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Описание

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Бикалутамид-тева таб. п/о плен., 50 мг, 28 шт.

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У продавца: 
нет • На Маркете: 4.5
(24)
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Дозировка: 50 мг

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Коротко о товаре

Артикул Маркета
3123957631
Действующее вещество
Возраст
от 18 лет
Инструкция
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Т1-Т2, N+, М0) в качестве монотерапии или адъювантной терапии в сочетании с радикальной простатэктомией или радиотерапией.\u003Cbr\u003EМестно-распространенный неметастатический рак предстательной железы в случаях, когда хирургическая кастрация или другие медицинские вмешательства неприменимы или неприемлемы."},{"name":"Противопоказания","value":"Одновременный прием с терфенадином, астемизолом и цизапридом; непереносимость лактозы, лактазная недостаточность или мальабсорбция глюкозы/галактозы; повышенная чувствительность к бикалутамиду и вспомогательным компонентам препарата; детям и женщинам.\u003Cbr\u003EС осторожностью: нарушения функции печени."},{"name":"Состав","value":"Действующее вещество: бикалутамид - 50 мг или 150 мг\u003Cbr\u003EВспомогательные вещества: целлюлоза микрокристаллическая, повидон (PVP K30), кроскармеллоза натрия, натрия лаурилсульфат, лактозы моногидрат, кремния диоксид коллоидный, магния стеарат.\u003Cbr/\u003E"},{"name":"Действующее вещество","value":"Бикалутамид","transition":{"type":"catalog","params":{"categorySlug":"protivoopukholevye-preparaty-i-immunomoduliatory","categoryId":"15756914","navnodeId":"72508","glfilters":["27144131:28709949"]}}},{"name":"Способ применения и дозы","value":"Взрослым мужчинам (в т.ч. пожилым):\u003Cbr\u003EПри распространенном раке предстательной железы в комбинации с аналогом ГнРГ или хирургической кастрацией\u003Cbr\u003Eназначают внутрь по 50 мг 1 раз/сутки. Лечение препаратом необходимо начинать одновременно с началом приема аналога ГнРГ или хирургической кастрацией.\u003Cbr\u003EПри местнораспространенном раке предстательной железы\u003Cbr\u003EНазначают внутрь по 150 мг 1 раз/сутки. Препарат следует принимать длительно, как минимум в течение 2 лет.\u003Cbr\u003EПри появлении признаков прогрессирования заболевания прием препарата следует прекратить.\u003Cbr\u003EПри нарушениях функции почек коррекция дозы не требуется.\u003Cbr\u003EПри легком нарушении функции печени коррекция дозы не требуется.\u003Cbr\u003EУ пациентов со средними и тяжелыми нарушениями функции печени может наблюдаться повышенная кумуляция бикалутамида."},{"name":"Побочные действия","value":"Фармакологическое действие бикалутамида может обуславливать следующие побочные эффекты: гинекомастия (может сохраняться даже после прекращения терапии, особенно в случае приема препарата в течение длительного времени); болезненность грудных желез; приливы крови к лицу; снижение полового влечения; сексуальные дисфункции; Диарея; тошнота; транзиторное повышение активности печеночных трансаминаз; холестаз; желтуха (описанные изменения функции печени редко оценивались, как серьезные, носили транзиторный характер, полностью исчезали или уменьшались при продолжении терапии или после отмены препарата); зуд; астения;\u003Cbr\u003EПри применении препарата в суточной дозе 150 мг: алопеция или восстановление роста волос; увеличение массы тела.\u003Cbr\u003EРеакции повышенной чувствительности, включая: ангионевротический отек; крапивницу; интерстициальные легочные заболевания.\u003Cbr\u003EПри применении препарата в суточной дозе 150 мг: боль в животе; депрессия; диспепсия; гематурия. Рвота; сухость кожи (при применении препарата в суточной дозе 150 мг сухость кожи наблюдается часто); печеночная недостаточность (причинно-следственная связь с приемом бикалутамида достоверно не установлена).