Рекомбинантный хориогонадотропин альфа, который имеет ту же... Инструкция
Показания к применению
В протоколе индукции множественного созревания фолликулов (суперовуляция) для вспомогательных репродуктивных технологий (в т.ч. для экстракорпорального оплодотворения) с целью индукции финального созревания фолликулов и лютеинизации после стимуляции препаратами гонадотропинов; - При ановуляторном или олигоовуляторном бесплодии для индукции овуляции и лютеинизации в конце стимуляции роста фолликулов.
Противопоказания
Опухоли в области гипоталамуса и гипофиза; - Объемные новообразования яичника или кисты, не связанные с поликистозом яичника; - Вагинальные кровотечения неясного генеза; - Рак яичника, матки или молочной железы; - Внематочная беременность в течение 3 предыдущих месяцев; - Тромбоэмболия; - Первичная овариальная недостаточность; - Врожденные пороки развития половых органов, несовместимые с беременностью; - Фибромиома матки, несовместимая с беременностью; - Постменопауза; - Повышенная чувствительность к компонентам препарата. С осторожностью следует назначать Овитрель пациенткам с серьезными системными заболеваниями в тех случаях, когда беременность может привести к их обострению.
Рекомбинантный хориогонадотропин альфа, который имеет ту же аминокислотную последовательность, что и естественный человеческий хорионический гонадотропин. Связывает трансмембранные рецепторы ЛГ на поверхности клеток теки и гранулезы яичника. Вызывает инициирование ооцитарного мейоза, разрыв фолликулов (овуляцию), формирование желтого тела, продукцию прогестерона и эстрадиола желтым телом.
Показания к применению
В протоколе индукции множественного созревания фолликулов (суперовуляция) для вспомогательных репродуктивных технологий (в т.ч. для экстракорпорального оплодотворения) с целью индукции финального созревания фолликулов и лютеинизации после стимуляции препаратами гонадотропинов; - При ановуляторном или олигоовуляторном бесплодии для индукции овуляции и лютеинизации в конце стимуляции роста фолликулов.
Противопоказания
Опухоли в области гипоталамуса и гипофиза; - Объемные новообразования яичника или кисты, не связанные с поликистозом яичника; - Вагинальные кровотечения неясного генеза; - Рак яичника, матки или молочной железы; - Внематочная беременность в течение 3 предыдущих месяцев; - Тромбоэмболия; - Первичная овариальная недостаточность; - Врожденные пороки развития половых органов, несовместимые с беременностью; - Фибромиома матки, несовместимая с беременностью; - Постменопауза; - Повышенная чувствительность к компонентам препарата. С осторожностью следует назначать Овитрель пациенткам с серьезными системными заболеваниями в тех случаях, когда беременность может привести к их обострению.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан при беременности и в период кормления грудью.
Способ применения и дозы
Препарат вводят п/к. Каждый шприц предназначены только для однократного использования. При применении в протоколе индукции множественного созревания фолликулов для вспомогательных репродуктивных технологий (в т.ч. для экстракорпорального оплодотворения) с целью индукции финального созревания фолликулов и лютеинизации после стимуляции препаратами гонадотропинов Овитрель в дозе 250 мкг (содержимое 1 шприца) вводят однократно через 24-48 ч после последнего введения препарата ФСГ или ЛГ и достижения оптимального уровня развития фолликула. При ановуляторном или олигоовуляторном бесплодии для индукции овуляции и лютеинизации в конце стимуляции роста фолликулов Овитрель в дозе 250 мкг (содержимое 1 шприца) вводится однократно через 24-48 ч после достижения оптимального уровня развития фолликула. Рекомендуется половой контакт в день введения препарата и на следующий день. Правила введения препаратаПри самостоятельном применении препарата пациенты должны внимательно изучить инструкцию.1. Инъекцию следует проводить с соблюдением правил асептики и антисептики.2. Для проведения инъекции необходимо разложить на чистой поверхности 2 пропитанных спиртом тампона, предварительно заполненный шприц или готовый к применению шприц.3. Далее следует сразу же провести инъекцию (в область живота или переднюю часть бедра). Для этого следует протереть выбранный по рекомендации врача участок тампоном со спиртом. Сильно стянуть кожу пальцами и, направив иглу под углом 45-90° в кожную складку, сделать п/к инъекцию. Необходимо избегать попадания препарата в вену. Препарат вводят медленно, осторожно нажимая на поршень, необходимо ввести весь объем раствора. После извлечения иглы протереть круговыми движениями место инъекции тампоном со спиртом.4. Сразу после инъекции следует поместить использованный шприц в контейнер для хранения острых предметов. Весь неиспользованный объем следует уничтожить. В случае введения повышенной дозы препарата или пропуска инъекции пациентка должна проконсультироваться с врачом.
