- состояния после резекции или облучения органов ЖКТ сопровождающиеся нарушениями переваривания пищи метеоризмом диареей (в составе комбинированной ...
- Повышенная чувствительность к любому из компонентов препарата;
- острый панкреатит или хронический панкреатит в стадии обострения. Тем не менее возможно применение в фазе затухающего обострения при расширении диеты если имеются признаки нарушения пищеварения;
- наследственная непереносимость галактозы дефицит лактазы или синдром глюкозо-галактозной ...
Действующее вещество: Панкреатин - 125,0001 мг, соответствующий ферментативной активности: липазы - не менее 10000 ЕД, амилазы - не менее 7500 ЕД, протеазы - не менее 375 ЕД
1 Количество может варьироваться в зависимости от липолитической активности исходной субстанции. Допустимо использование субстанции с липолитической активностью от 80 ЕД/мг до 44 ЕД/мг.
2 Количество может варьироваться в зависимости от липолитической активности исходной субстанции - от 101,600 мг до 0,000 мг.
3 В состав эмульсии входят симетикон (30%), эмульгаторы (5-10%), консерванты (0,5-1,0%), вода очищенная (60-65%).
Описание
Круглые, двояковыпуклые таблетки, покрытые оболочкой от светло-розового до темно-розового цвета, допускается наличие характерного запаха. Допускается шероховатость поверхности. На поперечном разрезе ядро светло-бежевого цвета с вкраплениями от почти белого до светло-коричневого цвета.
Фармакотерапевтическая группа
Пищеварительное ферментное средство
Фармакологические свойства
Фармакодинамика:
Панкреатин представляет собой порошок из поджелудочных желез свиней.
Панкреатические ферменты входящие в состав панкреатина оказывают протеолитическое амилолитическое и липолитическое действие и способствуют расщеплению белков жиров и углеводов улучшают функциональное состояние желудочно-кишечного тракта (ЖКТ) таким образом нормализуя процессы пищеварения.
Фармакокинетика:
Таблетки препарата Панкреатин 10 000 покрыты кислотоустойчивой оболочкой которая устойчива к воздействию соляной кислоты желудка и тем самым защищает содержащиеся в препарате панкреатические ферменты от инактивации. Растворение кишечнорастворимой оболочки и высвобождение ферментов происходит при нейтральном или слабощелочном значениях pH. Панкреатические ферменты не абсорбируются из ЖКТ.
Показания к применению
- Недостаточность внешнесекреторной функции поджелудочной железы (хронический панкреатит муковисцидоз и другие);
- состояния после резекции или облучения органов ЖКТ сопровождающиеся нарушениями переваривания пищи метеоризмом диареей (в составе комбинированной терапии);
- для улучшения переваривания пищи у пациентов с нормальной функцией ЖКТ в случае погрешностей в питании;
- подготовка к рентгенологическому и ультразвуковому исследованию органов брюшной полости;
- расстройства ЖКТ функционального характера (при острых кишечных инфекциях синдроме раздраженного кишечника и других).
Противопоказания
- Повышенная чувствительность к любому из компонентов препарата;
- острый панкреатит или хронический панкреатит в стадии обострения. Тем не менее возможно применение в фазе затухающего обострения при расширении диеты если имеются признаки нарушения пищеварения;
- наследственная непереносимость галактозы дефицит лактазы или синдром глюкозо-галактозной мальабсорбции;
- детский возраст до 3-х лет (для данной лекарственной формы).
Применение при беременности и в период грудного вскармливания
Безопасность применения панкреатина при беременности и в период грудного вскармливания изучена недостаточно. Применение возможно в случаях когда ожидаемая польза для матери превышает потенциальный риск для плода или младенца.
Способ применения и дозы
Доза препарата Панкреатин 10 000 устанавливается индивидуально в зависимости от заболевания и выраженности симптомов.
Если нет других указаний взрослым следует принимать по 2-4 таблетки препарата Панкреатин 10 000 во время еды. Препарат принимают внутрь не разламывая и не разжевывая таблетку (эффективность препарата Панкреатин 10 000 может снижаться при разжевывании и панкреатические ферменты при высвобождении могут раздражать слизистую оболочку полости рта) запивая достаточным количеством жидкости (например стаканом воды).
Суточную дозу панкреатических ферментов соответствующую 15000-20000 ЕД липазы/кг массы тела превышать не рекомендуется.
Увеличение дозы следует осуществлять только под контролем врача ориентируясь при этом на симптоматику (например уменьшение стеатореи и боли в животе). Продолжительность лечения определяется врачом и может варьироваться от нескольких дней (при нарушении пищеварения из-за погрешности в диете) до нескольких месяцев и даже лет (при необходимости постоянной заместительной терапии).
