Повышенная чувствительность к гемцитабину или другим компонентам препарата Беременность и период кормления грудью
Инструкция
Регистрационный номер
П N 013405/01-180510
Торговое название препарата
Гемзар
Международное непатентованное название:
гемцитабин (gemcitabine)
Лекарственная форма
лиофилизат для приготовления раствора для инфузий
Состав
В одном флаконе содержится:
активное вещество: гемцитабина гидрохлорид, эквивалентный 200 мг или 1 г гемцитабина
вспомогательные вещества: маннитол, натрия ацетат
Описание
Лиофилизат от белого до почти белого цвета.
Фармакотерапевтическая группа
противоопухолевое средство, антиметаболит.
Фармакологические свойства
Гемцитабин представляет собой антиметаболит группы аналогов пиримидина. Препарат проявляет циклоспецифичность, действуя на клетки в фазах S и G1/S.
Гемцитабин метаболизируется внутри клетки под действием нуклеозидкиназ с образованием активных дифосфатных и трифосфатных нуклеозидов. Дифосфатные нуклеозиды ингибируют рибонуклеотидредуктазу, которая действует в качестве единственного катализатора реакций, приводящих к образованию дезоксинуклеозидтрифосфатов, необходимых для синтеза ДНК. Трифосфатные нуклеозиды активно конкурируют с дезоксицитидинтрифосфатом за встраивание в молекулы ДНК и РНК. После встраивания внутриклеточных метаболитов гемцитабина в цепь ДНК, к ее растущим нитям добавляется ещё один дополнительный нуклеотид, что приводит к полному ингибированию дальнейшего синтеза ДНК и запрограммированной гибели клетки, известной как апоптоз.
Фармакокинетика
Гемцитабин быстро выводится из организма с мочой в основном в виде неактивного метаболита 2'-дезокси-2',2'-дифторуридина. Менее 10% введённой внутривенно дозы обнаруживается в моче в форме неизменённого препарата. Связывание гемцитабина с белками плазмы незначительное.
Фармакокинетический анализ исследований с однократным и многократным введением доз показывает, что объём распределения в значительной степени зависит от пола. Системный клиренс, который колеблется примерно от 30 л/ч/м2 до 90 л/ч/м2, зависит от возраста и пола. Период полувыведения колеблется от 32 минут до 94 минут.
Показания к применению
Немелкоклеточный рак лёгкого
Рак молочной железы
Рак мочевого пузыря
Рак яичников
Рак поджелудочной железы
Рак шейки матки
Гемцитабин в монотерапии или в комбинации с другими противоопухолевыми средствами также проявляет активность при местнораспространенном мелкоклеточном раке легкого, местнораспространенном рефрактерном раке яичка и раке желчевыводящих путей.
Противопоказания
Повышенная чувствительность к гемцитабину или другим компонентам препарата Беременность и период кормления грудью
С осторожностью
При нарушении функции печени и/или почек, угнетении костномозгового кроветворения (в том числе на фоне сопутствующей лучевой или химиотерапии), острых инфекционных заболеваниях вирусной, грибковой или бактериальной природы.
Способ применения и дозы
Гемцитабин вводится внутривенно капельно в течение 30 минут.
Немелкоклеточный рак легкого (местнораспространенный или метастатический).
Монотерапия. Рекомендованная доза препарата - 1000 мг/м2 в 1, 8 и 15 дни каждого 28-дневного цикла.
Рак молочной железы (местнораспространенный или метастатический).
Монотерапия. При прогрессировании заболевания после первой линии терапии, включающей антрациклины при отсутствии противопоказаний к ним. Рекомендованная доза препарата - 1000-1200 мг/м2 в 1, 8 и 15 дни каждого 28-дневного цикла.
Рак мочевого пузыря (местнораспространенный, метастатический и поверхностный).
Монотерапия. Рекомендованная доза препарата - 1250 мг/м2 в 1, 8 и 15 дни каждого 28-дневного цикла.
Комбинированная терапия. Рекомендованная доза препарата - 1000 мг/м2 в 1, 8 и 15 дни в сочетании с цисплатином, который вводится в дозе 70 мг/м2 сразу после инфузии гемцитабина в 1 или во 2 день каждого 28-дневного цикла.
Эпителиальный рак яичников (местнораспространенный или метастатический).
Монотерапия. Рекомендованная доза препарата - 800-1250 мг/м2 в 1, 8 и 15 дни каждого 28-дневного цикла.
