Вспомогательные вещества: N-метил-D-глюкамин, вода для инъекций
Фармакотерапевтическая группа
Радахлорин® является фотосенсибилизатором второго поколения, предназначенным для флуоресцентной диагностики (ФД) и фотодинамической терапии (ФДТ) злокачественных опухолей.
Метод ФДТ основан на способности Радахлорина® избирательно накапливаться в опухоли кожи при его в/в введении и генерировать синглетный кислород, оказывающий токсический эффект на опухолевые клетки и модифицирующее действие на их плазматические мембраны при воздействии света с длиной волны, соответствующей одному из пиков поглощения препарата (406, 506, 536, 608 или 662 нм).
В развитии эффекта после проведения ФДТ с препаратом Радахлорин® можно выделить 3 этапа:
1 этап — характерная реакция на световое воздействие при ФДТ, проявляющаяся в виде отека и гиперемии зоны облучения различной выраженности;
2 этап — некроз опухоли, который формируется через 2–4 дня после сеанса ФДТ;
3 этап — отторжение некротических масс и эпителизация дефекта раны через 2–8 нед в зависимости от размеров опухоли.
Радахлорин® в дозах 0,5–2,4 мг/кг при облучении опухоли лазерным излучением через 3 ч после введения препарата не обладает мутагенным действием и не повреждает ДНК нормальных клеток.
Фармакологические свойства
После однократного в/в введения Радахлорина® в дозах 0,5–2,4 мг/кг он в течение 0,5–5 ч распределяется между кровью и тканями. Cmax Радахлорина® в сыворотке крови достигается через 15–30 мин и быстро снижается, составляя через 1 ч после введения в дозе 0,5 мг/кг — 10 мкг/л, через 3 ч — 5 мкг/л, через 24 ч — 1 мкг/л.
Cmax Радахлорина® в опухоли достигается через 1 ч (10–20 мкг/мл), но при более быстром выведении его из окружающих опухоль здоровых тканей, максимальный терапевтический индекс (индекс контрастности) наблюдается через 3 ч после введения препарата. Концентрация препарата в опухолевой ткани выше, чем в окружающих здоровых тканях, в среднем в 3–6 раз, зависит от морфологической структуры опухоли, и составляет 2–10 мкг/мл.
Быстрое выведение Радахлорина® из крови, кожи и слизистых оболочек и высокий индекс контрастности исключают повреждение здоровых органов и тканей и гиперчувствительность кожных покровов к дневному свету.
Наиболее высокие уровни Радахлорина® через 3 ч после введения создаются в печени, почках, опухолевой ткани.
Около 70–80% Радахлорина® метаболизируется в печени до биладиенов (линейных тетрапирролов, являющихся также продуктами метаболизма гема). Препарат выводится в неизмененном виде с калом (15%) и мочой (3%). Кумулятивная экскреция Радахлорина® с калом и мочой за первые 12 ч составляет в среднем 15–20% от введенной дозы препарата. Основная часть (98%) Радахлорина® выводится или метаболизируется в течение первых 48 ч. Следовые количества препарата определяются в коже вплоть до 6 сут.
повышенная чувствительность к любому из компонентов препарата;
беременность и период кормления грудью;
детский возраст (опыта применения препарата нет).
Применение при беременности и в период грудного вскармливания
Противопоказано применение препарата Радахлорин® при беременности. На время лечения следует прекратить грудное вскармливание
Способ применения и дозы
Внутривенно, капельно в течение 30 минут.
Световое воздействие излучением с длиной волны(662±3) нм начинают через 3 ч после окончания инфузии.
Оптимальным режимом воздействия является введение препарата в дозе 1,0–1,2 мг/кг и световое воздействие излучением с длиной волны(662±3) нм в дозе 300 Дж/см2 .
При возможности проведения повторного лечения пациентов с частичным эффектом или стабилизацией, возможно использование и двух других режимов: 0,5–0,6 мг/кг — 300 Дж/см2 ;1,0–1,2 мг/кг — 200 Дж/см2 .
При этом выбор режима должен осуществляться индивидуально с учетом формы и распространенности опухолевого процесса.
При воздействии лазером используют дистанционное поверхностное облучение через кварцевый световод с применением или без применения микролинз.
В качестве источника лазерного излучения используют диодный лазер с длиной волны(662±3) нм.
