Раствор для подкожного введения Гонал-Ф - рекомбинантный фолликулостимулирующий гормон человека (р-чФСГ), стимулирующий рост и развитие фолликулов. Препарат получают методом генной инженерии на культуре клеток яичников китайского хомячка. Оказывает гонадотропное действие: стимулирует рост и созревание фолликула/фолликулов, способствует развитию нескольких фолликулов при проведении контролируемой овариальной гиперстимуляции для программ вспомогательных репродуктивных технологий. Препарат для удобства введения заполняется в шприц-ручку, в комплекте с ней 20 игл.
Фармакологические свойства
Рекомбинантный фолликулостимулирующий гормон человека (р-чФСГ), стимулирующий рост и развитие фолликулов. Препарат получают методом генной инженерии на культуре клеток яичников китайского хомячка. Оказывает гонадотропное действие: стимулирует рост и созревание фолликула/фолликулов, способствует развитию нескольких фолликулов при проведении контролируемой овариальной гиперстимуляции для программ вспомогательных репродуктивных технологий (ВРТ). Сравнительные клинические исследования р-чФСГ (фоллитропин альфа) и у-ФСГ (уринарного фолликулостимулирующего гормона) для ВРТ и индукции овуляции продемонстрировали большую эффективность Гонал-ф; для инициации созревания фолликулов по таким показателям как снижение кумулятивной дозы, так и продолжительности лечения, по сравнению с у-ФСГ и, таким образом, снижение риска нежелательной гиперстимуляции яичников. Для ВРТ назначение Гонал-ф; в меньшей суммарной дозе при более короткой продолжительности лечения приводит к получению большего количества извлеченных ооцитов по сравнению с у-ФСГ. Было показано также, что у женщин с подавленной секрецией эндогенных гонадотропинов, фоллитропин альфа эффективно стимулирует развитие фолликулов и стероидогенез, несмотря на недоступный для измерения малый уровень лютеинизирующего гормона (ЛГ).
Показания к применению
У женщин:
Ановуляция (включая синдром поликистозных яичников) у женщин в случае неэффективности терапии кломифеном,
Контролируемая овариальная гиперстимуляция в программах вспомогательных репродуктивных технологий,
Овариальная стимуляция у женщин с тяжелым дефицитом ФСГ и ЛГ (в комбинации с препаратом ЛГ). У мужчин:
Стимуляция сперматогенеза при гипогонадотропном гипогонадизме (в комбинации с хорионическим гонадотропином)
Противопоказания
Гипоталамо-гипофизарные опухоли
Повышенная чувствительность к компонентам препарата. У женщин:
Беременность
Объемные новообразования или кисты яичников (не обусловленные синдромом поликистоза яичников)
Маточные кровотечения неясной этиологии
Рак яичника
Рак матки
Рак молочной железы. Препарат не следует назначать в случаях, когда положительный эффект не может быть получен: У женщин:
Аномалии развития половых органов и фибромиоме матки, не совместимые с беременностью
Первичная овариальная недостаточность
Преждевременная менопауза. У мужчин:
Первичная тестикулярная недостаточность
Применение при беременности и в период грудного вскармливания
Препарат не назначают при беременности и в период грудного вскармливания.
Способ применения и дозы
Лечение препаратом Гонал-ф следует начинать под контролем врача-специалиста, имеющего опыт лечения бесплодия. Препарат Гонал-ф предназначен для п/к введения. Первую инъекцию Гонал-ф следует проводить под контролем лечащего врача или квалифицированного медицинского персонала. Самостоятельное введение Гонал-ф могут осуществлять только пациенты хорошо мотивированные, обученные и имеющие возможность получить советы специалиста. Рекомендуется ежедневно менять место инъекции. Более подробную информацию смотрите в инструкции.