У детей дозировка определяется врачом.
Доза для детей и взрослых при муковисцидозе
У пациентов с муковисцидозом дозу следует подбирать с учетом тяжести симптомов заболевания результатов контроля стеатореи и поддержания адекватного нутритивного статуса (смотри раздел "Особые указания").
Доза не должна превышать 10000 ЕД липазы/кг массы тела в сутки.
У детей режим дозирования и продолжительность лечения устанавливает врач в зависимости от степени выраженности пищеварительных нарушений и состава диеты из расчета 1000 ЕД липазы/кг массы тела ребенка на каждый прием пищи для детей младше 4-х лет и 500 ЕД липазы/кг массы тела ребенка на каждый прием пищи для детей старше 4-х лет.
Если после лечения улучшения не наступает или симптомы усугубляются или появляются новые симптомы необходимо проконсультироваться с врачом.
Применяйте препарат только согласно тем показаниям тому способу применения и в тех дозах которые указаны в инструкции.
Побочное действие
Возможные побочные эффекты приведены ниже по нисходящей частоте возникновения: 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) частота не установлена (по имеющимся данным оценить невозможно).
Нарушения со стороны иммунной системы
Очень редко: аллергические реакции немедленного типа (такие как кожная сыпь крапивница чихание слезотечение бронхоспазм диспноэ) гиперчувствительность ЖКТ.
Нарушения со стороны желудочно-кишечного тракта
Очень редко: диарея абдоминальный дискомфорт боль в животе тошнота рвота; образование стриктур в илеоцекальном и восходящем отделах ободочной кишки у пациентов с муковисцидозом при применении высоких доз панкреатина.
Нарушения со стороны мочеполовой системы
Частота неизвестна: гиперурикозурия (смотри раздел "Особые указания").
Если у Вас отмечаются побочные эффекты указанные в инструкции или они усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции сообщите об этом врачу.
Передозировка
Симптомы: гиперурикозурия гиперурикемия (особенно у больных муковисцидозом принимающих высокие дозы ферментных препаратов).
Взаимодействие с другими лекарственными средствами
Возможно снижение всасывания фолиевой кислоты при одновременном применении с препаратами панкреатина.
Эффект гипогликемических средств для приема внутрь (таких как акарбоза миглитол) может снижаться при одновременном применении с препаратами пищеварительных ферментов содержащих ферменты расщепляющие углеводы (например амилазу).
Если Вы применяете вышеперечисленные или другие лекарственные препараты (в том числе безрецептурные) перед применением препарата Панкреатин 10 000 проконсультируйтесь с врачом.
Особые указания
При остром панкреатите или обострении хронического панкреатита (на стадии затухания обострения) в период восстановительного диетического питания целесообразно принимать препарат Панкреатин 10 000 на фоне имеющей место и/или остающейся в дальнейшем экзокринной недостаточности поджелудочной железы.
У пациентов с муковисцидозом особенно при приеме высоких доз панкреатина может наблюдаться гиперурикозурия поэтому у этой группы пациентов необходимо контролировать концентрацию мочевой кислоты в моче.
У вышеуказанной группы пациентов описаны стриктуры в илеоцекальном и восходящем отделах ободочной кишки.
В качестве меры предосторожности при появлении непривычного дискомфорта в животе или изменения характера жалоб особенно при приеме более 10000 ЕД липазы/кг массы тела в сутки необходимо медицинское обследование.
Препарат Панкреатин 10 000 содержит активные ферменты которые при высвобождении в ротовой полости например при разжевывании могут повредить слизистую оболочку полости рта (вплоть до образования язв). Поэтому таблетку необходимо проглатывать целиком.
Влияние на способность управлять автомобилем и движущимися механизмами
Препарат Панкреатин 10 000 не влияет на способность к управлению транспортными средствами и другими механизмами.
