Рекомбинантный интерлейкин-2 (рИЛ-2), структурный и функциональный аналог эндогенного интерлейкина-2 (ИЛ-2).
ИЛ-2 продуцируется субпопуляцией Т-лимфоцитов (Т-хелперы I) в ответ на антигенную стимуляцию. Синтезированный ИЛ-2 воздействуетнаТ-лимфоциты, усиливая их пролиферацию и последующий синтез ИЛ-2.
Биологические эффекты ИЛ-2 опосредуются его связыванием со специфическими рецепторами, представленными на различных клеточных мишенях.
ИЛ-2 направленно влияет на рост, дифференцировку и активацию Т- и В- лимфоцитов, моноцитов, макрофагов, олигодендроглиальных клеток, клеток Лангерганса. От его присутствия зависит развитие цитолитической активности натуральных киллеров и цитотоксических Т-лимфоцитов. ИЛ-2 вызывает образование лимфокинактивированных киллеров и активирует опухоль-инфильтрирующие клетки.
Расширение спектра лизирующего действия эффекторных клеток обусловливает элиминацию разнообразных патогенных микроорганизмов, инфицированных и малигнизированных клеток, что обеспечивает иммунную защиту, направленную против опухолевых клеток, а также возбудителей вирусной, бактериальной и грибковой инфекции.
Показания к применению
В составе комплексной терапии у взрослых:
обычный вариабельный иммунодефицит;
комбинированный иммунодефицит;
острый перитонит;
острый панкреатит;
остеомиелит;
эндометрит;
тяжелая пневмония;
сепсис;
послеродовый сепсис;
туберкулез легких;
другие генерализованные и тяжелые локализованные инфекции;
инфицированные термические и химические ожоги;
диссеминированные и местнораспространенные формы почечноклеточного рака.
В составе комплексной терапии у детей от 0 лет:
обычный вариабельный иммунодефицит;
комбинированный иммунодефицит;
острый перитонит;
острый панкреатит;
остеомиелит;
тяжелая пневмония;
бактериальный сепсис новорожденных;
сепсис;
другие генерализованные и тяжелые локализованные инфекции.
Противопоказания
аутоиммунные заболевания;
сердечная недостаточность III ст.;
легочно-сердечная недостаточность III ст.;
метастатическое поражение головного мозга;
терминальная стадия почечно-клеточного рака;
беременность;
повышенная чувствительность к дрожжам;
повышенная чувствительность к интерлейкину-2 или любому компоненту препарата в анамнезе.
С осторожностью
при хронической почечной недостаточности, декомпенсированной печеночной недостаточности.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан при беременности.
Способ применения и дозы
Режим дозирования
Ронколейкин® вводят 1 раз/сут п/к или в/в капельно по 0.5-1.0 мг с интервалами 1-3 дня, на курс - 1-3 введения. Для в/в введения препарат из ампулы переносят в 400 мл изотонического раствора натрия хлорида для инъекций. Инфузия всего объема раствора осуществляется капельно в течение 4-6 ч.
Раствор препарата должен быть прозрачным, бесцветным и не содержать посторонних включений.
Иммунотерапию препаратом Ронколейкин® проводят после завершения неотложных и срочных оперативных вмешательств, направленных на устранение жизнеугрожающих последствий основного заболевания/травмы, санации и адекватного дренирования инфекционного очага.
При лечении тяжелого сепсиса проводят от 1 до 3 курсов лечения препаратом Ронколейкин®. Курс включает 2 в/в инфузии в дозе 0.5 мг через день. Критерием для назначения второго и третьего курсов лечения препаратом Ронколейкин® является сохраняющаяся в ходе лечения лимфопения (абсолютная и/или относительная).
При впервые выявленном инфильтративном деструктивном туберкулезе легких - 3 в/в инфузии препарата Ронколейкин® в дозе 0.5 мг с интервалом 48 ч на фоне специфической полихимиотерапии.
