Занамивир - сильный и высокоселективный ингибитор нейроамини... Инструкция
Показания к применению
Лечение и профилактика инфекции, вызванной вирусом гриппа типа А и В, у детей старше 5 лет и взрослых.
Противопоказания
Повышенная чувствительность к компонентам препарата. С осторожностью следует назначать препарат при заболеваниях дыхательных путей, сопровождающихся бронхоспазмом (в т. ч. в анамнезе).
Занамивир - сильный и высокоселективный ингибитор нейроаминидазы (поверхностного фермента вируса гриппа). Вирусная нейроаминидаза обеспечивает высвобождение вирусных частиц из инфицированной клетки и может ускорять проникновение вируса через слизистый барьер к поверхности эпителиальных клеток, тем самым обеспечивая инфицирование других клеток дыхательных путей. Ингибирующая активность занамивира показана как in vitro так и in vivo и включает все 9 подтипов нейраминидаз вирусов гриппа, в том числе циркулирующие и вирулентные для различных видов. Половина ингибирующей концентрации (1С50) для штаммов вируса А и В, составляет от 0. 09 до 95. 2 нМ. Репликация вируса гриппа ограничена клетками поверхностного эпителия дыхательных путей. Занамивир действует во внеклеточном пространстве, уменьшая воспроизведение обоих типов вируса гриппа (А и В) и предотвращая выброс вирусных частиц клеток из клеток поверхностного эпителия дыхательных путей. Эффективность занамивира при ингаляционном применении подтверждена в контролируемых клинических исследованиях. Использование занамавира в качестве терапии острых инфекций, вызванных вирусом гриппа, приводило к уменьшению выброса вируса (по сравнению с плацебо). Развития резистентности к занамивиру не зарегистрировано.
Показания к применению
Лечение и профилактика инфекции, вызванной вирусом гриппа типа А и В, у детей старше 5 лет и взрослых.
Противопоказания
Повышенная чувствительность к компонентам препарата. С осторожностью следует назначать препарат при заболеваниях дыхательных путей, сопровождающихся бронхоспазмом (в т. ч. в анамнезе).
Применение при беременности и в период грудного вскармливания
Эффективность и безопасность занамивира при беременности и лактации не изучалась. Экспериментальные исследования на животных показали, что занамивир проникает через плаценту и в грудное молоко, тем не менее не отмечено тератогенного эффекта или снижения фертильности или клинических проявлений каких-либо нарушений в пери- и постнатальном периодах. Информации о проникновении через плацентарный барьер или в грудное молоко у человека нет. Тем не менее, занамивир не следует применять во время беременности и в период грудного вскармливания, особенно в первом триместре, только если ожидаемая польза применения для матери превышает возможный риск для плода
Способ применения и дозы
Предназначен только для ингаляционного введения в дыхательные пути с использованием прилагаемого ингалятора Дискхалер. Другие ингаляционные препараты, например, быстродействующие бронходилататоры, следует принимать до начала ингаляции препаратом Реленза. При лечении гриппа А и В взрослым и детям старше 5 лет рекомендуется назначать по 2 ингаляции (2×5 мг) 2 раз в сутки в течение 5 дней. Суточная доза - 20 мг. Пациентам пожилого возраста и пациентам с нарушениями функции почек и печени коррекции дозы не требуется. Для достижения оптимального эффекта лечение должно быть начато как можно раньше. С целью профилактики гриппа А и В взрослым и детям старше 5 лет рекомендуется назначать по 2 ингаляции (2×5 мг) 1 разсут в течение 10 дней. Суточная доза - 10 мг. Курс профилактики может быть продлен до 1 мес, если риск возникновения заболевания сохраняется более 10 дней. Пациентам