1 ампула содержит: действующее вещество: Актовегин концентрат (в пересчете на сухой депротеинизированный гемодериват крови телят)1) – 80,0 мг;
Для ампул объемом 5 мл:
1 ампула содержит: действующее вещество: Актовегин концентрат (в пересчете на сухой депротеинизированный гемодериват крови телят)1) – 200,0 мг;
Для ампул объемом 10 мл:
1 ампула содержит: действующее вещество: Актовегин концентрат (в пересчете на сухой депротеинизированный гемодериват крови телят)1) – 400,0 мг;
вспомогательное вещество: вода для инъекций – до 10 мл.
1) В составе концентрата Актовегин присутствует натрия хлорид в виде ионов натрия и хлора, являющихся компонентами крови телят. Натрия хлорид не добавляется и не удаляется в процессе производства концентрата. Содержание натрия хлорида составляет около 53,6 мг (для ампул 2 мл), около 134,0 мг (для ампул 5 мл) и около 268,0 мг (для ампул 10 мл).
Описание
прозрачный желтоватый раствор.
Фармакотерапевтическая группа
регенерации тканей стимулятор.
Фармакологические свойства
Фармакодинамика
Актовегин – антигипоксант, оказывающий три вида эффектов: метаболический, нейропротективный и микроциркуляторный. Актовегин повышает поглощение и утилизацию кислорода; входящие в состав препарата инозитол фосфо-олигосахариды положительно влияют на транспорт и утилизацию глюкозы, что приводит к улучшению энергетического метаболизма клеток и снижению образования лактата в условиях ишемии.
Рассматривается несколько путей реализации нейропротективного механизма действия препарата.
Актовегин препятствует развитию апоптоза, индуцированного пептидом бета-амилоида (Aβ25-35).
Актовегин модулирует активность ядерного фактора каппа В (NF-kB), играющего важную роль в регуляции процессов апоптоза и воспаления в центральной и периферической нервной системе.
Другой механизм действия связан с ядерным ферментом поли(АДФ-рибоза)-полимеразой (PARP). PARP играет важную роль в выявлении и репарации повреждений одноцепочечной ДНК, однако чрезмерная активация фермента может запускать процессы клеточной гибели при таких состояниях, как цереброваскулярные заболевания и диабетическая полинейропатия. Актовегин ингибирует активность PARP, что приводит к функциональному и морфологическому улучшению состояния центральной и периферической нервной системы.
Положительными эффектами препарата Актовегин, влияющими на процессы микроциркуляции и на эндотелий, являются увеличение скорости капиллярного кровотока, уменьшение перикапиллярной зоны, снижение миогенного тонуса прекапиллярных артериол и капиллярных сфинктеров, снижение степени артериоловенулярного шунтирующего кровотока с преимущественной циркуляцией крови в капиллярном русле и стимуляция функции эндотелиальной синтазы оксида азота, влияющей на микроциркуляторное русло.
В ходе различных исследований было установлено, что эффект препарата Актовегин наступает не позднее, чем через 30 минут после его приема. Максимальный эффект отмечается через 3 часа после парентерального и через 2–6 часов после перорального применения.
Фармакокинетика
С помощью фармакокинетических методов невозможно изучать фармакокинетические параметры препарата Актовегин, поскольку он состоит только из физиологических компонентов, которые обычно присутствуют в организме.
Показания к применению
В составе комплексной терапии:
Симптоматическое лечение когнитивных нарушений, включая постинсультные когнитивные нарушения и деменцию.
Симптоматическое лечение нарушений периферического кровообращения и их последствий.
Применение при беременности и в период грудного вскармливания
Актовегин следует применять только в тех случаях, когда терапевтическая польза превышает потенциальный риск для плода или ребенка.
Способ применения и дозы
Внутриартериально, внутривенно, внутримышечно, препарат можно добавлять к растворам для инфузий.
Инструкция по использованию ампул с точкой разлома:
Расположить кончик ампулы точкой кверху! Осторожно постукивая пальцем и встряхивая ампулу дать раствору из кончика ампулы стечь вниз.
Расположить кончик ампулы точкой кверху! Отломать кончик, как это изображено на рисунке.
