Препарат представляет собой концентрированный раствор иммуно... Инструкция
Показания к применению
Показания профилактика гепатита А, кори, коклюша, менингококковой инфекции, полиомиелита, гриппа, лечение гипо- и агаммаглобулинемии, для повышения резистентности организма в период реконвалесценции инфекционных заболеваний.
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
Препарат представляет собой концентрированный раствор иммунологически активной белковой фракции, выделенной методом фракционирования этиловым спиртом при температуре ниже 0°С из плазмы крови здоровых доноров. Для изготовления серии иммуноглобулина используют плазму, полученную не менее, чем от 1000 здоровых доноров индивидуально проверенных на отсутствие поверхностного антигена вируса гепатита В (HBsAg), антител к вирусу гепатита С и вирусам иммунодефицита человека ВИЧ-1 и ВИЧ-2. Концентрация белка в иммуноглобулине составляет от 9,5 до 10,5 %. Стабилизатор глицин в концентрации (2,25±0,75) %. Препарат не содержит консервантов и антибиотиков. Действующим началом являются иммуноглобулины, обладающие активностью антител различной специфичности. Препарат обладает также неспецифической активностью, повышая резистентность организма.
Показания к применению
Показания профилактика гепатита А, кори, коклюша, менингококковой инфекции, полиомиелита, гриппа, лечение гипо- и агаммаглобулинемии, для повышения резистентности организма в период реконвалесценции инфекционных заболеваний.
Способ применения и дозы
Иммуноглобулин вводят внутримышечно в верхний наружный квадрант ягодичной мьшщы или наружную поверхность бедра. Запрещается вводить препарат внутривенно. Перед инъекцией ампулы с препаратом выдерживают в течение 2-х часов при комнатной температуре. Вскрытие ампул и процедуру введения осуществляют при строгом соблюдении правил асептики и антисептики. Во избежание образования пены препарат набирают в шприц иглой с широким просветом. Препарат во вскрытой ампуле хранению не подлежит. Непригоден к применению препарат в ампулах с нарушенной целостностью или маркировкой, при изменении физических свойств (изменение цвета, помутнение раствора, наличие не разбивающихся хлопьев), при истекшем сроке годности и несоблюдении условий хранения. Доза иммуноглобулина и кратность его введения зависят от показаний к применению. Профилактика гепатита А. Препарат вводят однократно в дозах: детям от 1 до 6 лет - 0,75 мл, до 10 лет - 1,5 мл, старше 10 лет и взрослым - 3 мл. Повторное введение иммуноглобулина в случае необходимости профилактики гепатита А показано не ранее, чем через 2 мес. Профилактика кори. Препарат вводят однократно с 3-месячного возраста лицам, не болевшим корью и непривитым против инфекции, не позднее 6 сут после контакта с больным. Дозу препарата детям (1,5 или 3 мл) устанавливают в зависимости от состояния здоровья и времени, прошедшего с момента контакта. Взрослым, а также детям при контакте со смешанными инфекциями препарат вводят в дозе 3 мл. Профилактика и лечение гриппа. Препарат вводят однократно в дозах: детям до 2 лет - 1,5 мл, от 2 до 7 лет - 3 мл, старше 7 лет и взрослым - 4,5-6 мл. При лечении тяжелых форм гриппа показано повторное (через 24-48 ч) введение иммуноглобулина в той же дозе. Профилактика коклюша. Препарат вводят двукратно с интервалом в 24 ч в разовой дозе 3 мл детям, не болевшим коклюшем и не привитым (не полностью привитым) против коклюша, в возможно более ранние сроки после контакта с больным, но не позже 3 суток. Профилактика менингококковой инфекции. Препарат вводят однократно детям в возрасте от 6 мес до 7 лет не позднее 7 сут после контакта с больным генерализованной формой менингококковой инфекции в дозах 1,5 мл (детям до 3 лет) и 3 мл (детям старше 3 лет). Профилактика полиомиелита. Препарат вводят однократно в дозах 3-6 мл непривитым или неполноценно привитым полиомиелитной вакциной детям в возможно более ранние сроки после контакта с больным полиомиелитом. Лечение гипо- и агаммаглобулинемии. Препарат вводят в дозе 1 мл на 1 кг массы тела, рассчитанную дозу можно ввести в 2-3 приема с интервалом в 24 ч. Последующие введения иммуноглобулина проводят по показаниям не ранее, чем через 1 месяц. Повышение резистентности организма в период реконвалесценции острых инфекционных заболеваний с затяжным течением и при хронических пневмониях. Препарат вводят в разовой дозе 0,15-0,2 мл на 1 кг массы тела. Кратность введения (до 4-х инъекций) определяет врач, интервалы между инъекциями составляют 2-3 суток.
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