Экстренная (посткоитальная) контрацепция в течение 72 часов (после незащищенного полового контакта или ненадежности используемого метода контрацепции).
Противопоказания
Повышенная чувствительность к левоноргестрелу или любому другому компоненту препарата; детский возраст до 16 лет; тяжелая печеночная недостаточность; беременность; непереносимость лактозы дефицит лактазы или глюкозо-галактозная мальабсорбция.
Круглые двояковыпуклые таблетки белого цвета с гравировкой "С" на одной стороне и "1" на другой стороне.
Фармакотерапевтическая группа
Гестаген
Фармакологические свойства
Фармакодинамика:
Левоноргестрел - синтетический гестаген. оказывающий контрацептивное действие. Применяется в качестве средства экстренной контрацепции благодаря выраженному гестагенному и антиэстрогенному эффектам. При рекомендуемом режиме дозирования левоноргестрел подавляет овуляцию и оплодотворение если половой контакт произошел в предовуляционную фазу менструального цикла. Он может также вызывать изменения в эндометрии которые предотвращают имплантацию оплодотворенной яйцеклетки и увеличивает вязкость секрета шейки матки что препятствует продвижению сперматозоидов. Левоноргестрел неэффективен в случае когда имплантация уже произошла.
При соблюдении рекомендуемого режима дозирования левоноргестрел не оказывает существенного влияния на факторы свертываемости крови обмен жиров и углеводов.
При применении одной таблетки левоноргестрела по 15 мг однократно в течение 72 ч после незащищенного полового акта можно предотвратить ожидаемую беременность в 84% случаев (по сравнению с 79% при применении 2-х таблеток левоноргестрела 075 мг принятых с 12-часовым интервалом).
Фармакокинетика:
Всасывание. При приеме внутрь левоноргестрел быстро и практически полностью всасывается. Абсолютная биодоступность составляет около 100% от принятой дозы. После приема левоноргестрела в дозе 15 мг максимальная концентрация в плазме крови (Сmах) равная 185 нг/мл достигается через 2 часа.
Распределение. Левоноргестрел связывается с альбумином сыворотки крови и с глобулином связывающим половые гормоны (ГСПГ). Лишь 15% поступившей в организм дозы находится в свободной форме а 65% связано с ГСПГ. Проникает в грудное молоко.
Метаболизм. Метаболизм левоноргестрела соответствует метаболизму стероидов. Метаболизируется в печени путем гидроксилирования метаболиты выводятся в форме конъюгированных глюкуронидов. Фармакологически активные метаболиты левоноргестрела неизвестны.
Выведение. Левоноргестрел выводится примерно в равной степени почками и через кишечник исключительно в форме метаболитов. Период полувыведения (Т1/2) составляет около 26 ч.
Показания к применению
Экстренная (посткоитальная) контрацепция в течение 72 часов (после незащищенного полового контакта или ненадежности используемого метода контрацепции).
Противопоказания
Повышенная чувствительность к левоноргестрелу или любому другому компоненту препарата; детский возраст до 16 лет; тяжелая печеночная недостаточность; беременность; непереносимость лактозы дефицит лактазы или глюкозо-галактозная мальабсорбция.
С осторожностью
Заболевания печени и желчевыводящих путей желтуха (в т.ч. в анамнезе) болезнь Крона.
Применение при беременности и в период грудного вскармливания
Препарат МОДЭЛЛЬ 911 противопоказан к применению при беременности. На основании имеющихся данных в случае возникновения беременности при применении экстренного метода контрацепции неблагоприятного эффекта препарата на плод не выявлено.
Левоноргестрел проникает в грудное молоко. После приема препарата грудное вскармливание следует прекратить на 24 часа.
Способ применения и дозы
Одну таблетку необходимо принять внутрь как можно скорее предпочтительно в течение 12 часов но не позднее 72 часов после незащищенного полового акта. Если в течение 3 ч после приема таблетки препарата МОДЭЛЛЬ 911 произошла рвота то следует принять еще одну таблетку препарата МОДЭЛЛЬ 911.
Препарат МОДЭЛЛЬ 911 можно применять в любой день менструального цикла. В случае нерегулярного менструального цикла необходимо предварительно исключить беременность.
