Фармакологическое действие — восполняющее дефицит железа, пр... Инструкция
Показания к применению
Железодефицитная анемия в том случае, когда пероральные препараты железа неэффективны или не могут быть использованы.Диагноз должен быть подтвержден лабораторными исследованиями.
Противопоказания
повышенная чувствительность к комплексу железа карбоксимальтозата, раствору железа карбоксимальтозата или любому из компонентов препарата;анемия, не связанная с дефицитом железа, например другая микроцитарная анемия;признаки перегрузки железом или нарушение утилизации железа;дети до 14 лет.С осторожностью: у пациентов с нарушенной функцией печени железо ...
Раствор для внутривенного введения1 млактивное вещество:железа карбоксимальтозат156–208 мг(эквивалентно содержанию железа 50 мг)вспомогательные вещества: натрия гидроксид/хлористоводородная кислота— до pH 5–7; вода для инъекций— до 1 млФеринжект® поставляется как недекстрановый (не содержащий декстран препарат)
Описание
Непрозрачный раствор темно-коричневого цвета.
Фармакологические свойства
Фармакологическое действие — восполняющее дефицит железа, противоанемическое.
Показания к применению
Железодефицитная анемия в том случае, когда пероральные препараты железа неэффективны или не могут быть использованы.Диагноз должен быть подтвержден лабораторными исследованиями.
Противопоказания
повышенная чувствительность к комплексу железа карбоксимальтозата, раствору железа карбоксимальтозата или любому из компонентов препарата;анемия, не связанная с дефицитом железа, например другая микроцитарная анемия;признаки перегрузки железом или нарушение утилизации железа;дети до 14 лет.С осторожностью: у пациентов с нарушенной функцией печени железо может применяться парентерально только после тщательной оценки соотношения пользы и риска. Необходимо избегать парентерального применения железа у пациентов с нарушением функции печени, в случае если перегрузка железом может ускорить течение заболевания, в особенности при поздней кожной порфирии. Во избежание перегрузки железом рекомендуется тщательный мониторинг статуса железа.Отсутствуют данные по безопасному применению у пациентов с хроническим заболеванием почек, находящихся на гемодиализе и получающих однократные дозы более 200 мг железа. Необходимо с осторожностью применять парентеральное железо при острой и хронической инфекции, астме, экземе и атопической аллергии. Рекомендуется прекратить применение препарата Феринжект® у пациентов с текущей бактериемией. У пациентов с хронической инфекцией необходимо взвесить все риски и преимущества терапии, принимая во внимание угнетенный эритропоэз, вызванный хронической инфекцией.1 мл препарата содержит до 5,5 мг натрия. Это необходимо учитывать для пациентов с натрийконтролируемой диетой.Применение препарата Феринжект® не исследовалось у детей до 14 лет.
Применение при беременности и в период грудного вскармливания
Данные по применению препарата в период беременности отсутствуют. Применять препарат во время беременности следует только в том случае, если потенциальная польза для матери превышает риск для плода. Если польза от лечения препаратом Феринжект® меньше потенциального риска для плода, рекомендовано ограничиться терапией во II и III триместрах.Имеется лишь небольшой опыт по применению препарата у кормящих грудью матерей. Клинические исследования показали, что поступление железа из препарата Феринжект® в грудное молоко незначительно (менее 1%). Основываясь на ограниченных данных по применению у кормящих грудью женщин, маловероятно, что препарат несет опасность для детей, находящихся на грудном вскармливании.