Рак поджелудочной железы (местнораспространенный или метастатический).
Рак шейки матки (местнораспространенный или метастатический).
Комбинированная терапия. При местнораспространённом раке при последовательной химиолучевой терапии (неоадъювантно) и при метастатическом раке гемцитабин вводится в дозе 1250 мг/м2 в 1 и 8 дни каждого 21-дневного цикла. Цисплатин вводится после введения гемцитабина в дозе 70 мг/м2 в 1 день цикла на фоне гипергидратации. При местнораспространённом раке при одновременной химиолучевой терапии гемцитабин вводится 1 раз в неделю за 1-2 часа до начала лучевой терапии в дозе 125 мг/м2 с последующим (непосредственно после введения гемцитабина) введением цисплатина в дозе 40 мг/м2.
Перед каждым введением гемцитабина необходимо контролировать количество тромбоцитов, лейкоцитов и гранулоцитов в крови. При признаках угнетения функции костного мозга необходимо приостановить лечение или скорректировать дозу.
В случае развития гематологической токсичности доза гемцитабина может быть уменьшена, либо её введение отложено в соответствии со следующей схемой:
Пожилые пациенты: доказательств, позволяющих предположить, что у пожилых больных необходимо корректировать дозу, не имеется, хотя клиренс гемцитабина и период полувыведения с возрастом изменяются.
Пациенты с нарушением функции печени и почек: применять гемцитабин у больных с печёночной недостаточностью или с нарушенной функцией почек следует с осторожностью, так как достаточных данных по применению препарата у этой категории пациентов нет. Умеренная или средней тяжести почечная недостаточность (скорость клубочковой фильтрации от 30 мл/мин до 80 мл/мин) не оказывает заметного влияния на фармакокинетику гемцитабина. Дети: применение гемцитабина у детей не изучалось.
Рекомендации по приготовлению раствора для инфузий
В качестве растворителя используется только 0,9 % раствор натрия хлорида (без консервантов). Для приготовления раствора для инфузий содержимое флакона 200 мг растворяют в не менее, чем 5 мл, и 1 г - в не менее, чем 25 мл 0,9% раствора натрия хлорида для инъекций. Каждый флакон аккуратно взбалтывают до полного растворения лиофилизата. Полученный раствор должен быть прозрачным.
Максимальная концентрация гемцитабина не должна превышать 40 мг/мл. Растворы, приготовленные с концентрацией выше, чем 40 мг/мл, могут сопровождаться неполным растворением.
Приготовленный раствор гемцитабина, содержащий нужную дозу препарата, перед введением разбавляют 0,9% раствором натрия хлорида для инъекций в количестве, достаточном для проведения 30-минутной внутривенной инфузий.
Перед парентеральным введением необходимо визуально контролировать приготовленный раствор на наличие механических примесей и изменение цвета.
Побочное действие
Побочное действие
Побочные реакции, встречавшиеся чаще, чем в единичных случаях, перечислены соответствии со следующей градацией: очень часто (> 10%); часто (> 1%, 0,1%, 0,01%,
Со стороны органов кроветворения: часто - лейкопения, тромбоцитопения, анемия; очень редко - тромбоцитоз.
Со стороны системы пищеварения: очень часто - тошнота, рвота, повышение уровня печеночных трансаминаз, щелочной фосфатазы; часто - анорексия, диарея, запор, стоматит, повышение уровня билирубина.
Со стороны мочеполовой системы: очень часто - легкая протеинурия и гематурия; редко - почечная недостаточность, клинические признаки и симптомы, схожие с гемолитико- уремическим синдромом (снижение уровня гемоглобина, тромбоцитопения, увеличение уровней билирубина, креатинина, мочевины и/или лактатдегидрогеназы в сыворотке крови).
Со стороны кожи и кожных придатков: часто - кожные высыпания, кожный зуд, алопеция.
Со стираны дыхательной системы: очень часто одышка, часто - кашель, ринит: иногда - бронхоспазм, интерстициальная пневмония, отек легкого; редко - острый респираторный дистресс-синдром.
Со стороны сердечно-сосудистой системы: редко - снижение артериального давления, инфаркт миокарда, сердечная недостаточность, аритмия.
Со стороны нервной системы: часто - головная боль, сонливость, бессонница.
