— поддерживающая бронходилатирующая терапия с целью облегчения симптомов ХОБЛ у взрослых.
Противопоказания
Повышенная чувствительность к аклидиния бромиду, атропину и его производным (ипратропий, окситропий, или тиотропий) или к лактозе
Возраст до 18 лет (эффективность и безопасность не установлена)
Непереносимость галактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция (препарат содержит лактозу)
Инструкция
Состав
Аклидиния бромид 375 мкг, что соответствует содержанию аклидиния 322 мкг. Вспомогательные вещества: лактозы моногидрат - 12.6 мг.
Показания к применению
— поддерживающая бронходилатирующая терапия с целью облегчения симптомов ХОБЛ у взрослых.
Противопоказания
Повышенная чувствительность к аклидиния бромиду, атропину и его производным (ипратропий, окситропий, или тиотропий) или к лактозе
Возраст до 18 лет (эффективность и безопасность не установлена)
Непереносимость галактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция (препарат содержит лактозу)
Способ применения и дозы
Для ингаляционного применения. Рекомендуемая доза составляет 322 мкг аклидиния (1 ингаляция) 2 раза/сут. В случае пропуска приема дозы следующую дозу необходимо принять как можно скорее. Однако в случае, если время для приема следующей дозы (после пропуска) почти подошло, пропущенную дозу принимать не следует. Применение у пациентов пожилого возраста Пациентам пожилого возраста корректировать дозу не требуется. Применение у пациентов с нарушениями функции почек Пациентам с нарушениями функции ночек корректировать дозу не требуется. Применение у пациентов с нарушениями функции печени Пациентам с нарушениями функции печени корректировать дозу не требуется. Способ применения Пациенты должны быть обучены правильному использованию ингалятора Дженуэйр . Инструкция по применению ингалятора Дженуэйр Знакомство с ингалятором Бретарис Дженуэйр : Достаньте ингалятор Дженуэйр из пакета и ознакомьтесь с его компонентами. Для использования ингалятора Бретарис Дженуэйр после снятия колпачка Вам необходимо сделать 2 шага: Шаг 1. Нажать и отпустить зеленую кнопку и полностью выдохнуть, но не в ингалятор. Шаг 2. Плотно обхватить губами мундштук и сильно и глубоко вдохнуть через ингалятор. После ингаляции не забудьте надеть защитный колпачок. Начало Перед первым применением вскройте закрытый пакет вдоль метки и выньте ингалятор Дженуэйр Когда Вы собираетесь принять дозу лекарственного препарата, снимите защитный колпачок, для чего слегка сожмите стрелки на каждой стороне и потяните наружу. Убедитесь в том, что мундштук ничто не блокирует. Держите ингалятор Дженуэйр горизонтально мундштуком по направлению к Вам, с зеленой кнопкой, обращенной прямо вверх. Шаг 1. Нажмите и отпустите зеленую кнопку. Не удерживайте зеленую кнопку нажатой. Остановитесь и проверьте . убедитесь, что доза готова для ингаляции. Убедитесь, что окно цветового контроля стало зеленым. Зеленый цвет контрольного окна подтверждает, что лекарственный препарат готов для ингаляции. Если окно цветового контроля остается красным, нажмите и опустите зеленую кнопку еще раз (см. Шаг 1). Шаг 2. Плотно обхватите губами мундштук ингалятора Дженуэйр и сильно и глубоко вдохните через мундштук. Такой сильный, глубокий вдох доставляет лекарственный препарат через ингалятор в легкие. Внимание: во время ингаляции нельзя держать прибор с нажатой зеленой кнопкой вниз. Во время вдоха Вы услышите "щелчок", означающий правильное использование ингалятора Дженуэйр. Для того, чтобы убедиться в том, что Вы приняли всю дозу, продолжайте дышать, даже после того, как услышали "щелчок" ингалятора. Уберите ингалятор Дженуэйр изо рта и задержите дыхание так долго, чтобы было комфортно, затем медленно выдохните через нос. Примечание: некоторые пациенты, в зависимости от индивидуальных особенностей, могут ощущать легкий сладковатый или горьковатый привкус при ингаляции данного лекарственного препарата. Не принимайте дополнительную дозу, если Вы не почувствовали никакого вкуса после ингаляции. Остановитесь и проверьте: Убедитесь, что Вы правильно провели ингаляцию. Убедитесь, что окно контроля стало красным. Это подтверждает то, что Вы правильно провели ингаляцию полной дозы. Если окно цветового контроля остается зеленым, необходимо вновь сильно и глубоко вдохнуть через мундштук (см. Шаг 2). Если окно все еще не изменяет свой цвет на красный, то возможно, что Вы могли забыть отпустить зеленую кнопку перед ингаляцией или могли неправильно вдохнуть. Если это так, попробуйте вновь. Убедитесь, что Вы отпустили зеленую кнопку и сделайте сильный глубокий вдох через мундштук. Примечание: если после нескольких попыток Вам так и не удалось правильно провести ингаляцию, обратитесь к лечащему врачу. Как только окно стало