Побочное действие
При применении Гонал-ф возможно развитие побочных эффектов, частота появления которых определяется следующим образом: очень часто (≥1/10), часто (≥1/100, <1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000, включая единичные сообщения). Частота побочных эффектов в каждой группе указана в порядке убывания. Применение у женщинСо стороны иммунной системы: очень редко - от легкой до средней тяжести системные аллергические реакции (например, покраснение кожи, сыпь, отечность лица, крапивница, затрудненное дыхание), тяжелые аллергические реакции (в т.ч. анафилактические реакции и шок). Со стороны ЦНС: очень часто - головная боль. Со стороны сердечно-сосудистой системы: очень редко - тромбоэмболия, обычно связанная с тяжелой формой синдрома гиперстимуляции яичников (СГЯ). Со стороны дыхательной системы: очень редко - у пациентов с бронхиальной астмой ухудшение течения или обострение заболевания. Со стороны пищеварительной системы: часто - боли в животе, тяжесть, дискомфорт в животе, тошнота, рвота, диарея. Со стороны репродуктивной системы и молочных желез: очень часто - кисты яичников, часто - (СГЯ легкой или средней степени тяжести( включая соответствующую симптоматику), нечасто - тяжелая форма СГЯ (включая соответствующую симптоматику), редко - осложнение СГЯ (см. "Особые указания"), эктопическая беременность (у женщин, имеющих в анамнезе заболевания маточных труб), многоплодная беременность. Местные реакции: очень часто - реакции легкой/средней степени выраженности в месте инъекции (боль, покраснение, кровоподтеки, отек). Применение у мужчинСо стороны иммунной системы: очень редко - от легких до средней тяжести системные аллергические реакции (например, покраснение кожи, сыпь, отечность лица, крапивница, затрудненное дыхание), тяжелые аллергические реакции (в т.ч. анафилактические реакции и шок). Со стороны дыхательной системы: очень редко - у пациентов с бронхиальной астмой ухудшение течения или обострение заболевания. Местные реакции: очень часто - реакции легкой/средней степени выраженности в месте инъекции (боль, покраснение, кровоподтеки, отек). Со стороны кожи и подкожной клетчатки: часто - появление угрей (акне). Со стороны репродуктивной системы и молочных желез: часто - гинекомастия, варикоцеле. Прочие: часто - увеличение массы тела. При появлении серьезных побочных эффектов или эффектов, не описанных выше, необходимо сообщить об этом лечащему врачу.
Передозировка
В настоящее время о случаях передозировки препарата Гонал-ф не сообщалось. При применении препарата в чрезмерных дозах, по-видимому, следует ожидать развития СГЯ.
Особые указания
Противопоказания:— гипоталамо-гипофизарные опухоли,— повышенная чувствительность к компонентам препарата. У женщин:— беременность,— объемные новообразования или кисты яичников (не обусловленные синдромом поликистоза яичников),— маточные кровотечения неясной этиологии,— рак яичника,— рак матки,— рак молочной железы. Препарат не следует назначать в случаях, когда положительный эффект не может быть получен: У женщин:— аномалии развития половых органов и фибромиоме матки, не совместимые с беременностью,— первичная овариальная недостаточность,— преждевременная менопауза. У мужчин:— первичная тестикулярная недостаточность.