пожилого возраста и пациентам с нарушениями функции почек и печени коррекция дозы не требуется. Правила применения Дискхалера. Устройство Дискхалер используется для ингаляций ротадиска (форма выпуска Релензы). Дискхалер состоит из следующих частей: корпус с крышкой и пластиковой иглой для прокалывания ячейки ротадиска, чехол для мундштука, выдвижной лоток с мундштуком и вращающимся колесом, на которое помещается Ротадиск. Ротадиск состоит из 4 блистеров, каждый из которых содержит определенную дозу препарата. Ротадиск может храниться в устройстве для ингаляций Дискхалер, тем не менее, блистер следует прокалывать непосредственно перед ингаляцией препарата. Несоблюдение этой рекомендации может нарушить работу Дискхалера и, соответственно, снизить эффективность препарата. Важно: не следует протыкать ротадиск до того, как он будет помещен в Дискхалер. Загрузка ротадиска в Дискхалер. 1. Снять чехол с мундштука, убедиться, что мундштук чистый внутри и снаружи. 2. Осторожно вытянуть выдвижной лоток до выхода пластмассовых зажимов, взявшись за углы лотка. Лоток следует выдвинуть до упора, чтобы были видны насечки на боковой стороне зажимов. 3. Вытянуть лоток полностью, сжавши большим и указательным пальцем насечки на боковой стороне зажимов. 4. Поместить ротадиск на колесо ячейками вниз и вставить лоток обратно в Дискхалер. Проведение ингаляции. 1. Поднять крышку Дискхалера вверх до упора, чтобы проколоть верхнюю и нижнюю фольгу Ротадиска. Закрыть крышку. Важно: не следует поднимать крышку до того, как выдвижной лоток будет полностью установлен. 2. После полного выдоха поместить мундштук между зубами, плотно обхватить мундштук губами, не закрывая отверстий для воздуха по обе стороны мундштука. Сделать медленный глубокий вдох (обязательно через рот, а не через нос). Вынуть мундштук изо рта. Задержать дыхание насколько возможно. Медленно выдохнуть. Нельзя делать выдох в ингалятор. 3. Осторожно однократно выдвинуть выдвижной лоток до упора, не нажимая на зажимы, и задвинуть. При этом ротадиск повернется на одну ячейку и готов для следующей ингаляции. Важно: прокалывать ячейку следует только непосредственно перед ингаляцией. Для проведения повторных ингаляций повторить п. 1 и п. 2. Замена пустого ротадиска. Каждый ротадиск содержит 4 ячейки. После четырех ингаляций пустой ротадиск следует заменить на новый (п. 2-4). Важно: дети должны использовать ингаляционное устройство под контролем взрослых.
Побочное действие
В контролируемых клинических исследованиях частота возникновения нежелательных явлений сходна в группе занамивира и группе плацебо. Спонтанные сообщения содержали информацию о нежелательных реакциях на применение занамивира и классифицировались следующим образом: очень часто (≥110), часто (≥1100, меньше110) иногда (≥11000, меньше1100), редко (≥110 000, меньше11000), очень редко (меньше110 000), включая отдельные случаи. Аллергические реакции: очень редко - аллергические реакции, включая отек лица и гортани. Со стороны дыхательной системы: очень редко - бронхоспазм, затруднение дыхания. Дерматологические реакции: очень редко - сыпь, крапивница, тяжелые кожные реакции, включая полиморфную эритему, синдром Стивенса-Джонсона, токсический эпидермальный некролиз.
Передозировка
Случайная передозировка маловероятна из-за особенностей самой формы выпуска, пути введения и низкой биодоступности после перорального приема занамивира. При ингаляционном применении 64 мг в сутки (более чем в 3 раза превышающей рекомендуемую суточную) не зарегистрировано побочных эффектов. Также они не зарегистрированы и при парентеральном применении в течение 5 дней 1200 мг в сутки.