После приема экстренного контрацептивного средства до наступления следующей менструации следует применять барьерные методы контрацепции (например презерватив влагалищная диафрагма шеечный колпачок).
Побочное действие
Частота побочных эффектов классифицирована в соответствии с рекомендациями Всемирной организации здравоохранения: очень часто - не менее 10%; часто - не менее 1% но менее 10%; нечасто - не менее 01% но менее 1%; редко - не менее 001% но менее 01%; очень редко (включая единичные случаи) - менее 001%.
Со стороны нервной системы: очень часто - головная боль; часто - головокружение.
Со стороны желудочно-кишечного тракта: очень часто - тошнота боль в эпигастрии; часто - рвота диарея.
Со стороны половых органов и молочной железы: очень часто - ациклические кровянистые выделения (кровотечения) боль внизу живота; часто - болезненность молочных желез задержка менструации более 5-7 дней; очень редко - дисменорея.
Со стороны кожи и подкожных тканей: очень редко - крапивница кожная сыпь зуд кожи отек лица.
Прочие: очень часто - чувство усталости.
Передозировка
Симптомы: тошнота рвота кровотечение "отмены".
Лечение:специфического антидота нет. Проводят симптоматическую терапию.
Взаимодействие с другими лекарственными средствами
При одновременном применении с индукторами микросомальных ферментов печени происходит ускорение метаболизма левоноргестрела.
Следующие препараты могут снизить эффективность левоноргестрела: ампренавир лансопразол невирапин окскарбазепин такролимус топирамат третиноин барбитураты (включая примидон) фенитоин и карбамазепин; препараты содержащие зверобой
продырявленный (Hypericum perforatum); а также рифампицин ритонавир ампициллин тетрациклин рифабутин гризеофульвин.
Левоноргестрел снижает эффективность гипогликемических и антикоагулянтных (производные кумарина фениндион) лекарственных средств. Повышает плазменные концентрации глюкокортикостероидов. Женщинам принимающим эти препараты следует обратиться к врачу за консультацией.
Препараты содержащие левоноргестрел могут повышать риск токсичности циклоспорина вследствие подавления его метаболизма.
Особые указания
Препарат МОДЭЛЛЬ 911 следует применять исключительно для экстренной контрацепции. Эффективность экстренной контрацепции при отсроченном применении препарата МОДЭЛЛЬ 911 снижается.
Препарат не заменяет применение постоянных методов контрацепции.
Повторное применение препарата МОДЭЛЛЬ 911 в течение одного менструального цикла не рекомендуется из-за увеличения частоты ациклических кровянистых выделений/кровотечений.
В большинстве случаев препарат МОДЭЛЛЬ 911 не оказывает влияния на характер менструального цикла. Однако возможно появление ациклических кровянистых выделений и задержка менструации на несколько дней. При задержке менструации более чем на 5-7 дней и изменении ее характера (скудные или обильные выделения) необходимо исключить беременность. Появление болей внизу живота обморочных состояний может свидетельствовать о внематочной (эктопической) беременности.
Применение левоноргестрела не рекомендуется у женщин с высоким риском развития внематочной беременности (с наличием сальпингоофорита или внематочной беременностью в анамнезе).
У детей до 16 лет опыт применения левоноргестрела таблетки 15 мг ограничен. Применение препарата МОДЭЛЛЬ 911 у них возможно только в исключительных случаях (в том числе при изнасиловании) и только после консультации гинеколога. После проведения экстренной контрацепции рекомендована повторная консультация гинеколога. Экстренная контрацепция не защищает от заболеваний передающихся половым путем. При нарушениях функции желудочно-кишечного тракта (например при болезни Крона) возможно снижение эффективности препарата.
Влияние на способность управлять автомобилем и движущимися механизмами
Влияние препарата на способность управлять транспортными средствами и механизмами не исследовалось. В случае развития головокружения при применении препарата МОДЭЛЛЬ 911 следует соблюдать осторожность при выполнении действий требующих повышенной концентрации внимания и быстроты психомоторных реакций.
