Росинсулин С - человеческий инсулин, полученный с использова... Инструкция
Показания к применению
Сахарный диабет.
Противопоказания
Повышенная индивидуальная чувствительность к инсулину или любому из компонентов препарата;
гипогликемия.
Инструкция
Состав
Активные вещества:
Инсулин человеческий рекомбинантный - 100 МЕ
Вспомогательные вещества:
Протамина сульфат - 0,27 - 0,40 м,
Натрия гидрофосфата дигидрат - 2,4 мг,
фенол - 0,6 мг,
Метакрезол -1,6 мг,
Глицерол (глицерин) 16 мг,
Вода для инъекций до 1 мл
Фармакологические свойства
Росинсулин С - человеческий инсулин, полученный с использованием технологии рекомбинантной ДНК. Является препаратом инсулина средней продолжительности действия. Взаимодействует со специфическим рецептором внешней цитоплазматической мембраны клеток и образует инсулин-рецепторный комплекс, стимулирующий внутриклеточные процессы, в т. ч. синтез ряда ключевых ферментов (гексокиназа, пируваткиназа, гликогенсинтетаза и др.).
Снижение содержания глюкозы в крови обусловлено повышением ее внутриклеточного транспорта, усилением поглощения и усвоения тканями, стимуляцией липогенеза, гликогеногенеза, снижением скорости продукции глюкозы печенью и др. Продолжительность действия препаратов инсулина в основном обусловлена скоростью всасывания, которая зависит от нескольких факторов (например, от дозы, способа и места введения), в связи с чем профиль действия инсулина подвержен значительным колебаниям, как у различных людей, так и у одного и того же человека.
Профиль действия при подкожной инъекции (приблизительные цифры): начало действия через 1-2 часа, максимальный эффект - в промежутке между 6 и 12 часами, продолжительность действия - 18-24 часа.
Показания к применению
Сахарный диабет.
Противопоказания
Повышенная индивидуальная чувствительность к инсулину или любому из компонентов препарата;
гипогликемия.
Способ применения и дозы
Росинсулин С предназначен для подкожного введения. Доза препарата определяется врачом индивидуально в каждом конкретном случае, на основании уровня глюкозы в крови. В среднем суточная доза препарата колеблется от 0,5 МЕ/кг до 1 МЕ/кг массы тела (зависит от индивидуальных особенностей пациента и уровня глюкозы крови).
Температура вводимого инсулина должна соответствовать комнатной.
Росинсулин С обычно вводится подкожно в бедро. Инъекции можно делать также в переднюю брюшную стенку, ягодицу или область дельтовидной мышцы плеча.
Необходимо менять места инъекций в пределах анатомической области, чтобы предотвратить развитие липодистрофий.
Росинсулин С может вводиться как самостоятельно, так и в комбинации с инсулином короткого действия (Росинсулин Р).
При использовании предварительно заполненных одноразовых мультидозовых шприц-ручек для многократных инъекций необходимо перед первым использованием вынуть шприц-ручку из холодильника и дать препарату достичь комнатной температуры. Препарат Росинсулин С в одноразовой шприц-ручке нельзя применять, если он был заморожен. Необходимо точно следовать указаниям руководства по использованию шприц-ручки, поставляемого с препаратом.
Побочное действие
Обусловленное влиянием на углеводный обмен: гипогликемические состояния (бледность кожных покровов, усиление потоотделения, сердцебиение, тремор, чувство голода, возбуждение, парестезии в области рта, головная боль). Выраженная гипогликемия может привести к развитию гипогликемической комы.
Аллергические реакции: редко - кожная сыпь, отек Квинке; крайне редко - анафилактический шок.
Местные реакции: гиперемия, отечность и зуд в месте инъекции; при длительном применении - липодистрофия в месте инъекции.
Прочие: отеки, преходящие нарушения рефракции (обычно в начале терапии).
Передозировка
При передозировке возможно развитие гипогликемии.
Лечение: легкую гипогликемию пациент может устранить сам, приняв внутрь сахар или богатые углеводами продукты питания. Поэтому больным сахарным диабетом рекомендуется постоянно носить с собой сахар, сладости, печенье или сладкий фруктовый сок.
В тяжелых случаях, при потере пациентом сознания, внутривенно вводят 40% раствор декстрозы; внутримышечно, подкожно, внутривенно - глюкагон. После восстановления сознания пациенту рекомендуют принять пищу, богатую углеводами, для предотвращения повторного развития гипогликемии.
