Недостаточность внешнесекреторной функции поджелудочной железы;
Для улучшения переваривания пищи у пациентов с нормальной функцией ЖКТ в случае погрешностей в питании.
Противопоказания
— острый панкреатит;
— обострение хронического панкреатита;
— детский возраст до 3 лет (для данной лекарственной формы);
— дети с муковисцидозом в возрасте до 15 лет;
— повышенная чувствительность к свиному белку или другим компонентам препарата.
Содержимого 1 капсулы (пеллеты)*:
ЯДРО ПЕЛЛЕТЫ:
Активное вещество:
Панкреатин порошок (свиной, в форме пеллет) 96,6-123,9 мг соответствующий:
активности липазы: 10 000 Ед.Евр.Ф.
активности амилазы: не менее 7 200 Ед.Евр.Ф.
общей протеолитической активности: не менее 400 Ед.Евр.Ф.
+ избыток для обеспечения стабильности:
по массе 10 % 9,6-12,4 мг
по ферментной активности: только относительно активности липазы 10 %
Масса активного вещества в сумме: 106,2-136,3 мг
ОБОЛОЧКА ПЕЛЛЕТЫ**: метакриловой кислоты и этилакрилата сополимер (1:1), дисперсия 30 %, сухая масса (вспомогательные вещества: лаурилсульфат натрия и полисорбат 80) 21,5-27,6 мг, триэтилцитрат 4,3-5,5 мг, тальк 10,8-13,8 мг, симетикон эмульсия 20 %, сухая масса (23 %) 0,1-0,1 мг.
Масса пеллет, покрытых пленочной оболочкой, в сумме*: 142,9-183,3 мг
СОСТАВ ПУСТОЙ КАПСУЛЫ:
КРЫШЕЧКА капсулы: желатин*** 18,8 мг, титана диоксид (Е171) 0,4 мг, натрия лаурилсульфат**** 0,04 мг.
КОРПУС капсулы: желатин*** 28,1 мг, титана диоксид (Е171) 0,6 мг, натрия лаурилсульфат**** 0,06 мг.
Масса пустой капсулы 48,0 мг
* Твердые желатиновые капсулы заполняют в соответствии с заявленными ферментными активностями, масса наполнения содержимого капсулы (пеллеты, покрытые оболочкой) остается в указанных пределах.
** При необходимости можно добавить дополнительное количество дисперсии пленочной оболочкой для обеспечения растворения в кишечнике.
*** Основано на потерях в массе при высушивании 14,5 %.
**** В сумме максимум 0,2 % относительно массы твердой желатиновой капсулы.
Описание
Капсулы твердые желатиновые, непрозрачные, корпус и крышечка белого цвета; содержимое капсул - пеллеты бежево-коричневого цвета.
Фармакологические свойства
Ферментный препарат. Препарат компенсирует недостаточность внешнесекреторной функции поджелудочной железы.
Высокая липазная активность играет важную роль в лечении мальдигестии, обусловленной панкреатической ферментной недостаточностью. Липаза расщепляет жиры путем гидролиза на жирные кислоты и глицерол, таким образом, способствует их абсорбции и абсорбции жирорастворимых витаминов. Амилаза расщепляет углеводы на декстрины и сахара, тогда как протеаза расщепляет белки.
Входящие в состав панкреатина ферменты липаза, амилаза и протеаза облегчают переваривание жиров, углеводов и белков, что способствует их более полному всасыванию в тонкой кишке. Устраняет симптомы, возникающие вследствие нарушения пищеварения (чувство тяжести и переполнения желудка, метеоризм, чувство нехватки воздуха, одышку, обусловленные скоплением газов в кишечнике, диарею). Улучшает процесс переваривания пищи у детей; стимулирует выделение собственных ферментов поджелудочной железы, желудка и тонкой кишки, а также желчи.
Капсула имеет защитную оболочку, благодаря которой активные ферменты высвобождаются в тонкой кишке, где действуют панкреатические ферменты.
Показания к применению
Недостаточность внешнесекреторной функции поджелудочной железы;
Для улучшения переваривания пищи у пациентов с нормальной функцией ЖКТ в случае погрешностей в питании.