Особые указания
Пожилые: биодоступность после введения терапевтической дозы 20 мг составляет 10-20%, в результате чего, концентрации в системном кровотоке незначительны. Коррекции режима дозирования не требуется, поскольку любые возрастные изменения, обычно приводящие к изменению фармакокинетических профилей различных препаратов, в данном случае не оказы-вают влияния на фармакокинетику занамивира. Дети: фармакокинетика занамивира оценивалась в контролируемом педиатрическом исследовании у 24 пациентов в возрасте от 3 месяцев до 12 лет при использовании небулайзера (10 мг) и порошкового ингалятора (10 мг). Фармакокинетические параметры у детей не отличались от таковых у взрослых. Пациенты с нарушением функции почек: при применении терапевтических доз 20 мг биодоступность низкая и составляет 10-20%, следовательно, системные концентрации занамивира незначительны. Учитывая широкий диапазон безопасности препарата, возможное увеличение системных концентраций у пациентов с почечной недостаточностью тяжелой степени остается клинически незначимым и не требует коррекции режима дозирования. Пациенты с нарушением функции печени: поскольку занамивир не подвергается метаболизму, не требуется коррекции режима дозирования. Клиническая эффективность и безопасность Занамивир, применяемый в дозах, используемых при лечении гриппа, у здоровых, относящихся к группе риска (как правило, находившихся в контакте с заболевшими) облегчает симптоматику и сокращает продолжительность заболевания. Комбинированный анализ результатов 3 исследований показал, что медиана времени до облегчения симптомов заболевания сокращается до 1,5 дней у пациентов в группе занамивира по сравнению с пациентами в группе плацебо (р меньше 0. 001). Количество осложнений снижалось в группе занамивира 171/769 (22%) по сравнению с плацебо 208/711 (29%) и относительный риск составил: 0. 77; (95% CI: 0. 65 to 0. 92; р=0. 004). Использование антибиотиков для лечения осложнений после перенесенного гриппа также снижалось от 136/711 (19%) в группе плацебо до 110/769 (14%) в группе занамивира (относительный риск: 0. 76; 95% CI: 0. 60 to 0. 95; р=0. 021). Оптимальная эффективность занамивира была показана в случае начала проведения лечения в максимально короткие сроки после появления первых симптомов заболевания. Было показано, что занамивир также эффективен в качестве средства профилактики гриппа у детей старше 5 лет и у взрослых. Процент эффективной защиты составляет 67-79% по сравнению с плацебо и 56-61% по сравнению с активным контролем.
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Вспомогательные вещества: лактозы моногидрат. Концентрация действующего вещества (мг): 5 мг"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Занамивир - сильный и высокоселективный ингибитор нейроаминидазы (поверхностного фермента вируса гриппа). Вирусная нейроаминидаза обеспечивает высвобождение вирусных частиц из инфицированной клетки и может ускорять проникновение вируса через слизистый барьер к поверхности эпителиальных клеток, тем самым обеспечивая инфицирование других клеток дыхательных путей. Ингибирующая активность занамивира показана как in vitro так и in vivo и включает все 9 подтипов нейраминидаз вирусов гриппа, в том числе циркулирующие и вирулентные для различных видов. Половина ингибирующей концентрации (1С50) для штаммов вируса А и В, составляет от 0. 09 до 95. 2 нМ. Репликация вируса гриппа ограничена клетками поверхностного эпителия дыхательных путей. Занамивир действует во внеклеточном пространстве, уменьшая воспроизведение обоих типов вируса гриппа (А и В) и предотвращая выброс вирусных частиц клеток из клеток поверхностного эпителия дыхательных путей. Эффективность занамивира при ингаляционном применении подтверждена в контролируемых клинических исследованиях. Использование занамавира в качестве терапии острых инфекций, вызванных вирусом гриппа, приводило к уменьшению выброса вируса (по сравнению с плацебо). Развития резистентности к занамивиру не зарегистрировано."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение и профилактика инфекции, вызванной вирусом гриппа типа А и В, у детей старше 5 лет и взрослых."