Способ применения и дозы
В/в— струйно или капельно (инфузионно) и путем прямого введения в венозный участок диализной системы.Перед применением следует осмотреть флаконы на наличие возможного осадка и повреждений. Можно использовать только однородный раствор без осадка.Феринжект® следует применять в отделениях, имеющих необходимое оснащение для оказания неотложной медицинской помощи в случае развития анафилактических реакций. Каждого пациента следует наблюдать на предмет развития признаков или симптомов реакций гиперчувствительности как минимум в течение 30 мин после каждого введения раствора железа карбоксимальтозата (см. «Особые указания»).Внутривенная инфузия: Феринжект® может вводиться в/в капельно (инфузионно) в максимальной однократной дозе до 1000 мг железа (максимально 20 мг железа/кг). Нельзя назначать в/в капельно (инфузионно) 1000 мг железа (20 мл препарата Феринжект®) более 1 раза в неделю. Непосредственно перед инфузионным введением препарат Феринжект® необходимо развести стерильным 0,9% раствором натрия хлорида для инъекций в соотношениях, указанных в таблице 1.Таблица 1Руководство по разведению препарата Феринжект® для инфузии Феринжект®, мл Железо, мг Стерильный 0,9% раствор натрия хлорида для инъекций, мл1 Минимальное время введения, мин >2 до 4 >100 до 200 50 - >4 до 10 >200 до 500 100 6 >10 до 20 >500 до 1000 250 15 1 Для сохранения стабильности препарата не разрешается разведение до концентрации, меньшей чем 2 мг железа/мл (объем раствора препарата Феринжект® не учитывается).Струйная инъекция: Феринжект® может вводиться в/в струйно, в максимальной однократной дозе до 4 мл (200 мг железа) в день, но не чаще 3 раз в неделю.Определение кумулятивной дозы железа: кумулятивная доза для восполнения запасов железа с помощью железа карбоксимальтозата определяется на основании массы тела пациента и уровня Нb и не должна быть превышена. При определении кумулятивной дозы железа следует использовать приведенную ниже таблицу 2. Таблица 2 Кумулятивная доза железа на основании массы тела пациента и уровня Hb Hb, г/дл Пациенты с массой тела от 35 до <70 кг Пациенты с массой тела ≥70 кг <10 1500 мг 2000 мг ≥10 1000 мг 1500 мг Примечание: у пациентов с массой тела менее 35 кг нельзя превышать кумулятивную дозу железа 500 мг.При определении потребности в железе у пациентов с избыточной массой тела следует основываться на нормальном соотношении массы тела и объема крови.Пациентам со значением Нb ≥14 г/дл следует вводить начальную дозу, равную 500 мг железа, и перед последующим введением необходимо проверять показатели содержания железа.После восполнения следует проводить регулярные оценки, чтобы убедиться в том, что уровень железа нормализовался и сохраняется на должном уровне.Максимально переносимая разовая доза: однократная доза препарата не должна превышать 1000 мг железа (20 мл) в сутки или 20 мг железа (0,4 мл) на 1 кг. Дозу 1000 мг железа (20 мл) нельзя вводить более одного раза в неделю.Применение препарата при хроническом заболевании почек, требующем проведения гемодиализа. Нельзя превышать максимальную суточную дозу в 200 мг у пациентов с хроническим заболеванием почек, требующих проведения гемодиализа.
Побочное действие
Побочные действия, по данным клинических исследований (до и после регистрации препарата, включая исследования по безопасности после регистрации препарата). Побочные действия препарата Феринжект®, наблюдавшиеся у пациентов, принимавших железа карбоксимальтозат (n=7391), по данным клинических исследований, суммированы в таблице 3. Самым частым побочным действием у пациентов при применении препарата была тошнота, которая наблюдалась с частотой >1/100, <1/10.Таблица 3Побочные действия препарата, по данным клинических исследований Система или орган Частота Часто (≥1/100, <1/10) Нечасто (≥1/1000, <1/100) Редко (≥1/10000, <1/1000) Со стороны иммунной системы — Гиперчувствительность Анафилактоидные реакции Со стороны обмена веществ и питания Гипофосфатемия — — Со стороны нервной системы Головная боль, головокружение Парестезия, извращения вкуса — Со стороны сердца — Тахикардия — Со стороны сосудов Прилив крови к лицу, повышение АД Снижение АД — Со стороны дыхательной системы, органов грудной клетки и средостения — Одышка — Со стороны ЖКТ Тошнота Рвота, диспепсия, боль в животе, запор, диарея Со стороны кожи и