красным, наденьте защитный колпачок на мундштук. Когда Вам необходим новый ингалятор Дженуэйр Ингалятор Дженуэйр оборудован индикатором доз, показывающим, сколько примерно доз осталось в ингаляторе. Индикатор доз медленно опускается, показывая интервалы до 10 (60, 50, 40, 30, 20, 10, 0). Каждый ингалятор Дженуэйр содержит по меньшей мере 30 или 60 доз, в зависимости от вида упаковки. Когда на индикаторе доз появится лента с красными полосками, это означает, что Вы приближаетесь к последней дозе и необходимо приобрести новый ингалятор Дженуэйр. Примечание: если Ваш ингалятор Дженуэйр окажется поврежденным или если Вы потеряли колпачок, необходимо заменить ингалятор. Ингалятор Дженуэйр чистить не нужно. Однако, в случае необходимости, это надо делать с помощью сухой ткани или бумажной салфетки снаружи мундштука. Никогда не используйте воду для чистки ингалятора Дженуэйр, т.к. это может повредить лекарственный препарат. Как узнать, что Ваш ингалятор Дженуэйр пуст? Когда в середине индикатора доз появится 0 (ноль), необходимо продолжить использование всех остающихся в ингаляторе Дженуэйр доз. Когда для ингаляции будет подготовлена последняя доза полностью в свое верхнее положение, а останется заблокированной в среднем положении. Даже когда зеленая кнопка заблокирована, Вы, тем не менее, сможете принять последнюю дозу. После этого ингалятор Дженуэйр не может быть использован вновь, и Вам необходимо будет начать использовать новый ингалятор Дженуэйр.
Побочное действие
Наиболее часто встречающимися побочными действиями при применении препарата Бретарис Дженуэйр являются головная боль (6.6%) и назофарингит (5.5%). Частота побочных действий основана на оценке общих коэффициентов возникновения побочных действий (т.е. событий, связанных с применением препарата Бретарис Дженуэйр), наблюдаемых при применении препарата Бретарис Дженуэйр в дозе 322 мкг (636 пациентов) при пуловом анализе одного 6-месячного и двух 3-х месячных рандомизированных клинических исследований с контролем плацебо. Частота побочных действий определена следующим образом: очень часто (≥ .1/10), часто (от ≥ .1/100 до меньше 1/10), нечасто (от ≥ .1/1000 до меньше 1/100), редко (от ≥ .1/10 000 до меньше 1/1000), очень редко ( меньше 1/10 000) . и частота неизвестна (побочные действия, частота возникновения которых неизвестна, т.е. частоту нельзя оценить, исходя из имеющихся данных). Инфекционные и паразитарные заболевания: часто - синусит, назофарингит. Со стороны иммунной системы: редко - реакции гиперчувствительности . частота неизвестна - ангионевротический отек. Со стороны нервной системы: часто - головная боль . нечасто - головокружение. Со стороны органа зрения: нечасто - нечеткость зрения. Со стороны сердечно-сосудистой системы: нечасто - тахикардия, ощущение сердцебиения. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель . нечасто - дисфония. Со стороны ЖКТ: часто - диарея . нечасто - сухость слизистой оболочки полости рта, стоматит. Со стороны кожных покровов и подкожных тканей: нечасто - сыпь, кожный зуд. Со стороны почек и мочевыводяших путей: нечасто - задержка мочи.
Особые указания
Наиболее часто встречающимися побочными действиями при применении препарата Бретарис Дженуэйр являются головная боль (6.6%) и назофарингит (5.5%). Частота побочных действий основана на оценке общих коэффициентов возникновения побочных действий (т.е. событий, связанных с применением препарата Бретарис Дженуэйр), наблюдаемых при применении препарата Бретарис Дженуэйр в дозе 322 мкг (636 пациентов) при пуловом анализе одного 6-месячного и двух 3-х месячных рандомизированных клинических исследований с контролем плацебо. Частота побочных действий определена следующим образом: очень часто (≥ .1/10), часто (от ≥ .1/100 до меньше 1/10), нечасто (от ≥ .1/1000 до меньше 1/100), редко (от ≥ .1/10 000 до меньше 1/1000), очень редко ( меньше 1/10 000) . и частота неизвестна (побочные действия, частота возникновения которых неизвестна, т.е. частоту нельзя оценить, исходя из имеющихся данных). Инфекционные и паразитарные заболевания: часто - синусит, назофарингит. Со стороны иммунной системы: редко - реакции гиперчувствительности . частота неизвестна - ангионевротический отек. Со стороны нервной системы: часто - головная боль . нечасто - головокружение. Со стороны органа зрения: нечасто - нечеткость зрения. Со стороны сердечно-сосудистой системы: нечасто - тахикардия, ощущение сердцебиения. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель . нечасто - дисфония. Со стороны ЖКТ: часто - диарея . нечасто - сухость слизистой оболочки полости рта, стоматит. Со стороны кожных покровов и подкожных тканей: нечасто - сыпь, кожный зуд. Со стороны почек и мочевыводяших путей: нечасто - задержка мочи.