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Вспомогательные вещества: полоксамер 188 - 0.15 мг, сахароза - 90 мг, метионин - 0.15 мг, натрия дигидрофосфата моногидрат - 0.675 мг, натрия гидрофосфата дигидрат - 1.665 мг, м-крезол - 4.5 мг, фосфорная кислота - q.s., натрия гидроксид - q.s., вода д/и - до 1.5 г."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Раствор для подкожного введения Гонал-Ф - рекомбинантный фолликулостимулирующий гормон человека (р-чФСГ), стимулирующий рост и развитие фолликулов. Препарат получают методом генной инженерии на культуре клеток яичников китайского хомячка. Оказывает гонадотропное действие: стимулирует рост и созревание фолликула/фолликулов, способствует развитию нескольких фолликулов при проведении контролируемой овариальной гиперстимуляции для программ вспомогательных репродуктивных технологий. Препарат для удобства введения заполняется в шприц-ручку, в комплекте с ней 20 игл."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рекомбинантный фолликулостимулирующий гормон человека (р-чФСГ), стимулирующий рост и развитие фолликулов. Препарат получают методом генной инженерии на культуре клеток яичников китайского хомячка. Оказывает гонадотропное действие: стимулирует рост и созревание фолликула/фолликулов, способствует развитию нескольких фолликулов при проведении контролируемой овариальной гиперстимуляции для программ вспомогательных репродуктивных технологий (ВРТ). Сравнительные клинические исследования р-чФСГ (фоллитропин альфа) и у-ФСГ (уринарного фолликулостимулирующего гормона) для ВРТ и индукции овуляции продемонстрировали большую эффективность Гонал-ф; для инициации созревания фолликулов по таким показателям как снижение кумулятивной дозы, так и продолжительности лечения, по сравнению с у-ФСГ и, таким образом, снижение риска нежелательной гиперстимуляции яичников. Для ВРТ назначение Гонал-ф; в меньшей суммарной дозе при более короткой продолжительности лечения приводит к получению большего количества извлеченных ооцитов по сравнению с у-ФСГ. Было показано также, что у женщин с подавленной секрецией эндогенных гонадотропинов, фоллитропин альфа эффективно стимулирует развитие фолликулов и стероидогенез, несмотря на недоступный для измерения малый уровень лютеинизирующего гормона (ЛГ)."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"У женщин:"}},{"type":"list","data":{"style":"unordered","items":["Ановуляция (включая синдром поликистозных яичников) у женщин в случае неэффективности терапии кломифеном,","Контролируемая овариальная гиперстимуляция в программах вспомогательных репродуктивных технологий,","Овариальная стимуляция у женщин с тяжелым дефицитом ФСГ и ЛГ (в комбинации с препаратом ЛГ). У мужчин:","Стимуляция сперматогенеза при гипогонадотропном гипогонадизме (в комбинации с хорионическим гонадотропином)"]}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Гипоталамо-гипофизарные опухоли","Повышенная чувствительность к компонентам препарата. У женщин:","Беременность","Объемные новообразования или кисты яичников (не обусловленные синдромом поликистоза яичников)","Маточные кровотечения неясной этиологии","Рак яичника","Рак матки","Рак молочной железы. Препарат не следует назначать в случаях, когда положительный эффект не может быть получен: У женщин:","Аномалии развития половых органов и фибромиоме матки, не совместимые с беременностью","Первичная овариальная недостаточность","Преждевременная менопауза. У мужчин:","Первичная тестикулярная недостаточность"]}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат не назначают при беременности и в период грудного вскармливания."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение препаратом Гонал-ф следует начинать под контролем врача-специалиста, имеющего опыт лечения бесплодия. Препарат Гонал-ф предназначен для п/к введения. Первую инъекцию Гонал-ф следует проводить под контролем лечащего врача или квалифицированного медицинского персонала. Самостоятельное введение Гонал-ф могут осуществлять только пациенты хорошо мотивированные, обученные и имеющие возможность получить советы специалиста. Рекомендуется ежедневно менять место инъекции. Более подробную информацию смотрите в инструкции."