Препарат представляет собой лиофилизированный комплекс иммун... Инструкция
Показания к применению
Комплексное лечение острых кишечных инфекций вызванных энтеробактериями у детей в возрасте от 1 месяца до 14 лет.
Противопоказания
Аллергические реакции (кожная сыпь ангионевротический отек (отек Квинке) анафилактический шок) на иммуноглобулин или другие препараты крови человека (в том числе в анамнезе).
Инструкция
Регистрационный номер
ЛС-001690
Торговое название препарата
Иммуноглобулиновый комплексный препарат для энтерального применения
Лекарственная форма
лиофилизат для приготовления раствора для приема внутрь
Состав
В 1 дозе препарата содержится (300±25) мг белка; стабилизатор - глицин (аминоуксусная кислота) - (150±25) мг.
Описание
Аморфная масса белого цвета, допускается голубоватый оттенок.
Фармакотерапевтическая группа
МИБП - глобулин
Фармакологические свойства
Фармакодинамика:
Препарат представляет собой лиофилизированный комплекс иммуноглобулинов классов IgG IgM IgA выделенных из плазмы крови здоровых доноров. Вся плазма используемая в производстве проверяется на отсутствие поверхностного антигена вируса гепатита В (HBsAg) антител к вирусу гепатита С вирусам иммунодефицита человека ВИЧ-1 и ВИЧ-2 методом ПЦР на отсутствие РНК к вирусу гепатита С РНК к ВИЧ и ДНК к вирусу гепатита В. Не менее 97% общего белка составляют иммуноглобулины классов IgG IgA IgM. Препарат не содержит консервантов и антибиотиков.
Иммуностимулирующее средство. Повышает специфический иммунитет увеличивает содержание иммуноглобулинов и антител к энтеробактериям (шигеллы сальмонеллы эшерихии и др.) и энтеровирусам. Иммунобиологические свойства препарата обусловлены содержанием входящих в его состав IgG IgA IgM.
Показания к применению
Комплексное лечение острых кишечных инфекций вызванных энтеробактериями у детей в возрасте от 1 месяца до 14 лет.
Противопоказания
Аллергические реакции (кожная сыпь ангионевротический отек (отек Квинке) анафилактический шок) на иммуноглобулин или другие препараты крови человека (в том числе в анамнезе).
Применение при беременности и в период грудного вскармливания
Препарат не предназначен для применения у взрослых.
Способ применения и дозы
Через рот по 1 дозе равной содержимому одного флакона 1-2 раза в сутки в течение 5 суток. Перед применением препарат растворяют в 5 мл (1/2 ст. ложки) кипяченой воды комнатной температуры путем легкого встряхивания не более 5 минут.
Растворенный препарат представляет собой бесцветную прозрачную жидкость допускается слабая опалесценция. Препарат применяют натощак за 30 минут до еды.
Препарат во вскрытом флаконе хранению не подлежит.
Побочное действие
Реакция на введение обычно отсутствует.
Иногда у лиц с повышенной аллергизацией могут возникать местные реакции в виде локальных полиморфных высыпаний на коже. В случае появления кожной сыпи назначают антигистаминные препараты.
Передозировка
Случаи передозировки не описаны.
Взаимодействие с другими лекарственными средствами
Нежелательных взаимодействий с другими лекарственными средствами не отмечено.
Возможно применение в комплексе с антибиотиками химиотерапевтическими средствами и бактериофагами.
Особые указания
Препарат нельзя применять: при нарушении целостности или отсутствии маркировки флакона при наличии грубых посторонних включений при изменении физических свойств препарата при нарушении температурного режима хранения.
Введение препарата регистрируют в установленных учетных формах с указанием номера серии срока годности предприятия-изготовителя даты введения дозы и характера реакции на введение препарата (при ее развитии).
Влияние на способность управлять автомобилем и движущимися механизмами
Препарат не оказывает влияния на управление транспортными средствами а также деятельность требующую повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Лиофилизат для приготовления раствора для приема внутрь 300 мг.
Условия хранения
Транспортировать в соответствии с СП 3.3.2.1248-03 при температуре от 2 до 8 °С.
Хранить в соответствии с СП 3.3.2.1248-03 при температуре от 2 до 8 °С в недоступном для детей месте.
Для описания товара использована информация от партнера 36.6
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