Телбивудин (INN - telbivudine - тельбивудин) является синтет... Инструкция
Показания к применению
Лечение хронического гепатита В у пациентов с явными признаками репликации вируса и активного воспаления печени. Показания определены на основе вирусологических, серологических, биохимических и гистологических реакций, которые отмечали у пациентов с хроническим гепатитом В, с положительной и отрицательной реакцией на антиген вируса гепатита В (HBеAg)....
повышенная чувствительность к активному веществу или одному из ингредиентов препарата.
Инструкция
Состав
1 мл ранибизумаб* 10 мг. 1 фл. ранибизумаб* 3 мг.
Фармакологические свойства
Телбивудин (INN - telbivudine - тельбивудин) является синтетическим аналогом нуклеозида тимидина, который обладает активностью по отношению к полимеразе ДНК вируса гепатита В. Телбивудин активно фосфорилируется клеточными киназами до активной трифосфатной формы с внутриклеточными периодом полураспада 14 ч. Телбивудин-5?-трифосфат тормозит полимеразу ДНК вируса гепатита В (обратная транскриптаза), конкурируя с естественным тимидин-5?-трифосфатом. Включение телбивудин-5?-трифосфата в вирусную ДНК вызывает обрыв цепи ДНК, и это тормозит репликацию вируса гепатита В. Телбивудин является ингибитором синтеза как первой нитки вируса гепатита В (50% эффективная концентрация 0,4–1,3 мкмоль), так и другой нитки (50% эффективная концентрация 0,12–0,24 мкмоль). Телбивудин-5?-фосфат в концентрации до 100 мкмоль не ингибировал клеточную ДНК-полимеразу (?, ? и ?) клеток человека. Препарат в концентрациях до 10 мкмоль не оказывал существенного токсического эффекта на структуру митохондрий, а также на содержание и функцию ДНК и не увеличивал образование молочной кислоты в условиях in vitro.
Показания к применению
Лечение хронического гепатита В у пациентов с явными признаками репликации вируса и активного воспаления печени. Показания определены на основе вирусологических, серологических, биохимических и гистологических реакций, которые отмечали у пациентов с хроническим гепатитом В, с положительной и отрицательной реакцией на антиген вируса гепатита В (HBеAg).
Противопоказания
повышенная чувствительность к активному веществу или одному из ингредиентов препарата.
Применение при беременности и в период грудного вскармливания
Клинические данные о влиянии телбивудина на течение беременности отсутствуют. В период беременности Себиво следует применять только в случае, когда ожидаемая польза для матери превышает потенциальную опасность для плода.
Способ применения и дозы
рекомендуемая доза Себиво для взрослых составляет 600 мг (1 таблетка) 1 раз в сутки. Таблетку принимают перорально во время еды или отдельно. Оптимальная продолжительность лечения не установлена. Себиво можно применять для лечения хронического гепатита В у пациентов с почечной недостаточностью. Для пациентов с клиренсом креатинина ?50 мл/мин в коррекции рекомендуемой дозы телбивудина нет необходимости. Если у пациентов клиренс креатинина ?50 мл/мин, включая почечную недостаточность терминальной стадии с гемодиализом. Терминальная стадия почечной недостаточности 600 мг 1 раз каждые 96 ч. При необходимости применения препарата Себиво пациентам с поражением печени коррекции дозы не требуется.
Побочное действие
В ходе клинических исследований продолжительностью 104 недели нежелательные реакции, о которых сообщалось, как правило, были легкой и средней степени тяжести. Частыми нежелательными реакциями с возможным связью с приемом телбивудину были повышение КФК в крови 3/4 степени (6,8%), усталость (4,4%), головная боль (3%) и тошнота (2,6%).
Передозировка
о случаях передозировки не сообщалось. Исследуемые дозы до 1800 мг/кг (в 3 раза выше рекомендуемой суточной дозы) переносились хорошо. Не определена максимальная переносимая доза телбивудина. Лечение: в случае передозировки следует отменить телбивудин и при необходимости назначить соответствующую общую поддерживающую и симптоматическую терапию.