подкожных тканей — Кожный зуд, крапивница, эритема, кожная сыпь1 — Со стороны скелетно-мышечной системы и соединительной ткани — Миалгия, боль в спине, боль в суставах, боль в конечностях, судороги мышц — Общие расстройства и нарушения в месте введения Реакции в области инъекции/инфузии2 Лихорадка, слабость, боль в груди, периферические отеки, боль, озноб Недомогание Лабораторные и инструментальные данные Увеличение уровня АЛТ Повышение активности АЛТ, АСТ, ГГТ, ЛДГ в крови, ЩФ в крови — 1 Включает следующие предпочтительные термины: кожная сыпь (индивидуальная частота этой нежелательной лекарственной реакции оценивается как нечастая) и эритематозная сыпь, генерализованная, макулезная, макулопапулезная зудящая (индивидуальная частота всех нежелательных лекарственных реакций оценивается как редкая).2 Включает следующие предпочтительные термины: ощущение боли в месте инъекции/инфузии, гематомы, изменение цвета кожи, экстравазация, раздражение (индивидуальная частота всех нежелательных лекарственных реакций оценивается как нечастая) и парестезия (индивидуальная частота нежелательной лекарственной реакции оценивается как редкая).Спонтанные постмаркетинговые сообщения о побочных действияхВ рамках постмаркетингового контроля применения препарата Феринжект® наблюдались указанные в Таблице 4 побочные действия.1Таблица 4Спонтанные постмаркетинговые сообщения Система или орган Наиболее часто встречающиеся симптомы1 Со стороны нервной системы Потеря сознания и вертиго Нарушения психики Тревога Со стороны сердца и сосудов Обморок, предобморочное состояние Со стороны кожи и подкожных тканей Ангионевротический отек, дерматит, бледность и отек лица Со стороны дыхательной системы, органов грудной клетки и средостения Бронхоспазм Общие расстройства и нарушения в месте введения Гриппоподобное заболевание 1 Частота не определена, поскольку общее количество пациентов, принимавших препарат в условиях постмаркетинговых исследований, не может быть точно установлено.
Передозировка
Введение препарата Феринжект® в количестве, превышающем потребности организма, может вызывать перегрузку железом, которая проявляется симптомами гемосидероза. Определение таких показателей обмена железа, как ферритин сыворотки и процент насыщения трансферрина, может помочь в диагностике чрезмерного отложения железа в организме. Если произошла аккумуляция железа, необходимо проводить лечение в соответствии со стандартной медицинской практикой, например может быть рассмотрено использование хелатирующего средства для связывания железа.
Взаимодействие с другими лекарственными средствами
Так же, как и любые другие парентеральные препараты железа, препарат Феринжект® уменьшает всасывание железа из ЖКТ при одновременном применении с препаратами железа для приема внутрь. Поэтому при необходимости терапия пероральными препаратами железа должна начинаться не ранее чем через 5 дней после последней инъекции препарата Феринжект®.Фармацевтическая совместимость: препарат Феринжект® совместим только с 0,9% раствором натрия хлорида. Никакие другие в/в растворы и лекарственные вещества не следует вводить, поскольку существует потенциальный риск выпадения осадка и/или взаимодействия.
Условия хранения
При температуре не выше 30°C, в оригинальной упаковке (не замораживать). Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
Условия отпуска
По рецепту.
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Необходимо избегать парентерального применения железа у пациентов с нарушением функции печени, в случае если перегрузка железом может ускорить течение заболевания, в особенности при поздней кожной порфирии. Во избежание перегрузки железом рекомендуется тщательный мониторинг статуса железа.Отсутствуют данные по безопасному применению у пациентов с хроническим заболеванием почек, находящихся на гемодиализе и получающих однократные дозы более 200 мг железа. Необходимо с осторожностью применять парентеральное железо при острой и хронической инфекции, астме, экземе и атопической аллергии. Рекомендуется прекратить применение препарата Феринжект® у пациентов с текущей бактериемией. У пациентов с хронической инфекцией необходимо взвесить все риски и преимущества терапии, принимая во внимание угнетенный эритропоэз, вызванный хронической инфекцией.1 мл препарата содержит до 5,5 мг натрия. 