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении Гонал-ф возможно развитие побочных эффектов, частота появления которых определяется следующим образом: очень часто (≥1/10), часто (≥1/100, \u003c1/10), нечасто (≥1/1000, \u003c1/100), редко (≥1/10 000, \u003c1/1000), очень редко (\u003c1/10 000, включая единичные сообщения). Частота побочных эффектов в каждой группе указана в порядке убывания. Применение у женщинСо стороны иммунной системы: очень редко - от легкой до средней тяжести системные аллергические реакции (например, покраснение кожи, сыпь, отечность лица, крапивница, затрудненное дыхание), тяжелые аллергические реакции (в т.ч. анафилактические реакции и шок). Со стороны ЦНС: очень часто - головная боль. Со стороны сердечно-сосудистой системы: очень редко - тромбоэмболия, обычно связанная с тяжелой формой синдрома гиперстимуляции яичников (СГЯ). Со стороны дыхательной системы: очень редко - у пациентов с бронхиальной астмой ухудшение течения или обострение заболевания. Со стороны пищеварительной системы: часто - боли в животе, тяжесть, дискомфорт в животе, тошнота, рвота, диарея. Со стороны репродуктивной системы и молочных желез: очень часто - кисты яичников, часто - (СГЯ легкой или средней степени тяжести( включая соответствующую симптоматику), нечасто - тяжелая форма СГЯ (включая соответствующую симптоматику), редко - осложнение СГЯ (см. \"Особые указания\"), эктопическая беременность (у женщин, имеющих в анамнезе заболевания маточных труб), многоплодная беременность. Местные реакции: очень часто - реакции легкой/средней степени выраженности в месте инъекции (боль, покраснение, кровоподтеки, отек). Применение у мужчинСо стороны иммунной системы: очень редко - от легких до средней тяжести системные аллергические реакции (например, покраснение кожи, сыпь, отечность лица, крапивница, затрудненное дыхание), тяжелые аллергические реакции (в т.ч. анафилактические реакции и шок). Со стороны дыхательной системы: очень редко - у пациентов с бронхиальной астмой ухудшение течения или обострение заболевания. Местные реакции: очень часто - реакции легкой/средней степени выраженности в месте инъекции (боль, покраснение, кровоподтеки, отек). Со стороны кожи и подкожной клетчатки: часто - появление угрей (акне). Со стороны репродуктивной системы и молочных желез: часто - гинекомастия, варикоцеле. Прочие: часто - увеличение массы тела. При появлении серьезных побочных эффектов или эффектов, не описанных выше, необходимо сообщить об этом лечащему врачу."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В настоящее время о случаях передозировки препарата Гонал-ф не сообщалось. При применении препарата в чрезмерных дозах, по-видимому, следует ожидать развития СГЯ."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказания:— гипоталамо-гипофизарные опухоли,— повышенная чувствительность к компонентам препарата. У женщин:— беременность,— объемные новообразования или кисты яичников (не обусловленные синдромом поликистоза яичников),— маточные кровотечения неясной этиологии,— рак яичника,— рак матки,— рак молочной железы. Препарат не следует назначать в случаях, когда положительный эффект не может быть получен: У женщин:— аномалии развития половых органов и фибромиоме матки, не совместимые с беременностью,— первичная овариальная недостаточность,— преждевременная менопауза. У мужчин:— первичная тестикулярная недостаточность."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Рекомбинантный фолликулостимулирующий гормон человека (р-чФСГ), стимулирующий рост и развитие фолликулов. Препарат получают методом генной инженерии на культуре клеток яичников китайского хомячка. Оказывает гонадотропное действие: стимулирует рост и созревание фолликула/фолликулов, способствует развитию нескольких фолликулов при проведении контролируемой овариальной гиперстимуляции для программ вспомогательных репродуктивных технологий (ВРТ). Сравнительные клинические исследования р-чФСГ (фоллитропин альфа) и у-ФСГ (уринарного фолликулостимулирующего гормона) для ВРТ и индукции овуляции продемонстрировали большую эффективность Гонал-ф; для инициации созревания фолликулов по таким показателям как снижение кумулятивной дозы, так и продолжительности лечения, по сравнению с у-ФСГ и, таким образом, снижение риска нежелательной гиперстимуляции яичников. Для ВРТ назначение Гонал-ф; в меньшей суммарной дозе при более короткой продолжительности лечения приводит к получению большего количества извлеченных ооцитов по сравнению с у-ФСГ. 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