменение цвета суспензии свидетельствуют о непригодности вакцины. Наполненный вакциной шприц предназначен только для однократного использования и только у одного человека. Вскрытие флаконов и процедуру вакцинации проводят при строгом соблюдении правил асептики и антисептики. Место введения до и после инъекции обрабатывают 70% спиртом. Следует вводить всю рекомендуемую дозу. Правила введения вакцины. Флаконы с разовой дозой вакцины: набрать 0,5 мл взвеси из флакона с разовой дозой вакцины стерильной иглой в одноразовый шприц, не содержащий консервантов, антисептиков и детергентов. Ввести всю дозу. Флакон с остатками вакцины выбросить. Шприцы с разовой дозой вакцины: ввести все содержимое шприца полностью. Одноразовые стерильные, предварительно заполненные шприцы с разовой дозой в комплекте с защитным устройством: для введения вакцины следует использовать вложенную иглу. При необходимости использования другой иглы следует убедиться, что она надежно присоединяется к шприцу и ее длина не превышает 2,5 см, это является необходимым условием для правильной работы защитного устройства. Снять колпачок с конца шприца. Нажав оба препятствующих вращению выступа, закрепить шприц и присоединить иглу Люэра поворотом по часовой стрелке. Удалить защитный колпачок с иглы. При проведении инъекции, как указано выше, следует нажимать на поршень, крепко удерживая шприц под пальцевыми выступами и ввести всю дозу. Защитное устройство иглы не сработает, если не будет введена вся доза. Извлечь иглу. Отпустить поршень и дать шприцу переместиться вверх до полного закрытия всей иглы. Для документирования вакцинации отделить съемные этикетки, медленно потянув их. После окончания процедуры выбросить шприц в контейнер для острых предметов.
Побочное действие
После введения вакцины в отдельных случаях могут развиваться местные и общие реакции: по данным проведенных клинических исследований следующие нежелательные явления встречались с частотой не менее 1% и чаще, чем в группе плацебо. Местные реакции: ≥1% — покраснение, припухлость, болезненность и зуд в месте введения. Продолжительность реакций не превышает 5 суток и не требует назначения медикаментозной терапии. Общие реакции: ≥1% — головная боль, кратковременное повышение температуры тела, в отдельных случаях — гастроэнтерит, воспаление органов малого таза. Учитывая теоретическую возможность развития аллергических реакций немедленного типа у особо чувствительных лиц, после введения вакцины необходимо обеспечить медицинское наблюдение в течение 30 минут. Вакцинацию следует проводить в медицинском учреждении, оснащенном средствами противошоковой терапии.
Передозировка
Имеются сообщения о случаях введения вакцины Гардасил в дозах, превышающих рекомендованные. В целом характер и выраженность нежелательных явлений при передозировке были сопоставимы с таковыми при введении рекомендованных разовых доз данной вакцины.
Особые указания
Эффективность и безопасность Гардасила при п/к и в/к введении не изучались, поэтому эти способы введения не рекомендуются. Гардасил не предназначен для лечения рака шейки матки, вульвы или влагалища, CIN, VIN или VaIN или активного кондиломатоза. Препарат не защищает от заболеваний, вызванных ВПЧ иных типов и другой этиологии. Как и при введении любой вакцины, всегда требуется иметь соответствующие ЛС для немедленного купирования анафилактической реакции. Решение о введении препарата или об отсрочке вакцинации в связи с текущей или недавней болезнью, сопровождающейся повышенной температурой, в большой степени зависит от этиологии и степени тяжести заболевания. Небольшое повышение температуры и легкая инфекция верхних отделов дыхательных путей обычно не являются противопоказаниями для вакцинации. У лиц с нарушенной реактивностью иммунной системы вследствие применения иммунодепрессантов (системные кортикостероиды, антиметаболиты, алкилирующие препараты, цитотоксичные препараты), генетического дефекта, ВИЧ-инфекции и других причин защитный эффект может быть снижен. Вакцину Гардасил следует вводить с осторожностью пациентам с тромбоцитопенией и любыми нарушениями свертывания крови, поскольку после в/м инъекции у таких лиц может развиться кровотечение. Медицинский персонал обязан предоставить всю необходимую информацию по вакцинации и вакцине пациентам, родителям и опекунам, включая информацию о преимуществах и сопряженном риске. Вакцинируемых следует предупредить об обязательном предохранении от беременности в течение курса вакцинации, необходимости сообщать врачу или медсестре о любых нежелательных реакциях, а также о том, что вакцинация не заменяет и не отменяет рутинных скрининговых осмотров. Для достижения эффективных результатов курс вакцинации должен быть завершен полностью, если для этого не имеется противопоказаний. Нет данных по оценке безопасности и эффективности вакцины Гардасил у взрослых старше 26 лет. Использование в педиатрии: у детей в возрасте до 9 лет безопасность и эффективность вакцины Гардасил не оценивалась.