Побочное действие
Со стороны пищеварительной системы: часто (больше 1/100, меньше 1/10) - тошнота, рвота, боль в животе; редко (больше 1/1000, меньше 1/100) - диарея. Со стороны половой системы: часто (больше 1/100, меньше 1/10) - синдром гиперстимуляции яичников (СГЯ); редко (больше 1/1000, меньше 1/100) - СГЯ тяжелой степени, болезненность молочных желез. Со стороны ЦНС: часто (больше 1/100, меньше 1/10) - головная боль; редко (больше 1/1000, меньше 1/100) - депрессия, раздражительность, беспокойство, утомляемость. Дерматологические реакции: очень редко (больше 1/10 000) - обратимая легкая кожная сыпь. Местные реакции: часто (больше 1/100, меньше 1/10) - боль и гиперемия в месте инъекции. Прочие: часто (больше 1/100, меньше 1/10) - чувство усталости; очень редко (больше 1/10 000) - аллергические реакции в легкой форме.
Передозировка
Данные о передозировке препарата отсутствуют. Симптомы: возможно развитие синдрома гиперстимуляции яичников, характеризующегося образованием крупных кист яичника с риском их разрыва (перфорации), развитием асцита и расстройств кровообращения. Лечение: при высоком риске развития СГЯ рекомендуется отменить введение чХГ. Пациенткам в течение не менее 4 дней рекомендуется воздержаться от полового контакта или использовать барьерные методы контрацепции.
Особые указания
Перед началом лечения необходимо установить причины бесплодия у пациентки и ее партнера и оценить предполагаемые факторы риска при наступлении беременности. Следует учитывать наличие клинически выраженного гипотиреоза, надпочечниковой недостаточности, гиперпролактинемии, наличие опухолей гипофиза и гипоталамуса, применяемые специфические методы терапии. В процессе стимуляции яичников пациентки подвергаются риску развития СГЯ из-за одновременного созревания большого числа фолликулов. В ходе клинических исследований СГЯ (в большинстве случаев легкой и средней степени) был отмечен приблизительно у 4% пациенток. СГЯ тяжелой степени может стать серьезным осложнением стимуляции. В редких случаях осложнением тяжелого СГЯ может быть гемоперитонеум, острый респираторный дистресс-синдром, перекрут яичника и тромбоэмболия. С целью снижения риска СГЯ в протоколе стимуляции роста фолликулов рекомендуется тщательное наблюдение за ответной реакцией яичников при помощи УЗИ и определение уровня эстрадиола в крови перед началом курса лечения и во время него. По сравнению с естественным оплодотворением при проведении стимуляции возрастает риск многоплодной беременности. В большинстве случаев рождаются двойни. При применении методов вспомогательной репродукции количество родившихся младенцев соответствует числу эмбрионов, перенесенных в полость матки. Статистика выкидышей после лечения ановуляторного бесплодия (в т.ч. с помощью вспомогательных репродуктивных технологий) превышает показатели в среднем по популяции, но сравнима с другими видами бесплодия. Введение Овитреля может влиять на иммунологическую картину уровня чХГ в сыворотке крови и в моче в течение 10 дней и привести к появлению ложноположительной реакции при проведении теста на беременность. Во время проведения терапии препаратом Овитрель возможна незначительная стимуляция функции щитовидной железы. Пациентов следует предупредить о необходимости сообщать врачу об усилении побочных эффектов или о побочных эффектах, не описанных выше. В пределах срока годности допускается хранение препарата вне холодильника при температуре не выше 25°С в течение 30 дней. Препарат следует уничтожить, если он в течение этого периода не использован. Влияние на способность к вождению автотранспорта и управлению механизмамиОвитрель не влияет на способность к вождению автотранспорта и работе с механизмами.
