У женщин: отсутствие овуляции и в случае неэффективности лечения кломифеном, отсутствие овуляции в результате дефицита ФСГ и ЛГ (в комбинации с ЛГ), для стимуляции суперовуляции (стимуляция роста множественных фолликулов) при использовании технологии вспомогательных методов репродукции. У мужчин: для активизации процесса сперматогенеза при гипогонадотропном ...
Увеличение яичника или киста яичника, не связанные с синдромом поликистоза яичников, гинекологические кровотечения неизвестной этиологии, карцинома яичника, матки или молочной железы, опухоли гипоталамуса или гипофиза, отсутствие овоцитов 1-го порядка, неправильное развитие половых органов, несовместимое с беременностью, фиброма матки, несовместимая ...
Гонал-Ф - это лиофилизат для приготовления раствора для п/к введения в виде белого порошка или белой лиофилизированной массы.
Фармакологические свойства
Гонал-Ф - рекомбинантный фолликулостимулирующий гормон человека, полученный методом генной инженерии на культуре клеток яичников китайского хомячка. Стимулирует рост фолликулов. Оказывает гонадотропное (стимулирует пролиферацию эндометрия, овуляцию у женщин с подавленной эндогенной секрецией гонадотропина) и эстрогенное (стимулирует рост и созревание фолликулов яичников, способствует развитию множественных фолликулов при проведении контролируемой овариальной гиперстимуляции для программ вспомогательных репродуктивных технологий) действие.
Показания к применению
У женщин: отсутствие овуляции и в случае неэффективности лечения кломифеном, отсутствие овуляции в результате дефицита ФСГ и ЛГ (в комбинации с ЛГ), для стимуляции суперовуляции (стимуляция роста множественных фолликулов) при использовании технологии вспомогательных методов репродукции. У мужчин: для активизации процесса сперматогенеза при гипогонадотропном гипогонадизме (в комбинации с ХГ).
Противопоказания
Увеличение яичника или киста яичника, не связанные с синдромом поликистоза яичников, гинекологические кровотечения неизвестной этиологии, карцинома яичника, матки или молочной железы, опухоли гипоталамуса или гипофиза, отсутствие овоцитов 1-го порядка, неправильное развитие половых органов, несовместимое с беременностью, фиброма матки, несовместимая с беременностью, беременность, повышенная чувствительность к компонентам препарата.
Применение при беременности и в период грудного вскармливания
Препарат не назначается при беременности и в период лактации (грудного вскармливания).
Способ применения и дозы
Гонал-Ф предназначен для п/к и в/м введения. При ановуляторном бесплодии пациенткам с сохраненным менструальным циклом лечение начинают в первые 7 дней цикла. Курс терапии проводят под контролем УЗИ (измеряют размеры фолликулов) и/или по концентрации эстрогена в сыворотке крови. Лечение начинают с введения препарата в дозе 75-150 МЕ ежедневно, повышая дозу на 37.5 МЕ (75 МЕ) через 7-14 дней до получения требуемого эффекта. При отсутствии положительной динамики через 5 недель терапию прекращают. После достижения оптимальной реакции через 24-48 ч после последней инъекции Гонала-Ф пациентке вводят однократно 10 000 МЕ чХГ (человеческого хорионического гонадотропина). В день инъекции чХГ и на следующий день пациентке рекомендуется иметь коитус. При развитии эффекта гиперстимуляции лечение следует прекратить и отменить назначение чХГ. В следующем цикле лечение следует возобновить с назначением препарата в более низкой (по сравнению с предыдущим циклом) дозе. При проведении вспомогательных методов репродукции Гонал-Ф назначают ежедневно в дозе 150-225 МЕ, начиная на 2-й и/или 3-й день цикла. Лечение продолжают до достижения адекватного развития фолликулов, что контролируется по концентрации эстрогенов в сыворотке крови и/или с помощью УЗИ. Доза препарата может варьировать, но при ежедневном введении, как правило, не превышает 450 МЕ. После выполнения последней инъекции препарата Гонал-Ф через 24-48 ч назначают однократную инъекцию чХГ в дозе 10 000 МЕ, что индуцирует окончательное созревание фолликулов. Для подавления эндогенного выброса ЛГ и поддержания его на низком уровне обычно используют агонисты гонадотропин-рилизинг фактора. В обычно используемой схеме Гонал-Ф назначают приблизительно через 2 недели после начала лечения агонистом. Курсы обеих препаратов проводятся до достижения адекватного уровня развития фолликулов. Правила приготовления раствора для инъекций Для приготовления раствора для инъекций содержимое ампулы следует растворить в прилагаемом растворителе непосредственно перед употреблением. В 1 мл растворителя можно растворить до 3 ампул, содержащих 75 МЕ или 150 МЕ препарата Гонал-Ф, что позволяет уменьшить объем раствора при инъекции. Приготовленные растворы для инъекций следует использовать ex tempore.
