Корпус: желатин – 65,40 мг, титана диоксид (Е 171) – 0,30 мг; краситель железа оксид желтый (Е 172) – 0,30 мг; краситель железа оксид красный (Е 172) - 0,02 мг;
Крышечка: желатин – 42,900 мг; титана диоксид (Е 171) – 0,800 мг; краситель хинолиновый желтый (Е 104) – 0,300 мг; индигокармин (Е 132) – 0,003 мг.
Описание
непрозрачные твердые желатиновые капсулы цилиндрической формы с полусферическими концами № 0: корпус капсулы светло-оранжевого цвета, крышечка капсулы желтовато-зеленого цвета.
Содержимое капсул: мини-таблетки цилиндрической формы, покрытые кишечнорастворимой оболочкой, светло-бежевого цвета с блестящей поверхностью.
Фармакотерапевтическая группа
пищеварительное ферментное средство
Код АТХ: А09АА02
Фармакологические свойства
Фармакодинамика
Действующим веществом препарата Мезим® нео 25000 является панкреатин, представляющий собой порошок из поджелудочных желез свиней. Ферменты, входящие в состав панкреатина, способствуют расщеплению жиров, углеводов и белков, поступающих с пищей. Панкреатин, оказывая протеолитическое, амилолитическое и липолитическое действие, компенсирует ферментативную недостаточность поджелудочной железы, улучшает функциональное состояние желудочно-кишечного тракта (ЖКТ), нормализует процессы пищеварения.
Фармакокинетика
Желатиновые капсулы препарата Мезим® нео 25000 быстро растворяются в желудке, высвобождая мини-таблетки, покрытые кишечнорастворимой (кислотоустойчивой) оболочкой. Таким образом, ферменты остаются защищенными от инактивации в кислой среде желудка. Форма выпуска препарата обеспечивает перемешивание мини-таблеток с кишечным содержимым и равномерное распределение ферментов. Растворение оболочки мини-таблеток и активация ферментов происходит при нейтральной или слабощелочной рН в тонкой кишке. Панкреатин не всасывается в ЖКТ, выводится с каловыми массами.
Показания к применению
Заместительная терапия недостаточности экзокринной функции поджелудочной железы у взрослых и детей при следующих состояниях:
хронический панкреатит;
муковисцидоз;
рак поджелудочной железы;
состояния после оперативных вмешательств на поджелудочной железе и желудке (полная или частичная резекция органа);
после облучения органов ЖКТ, сопровождающиеся нарушением переваривания пищи, метеоризмом, диареей (в составе комбинированной терапии);
сужение протока поджелудочной железы, например, из-за опухоли или желчных камней;
синдром Швахмана-Даймонда;
подострый панкреатит;
другие заболевания, сопровождающиеся экзокринной недостаточностью поджелудочной железы.
Относительная ферментная недостаточность при следующих состояниях и ситуациях:
употребление трудноперевариваемой растительной или жирной пищи;
Подготовка к рентгенологическому и ультразвуковому исследованиям органов брюшной полости.
Противопоказания
острый панкреатит;
обострение хронического панкреатита;
повышенная чувствительность к панкреатину свиного происхождения или другим компонентам препарата.
Применение при беременности и в период грудного вскармливания
Беременность
Клинические данные о лечении беременных женщин препаратами, содержащими ферменты поджелудочной железы, отсутствуют. В ходе исследований на животных не выявлено абсорбции ферментов поджелудочной железы свиного происхождения, поэтому токсического воздействия на репродуктивную функцию и развитие плода не предполагается.
Применение препарата Мезим® нео 25000 при беременности возможно в том случае, если ожидаемая польза для матери превышает возможный риск для плода.
Период грудного вскармливания
Исходя из исследований на животных, во время которых не выявлено негативного влияния ферментов поджелудочной железы, не ожидается никакого вредного влияния препарата на ребенка через грудное молоко. Во время кормления грудью можно принимать ферменты поджелудочной железы.
Способ применения и дозы
Доза препарата Мезим® нео 25000 подбирается индивидуально в зависимости от тяжести заболевания, а также объема и состава принимаемой пищи.