Противопоказания
— острый панкреатит;
— обострение хронического панкреатита;
— детский возраст до 3 лет (для данной лекарственной формы);
— дети с муковисцидозом в возрасте до 15 лет;
— повышенная чувствительность к свиному белку или другим компонентам препарата.
Применение при беременности и в период грудного вскармливания
С осторожностью следует назначать препарат при беременности.
Способ применения и дозы
Внутрь. Капсулы следует принимать во время или сразу после каждого приема пищи (в т.ч. легкой закуски), проглатывать целиком, не разламывать и не разжевывать, запивая достаточным количеством жидкости. Дозу препарата Панзинорм® 10 000 подбирают индивидуально, в зависимости от тяжести заболевания и состава диеты.
При затрудненном глотании (например у маленьких детей или пациентов пожилого возраста) капсулы осторожно вскрывают, а пеллеты добавляют к мягкой пище, не требующей пережевывания и имеющей кислый вкус (pH <5,5), или принимают с жидкостью, также имеющей кислый вкус (pH <5,5). Например, пеллеты можно добавлять к яблочному пюре, йогурту или фруктовому соку (яблочному, апельсиновому или ананасовому) с pH менее 5,5. Не рекомендуется добавлять содержимое капсул в горячую пищу. Любая смесь пеллет с пищей или жидкостью не подлежит хранению, и ее следует принимать сразу же после приготовления.
Размельчение или разжевывание пеллет, а также смешивание их с пищей или жидкостью с pH более 5,5 может разрушить их защитную кишечнорастворимую оболочку. Это может привести к раннему высвобождению ферментов в полости рта, снижению эффективности и раздражению слизистых оболочек. Необходимо убедиться, что во рту не осталось пеллет.
Важно обеспечить достаточный постоянный прием жидкости пациентом, особенно при повышенной потере жидкости. Неадекватное потребление жидкости может приводить к возникновению или усилению запора.
Доза для взрослых и детей при муковисцидозе:
Доза зависит от массы тела и должна составлять в начале лечения 1 000 липазных ЕД/кг на каждый прием пищи для детей младше 4 лет и 500 липазных ЕД/кг во время приема пищи для детей старше 4 лет и взрослых.
Дозу следует определять в зависимости от выраженности симптомов заболевания, результатов контроля за стеатореей и поддержания адекватного нутритивного статуса.
У большинства пациентов доза должна оставаться меньше или не превышать 10 000 липазных единиц/кг/сут или 4 000 липазных единиц/г потребленного жира.
Доза при других состояниях, сопровождающихся экзокринной недостаточностью поджелудочной железы:
Дозу следует устанавливать с учетом индивидуальных особенностей пациента, к которым относятся степень недостаточности пищеварения и содержание жира в пище.
Доза, которая требуется пациенту вместе с основным приемом пищи, варьирует от 25 000 до 80 000 ЕД липазы, а во время приема легкой закуски — половина индивидуальной дозы.
У детей препарат должен применяться в соответствии с назначением врача.
Побочное действие
Панзинорм® 10 000 редко вызывает нежелательные эффекты.
Со стороны пищеварительной системы: при приеме больших доз препарата - тошнота, рвота, боль в животе (в т.ч. кишечная колика), диарея, запор, перианальное раздражение, раздражение слизистой оболочки полости рта. При муковисцидозе в случае превышения необходимой дозы панкреатина (более 10 000 ЕД Ph.Eur. липазы/кг массы тела) редко возможно развитие стриктур (фиброзной колонопатии) в илеоцекальном отделе и в восходящей ободочной кишке.
Аллергические реакции: реакции повышенной чувствительности, в т.ч. гиперемия кожи, кожная сыпь, кожный зуд; обструкция дыхательных путей.
Прочие: гиперурикемия, гиперурикозурия, недостаточность фолатов.
Передозировка
Передозировка препаратом Панзинорм® 10 000 не вызывает системной интоксикации.
Симптомы: тошнота, рвота, диарея, гиперурикозурия, гиперурикемия, перианальное раздражение; редко развивается фиброзная колонопатия (при муковисцидозе).
