Длительная поддерживающая терапия нарушений бронхиальной проходимости у пациентов с ХОБЛ.
Противопоказания
Возраст до 18 лет (эффективность и безопасность не установлены). Беременность. Период грудного вскармливания. Повышенная чувствительность к любому из компонентов препарата. С осторожностью следует назначать препарат пациентам с: Сопутствующими сердечно-сосудистыми нарушениями: Ишемическая болезнь сердца Острый инфаркт миокарда. Аритмии. Артериальная ...
Длительная поддерживающая терапия нарушений бронхиальной проходимости у пациентов с ХОБЛ.
Противопоказания
Возраст до 18 лет (эффективность и безопасность не установлены). Беременность. Период грудного вскармливания. Повышенная чувствительность к любому из компонентов препарата. С осторожностью следует назначать препарат пациентам с: Сопутствующими сердечно-сосудистыми нарушениями: Ишемическая болезнь сердца Острый инфаркт миокарда. Аритмии. Артериальная гипертензия. Судорожными расстройствами. Тиреотоксикозом. Сахарным диабетом. Неадекватным ответом на действие агонистов 2 -адренорецепторов в анамнезе.
Способ применения и дозы
Только для ингаляционного применения! Препарат представляет собой капсулы с порошком для ингаляций, которые следует применять только для ингаляций через рот с помощью специального устройства — Бризхалера, который входит в комплект. Препарат нельзя принимать внутрь. Капсулы с порошком для ингаляций должны храниться в блистере и извлекаться из него непосредственно перед применением. Ингаляцию препарата проводят ежедневно 1 раз/ в одно и то же время. В случае пропуска ингаляции, на следующий день препарат Онбрез Бризхалер применяют в обычное время. Рекомендуемая доза препарата составляет 150 мкг (содержимое 1 капсулы 150 мкг) 1 раз/сут. (1 ингаляция в сутки). Доза препарата может быть увеличена только по рекомендации врача. Ингаляции препарата в дозе 300 мкг (содержимое 1 капсулы 300 мкг) 1 раз/сут. может обеспечить дополнительный клинический эффект у некоторых пациентов, например у больных с тяжелой формой ХОБЛ. Максимальная доза - 300 мкг (содержимое 1 капсулы 300 мкг) 1 раз/сут. (1 ингаляция в сутки). Максимально допустимую дозу препарата превышать нельзя. Не требуется коррекции дозы препарата у пациентов в возрасте 65 лет и старше, больных с легкими и умеренными нарушениями функции печени и почек. Применение препарата у пациентов с тяжелыми нарушениями функций печени или почек не изучалось. Правила применения препарата Капсулы с порошком для ингаляций нельзя принимать внутрь! Ингаляционное устройство - Бризхалер, находящийся в упаковке, предназначен для использования только вместе с капсулами препарата. Для ингаляции капсул, находящихся в упаковке, используется только устройство для ингаляций - Бризхалер. Не используйте капсулы препарата с каким-либо другим ингаляционным устройством и, в свою очередь, не используйте Бризхалер для ингаляции с других препаратов. Как использовать Бризхалер Заправка капсулы в Бризхалер Снять крышку. Держа Бризхалер за основание и, отклонив мундштук в направлении стрелки, открыть его. Сухими руками достать капсулу из блистера непосредственно перед использованием. Вставить капсулу в Бризхалер положив ее в специально предназначенное место. Никогда не класть капсулу в мундштук. Закрыть Бризхалер. При закрытии должен быть щелчок. Проколоть капсулу. Держа Бризхалер строго вертикально, нажать одновременно с двух сторон на кнопки прокалывающего устройства. При этом должен быть щелчок. Это означает, что капсула проколота. Не нажимать на кнопки более одного раза. Полностью отпустить кнопки Бризхалера с обеих сторон. Правила проведения ингаляции Пациент должен сделать полный выдох (до того как он возьмет в рот мундштук Бризхалера). Нельзя дуть в мундштук. Вложить мундштук Бризхалера в рот и плотно сжать губы вокруг него. Держа Бризхалер рукой, сделать быстрый равномерный максимально глубокий вдох. Не нажимать на кнопки прокалывающего устройства. Во время ингаляции пациент должен услышать характерный дребезжащий звук, создаваемый вращением капсулы и распылением порошка. Он может почувствовать сладковатый привкус препарата во рту. Если пациент не услышал характерного звука, то надо открыть Бризхалер и посмотреть, что произошло с капсулой. Возможно, она застряла в ячейке. В этом случае нужно аккуратно извлечь капсулу легким постукиванием по основанию устройства. Ни в коем случае не пытататься высвободить капсулу путем повторных нажатий на кнопки по бокам. Если при вдыхании пациент услышал характерный звук, он должен задержать дыхание как можно дольше (чтобы не испытывать неприятных ощущений), и в это же время вынуть мундштук изо рта. После этого сделать выдох. Далее пациент должен открыть Бризхалер и посмотреть, остался ли порошок в капсуле. Если порошок остался в капсуле, закрыть Бризхалер и повторить действия, описанные в пунктах с 1 по 4. Как правило, достаточно 1-2 ингаляций, для полного освобождения капсулы. У некоторых пациентов сразу после проведения ингаляции может начаться кашель. Если это произошло, пациент не должен волноваться, потому что во время ингаляции он получили полную дозу препарата. После того, как пациент сделал ингаляцию, он должен открыть Бризхалер, отклонив мундштук, вынуть пустую капсулу и выбросить ее. Закрыть мундштук Бризхалера и закрыть ингалятор крышкой. Не оставлять капсулы в Бризхалере. Если пациенту удобно, он может сделать отметку в календаре для учета ингаляций На внутренней поверхности упаковки препарата находится календарь для учета ингаляций. Заполнение данного календаря позволит не забыть о необходимости проведения следующей ингаляции препарата. Как чистить Бризхалер Чистить Бризхалер следует 1 раз в неделю, протерев мундштук снаружи и внутри чистой сухой тканью. Никогда не использовать воду для чистки Бризхалера. Сохранять его сухим. В очень редких случаях небольшое количество содержимого капсул может попасть в рот. Пациент не должен об этом волноваться. Следует обратить внимание, что если капсула проколота более одного раза, возрастает риск ее разламывания.