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свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Левоноргестрел - синтетический гестаген. оказывающий контрацептивное действие. Применяется в качестве средства экстренной контрацепции благодаря выраженному гестагенному и антиэстрогенному эффектам. При рекомендуемом режиме дозирования левоноргестрел подавляет овуляцию и оплодотворение если половой контакт произошел в предовуляционную фазу менструального цикла. Он может также вызывать изменения в эндометрии которые предотвращают имплантацию оплодотворенной яйцеклетки и увеличивает вязкость секрета шейки матки что препятствует продвижению сперматозоидов. Левоноргестрел неэффективен в случае когда имплантация уже произошла."}},{"type":"paragraph","data":{"text":"При соблюдении рекомендуемого режима дозирования левоноргестрел не оказывает существенного влияния на факторы свертываемости крови обмен жиров и углеводов."}},{"type":"paragraph","data":{"text":"При применении одной таблетки левоноргестрела по 15 мг однократно в течение 72 ч после незащищенного полового акта можно предотвратить ожидаемую беременность в 84% случаев (по сравнению с 79% при применении 2-х таблеток левоноргестрела 075 мг принятых с 12-часовым интервалом)."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Всасывание. При приеме внутрь левоноргестрел быстро и практически полностью всасывается. Абсолютная биодоступность составляет около 100% от принятой дозы. После приема левоноргестрела в дозе 15 мг максимальная концентрация в плазме крови (С\u003csub\u003em\u003c/sub\u003e\u003csub\u003eах\u003c/sub\u003e) равная 185 нг/мл достигается через 2 часа."}},{"type":"paragraph","data":{"text":"Распределение. Левоноргестрел связывается с альбумином сыворотки крови и с глобулином связывающим половые гормоны (ГСПГ). Лишь 15% поступившей в организм дозы находится в свободной форме а 65% связано с ГСПГ. Проникает в грудное молоко."}},{"type":"paragraph","data":{"text":"Метаболизм. Метаболизм левоноргестрела соответствует метаболизму стероидов. Метаболизируется в печени путем гидроксилирования метаболиты выводятся в форме конъюгированных глюкуронидов. Фармакологически активные метаболиты левоноргестрела неизвестны."}},{"type":"paragraph","data":{"text":"Выведение. Левоноргестрел выводится примерно в равной степени почками и через кишечник исключительно в форме метаболитов. Период полувыведения (Т1/2) составляет около 26 ч."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Экстренная (посткоитальная) контрацепция в течение 72 часов (после незащищенного полового контакта или ненадежности используемого метода контрацепции)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к левоноргестрелу или любому другому компоненту препарата; детский возраст до 16 лет; тяжелая печеночная недостаточность; беременность; непереносимость лактозы дефицит лактазы или глюкозо-галактозная мальабсорбция."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Заболевания печени и желчевыводящих путей желтуха (в т.ч. в анамнезе) болезнь Крона."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат МОДЭЛЛЬ 911 противопоказан к применению при беременности. На основании имеющихся данных в случае возникновения беременности при применении экстренного метода контрацепции неблагоприятного эффекта препарата на плод не выявлено."}},{"type":"paragraph","data":{"text":"Левоноргестрел проникает в грудное молоко. После приема препарата грудное вскармливание следует прекратить на 24 часа."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Одну таблетку необходимо принять внутрь как можно скорее предпочтительно в течение 12 часов но не позднее 72 часов после незащищенного полового акта. Если в течение 3 ч после приема таблетки препарата МОДЭЛЛЬ 911 произошла рвота то следует принять еще одну таблетку препарата МОДЭЛЛЬ 911."}},{"type":"paragraph","data":{"text":"Препарат МОДЭЛЛЬ 911 можно применять в любой день менструального цикла. В случае нерегулярного менструального цикла необходимо предварительно исключить беременность."}},{"type":"paragraph","data":{"text":"После приема экстренного контрацептивного средства до наступления следующей менструации следует применять барьерные методы контрацепции (например презерватив влагалищная диафрагма шеечный колпачок)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Частота побочных эффектов классифицирована в соответствии с рекомендациями Всемирной организации здравоохранения: очень часто - не менее 10%; часто - не менее 1% но менее 10%; нечасто - не менее 01% но менее 1%; редко - не менее 001% но менее 01%; очень редко (включая единичные случаи) - менее 001%."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: очень часто - головная боль; часто - головокружение."