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бромид 375 мкг, что соответствует содержанию аклидиния 322 мкг. Вспомогательные вещества: лактозы моногидрат - 12.6 мг."}}]},{"id":2,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"— поддерживающая бронходилатирующая терапия с целью облегчения симптомов ХОБЛ у взрослых."}}]},{"id":3,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Повышенная чувствительность к аклидиния бромиду, атропину и его производным (ипратропий, окситропий, или тиотропий) или к лактозе","Возраст до 18 лет (эффективность и безопасность не установлена)","Непереносимость галактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция (препарат содержит лактозу)"]}}]},{"id":4,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Для ингаляционного применения. Рекомендуемая доза составляет 322 мкг аклидиния (1 ингаляция) 2 раза/сут. В случае пропуска приема дозы следующую дозу необходимо принять как можно скорее. Однако в случае, если время для приема следующей дозы (после пропуска) почти подошло, пропущенную дозу принимать не следует. Применение у пациентов пожилого возраста Пациентам пожилого возраста корректировать дозу не требуется. Применение у пациентов с нарушениями функции почек Пациентам с нарушениями функции ночек корректировать дозу не требуется. Применение у пациентов с нарушениями функции печени Пациентам с нарушениями функции печени корректировать дозу не требуется. Способ применения Пациенты должны быть обучены правильному использованию ингалятора Дженуэйр . Инструкция по применению ингалятора Дженуэйр Знакомство с ингалятором Бретарис Дженуэйр : Достаньте ингалятор Дженуэйр из пакета и ознакомьтесь с его компонентами. Для использования ингалятора Бретарис Дженуэйр после снятия колпачка Вам необходимо сделать 2 шага: Шаг 1. Нажать и отпустить зеленую кнопку и полностью выдохнуть, но не в ингалятор. Шаг 2. Плотно обхватить губами мундштук и сильно и глубоко вдохнуть через ингалятор. После ингаляции не забудьте надеть защитный колпачок. Начало Перед первым применением вскройте закрытый пакет вдоль метки и выньте ингалятор Дженуэйр Когда Вы собираетесь принять дозу лекарственного препарата, снимите защитный колпачок, для чего слегка сожмите стрелки на каждой стороне и потяните наружу. Убедитесь в том, что мундштук ничто не блокирует. Держите ингалятор Дженуэйр горизонтально мундштуком по направлению к Вам, с зеленой кнопкой, обращенной прямо вверх. Шаг 1. Нажмите и отпустите зеленую кнопку. Не удерживайте зеленую кнопку нажатой. Остановитесь и проверьте . убедитесь, что доза готова для ингаляции. Убедитесь, что окно цветового контроля стало зеленым. Зеленый цвет контрольного окна подтверждает, что лекарственный препарат готов для ингаляции. Если окно цветового контроля остается красным, нажмите и опустите зеленую кнопку еще раз (см. Шаг 1). Шаг 2. Плотно обхватите губами мундштук ингалятора Дженуэйр и сильно и глубоко вдохните через мундштук. Такой сильный, глубокий вдох доставляет лекарственный препарат через ингалятор в легкие. Внимание: во время ингаляции нельзя держать прибор с нажатой зеленой кнопкой вниз. Во время вдоха Вы услышите \"щелчок\", означающий правильное использование ингалятора Дженуэйр. Для того, чтобы убедиться в том, что Вы приняли всю дозу, продолжайте дышать, даже после того, как услышали \"щелчок\" ингалятора. Уберите ингалятор Дженуэйр изо рта и задержите дыхание так долго, чтобы было комфортно, затем медленно выдохните через нос. Примечание: некоторые пациенты, в зависимости от индивидуальных особенностей, могут ощущать легкий сладковатый или горьковатый привкус при ингаляции данного лекарственного препарата. Не принимайте дополнительную дозу, если Вы не почувствовали никакого вкуса после ингаляции. Остановитесь и проверьте: Убедитесь, что Вы правильно провели ингаляцию. Убедитесь, что окно контроля стало красным. Это подтверждает то, что Вы правильно провели ингаляцию полной дозы. Если окно цветового контроля остается зеленым, необходимо вновь сильно и глубоко вдохнуть через мундштук (см. Шаг 2). Если окно все еще не изменяет свой цвет на красный, то возможно, что Вы могли забыть