Описание
Гардасил (Gardasil) — это препарат-вакцина для проведения профилактики от вируса папилломы человека (ВПЧ). Принцип действия вакцины вируса папилломы человека основан на создании иммунитета с развитием гуморального и клеточного иммунного ответа организма. Риск инфицирования ВПЧ в течение жизни, без вакцинации, у сексуально активных людей более 50%, и он постоянно растет. Проведение курса вакцинации приводит к профилактике заболеваний, вызываемых ВПЧ.
Как у женщин, так и у мужчин ВПЧ является причиной возникновения рака анального канала и наружных половых органов, значительно увеличивает риск развития рака органов ротоглотки, головы и шеи. ВПЧ также провоцирует развитие рака шейки матки (плоскоклеточного и аденокарциномы) , а также предраковых диспластических состояний, таких как рецидивирующий респираторный папилломатоз детей и взрослых. Приводит к развитию аногенитальных кондилом.
Вакцина обладает практически 100 процентной эффективностью и предотвращает воспроизводство ВПЧ 6, 11, 16 и 18 типа, а также снижает риск раковых заболеваний половых органов, появления генитальных кондилом и предраковых эпителиальных дисплазий.
Состав
Суспензия для внутримышечного введения 0,5 мл соержит:
- L1 белки вируса папилломы человека 120 мкг следующих типов: тип 6 (20 мкг), тип 11 (40 мкг), тип 16 (40 мкг), тип 18 (20 мкг).
- Также вспомогательные вещества: натрия хлорид, алюминия гидроксифосфат, сульфат аморфный, полисорбат 80, L-гистидиннатрия борат, вода для инъекций.
- Консервантов и антибиотиков не содержит.
Фармакодинамика
Квадривалентная вакцина против вируса папилломы человека — это стерильная суспензия для внутримышечного введения. Она собирается из сочетания высокоочищенных вирусоподобных частиц основного рекомбинантного капсидного белка (L1) ВПЧ типа 6, 11, 16 и 18. Белок L1 производится способом раздельной ферментации в рекомбинантных Saccharomyces cerevisiae CANADE 3C-5 (Штамм 1895), после чего создаются вирусоподобные частицы путем самосборки. Для каждого отдельного типа ВПЧ вирусоподобные частицы очищаются и позже адсорбируются на алюминий содержащем адъюванте (аморфный гидроксифосфатсульфат алюминия).
Прохождение полного курса вакцинации приводит к появлению специфических антител к следующим типам ВПЧ: 6, 11, 16 и 18 — в защитном титре более чем у 99 процентов вакцинированных на период не менее 3 лет во всех возрастных группах.
Фармакокинетика
Данные по фармакокинетике вакцины Гардасил отсутствуют.
Показания активных веществ препарата Гардасил
Для профилактики следующих заболеваний:
- для девочек и женщин в возрасте от 9 до 45 лет: рак вульвы, влагалища, шейки матки и анального канала, аногенитальные кондиломы (condiloma acuminata), цервикальная внутриэпителиальная неоплазия 1/2/3 степени (СIN), аденокарцинома шейки матки in situ (AIS) и влагалища (VaIN) 1/2/3 степени, внутриэпителиальная неоплазия вульвы (VIN) и внутриэпителиальная неоплазия анального канала 1/2/3 степени.
- для девочек и женщин в возрасте от 9 до 26 лет: от ВПЧ типов, которые не входят в состав вакцины.
- для мальчиков и мужчин в возрасте от 9 до 26 лет следующих патологий: аногенитальных кондилом (condiloma acuminate), рака анального канала, предраковых, диспластических состояний и внутриэпителиальной неоплазии анального канала 1/2/3-й степени.
Фармацевтические характеристики
Суспензия для в/м введения белого цвета, непрозрачная.
Упаковка, срок годности, условия хранения
- во флаконах объемом 3 мл по 0,5 мл, запакованных в картонную пачку по одному или по десять флаконов 3 мл;
- в одноразовых шприцах по 0,5 мл, в контурной ячеистой упаковке по одному или по шесть шприцев 3 мл, упакованных в картонную пачку.
Хранить при температуре 2–8 °C, не замораживать. Хранить в недоступном для детей месте.
Срок годности препарата Гардасил 3 года.
Наша компания работает как на территории Кыргызстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
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