Рекомбинантный фолликулостимулирующий гормон человека. препа... Инструкция
Показания к применению
Овариальная стимуляция при отсутствии роста и созревания фолликулов и в случае неэффективности терапии кломифеном; контролируемая овариальная гиперстимуляция в программах вспомогательных репродуктивных технологий; овариальная стимуляция при гипогонадотропных состояниях у женщин; стимуляция сперматогенеза при гипогонадотропном гипогонадизме у мужчин....
Рекомбинантный фолликулостимулирующий гормон человека. 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.
Показания к применению
Овариальная стимуляция при отсутствии роста и созревания фолликулов и в случае неэффективности терапии кломифеном; контролируемая овариальная гиперстимуляция в программах вспомогательных репродуктивных технологий; овариальная стимуляция при гипогонадотропных состояниях у женщин; стимуляция сперматогенеза при гипогонадотропном гипогонадизме у мужчин.
Противопоказания
Опухоли гипоталамуса или гипофиза; повышенная чувствительность к компонентам препарата; беременность; объемные новообразования или кисты яичников; маточные кровотечения неясной этиологии; карцинома яичника; рак матки; рак молочных желез; аномалии развития половых органов и фибромиоме матки, не совместимые с беременностью; первичная овариальная недостаточность; преждевременная менопауза; первичная тестикулярная недостаточность.
Применение при беременности и в период грудного вскармливания
Препарат не назначается при беременности и в период лактации (грудного вскармливания).
Способ применения и дозы
1. Инъекцию следует проводить с соблюдением правил асептики и антисептики.2. Для проведения инъекции необходимо разложить на чистой поверхности 2 пропитанных спиртом тампона; одну иглу для приготовления раствора и иглу для п/к введения; контейнер для утилизации.3. Приготовление раствора для инъекции: снять защелкивающуюся крышку с флакона и защитный колпачок с иглы шприца. Ввести иглу шприца с растворителем во флакон, проткнув резиновую крышку флакона; медленно впрыснуть все содержимое шприца во флакон. Для лучшего растворения следует вращать флакон, но не трясите его.4. После растворения лиофилизата, проверить прозрачность раствора, не содержит ли он каких-либо частиц. Перевернуть флакон дном кверху и набрать раствор обратно в шприц. Удалить иглу шприца из флакона. Если назначена доза, содержащаяся в нескольких флаконах, то следует медленно впрыснуть содержимое шприца в следующий флакон. Повторить операцию как описано выше до тех пор, пока не будет получена нужная доза. Если назначен лутропин альфа, можно смешать два препарата в одном шприце. Приготовить раствор лутропина альфа, набрать его в шприц, ввести раствор во флакон с препаратом Гонал-ф, растворить препарат и набрать раствор обратно в шприц. В 1 мл растворителя можно растворить до 3 флаконов.5. Сменить иглу на иглу для п/к введения. При наличии пузырьков воздуха в шприце, следует повернуть его иглой вверх и постучать осторожно по шприцу, чтобы все пузырьки собрались в верхней части шприца. Нажимать на поршень до тех пор, пока все пузырьки не исчезнут.6. Немедленно ввести раствор. Лечащий врач или медсестра должны заранее посоветовать пациенту, в какое место следует делать инъекцию - в живот или в бедро. Про проведении п/к инъекции следует сжать кожу и резко ввести иглу под углом 45° или 90°. При инъекции следует нажимать на поршень осторожно, пока не будет введена вся доза. После этого следует немедленно вынуть иглу и круговыми движениями протереть место инъекции спиртовым тампоном. Не вводить в/в.7. Сразу после окончания инъекции следует выбросить использованные шприцы (лучше в отдельный контейнер) и остатки раствора препарата.
Побочное действие
Кисты яичников; синдром гиперстимуляции яичников (СГЯ) легкой или средней степени тяжести; тяжелая форма СГЯ, перекрут кисты яичника , апоплексия яичника, внематочная беременность, многоплодная беременность, головная боль, боли в животе, тошнота, рвота, диарея, колика, отрыжка, повышение свертываемости крови (тромбоэмболия), легочная эмболия, ишемический инсульт, инфаркт миокарда, слабо выраженные покраснение кожи, сыпь, отечность лица, крапивница, затрудненное дыхание, тяжелые аллергические реакции (в т.ч. анафилаксия), реакции легкой/средней степени выраженности в месте инъекции (боль, покраснение, кровоподтеки, отек), лихорадка, артралгия, острая легочная недостаточность, угри (акне), гинекомастия, варикоцеле, , увеличение массы тела.