\u003Cbr\u003EПри одновременном применении бикалутамида и аналогов ГнРГ могут также наблюдаться указанные ниже побочные явления:\u003Cbr\u003EСо стороны сердечно-сосудистой системы: сердечная недостаточность, стенокардия, нарушения проводимости, включая удлинение интервалов PR и QT, нарушения ритма, неспецифические изменения на ЭКГ, повышение АД, инфаркт миокарда, обморок.\u003Cbr\u003EСо стороны пищеварительной системы: желудочное кровотечение, анорексия, сухость во рту, диспепсия, запор, метеоризм, периодонтальный абсцесс, рак желудка/кишечника.\u003Cbr\u003EСо стороны нервной системы: головокружение, головная боль, бессонница, тревожность, сонливость, невропатия.\u003Cbr\u003EСо стороны дыхательной системы: одышка, боль в груди, кашель, фарингит, бронхит, пневмония, ринит, бронхоспазм, носовое кровотечение.\u003Cbr\u003EСо стороны мочевыделителъной системы: никтурия, дизурия, задержка мочи, отеки, учащенное мочеиспускание, гидронефроз, инфекции.\u003Cbr\u003EСо стороны системы кроветворения: анемия.\u003Cbr\u003EДерматологические реакции: алопеция, кожная сыпь, повышенная потливость, гирсутизм, сухость кожи, герпетическая инфекция, рак кожи.\u003Cbr\u003EСо стороны костно-мышечной системы: миастения, миалгия, судороги, артрит, контрактуры суставов, боли в костях, судороги в ногах.\u003Cbr\u003EСо стороны лабораторных показателей: гипергликемия, повышение активности ЩФ, гиперкреатининемия, иперхолестеринемия, гипербилирубинемия.\u003Cbr\u003EПрочие: сахарный диабет, полиурия, повышение или снижение массы тела, боль в животе, груди, тазовой области, сексуальные дисфункции, развитие опухолевого процесса, озноб, дегидратация, подагра, катаракта."},{"name":"Фармакологическое действие","value":"Антиандрогенное действие лекарственных препаратов заключается в снижении концентрации мужских половых гормонов в крови.\u003Cbr\u003EПротивоопухолевое действие направлено на подавление и предупреждение роста различных опухолей."},{"name":"Фармакологическая группа","value":"противоопухолевые средства","transition":{"type":"catalog","params":{"categorySlug":"protivoopukholevye-preparaty-i-immunomoduliatory","categoryId":"15756914","navnodeId":"72508","glfilters":["34045110:34518988"]}}},{"name":"Форма выпуска","value":"таблетки"},{"name":"Способ применения/введения","value":"пероральный","transition":{"type":"catalog","params":{"categorySlug":"protivoopukholevye-preparaty-i-immunomoduliatory","categoryId":"15756914","navnodeId":"72508","glfilters":["35947170:36763744"]}}},{"name":"Минимальный возраст применения","value":"от 18 лет"},{"name":"Условия хранения","value":"В сухом месте при температуре не выше 25°C. Срок годности - 3 года."},{"name":"Передозировка","value":"Случаи передозировки у человека не описаны.\u003Cbr\u003EЛечение: специфического антидота не существует. Лечение симптоматическое. Проведение диализа не эффективно, так как бикалутамид прочно связывается с белками и не выводится с мочой в неизмененном виде. Показана общая поддерживающая терапия и мониторинг жизненно важных функций организма."},{"name":"Влияние на способность управлять транспортом и механизмами","value":"В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."},{"name":"Особые указания","value":"При назначении препарата пациентам, получающим антикоагулянты кумаринового ряда, рекомендуется регулярно контролировать протромбиновое время.\u003Cbr\u003EПациентов с непереносимостью лактозы необходимо проинформировать о том, что каждая таблетка 50 мг содержит 35 мг лактозы моногидрата, таблетка 150 мг содержит 105 мг лактозы моногидрата.\u003Cbr\u003EУчитывая возможность ингибирования бикалутамидом активности ферментов цитохрома Р450 (CYP3А4), следует проявлять осторожность при одновременном назначении препарата с препаратами, преимущественно метаболизирующимися с участием CYP3A4."},{"name":"Взаимодействие","value":"Нет данных о фармакокинетических или фармакодинамических взаимодействиях между бикалутамидом и аналогами ГнРГ.