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вещество: L1 белки вируса папилломы человека (6, 11, 16, 18 типы). Вспомогательные вещества: алюминий в виде адъюванта алюминия гидроксифосфат-сульфат аморфного, хлорид натрия, L-гистидин, полисорбат, борат натрия, вода для инъекций."}}]},{"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":"Квадривалентная вакцина против вируса папилломы человека (ВПЧ). Представляет собой стерильную суспензию для в/м введения, приготовленную из смеси высокоочищенных вирусоподобных частиц (ВВЧ) рекомбинантного основного капсидного белка (L1) ВПЧ типов 6, 11, 16 и 18. Белки L1 продуцируются путем раздельной ферментации в рекомбинантных Saccharomyces cerevisiae CANADE 3C-5 (Штамм 1895) и образуют ВВЧ путем самосборки. ВВЧ для каждого типа очищаются и адсорбируются на алюминийсодержащем адъюванте (аморфный гидроксифосфатсульфат алюминия). Проведение полного курса вакцинации приводит к образованию специфических антител к четырем типам ВПЧ - 6, 11, 16 и 18 - в защитном титре более чем у 99% вакцинированных на период не менее 36 месяцев во всех возрастных группах. Вакцина обладает практически 100% эффективностью в предотвращении индуцированных 6, 11, 16 и 18 типами ВПЧ раковых заболеваний половых органов, предраковых эпителиальных дисплазий и генитальных кондилом."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Профилактика следующих заболеваний, вызываемых вирусом папилломы человека типов 6, 11, 16 и 18, у детей и подростков в возрасте от 9 до 17 лет и у молодых женщин в возрасте от 18 до 26 лет: рак шейки матки, вульвы и влагалища, генитальные кондиломы (condyloma acuminata). Профилактика предраковых диспластических состояний у детей и подростков в возрасте от 9 до 17 лет и у молодых женщин в возрасте от 18 до 26 лет: аденокарцинома шейки матки in situ (AIS), цервикальная внутриэпителиальная неоплазия степени 2 и 3 (СIN 2/3), внутриэпителиальная неоплазия вульвы степени 2 и 3 (VIN 2/3), внутриэпителиальная неоплазия влагалища степени 2 и 3 (VaIN 2/3), цервикальная внутриэпителиальная неоплазия степени 1 (CIN 1)."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к активным компонентам и наполнителям вакцины, введение последующей дозы вакцины при возникновении симптомов повышенной чувствительности. Относительные противопоказания — нарушения свертываемости крови вследствие гемофилии, тромбоцитопении или на фоне приема антикоагулянтов. При необходимости применения вакцины у данной категории пациентов следует оценить потенциальные преимущества вакцинации и сопряженный с ней риск. При вакцинации в таких случаях необходимо принять меры для снижения риска образования постинъекционной гематомы."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Адекватных и строго контролируемых исследований безопасности применения Гардасила при беременности не проводилось. Потенциальное воздействие вакцины на репродуктивную функцию у женщин и на плод не изучалось. Данных, свидетельствующих о том, что введение вакцины Гардасил оказывает нежелательное воздействие на фертильность, беременность или на плод, не имеется. Вакцину Гардасил можно вводить женщинам в период лактации (грудного вскармливания)."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутримышечно в дельтовидную мышцу или переднелатеральную область бедра. Вакцина не предназначена для внутривенного введения. Для детей и подростков в возрасте от 9 до 17 лет и молодых женщин в возрасте от 18 до 26 лет разовая доза вакцины составляет 0,5 мл. Рекомендуемый курс вакцинации состоит из 3 доз и проводится по схеме: первая доза — в назначенный день, вторая — через 2 месяца после первой, третья — через 6 месяцев после первой. Допускается ускоренная схема вакцинации, при которой вторая доза вводится через 1 месяц после первой прививки, а третья — через 3 месяца после второй прививки. При нарушении интервала между прививками курс вакцинации считается завершенным, если 3 вакцинации проведены в течение 1 года. Вакцина готова к применению, дополнительного разведения или ресуспендирования не требуется. Перед употреблением флакон/шприц с вакциной встряхивают до получения однородной мутной взвеси. Утрата гомогенности, появление включенных частиц и изменение цвета суспензии свидетельствуют о непригодности вакцины. Наполненный вакциной шприц предназначен только для однократного использования и только у одного человека. Вскрытие флаконов и процедуру вакцинации проводят при строгом соблюдении правил асептики и антисептики. Место введения до и после инъекции обрабатывают 70% спиртом. Следует вводить всю рекомендуемую дозу. Правила введения вакцины. Флаконы с разовой дозой вакцины: набрать 0,5 мл взвеси из флакона с разовой дозой вакцины стерильной иглой в одноразовый