Если нет других указаний, взрослым следует принимать по 1-2 капсулы препарата Мезим® нео 25000 во время каждого приема пищи, проглатывая целиком (не разжевывать), запивая достаточным количеством жидкости (например, стаканом воды).
Если прием целой капсулы для пациента затруднителен (например, у маленьких детей или пациентов пожилого возраста) можно высыпать ее содержимое, например, в стакан, раскрыв капсулу путем отделения крышечки от корпуса, и затем принять содержимое (мини-таблетки), запивая некоторым количеством жидкости или добавить к жидкой пище, не требующей пережевывания (например, яблочное пюре или фруктовый сок). Смесь мини-таблеток с пищей или жидкостью не подлежит хранению (принимать сразу после приготовления).
Увеличение дозы препарата следует осуществлять только под контролем врача, ориентируясь при этом на динамику симптоматики (например, уменьшение стеатореи, ослабление боли в животе).
Суточную дозу ферментов, составляющую 15000-20000 липазных единиц/кг массы тела, превышать не рекомендуется.
Продолжительность курса лечения устанавливается врачом и зависит от течения заболевания.
Детям режим дозирования и продолжительность лечения устанавливает врач в зависимости от степени выраженности заболевания и состава пищи из расчета 500 – 1000 липазных единиц/кг массы тела ребенка на каждый прием пищи.
Применение при муковисцидозе
Доза препарата Мезим® нео 25000 зависит от массы тела и должна составлять в начале лечения 1000 липазных единиц/кг на каждый прием пищи для детей младше 4 лет, и 500 липазных единиц/кг во время каждого приема пищи для детей старше 4 лет.
Дозу препарата следует подбирать индивидуально в зависимости от тяжести заболевания, под контролем стеатореи и поддержке оптимальной диеты. У большинства пациентов доза должна составлять не более 10000 липазных единиц/кг массы тела в сутки или 4000 липазных единиц/г потребленного жира.
Побочное действие
Возможные побочные эффекты приведены ниже по нисходящей частоте возникновения: часто (> 1/100, < 1/10), нечасто (> 1/1000, < 1/100), редко (> 1/10000, < 1/1000), очень редко (< 1/10000), включая отдельные сообщения.
Нарушения со стороны желудочно-кишечного тракта:
Часто: тошнота, рвота и вздутие живота.
Желудочно-кишечные расстройства связаны, главным образом, с основным заболеванием. Частота возникновения следующих неблагоприятных реакций была ниже или схожа с таковыми при применении плацебо:
Очень часто: боль в области живота;
Нарушения со стороны кожи и подкожных тканей:
Редко: сыпь;
Зуд, крапивница - для оценки частоты случаев данных недостаточно.
Передозировка
Симптомы: Применение больших доз ферментов поджелудочной железы может сопровождаться гиперурикозурией и гиперурикемий у пациентов с муковисцидозом.
Взаимодействие с другими лекарственными средствами
Исследований по взаимодействию не проводилось.
Особые указания
У пациентов, страдающих муковисцидозом, получавших высокие дозы препаратов панкреатина описаны стриктуры подвздошной, слепой и толстой кишки (фиброзирующая колонопатия). В качестве меры предосторожности, при появлении непривычных симптомов или изменения характера симптомов основного заболевания необходимо медицинское обследование для исключения поражения толстой кишки, особенно в случае применения препарата в дозе свыше 10000 липазных единиц на кг массы тела в сутки.
Влияние препарата на способность к управлению автотранспортом и другими механизмами
Мезим® нео 25000 не оказывает влияния на выполнение потенциально опасных видов деятельности, требующих особого внимания и быстроты реакции.
Форма выпуска
Капсулы кишечнорастворимые, 25 000 ЕД.
По 20, 50 или 100 капсул в полипропиленовом флаконе с полиэтиленовой крышкой, снабженной осушителем.
По 1 флакону вместе с инструкцией по применению в картонной пачке.
Условия хранения
Хранить при температуре не выше 25оС.
Лекарственное средство хранить в недоступном для детей месте!
Срок годности
2 года.
Не применять после истечения срока годности, указанного на упаковке.
Условия отпуска
Без рецепта.