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
Гонал-ф способен вызывать различные побочные реакции, поэтому его должны назначать только врачи-специалисты, непосредственно занимающиеся проблемами бесплодия. Перед началом терапии требуется обследование бесплодной пары, в частности, проведение исследований для исключения гипотиреоза, недостаточности коры надпочечников, гиперпролактинемии, гипоталамо-гипофизарных новообразований; при необходимости - назначают соответствующую терапию. Необходимо оценить проходимость фаллопиевых труб с целью выбора метода вспомогательных репродуктивных технологий. Следует исключить непроходимость фаллопиевых труб, если пациентка не участвует в программе экстракорпорального оплодотворения. У больных порфирией, а также при наличии порфирии у родственников, во время терапии препаратом Гонал-ф требуется проведение тщательного мониторинга. При ухудшении состояния или появлении первых признаков этого заболевания может потребоваться прекращение терапии. При лечении препаратом Гонал-ф требуется оценка состояния яичников с помощью УЗИ как отдельно, так и в сочетании с определением эстрадиола в плазме крови. Препарат следует применять в минимальных эффективных дозах как у женщин, так и у мужчин. При назначении чХГ возрастает вероятность возникновения СГЯ и множественной суперовуляции. Поэтому при чрезмерном ответе яичников на стимуляцию чХГ не назначают, а пациенткам рекомендуют воздержаться от коитуса не менее 4 дней или использовать барьерные методы контрацепции. Вероятность возникновения СГЯ у пациенток, проходящих контролируемую овариальную гиперстимуляцию для вспомогательных репродуктивных технологий, снижают путем аспирации всех фолликулов. Степень риска многоплодной беременности при вспомогательных репродуктивных технологиях зависит от количества перенесенных эмбрионов, чаще встречаются беременности двойней. После индукции овуляции частота многоплодных беременностей и родов повышается, по сравнению с естественным зачатием. Частота прерывания беременностей после индукции овуляции и программ вспомогательных репродуктивных технологий несколько выше, чем в популяции, но сопоставима с показателями у женщин, страдающих другими формами бесплодия. Вероятность внематочной беременности после применения программ вспомогательных репродуктивных технологий составляет 2-5%, по сравнению с 1-1.5% в общей популяции. Пациенты должны информировать врача обо всех типах аллергических реакций, которые имеются, а также обо всех препаратах, которые получает пациент до начала лечения препаратом Гонал-ф. Необходимо получить сведения о всех типах аллергических реакций, которые имеются у пациентов, а также о всех препаратах, которые получали пациенты до начала лечения препаратом Гонал-ф. Высокий уровень ФСГ в сыворотке крови мужчин может свидетельствовать о первичной тестикулярной недостаточности. В этом случае лечение препаратом Гонал-ф не эффективно. Для оценки ответа на стимуляцию препаратом Гонал-ф рекомендуется контроль спермограммы через 4-6 месяцев после начала курса терапии. В случае назначения препарата Гонал-ф вместе с лутропином альфа их можно смешивать в одном шприце. Влияние на способность к вождению автотранспорта и управлению механизмамиГонал-ф не влияет на способность к вождению автотранспорта и управлению другими механизмами.
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Инъекцию следует проводить с соблюдением правил асептики и антисептики.2. Для проведения инъекции необходимо разложить на чистой поверхности 2 пропитанных спиртом тампона; одну иглу для приготовления раствора и иглу для п/к введения; контейнер для утилизации.3. Приготовление раствора для инъекции: снять защелкивающуюся крышку с флакона и защитный колпачок с иглы шприца. Ввести иглу шприца с растворителем во флакон, проткнув резиновую крышку флакона; медленно впрыснуть все содержимое шприца во флакон. Для лучшего растворения следует вращать флакон, но не трясите его.4. После растворения лиофилизата, проверить прозрачность раствора, не содержит ли он каких-либо частиц. Перевернуть флакон дном кверху и набрать раствор обратно в шприц. Удалить иглу шприца из флакона. Если назначена доза, содержащаяся в нескольких флаконах, то следует медленно впрыснуть содержимое шприца в следующий флакон. Повторить операцию как описано выше до тех пор, пока не будет получена нужная доза. Если назначен лутропин альфа, можно смешать два препарата в одном шприце. Приготовить раствор лутропина альфа, набрать его в шприц, ввести раствор во флакон с препаратом Гонал-ф, растворить препарат и набрать раствор обратно в шприц. В 1 мл растворителя можно растворить до 3 флаконов.5. Сменить иглу на иглу для п/к введения. При наличии пузырьков воздуха в шприце, следует повернуть его иглой вверх и постучать осторожно по шприцу, чтобы все пузырьки собрались в верхней части шприца. Нажимать на поршень до тех пор, пока все пузырьки не исчезнут.6. Немедленно ввести раствор. Лечащий врач или медсестра должны заранее посоветовать пациенту, в какое место следует делать инъекцию - в живот или в бедро. Про проведении п/к инъекции следует сжать кожу и резко ввести иглу под углом 45° или 90°. При инъекции следует нажимать на поршень осторожно, пока не будет введена вся доза. После этого следует немедленно вынуть иглу и круговыми движениями протереть место инъекции спиртовым тампоном. Не вводить в/в.7. Сразу после окончания инъекции следует выбросить использованные шприцы (лучше в отдельный контейнер) и остатки раствора препарата."