Для выявления дополнительных очагов и уточнения границ распространения опухолевого очага рекомендуется совмещать введение Радахлорина® с ФД (например с использованием спектрофлюориметров). Интенсивность флюоресценции достигает максимума через 3 ч после введения препарата и существенно выше для дозы 1,2 мг/кг. Флуоресцентная контрастность на границе «опухоль/норма» варьирует в пределах (2–4)/1 (для дозы 0,6 мг/кг) и (4–6)/1 (для дозы 1,2 мг/кг).
Приготовление раствора для внутривенной инфузии
Содержимое одного или нескольких флаконов разводят в 200 мл одного из ниже перечисленных инфузионных растворов:
- 0,9% раствор натрия хлорида;
- 5 или 10% раствор декстрозы;
- 10% раствор маннитола;
- раствор Рингера;
- 4 или 8% раствор калия хлорида;
Для приготовления раствора не следует использовать инфузионные растворы с кислым показателем рН.
Побочное действие
Возможны боли в месте облучаемого очага в течение всей процедуры ФДТ и вплоть до 1 ч после ФДТ
отек окружающих тканей и мягких тканей головы, продолжающийся 2–7 сут
кожный зуд, реакции гиперчувствительности нормальной кожи к лазерному излучению.
Передозировка
Симптомы передозировки сходны с неблагоприятными побочными реакциями.
Показана симптоматическая и дезинтоксикационная терапия (инфузионная терапия по показаниям, приём анальгетиков, антигистаминных препаратов, антиоксидантов).
Взаимодействие с другими лекарственными средствами
Выявлена несовместимость Радахлорина® при одновременном введении с препаратами, имеющими кислый показатель рН среды, например, с аскорбиновой кислотой.
Особые указания
Во время воздействия лазером врач и пациент должны использовать защитные очки со светофильтром, поглощающим излучение (662±3) нм.
Во время воздействия лазером врач и пациент должны использовать защитные очки со светофильтром, поглощающим излучение (662±3) нм.
Для купирования болевых реакций используют местные анестетики, НПВС, наркотические анальгетики.
Радахлорин® не следует вводить тем же шприцем или через ту же систему для в/в введений, через которые вводились другие лекарственные препараты.
У больных, подвергающихся ФДТ с использованием Радахлорина® ,может наблюдаться увеличение абсолютного числа лейкоцитов в периферической крови с увеличением числа гранулоцитов, что, по-видимому, связано с общей реакцией организма на развитие воспалительного процесса в зоне лечения (некроза).
Некроз в зоне лечения обычно начинает формироваться через 2–4 дня, а отторжение струпа происходит через 2–8 нед после воздействия лазером.
Препарат можно хранить разведенным при температуре 2–8 °C не более 24 ч до начала введения. При этом приготовленный раствор устойчив в условиях комнатной освещенности или при дневном свете, однако следует избегать прямого светового воздействия.
Влияние на способность управлять автомобилем и движущимися механизмами
Прямых противопоказаний к управлению автомобилем после сеанса ФДТ Радахлорином® в настоящее время не выявлено.
При проявлении, каких-либо побочных действий, вопрос о вождении транспорта и работе с другими механизмами требует индивидуального рассмотрения.
Форма выпуска
Раствор для внутривенного введения
Условия хранения
В защищенном от света месте, при температуре 0–8 °C.