Производитель
Адэр Фармасьютиклс С.р.л., Италия
Виа Мартин Лютер Кинг, 13
20060, Пессано кон Борнаго
Милан, Италия
Произведено по технологии «Eurand Minitabs® Technology»
Выпускающий контроль
Берлин - Хеми АГ
Глиникер Вег 125
12489, Берлин
Германия
Организация, принимающая претензии потребителей
ООО «Берлин-Хеми/А. Менарини», Россия
123112, г. Москва, Пресненская набережная, д. 10, БЦ «Башня на Набережной»,
Блок Б, тел.: (495) 785-01-00, факс (495) 785-01-01.
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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нео 25000"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eДействующее вещество:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Панкреатин – 356,10 мг"}},{"type":"paragraph","data":{"text":"с минимальной активностью:"}},{"type":"paragraph","data":{"text":"липазы 25000 ЕД"}},{"type":"paragraph","data":{"text":"амилазы 22500 ЕД"}},{"type":"paragraph","data":{"text":"протеазы 1250 ЕД"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества:\u003c/i\u003e кроскармеллоза натрия – 11,87 мг, целлюлоза микрокристаллическая – 19,77 мг, масло касторовое гидрированное – 3,96 мг, кремния диоксид коллоидный безводный – 1,97 мг, магния стеарат – 1,97 мг;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eОболочка\u003c/i\u003e: метакриловой кислоты и этилакрилата сополимер (1:1), 30 % дисперсия – 57,9 мг, триэтилцитрат – 5,82 мг, эмульсия симетикона 30 % (сухая масса) – 0,036 мг; тальк – 11,63 мг;"}},{"type":"paragraph","data":{"text":"Капсула:"}},{"type":"paragraph","data":{"text":"\u003ci\u003eКорпус:\u003c/i\u003e желатин – 65,40 мг, титана диоксид (Е 171) – 0,30 мг; краситель железа оксид желтый (Е 172) – 0,30 мг; краситель железа оксид красный (Е 172) - 0,02 мг;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eКрышечка:\u003c/i\u003e желатин – 42,900 мг; титана диоксид (Е 171) – 0,800 мг; краситель хинолиновый желтый (Е 104) – 0,300 мг; индигокармин (Е 132) – 0,003 мг."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"непрозрачные твердые желатиновые капсулы цилиндрической формы с полусферическими концами № 0: корпус капсулы светло-оранжевого цвета, крышечка капсулы желтовато-зеленого цвета."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСодержимое капсул:\u003c/i\u003e мини-таблетки цилиндрической формы, покрытые кишечнорастворимой оболочкой, светло-бежевого цвета с блестящей поверхностью."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"пищеварительное ферментное средство"}},{"type":"paragraph","data":{"text":"Код АТХ: А09АА02"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eФармакодинамика\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Действующим веществом препарата Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 является панкреатин, представляющий собой порошок из поджелудочных желез свиней. Ферменты, входящие в состав панкреатина, способствуют расщеплению жиров, углеводов и белков, поступающих с пищей. Панкреатин, оказывая протеолитическое, амилолитическое и липолитическое действие, компенсирует ферментативную недостаточность поджелудочной железы, улучшает функциональное состояние желудочно-кишечного тракта (ЖКТ), нормализует процессы пищеварения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФармакокинетика\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Желатиновые капсулы препарата Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 быстро растворяются в желудке, высвобождая мини-таблетки, покрытые кишечнорастворимой (кислотоустойчивой) оболочкой. Таким образом, ферменты остаются защищенными от инактивации в кислой среде желудка. Форма выпуска препарата обеспечивает перемешивание мини-таблеток с кишечным содержимым и равномерное распределение ферментов. Растворение оболочки мини-таблеток и активация ферментов происходит при нейтральной или слабощелочной рН в тонкой кишке. Панкреатин не всасывается в ЖКТ, выводится с каловыми массами."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Заместительная терапия недостаточности экзокринной функции поджелудочной железы у взрослых и детей при следующих состояниях:"}},{"type":"list","data":{"style":"ordered","items":[" хронический панкреатит;","муковисцидоз;","рак поджелудочной железы;","состояния после оперативных вмешательств на поджелудочной железе и желудке (полная или частичная резекция органа);","после облучения органов ЖКТ, сопровождающиеся нарушением переваривания пищи, метеоризмом, диареей (в составе комбинированной терапии);","сужение протока поджелудочной железы, например, из-за опухоли или желчных камней;","синдром Швахмана-Даймонда;","подострый панкреатит;","другие заболевания, сопровождающиеся экзокринной недостаточностью поджелудочной железы."]