Прочие: очень часто - гриппоподобный синдром, периферические отеки; часто - повышение температуры тела, озноб, астения, боли в спине, миалгия; иногда - отечность лица; очень редко - анафилактические реакции.
Передозировка
Антидот для гемцитабина не известен. Клинически допустимая токсичность наблюдалась при введении однократных доз вплоть до 5,7 г/м2 внутривенно в течение 30 минут каждые две недели. В случае подозрения на передозировку, больной должен находится под постоянным врачебным контролем, включая подсчет формулы крови. При необходимости больному проводят симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Гемцитабин обладает радиосенсибилизирующим действием, в связи с чем при применении данного препарата на фоне проведения лучевой терапии можно ожидать усиления лучевых реакций. В случае последовательной химиолучевой терапии гемцитабин можно начинать вводить после разрешения острых лучевых реакций или не менее чем через одну неделю после окончания лучевой терапии.
Особые указания
Лечение гемцитабином можно проводить только под наблюдением врача, имеющего опыт применения противоопухолевой химиотерапии.
Перед началом лечения абсолютное количество гранулоцитов должно быть не менее 1500/мкл, тромбоцитов - не менее 100000/мкл.
Для выявления негематологической токсичности необходимо проводить регулярное обследование больного и оценку функции печени и почек. В зависимости от степени токсичности дозу можно снижать в ходе каждого цикла или с началом нового цикла ступенчато.
Решение об отсрочке очередного введения препарата должно базироваться на клинической оценке врачом динамики токсичности.
Увеличение длительности инфузии и частоты введений приводит к возрастанию токсичности. Введение гемцитабина при метастазах в печени, при гепатите и алкоголизме в анамнезе, а также при циррозе печени увеличивает риск развития печёночной недостаточности. При возникновении первых признаков гемолитико-уремического синдрома лечение гемцитабином следует прекратить.
У больных раком легкого или с метастазами в легких повышен риск возникновения побочных эффектов со стороны системы дыхания.
При появлении первых признаков пневмонита или появлении инфильтратов в легких лечение гемцитабином следует прекратить.
Женщинам и мужчинам во время лечения гемцитабином и, как минимум, в течение 6 месяцев после терапии следует использовать надежные способы контрацепции.
Форма выпуска
Влияние на способность управлять автомобилем и движущимися механизмами
Исследований влияния гемцитабина на способность управлять автотранспортными средствами и другими механизмами не проводилось. Тем не менее известно, что гемцитабин может вызывать сонливость от слабой до умеренной степени выраженности, особенно совместно с употреблением алкоголя.
Пациентов следует предостерегать от управления механизмами в тех случаях, когда они чувствуют сонливость.
Форма выпуска
Лиофилизат для приготовления раствора для инфузий по 200 мг или 1 г во флаконах из стекла типа I. По одному флакону с инструкцией по применению в картонной пачке.
Условия хранения
Список Б. При температуре 15-30°С в местах, недоступных для детей. Не охлаждать и не замораживать.
Приготовленный раствор: при температуре 15-30°С не более 24 часов, не охлаждать и не замораживать.
Срок годности
3 года.
Не использовать по истечении срока годности, указанного на упаковке.