Срок годности
2,5 года
Условия отпуска
По рецепту
Производитель
Рада-фарма
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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кислород, оказывающий токсический эффект на опухолевые клетки и модифицирующее действие на их плазматические мембраны при воздействии света с длиной волны, соответствующей одному из пиков поглощения препарата (406, 506, 536, 608 или 662 нм)."}},{"type":"paragraph","data":{"text":"В развитии эффекта после проведения ФДТ с препаратом Радахлорин\u003csup\u003e®\u003c/sup\u003e можно выделить 3 этапа:"}},{"type":"paragraph","data":{"text":"1 этап — характерная реакция на световое воздействие при ФДТ, проявляющаяся в виде отека и гиперемии зоны облучения различной выраженности;"}},{"type":"paragraph","data":{"text":"2 этап — некроз опухоли, который формируется через 2–4 дня после сеанса ФДТ;"}},{"type":"paragraph","data":{"text":"3 этап — отторжение некротических масс и эпителизация дефекта раны через 2–8 нед в зависимости от размеров опухоли."}},{"type":"paragraph","data":{"text":"Радахлорин\u003csup\u003e®\u003c/sup\u003e в дозах 0,5–2,4 мг/кг при облучении опухоли лазерным излучением через 3 ч после введения препарата не обладает мутагенным действием и не повреждает ДНК нормальных клеток."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"После однократного в/в введения Радахлорина\u003csup\u003e®\u003c/sup\u003e в дозах 0,5–2,4 мг/кг он в течение 0,5–5 ч распределяется между кровью и тканями. C\u003csub\u003emax\u003c/sub\u003e Радахлорина\u003csup\u003e®\u003c/sup\u003e в сыворотке крови достигается через 15–30 мин и быстро снижается, составляя через 1 ч после введения в дозе 0,5 мг/кг — 10 мкг/л, через 3 ч — 5 мкг/л, через 24 ч — 1 мкг/л."}},{"type":"paragraph","data":{"text":"C\u003csub\u003emax\u003c/sub\u003e Радахлорина\u003csup\u003e®\u003c/sup\u003e в опухоли достигается через 1 ч (10–20 мкг/мл), но при более быстром выведении его из окружающих опухоль здоровых тканей, максимальный терапевтический индекс (индекс контрастности) наблюдается через 3 ч после введения препарата. Концентрация препарата в опухолевой ткани выше, чем в окружающих здоровых тканях, в среднем в 3–6 раз, зависит от морфологической структуры опухоли, и составляет 2–10 мкг/мл."}},{"type":"paragraph","data":{"text":"Быстрое выведение Радахлорина\u003csup\u003e®\u003c/sup\u003e из крови, кожи и слизистых оболочек и высокий индекс контрастности исключают повреждение здоровых органов и тканей и гиперчувствительность кожных покровов к дневному свету."}},{"type":"paragraph","data":{"text":"Наиболее высокие уровни Радахлорина\u003csup\u003e®\u003c/sup\u003e через 3 ч после введения создаются в печени, почках, опухолевой ткани."}},{"type":"paragraph","data":{"text":"Около 70–80% Радахлорина\u003csup\u003e®\u003c/sup\u003e метаболизируется в печени до биладиенов (линейных тетрапирролов, являющихся также продуктами метаболизма гема). Препарат выводится в неизмененном виде с калом (15%) и мочой (3%). Кумулятивная экскреция Радахлорина\u003csup\u003e®\u003c/sup\u003e с калом и мочой за первые 12 ч составляет в среднем 15–20% от введенной дозы препарата. Основная часть (98%) Радахлорина\u003csup\u003e®\u003c/sup\u003e выводится или метаболизируется в течение первых 48 ч. Следовые количества препарата определяются в коже вплоть до 6 сут."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["Флюоресцентная диагностика рака кожи.","Фотодинамическая терапия поверхностных опухолей кожи (исключая меланому)"]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Индивидуальная непереносимость компонентов Радахлорин."}},{"type":"list","data":{"style":"ordered","items":["повышенная чувствительность к любому из компонентов препарата;","беременность и период кормления грудью;","детский возраст (опыта применения препарата нет)."]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано применение препарата Радахлорин® при беременности. На время лечения следует прекратить грудное вскармливание "}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенно, капельно в течение 30 минут."}},{"type":"paragraph","data":{"text":"Световое воздействие излучением с длиной волны(662±3) нм начинают через 3 ч после окончания инфузии."}},{"type":"paragraph","data":{"text":"Оптимальным режимом воздействия является введение препарата в дозе 1,0–1,2 мг/кг и световое воздействие излучением с длиной волны(662±3) нм в дозе 300 Дж/см\u003csup\u003e2\u003c/sup\u003e ."}},{"type":"paragraph","data":{"text":"При возможности проведения повторного лечения пациентов с частичным эффектом или стабилизацией, возможно использование и двух других режимов: 0,5–0,6 мг/кг — 300 Дж/см\u003csup\u003e2\u003c/sup\u003e ;1,0–1,2 мг/кг — 200 Дж/см\u003csup\u003e2\u003c/sup\u003e ."}},{"type":"paragraph","data":{"text":"При этом выбор режима должен осуществляться индивидуально с учетом формы и распространенности опухолевого процесса."