1 доза: вилантерола трифенатат микронизированный 40 мкг, что соответствует содержанию вилантерола (доставленная доза) 22 мкг. Вспомогательные вещества: стеарат магния - 125 мг, лактозы моногидрат - до 12.5 мг. Порошок для ингаляций дозированный белого цвета. 1 доза: умеклидиния бромид 74.2 мкг, что соответствует содержанию умеклидиния (доставленная доза) 55 мкг. Вспомогательные вещества: стеарат магния - 75 мг, лактозы моногидрат - до 12.5 мг.
Описание
Дозированный порошок для ингаляций Аноро Эллипта представляет собой комбинацию ингаляционного антагониста мускариновых холинорецепторов длительного действия и ингаляционного бета2-адреномиметика длительного действия (АХДД/ДДБА). После пероральной ингаляции оба соединения оказывают местное воздействие на дыхательные пути, вызывая бронходилатацию за счет различных механизмов действия.
Показания к применению
В качестве поддерживающей бронхорасширяющей терапии, направленной на облегчение симптомов хронической обструктивной болезни легких (ХОБЛ).
Применение при беременности и в период грудного вскармливания
Данные по влиянию препарата Аноро Эллипта на фертильность человека отсутствуют. В доклинических исследованиях воздействия вилантерола или умеклидиния на фертильность не обнаружено. Данные по применению комбинации вилантерола и умеклидиния у беременных женщин отсутствуют или ограничены. В доклинических исследованиях была выявлена репродуктивная токсичность при ингаляционном применении вилантерола. Применение препарата Аноро Эллипта у беременных женщин допустимо только в том случае, если потенциальная польза для матери превышает возможный риск для плода. Данные об экскреции вилантерола или умеклидиния в грудное молоко человека отсутствуют. Однако другие бета2-агонисты определяются в грудном молоке. Риск проникновения препарата вместе с молоком в организм новорожденного или ребенка не может быть исключен. Принимая во внимание соотношение пользы терапии для матери и грудного вскармливания для ребенка, необходимо принять решение либо об отмене препарата, либо о прекращении грудного вскармливания.
Способ применения и дозы
Препарат Аноро Эллипта предназначен только для ингаляционного применения. Рекомендуемая и максимальная доза препарата Аноро Эллипта - одна ингаляция 22 мкг+55 мкг/доза 1 раз/сут в одно и то же время. При первом использовании ингалятора Эллипта нет необходимости в проверке правильности его работы или специальной подготовки ингалятора к эксплуатации. Просто последовательно соблюдайте рекомендации по применению, указанные ниже. Ингалятор Эллипта упакован в контейнер, содержащий влагопоглощающий пакетик с силикагелем, который не предназначен для еды или ингаляций. Данный пакетик следует утилизировать. Когда Вы достаете ингалятор из контейнера, его крышка находится в закрытом положении. Не открывайте ее до тех пор, пока Вы нс будете готовы к приему препарата. Ниже приведены подробные инструкции использования ингалятора Эллипта:I. Прочитайте следующую информацию перед использованиемПри открытии и закрытии крышки ингалятора Эллипта без приема лекарственного препарата происходит потеря одной дозы. Эта доза остается закрытой внутри ингалятора, но она будет недоступна для приема. Невозможно случайно получить большую дозу или двойную дозу за одну ингаляцию. Одна доза лекарственного препарата готова к ингаляции после каждого открытия крышки. Счетчик доз показывает, сколько доз лекарственного препарата осталось в ингаляторе. Перед началом использования ингалятора счетчик доз показывает число 30. При каждом открытии крышки количество доз уменьшается на 1. Когда остается менее 10 доз, половина счетчика становится красной. После того, как израсходована последняя доза препарата, половина счетчика выделена красным цветом, счетчик показывает цифру 0. Это означает, что ингалятор пуст. Если Вы откроете крышку после этого, счетчик доз станет полностью красным. II. Подготовка дозыНе открывайте крышку, пока Вы не будете готовы к приему препарата. Не встряхивайте ингалятор.1. Опустите крышку вниз до щелчка.2. Доза препарата готова к ингаляции, и в подтверждение этого счетчик доз уменьшает число доз на единицу.3. Если счетчик доз не уменьшил число доз после того, как Вы услышали щелчок, то ингалятор не готов к подаче дозы лекарственного препарата. В этом случае следует обратиться по телефону или адресу, указанному в подразделе "За дополнительной информацией обращаться".4. Никогда не встряхивайте ингалятор.III. Ингаляции лекарственного препарата1. Удерживая ингалятор на некотором расстоянии ото рта, сделайте выдох максимальной глубины. Не выдыхайте в ингалятор.2. Поместите мундштук между губами и плотно обхватите его губами. Губы должны точно повторять форму мундштука ингалятора. Не закрывайте пальцами вентиляционное отверстие.3. Сделайте один глубокий, долгий, равномерный, глубокий вдох через рот. Задержите дыхание насколько возможно (по крайней мере, на 3-4 секунды).4. Уберите ингалятор изо рта.5. Медленно и спокойно выдохните. При правильном использовании ингалятора Вы можете не почувствовать вкус или не ощутить поступление лекарственного препарата.IV. Закрытие ингалятораЕсли Вы хотите протереть мундштук перед закрытием крышки, используйте сухую салфетку. Поднимите крышку до упора, добившись полного закрытия мундштука. При хранении в холодильнике ингалятор следует выдержать при комнатной температуре не менее часа перед использованием.