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата. С осторожностью следует назначать препарат при заболеваниях дыхательных путей, сопровождающихся бронхоспазмом (в т. ч. в анамнезе)."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Эффективность и безопасность занамивира при беременности и лактации не изучалась. Экспериментальные исследования на животных показали, что занамивир проникает через плаценту и в грудное молоко, тем не менее не отмечено тератогенного эффекта или снижения фертильности или клинических проявлений каких-либо нарушений в пери- и постнатальном периодах. Информации о проникновении через плацентарный барьер или в грудное молоко у человека нет. Тем не менее, занамивир не следует применять во время беременности и в период грудного вскармливания, особенно в первом триместре, только если ожидаемая польза применения для матери превышает возможный риск для плода"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Предназначен только для ингаляционного введения в дыхательные пути с использованием прилагаемого ингалятора Дискхалер. Другие ингаляционные препараты, например, быстродействующие бронходилататоры, следует принимать до начала ингаляции препаратом Реленза. При лечении гриппа А и В взрослым и детям старше 5 лет рекомендуется назначать по 2 ингаляции (2×5 мг) 2 раз в сутки в течение 5 дней. Суточная доза - 20 мг. Пациентам пожилого возраста и пациентам с нарушениями функции почек и печени коррекции дозы не требуется. Для достижения оптимального эффекта лечение должно быть начато как можно раньше. С целью профилактики гриппа А и В взрослым и детям старше 5 лет рекомендуется назначать по 2 ингаляции (2×5 мг) 1 разсут в течение 10 дней. Суточная доза - 10 мг. Курс профилактики может быть продлен до 1 мес, если риск возникновения заболевания сохраняется более 10 дней. Пациентам пожилого возраста и пациентам с нарушениями функции почек и печени коррекция дозы не требуется. Правила применения Дискхалера. Устройство Дискхалер используется для ингаляций ротадиска (форма выпуска Релензы). Дискхалер состоит из следующих частей: корпус с крышкой и пластиковой иглой для прокалывания ячейки ротадиска, чехол для мундштука, выдвижной лоток с мундштуком и вращающимся колесом, на которое помещается Ротадиск. Ротадиск состоит из 4 блистеров, каждый из которых содержит определенную дозу препарата. Ротадиск может храниться в устройстве для ингаляций Дискхалер, тем не менее, блистер следует прокалывать непосредственно перед ингаляцией препарата. Несоблюдение этой рекомендации может нарушить работу Дискхалера и, соответственно, снизить эффективность препарата. Важно: не следует протыкать ротадиск до того, как он будет помещен в Дискхалер. Загрузка ротадиска в Дискхалер. 1. Снять чехол с мундштука, убедиться, что мундштук чистый внутри и снаружи. 2. Осторожно вытянуть выдвижной лоток до выхода пластмассовых зажимов, взявшись за углы лотка. Лоток следует выдвинуть до упора, чтобы были видны насечки на боковой стороне зажимов. 3. Вытянуть лоток полностью, сжавши большим и указательным пальцем насечки на боковой стороне зажимов. 4. Поместить ротадиск на колесо ячейками вниз и вставить лоток обратно в Дискхалер. Проведение ингаляции. 1. Поднять крышку Дискхалера вверх до упора, чтобы проколоть верхнюю и нижнюю фольгу Ротадиска. Закрыть крышку. Важно: не следует поднимать крышку до того, как выдвижной лоток будет полностью установлен. 2. После полного выдоха поместить мундштук между зубами, плотно обхватить мундштук губами, не закрывая отверстий для воздуха по обе стороны мундштука. Сделать медленный глубокий вдох (обязательно через рот, а не через нос). Вынуть мундштук изо рта. Задержать дыхание насколько возможно. Медленно выдохнуть. Нельзя делать выдох в ингалятор. 3. Осторожно однократно выдвинуть выдвижной лоток до упора, не нажимая на зажимы, и задвинуть. При этом ротадиск повернется на одну ячейку и готов для следующей ингаляции. Важно: прокалывать ячейку следует только непосредственно перед ингаляцией. Для проведения повторных ингаляций повторить п. 1 и п. 2. Замена пустого ротадиска. Каждый ротадиск содержит 4 ячейки. После четырех ингаляций пустой ротадиск следует заменить на новый (п. 2-4). Важно: дети должны использовать ингаляционное устройство под контролем взрослых."