Для предоперационной подготовки при прогрессирующем фиброзно-кавернозном туберкулезе (ФКТ) легких на фоне специфической полихимиотерапии: при одностороннем ФКТ - 3 в/в введения препарата Ронколейкин® по 1 мг с интервалом 48 ч; при распространенном ФКТ легких с двусторонней очаговой диссеминацией - 7 в/в введений препарата Ронколейкин®: 3 введения в течение первой недели по 1 мг с интервалом 48 ч, далее по 1 мг 2 раза в неделю в течение 2 недель. Рекомендуемый курс иммунотерапии должен быть завершен за 7-10 дней до оперативного вмешательства.
Назначение препарата Ронколейкин® при туберкулезе легких нецелесообразно при дефиците массы тела более 30%.
Курс лечения препаратом Ронколейкин®диссеминированных и местнораспространенных форм почечно-клеточного рака включает:
однократное п/к или в/в введение препарата в дозе 0.5 мг за 24 ч до операции;
в составе 8-недельного курса иммунохимиотерапии по 2.0 мг в/в через день в течение первых 4 недель лечения. Повторные курсы проводят через 1-2 мес.
У детей Ронколейкин® применяют в/в капельно. Схемы применения соответствуют таковым у взрослых. Препарат разводят в изотоническом (0.9%) растворе натрия хлорида. Разовая доза препарата и объем изотонического раствора у детей зависит от возраста:
от 0 до 1 мес - 0.1 мг в 30-50 мл раствора;
от 1 мес до 1 года - 0.125 мг в 100 мл раствора;
от 1 года до 7 лет - 0.25 мг в 200 мл раствора;
старше 7 лет - 0.5 мг в 200 мл раствора;
старше 14 лет - 0.5 мг в 400 мл раствора.
Побочное действие
Системные реакции: в отдельных случаях возможно появление кратковременного озноба и повышение температуры тела в процессе введения препарата Ронколейкин®, что купируется обычными терапевтическими средствами и не является основанием для прерывания введения препарата, а также отмены курса терапии.
Местные реакции: при п/к введении препарата отмечались болезненность, уплотнение, покраснение в месте инъекции.
Передозировка
Симптомы передозировки наблюдались при приеме препарата Ронколейкин® в разовой дозе выше 7 мг в виде лихорадки, нарушения ритма сердца, гипотонии, дерматологических аллергических реакций.
Лечение: данные симптомы купируются после отмены введения препарата, при необходимости проводится симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
Лечение препаратом Ронколейкин® можно сочетать с лечением всеми другими лекарственными средствами.
При применении препарата Ронколейкин® на фоне длительной терапии ГКС активность действия препарата может снижаться.
Ронколейкин® нельзя смешивать с другими лекарственными препаратами в одном шприце или флаконе.
Особые указания
Влияние на способность к управлению транспортными средствами и механизмами
Специальных исследований влияния препарата на способность управлять транспортными средствами и использовать сложное оборудование не проводилось. В случае развития нежелательных реакций со стороны органа зрения и/или снижения способности к концентрации внимания и быстроты реакции пациентам рекомендуется воздержаться от управления транспортными средствами или работы со сложным оборудованием до разрешения указанных нежелательных реакций.
Условия хранения
Препарат следует хранить в недоступном для детей месте при температуре от 2° до 8°С.
Срок годности
Срок годности - 2 года.
Транспортировка допускается при температуре от 9° до 25°С в течение 10 суток.
