Железодефицитная анемия при неэффективности или невозможности приема препаратов железа внутрь (в т.ч. у пациентов с заболеваниями ЖКТ и синдромом мальабсорбции).Препарат вводится в/м только при подтвержденном соответствующими исследованиями железодефицитном состоянии (например измерение ферритина сыворотки крови, гемоглобина (Hb), гематокрита или количества ...
Раствор для внутримышечного введения1 млактивное вещество:железа (III) гидроксида полимальтозат 141–182 мгэквивалентно содержанию железа— 50 мгвспомогательные вещества: гидроксид натрия/кислота хлористоводородная— до рН 5,2– 6,5; вода для инъекций— до 1 мл
Описание
Раствор коричневого цвета.
Фармакологические свойства
Фармакологическое действие — восполняющее дефицит железа.
Показания к применению
Железодефицитная анемия при неэффективности или невозможности приема препаратов железа внутрь (в т.ч. у пациентов с заболеваниями ЖКТ и синдромом мальабсорбции).Препарат вводится в/м только при подтвержденном соответствующими исследованиями железодефицитном состоянии (например измерение ферритина сыворотки крови, гемоглобина (Hb), гематокрита или количества эритроцитов, а также их параметров— среднего объема эритроцита, среднего содержания Hb в эритроците или средней концентрации Hb в эритроците).
Противопоказания
гиперчувствительность;анемии, не связанные с дефицитом железа (гемолитическая, мегалобластная, вызванная недостаточностью витамина B12);нарушения эритропоэза;гипоплазия костного мозга; избыток железа в организме (гемохроматоз, гемосидероз); нарушение утилизации железа (сидероахрестическая анемия, талассемия, свинцовая анемия, поздняя порфирия кожи);синдром Ослера-Рандю-Вебера;хронический полиартрит;бронхиальная астма;инфекционные болезни почек в острой стадии;неконтролируемый гиперпаратиреоз;декомпенсированный цирроз печени;инфекционный гепатит;использование для в/в введения;I триместр беременности;детский возраст до 4 мес (опыт применения препарата ограничен). С осторожностью: нарушение функции почек и/или печени.
Применение при беременности и в период грудного вскармливания
Клинических данных о применении препарата у беременных в настоящее время недостаточно. В исследованиях на животных не изучалась репродуктивная токсичность препарата. При беременности применять препарат следует только в том случае, когда предполагаемая польза для матери превышает потенциальный риск для плода и/или ребенка. Противопоказано применять препарат в I триместре беременности.В малых количествах неизмененное железо из полимальтозного комплекса может проникать в грудное молоко. При необходимости применения препарата в период лактации грудное вскармливание необходимо прекратить.
Способ применения и дозы
В/м.Перед первым введением необходимо провести тест: взрослым— 1/4–1/2 дозы (25–50мг железа), с 4 мес— 1/2 суточной дозы; при отсутствии побочных реакций в течение 15 мин вводят оставшуюся часть начальной дозы. Доза рассчитывается индивидуально и адаптируется в соответствии с общим дефицитом железа по следующей формуле:Общий дефицит железа, мг = масса тела, кг × (нормальный уровень Hb − уровень Hb больного), г/л × 0,24* + железо запасов, мг.При массе тела до 34 кг: нормальный уровень Hb=130 г/л, что соответствует железу запасов = 15 мг/кг.При массе тела выше 34 кг: нормальный уровень Hb=150 г/л, что соответствует железу запасов = 500 мг.*Фактор 0,24 = 0,0034×0,07×1000 (содержание железа в Hb = 0,34%; объем крови = 7% от массы тела; фактор 1000 = перевод из г в мг).Общее количество ампул для введения = общий дефицит железа (мг)/100 мг. Масса тела, кг Общее количество мл/ампул для введения Hb 60 г/л Hb 75 г/л Hb 90 г/л Hb 105 г/л мл амп. мл амп. мл амп. мл амп. 5 3 1,5 3 1,5 3 1,5 2 1 10 6 3 6 3 5 2,5 4 2 15 10 5 9 4,5 7 3,5 6 3 20 13 6,5 11 5,5 10 5 8 4 25 16 8 14 7 12 6 11 5,5 30 19 9,5 17 8,5 15 7,5 13 6,5 35 25 12,5 23 11,5 20 10 18 9 40 27 13,5 24 12 22 11 19 9,5 45 30 15 26 13 23 11,5 20 10 50 32 16 28 14 24 12 21 10,5 55 34 17 30 15 26 13 22 11 60 36 18 32 16 27 13,5 23 11,5 65 38 19 33 16,5 29 14,5 24 12 70 40 20 35 17,5 30 15 25 12,5 75 42 21 37 18,5 32 16 26 13 80 45 22,5 39 19,5 33 16,5 27 13,5 85 47 23,5 41 20,5 34 17 28 14 90 49 24,5 43 21,5 36 18 29 14,5 Если необходимая доза превышает максимальную суточную дозу, введение препарата должно быть дробным.