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В контролируемых клинических исследованиях частота возникновения нежелательных явлений сходна в группе занамивира и группе плацебо. Спонтанные сообщения содержали информацию о нежелательных реакциях на применение занамивира и классифицировались следующим образом: очень часто (≥110), часто (≥1100, меньше110) иногда (≥11000, меньше1100), редко (≥110 000, меньше11000), очень редко (меньше110 000), включая отдельные случаи. Аллергические реакции: очень редко - аллергические реакции, включая отек лица и гортани. Со стороны дыхательной системы: очень редко - бронхоспазм, затруднение дыхания. Дерматологические реакции: очень редко - сыпь, крапивница, тяжелые кожные реакции, включая полиморфную эритему, синдром Стивенса-Джонсона, токсический эпидермальный некролиз."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Случайная передозировка маловероятна из-за особенностей самой формы выпуска, пути введения и низкой биодоступности после перорального приема занамивира. При ингаляционном применении 64 мг в сутки (более чем в 3 раза превышающей рекомендуемую суточную) не зарегистрировано побочных эффектов. Также они не зарегистрированы и при парентеральном применении в течение 5 дней 1200 мг в сутки."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Пожилые: биодоступность после введения терапевтической дозы 20 мг составляет 10-20%, в результате чего, концентрации в системном кровотоке незначительны. Коррекции режима дозирования не требуется, поскольку любые возрастные изменения, обычно приводящие к изменению фармакокинетических профилей различных препаратов, в данном случае не оказы-вают влияния на фармакокинетику занамивира. Дети: фармакокинетика занамивира оценивалась в контролируемом педиатрическом исследовании у 24 пациентов в возрасте от 3 месяцев до 12 лет при использовании небулайзера (10 мг) и порошкового ингалятора (10 мг). Фармакокинетические параметры у детей не отличались от таковых у взрослых. Пациенты с нарушением функции почек: при применении терапевтических доз 20 мг биодоступность низкая и составляет 10-20%, следовательно, системные концентрации занамивира незначительны. Учитывая широкий диапазон безопасности препарата, возможное увеличение системных концентраций у пациентов с почечной недостаточностью тяжелой степени остается клинически незначимым и не требует коррекции режима дозирования. Пациенты с нарушением функции печени: поскольку занамивир не подвергается метаболизму, не требуется коррекции режима дозирования. Клиническая эффективность и безопасность Занамивир, применяемый в дозах, используемых при лечении гриппа, у здоровых, относящихся к группе риска (как правило, находившихся в контакте с заболевшими) облегчает симптоматику и сокращает продолжительность заболевания. Комбинированный анализ результатов 3 исследований показал, что медиана времени до облегчения симптомов заболевания сокращается до 1,5 дней у пациентов в группе занамивира по сравнению с пациентами в группе плацебо (р меньше 0. 001). Количество осложнений снижалось в группе занамивира 171/769 (22%) по сравнению с плацебо 208/711 (29%) и относительный риск составил: 0. 77; (95% CI: 0. 65 to 0. 92; р=0. 004). Использование антибиотиков для лечения осложнений после перенесенного гриппа также снижалось от 136/711 (19%) в группе плацебо до 110/769 (14%) в группе занамивира (относительный риск: 0. 76; 95% CI: 0. 60 to 0. 95; р=0. 021). Оптимальная эффективность занамивира была показана в случае начала проведения лечения в максимально короткие сроки после появления первых симптомов заболевания. Было показано, что занамивир также эффективен в качестве средства профилактики гриппа у детей старше 5 лет и у взрослых. Процент эффективной защиты составляет 67-79% по сравнению с плацебо и 56-61% по сравнению с активным контролем."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Занамивир - сильный и высокоселективный ингибитор нейроаминидазы (поверхностного фермента вируса гриппа). 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Использование занамавира в качестве терапии острых инфекций, вызванных вирусом гриппа, приводило к уменьшению выброса вируса (по сравнению с плацебо). 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