Условия отпуска
Препарат отпускается по рецепту
Для описания товара использована информация от партнера 36.6
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"}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"МИБП-цитокин"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Рекомбинантный интерлейкин-2 (рИЛ-2), структурный и функциональный аналог эндогенного интерлейкина-2 (ИЛ-2)."}},{"type":"paragraph","data":{"text":"ИЛ-2 продуцируется субпопуляцией Т-лимфоцитов (Т-хелперы I) в ответ на антигенную стимуляцию. Синтезированный ИЛ-2 воздействуетнаТ-лимфоциты, усиливая их пролиферацию и последующий синтез ИЛ-2."}},{"type":"paragraph","data":{"text":"Биологические эффекты ИЛ-2 опосредуются его связыванием со специфическими рецепторами, представленными на различных клеточных мишенях."}},{"type":"paragraph","data":{"text":"ИЛ-2 направленно влияет на рост, дифференцировку и активацию Т- и В- лимфоцитов, моноцитов, макрофагов, олигодендроглиальных клеток, клеток Лангерганса. От его присутствия зависит развитие цитолитической активности натуральных киллеров и цитотоксических Т-лимфоцитов. ИЛ-2 вызывает образование лимфокинактивированных киллеров и активирует опухоль-инфильтрирующие клетки."}},{"type":"paragraph","data":{"text":"Расширение спектра лизирующего действия эффекторных клеток обусловливает элиминацию разнообразных патогенных микроорганизмов, инфицированных и малигнизированных клеток, что обеспечивает иммунную защиту, направленную против опухолевых клеток, а также возбудителей вирусной, бактериальной и грибковой инфекции."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"В составе комплексной терапии у \u003cb\u003eвзрослых\u003c/b\u003e:"}},{"type":"list","data":{"style":"ordered","items":["обычный вариабельный иммунодефицит;","комбинированный иммунодефицит;","острый перитонит;","острый панкреатит;","остеомиелит;","эндометрит;","тяжелая пневмония;","сепсис;","послеродовый сепсис;","туберкулез легких;","другие генерализованные и тяжелые локализованные инфекции;","инфицированные термические и химические ожоги;","диссеминированные и местнораспространенные формы почечноклеточного рака."]}},{"type":"paragraph","data":{"text":"В составе комплексной терапии у \u003cb\u003eдетей от 0 лет\u003c/b\u003e:"}},{"type":"list","data":{"style":"ordered","items":["обычный вариабельный иммунодефицит;","комбинированный иммунодефицит;","острый перитонит;","острый панкреатит;","остеомиелит;","тяжелая пневмония;","бактериальный сепсис новорожденных;","сепсис;","другие генерализованные и тяжелые локализованные инфекции."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["аутоиммунные заболевания;","сердечная недостаточность III ст.;","легочно-сердечная недостаточность III ст.;","метастатическое поражение головного мозга;","терминальная стадия почечно-клеточного рака;","беременность;","повышенная чувствительность к дрожжам;","повышенная чувствительность к интерлейкину-2 или любому компоненту препарата в анамнезе."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"при хронической почечной недостаточности, декомпенсированной печеночной недостаточности."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат противопоказан при беременности."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"header","data":{"text":"Режим дозирования","level":4}},{"type":"paragraph","data":{"text":"Ронколейкин\u003csup\u003e®\u003c/sup\u003e вводят 1 раз/сут п/к или в/в капельно по 0.5-1.0 мг с интервалами 1-3 дня, на курс - 1-3 введения. Для в/в введения препарат из ампулы переносят в 400 мл изотонического раствора натрия хлорида для инъекций. Инфузия всего объема раствора осуществляется капельно в течение 4-6 ч."}},{"type":"paragraph","data":{"text":"Раствор препарата должен быть прозрачным, бесцветным и не содержать посторонних включений."}},{"type":"paragraph","data":{"text":"Иммунотерапию препаратом Ронколейкин\u003csup\u003e®\u003c/sup\u003e проводят после завершения неотложных и срочных оперативных вмешательств, направленных на устранение жизнеугрожающих последствий основного заболевания/травмы, санации и адекватного дренирования инфекционного очага."}},{"type":"paragraph","data":{"text":"При\u003ci\u003e лечении тяжелого сепсиса \u003c/i\u003eпроводят от 1 до 3 курсов лечения препаратом Ронколейкин\u003csup\u003e®\u003c/sup\u003e. Курс включает 2 в/в инфузии в дозе 0.5 мг через день. Критерием для назначения второго и третьего курсов лечения препаратом Ронколейкин\u003csup\u003e®\u003c/sup\u003e является сохраняющаяся в ходе лечения лимфопения (абсолютная и/или относительная)."}},{"type":"paragraph","data":{"text":"При\u003ci\u003e впервые выявленном инфильтративном деструктивном туберкулезе легких - \u003c/i\u003e3 в/в инфузии препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e в дозе 0.5 мг с интервалом 48 ч на фоне специфической полихимиотерапии."