В зависимости от степени тяжести клинической картины, сначала следует вводить по 10 –20 мл препарата внутривенно или внутриартериально ежедневно; для дальнейшего лечения по 5 мл внутривенно или внутримышечно медленно, ежедневно или несколько раз в неделю. Для инфузионного введения от 10 до 50 мл препарата следует добавить к 200–300 мл основного раствора (изотонического раствора натрия хлорида или 5 % раствора глюкозы). Скорость инфузии около 2 мл/мин.
Для внутримышечных инъекций используют не более 5 мл препарата, который следует вводить медленно, поскольку раствор является гипертоническим.
Постинсультные когнитивные нарушения
В остром периоде ишемического инсульта, начиная с 5-7 дня, по 2000 мг в сутки внутривенно капельно до 20 инфузий с переходом на таблетированную форму по 2 таблетки 3 раза в день (1200 мг/день). Общая продолжительность лечения 6 месяцев.
Деменция
По 2000 мг в сутки внутривенно капельно до 4 недель.
Нарушения периферического кровообращения и их последствия
По 800-2000 мг в сутки внутриартериально или внутривенно капельно. Продолжительность лечения до 4 недель.
Диабетическая полинейропатия
По 2000 мг в сутки внутривенно капельно 20 инфузий с переходом на таблетированную форму по 3 таблетки 3 раза в день (1800 мг/день) продолжительность от 4 до 5 месяцев.
Побочное действие
Частота побочных эффектов определялась в соответствии с классификацией Совета международных медицинских научных организаций (CIOMS): очень часто (≥ 1/10); часто (≥ 1/100 до <1/10); нечасто (≥ 1/1000 до <1/100); редко (≥ 1/10000 до <1/1000); очень редко (<1/10000); не известно (не может быть оценена по имеющимся данным).
Нарушения со стороны иммунной системы
Нарушения со стороны кожи и подкожной клетчатки
Нарушения со стороны скелетно-мышечной системы и соединительных тканей:
Не известно: миалгия.
Передозировка
Согласно данным доклинических исследований Актовегин не проявляет токсических эффектов даже при превышении дозы в 30–40 раз по сравнению с дозами, рекомендованными для использования у человека. Не было отмечено случаев передозировки препаратом Актовегин.
Взаимодействие с другими лекарственными средствами
В настоящее время неизвестно.
Особые указания
Парентеральное введение препарата следует проводить в стерильных условиях.
Из-за возможности возникновения анафилактической реакции рекомендуется проводить пробную инъекцию (тест на гиперчувствительность).
В случае электролитных расстройств (таких как гиперхлоремия и гипернатриемия), указанные состояния должны быть соответствующим образом скорректированы.
Раствор для инъекций имеет 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 используйте непрозрачный раствор или раствор, содержащий частицы.
После вскрытия ампулы раствор нельзя хранить.
Клинические данные
В мультицентровом рандомизированном двойном слепом плацебо-контролируемом исследовании ARTEMIDA (NCT01582854), целью которого было изучение терапевтического эффекта препарата Актовегин в отношении когнитивных нарушений у 503 пациентов с ишемическим инсультом, общая частота серьезных нежелательных явлений и смерти была одинаковой в обеих группах лечения. Хотя частота повторных ишемических инсультов была в пределах ожидаемой в данной популяции пациентов, было зафиксировано большее число случаев в группе, принимавшей препарат Актовегин, по сравнению с группой плацебо, однако данное различие было статистически незначимо. Взаимосвязи между случаями повторного инсульта и исследуемым препаратом установлено не было.
Применение у пациентов детского возраста
В настоящее время данные о применении препарата Актовегин у лиц детского возраста отсутствуют, поэтому его применение у данной группы лиц не рекомендуется.
Влияние на способность управлять автомобилем и движущимися механизмами
Не установлено.
Форма выпуска
Раствор для инъекций, 40 мг/мл.
В случае производства и упаковки на Такеда Австрия ГмбХ, Австрия:
В случае производства и/или упаковки на ООО «Такеда Фармасьютикалс», Россия:
В случае производства и упаковки препарата на ЗАО «ФармФирма «Сотекс», Россия:
По 2, 5 и 10 мл в ампулы бесцветного нейтрального стекла с цветным кольцом разлома или с цветной точкой и насечкой. На ампулы дополнительно наносят одно, два или три цветных кольца и/или двухмерный штрих-код, и/или буквенно-цифровую кодировку или без дополнительных цветных колец, двухмерного штрих-кода, буквенно-цифровой кодировки.