Форма выпуска
Раствор.
Условия хранения
В оригинальной упаковке при температуре не выше 25°С. Хранить в недоступном для детей месте. Список Б.
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Вспомогательные вещества: маннитол, метионин, полоксамер 188, фосфорная кислота, натрия гидроксид, вода д/и."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рекомбинантный хориогонадотропин альфа, который имеет ту же аминокислотную последовательность, что и естественный человеческий хорионический гонадотропин. Связывает трансмембранные рецепторы ЛГ на поверхности клеток теки и гранулезы яичника. Вызывает инициирование ооцитарного мейоза, разрыв фолликулов (овуляцию), формирование желтого тела, продукцию прогестерона и эстрадиола желтым телом."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["В протоколе индукции множественного созревания фолликулов (суперовуляция) для вспомогательных репродуктивных технологий (в т.ч. для экстракорпорального оплодотворения) с целью индукции финального созревания фолликулов и лютеинизации после стимуляции препаратами гонадотропинов; - При ановуляторном или олигоовуляторном бесплодии для индукции овуляции и лютеинизации в конце стимуляции роста фолликулов."]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Опухоли в области гипоталамуса и гипофиза; - Объемные новообразования яичника или кисты, не связанные с поликистозом яичника; - Вагинальные кровотечения неясного генеза; - Рак яичника, матки или молочной железы; - Внематочная беременность в течение 3 предыдущих месяцев; - Тромбоэмболия; - Первичная овариальная недостаточность; - Врожденные пороки развития половых органов, несовместимые с беременностью; - Фибромиома матки, несовместимая с беременностью; - Постменопауза; - Повышенная чувствительность к компонентам препарата. С осторожностью следует назначать Овитрель пациенткам с серьезными системными заболеваниями в тех случаях, когда беременность может привести к их обострению."]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат противопоказан при беременности и в период кормления грудью."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат вводят п/к. Каждый шприц предназначены только для однократного использования. При применении в протоколе индукции множественного созревания фолликулов для вспомогательных репродуктивных технологий (в т.ч. для экстракорпорального оплодотворения) с целью индукции финального созревания фолликулов и лютеинизации после стимуляции препаратами гонадотропинов Овитрель в дозе 250 мкг (содержимое 1 шприца) вводят однократно через 24-48 ч после последнего введения препарата ФСГ или ЛГ и достижения оптимального уровня развития фолликула. При ановуляторном или олигоовуляторном бесплодии для индукции овуляции и лютеинизации в конце стимуляции роста фолликулов Овитрель в дозе 250 мкг (содержимое 1 шприца) вводится однократно через 24-48 ч после достижения оптимального уровня развития фолликула. Рекомендуется половой контакт в день введения препарата и на следующий день. Правила введения препаратаПри самостоятельном применении препарата пациенты должны внимательно изучить инструкцию.1. Инъекцию следует проводить с соблюдением правил асептики и антисептики.2. Для проведения инъекции необходимо разложить на чистой поверхности 2 пропитанных спиртом тампона, предварительно заполненный шприц или готовый к применению шприц.3. Далее следует сразу же провести инъекцию (в область живота или переднюю часть бедра). Для этого следует протереть выбранный по рекомендации врача участок тампоном со спиртом. Сильно стянуть кожу пальцами и, направив иглу под углом 45-90° в кожную складку, сделать п/к инъекцию. Необходимо избегать попадания препарата в вену. Препарат вводят медленно, осторожно нажимая на поршень, необходимо ввести весь объем раствора. После извлечения иглы протереть круговыми движениями место инъекции тампоном со спиртом.4. Сразу после инъекции следует поместить использованный шприц в контейнер для хранения острых предметов. Весь неиспользованный объем следует уничтожить. В случае введения повышенной дозы препарата или пропуска инъекции пациентка должна проконсультироваться с врачом."