}},{"type":"paragraph","data":{"text":"Для\u003ci\u003e предоперационной подготовки при прогрессирующем фиброзно-кавернозном туберкулезе (ФКТ) легких \u003c/i\u003eна фоне специфической полихимиотерапии: при одностороннем ФКТ - 3 в/в введения препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e по 1 мг с интервалом 48 ч; при распространенном ФКТ легких с двусторонней очаговой диссеминацией - 7 в/в введений препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e: 3 введения в течение первой недели по 1 мг с интервалом 48 ч, далее по 1 мг 2 раза в неделю в течение 2 недель. Рекомендуемый курс иммунотерапии должен быть завершен за 7-10 дней до оперативного вмешательства."}},{"type":"paragraph","data":{"text":"Назначение препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e при туберкулезе легких нецелесообразно при дефиците массы тела более 30%."}},{"type":"paragraph","data":{"text":"Курс лечения препаратом Ронколейкин\u003csup\u003e®\u003c/sup\u003e \u003ci\u003eдиссеминированных и местнораспространенных форм почечно-клеточного рака \u003c/i\u003eвключает:"}},{"type":"list","data":{"style":"ordered","items":["однократное п/к или в/в введение препарата в дозе 0.5 мг за 24 ч до операции;","в составе 8-недельного курса иммунохимиотерапии по 2.0 мг в/в через день в течение первых 4 недель лечения. Повторные курсы проводят через 1-2 мес."]}},{"type":"paragraph","data":{"text":"У \u003cb\u003eдетей \u003c/b\u003eРонколейкин\u003csup\u003e®\u003c/sup\u003e применяют в/в капельно. Схемы применения соответствуют таковым у взрослых. Препарат разводят в изотоническом (0.9%) растворе натрия хлорида. Разовая доза препарата и объем изотонического раствора у детей зависит от возраста:"}},{"type":"list","data":{"style":"ordered","items":["от 0 до 1 мес - 0.1 мг в 30-50 мл раствора;","от 1 мес до 1 года - 0.125 мг в 100 мл раствора;","от 1 года до 7 лет - 0.25 мг в 200 мл раствора;","старше 7 лет - 0.5 мг в 200 мл раствора;","старше 14 лет - 0.5 мг в 400 мл раствора."]}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСистемные реакции:\u003c/i\u003e в отдельных случаях возможно появление кратковременного озноба и повышение температуры тела в процессе введения препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e, что купируется обычными терапевтическими средствами и не является основанием для прерывания введения препарата, а также отмены курса терапии."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМестные реакции:\u003c/i\u003e при п/к введении препарата отмечались болезненность, уплотнение, покраснение в месте инъекции."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы\u003c/i\u003e передозировки наблюдались при приеме препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e в разовой дозе выше 7 мг в виде лихорадки, нарушения ритма сердца, гипотонии, дерматологических аллергических реакций."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e данные симптомы купируются после отмены введения препарата, при необходимости проводится симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Лечение препаратом Ронколейкин\u003csup\u003e®\u003c/sup\u003e можно сочетать с лечением всеми другими лекарственными средствами."}},{"type":"paragraph","data":{"text":"При применении препарата Ронколейкин\u003csup\u003e®\u003c/sup\u003e на фоне длительной терапии ГКС активность действия препарата может снижаться."}},{"type":"paragraph","data":{"text":"Ронколейкин\u003csup\u003e®\u003c/sup\u003e нельзя смешивать с другими лекарственными препаратами в одном шприце или флаконе."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Специальных исследований влияния препарата на способность управлять транспортными средствами и использовать сложное оборудование не проводилось. В случае развития нежелательных реакций со стороны органа зрения и/или снижения способности к концентрации внимания и быстроты реакции пациентам рекомендуется воздержаться от управления транспортными средствами или работы со сложным оборудованием до разрешения указанных нежелательных реакций."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в недоступном для детей месте при температуре от 2° до 8°С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"Срок годности - 2 года."}},{"type":"paragraph","data":{"text":"Транспортировка допускается при температуре от 9° до 25°С в течение 10 суток."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Препарат отпускается по рецепту"}}]}],"source":null},"description_toggle":false,"short_description":"Рекомбинантный интерлейкин-2 (рИЛ-2), структурный и функциональный аналог эндогенного интерлейкина-2 (ИЛ-2). 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