Стандартная дозаВзрослым— 1 амп. ежедневно (2 мл = 100 мг железа); детям с 4 мес— дозировка определяется в зависимости от массы тела.Максимально допустимые суточные дозы: детям с массой тела до 5 кг— 1/4 амп. (0,5мл = 25мг железа), от 5 до 10 кг— 1/2 амп. (1мл = 50мг железа), от 10 до 45 кг— 1 амп. (2 мл = 100 мг железа); взрослым— 2 амп. (4мл = 200мг железа). Если ответная реакция со стороны гематологических параметров (например увеличение уровня Hb примерно на 0,1г/дл в сутки) отсутствует через 1–2 нед, первоначальный диагноз следует пересмотреть. Общая доза препарата на курс лечения не должна превышать рассчитанное число ампул.Техника инъекции (см. Рисунки):Техника инъекции имеет решающее значение. В результате неправильного введения препарата могут возникнуть болевые ощущения и окрашивание кожи в месте инъекции. Описанная ниже методика вентро-ягодичной инъекции рекомендована вместо общепринятой— в верхний наружный квадрант большой ягодичной мышцы:a) длина иглы должна быть не менее 5–6 см. Просвет иглы не должен быть слишком широким. Для детей, а также для взрослых с небольшой массой тела иглы должны быть короче и тоньше;b) место инъекции определяется следующим образом (см. Рисунок 1): по линии позвоночного столба на уровне, соответствующем пояснично-подвздошному сочленению, зафиксировать точку A. Если больной лежит на правом боку, расположить средний палец левой руки в точке A. Отставить указательный палец от среднего так, чтобы он находился под линией подвздошного гребня в точке B. Треугольник, располагающийся между проксимальными фалангами среднего и указательного пальцев является местом инъекции (см. Рисунок 2). c) инструменты дезинфицируются обычным методом; прежде чем ввести иглу, необходимо сдвинуть кожу примерно на 2 см (см. Рисунок 3) для того, чтобы хорошо закрыть канал прокола после извлечения иглы. Это предотвращает проникновение введенного раствора в подкожные ткани и окрашивание кожи;d) расположить иглу вертикально по отношению к поверхности кожи, под бóльшим углом к точке подвздошного сочленения, чем к точке бедренного сустава (см. Рисунок 4);e) после инъекции медленно извлечь иглу и прижать пальцем участок кожи, прилегающий к месту инъекции, примерно на 1 мин;f) после инъекции больному необходимо подвигаться.
Побочное действие
Редко— возможны артралгия, увеличение лимфатических узлов, лихорадка, головная боль, диспепсия (тошнота, рвота).Очень редко— возможны аллергические или анафилактические реакции.Местные реакции (при неправильной технике введения препарата): окрашивание кожи, болезненность в месте введения, воспаление.
Передозировка
Симптомы: на сегодняшний день о случаях передозировки железом не сообщалось. Передозировка может вызывать острую перегрузку железом, которая проявляется симптомами гемосидероза.Лечение: рекомендуется применять симптоматические средства и, если необходимо,— вещества, связывающие железо (хелаты), например дефероксамин (в/в).
Взаимодействие с другими лекарственными средствами
Как и все другие препараты железа, Мальтофер® не следует применять одновременно с железосодержащими препаратами для приема внутрь, поскольку всасывание последних из ЖКТ уменьшается. Поэтому лечение железосодержащими препаратами для приема внутрь следует начинать не ранее чем через 1 нед после последней инъекции препарата Мальтофер®.Одновременный прием ингибиторов АПФ (например эналаприл) может вызвать усиление системных эффектов парентеральных препаратов железа.
Условия хранения
В защищенном от света месте, при температуре не выше 25°C. В оригинальной упаковке.Хранить в недоступном для детей месте.
Срок годности
5 лет. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
Условия отпуска
По рецепту.