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Кисты яичников; синдром гиперстимуляции яичников (СГЯ) легкой или средней степени тяжести; тяжелая форма СГЯ, перекрут кисты яичника , апоплексия яичника, внематочная беременность, многоплодная беременность, головная боль, боли в животе, тошнота, рвота, диарея, колика, отрыжка, повышение свертываемости крови (тромбоэмболия), легочная эмболия, ишемический инсульт, инфаркт миокарда, слабо выраженные покраснение кожи, сыпь, отечность лица, крапивница, затрудненное дыхание, тяжелые аллергические реакции (в т.ч. анафилаксия), реакции легкой/средней степени выраженности в месте инъекции (боль, покраснение, кровоподтеки, отек), лихорадка, артралгия, острая легочная недостаточность, угри (акне), гинекомастия, варикоцеле, , увеличение массы тела."}}]},{"id":8,"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":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гонал-ф способен вызывать различные побочные реакции, поэтому его должны назначать только врачи-специалисты, непосредственно занимающиеся проблемами бесплодия. Перед началом терапии требуется обследование бесплодной пары, в частности, проведение исследований для исключения гипотиреоза, недостаточности коры надпочечников, гиперпролактинемии, гипоталамо-гипофизарных новообразований; при необходимости - назначают соответствующую терапию. Необходимо оценить проходимость фаллопиевых труб с целью выбора метода вспомогательных репродуктивных технологий. Следует исключить непроходимость фаллопиевых труб, если пациентка не участвует в программе экстракорпорального оплодотворения. У больных порфирией, а также при наличии порфирии у родственников, во время терапии препаратом Гонал-ф требуется проведение тщательного мониторинга. При ухудшении состояния или появлении первых признаков этого заболевания может потребоваться прекращение терапии. При лечении препаратом Гонал-ф требуется оценка состояния яичников с помощью УЗИ как отдельно, так и в сочетании с определением эстрадиола в плазме крови. Препарат следует применять в минимальных эффективных дозах как у женщин, так и у мужчин. При назначении чХГ возрастает вероятность возникновения СГЯ и множественной суперовуляции. Поэтому при чрезмерном ответе яичников на стимуляцию чХГ не назначают, а пациенткам рекомендуют воздержаться от коитуса не менее 4 дней или использовать барьерные методы контрацепции. Вероятность возникновения СГЯ у пациенток, проходящих контролируемую овариальную гиперстимуляцию для вспомогательных репродуктивных технологий, снижают путем аспирации всех фолликулов. Степень риска многоплодной беременности при вспомогательных репродуктивных технологиях зависит от количества перенесенных эмбрионов, чаще встречаются беременности двойней. После индукции овуляции частота многоплодных беременностей и родов повышается, по сравнению с естественным зачатием. Частота прерывания беременностей после индукции овуляции и программ вспомогательных репродуктивных технологий несколько выше, чем в популяции, но сопоставима с показателями у женщин, страдающих другими формами бесплодия. Вероятность внематочной беременности после применения программ вспомогательных репродуктивных технологий составляет 2-5%, по сравнению с 1-1.5% в общей популяции. Пациенты должны информировать врача обо всех типах аллергических реакций, которые имеются, а также обо всех препаратах, которые получает пациент до начала лечения препаратом Гонал-ф. Необходимо получить сведения о всех типах аллергических реакций, которые имеются у пациентов, а также о всех препаратах, которые получали пациенты до начала лечения препаратом Гонал-ф. Высокий уровень ФСГ в сыворотке крови мужчин может свидетельствовать о первичной тестикулярной недостаточности. В этом случае лечение препаратом Гонал-ф не эффективно. Для оценки ответа на стимуляцию препаратом Гонал-ф рекомендуется контроль спермограммы через 4-6 месяцев после начала курса терапии. В случае назначения препарата Гонал-ф вместе с лутропином альфа их можно смешивать в одном шприце. 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