\u003Cbr\u003EВ исследованиях in vitro показано, что (R)-энантиомер бикалутамида ингибирует CYP3А4, в меньшей степени влияя на активность CYP 2C9, 2С19 и 2D6. Потенциальной способности бикалутамида к взаимодействию с другими лекарственными препаратами не обнаружено, однако при его использовании в течение 28 дней на фоне приема мидазолама, AUC мидазолама увеличивается на 80%.\u003Cbr\u003EНесовместим с терфенадином, астемизолом и цизапридом.\u003Cbr\u003EСледует соблюдать осторожность при назначении бикалутамида одновременно с циклоспорином или блокаторами кальциевых каналов. Возможно, потребуется снижение дозы этих препаратов, особенно, в случае потенцирования эффекта или развития побочных явлений. После начала использования или отмены бикалутамида рекомендуют проводить тщательный мониторинг концентрации циклоспорина в плазме и клинического состояния пациента.\u003Cbr\u003EОдновременное применение бикалутамида и препаратов, ингибирующих микросомальное окисление лекарственных средств, например, циметидина или кетоконазола может привести к увеличению концентрации бикалутамида в плазме и, возможно, к увеличению частоты возникновения побочных эффектов.\u003Cbr\u003EУсиливает действие антикоагулянтов кумаринового ряда, в т.ч. варфарина (конкуренция за связь с белками)."},{"name":"Источник","value":"\u003Ca href=\"https://www.vidal.ru\" target=\"_blank\"\u003EСправочник лекарственных препаратов Видаль<\u002Fa\u003E"},{"name":"Регистрационный номер","value":"ЛCP-007880/09"},{"name":"Дата государственной регистрации","value":"04.06.2020"},{"name":"Владелец регистрационного удостоверения","value":"TEVA","transition":{"type":"catalog","params":{"categorySlug":"protivoopukholevye-preparaty-i-immunomoduliatory","categoryId":"15756914","navnodeId":"72508","glfilters":["34324371:35649313","7893318:14909142"]}}},{"name":"Изготовитель","value":"Тева Фармацевтические Предприятия Лтд."},{"name":"Страна бренда","value":"Израиль"},{"name":"Страна-производитель","value":"Израиль"},{"name":"Название препарата","value":"Бикалутамид-Тева","transition":{"type":"catalog","params":{"categorySlug":"protivoopukholevye-preparaty-i-immunomoduliatory","categoryId":"15756914","navnodeId":"72508","glfilters":["17796364:18053075"]}}},{"name":"Срок годности","value":"36 мес."}]}},"fullSpecsGrouped":{"14557872093920862948":{"groups":[{"name":"Общие характеристики","items":[{"name":"Тип препарата","value":"лекарственный препарат"},{"name":"Рецептурный препарат","value":"да"},{"name":"Органы и системы","value":"половые железы"},{"name":"Назначение","value":"рак предстательной железы"},{"name":"Показания к применению","value":"Распространенный рак предстательной железы в комбинации с аналогом ГнРГ (гонадотропин-рилизинг гормон) или хирургической кастрацией.\u003Cbr\u003EМестно-распространенный рак предстательной железы (Т3-Т4, любая N, М0; Т1-Т2, N+, М0) в качестве монотерапии или адъювантной терапии в сочетании с радикальной простатэктомией или радиотерапией.\u003Cbr\u003EМестно-распространенный неметастатический рак предстательной железы в случаях, когда хирургическая кастрация или другие медицинские вмешательства неприменимы или неприемлемы."},{"name":"Противопоказания","value":"Одновременный прием с терфенадином, астемизолом и цизапридом; непереносимость лактозы, лактазная недостаточность или мальабсорбция глюкозы/галактозы; повышенная чувствительность к бикалутамиду и вспомогательным компонентам препарата; детям и женщинам.\u003Cbr\u003EС осторожностью: нарушения функции печени."},{"name":"Состав","value":"Действующее вещество: бикалутамид - 50 мг или 150 мг\u003Cbr\u003EВспомогательные вещества: целлюлоза микрокристаллическая, повидон (PVP K30), кроскармеллоза натрия, натрия лаурилсульфат, лактозы моногидрат, кремния диоксид коллоидный, магния стеарат.\u003Cbr/\u003E"},{"name":"Действующее вещество","value":"Бикалутамид"},{"name":"Способ применения и дозы","value":"Взрослым мужчинам (в т.