Взаимодействие с другими лекарственными средствами
Имеется ряд лекарственных средств, которые влияют на потребность в инсулине.
Под влиянием резерпина и салицилатов возможно как ослабление, так и усиление действия препарата.
Особые указания
Перед каждым использованием тщательно проверять внешний вид содержимого флакона и НЕ ИСПОЛЬЗОВАТЬ Росинсулин С, если после перемешивания суспензия содержит хлопья или если частички белого цвета прилипли ко дну или стенкам флакона, создавая эффект морозного узора.
Нельзя использовать Росинсулин С, если после взбалтывания суспензия не становится белой и равномерно мутной.
На фоне терапии инсулином необходим постоянный контроль уровня глюкозы в крови.
Причинами гипогликемии помимо передозировки инсулина могут быть: замена препарата, пропуск приема пищи, рвота, диарея, увеличение физической активности, заболевания, снижающие потребность в инсулине (нарушения функции печени и почек, гипофункция коры надпочечников, гипофиза или щитовидной железы), смена места инъекции, а также взаимодействие с другими лекарственными средствами.
Неправильное дозирование или перерывы во введении инсулина, особенно у больных с сахарным диабетом типа I, могут привести к гипергликемии. Обычно первые симптомы гипергликемии развиваются постепенно, на протяжении нескольких часов или дней. Они включают появление жажды, учащение мочеиспускания, тошноту, рвоту, головокружение, покраснение и сухость кожи, сухость во рту, потерю аппетита, запах ацетона в выдыхаемом воздухе. Если не проводить лечение, гипергликемия при сахарном диабете типа 1 может приводить к развитию опасного для жизни диабетического кетоацидоза.
Дозу инсулина необходимо корригировать при нарушении функции щитовидной железы, болезни Аддисона, гипопитуитаризме, нарушениях функции печени и почек и сахарном диабете у лиц старше 65 лет.
Коррекция дозы инсулина может также потребоваться, если больной увеличивает интенсивность физической активности или изменяет привычную диету.
Сопутствующие заболевания, особенно инфекции и состояния, сопровождающиеся лихорадкой, увеличивают потребность в инсулине.
Переход с одного вида инсулина па другой следует проводить под контролем уровня глюкозы в крови.
Препарат понижает толерантность к алкоголю.
В связи с возможностью к преципитации в некоторых катетерах, не рекомендуется использование препарата в инсулиновых насосах.
Условия хранения
В защищенном от света месте при температуре от 2 до 8 °С. Не допускать замораживания.
Находящийся в употреблении препарат хранить при комнатной температуре 15-25 °С не более 28 дней, предохранять от прямых солнечных лучей и нагревания.
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вещества:"}},{"type":"paragraph","data":{"text":"Инсулин человеческий рекомбинантный - 100 МЕ"}},{"type":"paragraph","data":{"text":"Вспомогательные вещества:"}},{"type":"paragraph","data":{"text":"Протамина сульфат - 0,27 - 0,40 м,"}},{"type":"paragraph","data":{"text":"Натрия гидрофосфата дигидрат - 2,4 мг,"}},{"type":"paragraph","data":{"text":"фенол - 0,6 мг,"}},{"type":"paragraph","data":{"text":"Метакрезол -1,6 мг,"}},{"type":"paragraph","data":{"text":"Глицерол (глицерин) 16 мг,"}},{"type":"paragraph","data":{"text":"Вода для инъекций до 1 мл"}}]},{"id":9,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Росинсулин С - человеческий инсулин, полученный с использованием технологии рекомбинантной ДНК. Является препаратом инсулина средней продолжительности действия. Взаимодействует со специфическим рецептором внешней цитоплазматической мембраны клеток и образует инсулин-рецепторный комплекс, стимулирующий внутриклеточные процессы, в т. ч. синтез ряда ключевых ферментов (гексокиназа, пируваткиназа, гликогенсинтетаза и др.)."}},{"type":"paragraph","data":{"text":"Снижение содержания глюкозы в крови обусловлено повышением ее внутриклеточного транспорта, усилением поглощения и усвоения тканями, стимуляцией липогенеза, гликогеногенеза, снижением скорости продукции глюкозы печенью и др. Продолжительность действия препаратов инсулина в основном обусловлена скоростью всасывания, которая зависит от нескольких факторов (например, от дозы, способа и места введения), в связи с чем профиль действия инсулина подвержен значительным колебаниям, как у различных людей, так и у одного и того же человека."