АО "Производственная фармацевтическая компания Обновление" (АО "ПФК Обновление"), г. Новосибирск, ул. Станционная, д.80, Россия
Организация, принимающая претензии потребителей
АО "ПФК Обновление"
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Допустимо использование субстанции с липолитической активностью от 80 ЕД/мг до 44 ЕД/мг."}},{"type":"paragraph","data":{"text":"\u003csup\u003e2 \u003c/sup\u003eКоличество может варьироваться в зависимости от липолитической активности исходной субстанции - от 101,600 мг до 0,000 мг."}},{"type":"paragraph","data":{"text":"\u003csup\u003e3 \u003c/sup\u003eВ состав эмульсии входят симетикон (30%), эмульгаторы (5-10%), консерванты (0,5-1,0%), вода очищенная (60-65%)."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Круглые, двояковыпуклые таблетки, покрытые оболочкой от светло-розового до темно-розового цвета, допускается наличие характерного запаха. Допускается шероховатость поверхности. На поперечном разрезе ядро светло-бежевого цвета с вкраплениями от почти белого до светло-коричневого цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Пищеварительное ферментное средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Панкреатин представляет собой порошок из поджелудочных желез свиней."}},{"type":"paragraph","data":{"text":"Панкреатические ферменты входящие в состав панкреатина оказывают протеолитическое амилолитическое и липолитическое действие и способствуют расщеплению белков жиров и углеводов улучшают функциональное состояние желудочно-кишечного тракта (ЖКТ) таким образом нормализуя процессы пищеварения."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Таблетки препарата Панкреатин 10 000 покрыты кислотоустойчивой оболочкой которая устойчива к воздействию соляной кислоты желудка и тем самым защищает содержащиеся в препарате панкреатические ферменты от инактивации. Растворение кишечнорастворимой оболочки и высвобождение ферментов происходит при нейтральном или слабощелочном значениях pH. Панкреатические ферменты не абсорбируются из ЖКТ."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Недостаточность внешнесекреторной функции поджелудочной железы (хронический панкреатит муковисцидоз и другие);"}},{"type":"paragraph","data":{"text":"- хронические воспалительно-дистрофические заболевания желудка кишечника печени желчного пузыря;"}},{"type":"paragraph","data":{"text":"- состояния после резекции или облучения органов ЖКТ сопровождающиеся нарушениями переваривания пищи метеоризмом диареей (в составе комбинированной терапии);"}},{"type":"paragraph","data":{"text":"- для улучшения переваривания пищи у пациентов с нормальной функцией ЖКТ в случае погрешностей в питании;"}},{"type":"paragraph","data":{"text":"- подготовка к рентгенологическому и ультразвуковому исследованию органов брюшной полости;"}},{"type":"paragraph","data":{"text":"- расстройства ЖКТ функционального характера (при острых кишечных инфекциях синдроме раздраженного кишечника и других)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к любому из компонентов препарата;"}},{"type":"paragraph","data":{"text":"- острый панкреатит или хронический панкреатит в стадии обострения. Тем не менее возможно применение в фазе затухающего обострения при расширении диеты если имеются признаки нарушения пищеварения;"}},{"type":"paragraph","data":{"text":"- наследственная непереносимость галактозы дефицит лактазы или синдром глюкозо-галактозной мальабсорбции;"}},{"type":"paragraph","data":{"text":"- детский возраст до 3-х лет (для данной лекарственной формы)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Безопасность применения панкреатина при беременности и в период грудного вскармливания изучена недостаточно. Применение возможно в случаях когда ожидаемая польза для матери превышает потенциальный риск для плода или младенца."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Доза препарата Панкреатин 10 000 устанавливается индивидуально в зависимости от заболевания и выраженности симптомов."}},{"type":"paragraph","data":{"text":"Если нет других указаний взрослым следует принимать по 2-4 таблетки препарата Панкреатин 10 000 во время еды. Препарат принимают внутрь не разламывая и не разжевывая таблетку (эффективность препарата Панкреатин 10 000 может снижаться при разжевывании и панкреатические ферменты при высвобождении могут раздражать слизистую оболочку полости рта) запивая достаточным количеством жидкости (например стаканом воды)."}},{"type":"paragraph","data":{"text":"Суточную дозу панкреатических ферментов соответствующую 15000-20000 ЕД липазы/кг массы тела превышать не рекомендуется."}},{"type":"paragraph","data":{"text":"Увеличение дозы следует осуществлять только под контролем врача ориентируясь при этом на симптоматику (например уменьшение стеатореи и боли в животе). Продолжительность лечения определяется врачом и может варьироваться от нескольких дней (при нарушении пищеварения из-за погрешности в диете) до нескольких месяцев и даже лет (при необходимости постоянной заместительной терапии)."}},{"type":"paragraph","data":{"text":"У детей дозировка определяется врачом."}},{"type":"paragraph","data":{"text":"Доза для детей и взрослых при муковисцидозе"}},{"type":"paragraph","data":{"text":"У пациентов с муковисцидозом дозу следует подбирать с учетом тяжести симптомов заболевания результатов контроля стеатореи и поддержания адекватного нутритивного статуса (смотри раздел \"Особые указания\")."}},{"type":"paragraph","data":{"text":"Доза не должна превышать 10000 ЕД липазы/кг массы тела в сутки."