По 5 ампул помещают в контурную ячейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой или пленки полимерной или без фольги и пленки. По 1, 2 или 5 контурных ячейковых упаковок вместе с инструкцией по применению помещают в пачку из картона.
Условия хранения
В защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте!
Срок годности
3 года. Не использовать по истечении срока годности.
Условия отпуска
Отпускают по рецепту.
Производитель
«Такеда Австрия ГмбХ», Австрия.
«Takeda Austria GmbH», Austria.
St. Peter-Strasse 25, 4020 Linz, Austria.
или
ООО «Такеда Фармасьютикалс»
Россия, 150066, г. Ярославль, ул. Технопарковая, д.9
или
ЗАО «ФармФирма «Сотекс»
Россия, 141345, Московская обл., Сергиево-Посадский муниципальный район, сельское поселение Березняковское, пос. Беликово, д.11.
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мл:"}},{"type":"paragraph","data":{"text":"1 ампула содержит: действующее вещество: Актовегин концентрат (в пересчете на сухой депротеинизированный гемодериват крови телят)\u003csup\u003e1)\u003c/sup\u003e – 400,0 мг;"}},{"type":"paragraph","data":{"text":"вспомогательное вещество: вода для инъекций – до 10 мл."}},{"type":"paragraph","data":{"text":"\u003csup\u003e1)\u003c/sup\u003e В составе концентрата Актовегин присутствует натрия хлорид в виде ионов натрия и хлора, являющихся компонентами крови телят. Натрия хлорид не добавляется и не удаляется в процессе производства концентрата. Содержание натрия хлорида составляет около 53,6 мг (для ампул 2 мл), около 134,0 мг (для ампул 5 мл) и около 268,0 мг (для ампул 10 мл)."}}]},{"id":11,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"прозрачный желтоватый раствор."}}]},{"id":12,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"регенерации тканей стимулятор."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Фармакодинамика"}},{"type":"paragraph","data":{"text":"Актовегин – антигипоксант, оказывающий три вида эффектов: метаболический, нейропротективный и микроциркуляторный. Актовегин повышает поглощение и утилизацию кислорода; входящие в состав препарата инозитол фосфо-олигосахариды положительно влияют на транспорт и утилизацию глюкозы, что приводит к улучшению энергетического метаболизма клеток и снижению образования лактата в условиях ишемии."}},{"type":"paragraph","data":{"text":"Рассматривается несколько путей реализации нейропротективного механизма действия препарата."}},{"type":"paragraph","data":{"text":"Актовегин препятствует развитию апоптоза, индуцированного пептидом бета-амилоида (Aβ25-35)."}},{"type":"paragraph","data":{"text":"Актовегин модулирует активность ядерного фактора каппа В (NF-kB), играющего важную роль в регуляции процессов апоптоза и воспаления в центральной и периферической нервной системе."}},{"type":"paragraph","data":{"text":"Другой механизм действия связан с ядерным ферментом поли(АДФ-рибоза)-полимеразой (PARP). PARP играет важную роль в выявлении и репарации повреждений одноцепочечной ДНК, однако чрезмерная активация фермента может запускать процессы клеточной гибели при таких состояниях, как цереброваскулярные заболевания и диабетическая полинейропатия. Актовегин ингибирует активность PARP, что приводит к функциональному и морфологическому улучшению состояния центральной и периферической нервной системы."}},{"type":"paragraph","data":{"text":"Положительными эффектами препарата Актовегин, влияющими на процессы микроциркуляции и на эндотелий, являются увеличение скорости капиллярного кровотока, уменьшение перикапиллярной зоны, снижение миогенного тонуса прекапиллярных артериол и капиллярных сфинктеров, снижение степени артериоловенулярного шунтирующего кровотока с преимущественной циркуляцией крови в капиллярном русле и стимуляция функции эндотелиальной синтазы оксида азота, влияющей на микроциркуляторное русло."}},{"type":"paragraph","data":{"text":"В ходе различных исследований было установлено, что эффект препарата Актовегин наступает не позднее, чем через 30 минут после его приема. Максимальный эффект отмечается через 3 часа после парентерального и через 2–6 часов после перорального применения."