Побочное действие
Со стороны эндокринной и половой системы: внематочная беременность (у женщин, имеющих в анамнезе заболевания фаллопиевых труб), многоплодная беременность. Возможно развитие синдрома гиперстимуляции яичников (легкая форма характеризуются болями в нижней части живота, тошнотой, рвотой, увеличением массы тела, увеличением яичников, появлением кист яичников, тяжелая форма - возникновением больших кист яичников, склонных к разрыву, асцитом, гидротораксом). Местные реакции: боль и гиперемия. Прочие: лихорадка, артралгия, редко - тромбоэмболии, аллергические реакции.
Передозировка
В настоящее время о случаях передозировки препарата Гонал-Ф не сообщалось. Возможно развитие синдрома гиперстимуляции яичников.
Особые указания
До назначения курса лечения следует установить факт наличия супружеского бесплодия и возможные противопоказания к беременности. Необходимо исключить сопутствующие эндокринные заболевания (гипотиреоз, надпочечниковая недостаточность, гиперпролактинемия, опухоль гипоталамуса и гипофиза). При назначении чХГ возрастает вероятность синдрома гиперстимуляции яичников и множественной суперовуляции, что может привести к разрыву яичника. Поэтому при чрезмерном ответе яичников на стимуляцию чХГ не назначают, а пациенткам рекомендуют воздержаться от коитуса не менее 4 дней. Вероятность возникновения синдрома гиперстимуляции яичников у пациенток после стимуляции роста фолликулов можно снизить путем аспирации всех фолликулов перед овуляцией. Степень риска многоплодной беременности при применении вспомогательных репродуктивных технологий зависит от числа перенесенных эмбрионов, при этом в большинстве случаев наблюдаются двойни. У мужчин повышенный уровень ФСГ в крови указывает на повреждение семенников. В этом случае лечение Гоналом-Ф не эффективно. Поэтому через 4-6 мес после начала курса терапии следует сделать анализ спермы. В случае назначения Гонала-Ф с лутропином альфа их можно смешивать в одном шприце. Влияние на способность к вождению автотранспорта и управлению механизмами: Гонал-Ф не влияет на способность к вождению автотранспорта и управлению другими механизмами.
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При проведении вспомогательных методов репродукции Гонал-Ф назначают ежедневно в дозе 150-225 МЕ, начиная на 2-й и/или 3-й день цикла. Лечение продолжают до достижения адекватного развития фолликулов, что контролируется по концентрации эстрогенов в сыворотке крови и/или с помощью УЗИ. Доза препарата может варьировать, но при ежедневном введении, как правило, не превышает 450 МЕ. После выполнения последней инъекции препарата Гонал-Ф через 24-48 ч назначают однократную инъекцию чХГ в дозе 10 000 МЕ, что индуцирует окончательное созревание фолликулов. Для подавления эндогенного выброса ЛГ и поддержания его на низком уровне обычно используют агонисты гонадотропин-рилизинг фактора. В обычно используемой схеме Гонал-Ф назначают приблизительно через 2 недели после начала лечения агонистом. Курсы обеих препаратов проводятся до достижения адекватного уровня развития фолликулов. Правила приготовления раствора для инъекций Для приготовления раствора для инъекций содержимое ампулы следует растворить в прилагаемом растворителе непосредственно перед употреблением. В 1 мл растворителя можно растворить до 3 ампул, содержащих 75 МЕ или 150 МЕ препарата Гонал-Ф, что позволяет уменьшить объем раствора при инъекции. Приготовленные растворы для инъекций следует использовать ex tempore."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны эндокринной и половой системы: внематочная беременность (у женщин, имеющих в анамнезе заболевания фаллопиевых труб), многоплодная беременность. Возможно развитие синдрома гиперстимуляции яичников (легкая форма характеризуются болями в нижней части живота, тошнотой, рвотой, увеличением массы тела, увеличением яичников, появлением кист яичников, тяжелая форма - возникновением больших кист яичников, склонных к разрыву, асцитом, гидротораксом). 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