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для внутримышечного введения1 млактивное вещество:железа (III) гидроксида полимальтозат 141–182 мгэквивалентно содержанию железа— 50 мгвспомогательные вещества: гидроксид натрия/кислота хлористоводородная— до рН 5,2– 6,5; вода для инъекций— до 1 мл"}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Раствор коричневого цвета."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Фармакологическое действие — восполняющее дефицит железа."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Железодефицитная анемия при неэффективности или невозможности приема препаратов железа внутрь (в т.ч. у пациентов с заболеваниями ЖКТ и синдромом мальабсорбции).Препарат вводится в/м только при подтвержденном соответствующими исследованиями железодефицитном состоянии (например измерение ферритина сыворотки крови, гемоглобина (Hb), гематокрита или количества эритроцитов, а также их параметров— среднего объема эритроцита, среднего содержания Hb в эритроците или средней концентрации Hb в эритроците)."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"гиперчувствительность;анемии, не связанные с дефицитом железа (гемолитическая, мегалобластная, вызванная недостаточностью витамина B12);нарушения эритропоэза;гипоплазия костного мозга; избыток железа в организме (гемохроматоз, гемосидероз); нарушение утилизации железа (сидероахрестическая анемия, талассемия, свинцовая анемия, поздняя порфирия кожи);синдром Ослера-Рандю-Вебера;хронический полиартрит;бронхиальная астма;инфекционные болезни почек в острой стадии;неконтролируемый гиперпаратиреоз;декомпенсированный цирроз печени;инфекционный гепатит;использование для в/в введения;I триместр беременности;детский возраст до 4 мес (опыт применения препарата ограничен). С осторожностью: нарушение функции почек и/или печени."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Клинических данных о применении препарата у беременных в настоящее время недостаточно. В исследованиях на животных не изучалась репродуктивная токсичность препарата. При беременности применять препарат следует только в том случае, когда предполагаемая польза для матери превышает потенциальный риск для плода и/или ребенка. Противопоказано применять препарат в I триместре беременности.В малых количествах неизмененное железо из полимальтозного комплекса может проникать в грудное молоко. При необходимости применения препарата в период лактации грудное вскармливание необходимо прекратить."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В/м.Перед первым введением необходимо провести тест: взрослым— 1/4–1/2 дозы (25–50мг железа), с 4 мес— 1/2 суточной дозы; при отсутствии побочных реакций в течение 15 мин вводят оставшуюся часть начальной дозы. Доза рассчитывается индивидуально и адаптируется в соответствии с общим дефицитом железа по следующей формуле:Общий дефицит железа, мг = масса тела, кг × (нормальный уровень Hb − уровень Hb больного), г/л × 0,24* + железо запасов, мг.При массе тела до 34 кг: нормальный уровень Hb=130 г/л, что соответствует железу запасов = 15 мг/кг.При массе тела выше 34 кг: нормальный уровень Hb=150 г/л, что соответствует железу запасов = 500 мг.*Фактор 0,24 = 0,0034×0,07×1000 (содержание железа в Hb = 0,34%; объем крови = 7% от массы тела; фактор 1000 = перевод из г в мг).Общее количество ампул для введения = общий дефицит железа (мг)/100 мг.\t\t\tМасса тела, кг\t\tОбщее количество мл/ампул для введения\t\t\t\tHb 60 г/л\t\tHb 75 г/л\t\tHb 90 г/л\t\tHb 105 г/л\t\t\t\tмл\t\tамп.\t\tмл\t\tамп.\t\tмл\t\tамп.\t\tмл\t\tамп.\t\t\t\t5\t\t3\t\t1,5\t\t3\t\t1,5\t\t3\t\t1,5\t\t2\t\t1\t\t\t\t10\t\t6\t\t3\t\t6\t\t3\t\t5\t\t2,5\t\t4\t\t2\t\t\t\t15\t\t10\t\t5\t\t9\t\t4,5\t\t7\t\t3,5\t\t6\t\t3\t\t\t\t20\t\t13\t\t6,5\t\t11\t\t5,5\t\t10\t\t5\t\t8\t\t4\t\t\t\t25\t\t16\t\t8\t\t14\t\t7\t\t12\t\t6\t\t11\t\t5,5\t\t\t\t30\t\t19\t\t9,5\t\t17\t\t8,5\t\t15\t\t7,5\t\t13\t\t6,5\t\t\t\t35\t\t25\t\t12,5\t\t23\t\t11,5\t\t20\t\t10\t\t18\t\t9\t\t\t\t40\t\t27\t\t13,5\t\t24\t\t12\t\t22\t\t11\t\t19\t\t9,5\t\t\t\t45\t\t30\t\t15\t\t26\t\t13\t\t23\t\t11,5\t\t20\t\t10\t\t\t\t50\t\t32\t\t16\t\t28\t\t14\t\t24\t\t12\t\t21\t\t10,5\t\t\t\t55\t\t34\t\t17\t\t30\t\t15\t\t26\t\t13\t\t22\t\t11\t\t\t\t60\t\t36\t\t18\t\t32\t\t16\t\t27\t\t13,5\t\t23\t\t11,5\t\t\t\t65\t\t38\t\t19\t\t33\t\t16,5\t\t29\t\t14,5\t\t24\t\t12\t\t\t\t70\t\t40\t\t20\t\t35\t\t17,5\t\t30\t\t15\t\t25\t\t12,5\t\t\t\t75\t\t42\t\t21\t\t37\t\t18,5\t\t32\t\t16\t\t26\t\t13\t\t\t\t80\t\t45\t\t22,5\t\t39\t\t19,5\t\t33\t\t16,5\t\t27\t\t13,5\t\t\t\t85\t\t47\t\t23,5\t\t41\t\t20,5\t\t34\t\t17\t\t28\t\t14\t\t\t\t90\t\t49\t\t24,5\t\t43\t\t21,5\t\t36\t\t18\t\t29\t\t14,5\tЕсли необходимая доза превышает максимальную суточную дозу, введение препарата должно быть дробным.