}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта: очень часто - тошнота боль в эпигастрии; часто - рвота диарея."}},{"type":"paragraph","data":{"text":"Со стороны половых органов и молочной железы: очень часто - ациклические кровянистые выделения (кровотечения) боль внизу живота; часто - болезненность молочных желез задержка менструации более 5-7 дней; очень редко - дисменорея."}},{"type":"paragraph","data":{"text":"Со стороны кожи и подкожных тканей: очень редко - крапивница кожная сыпь зуд кожи отек лица."}},{"type":"paragraph","data":{"text":"Прочие: очень часто - чувство усталости."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота рвота кровотечение \"отмены\"."}},{"type":"paragraph","data":{"text":"Лечение:специфического антидота нет. Проводят симптоматическую терапию."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении с индукторами микросомальных ферментов печени происходит ускорение метаболизма левоноргестрела."}},{"type":"paragraph","data":{"text":"Следующие препараты могут снизить эффективность левоноргестрела: ампренавир лансопразол невирапин окскарбазепин такролимус топирамат третиноин барбитураты (включая примидон) фенитоин и карбамазепин; препараты содержащие зверобой"}},{"type":"paragraph","data":{"text":"продырявленный (Hypericum perforatum); а также рифампицин ритонавир ампициллин тетрациклин рифабутин гризеофульвин."}},{"type":"paragraph","data":{"text":"Левоноргестрел снижает эффективность гипогликемических и антикоагулянтных (производные кумарина фениндион) лекарственных средств. Повышает плазменные концентрации глюкокортикостероидов. Женщинам принимающим эти препараты следует обратиться к врачу за консультацией."}},{"type":"paragraph","data":{"text":"Препараты содержащие левоноргестрел могут повышать риск токсичности циклоспорина вследствие подавления его метаболизма."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат МОДЭЛЛЬ 911 следует применять исключительно для экстренной контрацепции. Эффективность экстренной контрацепции при отсроченном применении препарата МОДЭЛЛЬ 911 снижается."}},{"type":"paragraph","data":{"text":"Препарат не заменяет применение постоянных методов контрацепции."}},{"type":"paragraph","data":{"text":"Повторное применение препарата МОДЭЛЛЬ 911 в течение одного менструального цикла не рекомендуется из-за увеличения частоты ациклических кровянистых выделений/кровотечений."}},{"type":"paragraph","data":{"text":"В большинстве случаев препарат МОДЭЛЛЬ 911 не оказывает влияния на характер менструального цикла. Однако возможно появление ациклических кровянистых выделений и задержка менструации на несколько дней. При задержке менструации более чем на 5-7 дней и изменении ее характера (скудные или обильные выделения) необходимо исключить беременность. Появление болей внизу живота обморочных состояний может свидетельствовать о внематочной (эктопической) беременности."}},{"type":"paragraph","data":{"text":"Применение левоноргестрела не рекомендуется у женщин с высоким риском развития внематочной беременности (с наличием сальпингоофорита или внематочной беременностью в анамнезе)."}},{"type":"paragraph","data":{"text":"У детей до 16 лет опыт применения левоноргестрела таблетки 15 мг ограничен. Применение препарата МОДЭЛЛЬ 911 у них возможно только в исключительных случаях (в том числе при изнасиловании) и только после консультации гинеколога. После проведения экстренной контрацепции рекомендована повторная консультация гинеколога. Экстренная контрацепция не защищает от заболеваний передающихся половым путем. При нарушениях функции желудочно-кишечного тракта (например при болезни Крона) возможно снижение эффективности препарата."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Влияние препарата на способность управлять транспортными средствами и механизмами не исследовалось. В случае развития головокружения при применении препарата МОДЭЛЛЬ 911 следует соблюдать осторожность при выполнении действий требующих повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки 15 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25°С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Лабораториос Леон Фарма С.А., C/La Vallina s/n, Poligono Industrial Navatejera, 24008 Villaquilambre (Leon), Spain, Испания"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Тева Фармацевтические Предприятия Лтд"}}]}],"source":null},"description_toggle":false,"short_description":"Левоноргестрел - синтетический гестаген. оказывающий контрацептивное действие. Применяется в качестве средства экстренной контрацепции благодаря выраженному гестагенному и антиэстрогенному эффектам. При рекомендуемом режиме дозирования левоноргестрел подавляет овуляцию и оплодотворение если половой контакт произошел в предовуляционную фазу менструального цикла. 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