Условия отпуска
по ренцепту
Производитель
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Препарат проявляет циклоспецифичность, действуя на клетки в фазах S и G1/S."}},{"type":"paragraph","data":{"text":"Гемцитабин метаболизируется внутри клетки под действием нуклеозидкиназ с образованием активных дифосфатных и трифосфатных нуклеозидов. Дифосфатные нуклеозиды ингибируют рибонуклеотидредуктазу, которая действует в качестве единственного катализатора реакций, приводящих к образованию дезоксинуклеозидтрифосфатов, необходимых для синтеза ДНК. Трифосфатные нуклеозиды активно конкурируют с дезоксицитидинтрифосфатом за встраивание в молекулы ДНК и РНК. После встраивания внутриклеточных метаболитов гемцитабина в цепь ДНК, к ее растущим нитям добавляется ещё один дополнительный нуклеотид, что приводит к полному ингибированию дальнейшего синтеза ДНК и запрограммированной гибели клетки, известной как апоптоз."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Гемцитабин быстро выводится из организма с мочой в основном в виде неактивного метаболита 2'-дезокси-2',2'-дифторуридина. Менее 10% введённой внутривенно дозы обнаруживается в моче в форме неизменённого препарата. Связывание гемцитабина с белками плазмы незначительное."}},{"type":"paragraph","data":{"text":"Фармакокинетический анализ исследований с однократным и многократным введением доз показывает, что объём распределения в значительной степени зависит от пола. Системный клиренс, который колеблется примерно от 30 л/ч/м\u003csup\u003e2\u003c/sup\u003e до 90 л/ч/м\u003csup\u003e2\u003c/sup\u003e, зависит от возраста и пола. 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Рекомендованная доза препарата - 1000 мг/м\u003csup\u003e2\u003c/sup\u003e в 1, 8 и 15 дни в сочетании с цисплатином, который вводится в дозе 70 мг/м\u003csup\u003e2\u003c/sup\u003e сразу после инфузии гемцитабина в 1 или во 2 день каждого 28-дневного цикла."}},{"type":"paragraph","data":{"text":"Эпителиальный рак яичников (местнораспространенный или метастатический)."}},{"type":"paragraph","data":{"text":"Монотерапия. Рекомендованная доза препарата - 800-1250 мг/м\u003csup\u003e2\u003c/sup\u003e в 1, 8 и 15 дни каждого 28-дневного цикла."}},{"type":"paragraph","data":{"text":"Рак поджелудочной железы (местнораспространенный или метастатический)."}},{"type":"paragraph","data":{"text":"Рак шейки матки (местнораспространенный или метастатический)."}},{"type":"paragraph","data":{"text":"Комбинированная терапия. При местнораспространённом раке при последовательной химиолучевой терапии (неоадъювантно) и при метастатическом раке гемцитабин вводится в дозе 1250 мг/м\u003csup\u003e2\u003c/sup\u003e в 1 и 8 дни каждого 21-дневного цикла. Цисплатин вводится после введения гемцитабина в дозе 70 мг/м\u003csup\u003e2\u003c/sup\u003e в 1 день цикла на фоне гипергидратации. При местнораспространённом раке при одновременной химиолучевой терапии гемцитабин вводится 1 раз в неделю за 1-2 часа до начала лучевой терапии в дозе 125 мг/м\u003csup\u003e2\u003c/sup\u003e с последующим (непосредственно после введения гемцитабина) введением цисплатина в дозе 40 мг/м\u003csup\u003e2\u003c/sup\u003e."}},{"type":"paragraph","data":{"text":"Перед каждым введением гемцитабина необходимо контролировать количество тромбоцитов, лейкоцитов и гранулоцитов в крови. При признаках угнетения функции костного мозга необходимо приостановить лечение или скорректировать дозу."}},{"type":"paragraph","data":{"text":"В случае развития гематологической токсичности доза гемцитабина может быть уменьшена, либо её введение отложено в соответствии со следующей схемой:"}},{"type":"paragraph","data":{"text":"Абсолютное количество гранулоцитов (в 1 мкл)"}},{"type":"paragraph","data":{"text":"Количество тромбоцитов (в 1 мкл)"}},{"type":"paragraph","data":{"text":"% от предыдущей дозы"}},{"type":"paragraph","data":{"text":"> 1000и> 100000100500-1000или50000-10000075< 500или< 50000Отложить введение"}},{"type":"paragraph","data":{"text":"Особые группы пациентов"}},{"type":"paragraph","data":{"text":"Пожилые пациенты: доказательств, позволяющих предположить, что у пожилых больных необходимо корректировать дозу, не имеется, хотя клиренс гемцитабина и период полувыведения с возрастом изменяются."}},{"type":"paragraph","data":{"text":"Пациенты с нарушением функции печени и почек: применять гемцитабин у больных с печёночной недостаточностью или с нарушенной функцией почек следует с осторожностью, так как достаточных данных по применению препарата у этой категории пациентов нет. Умеренная или средней тяжести почечная недостаточность (скорость клубочковой фильтрации от 30 мл/мин до 80 мл/мин) не оказывает заметного влияния на фармакокинетику гемцитабина. Дети: применение гемцитабина у детей не изучалось."