Стандартная дозаВзрослым— 1 амп. ежедневно (2 мл = 100 мг железа); детям с 4 мес— дозировка определяется в зависимости от массы тела.Максимально допустимые суточные дозы: детям с массой тела до 5 кг— 1/4 амп. (0,5мл = 25мг железа), от 5 до 10 кг— 1/2 амп. (1мл = 50мг железа), от 10 до 45 кг— 1 амп. (2 мл = 100 мг железа); взрослым— 2 амп. (4мл = 200мг железа). Если ответная реакция со стороны гематологических параметров (например увеличение уровня Hb примерно на 0,1г/дл в сутки) отсутствует через 1–2 нед, первоначальный диагноз следует пересмотреть. Общая доза препарата на курс лечения не должна превышать рассчитанное число ампул.Техника инъекции (см. Рисунки):Техника инъекции имеет решающее значение. В результате неправильного введения препарата могут возникнуть болевые ощущения и окрашивание кожи в месте инъекции. Описанная ниже методика вентро-ягодичной инъекции рекомендована вместо общепринятой— в верхний наружный квадрант большой ягодичной мышцы:a) длина иглы должна быть не менее 5–6 см. Просвет иглы не должен быть слишком широким. Для детей, а также для взрослых с небольшой массой тела иглы должны быть короче и тоньше;b) место инъекции определяется следующим образом (см. Рисунок 1): по линии позвоночного столба на уровне, соответствующем пояснично-подвздошному сочленению, зафиксировать точку A. Если больной лежит на правом боку, расположить средний палец левой руки в точке A. Отставить указательный палец от среднего так, чтобы он находился под линией подвздошного гребня в точке B. Треугольник, располагающийся между проксимальными фалангами среднего и указательного пальцев является местом инъекции (см. Рисунок 2). c) инструменты дезинфицируются обычным методом; прежде чем ввести иглу, необходимо сдвинуть кожу примерно на 2 см (см. Рисунок 3) для того, чтобы хорошо закрыть канал прокола после извлечения иглы. Это предотвращает проникновение введенного раствора в подкожные ткани и окрашивание кожи;d) расположить иглу вертикально по отношению к поверхности кожи, под бóльшим углом к точке подвздошного сочленения, чем к точке бедренного сустава (см. Рисунок 4);e) после инъекции медленно извлечь иглу и прижать пальцем участок кожи, прилегающий к месту инъекции, примерно на 1 мин;f) после инъекции больному необходимо подвигаться."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Редко— возможны артралгия, увеличение лимфатических узлов, лихорадка, головная боль, диспепсия (тошнота, рвота).Очень редко— возможны аллергические или анафилактические реакции.Местные реакции (при неправильной технике введения препарата): окрашивание кожи, болезненность в месте введения, воспаление."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: на сегодняшний день о случаях передозировки железом не сообщалось. Передозировка может вызывать острую перегрузку железом, которая проявляется симптомами гемосидероза.Лечение: рекомендуется применять симптоматические средства и, если необходимо,— вещества, связывающие железо (хелаты), например дефероксамин (в/в)."}}]},{"id":10,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Как и все другие препараты железа, Мальтофер® не следует применять одновременно с железосодержащими препаратами для приема внутрь, поскольку всасывание последних из ЖКТ уменьшается. Поэтому лечение железосодержащими препаратами для приема внутрь следует начинать не ранее чем через 1 нед после последней инъекции препарата Мальтофер®.Одновременный прием ингибиторов АПФ (например эналаприл) может вызвать усиление системных эффектов парентеральных препаратов железа."}}]},{"id":11,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В защищенном от света месте, при температуре не выше 25°C. В оригинальной упаковке.Хранить в недоступном для детей месте."}}]},{"id":12,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"5 лет. Не применять по истечении срока годности, указанного на упаковке.2000-2017. 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