}},{"type":"paragraph","data":{"text":"При воздействии лазером используют дистанционное поверхностное облучение через кварцевый световод с применением или без применения микролинз."}},{"type":"paragraph","data":{"text":"В качестве источника лазерного излучения используют диодный лазер с длиной волны(662±3) нм."}},{"type":"paragraph","data":{"text":"Для выявления дополнительных очагов и уточнения границ распространения опухолевого очага рекомендуется совмещать введение Радахлорина\u003csup\u003e®\u003c/sup\u003e с ФД (например с использованием спектрофлюориметров). Интенсивность флюоресценции достигает максимума через 3 ч после введения препарата и существенно выше для дозы 1,2 мг/кг. Флуоресцентная контрастность на границе «опухоль/норма» варьирует в пределах (2–4)/1 (для дозы 0,6 мг/кг) и (4–6)/1 (для дозы 1,2 мг/кг)."}},{"type":"paragraph","data":{"text":"Приготовление раствора для внутривенной инфузии"}},{"type":"paragraph","data":{"text":"Содержимое одного или нескольких флаконов разводят в 200 мл одного из ниже перечисленных инфузионных растворов:"}},{"type":"paragraph","data":{"text":"- 0,9% раствор натрия хлорида;"}},{"type":"paragraph","data":{"text":"- 5 или 10% раствор декстрозы;"}},{"type":"paragraph","data":{"text":"- 10% раствор маннитола;"}},{"type":"paragraph","data":{"text":"- раствор Рингера;"}},{"type":"paragraph","data":{"text":"- 4 или 8% раствор калия хлорида;"}},{"type":"paragraph","data":{"text":"Для приготовления раствора не следует использовать инфузионные растворы с кислым показателем рН."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"list","data":{"style":"ordered","items":["Возможны боли в месте облучаемого очага в течение всей процедуры ФДТ и вплоть до 1 ч после ФДТ","отек окружающих тканей и мягких тканей головы, продолжающийся 2–7 сут","кожный зуд, реакции гиперчувствительности нормальной кожи к лазерному излучению."]}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы передозировки сходны с неблагоприятными побочными реакциями."}},{"type":"paragraph","data":{"text":"Показана симптоматическая и дезинтоксикационная терапия (инфузионная терапия по показаниям, приём анальгетиков, антигистаминных препаратов, антиоксидантов)."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":" Выявлена несовместимость Радахлорина\u003csup\u003e®\u003c/sup\u003e при одновременном введении с препаратами, имеющими кислый показатель рН среды, например, с аскорбиновой кислотой. "}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Во время воздействия лазером врач и пациент должны использовать защитные очки со светофильтром, поглощающим излучение (662±3) нм."}},{"type":"paragraph","data":{"text":"Во время воздействия лазером врач и пациент должны использовать защитные очки со светофильтром, поглощающим излучение (662±3) нм."}},{"type":"paragraph","data":{"text":"Для купирования болевых реакций используют местные анестетики, НПВС, наркотические анальгетики."}},{"type":"paragraph","data":{"text":"Радахлорин\u003csup\u003e®\u003c/sup\u003e не следует вводить тем же шприцем или через ту же систему для в/в введений, через которые вводились другие лекарственные препараты."}},{"type":"paragraph","data":{"text":"У больных, подвергающихся ФДТ с использованием Радахлорина\u003csup\u003e®\u003c/sup\u003e ,может наблюдаться увеличение абсолютного числа лейкоцитов в периферической крови с увеличением числа гранулоцитов, что, по-видимому, связано с общей реакцией организма на развитие воспалительного процесса в зоне лечения (некроза)."}},{"type":"paragraph","data":{"text":"Некроз в зоне лечения обычно начинает формироваться через 2–4 дня, а отторжение струпа происходит через 2–8 нед после воздействия лазером."}},{"type":"paragraph","data":{"text":"Препарат можно хранить разведенным при температуре 2–8 °C не более 24 ч до начала введения. При этом приготовленный раствор устойчив в условиях комнатной освещенности или при дневном свете, однако следует избегать прямого светового воздействия."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nПрямых противопоказаний к управлению автомобилем после сеанса ФДТ Радахлорином® в настоящее время не выявлено."}},{"type":"paragraph","data":{"text":"При проявлении, каких-либо побочных действий, вопрос о вождении транспорта и работе с другими механизмами требует индивидуального рассмотрения.\n\n"}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для внутривенного введения"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте, при температуре 0–8 °C."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2,5 года"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Рада-фарма"}}]}],"source":null},"description_toggle":false,"short_description":"После однократного в/в введения Радахлорина®в дозах 0,5–2,4 мг/кг он в течение 0,5–5 ч распределяется между кровью и тканями. 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