Побочное действие
Профиль безопасности комбинации вилантерола и умеклидиния основан на данных клинических исследований, в которых участвовали приблизительно 3000 пациентов с ХОБЛ, получавших препарат в дозировке 22+55 мкг/доза или более на протяжении до 1 года во время исследований. Из них около 1600 пациентов получали препарат в дозировке 22+55 мкг/доза 1 раз в сутки и около 1300 пациентов - в дозировке 22+113 мкг/доза 1 раз в сутки. Нежелательные реакции, представленные ниже, перечислены в соответствии с поражением органов и систем органов и частотой встречаемости. Частота встречаемости определяется следующим образом: очень часто (≥1/10), часто (≥1/100 и <1/10), нечасто (≥1/1000 и <1/100), редко (≥ 1/10 000 и <1/1000), очень редко (<1/10 000, включая отдельные случаи). Частота встречаемости нежелательных реакцийИнфекционные и паразитарные заболевания: часто - инфекции мочевыводящих путей, синусит, назофарингит, фарингит, инфекции верхних дыхательных путей. Со стороны сердца: нечасто - фибрилляция предсердий, наджелудочковая тахикардия, тахикардия. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель, боль в ротоглотке. Со стороны ЖКТ: часто - запор, сухость во рту. Данные наблюдения пострегистрационного наблюденияСо стороны иммунной системы: реакции гиперчувствительности, в т.ч. нечасто - сыпь, редко - анафилаксия, ангионевротический отек, крапивница. Нарушения психики: нечасто - тревожность. Со стороны нервной системы: нечасто - тремор, нарушение вкуса. Со стороны сердца: нечасто - учащенное сердцебиение. Со стороны костно-мышечной системы и соединительной ткани: нечасто - мышечные спазмы.
Передозировка
Симптомы: передозировка препаратом Аноро Эллипта может вызывать развитие симптомов и признаков, обусловленных действием отдельных компонентов препарата, включая известные нежелательные реакции, развивающиеся при воздействии антагонистов мускариновых рецепторов (например, сухость во рту, нарушения аккомодации и тахикардия) и признаки, наблюдаемые при передозировке другими бета2-агонистами (например, тремор, головная боль и тахикардия). Лечение: в случае передозировки требуется симптоматическая терапия и, при необходимости, за больным обеспечивается соответствующее наблюдение. Дальнейшее ведение больных в случае передозировки необходимо проводить в соответствии с клиническими показаниями.
Особые указания
Исследований по применению препарата Аноро Эллипта у пациентов с бронхиальной астмой не проводилось, поэтому использовать указанный препарат для терапии в данной группе больных не рекомендуется. Препарат Аноро Эллипта предназначен для применения в качестве поддерживающей терапии ХОБЛ. Не следует применять данный препарат для купирования острых симптомов, т.е. в качестве терапии неотложной помощи при остром эпизоде бронхоспазма. Для купирования острых симптомов необходимо использовать бронходилататор короткого действия. Увеличение частоты применения бронходилататоров короткого действия с целью купирования симптомов свидетельствует об ухудшении контроля над заболеванием, в этом случае пациенту требуется консультация врача. Как и при других видах ингаляционной терапии, применение препарата Аноро Эллипта может вызвать парадоксальный бронхоспазм. который может быть опасным для жизни. При развитии парадоксального бронхоспазма необходимо прекратить лечение препаратом, и при необходимости может быть назначена альтернативная терапия. Препарат Аноро Эллипта предназначен для поддерживающего лечения больных ХОБЛ. В связи с тем обстоятельством, что в общей популяции ХОБЛ существенно преобладают больные в возрасте старше 40 лет, при назначении препарата пациентам до 40 лет требуется спирометрическое подтверждение диагноза ХОБЛ. Влияние на способность к вождению автотранспорта и управлению механизмамиИсследования по изучению влияния препарата Аноро Эллипта на способность к вождению автотранспорта и работе с механизмами не проводились.