отпустить зеленую кнопку перед ингаляцией или могли неправильно вдохнуть. Если это так, попробуйте вновь. Убедитесь, что Вы отпустили зеленую кнопку и сделайте сильный глубокий вдох через мундштук. Примечание: если после нескольких попыток Вам так и не удалось правильно провести ингаляцию, обратитесь к лечащему врачу. Как только окно стало красным, наденьте защитный колпачок на мундштук. Когда Вам необходим новый ингалятор Дженуэйр Ингалятор Дженуэйр оборудован индикатором доз, показывающим, сколько примерно доз осталось в ингаляторе. Индикатор доз медленно опускается, показывая интервалы до 10 (60, 50, 40, 30, 20, 10, 0). Каждый ингалятор Дженуэйр содержит по меньшей мере 30 или 60 доз, в зависимости от вида упаковки. Когда на индикаторе доз появится лента с красными полосками, это означает, что Вы приближаетесь к последней дозе и необходимо приобрести новый ингалятор Дженуэйр. Примечание: если Ваш ингалятор Дженуэйр окажется поврежденным или если Вы потеряли колпачок, необходимо заменить ингалятор. Ингалятор Дженуэйр чистить не нужно. Однако, в случае необходимости, это надо делать с помощью сухой ткани или бумажной салфетки снаружи мундштука. Никогда не используйте воду для чистки ингалятора Дженуэйр, т.к. это может повредить лекарственный препарат. Как узнать, что Ваш ингалятор Дженуэйр пуст? Когда в середине индикатора доз появится 0 (ноль), необходимо продолжить использование всех остающихся в ингаляторе Дженуэйр доз. Когда для ингаляции будет подготовлена последняя доза полностью в свое верхнее положение, а останется заблокированной в среднем положении. Даже когда зеленая кнопка заблокирована, Вы, тем не менее, сможете принять последнюю дозу. После этого ингалятор Дженуэйр не может быть использован вновь, и Вам необходимо будет начать использовать новый ингалятор Дженуэйр."}}]},{"id":5,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наиболее часто встречающимися побочными действиями при применении препарата Бретарис Дженуэйр являются головная боль (6.6%) и назофарингит (5.5%). Частота побочных действий основана на оценке общих коэффициентов возникновения побочных действий (т.е. событий, связанных с применением препарата Бретарис Дженуэйр), наблюдаемых при применении препарата Бретарис Дженуэйр в дозе 322 мкг (636 пациентов) при пуловом анализе одного 6-месячного и двух 3-х месячных рандомизированных клинических исследований с контролем плацебо. Частота побочных действий определена следующим образом: очень часто (≥ .1/10), часто (от ≥ .1/100 до меньше 1/10), нечасто (от ≥ .1/1000 до меньше 1/100), редко (от ≥ .1/10 000 до меньше 1/1000), очень редко ( меньше 1/10 000) . и частота неизвестна (побочные действия, частота возникновения которых неизвестна, т.е. частоту нельзя оценить, исходя из имеющихся данных). Инфекционные и паразитарные заболевания: часто - синусит, назофарингит. Со стороны иммунной системы: редко - реакции гиперчувствительности . частота неизвестна - ангионевротический отек. Со стороны нервной системы: часто - головная боль . нечасто - головокружение. Со стороны органа зрения: нечасто - нечеткость зрения. Со стороны сердечно-сосудистой системы: нечасто - тахикардия, ощущение сердцебиения. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель . нечасто - дисфония. Со стороны ЖКТ: часто - диарея . нечасто - сухость слизистой оболочки полости рта, стоматит. Со стороны кожных покровов и подкожных тканей: нечасто - сыпь, кожный зуд. Со стороны почек и мочевыводяших путей: нечасто - задержка мочи."}}]},{"id":6,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наиболее часто встречающимися побочными действиями при применении препарата Бретарис Дженуэйр являются головная боль (6.6%) и назофарингит (5.5%). Частота побочных действий основана на оценке общих коэффициентов возникновения побочных действий (т.е. событий, связанных с применением препарата Бретарис Дженуэйр), наблюдаемых при применении препарата Бретарис Дженуэйр в дозе 322 мкг (636 пациентов) при пуловом анализе одного 6-месячного и двух 3-х месячных рандомизированных клинических исследований с контролем плацебо. 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