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Основываясь на ограниченных данных по применению у кормящих грудью женщин, маловероятно, что препарат несет опасность для детей, находящихся на грудном вскармливании."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В/в— струйно или капельно (инфузионно) и путем прямого введения в венозный участок диализной системы.Перед применением следует осмотреть флаконы на наличие возможного осадка и повреждений. Можно использовать только однородный раствор без осадка.Феринжект® следует применять в отделениях, имеющих необходимое оснащение для оказания неотложной медицинской помощи в случае развития анафилактических реакций. Каждого пациента следует наблюдать на предмет развития признаков или симптомов реакций гиперчувствительности как минимум в течение 30 мин после каждого введения раствора железа карбоксимальтозата (см. «Особые указания»).Внутривенная инфузия: Феринжект® может вводиться в/в капельно (инфузионно) в максимальной однократной дозе до 1000 мг железа (максимально 20 мг железа/кг). Нельзя назначать в/в капельно (инфузионно) 1000 мг железа (20 мл препарата Феринжект®) более 1 раза в неделю. Непосредственно перед инфузионным введением препарат Феринжект® необходимо развести стерильным 0,9% раствором натрия хлорида для инъекций в соотношениях, указанных в таблице 1.Таблица 1Руководство по разведению препарата Феринжект® для инфузии\t\t\tФеринжект®, мл\t\tЖелезо, мг\t\tСтерильный 0,9% раствор натрия хлорида для инъекций, мл1\t\tМинимальное время введения, мин\t\t\t\t\u003e2 до 4\t\t\u003e100 до 200\t\t50\t\t-\t\t\t\t\u003e4 до 10\t\t\u003e200 до 500\t\t100\t\t6\t\t\t\t\u003e10 до 20\t\t\u003e500 до 1000\t\t250\t\t15\t1 Для сохранения стабильности препарата не разрешается разведение до концентрации, меньшей чем 2 мг железа/мл (объем раствора препарата Феринжект® не учитывается).Струйная инъекция: Феринжект® может вводиться в/в струйно, в максимальной однократной дозе до 4 мл (200 мг железа) в день, но не чаще 3 раз в неделю.Определение кумулятивной дозы железа: кумулятивная доза для восполнения запасов железа с помощью железа карбоксимальтозата определяется на основании массы тела пациента и уровня Нb и не должна быть превышена. При определении кумулятивной дозы железа следует использовать приведенную ниже таблицу 2. Таблица 2 Кумулятивная доза железа на основании массы тела пациента и уровня Hb\t\t\tHb, г/дл\t\tПациенты с массой тела от 35 \t\tдо \u003c70 кг\t\tПациенты с массой тела ≥70 кг\t\t\t\t\u003c10\t\t1500 мг\t\t2000 мг\t\t\t\t≥10\t\t1000 мг\t\t1500 мг\tПримечание: у пациентов с массой тела менее 35 кг нельзя превышать кумулятивную дозу железа 500 мг.При определении потребности в железе у пациентов с избыточной массой тела следует основываться на нормальном соотношении массы тела и объема крови.Пациентам со значением Нb ≥14 г/дл следует вводить начальную дозу, равную 500 мг железа, и перед последующим введением необходимо проверять показатели содержания железа.После восполнения следует проводить регулярные оценки, чтобы убедиться в том, что уровень железа нормализовался и сохраняется на должном уровне.Максимально переносимая разовая доза: однократная доза препарата не должна превышать 1000 мг железа (20 мл) в сутки или 20 мг железа (0,4 мл) на 1 кг. Дозу 1000 мг железа (20 мл) нельзя вводить более одного раза в неделю.Применение препарата при хроническом заболевании почек, требующем проведения гемодиализа. Нельзя превышать максимальную суточную дозу в 200 мг у пациентов с хроническим заболеванием почек, требующих проведения гемодиализа."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Побочные действия, по данным клинических исследований (до и после регистрации препарата, включая исследования по безопасности после регистрации препарата). Побочные действия препарата Феринжект®, наблюдавшиеся у пациентов, принимавших железа карбоксимальтозат (n=7391), по данным клинических исследований, суммированы в таблице 3. Самым частым побочным действием у пациентов при применении препарата была тошнота, которая наблюдалась с частотой \u003e1/100, \u003c1/10.