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доза: вилантерола трифенатат микронизированный 40 мкг, что соответствует содержанию вилантерола (доставленная доза) 22 мкг. Вспомогательные вещества: стеарат магния - 125 мг, лактозы моногидрат - до 12.5 мг. Порошок для ингаляций дозированный белого цвета. 1 доза: умеклидиния бромид 74.2 мкг, что соответствует содержанию умеклидиния (доставленная доза) 55 мкг. Вспомогательные вещества: стеарат магния - 75 мг, лактозы моногидрат - до 12.5 мг."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Дозированный порошок для ингаляций Аноро Эллипта представляет собой комбинацию ингаляционного антагониста мускариновых холинорецепторов длительного действия и ингаляционного бета2-адреномиметика длительного действия (АХДД/ДДБА). После пероральной ингаляции оба соединения оказывают местное воздействие на дыхательные пути, вызывая бронходилатацию за счет различных механизмов действия."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В качестве поддерживающей бронхорасширяющей терапии, направленной на облегчение симптомов хронической обструктивной болезни легких (ХОБЛ)."}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные по влиянию препарата Аноро Эллипта на фертильность человека отсутствуют. В доклинических исследованиях воздействия вилантерола или умеклидиния на фертильность не обнаружено. Данные по применению комбинации вилантерола и умеклидиния у беременных женщин отсутствуют или ограничены. В доклинических исследованиях была выявлена репродуктивная токсичность при ингаляционном применении вилантерола. Применение препарата Аноро Эллипта у беременных женщин допустимо только в том случае, если потенциальная польза для матери превышает возможный риск для плода. Данные об экскреции вилантерола или умеклидиния в грудное молоко человека отсутствуют. Однако другие бета2-агонисты определяются в грудном молоке. Риск проникновения препарата вместе с молоком в организм новорожденного или ребенка не может быть исключен. Принимая во внимание соотношение пользы терапии для матери и грудного вскармливания для ребенка, необходимо принять решение либо об отмене препарата, либо о прекращении грудного вскармливания."}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Аноро Эллипта предназначен только для ингаляционного применения. Рекомендуемая и максимальная доза препарата Аноро Эллипта - одна ингаляция 22 мкг+55 мкг/доза 1 раз/сут в одно и то же время. При первом использовании ингалятора Эллипта нет необходимости в проверке правильности его работы или специальной подготовки ингалятора к эксплуатации. Просто последовательно соблюдайте рекомендации по применению, указанные ниже. Ингалятор Эллипта упакован в контейнер, содержащий влагопоглощающий пакетик с силикагелем, который не предназначен для еды или ингаляций. Данный пакетик следует утилизировать. Когда Вы достаете ингалятор из контейнера, его крышка находится в закрытом положении. Не открывайте ее до тех пор, пока Вы нс будете готовы к приему препарата. Ниже приведены подробные инструкции использования ингалятора Эллипта:I. Прочитайте следующую информацию перед использованиемПри открытии и закрытии крышки ингалятора Эллипта без приема лекарственного препарата происходит потеря одной дозы. Эта доза остается закрытой внутри ингалятора, но она будет недоступна для приема. Невозможно случайно получить большую дозу или двойную дозу за одну ингаляцию. Одна доза лекарственного препарата готова к ингаляции после каждого открытия крышки. Счетчик доз показывает, сколько доз лекарственного препарата осталось в ингаляторе. Перед началом использования ингалятора счетчик доз показывает число 30. При каждом открытии крышки количество доз уменьшается на 1. Когда остается менее 10 доз, половина счетчика становится красной. После того, как израсходована последняя доза препарата, половина счетчика выделена красным цветом, счетчик показывает цифру 0. Это означает, что ингалятор пуст. Если Вы откроете крышку после этого, счетчик доз станет полностью красным. II. Подготовка дозыНе открывайте крышку, пока Вы не будете готовы к приему препарата. Не встряхивайте ингалятор.1. Опустите крышку вниз до щелчка.2. Доза препарата готова к ингаляции, и в подтверждение этого счетчик доз уменьшает число доз на единицу.3. Если счетчик доз не уменьшил число доз после того, как Вы услышали щелчок, то ингалятор не готов к подаче дозы лекарственного препарата. В этом случае следует обратиться по телефону или адресу, указанному в подразделе \"За дополнительной информацией обращаться\".4. Никогда не встряхивайте ингалятор.III. Ингаляции лекарственного препарата1. Удерживая ингалятор на некотором расстоянии ото рта, сделайте выдох максимальной глубины. Не выдыхайте в ингалятор.2. Поместите мундштук между губами и плотно обхватите его губами. Губы должны точно повторять форму мундштука ингалятора. Не закрывайте пальцами вентиляционное отверстие.3. Сделайте один глубокий, долгий, равномерный, глубокий вдох через рот. Задержите дыхание насколько возможно (по крайней мере, на 3-4 секунды).4. Уберите ингалятор изо рта.5. Медленно и спокойно выдохните. При правильном использовании ингалятора Вы можете не почувствовать вкус или не ощутить поступление лекарственного препарата.IV. Закрытие ингалятораЕсли Вы хотите протереть мундштук перед закрытием крышки, используйте сухую салфетку. Поднимите крышку до упора, добившись полного закрытия мундштука. При хранении в холодильнике ингалятор следует выдержать при комнатной температуре не менее часа перед использованием."