}},{"type":"paragraph","data":{"text":"Относительная ферментная недостаточность при следующих состояниях и ситуациях:"}},{"type":"list","data":{"style":"ordered","items":["расстройства ЖКТ функционального характера, при острых кишечных инфекциях, синдроме раздраженного кишечника;","употребление трудноперевариваемой растительной или жирной пищи;"]}},{"type":"paragraph","data":{"text":"Подготовка к рентгенологическому и ультразвуковому исследованиям органов брюшной полости."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["острый панкреатит;","обострение хронического панкреатита;","повышенная чувствительность к панкреатину свиного происхождения или другим компонентам препарата."]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Клинические данные о лечении беременных женщин препаратами, содержащими ферменты поджелудочной железы, отсутствуют. В ходе исследований на животных не выявлено абсорбции ферментов поджелудочной железы свиного происхождения, поэтому токсического воздействия на репродуктивную функцию и развитие плода не предполагается."}},{"type":"paragraph","data":{"text":"Применение препарата Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 при беременности возможно в том случае, если ожидаемая польза для матери превышает возможный риск для плода."}},{"type":"paragraph","data":{"text":"Период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Исходя из исследований на животных, во время которых не выявлено негативного влияния ферментов поджелудочной железы, не ожидается никакого вредного влияния препарата на ребенка через грудное молоко. Во время кормления грудью можно принимать ферменты поджелудочной железы."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Доза препарата Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 подбирается индивидуально в зависимости от тяжести заболевания, а также объема и состава принимаемой пищи."}},{"type":"paragraph","data":{"text":"Если нет других указаний, \u003ci\u003eвзрослым\u003c/i\u003e следует принимать по 1-2 капсулы препарата Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 во время каждого приема пищи, проглатывая целиком (не разжевывать), запивая достаточным количеством жидкости (например, стаканом воды)."}},{"type":"paragraph","data":{"text":"Если прием целой капсулы для пациента затруднителен (например, у маленьких детей или пациентов пожилого возраста) можно высыпать ее содержимое, например, в стакан, раскрыв капсулу путем отделения крышечки от корпуса, и затем принять содержимое (мини-таблетки), запивая некоторым количеством жидкости или добавить к жидкой пище, не требующей пережевывания (например, яблочное пюре или фруктовый сок). Смесь мини-таблеток с пищей или жидкостью не подлежит хранению (принимать сразу после приготовления)."}},{"type":"paragraph","data":{"text":"Увеличение дозы препарата следует осуществлять только под контролем врача, ориентируясь при этом на динамику симптоматики (например, уменьшение стеатореи, ослабление боли в животе)."}},{"type":"paragraph","data":{"text":"Суточную дозу ферментов, составляющую 15000-20000 липазных единиц/кг массы тела, превышать не рекомендуется."}},{"type":"paragraph","data":{"text":"Продолжительность курса лечения устанавливается врачом и зависит от течения заболевания."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям\u003c/i\u003e режим дозирования и продолжительность лечения устанавливает врач в зависимости от степени выраженности заболевания и состава пищи из расчета 500 – 1000 липазных единиц/кг массы тела ребенка на каждый прием пищи."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрименение при муковисцидозе\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Доза препарата Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 зависит от массы тела и должна составлять в начале лечения 1000 липазных единиц/кг на каждый прием пищи для детей младше 4 лет, и 500 липазных единиц/кг во время каждого приема пищи для детей старше 4 лет."}},{"type":"paragraph","data":{"text":"Дозу препарата следует подбирать индивидуально в зависимости от тяжести заболевания, под контролем стеатореи и поддержке оптимальной диеты. У большинства пациентов доза должна составлять не более 10000 липазных единиц/кг массы тела в сутки или 4000 липазных единиц/г потребленного жира."