Инактивированный вирус простого герпеса I и II антигенных ти... Инструкция
Показания к применению
Профилактика рецидивов герпетической инфекции.
Противопоказания
Герпетическая инфекция в активной стадии (рецидив). Вакцинацию проводят не ранее, чем через 14 дней после исчезновения клинических проявлений; при офтальмогерпесе - не ранее, чем через 1 месОстрые инфекционные и неинфекционные заболевания. (Вакцинацию проводят не ранее, чем через 30 дней после выздоровления). Хронические заболевания в стадии обострения ...
В одной прививочной дозе (0,2 мл) содержится: Специфические антигены вируса простого герпеса (ВПГ) I и II типов, (штамм «УС» и штамм «ВН» соответственно), полученные путем репродукции в культуре перевиваемых клеток почек африканской зеленой мартышки (VERO В), инактивированные формальдегидом и лиофилизированные с добавлением в качестве стабилизатора сахарозо-желатозной среды. Вспомогательные вещества: формальдегид не более 200 мкг/мл; гентамицина сульфат не более 40 мкг/мл, сахароза не более 0,075 г/мл; желатоза не более 0,01 г/мл.
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
Инактивированный вирус простого герпеса I и II антигенных типов, полученный путем репродукции в культуре клеток Vero В, лиофилизированный. Стимулирует клеточные механизмы резистентности организма человека к вирусу простого герпеса I и II типов.
Показания к применению
Профилактика рецидивов герпетической инфекции.
Противопоказания
Герпетическая инфекция в активной стадии (рецидив). Вакцинацию проводят не ранее, чем через 14 дней после исчезновения клинических проявлений; при офтальмогерпесе - не ранее, чем через 1 месОстрые инфекционные и неинфекционные заболевания. (Вакцинацию проводят не ранее, чем через 30 дней после выздоровления). Хронические заболевания в стадии обострения или декомпенсации. Злокачественные новообразования. Беременность. Аллергия к гентамицину и другим антибиотикам группы аминогликозидов.
Применение при беременности и в период грудного вскармливания
Противопоказано.
Способ применения и дозы
Вакцинацию проводят в лечебно-оздоровительных учреждениях по назначению и под контролем врача. Вакцину применяют в стадии ремиссии, не ранее, чем через 10 дней после полного исчезновения клинических проявлений герпетической инфекции, при офтальмогерпесе не ранее, чем через 1 месяц. Содержимое флакона растворяют в 0,3 мл растворителя (стерильная вода для инъекций). Для этого растворитель с помощью шприца с иглой вносят во флакон с вакциной, который затем встряхивают до полного растворения содержимого. Растворенный препарат должен представлять собой опалесцирующую жидкость розового или розового с желтым оттенком цвета. Видимые механические включения должны отсутствовать. Растворенная вакцина хранению не подлежит. Не пригоден к применению препарат во флаконах с нарушенной целостностью, маркировкой, при изменении цвета, при истекшем сроке годности, при неправильном хранении. Вскрытие флакона, растворение препарата и процедуру вакцинации осуществляют при строгом соблюдении правил асептики. Препарат вводят внутрикожно в область внутренней поверхности предплечья в разовой дозе 0,2 мл. Основной цикл вакцинации состоит из 5 инъекций, которые проводят с интервалом в 7 дней. Повторный цикл проводят через 7-10 дней по той же схеме. Через 6 месяцев проводят повторный курс вакцинации, состоящий из двух циклов по 5 инъекций. Больным с тяжелой формой герпетической инфекции (рецидивы ежемесячно или 1 раз в 2-3 мес) препарат вводят с интервалом не менее 10 дней.
Побочное действие
После введения вакцины у отдельных лиц могут развиваться местные и общие реакции. Местная реакция: Проявляется гиперемией кожи диаметром до 2 см в течение первых суток и слабое кратковременное жжение в месте инъекции. Общая реакция может выражаться в незначительном повышении температуры (не выше 37,5°С), слабости, проходящих без лечения. При возникновении более выраженных местных и общих реакций или развитии обострения рецидива герпетической инфекции, введение препарата следует приостановить. Вакцинация может быть продолжена через 14 дней после полного исчезновения клинических проявлений герпетической инфекции и общей реакции на введение вакцины.
Особые указания
Вакцинацию проводят в лечебных учреждениях (стационар, диспансер, поликлиника) под контролем врача. Вакцинацию проводят в стадии ремиссии, не ранее, чем через 5 дней после полного исчезновения клинических проявлений герпетической инфекции. При возникновении более выраженных местных и общих реакций или при обострении основного процесса вакцинацию следует прекратить. Вакцинация может быть продолжена после полного исчезновения клинических проявлений общей реакции на введение вакцины. Все случаи более выраженных местных и общих реакций у больного должны быть обследованы врачом и занесены в соответствующий документ. Растворенный препарат должен представлять собой слегка опалесцирующую жидкость розового цвета. Не пригоден к применению препарат во флаконах с нарушенной целостностью, маркировкой, при изменении цвета, с истекшим сроком годности, при неправильном хранении. Растворенная вакцина хранению не подлежит. Вскрытие флакона, растворение препарата и процедуру вакцинации осуществляют при строгом соблюдении правил асептики.
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