}}]},{"id":6,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Профиль безопасности комбинации вилантерола и умеклидиния основан на данных клинических исследований, в которых участвовали приблизительно 3000 пациентов с ХОБЛ, получавших препарат в дозировке 22+55 мкг/доза или более на протяжении до 1 года во время исследований. Из них около 1600 пациентов получали препарат в дозировке 22+55 мкг/доза 1 раз в сутки и около 1300 пациентов - в дозировке 22+113 мкг/доза 1 раз в сутки. Нежелательные реакции, представленные ниже, перечислены в соответствии с поражением органов и систем органов и частотой встречаемости. Частота встречаемости определяется следующим образом: очень часто (≥1/10), часто (≥1/100 и \u003c1/10), нечасто (≥1/1000 и \u003c1/100), редко (≥ 1/10 000 и \u003c1/1000), очень редко (\u003c1/10 000, включая отдельные случаи). Частота встречаемости нежелательных реакцийИнфекционные и паразитарные заболевания: часто - инфекции мочевыводящих путей, синусит, назофарингит, фарингит, инфекции верхних дыхательных путей. Со стороны сердца: нечасто - фибрилляция предсердий, наджелудочковая тахикардия, тахикардия. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель, боль в ротоглотке. Со стороны ЖКТ: часто - запор, сухость во рту. Данные наблюдения пострегистрационного наблюденияСо стороны иммунной системы: реакции гиперчувствительности, в т.ч. нечасто - сыпь, редко - анафилаксия, ангионевротический отек, крапивница. Нарушения психики: нечасто - тревожность. Со стороны нервной системы: нечасто - тремор, нарушение вкуса. Со стороны сердца: нечасто - учащенное сердцебиение. Со стороны костно-мышечной системы и соединительной ткани: нечасто - мышечные спазмы."}}]},{"id":7,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: передозировка препаратом Аноро Эллипта может вызывать развитие симптомов и признаков, обусловленных действием отдельных компонентов препарата, включая известные нежелательные реакции, развивающиеся при воздействии антагонистов мускариновых рецепторов (например, сухость во рту, нарушения аккомодации и тахикардия) и признаки, наблюдаемые при передозировке другими бета2-агонистами (например, тремор, головная боль и тахикардия). Лечение: в случае передозировки требуется симптоматическая терапия и, при необходимости, за больным обеспечивается соответствующее наблюдение. Дальнейшее ведение больных в случае передозировки необходимо проводить в соответствии с клиническими показаниями."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Исследований по применению препарата Аноро Эллипта у пациентов с бронхиальной астмой не проводилось, поэтому использовать указанный препарат для терапии в данной группе больных не рекомендуется. Препарат Аноро Эллипта предназначен для применения в качестве поддерживающей терапии ХОБЛ. Не следует применять данный препарат для купирования острых симптомов, т.е. в качестве терапии неотложной помощи при остром эпизоде бронхоспазма. Для купирования острых симптомов необходимо использовать бронходилататор короткого действия. Увеличение частоты применения бронходилататоров короткого действия с целью купирования симптомов свидетельствует об ухудшении контроля над заболеванием, в этом случае пациенту требуется консультация врача. Как и при других видах ингаляционной терапии, применение препарата Аноро Эллипта может вызвать парадоксальный бронхоспазм. который может быть опасным для жизни. При развитии парадоксального бронхоспазма необходимо прекратить лечение препаратом, и при необходимости может быть назначена альтернативная терапия. Препарат Аноро Эллипта предназначен для поддерживающего лечения больных ХОБЛ. В связи с тем обстоятельством, что в общей популяции ХОБЛ существенно преобладают больные в возрасте старше 40 лет, при назначении препарата пациентам до 40 лет требуется спирометрическое подтверждение диагноза ХОБЛ. Влияние на способность к вождению автотранспорта и управлению механизмамиИсследования по изучению влияния препарата Аноро Эллипта на способность к вождению автотранспорта и работе с механизмами не проводились."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Дозированный порошок для ингаляций Аноро Эллипта представляет собой комбинацию ингаляционного антагониста мускариновых холинорецепторов длительного действия и ингаляционного бета2-адреномиметика длительного действия (АХДД/ДДБА). 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