Таблица 3Побочные действия препарата, по данным клинических исследований\t\t\t\t\tСистема или орган\t\t\t\tЧастота\t\t\t\t\t\tЧасто (≥1/100, \u003c1/10)\t\t\t\tНечасто (≥1/1000, \u003c1/100)\t\t\t\tРедко (≥1/10000, \u003c1/1000)\t\t\t\tСо стороны иммунной системы\t\t—\t\tГиперчувствительность\t\tАнафилактоидные реакции\t\t\t\t\tСо стороны обмена веществ и питания\t\t\tГипофосфатемия\t\t—\t\t—\t\t\t\tСо стороны нервной системы\t\tГоловная боль, головокружение\t\tПарестезия, извращения вкуса\t\t—\t\t\t\tСо стороны сердца\t\t—\t\tТахикардия\t\t—\t\t\t\tСо стороны сосудов\t\t\tПрилив крови к лицу, повышение АД\t\t\tСнижение АД\t\t—\t\t\t\tСо стороны дыхательной системы, \tорганов грудной клетки и средостения\t\t—\t\t\t\tОдышка\t\t—\t\t\t\tСо стороны ЖКТ\t\tТошнота\t\tРвота, диспепсия, боль в животе, запор, диарея\t\t\t\t\t\t\tСо стороны кожи и подкожных тканей\t\t—\t\t\tКожный зуд, крапивница, эритема, кожная сыпь1\t\t—\t\t\t\tСо стороны \t\tскелетно-мышечной системы и соединительной ткани\t\t—\t\tМиалгия, боль в спине, боль в суставах, \t\tболь в конечностях, судороги мышц\t\t—\t\t\t\tОбщие \t\tрасстройства и нарушения в месте введения\t\t\t\tРеакции в области инъекции/инфузии2\t\t\t\tЛихорадка, слабость, боль в груди, периферические отеки, боль, озноб\t\t\t\tНедомогание\t\t\t\t\t\tЛабораторные и инструментальные данные\t\tУвеличение уровня АЛТ\t\t\tПовышение активности АЛТ, АСТ, ГГТ, ЛДГ в крови, ЩФ в крови\t\t—\t\t1 Включает следующие предпочтительные термины: кожная сыпь (индивидуальная частота этой нежелательной лекарственной реакции оценивается как нечастая) и эритематозная сыпь, генерализованная, макулезная, макулопапулезная зудящая (индивидуальная частота всех нежелательных лекарственных реакций оценивается как редкая).2 Включает следующие предпочтительные термины: ощущение боли в месте инъекции/инфузии, гематомы, изменение цвета кожи, экстравазация, раздражение (индивидуальная частота всех нежелательных лекарственных реакций оценивается как нечастая) и парестезия (индивидуальная частота нежелательной лекарственной реакции оценивается как редкая).Спонтанные постмаркетинговые сообщения о побочных действияхВ рамках постмаркетингового контроля применения препарата Феринжект® наблюдались указанные в Таблице 4 побочные действия.1Таблица 4Спонтанные постмаркетинговые сообщения\t\t\tСистема или орган\t\tНаиболее часто встречающиеся симптомы1\t\t\t\tСо стороны нервной системы\t\tПотеря сознания и вертиго\t\t\t\tНарушения психики\t\tТревога\t\t\t\tСо стороны сердца и сосудов\t\tОбморок, предобморочное состояние\t\t\t\tСо стороны кожи и подкожных тканей\t\tАнгионевротический отек, дерматит, бледность и \t\tотек лица\t\t\t\tСо стороны дыхательной системы, органов грудной \t\tклетки и средостения\t\tБронхоспазм\t\t\t\tОбщие расстройства и нарушения в месте введения\t\tГриппоподобное заболевание\t1 Частота не определена, поскольку общее количество пациентов, принимавших препарат в условиях постмаркетинговых исследований, не может быть точно установлено."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Введение препарата Феринжект® в количестве, превышающем потребности организма, может вызывать перегрузку железом, которая проявляется симптомами гемосидероза. Определение таких показателей обмена железа, как ферритин сыворотки и процент насыщения трансферрина, может помочь в диагностике чрезмерного отложения железа в организме. Если произошла аккумуляция железа, необходимо проводить лечение в соответствии со стандартной медицинской практикой, например может быть рассмотрено использование хелатирующего средства для связывания железа."}}]},{"id":10,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Так же, как и любые другие парентеральные препараты железа, препарат Феринжект® уменьшает всасывание железа из ЖКТ при одновременном применении с препаратами железа для приема внутрь. Поэтому при необходимости терапия пероральными препаратами железа должна начинаться не ранее чем через 5 дней после последней инъекции препарата Феринжект®.Фармацевтическая совместимость: препарат Феринжект® совместим только с 0,9% раствором натрия хлорида. Никакие другие в/в растворы и лекарственные вещества не следует вводить, поскольку существует потенциальный риск выпадения осадка и/или взаимодействия."}}]},{"id":11,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При температуре не выше 30°C, в оригинальной упаковке (не замораживать). Хранить в недоступном для детей месте."}}]},{"id":12,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. 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