}},{"type":"paragraph","data":{"text":"Профиль действия при подкожной инъекции (приблизительные цифры): начало действия через 1-2 часа, максимальный эффект - в промежутке между 6 и 12 часами, продолжительность действия - 18-24 часа."}}]},{"id":10,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Сахарный диабет."}}]},{"id":11,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":" Повышенная индивидуальная чувствительность к инсулину или любому из компонентов препарата;"}},{"type":"paragraph","data":{"text":"гипогликемия."}}]},{"id":14,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Росинсулин С предназначен для подкожного введения. Доза препарата определяется врачом индивидуально в каждом конкретном случае, на основании уровня глюкозы в крови. В среднем суточная доза препарата колеблется от 0,5 МЕ/кг до 1 МЕ/кг массы тела (зависит от индивидуальных особенностей пациента и уровня глюкозы крови)."}},{"type":"paragraph","data":{"text":"Температура вводимого инсулина должна соответствовать комнатной."}},{"type":"paragraph","data":{"text":"Росинсулин С обычно вводится подкожно в бедро. Инъекции можно делать также в переднюю брюшную стенку, ягодицу или область дельтовидной мышцы плеча."}},{"type":"paragraph","data":{"text":"Необходимо менять места инъекций в пределах анатомической области, чтобы предотвратить развитие липодистрофий."}},{"type":"paragraph","data":{"text":"Росинсулин С может вводиться как самостоятельно, так и в комбинации с инсулином короткого действия (Росинсулин Р)."}},{"type":"paragraph","data":{"text":"При использовании предварительно заполненных одноразовых мультидозовых шприц-ручек для многократных инъекций необходимо перед первым использованием вынуть шприц-ручку из холодильника и дать препарату достичь комнатной температуры. Препарат Росинсулин С в одноразовой шприц-ручке нельзя применять, если он был заморожен. Необходимо точно следовать указаниям руководства по использованию шприц-ручки, поставляемого с препаратом."}}]},{"id":15,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Обусловленное влиянием на углеводный обмен: гипогликемические состояния (бледность кожных покровов, усиление потоотделения, сердцебиение, тремор, чувство голода, возбуждение, парестезии в области рта, головная боль). Выраженная гипогликемия может привести к развитию гипогликемической комы."}},{"type":"paragraph","data":{"text":"Аллергические реакции: редко - кожная сыпь, отек Квинке; крайне редко - анафилактический шок."}},{"type":"paragraph","data":{"text":"Местные реакции: гиперемия, отечность и зуд в месте инъекции; при длительном применении - липодистрофия в месте инъекции."}},{"type":"paragraph","data":{"text":"Прочие: отеки, преходящие нарушения рефракции (обычно в начале терапии)."}}]},{"id":16,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При передозировке возможно развитие гипогликемии."}},{"type":"paragraph","data":{"text":"Лечение: легкую гипогликемию пациент может устранить сам, приняв внутрь сахар или богатые углеводами продукты питания. Поэтому больным сахарным диабетом рекомендуется постоянно носить с собой сахар, сладости, печенье или сладкий фруктовый сок."}},{"type":"paragraph","data":{"text":"В тяжелых случаях, при потере пациентом сознания, внутривенно вводят 40% раствор декстрозы; внутримышечно, подкожно, внутривенно - глюкагон. После восстановления сознания пациенту рекомендуют принять пищу, богатую углеводами, для предотвращения повторного развития гипогликемии."}}]},{"id":17,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Имеется ряд лекарственных средств, которые влияют на потребность в инсулине."}},{"type":"paragraph","data":{"text":"Гипогликемическое действие инсулина усиливают пероральные гипогликемические препараты, ингибиторы моноаминоксидазы, ингибиторы ангиотензинпревращающего фермента, ингибиторы карбоангидразы, неселективные бета-адреноблокаторы, бромокриптин, октреотид, сульфаниламиды, анаболические стероиды, тетрациклины, клофибрат, кетоконазол, мебендазол, пиридоксин, теофиллин, циклофосфамид, фенфлурамин, препараты лития, препараты, содержащие этанол."}},{"type":"paragraph","data":{"text":"Гипогликемическое действие инсулина ослабляют пероральные контрацептивы, глюкокортикостероиды, тиреоидные гормоны, тиазидные диуретики, гепарин, трициклические антидепрессанты, симпатомиметики, даназол, клонидин, блокаторы кальциевых каналов, диазоксид, морфин, фенитоин, никотин."