Побочное действие
При применении препарата в терапевтических дозах наиболее часто отмечались следующие нежелательные явления: Назофарингит. Кашель. Инфекции верхних дыхательных путей. Мышечные спазмы. Большинство вышеназванных нежелательных явлений были легкой или средней степени выраженности, частота развития данных нежелательных явлений уменьшалась по мере дальнейшего применения. Ниже приведены нежелательные явления, отмечавшиеся при применении препарата в дозах 150 и 300 мкг 1 раз/сут. у пациентов с ХОБЛ. Нежелательные реакции распределены в соответствии с частотой возникновения. Для оценки частоты использованы следующие критерии: Очень часто 1/10. Часто 1/100, <1/10. Нечасто 1/1000, <1/100. Редко 1/10 000, <1/1000. Очень редко <1/10 000, включая отдельные сообщения. Инфекции и инвазии Часто - назофарингит, инфекции верхних дыхательных путей, синусит. Со стороны дыхательной системы Часто - кашель, боль в горле, ринорея. Со стороны костно-мышечной системы Часто - мышечный спазм, Миалгия боль в костях. Со стороны нервной системы Нечасто - Головокружение Парестезии Со стороны сердечно-сосудистой системы Часто - Ишемическая болезнь сердца Нечасто - фибрилляция предсердий. Со стороны пищеварительной системы Часто - сухость во рту. Нарушения метаболизма Часто - гипергликемия /впервые выявленный сахарный диабет. Общие нарушения Часто - периферические отеки, боль в области грудной клетки (некардиогенная). Нечасто - дискомфорт в области грудной клетки. При применении препарата в дозе 600 мкг 1 раз/сут., профиль безопасности существенно не отличался от такового при ингаляции терапевтических доз (150 и 300 мкг 1 раз/сут. ). Дополнительными нежелательными явлениями были Анемия и тремор. Также более часто выявлялись мышечные спазмы и назофарингит. У пациентов с ХОБЛ при ингаляции в рекомендованных дозах препарат не оказывает клинически значимого системного 2 -адреномиметического действия. Частота сердечных сокращений в среднем изменялась не более чем на 1 уд. /мин. Частота развития тахикардии (отмечалась в редких случая), значимого удлинения интервала QT c (>450 мс для мужчин и >470 мс для женщин) и гипокалиемия были сходны с таковыми при приеме плацебо. Изменения концентрации глюкозы в плазме крови были сходными с таковыми в группе плацебо. В клинических исследованиях в течение 15 сек после ингаляции препарата у пациентов (в 17-20% случаев) отмечалось развитие спорадического кашля длительностью около 5 сек. Возникновение кашля после ингаляции препарата незначительно беспокоило пациентов и не требовало прекращения лечения препаратом (поскольку кашель является симптомом ХОБЛ, и только в 6. 6% случаев больные связывали кашель с применением препарата). Не отмечалось связи между кашлем, наблюдавшимся сразу после ингаляции препарата, и развитием бронхоспазма, обострением ХОБЛ, ухудшением течения ХОБЛ и снижением эффективности препарата.