шприц, не содержащий консервантов, антисептиков и детергентов. Ввести всю дозу. Флакон с остатками вакцины выбросить. Шприцы с разовой дозой вакцины: ввести все содержимое шприца полностью. Одноразовые стерильные, предварительно заполненные шприцы с разовой дозой в комплекте с защитным устройством: для введения вакцины следует использовать вложенную иглу. При необходимости использования другой иглы следует убедиться, что она надежно присоединяется к шприцу и ее длина не превышает 2,5 см, это является необходимым условием для правильной работы защитного устройства. Снять колпачок с конца шприца. Нажав оба препятствующих вращению выступа, закрепить шприц и присоединить иглу Люэра поворотом по часовой стрелке. Удалить защитный колпачок с иглы. При проведении инъекции, как указано выше, следует нажимать на поршень, крепко удерживая шприц под пальцевыми выступами и ввести всю дозу. Защитное устройство иглы не сработает, если не будет введена вся доза. Извлечь иглу. Отпустить поршень и дать шприцу переместиться вверх до полного закрытия всей иглы. Для документирования вакцинации отделить съемные этикетки, медленно потянув их. После окончания процедуры выбросить шприц в контейнер для острых предметов."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"После введения вакцины в отдельных случаях могут развиваться местные и общие реакции: по данным проведенных клинических исследований следующие нежелательные явления встречались с частотой не менее 1% и чаще, чем в группе плацебо. Местные реакции: ≥1% — покраснение, припухлость, болезненность и зуд в месте введения. Продолжительность реакций не превышает 5 суток и не требует назначения медикаментозной терапии. Общие реакции: ≥1% — головная боль, кратковременное повышение температуры тела, в отдельных случаях — гастроэнтерит, воспаление органов малого таза. Учитывая теоретическую возможность развития аллергических реакций немедленного типа у особо чувствительных лиц, после введения вакцины необходимо обеспечить медицинское наблюдение в течение 30 минут. Вакцинацию следует проводить в медицинском учреждении, оснащенном средствами противошоковой терапии."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Имеются сообщения о случаях введения вакцины Гардасил в дозах, превышающих рекомендованные. В целом характер и выраженность нежелательных явлений при передозировке были сопоставимы с таковыми при введении рекомендованных разовых доз данной вакцины."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Эффективность и безопасность Гардасила при п/к и в/к введении не изучались, поэтому эти способы введения не рекомендуются. Гардасил не предназначен для лечения рака шейки матки, вульвы или влагалища, CIN, VIN или VaIN или активного кондиломатоза. Препарат не защищает от заболеваний, вызванных ВПЧ иных типов и другой этиологии. Как и при введении любой вакцины, всегда требуется иметь соответствующие ЛС для немедленного купирования анафилактической реакции. Решение о введении препарата или об отсрочке вакцинации в связи с текущей или недавней болезнью, сопровождающейся повышенной температурой, в большой степени зависит от этиологии и степени тяжести заболевания. Небольшое повышение температуры и легкая инфекция верхних отделов дыхательных путей обычно не являются противопоказаниями для вакцинации. У лиц с нарушенной реактивностью иммунной системы вследствие применения иммунодепрессантов (системные кортикостероиды, антиметаболиты, алкилирующие препараты, цитотоксичные препараты), генетического дефекта, ВИЧ-инфекции и других причин защитный эффект может быть снижен. Вакцину Гардасил следует вводить с осторожностью пациентам с тромбоцитопенией и любыми нарушениями свертывания крови, поскольку после в/м инъекции у таких лиц может развиться кровотечение. Медицинский персонал обязан предоставить всю необходимую информацию по вакцинации и вакцине пациентам, родителям и опекунам, включая информацию о преимуществах и сопряженном риске. Вакцинируемых следует предупредить об обязательном предохранении от беременности в течение курса вакцинации, необходимости сообщать врачу или медсестре о любых нежелательных реакциях, а также о том, что вакцинация не заменяет и не отменяет рутинных скрининговых осмотров. Для достижения эффективных результатов курс вакцинации должен быть завершен полностью, если для этого не имеется противопоказаний. Нет данных по оценке безопасности и эффективности вакцины Гардасил у взрослых старше 26 лет. Использование в педиатрии: у детей в возрасте до 9 лет безопасность и эффективность вакцины Гардасил не оценивалась."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Квадривалентная вакцина против вируса папилломы человека (ВПЧ). 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