Действующее вещество: актовегин® концентрат (в пересчете на сухой депротеинизированный гемодериват крови телят)1) - 80,0 мг.
Вспомогательное вещество: вода для инъекций - до 2 мл.
Фармакологические свойства
Актовегин - антигипоксант. Актовегин® является гемодериватом, который получают посредством диализа и ультрафильтрации (проходят соединения с молекулярной массой менее 5000 Да). Положительно влияет на транспорт и утилизацию глюкозы, стимулирует потребление кислорода (что приводит к стабилизации плазматических мембран клеток при ишемии и снижению образования лактата), обладает, таким образом, антигипоксическим действием, которое начинает проявляться самое позднее через 30 мин после перорального приема и достигает максимума в среднем через 3 ч (2–6 ч). Актовегин® увеличивает концентрации АТФ, АДФ, фосфокреатина, а также аминокислот — глутамата, аспартата и ГАМК. Влияние Актовегина® на усвоение и утилизацию кислорода, а также инсулиноподобная активность со стимуляцией транспорта и окисления глюкозы являются значимыми в лечении диабетической полинейропатии (ДПН). У пациентов с сахарным диабетом и ДПН Актовегин® достоверно уменьшает симптомы полинейропатии (колющая боль, чувство жжения, парестезии, онемение в нижних конечностях). Объективно уменьшаются расстройства чувствительности, улучшается психическое самочувствие пациентов.
Показания к применению
метаболические и сосудистые нарушения головного мозга (в т.ч. ишемический инсульт, черепно-мозговая травма);
периферические (артериальные и венозные) сосудистые нарушения и их последствия (артериальная ангиопатия, трофические язвы);
заживление ран (язвы различной этиологии, трофические нарушения /пролежни/, ожоги, нарушение процессов заживления ран);
профилактика и лечение лучевых поражений кожи и слизистых оболочек при лучевой терапии.
Противопоказания
гиперчувствительность к препарату Актовегин® или аналогичным препаратам.
декомпенсированная сердечная недостаточность;
отек легких;
олигурия;
анурия;
задержка жидкости в организме.
Применение при беременности и в период грудного вскармливания
Применение Актовегина при беременности не оказывало негативного воздействия на мать или плод, однако при необходимости применения препарата при беременности следует учитывать потенциальный риск для плода.
Способ применения и дозы
Раствор для инъекций вводят в/а, в/в (в т.ч. и в виде инфузии) и в/м. В зависимости от тяжести клинической картины начальная доза составляет 10-20 мл/ в/в или в/а, в дальнейшем вводят по 5 мл в/в или 5 мл в/м ежедневно или несколько раз в неделю. При введении в форме инфузии к 200-300 мл инфузионного раствора (изотонический раствор натрия хлорида или 5% раствор декстрозы) добавляют 10-20 мл Актовегина. Скорость введения - около 2 мл/мин. При метаболических и сосудистых нарушениях головного мозга лечение начинают с ежедневного в/в введения 10 мл раствора для инъекций в течение 2 недель, далее вводят по 5-10 мл в/в 3-4 раза в неделю в течение не менее 2 недель. При ишемическом инсульте 20-50 мл разводят в 200-300 мл инфузионного раствора и вводят в/в капельно ежедневно в течение 1 недели с последующим введением по 10-20 мл в/в капельно в течение 2 недель. При периферических (артериальных и венозных) сосудистых нарушениях и их последствиях вводят 20-30 мл препарата в 200 мл инфузионного раствора в/а или в/в ежедневно; продолжительность лечения около 4 недель. Для заживления ран вводят 10 мл в/в или 5 мл в/м ежедневно или 3-4 раза в неделю в зависимости от процесса заживления (дополнительно к местной терапии Актовегином). С целью профилактики и лечения лучевых поражений кожи и слизистых оболочек вводят в среднем 5 мл в/в ежедневно в интервалах между радиационным воздействием. При радиационном цистите вводят трансуретрально ежедневно по 10 мл в комбинации с антибактериальной терапией.
Побочное действие
Аллергические реакции:
кожная сыпь;
гиперемия кожи;
гипертермия, вплоть до анафилактического шока.
Передозировка
Информация о передозировке препарата Актовегин не предоставлена.
Взаимодействие с другими лекарственными средствами
В настоящее время неизвестно. Однако во избежание возможной фармацевтической несовместимости не рекомендуется добавлять другие ЛС к инфузионному раствору Актовегин®.
Особые указания
При многократных введениях раствора для инфузий следует контролировать водно-электролитный баланс плазмы крови. Инфузионный раствор и раствор для инъекций имеют слегка желтоватый оттенок. Интенсивность окраски может варьироваться от одной партии к другой в зависимости от особенностей использованных исходных материалов, однако это не сказывается отрицательно на активности препарата или его переносимости. Не следует использовать непрозрачный раствор или раствор, содержащий посторонние частицы. После вскрытия флакона (ампулы), раствор нельзя хранить. В случае в/м способа применения препарат вводят медленно, не более 5 мл. Из-за возможности возникновения анафилактической реакции рекомендуется проводить пробную инъекцию (2 мл в/м).
Форма выпуска
Раствор для инъекций
Условия хранения
При температуре 18–25°C. Хранить в недоступном для детей месте.
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