ч. пожилым):\u003Cbr\u003EПри распространенном раке предстательной железы в комбинации с аналогом ГнРГ или хирургической кастрацией\u003Cbr\u003Eназначают внутрь по 50 мг 1 раз/сутки. Лечение препаратом необходимо начинать одновременно с началом приема аналога ГнРГ или хирургической кастрацией.\u003Cbr\u003EПри местнораспространенном раке предстательной железы\u003Cbr\u003EНазначают внутрь по 150 мг 1 раз/сутки. Препарат следует принимать длительно, как минимум в течение 2 лет.\u003Cbr\u003EПри появлении признаков прогрессирования заболевания прием препарата следует прекратить.\u003Cbr\u003EПри нарушениях функции почек коррекция дозы не требуется.\u003Cbr\u003EПри легком нарушении функции печени коррекция дозы не требуется.\u003Cbr\u003EУ пациентов со средними и тяжелыми нарушениями функции печени может наблюдаться повышенная кумуляция бикалутамида."},{"name":"Побочные действия","value":"Фармакологическое действие бикалутамида может обуславливать следующие побочные эффекты: гинекомастия (может сохраняться даже после прекращения терапии, особенно в случае приема препарата в течение длительного времени); болезненность грудных желез; приливы крови к лицу; снижение полового влечения; сексуальные дисфункции; Диарея; тошнота; транзиторное повышение активности печеночных трансаминаз; холестаз; желтуха (описанные изменения функции печени редко оценивались, как серьезные, носили транзиторный характер, полностью исчезали или уменьшались при продолжении терапии или после отмены препарата); зуд; астения;\u003Cbr\u003EПри применении препарата в суточной дозе 150 мг: алопеция или восстановление роста волос; увеличение массы тела.\u003Cbr\u003EРеакции повышенной чувствительности, включая: ангионевротический отек; крапивницу; интерстициальные легочные заболевания.\u003Cbr\u003EПри применении препарата в суточной дозе 150 мг: боль в животе; депрессия; диспепсия; гематурия. Рвота; сухость кожи (при применении препарата в суточной дозе 150 мг сухость кожи наблюдается часто); печеночная недостаточность (причинно-следственная связь с приемом бикалутамида достоверно не установлена).\u003Cbr\u003EПри одновременном применении бикалутамида и аналогов ГнРГ могут также наблюдаться указанные ниже побочные явления:\u003Cbr\u003EСо стороны сердечно-сосудистой системы: сердечная недостаточность, стенокардия, нарушения проводимости, включая удлинение интервалов PR и QT, нарушения ритма, неспецифические изменения на ЭКГ, повышение АД, инфаркт миокарда, обморок.\u003Cbr\u003EСо стороны пищеварительной системы: желудочное кровотечение, анорексия, сухость во рту, диспепсия, запор, метеоризм, периодонтальный абсцесс, рак желудка/кишечника.\u003Cbr\u003EСо стороны нервной системы: головокружение, головная боль, бессонница, тревожность, сонливость, невропатия.\u003Cbr\u003EСо стороны дыхательной системы: одышка, боль в груди, кашель, фарингит, бронхит, пневмония, ринит, бронхоспазм, носовое кровотечение.\u003Cbr\u003EСо стороны мочевыделителъной системы: никтурия, дизурия, задержка мочи, отеки, учащенное мочеиспускание, гидронефроз, инфекции.\u003Cbr\u003EСо стороны системы кроветворения: анемия.\u003Cbr\u003EДерматологические реакции: алопеция, кожная сыпь, повышенная потливость, гирсутизм, сухость кожи, герпетическая инфекция, рак кожи.\u003Cbr\u003EСо стороны костно-мышечной системы: миастения, миалгия, судороги, артрит, контрактуры суставов, боли в костях, судороги в ногах.\u003Cbr\u003EСо стороны лабораторных показателей: гипергликемия, повышение активности ЩФ, гиперкреатининемия, иперхолестеринемия, гипербилирубинемия.\u003Cbr\u003EПрочие: сахарный диабет, полиурия, повышение или снижение массы тела, боль в животе, груди, тазовой области, сексуальные дисфункции, развитие опухолевого процесса, озноб, дегидратация, подагра, катаракта."},{"name":"Фармакологическое действие","value":"Антиандрогенное действие лекарственных препаратов заключается в снижении концентрации мужских половых гормонов в крови.