}},{"type":"paragraph","data":{"text":"Под влиянием резерпина и салицилатов возможно как ослабление, так и усиление действия препарата."}}]},{"id":18,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед каждым использованием тщательно проверять внешний вид содержимого флакона и НЕ ИСПОЛЬЗОВАТЬ Росинсулин С, если после перемешивания суспензия содержит хлопья или если частички белого цвета прилипли ко дну или стенкам флакона, создавая эффект морозного узора."}},{"type":"paragraph","data":{"text":"Нельзя использовать Росинсулин С, если после взбалтывания суспензия не становится белой и равномерно мутной."}},{"type":"paragraph","data":{"text":"На фоне терапии инсулином необходим постоянный контроль уровня глюкозы в крови."}},{"type":"paragraph","data":{"text":"Причинами гипогликемии помимо передозировки инсулина могут быть: замена препарата, пропуск приема пищи, рвота, диарея, увеличение физической активности, заболевания, снижающие потребность в инсулине (нарушения функции печени и почек, гипофункция коры надпочечников, гипофиза или щитовидной железы), смена места инъекции, а также взаимодействие с другими лекарственными средствами."}},{"type":"paragraph","data":{"text":"Неправильное дозирование или перерывы во введении инсулина, особенно у больных с сахарным диабетом типа I, могут привести к гипергликемии. Обычно первые симптомы гипергликемии развиваются постепенно, на протяжении нескольких часов или дней. Они включают появление жажды, учащение мочеиспускания, тошноту, рвоту, головокружение, покраснение и сухость кожи, сухость во рту, потерю аппетита, запах ацетона в выдыхаемом воздухе. Если не проводить лечение, гипергликемия при сахарном диабете типа 1 может приводить к развитию опасного для жизни диабетического кетоацидоза."}},{"type":"paragraph","data":{"text":"Дозу инсулина необходимо корригировать при нарушении функции щитовидной железы, болезни Аддисона, гипопитуитаризме, нарушениях функции печени и почек и сахарном диабете у лиц старше 65 лет."}},{"type":"paragraph","data":{"text":"Коррекция дозы инсулина может также потребоваться, если больной увеличивает интенсивность физической активности или изменяет привычную диету."}},{"type":"paragraph","data":{"text":"Сопутствующие заболевания, особенно инфекции и состояния, сопровождающиеся лихорадкой, увеличивают потребность в инсулине."}},{"type":"paragraph","data":{"text":"Переход с одного вида инсулина па другой следует проводить под контролем уровня глюкозы в крови."}},{"type":"paragraph","data":{"text":"Препарат понижает толерантность к алкоголю."}},{"type":"paragraph","data":{"text":"В связи с возможностью к преципитации в некоторых катетерах, не рекомендуется использование препарата в инсулиновых насосах."}}]},{"id":21,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте при температуре от 2 до 8 °С. Не допускать замораживания."}},{"type":"paragraph","data":{"text":"Находящийся в употреблении препарат хранить при комнатной температуре 15-25 °С не более 28 дней, предохранять от прямых солнечных лучей и нагревания."}},{"type":"paragraph","data":{"text":"Хранить в местах, недоступных для детей."}}]},{"id":22,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}}]}],"source":{"title":"('Эркафарм/Столетов',)","url":"https://stoletov.ru/"}},"description_toggle":false,"short_description":"Росинсулин С - человеческий инсулин, полученный с использованием технологии рекомбинантной ДНК. Является препаратом инсулина средней продолжительности действия. Взаимодействует со специфическим рецептором внешней цитоплазматической мембраны клеток и образует инсулин-рецепторный комплекс, стимулирующий внутриклеточные процессы, в т. ч. синтез ряда ключевых ферментов (гексокиназа, пируваткиназа, гликогенсинтетаза и др.). Снижение содержания глюкозы в крови обусловлено повышением ее внутриклеточного транспорта, усилением поглощения и усвоения тканями, стимуляцией липогенеза, гликогеногенеза, снижением скорости продукции глюкозы печенью и др. Продолжительность действия препаратов инсулина в основном обусловлена скоростью всасывания, которая зависит от нескольких факторов (например, от дозы, способа и места введения), в связи с чем профиль действия инсулина подвержен значительным колебаниям, как у различных людей, так и у одного и того же человека. 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