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто (больше 1/100, меньше 1/10) - тошнота, рвота, боль в животе; редко (больше 1/1000, меньше 1/100) - диарея. Со стороны половой системы: часто (больше 1/100, меньше 1/10) - синдром гиперстимуляции яичников (СГЯ); редко (больше 1/1000, меньше 1/100) - СГЯ тяжелой степени, болезненность молочных желез. Со стороны ЦНС: часто (больше 1/100, меньше 1/10) - головная боль; редко (больше 1/1000, меньше 1/100) - депрессия, раздражительность, беспокойство, утомляемость. Дерматологические реакции: очень редко (больше 1/10 000) - обратимая легкая кожная сыпь. Местные реакции: часто (больше 1/100, меньше 1/10) - боль и гиперемия в месте инъекции. Прочие: часто (больше 1/100, меньше 1/10) - чувство усталости; очень редко (больше 1/10 000) - аллергические реакции в легкой форме."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные о передозировке препарата отсутствуют. Симптомы: возможно развитие синдрома гиперстимуляции яичников, характеризующегося образованием крупных кист яичника с риском их разрыва (перфорации), развитием асцита и расстройств кровообращения. Лечение: при высоком риске развития СГЯ рекомендуется отменить введение чХГ. Пациенткам в течение не менее 4 дней рекомендуется воздержаться от полового контакта или использовать барьерные методы контрацепции."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Перед началом лечения необходимо установить причины бесплодия у пациентки и ее партнера и оценить предполагаемые факторы риска при наступлении беременности. Следует учитывать наличие клинически выраженного гипотиреоза, надпочечниковой недостаточности, гиперпролактинемии, наличие опухолей гипофиза и гипоталамуса, применяемые специфические методы терапии. В процессе стимуляции яичников пациентки подвергаются риску развития СГЯ из-за одновременного созревания большого числа фолликулов. В ходе клинических исследований СГЯ (в большинстве случаев легкой и средней степени) был отмечен приблизительно у 4% пациенток. СГЯ тяжелой степени может стать серьезным осложнением стимуляции. В редких случаях осложнением тяжелого СГЯ может быть гемоперитонеум, острый респираторный дистресс-синдром, перекрут яичника и тромбоэмболия. С целью снижения риска СГЯ в протоколе стимуляции роста фолликулов рекомендуется тщательное наблюдение за ответной реакцией яичников при помощи УЗИ и определение уровня эстрадиола в крови перед началом курса лечения и во время него. По сравнению с естественным оплодотворением при проведении стимуляции возрастает риск многоплодной беременности. В большинстве случаев рождаются двойни. При применении методов вспомогательной репродукции количество родившихся младенцев соответствует числу эмбрионов, перенесенных в полость матки. Статистика выкидышей после лечения ановуляторного бесплодия (в т.ч. с помощью вспомогательных репродуктивных технологий) превышает показатели в среднем по популяции, но сравнима с другими видами бесплодия. Введение Овитреля может влиять на иммунологическую картину уровня чХГ в сыворотке крови и в моче в течение 10 дней и привести к появлению ложноположительной реакции при проведении теста на беременность. Во время проведения терапии препаратом Овитрель возможна незначительная стимуляция функции щитовидной железы. Пациентов следует предупредить о необходимости сообщать врачу об усилении побочных эффектов или о побочных эффектах, не описанных выше. В пределах срока годности допускается хранение препарата вне холодильника при температуре не выше 25°С в течение 30 дней. Препарат следует уничтожить, если он в течение этого периода не использован. Влияние на способность к вождению автотранспорта и управлению механизмамиОвитрель не влияет на способность к вождению автотранспорта и работе с механизмами."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В оригинальной упаковке при температуре не выше 25°С. Хранить в недоступном для детей месте. 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