}},{"type":"paragraph","data":{"text":"Рекомендации по приготовлению раствора для инфузий"}},{"type":"paragraph","data":{"text":"В качестве растворителя используется только 0,9 % раствор натрия хлорида (без консервантов). Для приготовления раствора для инфузий содержимое флакона 200 мг растворяют в не менее, чем 5 мл, и 1 г - в не менее, чем 25 мл 0,9% раствора натрия хлорида для инъекций. Каждый флакон аккуратно взбалтывают до полного растворения лиофилизата. Полученный раствор должен быть прозрачным."}},{"type":"paragraph","data":{"text":"Максимальная концентрация гемцитабина не должна превышать 40 мг/мл. Растворы, приготовленные с концентрацией выше, чем 40 мг/мл, могут сопровождаться неполным растворением."}},{"type":"paragraph","data":{"text":"Приготовленный раствор гемцитабина, содержащий нужную дозу препарата, перед введением разбавляют 0,9% раствором натрия хлорида для инъекций в количестве, достаточном для проведения 30-минутной внутривенной инфузий."}},{"type":"paragraph","data":{"text":"Перед парентеральным введением необходимо визуально контролировать приготовленный раствор на наличие механических примесей и изменение цвета."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Побочное действие"}},{"type":"paragraph","data":{"text":"Побочные реакции, встречавшиеся чаще, чем в единичных случаях, перечислены соответствии со следующей градацией: очень часто (> 10%); часто (> 1%, 0,1%, 0,01%,"}},{"type":"paragraph","data":{"text":"Со стороны органов кроветворения: часто - лейкопения, тромбоцитопения, анемия; очень редко - тромбоцитоз."}},{"type":"paragraph","data":{"text":"Со стороны системы пищеварения: очень часто - тошнота, рвота, повышение уровня печеночных трансаминаз, щелочной фосфатазы; часто - анорексия, диарея, запор, стоматит, повышение уровня билирубина."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: очень часто - легкая протеинурия и гематурия; редко - почечная недостаточность, клинические признаки и симптомы, схожие с гемолитико- уремическим синдромом (снижение уровня гемоглобина, тромбоцитопения, увеличение уровней билирубина, креатинина, мочевины и/или лактатдегидрогеназы в сыворотке крови)."}},{"type":"paragraph","data":{"text":"Со стороны кожи и кожных придатков: часто - кожные высыпания, кожный зуд, алопеция."}},{"type":"paragraph","data":{"text":"Со стираны дыхательной системы: очень часто одышка, часто - кашель, ринит: иногда - бронхоспазм, интерстициальная пневмония, отек легкого; редко - острый респираторный дистресс-синдром."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: редко - снижение артериального давления, инфаркт миокарда, сердечная недостаточность, аритмия."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: часто - головная боль, сонливость, бессонница."}},{"type":"paragraph","data":{"text":"Прочие: очень часто - гриппоподобный синдром, периферические отеки; часто - повышение температуры тела, озноб, астения, боли в спине, миалгия; иногда - отечность лица; очень редко - анафилактические реакции."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":" Антидот для гемцитабина не известен. Клинически допустимая токсичность наблюдалась при введении однократных доз вплоть до 5,7 г/м\u003csup\u003e2\u003c/sup\u003e внутривенно в течение 30 минут каждые две недели. В случае подозрения на передозировку, больной должен находится под постоянным врачебным контролем, включая подсчет формулы крови. При необходимости больному проводят симптоматическое лечение. "}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Гемцитабин обладает радиосенсибилизирующим действием, в связи с чем при применении данного препарата на фоне проведения лучевой терапии можно ожидать усиления лучевых реакций. В случае последовательной химиолучевой терапии гемцитабин можно начинать вводить после разрешения острых лучевых реакций или не менее чем через одну неделю после окончания лучевой терапии."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Лечение гемцитабином можно проводить только под наблюдением врача, имеющего опыт применения противоопухолевой химиотерапии."}},{"type":"paragraph","data":{"text":"Перед началом лечения абсолютное количество гранулоцитов должно быть не менее 1500/мкл, тромбоцитов - не менее 100000/мкл."}},{"type":"paragraph","data":{"text":"Для выявления негематологической токсичности необходимо проводить регулярное обследование больного и оценку функции печени и почек. В зависимости от степени токсичности дозу можно снижать в ходе каждого цикла или с началом нового цикла ступенчато."}},{"type":"paragraph","data":{"text":"Решение об отсрочке очередного введения препарата должно базироваться на клинической оценке врачом динамики токсичности."