Особые указания
после прекращения терапии гепатита В телбивудином сообщалось о тяжелых обострениях болезни у пациентов. Необходимо тщательно контролировать функцию печени по клиническим и лабораторным показателям у пациентов, по той или иной причине приостановивших лечение телбивудином. В случае необходимости следует сразу возобновить терапию препаратами для лечения гепатита В. При применении аналогов нуклеотида/нуклеозида в качестве монотерапии или в комбинации с антиретровирусными препаратами сообщали о развитии лактоацидоза и тяжелой гепатомегалии, иногда с летальным исходом. При применении тельбивудина и других препаратов этого класса сообщалось о случаях миопатии, зафиксированных при применении препарата сроком от нескольких недель до месяцев от начала терапии. Факторы, способствующие развитию миопатии среди пациентов, принимающих телбивудин, не известны. Пациентам следует немедленно сообщать о какой-либо постоянной боли неустановленной этиологии или слабости в мышцах. Терапию телбивудином необходимо прекратить, если диагностирована миопатия. Врач должен регулярно контролировать пациентов с риском возникновения миопатии. Пациенты с нарушением функции почек Телбивудин в основном выводится через почки, поэтому пациентам с клиренсом креатинина ?50 мл/мин, включая больных, находящихся на гемодиализе, необходимо подобрать интервал между приемом доз в соответствии с приведенными рекомендациями. Кроме того, прием Себиво одновременно с лекарственными средствами, способными влиять на функцию почек, может стать причиной изменения концентраций телбивудина или соответствующих препаратов в плазме крови. Инфицированные гепатитом В пациенты с резистентностью к антивирусным препаратам Адекватные и надлежащим образом контролируемые исследования лечения телбивудином пациентов, инфицированных гепатитом В, с установленной резистентностью к ламивудину не проводились. В условиях in vitro телбивудин продемонстрировал эффективность в отношении одинарных мутаций штамма вируса гепатита В M204V при отсутствии активности к двойным мутациям M204V/L180M и одинарным мутациям штаммов вируса M204I. Также не проводились адекватные и надлежащим образом контролируемые исследования лечения телбивудином инфицированных гепатитом В пациентов с установленной резистентностью к адефовиру. При условии in vitro телбивудин демонстрировал активность по отношению к мутантным штаммам вируса N236T. Пациенты после пересадки печени Безопасность и эффективность применения телбивудина среди пациентов с пересаженной печенью не известны. Фармакокинетика достигнутого уровня телбивудина не изменялась при постоянном приеме сочетанно с циклоспорином. Если есть необходимость в проведении терапии телбивудином пациентам с пересаженной печенью, которые принимали или принимают иммунодепрессанты с известным влиянием на функцию печени (в частности циклоспорин или такролимус), необходимо контролировать функцию печени до и во время лечения Себиво. Отдельные группы пациентов Применение препарата Себиво не исследовали среди пациентов с гепатитом В, имевших сопутствующие инфекции (например одновременно были инфицированы ВИЧ, вирусом гепатита С или D). Пациенты пожилого возраста Клинические исследования телбивудина не проводили у пациентов в возрасте старше 65 лет в количестве, достаточном для определения отличия их реакций по сравнению с пациентами молодого возраста. В целом назначать Себиво пациентам пожилого возраста необходимо с осторожностью, учитывая распространенное в этой возрастной группе нарушение функции печени из-за сопутствующих заболеваний и в связи с параллельным приемом других лекарственных препаратов. Информация для пациентов Пациентов необходимо проинформировать, что лечение Себиво не снижает риск передачи вируса гепатита В половым путем или с кровью. Клинические данные о влиянии телбивудина на женскую и мужскую репродуктивную функцию отсутствуют. Дети. Исследований по применению данного препарата у детей в возрасте до 18 лет не проводили. Поэтому до получения более полного объема информации Себиво не рекомендуется применять при лечении детей. Способность влиять на скорость реакции при управлении транспортными средствами или другими механизмами. Данные о влиянии препарата и рекомендации отсутствуют.
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Телбивудин активно фосфорилируется клеточными киназами до активной трифосфатной формы с внутриклеточными периодом полураспада 14 ч. Телбивудин-5?-трифосфат тормозит полимеразу ДНК вируса гепатита В (обратная транскриптаза), конкурируя с естественным тимидин-5?-трифосфатом. Включение телбивудин-5?-трифосфата в вирусную ДНК вызывает обрыв цепи ДНК, и это тормозит репликацию вируса гепатита В. Телбивудин является ингибитором синтеза как первой нитки вируса гепатита В (50% эффективная концентрация 0,4–1,3 мкмоль), так и другой нитки (50% эффективная концентрация 0,12–0,24 мкмоль). Телбивудин-5?-фосфат в концентрации до 100 мкмоль не ингибировал клеточную ДНК-полимеразу (?, ? и ?) клеток человека. Препарат в концентрациях до 10 мкмоль не оказывал существенного токсического эффекта на структуру митохондрий, а также на содержание и функцию ДНК и не увеличивал образование молочной кислоты в условиях in vitro."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение хронического гепатита В у пациентов с явными признаками репликации вируса и активного воспаления печени. Показания определены на основе вирусологических, серологических, биохимических и гистологических реакций, которые отмечали у пациентов с хроническим гепатитом В, с положительной и отрицательной реакцией на антиген вируса гепатита В (HBеAg)."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"повышенная чувствительность к активному веществу или одному из ингредиентов препарата."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Клинические данные о влиянии телбивудина на течение беременности отсутствуют. В период беременности Себиво следует применять только в случае, когда ожидаемая польза для матери превышает потенциальную опасность для плода."