\u003Cbr\u003EПротивоопухолевое действие направлено на подавление и предупреждение роста различных опухолей."},{"name":"Фармакологическая группа","value":"противоопухолевые средства"},{"name":"Форма выпуска","value":"таблетки"},{"name":"Способ применения/введения","value":"пероральный"},{"name":"Минимальный возраст применения","value":"от 18 лет"}]},{"name":"Дополнительно","items":[{"name":"Условия хранения","value":"В сухом месте при температуре не выше 25°C. Срок годности - 3 года."},{"name":"Передозировка","value":"Случаи передозировки у человека не описаны.\u003Cbr\u003EЛечение: специфического антидота не существует. Лечение симптоматическое. Проведение диализа не эффективно, так как бикалутамид прочно связывается с белками и не выводится с мочой в неизмененном виде. Показана общая поддерживающая терапия и мониторинг жизненно важных функций организма."},{"name":"Влияние на способность управлять транспортом и механизмами","value":"В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."},{"name":"Особые указания","value":"При назначении препарата пациентам, получающим антикоагулянты кумаринового ряда, рекомендуется регулярно контролировать протромбиновое время.\u003Cbr\u003EПациентов с непереносимостью лактозы необходимо проинформировать о том, что каждая таблетка 50 мг содержит 35 мг лактозы моногидрата, таблетка 150 мг содержит 105 мг лактозы моногидрата.\u003Cbr\u003EУчитывая возможность ингибирования бикалутамидом активности ферментов цитохрома Р450 (CYP3А4), следует проявлять осторожность при одновременном назначении препарата с препаратами, преимущественно метаболизирующимися с участием CYP3A4."},{"name":"Взаимодействие","value":"Нет данных о фармакокинетических или фармакодинамических взаимодействиях между бикалутамидом и аналогами ГнРГ.\u003Cbr\u003EВ исследованиях in vitro показано, что (R)-энантиомер бикалутамида ингибирует CYP3А4, в меньшей степени влияя на активность CYP 2C9, 2С19 и 2D6. Потенциальной способности бикалутамида к взаимодействию с другими лекарственными препаратами не обнаружено, однако при его использовании в течение 28 дней на фоне приема мидазолама, AUC мидазолама увеличивается на 80%.\u003Cbr\u003EНесовместим с терфенадином, астемизолом и цизапридом.\u003Cbr\u003EСледует соблюдать осторожность при назначении бикалутамида одновременно с циклоспорином или блокаторами кальциевых каналов. Возможно, потребуется снижение дозы этих препаратов, особенно, в случае потенцирования эффекта или развития побочных явлений. После начала использования или отмены бикалутамида рекомендуют проводить тщательный мониторинг концентрации циклоспорина в плазме и клинического состояния пациента.\u003Cbr\u003EОдновременное применение бикалутамида и препаратов, ингибирующих микросомальное окисление лекарственных средств, например, циметидина или кетоконазола может привести к увеличению концентрации бикалутамида в плазме и, возможно, к увеличению частоты возникновения побочных эффектов.\u003Cbr\u003EУсиливает действие антикоагулянтов кумаринового ряда, в т.ч. варфарина (конкуренция за связь с белками)."},{"name":"Источник","value":"\u003Ca href=\"https://www.vidal.ru\" target=\"_blank\"\u003EСправочник лекарственных препаратов Видаль<\u002Fa\u003E"},{"name":"Регистрационный номер","value":"ЛCP-007880/09"},{"name":"Дата государственной регистрации","value":"04.06.2020"},{"name":"Владелец регистрационного удостоверения","value":"TEVA"},{"name":"Изготовитель","value":"Тева Фармацевтические Предприятия Лтд."},{"name":"Страна бренда","value":"Израиль"},{"name":"Страна-производитель","value":"Израиль"},{"name":"Название препарата","value":"Бикалутамид-Тева"},{"name":"Срок годности","value":"36 мес."}]}],"transitionId":"tr_142648079802625100"}}}}
Внешний вид товаров и/или упаковки может быть изменён изготовителем и отличаться от изображенных на Яндекс Маркете.
Есть противопоказания, посоветуйтесь с врачом. Отпускается по рецепту врача. Приобретение лекарственных препаратов осуществляется только в торговом зале аптеки