}},{"type":"paragraph","data":{"text":"Увеличение длительности инфузии и частоты введений приводит к возрастанию токсичности. Введение гемцитабина при метастазах в печени, при гепатите и алкоголизме в анамнезе, а также при циррозе печени увеличивает риск развития печёночной недостаточности. При возникновении первых признаков гемолитико-уремического синдрома лечение гемцитабином следует прекратить."}},{"type":"paragraph","data":{"text":"У больных раком легкого или с метастазами в легких повышен риск возникновения побочных эффектов со стороны системы дыхания."}},{"type":"paragraph","data":{"text":"При появлении первых признаков пневмонита или появлении инфильтратов в легких лечение гемцитабином следует прекратить."}},{"type":"paragraph","data":{"text":"Женщинам и мужчинам во время лечения гемцитабином и, как минимум, в течение 6 месяцев после терапии следует использовать надежные способы контрацепции."}},{"type":"paragraph","data":{"text":"Форма выпуска"}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Исследований влияния гемцитабина на способность управлять автотранспортными средствами и другими механизмами не проводилось. Тем не менее известно, что \u003ca target=\"_blank\" href=\"http://www.lsgeotar.ru/pharma_mnn/622.html?XFrom=www.lsgeotar.ru\"\u003eгемцитабин\u003c/a\u003e может вызывать сонливость от слабой до умеренной степени выраженности, особенно совместно с употреблением алкоголя."}},{"type":"paragraph","data":{"text":"Пациентов следует предостерегать от управления механизмами в тех случаях, когда они чувствуют сонливость."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Лиофилизат для приготовления раствора для инфузий по 200 мг или 1 г во флаконах из стекла типа I. По одному флакону с инструкцией по применению в картонной пачке."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Список Б. При температуре 15-30°С в местах, недоступных для детей. Не охлаждать и не замораживать."}},{"type":"paragraph","data":{"text":"Приготовленный раствор: при температуре 15-30°С не более 24 часов, не охлаждать и не замораживать."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"\n\n3 года."}},{"type":"paragraph","data":{"text":"Не использовать по истечении срока годности, указанного на упаковке.\n\n"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":" по ренцепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\n\n«Лилли Франс C.A.C.», Франция Ру ду Колонел Лилли, 67640 Фегершейм, Франция"}},{"type":"paragraph","data":{"text":"«Lilly France S.A.S.», France -Rue\"duC6lonirLill^\n\n"}}]}],"source":null},"description_toggle":false,"short_description":"Гемцитабин представляет собой антиметаболит группы аналогов пиримидина. Препарат проявляет циклоспецифичность, действуя на клетки в фазах S и G1/S. Гемцитабин метаболизируется внутри клетки под действием нуклеозидкиназ с образованием активных дифосфатных и трифосфатных нуклеозидов. Дифосфатные нуклеозиды ингибируют рибонуклеотидредуктазу, которая действует в качестве единственного катализатора реакций, приводящих к образованию дезоксинуклеозидтрифосфатов, необходимых для синтеза ДНК. Трифосфатные нуклеозиды активно конкурируют с дезоксицитидинтрифосфатом за встраивание в молекулы ДНК и РНК. После встраивания внутриклеточных метаболитов гемцитабина в цепь ДНК, к ее растущим нитям добавляется ещё один дополнительный нуклеотид, что приводит к полному ингибированию дальнейшего синтеза ДНК и запрограммированной гибели клетки, известной как апоптоз. Фармакокинетика Гемцитабин быстро выводится из организма с мочой в основном в виде неактивного метаболита 2'-дезокси-2',2'-дифторуридина. Менее 10% введённой внутривенно дозы обнаруживается в моче в форме неизменённого препарата. Связывание гемцитабина с белками плазмы незначительное. Фармакокинетический анализ исследований с однократным и многократным введением доз показывает, что объём распределения в значительной степени зависит от пола. Системный клиренс, который колеблется примерно от 30 л/ч/м2до 90 л/ч/м2, зависит от возраста и пола. Период полувыведения колеблется от 32 минут до 94 минут.","substance":[{"id":1183,"title":"Гемцитабин","title_latin":null,"slug":"gemtsitabin_1183"}],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Гемзар - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/79248/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/79248/share_default/"}},"diseases":[],"other_packages":[],"other_product_forms":[],"related_products":{"title":"Похожие товары","type":"nondrugs","products":[{"id":133122,"title":"Доксорубицин-Лэнс","subtitle":{"full":"Лиофилизат, флакон, 1 шт, 50 мг, для инъекций","short":"Лиофилизат, 1 шт, 50 мг","package":"1 шт, 50 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