Артериальная легочная гипертензия, обусловленная заболеванием соединительной ткани или действием лекарственных средств или токсинов
Легочная гипертензия вследствие хронических тромбозов и/или эмболии легочной артерии при отсутствии возможности хирургического лечения
Противопоказания
Патологические состояния, при которых воздействие препарата Вентавис на тромбоциты может повысить риск кровотечения (в т.ч. язвенная болезнь желудка и двенадцатиперстной кишки в фазе обострения, травма, внутричерепное кровоизлияние)
Тяжелая ИБС или нестабильная стенокардия
Инфаркт миокарда в предыдущие 6 месяцев
Декомпенсированная сердечная недостаточность при отсутствии надлежащего врачебного контроля
Антиагрегант. Синтетический аналог простациклина. Препарат ингибирует агрегацию тромбоцитов, адгезию тромбоцитов и реакции высвобождения растворимых молекул адгезии, расширяет артериолы и венулы, увеличивает плотность капилляров и снижает повышенную сосудистую проницаемость, вызванную такими медиаторами как серотонин или гистамин на уровне микроциркулярного русла, стимулирует эндогенную фибринолитическую активность, оказывает противовоспалительные эффекты, такие как ингибирование адгезии лейкоцитов после повреждения эндотелия и лейкоцитарной инфильтрации в поврежденных тканях, а также уменьшение высвобождения фактора некроза опухоли альфа. После ингаляции препарата Вентавис наблюдается прямая вазодилатация легочного артериального русла с последующим значительным улучшением таких показателей как давление в легочных артериях, легочное сосудистое сопротивление, сердечный выброс, а также насыщение кислородом смешанной венозной крови. Влияние на системное сосудистое сопротивление и системное АД было минимальным.
Показания к применению
Лечение среднетяжелой и тяжелой стадии легочной гипертензии в следующих случаях:
Артериальная легочная гипертензия, обусловленная заболеванием соединительной ткани или действием лекарственных средств или токсинов
Легочная гипертензия вследствие хронических тромбозов и/или эмболии легочной артерии при отсутствии возможности хирургического лечения
Противопоказания
Патологические состояния, при которых воздействие препарата Вентавис на тромбоциты может повысить риск кровотечения (в т.ч. язвенная болезнь желудка и двенадцатиперстной кишки в фазе обострения, травма, внутричерепное кровоизлияние)
Тяжелая ИБС или нестабильная стенокардия
Инфаркт миокарда в предыдущие 6 месяцев
Декомпенсированная сердечная недостаточность при отсутствии надлежащего врачебного контроля
Тяжелые аритмии
Подозрение на застой крови в легких
Цереброваскулярные осложнения (в т.ч. транзиторная ишемическая атака, инсульт) в предыдущие 3 месяца
Легочная гипертензия вследствие легочной вено-окклюзионной болезни
Врожденные или приобретенные пороки клапанов сердца с клинически значимыми нарушениями функции миокарда, которые не обусловлены легочной гипертензией
Дети и подростки до 18 лет (в связи с тем, что опыт применения ограничен)
Повышенная чувствительность к илопросту или другим компонентам препарата. С осторожностью
Нарушение функции печени и почечная недостаточность у пациентов, нуждающихся в проведении диализа
Артериальная гипотензия
ХОБЛ
Тяжелая бронхиальная астма
Способ применения и дозы
Препарат Вентавис используется для длительной терапии. Готовый к применению раствор назначается через соответствующий прибор для ингаляций (небулайзер). Предшествующую терапию следует скорректировать в соответствии с индивидуальными потребностями пациента. Взрослые: в начале лечения Вентависом первая ингаляционная доза илопроста должна составлять 2.5 мкг (доставляемой через мундштук ингалятора). Если пациент переносит лечение хорошо, дозу илопроста следует увеличить до 5 мкг и поддерживать эту дозу при последующих ингаляциях. В случае плохой переносимости следует вернуться к дозе 2.5 мкг. Ингаляции илопроста следует проводить от 6 до 9 раз в день в соответствии с индивидуальной потребностью пациента и переносимостью препарата. В зависимости от требующейся дозы препарата, доставляемой через мундштук, и типа небулайзера продолжительность сеанса ингаляции составляет примерно от 4 до 10 мин. Выведение илопроста уменьшается у пациентов с нарушением функции печени. Во избежание нежелательного накопления препарата в течение дня, при подборе начальной дозы препарата у данных пациентов необходимо принимать специальные меры предосторожности. Рекомендуется осторожное титрование начальной дозы с интервалом между введениями 3-4 ч. Начальная доза должна составлять 2.5 мкг с интервалом между введениями 3-4 ч (что соответствует назначению максимум 6 раз в день). Впоследствии возможно осторожно уменьшить интервалы между введениями, с учетом индивидуальной переносимости препарата. Если показано дальнейшее увеличение дозы до 5 мкг, интервалы между введениями на начальном этапе должны составлять 3-4 ч, затем они могут быть уменьшены с учетом индивидуальной переносимости. Дальнейшее накопление препарата после нескольких дней терапии представляется маловероятным благодаря ночному перерыву в назначении. У пациентов с КК > 30 мл/мин нет необходимости корригировать дозу препарата. Применение препарата Вентавис у пациентов с КК ≤ 30 мл/мин в клинических исследованиях не изучалось. Выведение илопроста снижается у пациентов с почечной недостаточностью, нуждающихся в проведении диализа. Рекомендации по дозированию такие же, как у пациентов с нарушением функции печени. Инструкции по введению препарата Для выполнения каждой ингаляции необходимо использовать новую ампулу препарата Вентавис. Содержимое ампулы необходимо полностью перелить в камеру небулайзера непосредственно перед использованием. Необходимо строго соблюдать инструкции по гигиене и очистке ингалятора, предоставленные производителем устройства. Раствор для небулайзера, не использованный для ингаляции, необходимо вылить. В целом, небулайзеры, которые подходят для проведения ингаляционной терапии раствором препарата Вентавис, - это сертифицированные небулайзеры компрессорного типа, ультразвуковые или небулайзеры, основанные на вибрационной технологии. Небулайзеры, подходящие для ингаляционного введения илопроста, должны обеспечивать доставку илопроста через мундштук в дозе 2.5 мкг или 5 мкг в течение периода времени приблизительно от 4 до 10 мин. Масс-медианный аэродинамический диаметр частиц аэрозоля составляет 1-5 мкм. Чтобы минимизировать случайное воздействие препарата, рекомендуется использовать Вентавис в небулайзерах, снабженных фильтром или ингаляционно-пусковой системой, а также хорошо проветривать помещение. Переход на другой тип ингалятора следуем производить под наблюдением лечащего врача.
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Необходимо строго соблюдать инструкции по гигиене и очистке ингалятора, предоставленные производителем устройства. Раствор для небулайзера, не использованный для ингаляции, необходимо вылить. В целом, небулайзеры, которые подходят для проведения ингаляционной терапии раствором препарата Вентавис, - это сертифицированные небулайзеры компрессорного типа, ультразвуковые или небулайзеры, основанные на вибрационной технологии. Небулайзеры, подходящие для ингаляционного введения илопроста, должны обеспечивать доставку илопроста через мундштук в дозе 2.5 мкг или 5 мкг в течение периода времени приблизительно от 4 до 10 мин. Масс-медианный аэродинамический диаметр частиц аэрозоля составляет 1-5 мкм. Чтобы минимизировать случайное воздействие препарата, рекомендуется использовать Вентавис в небулайзерах, снабженных фильтром или ингаляционно-пусковой системой, а также хорошо проветривать помещение. 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