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Ещё может подойти

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Инструкция

Показания к применению

Распространенный рак предстательной железы в комбинации с аналогом ГнРГ (гонадотропин-рилизинг гормон) или хирургической кастрацией.
Местно-распространенный рак предстательной железы (Т3-Т4, любая N, М0; Т1-Т2, N+, М0) в качестве монотерапии или адъювантной терапии в сочетании с радикальной простатэктомией или радиотерапией.
Местно-распространенный неметастатический рак предстательной железы в случаях, когда хирургическая кастрация или другие медицинские вмешательства неприменимы или неприемлемы.

Противопоказания

Одновременный прием с терфенадином, астемизолом и цизапридом; непереносимость лактозы, лактазная недостаточность или мальабсорбция глюкозы/галактозы; повышенная чувствительность к бикалутамиду и вспомогательным компонентам препарата; детям и женщинам.
С осторожностью: нарушения функции печени.

Способ применения и дозы

Взрослым мужчинам (в т.ч. пожилым):
При распространенном раке предстательной железы в комбинации с аналогом ГнРГ или хирургической кастрацией
назначают внутрь по 50 мг 1 раз/сутки. Лечение препаратом необходимо начинать одновременно с началом приема аналога ГнРГ или хирургической кастрацией.
При местнораспространенном раке предстательной железы
Назначают внутрь по 150 мг 1 раз/сутки. Препарат следует принимать длительно, как минимум в течение 2 лет.
При появлении признаков прогрессирования заболевания прием препарата следует прекратить.
При нарушениях функции почек коррекция дозы не требуется.
При легком нарушении функции печени коррекция дозы не требуется.
У пациентов со средними и тяжелыми нарушениями функции печени может наблюдаться повышенная кумуляция бикалутамида.
Полная инструкция
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Бикалутамид-тева таб. п/о плен.
Бикалутамид-тева таб. п/о плен., 50 мг, 28 шт.
У продавца: 
нет • На Маркете: 4.5
(24)
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Инструкция

823 ₽

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У других продавцов:24 оценки·5 отзывов
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