Лечение: отмена препарата, гидратация, симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
При одновременном длительном применении панкреатина в высоких дозах возможно снижение всасывания препаратов железа (клинически незначимо) и фолиевой кислоты. Рекомендуется периодически контролировать уровень фолатов и/или назначение фолиевой кислоты.
При одновременном применении с циметидином, бикарбонатами так же рекомендуется периодически контролировать уровень фолатов и/или назначение фолиевой кислоты.
Панкреатин может уменьшать эффективность акарбозы и миглитола.
Устойчивая к кислоте оболочка пеллет Панзинорм® 10 000 растворяется в двенадцатиперстной кишке. При низком значении рН в двенадцатиперстной кишке панкреатин не высвобождается. Одновременное применение блокаторов гистаминовых Н2-рецепторов (циметидин), гидрокарбонатов, ингибиторов протонового насоса может привести к повышению эффективности панкреатина, что позволяет снизить дозу Панзинорма 10 000.
Особые указания
При муковисцидозе в случае превышения необходимой дозы панкреатина (более 10 000 ЕД Ph.Eur. липазы/кг массы тела) возможно развитие стриктур (фиброзной колонопатии) в илеоцекальном отделе и в восходящей ободочной кишке. Поэтому при муковисцидозе доза должна быть адекватна количеству ферментов, которое необходимо для всасывания жиров с учетом качества и количества потребляемой пищи.
Если на фоне приема капсул Панзинорм® появляются симптомы кишечной непроходимости, следует исключить фиброзную колонопатию.
При длительном применении одновременно назначают препараты железа.
Влияние на способность к вождению автотранспорта и управлению механизмами:
Неизвестно об отрицательном влиянии на способность управления автомобилем и работе с другими механизмами.
Срок годности
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Условия отпуска
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1 капсулы (пеллеты)*:\u003cbr /\u003e\nЯДРО ПЕЛЛЕТЫ:\u003cbr /\u003e\nАктивное вещество:\u003cbr /\u003e\nПанкреатин порошок (свиной, в форме пеллет) 96,6-123,9 мг соответствующий:\u003cbr /\u003e"}},{"type":"list","data":{"style":"unordered","items":["активности липазы: 10 000 Ед.Евр.Ф.\u003cbr /\u003e","активности амилазы: не менее 7 200 Ед.Евр.Ф.\u003cbr /\u003e","общей протеолитической активности: не менее 400 Ед.Евр.Ф.\u003cbr /\u003e"]}},{"type":"paragraph","data":{"text":"+ избыток для обеспечения стабильности:\u003cbr /\u003e"}},{"type":"list","data":{"style":"unordered","items":["по массе 10 % 9,6-12,4 мг\u003cbr /\u003e","по ферментной активности: только относительно активности липазы 10 %\u003cbr /\u003e"]}},{"type":"paragraph","data":{"text":"Масса активного вещества в сумме: 106,2-136,3 мг\u003cbr /\u003e\nОБОЛОЧКА ПЕЛЛЕТЫ**: метакриловой кислоты и этилакрилата сополимер (1:1), дисперсия 30 %, сухая масса (вспомогательные вещества: лаурилсульфат натрия и полисорбат 80) 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Препарат компенсирует недостаточность внешнесекреторной функции поджелудочной железы.\u003cbr /\u003e\nВысокая липазная активность играет важную роль в лечении мальдигестии, обусловленной панкреатической ферментной недостаточностью. Липаза расщепляет жиры путем гидролиза на жирные кислоты и глицерол, таким образом, способствует их абсорбции и абсорбции жирорастворимых витаминов. Амилаза расщепляет углеводы на декстрины и сахара, тогда как протеаза расщепляет белки.\u003cbr /\u003e\nВходящие в состав панкреатина ферменты липаза, амилаза и протеаза облегчают переваривание жиров, углеводов и белков, что способствует их более полному всасыванию в тонкой кишке. Устраняет симптомы, возникающие вследствие нарушения пищеварения (чувство тяжести и переполнения желудка, метеоризм, чувство нехватки воздуха, одышку, обусловленные скоплением газов в кишечнике, диарею). Улучшает процесс переваривания пищи у детей; стимулирует выделение собственных ферментов поджелудочной железы, желудка и тонкой кишки, а также желчи.