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"рекомендуемая доза Себиво для взрослых составляет 600 мг (1 таблетка) 1 раз в сутки. Таблетку принимают перорально во время еды или отдельно. Оптимальная продолжительность лечения не установлена. Себиво можно применять для лечения хронического гепатита В у пациентов с почечной недостаточностью. Для пациентов с клиренсом креатинина ?50 мл/мин в коррекции рекомендуемой дозы телбивудина нет необходимости. Если у пациентов клиренс креатинина ?50 мл/мин, включая почечную недостаточность терминальной стадии с гемодиализом. Терминальная стадия почечной недостаточности 600 мг 1 раз каждые 96 ч. При необходимости применения препарата Себиво пациентам с поражением печени коррекции дозы не требуется."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В ходе клинических исследований продолжительностью 104 недели нежелательные реакции, о которых сообщалось, как правило, были легкой и средней степени тяжести. Частыми нежелательными реакциями с возможным связью с приемом телбивудину были повышение КФК в крови 3/4 степени (6,8%), усталость (4,4%), головная боль (3%) и тошнота (2,6%)."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"о случаях передозировки не сообщалось. Исследуемые дозы до 1800 мг/кг (в 3 раза выше рекомендуемой суточной дозы) переносились хорошо. Не определена максимальная переносимая доза телбивудина. Лечение: в случае передозировки следует отменить телбивудин и при необходимости назначить соответствующую общую поддерживающую и симптоматическую терапию."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"после прекращения терапии гепатита В телбивудином сообщалось о тяжелых обострениях болезни у пациентов. Необходимо тщательно контролировать функцию печени по клиническим и лабораторным показателям у пациентов, по той или иной причине приостановивших лечение телбивудином. В случае необходимости следует сразу возобновить терапию препаратами для лечения гепатита В. При применении аналогов нуклеотида/нуклеозида в качестве монотерапии или в комбинации с антиретровирусными препаратами сообщали о развитии лактоацидоза и тяжелой гепатомегалии, иногда с летальным исходом. При применении тельбивудина и других препаратов этого класса сообщалось о случаях миопатии, зафиксированных при применении препарата сроком от нескольких недель до месяцев от начала терапии. Факторы, способствующие развитию миопатии среди пациентов, принимающих телбивудин, не известны. Пациентам следует немедленно сообщать о какой-либо постоянной боли неустановленной этиологии или слабости в мышцах. Терапию телбивудином необходимо прекратить, если диагностирована миопатия. Врач должен регулярно контролировать пациентов с риском возникновения миопатии. Пациенты с нарушением функции почек Телбивудин в основном выводится через почки, поэтому пациентам с клиренсом креатинина ?50 мл/мин, включая больных, находящихся на гемодиализе, необходимо подобрать интервал между приемом доз в соответствии с приведенными рекомендациями. Кроме того, прием Себиво одновременно с лекарственными средствами, способными влиять на функцию почек, может стать причиной изменения концентраций телбивудина или соответствующих препаратов в плазме крови. Инфицированные гепатитом В пациенты с резистентностью к антивирусным препаратам Адекватные и надлежащим образом контролируемые исследования лечения телбивудином пациентов, инфицированных гепатитом В, с установленной резистентностью к ламивудину не проводились. В условиях in vitro телбивудин продемонстрировал эффективность в отношении одинарных мутаций штамма вируса гепатита В M204V при отсутствии активности к двойным мутациям M204V/L180M и одинарным мутациям штаммов вируса M204I. Также не проводились адекватные и надлежащим образом контролируемые исследования лечения телбивудином инфицированных гепатитом В пациентов с установленной резистентностью к адефовиру. При условии in vitro телбивудин демонстрировал активность по отношению к мутантным штаммам вируса N236T. Пациенты после пересадки печени Безопасность и эффективность применения телбивудина среди пациентов с пересаженной печенью не известны. Фармакокинетика достигнутого уровня телбивудина не изменялась при постоянном приеме сочетанно с циклоспорином. Если есть необходимость в проведении терапии телбивудином пациентам с пересаженной печенью, которые принимали или принимают иммунодепрессанты с известным влиянием на функцию печени (в частности циклоспорин или такролимус), необходимо контролировать функцию печени до и во время лечения Себиво. Отдельные группы пациентов Применение препарата Себиво не исследовали среди пациентов с гепатитом В, имевших сопутствующие инфекции (например одновременно были инфицированы ВИЧ, вирусом гепатита С или D). Пациенты пожилого возраста Клинические исследования телбивудина не проводили у пациентов в возрасте старше 65 лет в количестве, достаточном для определения отличия их реакций по сравнению с пациентами молодого возраста. В целом назначать Себиво пациентам пожилого возраста необходимо с осторожностью, учитывая распространенное в этой возрастной группе нарушение функции печени из-за сопутствующих заболеваний и в связи с параллельным приемом других лекарственных препаратов. Информация для пациентов Пациентов необходимо проинформировать, что лечение Себиво не снижает риск передачи вируса гепатита В половым путем или с кровью. Клинические данные о влиянии телбивудина на женскую и мужскую репродуктивную функцию отсутствуют. Дети. Исследований по применению данного препарата у детей в возрасте до 18 лет не проводили. Поэтому до получения более полного объема информации Себиво не рекомендуется применять при лечении детей. Способность влиять на скорость реакции при управлении транспортными средствами или другими механизмами. 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