}},{"type":"paragraph","data":{"text":"У детей режим дозирования и продолжительность лечения устанавливает врач в зависимости от степени выраженности пищеварительных нарушений и состава диеты из расчета 1000 ЕД липазы/кг массы тела ребенка на каждый прием пищи для детей младше 4-х лет и 500 ЕД липазы/кг массы тела ребенка на каждый прием пищи для детей старше 4-х лет."}},{"type":"paragraph","data":{"text":"Если после лечения улучшения не наступает или симптомы усугубляются или появляются новые симптомы необходимо проконсультироваться с врачом."}},{"type":"paragraph","data":{"text":"Применяйте препарат только согласно тем показаниям тому способу применения и в тех дозах которые указаны в инструкции."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Возможные побочные эффекты приведены ниже по нисходящей частоте возникновения: 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) частота не установлена (по имеющимся данным оценить невозможно)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы"}},{"type":"paragraph","data":{"text":"Очень редко: аллергические реакции немедленного типа (такие как кожная сыпь крапивница чихание слезотечение бронхоспазм диспноэ) гиперчувствительность ЖКТ."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта"}},{"type":"paragraph","data":{"text":"Очень редко: диарея абдоминальный дискомфорт боль в животе тошнота рвота; образование стриктур в илеоцекальном и восходящем отделах ободочной кишки у пациентов с муковисцидозом при применении высоких доз панкреатина."}},{"type":"paragraph","data":{"text":"Нарушения со стороны мочеполовой системы"}},{"type":"paragraph","data":{"text":"Частота неизвестна: гиперурикозурия (смотри раздел \"Особые указания\")."}},{"type":"paragraph","data":{"text":"Если у Вас отмечаются побочные эффекты указанные в инструкции или они усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции сообщите об этом врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: гиперурикозурия гиперурикемия (особенно у больных муковисцидозом принимающих высокие дозы ферментных препаратов)."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическая терапия отмена препарата."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Возможно снижение всасывания фолиевой кислоты при одновременном применении с препаратами панкреатина."}},{"type":"paragraph","data":{"text":"Эффект гипогликемических средств для приема внутрь (таких как акарбоза миглитол) может снижаться при одновременном применении с препаратами пищеварительных ферментов содержащих ферменты расщепляющие углеводы (например амилазу)."}},{"type":"paragraph","data":{"text":"Если Вы применяете вышеперечисленные или другие лекарственные препараты (в том числе безрецептурные) перед применением препарата Панкреатин 10 000 проконсультируйтесь с врачом."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При остром панкреатите или обострении хронического панкреатита (на стадии затухания обострения) в период восстановительного диетического питания целесообразно принимать препарат Панкреатин 10 000 на фоне имеющей место и/или остающейся в дальнейшем экзокринной недостаточности поджелудочной железы."}},{"type":"paragraph","data":{"text":"У пациентов с муковисцидозом особенно при приеме высоких доз панкреатина может наблюдаться гиперурикозурия поэтому у этой группы пациентов необходимо контролировать концентрацию мочевой кислоты в моче."}},{"type":"paragraph","data":{"text":"У вышеуказанной группы пациентов описаны стриктуры в илеоцекальном и восходящем отделах ободочной кишки."}},{"type":"paragraph","data":{"text":"В качестве меры предосторожности при появлении непривычного дискомфорта в животе или изменения характера жалоб особенно при приеме более 10000 ЕД липазы/кг массы тела в сутки необходимо медицинское обследование."}},{"type":"paragraph","data":{"text":"Препарат Панкреатин 10 000 содержит активные ферменты которые при высвобождении в ротовой полости например при разжевывании могут повредить слизистую оболочку полости рта (вплоть до образования язв). Поэтому таблетку необходимо проглатывать целиком."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат Панкреатин 10 000 не влияет на способность к управлению транспортными средствами и другими механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки кишечнорастворимые покрытые пленочной оболочкой 10000 ЕД."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не использовать по истечении срока годности."}}]},{"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":"АО \"Производственная фармацевтическая компания Обновление\" (АО \"ПФК Обновление\"), г. Новосибирск, ул. Станционная, д.80, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"АО \"ПФК Обновление\""}}]}],"source":null},"description_toggle":false,"short_description":"Панкреатин представляет собой порошок из поджелудочных желез свиней. Панкреатические ферменты входящие в состав панкреатина оказывают протеолитическое амилолитическое и липолитическое действие и способствуют расщеплению белков жиров и углеводов улучшают функциональное состояние желудочно-кишечного тракта (ЖКТ) таким образом нормализуя процессы пищеварения. Таблетки препарата Панкреатин 10 000 покрыты кислотоустойчивой оболочкой которая устойчива к воздействию соляной кислоты желудка и тем самым защищает содержащиеся в препарате панкреатические ферменты от инактивации. Растворение кишечнорастворимой оболочки и высвобождение ферментов происходит при нейтральном или слабощелочном значениях pH. 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