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Возможные побочные эффекты приведены ниже по нисходящей частоте возникновения: часто (> 1/100, < 1/10), нечасто (> 1/1000, < 1/100), редко (> 1/10000, < 1/1000), очень редко (< 1/10000), включая отдельные сообщения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны желудочно-кишечного тракта:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eЧасто:\u003c/i\u003e тошнота, рвота и вздутие живота."}},{"type":"paragraph","data":{"text":"Желудочно-кишечные расстройства связаны, главным образом, с основным заболеванием. Частота возникновения следующих неблагоприятных реакций была ниже или схожа с таковыми при применении плацебо:"}},{"type":"paragraph","data":{"text":"\u003ci\u003eОчень часто:\u003c/i\u003e боль в области живота;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны кожи и подкожных тканей:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eРедко:\u003c/i\u003e сыпь;"}},{"type":"paragraph","data":{"text":"Зуд, крапивница - для оценки частоты случаев данных недостаточно."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы:\u003c/i\u003e Применение больших доз ферментов поджелудочной железы может сопровождаться гиперурикозурией и гиперурикемий у пациентов с муковисцидозом."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e отмена препарата, симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Исследований по взаимодействию не проводилось."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"У пациентов, страдающих муковисцидозом, получавших высокие дозы препаратов панкреатина описаны стриктуры подвздошной, слепой и толстой кишки (фиброзирующая колонопатия). В качестве меры предосторожности, при появлении непривычных симптомов или изменения характера симптомов основного заболевания необходимо медицинское обследование для исключения поражения толстой кишки, особенно в случае применения препарата в дозе свыше 10000 липазных единиц на кг массы тела в сутки."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние препарата на способность к управлению автотранспортом и другими механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Мезим\u003csup\u003e®\u003c/sup\u003e нео 25000 не оказывает влияния на выполнение потенциально опасных видов деятельности, требующих особого внимания и быстроты реакции."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы кишечнорастворимые, 25 000 ЕД."}},{"type":"paragraph","data":{"text":"По 20, 50 или 100 капсул в полипропиленовом флаконе с полиэтиленовой крышкой, снабженной осушителем."}},{"type":"paragraph","data":{"text":"По 1 флакону вместе с инструкцией по применению в картонной пачке."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25оС."}},{"type":"paragraph","data":{"text":"Лекарственное средство хранить в недоступном для детей месте!"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не применять после истечения срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Адэр Фармасьютиклс С.р.л., Италия"}},{"type":"paragraph","data":{"text":"Виа Мартин Лютер Кинг, 13"}},{"type":"paragraph","data":{"text":"20060, Пессано кон Борнаго"}},{"type":"paragraph","data":{"text":"Милан, Италия"}},{"type":"paragraph","data":{"text":"Произведено по технологии «Eurand Minitabs\u003csup\u003e®\u003c/sup\u003e Technology»"}},{"type":"paragraph","data":{"text":"Выпускающий контроль"}},{"type":"paragraph","data":{"text":"Берлин - Хеми АГ"}},{"type":"paragraph","data":{"text":"Глиникер Вег 125"}},{"type":"paragraph","data":{"text":"12489, Берлин"}},{"type":"paragraph","data":{"text":"Германия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО «Берлин-Хеми/А. Менарини», Россия"}},{"type":"paragraph","data":{"text":"123112, г. Москва, Пресненская набережная, д. 10, БЦ «Башня на Набережной»,"}},{"type":"paragraph","data":{"text":"Блок Б, тел.: (495) 785-01-00, факс (495) 785-01-01."}}]}],"source":null},"description_toggle":false,"short_description":"ФармакодинамикаДействующим веществом препарата Мезим®нео 25000 является панкреатин, представляющий собой порошок из поджелудочных желез свиней. Ферменты, входящие в состав панкреатина, способствуют расщеплению жиров, углеводов и белков, поступающих с пищей. Панкреатин, оказывая протеолитическое, амилолитическое и липолитическое действие, компенсирует ферментативную недостаточность поджелудочной железы, улучшает функциональное состояние желудочно-кишечного тракта (ЖКТ), нормализует процессы пищеварения.ФармакокинетикаЖелатиновые капсулы препарата Мезим®нео 25000 быстро растворяются в желудке, высвобождая мини-таблетки, покрытые кишечнорастворимой (кислотоустойчивой) оболочкой. 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