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Беременность. Период грудного вскармливания. Повышенная чувствительность к любому из компонентов препарата. С осторожностью следует назначать препарат пациентам с: Сопутствующими сердечно-сосудистыми нарушениями: Ишемическая болезнь сердца Острый инфаркт миокарда. Аритмии. Артериальная гипертензия. Судорожными расстройствами. Тиреотоксикозом. Сахарным диабетом. Неадекватным ответом на действие агонистов 2 -адренорецепторов в анамнезе."}}]},{"id":3,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Только для ингаляционного применения! Препарат представляет собой капсулы с порошком для ингаляций, которые следует применять только для ингаляций через рот с помощью специального устройства — Бризхалера, который входит в комплект. Препарат нельзя принимать внутрь. Капсулы с порошком для ингаляций должны храниться в блистере и извлекаться из него непосредственно перед применением. Ингаляцию препарата проводят ежедневно 1 раз/ в одно и то же время. В случае пропуска ингаляции, на следующий день препарат Онбрез Бризхалер применяют в обычное время. Рекомендуемая доза препарата составляет 150 мкг (содержимое 1 капсулы 150 мкг) 1 раз/сут. (1 ингаляция в сутки). Доза препарата может быть увеличена только по рекомендации врача. Ингаляции препарата в дозе 300 мкг (содержимое 1 капсулы 300 мкг) 1 раз/сут. может обеспечить дополнительный клинический эффект у некоторых пациентов, например у больных с тяжелой формой ХОБЛ. Максимальная доза - 300 мкг (содержимое 1 капсулы 300 мкг) 1 раз/сут. (1 ингаляция в сутки). Максимально допустимую дозу препарата превышать нельзя. Не требуется коррекции дозы препарата у пациентов в возрасте 65 лет и старше, больных с легкими и умеренными нарушениями функции печени и почек. Применение препарата у пациентов с тяжелыми нарушениями функций печени или почек не изучалось. Правила применения препарата Капсулы с порошком для ингаляций нельзя принимать внутрь! Ингаляционное устройство - Бризхалер, находящийся в упаковке, предназначен для использования только вместе с капсулами препарата. Для ингаляции капсул, находящихся в упаковке, используется только устройство для ингаляций - Бризхалер. Не используйте капсулы препарата с каким-либо другим ингаляционным устройством и, в свою очередь, не используйте Бризхалер для ингаляции с других препаратов. Как использовать Бризхалер Заправка капсулы в Бризхалер Снять крышку. Держа Бризхалер за основание и, отклонив мундштук в направлении стрелки, открыть его. Сухими руками достать капсулу из блистера непосредственно перед использованием. Вставить капсулу в Бризхалер положив ее в специально предназначенное место. Никогда не класть капсулу в мундштук. Закрыть Бризхалер. При закрытии должен быть щелчок. Проколоть капсулу. Держа Бризхалер строго вертикально, нажать одновременно с двух сторон на кнопки прокалывающего устройства. При этом должен быть щелчок. Это означает, что капсула проколота. Не нажимать на кнопки более одного раза. Полностью отпустить кнопки Бризхалера с обеих сторон. Правила проведения ингаляции Пациент должен сделать полный выдох (до того как он возьмет в рот мундштук Бризхалера). Нельзя дуть в мундштук. Вложить мундштук Бризхалера в рот и плотно сжать губы вокруг него. Держа Бризхалер рукой, сделать быстрый равномерный максимально глубокий вдох. Не нажимать на кнопки прокалывающего устройства. Во время ингаляции пациент должен услышать характерный дребезжащий звук, создаваемый вращением капсулы и распылением порошка. Он может почувствовать сладковатый привкус препарата во рту. Если пациент не услышал характерного звука, то надо открыть Бризхалер и посмотреть, что произошло с капсулой. Возможно, она застряла в ячейке. В этом случае нужно аккуратно извлечь капсулу легким постукиванием по основанию устройства. Ни в коем случае не пытататься высвободить капсулу путем повторных нажатий на кнопки по бокам. Если при вдыхании пациент услышал характерный звук, он должен задержать дыхание как можно дольше (чтобы не испытывать неприятных ощущений), и в это же время вынуть мундштук изо рта. После этого сделать выдох. Далее пациент должен открыть Бризхалер и посмотреть, остался ли порошок в капсуле. Если порошок остался в капсуле, закрыть Бризхалер и повторить действия, описанные в пунктах с 1 по 4. Как правило, достаточно 1-2 ингаляций, для полного освобождения капсулы. У некоторых пациентов сразу после проведения ингаляции может начаться кашель. Если это произошло, пациент не должен волноваться, потому что во время ингаляции он получили полную дозу препарата. После того, как пациент сделал ингаляцию, он должен открыть Бризхалер, отклонив мундштук, вынуть пустую капсулу и выбросить ее. Закрыть мундштук Бризхалера и закрыть ингалятор крышкой. Не оставлять капсулы в Бризхалере. Если пациенту удобно, он может сделать отметку в календаре для учета ингаляций На внутренней поверхности упаковки препарата находится календарь для учета ингаляций. Заполнение данного календаря позволит не забыть о необходимости проведения следующей ингаляции препарата. Как чистить Бризхалер Чистить Бризхалер следует 1 раз в неделю, протерев мундштук снаружи и внутри чистой сухой тканью. Никогда не использовать воду для чистки Бризхалера. Сохранять его сухим. В очень редких случаях небольшое количество содержимого капсул может попасть в рот. Пациент не должен об этом волноваться. 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