\u003cbr /\u003e\nКапсула имеет защитную оболочку, благодаря которой активные ферменты высвобождаются в тонкой кишке, где действуют панкреатические ферменты.\u003cbr /\u003e"}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Недостаточность внешнесекреторной функции поджелудочной железы;\u003cbr /\u003e\nДля улучшения переваривания пищи у пациентов с нормальной функцией ЖКТ в случае погрешностей в питании.\u003cbr /\u003e"}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"— острый панкреатит;\u003cbr /\u003e\n— обострение хронического панкреатита;\u003cbr /\u003e\n— детский возраст до 3 лет (для данной лекарственной формы);\u003cbr /\u003e\n— дети с муковисцидозом в возрасте до 15 лет;\u003cbr /\u003e\n— повышенная чувствительность к свиному белку или другим компонентам препарата.\u003cbr /\u003e"}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при беременности."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь. Капсулы следует принимать во время или сразу после каждого приема пищи (в т.ч. легкой закуски), проглатывать целиком, не разламывать и не разжевывать, запивая достаточным количеством жидкости. Дозу препарата Панзинорм® 10 000 подбирают индивидуально, в зависимости от тяжести заболевания и состава диеты.\u003cbr /\u003e\nПри затрудненном глотании (например у маленьких детей или пациентов пожилого возраста) капсулы осторожно вскрывают, а пеллеты добавляют к мягкой пище, не требующей пережевывания и имеющей кислый вкус (pH \u003c5,5), или принимают с жидкостью, также имеющей кислый вкус (pH \u003c5,5). Например, пеллеты можно добавлять к яблочному пюре, йогурту или фруктовому соку (яблочному, апельсиновому или ананасовому) с pH менее 5,5. Не рекомендуется добавлять содержимое капсул в горячую пищу. Любая смесь пеллет с пищей или жидкостью не подлежит хранению, и ее следует принимать сразу же после приготовления.\u003cbr /\u003e\nРазмельчение или разжевывание пеллет, а также смешивание их с пищей или жидкостью с pH более 5,5 может разрушить их защитную кишечнорастворимую оболочку. Это может привести к раннему высвобождению ферментов в полости рта, снижению эффективности и раздражению слизистых оболочек. Необходимо убедиться, что во рту не осталось пеллет.\u003cbr /\u003e\nВажно обеспечить достаточный постоянный прием жидкости пациентом, особенно при повышенной потере жидкости. Неадекватное потребление жидкости может приводить к возникновению или усилению запора.\u003cbr /\u003e\nДоза для взрослых и детей при муковисцидозе:\u003cbr /\u003e\nДоза зависит от массы тела и должна составлять в начале лечения 1 000 липазных ЕД/кг на каждый прием пищи для детей младше 4 лет и 500 липазных ЕД/кг во время приема пищи для детей старше 4 лет и взрослых.\u003cbr /\u003e\nДозу следует определять в зависимости от выраженности симптомов заболевания, результатов контроля за стеатореей и поддержания адекватного нутритивного статуса.\u003cbr /\u003e\nУ большинства пациентов доза должна оставаться меньше или не превышать 10 000 липазных единиц/кг/сут или 4 000 липазных единиц/г потребленного жира.\u003cbr /\u003e\nДоза при других состояниях, сопровождающихся экзокринной недостаточностью поджелудочной железы:\u003cbr /\u003e\nДозу следует устанавливать с учетом индивидуальных особенностей пациента, к которым относятся степень недостаточности пищеварения и содержание жира в пище.\u003cbr /\u003e\nДоза, которая требуется пациенту вместе с основным приемом пищи, варьирует от 25 000 до 80 000 ЕД липазы, а во время приема легкой закуски — половина индивидуальной дозы.\u003cbr /\u003e\nУ детей препарат должен применяться в соответствии с назначением врача.\u003cbr /\u003e"}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Панзинорм® 10 000 редко вызывает нежелательные эффекты.\u003cbr /\u003e\nСо стороны пищеварительной системы: при приеме больших доз препарата - тошнота, рвота, боль в животе (в т.ч. кишечная колика), диарея, запор, перианальное раздражение, раздражение слизистой оболочки полости рта. 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