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"С помощью фармакокинетических методов невозможно изучать фармакокинетические параметры препарата Актовегин, поскольку он состоит только из физиологических компонентов, которые обычно присутствуют в организме."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В составе комплексной терапии:"}},{"type":"list","data":{"style":"ordered","items":["Симптоматическое лечение когнитивных нарушений, включая постинсультные когнитивные нарушения и деменцию.","Симптоматическое лечение нарушений периферического кровообращения и их последствий.","Симптоматическое лечение диабетической полинейропатии (ДПН)."]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"ordered","items":["Гиперчувствительность к препарату Актовегин и аналогичным препаратам или вспомогательным веществам.","Декомпенсированная сердечная недостаточность, отек легких, олигурия, анурия, задержка жидкости в организме.","Детский возраст до 18 лет."]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":" Актовегин следует применять только в тех случаях, когда терапевтическая польза превышает потенциальный риск для плода или ребенка. "}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутриартериально, внутривенно, внутримышечно, препарат можно добавлять к растворам для инфузий."}},{"type":"paragraph","data":{"text":"Инструкция по использованию ампул с точкой разлома:"}},{"type":"paragraph","data":{"text":"Расположить кончик ампулы точкой кверху! Осторожно постукивая пальцем и встряхивая ампулу дать раствору из кончика ампулы стечь вниз."}},{"type":"paragraph","data":{"text":"Расположить кончик ампулы точкой кверху! Отломать кончик, как это изображено на рисунке."}},{"type":"paragraph","data":{"text":"В зависимости от степени тяжести клинической картины, сначала следует вводить по 10 –20 мл препарата внутривенно или внутриартериально ежедневно; для дальнейшего лечения по 5 мл внутривенно или внутримышечно медленно, ежедневно или несколько раз в неделю. Для инфузионного введения от 10 до 50 мл препарата следует добавить к 200–300 мл основного раствора (изотонического раствора натрия хлорида или 5 % раствора глюкозы). Скорость инфузии около 2 мл/мин."}},{"type":"paragraph","data":{"text":"Для внутримышечных инъекций используют не более 5 мл препарата, который следует вводить медленно, поскольку раствор является гипертоническим."}},{"type":"paragraph","data":{"text":"Постинсультные когнитивные нарушения"}},{"type":"paragraph","data":{"text":"В остром периоде ишемического инсульта, начиная с 5-7 дня, по 2000 мг в сутки внутривенно капельно до 20 инфузий с переходом на таблетированную форму по 2 таблетки 3 раза в день (1200 мг/день). Общая продолжительность лечения 6 месяцев."}},{"type":"paragraph","data":{"text":"Деменция"}},{"type":"paragraph","data":{"text":"По 2000 мг в сутки внутривенно капельно до 4 недель."}},{"type":"paragraph","data":{"text":"Нарушения периферического кровообращения и их последствия"}},{"type":"paragraph","data":{"text":"По 800-2000 мг в сутки внутриартериально или внутривенно капельно. Продолжительность лечения до 4 недель."}},{"type":"paragraph","data":{"text":"Диабетическая полинейропатия"}},{"type":"paragraph","data":{"text":"По 2000 мг в сутки внутривенно капельно 20 инфузий с переходом на таблетированную форму по 3 таблетки 3 раза в день (1800 мг/день) продолжительность от 4 до 5 месяцев."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота побочных эффектов определялась в соответствии с классификацией Совета международных медицинских научных организаций (CIOMS): очень часто (≥ 1/10); часто (≥ 1/100 до <1/10); нечасто (≥ 1/1000 до <1/100); редко (≥ 1/10000 до <1/1000); очень редко (<1/10000); не известно (не может быть оценена по имеющимся данным)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы"}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожной клетчатки"}},{"type":"paragraph","data":{"text":"Нарушения со стороны скелетно-мышечной системы и соединительных тканей:"}},{"type":"paragraph","data":{"text":"Не известно: миалгия."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":" Согласно данным доклинических исследований Актовегин не проявляет токсических эффектов даже при превышении дозы в 30–40 раз по сравнению с дозами, рекомендованными для использования у человека. Не было отмечено случаев передозировки препаратом Актовегин. "}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"В настоящее время неизвестно."}}]},{"id":8,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Парентеральное введение препарата следует проводить в стерильных условиях."}},{"type":"paragraph","data":{"text":"Из-за возможности возникновения анафилактической реакции рекомендуется проводить пробную инъекцию (тест на гиперчувствительность)."}},{"type":"paragraph","data":{"text":"В случае электролитных расстройств (таких как гиперхлоремия и гипернатриемия), указанные состояния должны быть соответствующим образом скорректированы."}},{"type":"paragraph","data":{"text":"Раствор для инъекций имеет 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."}},{"type":"paragraph","data":{"text":"Не используйте непрозрачный раствор или раствор, содержащий частицы."}},{"type":"paragraph","data":{"text":"После вскрытия ампулы раствор нельзя хранить."}},{"type":"paragraph","data":{"text":"Клинические данные"}},{"type":"paragraph","data":{"text":"В мультицентровом рандомизированном двойном слепом плацебо-контролируемом исследовании ARTEMIDA (NCT01582854), целью которого было изучение терапевтического эффекта препарата Актовегин в отношении когнитивных нарушений у 503 пациентов с ишемическим инсультом, общая частота серьезных нежелательных явлений и смерти была одинаковой в обеих группах лечения. Хотя частота повторных ишемических инсультов была в пределах ожидаемой в данной популяции пациентов, было зафиксировано большее число случаев в группе, принимавшей препарат Актовегин, по сравнению с группой плацебо, однако данное различие было статистически незначимо. Взаимосвязи между случаями повторного инсульта и исследуемым препаратом установлено не было."}},{"type":"paragraph","data":{"text":"Применение у пациентов детского возраста"}},{"type":"paragraph","data":{"text":"В настоящее время данные о применении препарата Актовегин у лиц детского возраста отсутствуют, поэтому его применение у данной группы лиц не рекомендуется."}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Не установлено."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для инъекций, 40 мг/мл."}},{"type":"paragraph","data":{"text":"В случае производства и упаковки на Такеда Австрия ГмбХ, Австрия:"}},{"type":"paragraph","data":{"text":"В случае производства и/или упаковки на ООО «Такеда Фармасьютикалс», Россия:"}},{"type":"paragraph","data":{"text":"В случае производства и упаковки препарата на ЗАО «ФармФирма «Сотекс», Россия:"}},{"type":"paragraph","data":{"text":"По 2, 5 и 10 мл в ампулы бесцветного нейтрального стекла с цветным кольцом разлома или с цветной точкой и насечкой. На ампулы дополнительно наносят одно, два или три цветных кольца и/или двухмерный штрих-код, и/или буквенно-цифровую кодировку или без дополнительных цветных колец, двухмерного штрих-кода, буквенно-цифровой кодировки."}},{"type":"paragraph","data":{"text":"По 5 ампул помещают в контурную ячейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой или пленки полимерной или без фольги и пленки. По 1, 2 или 5 контурных ячейковых упаковок вместе с инструкцией по применению помещают в пачку из картона."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nВ защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте!\n\n"}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не использовать по истечении срока годности."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускают по рецепту."}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"«Такеда Австрия ГмбХ», Австрия."}},{"type":"paragraph","data":{"text":"«Takeda Austria GmbH», Austria."}},{"type":"paragraph","data":{"text":"St. Peter-Strasse 25, 4020 Linz, Austria."}},{"type":"paragraph","data":{"text":"или"}},{"type":"paragraph","data":{"text":"ООО «Такеда Фармасьютикалс»"}},{"type":"paragraph","data":{"text":"Россия, 150066, г. Ярославль, ул. Технопарковая, д.9"}},{"type":"paragraph","data":{"text":"или"}},{"type":"paragraph","data":{"text":"ЗАО «ФармФирма «Сотекс»"}},{"type":"paragraph","data":{"text":"Россия, 141345, Московская обл., Сергиево-Посадский муниципальный район, сельское поселение Березняковское, пос. 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