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Описание

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Имурон-вак лиоф. д/приг. сусп. для в/пузырного введ.фл., 50 мг, 2 шт.

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Коротко о товаре

Артикул Маркета
4453152379
Тип препарата
Рецептурный препарат
Назначение
Действующее вещество
Инструкция
{"widgets":{"@card/SpecsList":{"/content/page/fancyPage/productSpecsList":{"wrapperProps":{"margins":{"top":4,"bottom":4}},"specsLimit":5,"title":"Коротко о товаре","titleSize":"14","type":"minimal","offset":"s","isHealthCategory":true,"forceShowWidget":true,"withFridge":true}}},"meta":{"/content/page/fancyPage/productSpecsList":{"name":"@card/SpecsList"}},"collections":{"minimalSpecs":{"13419614176640180843":{"specItems":[{"name":"Артикул Маркета","value":"4453152379","withCopyValueButton":true},{"name":"тип препарата","value":"лекарственный препарат, вакцина","transition":{"type":"list","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["34324371:35649313"]}}},{"name":"рецептурный препарат","value":"да","transition":{"type":"list","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["27272850:1,0"]}}},{"name":"назначение","value":"иммунотерапия поверхностного рака мочевого пузыря или профилактика его рецидивов после трансуретрального удаления опухолей","transition":{"type":"list","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["36476390:36618381"]}}},{"name":"действующее вещество","value":"Вакцина БЦЖ для иммунотерапии рака мочевого пузыря","transition":{"type":"list","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["27144131:36090614"]}}},{"name":"возраст","value":"от 18 лет"},{"name":"форма выпуска","value":"лиофилизат для приготовления суспензии для внутрипузырного введения"},{"name":"страна-производитель","value":"Россия"}]}},"compactSpecs":{"13419614176640180843":{"specItems":[{"name":"Артикул Маркета","value":"4453152379","withCopyValueButton":true},{"name":"Тип препарата","value":"Лекарственный препарат, вакцина","transition":{"type":"list","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["34324371:35649313"]}}},{"name":"Рецептурный препарат","value":"Да","transition":{"type":"list","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["27272850:1,0"]}}},{"name":"Возраст","value":"От 18 лет"},{"name":"Страна-производитель","value":"Россия"}]}},"fullSpecs":{"13419614176640180843":{"specItems":[{"name":"Тип препарата","value":"лекарственный препарат, вакцина","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["34324371:35649313"]}}},{"name":"Рецептурный препарат","value":"да","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["27272850:1,0"]}}},{"name":"Органы и системы","value":"мочевой пузырь"},{"name":"Назначение","value":"иммунотерапия поверхностного рака мочевого пузыря или профилактика его рецидивов после трансуретрального удаления опухолей","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["36476390:36618381"]}}},{"name":"Показания к применению","value":"Препарат предназначен для иммунотерапии поверхностного (Та, Тl, Тis) рака мочевого пузыря или профилактики его рецидивов после трансуретрального удаления опухолей."},{"name":"Противопоказания","value":"1. Ранее перенесенный туберкулез.\u003Cb\u003E2. Размер местной реакции на внутрикожное введение туберкулина в дозе 2 ТЕ (проба Манту) 17 мм и более.\u003Cb\u003E3. Иммунодефицитные состояния.\u003Cb\u003E4. Острый цистит или макрогематурия (до исчезновения клинических проявлений).\u003Cb\u003E5. Тяжелые сопутствующие заболевания в стадии декомпенсации. Травматическая катетеризация или появление крови после катетеризации мочевого пузыря являются противопоказаниями для инстилляции БЦЖ в данный день.\u003Cb\u003EИмурон-вак не рекомендуется для применения у детей в связи с отсутствием данных по эффективности и безопасности."},{"name":"Состав","value":"Активное вещество:\u003Cb\u003EВ одной ампуле Имурон-вак содержится:\u003Cb\u003E- 25 мг микробных клеток БЦЖ (не менее 2x108 и не более 3,75x108 жизнеспособных клеток БЦЖ)\u003Cb\u003E- 30 мг микробных клеток БЦЖ (не менее 2,4x108 и не более 4,5x108 жизнеспособных клеток БЦЖ)\u003Cb\u003EВ одном флаконе Имурон-вак содержится:\u003Cb\u003E- 25 мг микробных клеток БЦЖ (не менее 2x108 и не более 3,75x108 жизнеспособных клеток БЦЖ)\u003Cb\u003E- 50 мг микробных клеток БЦЖ (не менее 4x108 и не более 7,5x108 жизнеспособных клеток БЦЖ)\u003Cb\u003EВспомогательные вещества: стабилизатор - натрия глутамат моногидрат."},{"name":"Действующее вещество","value":"Вакцина БЦЖ для иммунотерапии рака мочевого пузыря","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["27144131:36090614"]}}},{"name":"Способ применения и дозы","value":"За 3-11 сут. до проведения иммунотерапии больному ставят внутрикожную пробу Манту с 2 ТЕ очищенного туберкулина в стандартном разведении.\u003Cb\u003EПостановку пробы и учет ответной реакции проводят в соответствии с инструкцией по применению туберкулина. Пробу Манту выполняют в противотуберкулезном диспансере или сотрудник, имеющий специальную справку-допуск для постановки туберкулиновых проб. Применение Имурон-вак разрешается при размере папулы менее 17 мм в диаметре.\u003Cb\u003EРазовая терапевтическая доза (50-100 мг микробных клеток БЦЖ) содержится в двух-четырех ампулах/флаконах по 25 мг или одном-двух флаконах по 50 мг препарата.\u003Cb\u003EИмурон-вак применяют внутрипузырно.\u003Cb\u003EВнутрипузырные инстилляции рекомендуется начинать не ранее чем через 3 недели после проведения биопсии при лечении поверхностного рака мочевого пузыря или после трансуретрального удаления опухоли.\u003Cb\u003EПри наличии пиурии, бактериурии, дизурии до начала лечения необходимо провести антибактериальную терапию до полной ликвидации клинических симптомов цистита.\u003Cb\u003EПациенту не следует пить за 4 часа до процедуры и в течение 2 часов после инстилляции. Катетеризацию мочевого пузыря производят эластичным катетером, не травмируя слизистую уретры и мочевого пузыря. После опорожнения мочевого пузыря его следует промыть раствором натрия хлорида 0,9 % для инъекций и убедиться, что в промывной жидкости отсутствует примесь крови. После этого разовую терапевтическую дозу препарата разводят в 50 мл раствора натрия хлорида 0,9 % для инъекций и вводят по катетеру в мочевой пузырь. Больного просят удерживать раствор в мочевом пузыре в течение 2 ч. Желательно, чтобы в течение этого времени пациент двигался, менял положение тела каждые 15 минут для равномерного контакта препарата со стенками мочевого пузыря. Через 2 ч мочевой пузырь опорожняется в емкость, содержащую не менее 500 мл аттестованного дезинфицирующего раствора (следуя режимам дезинфекции, указанным в инструкции по применению). После каждой инстилляции рекомендуется гипергидратация в течение 48 часов (при отсутствии противопоказаний).\u003Cb\u003EРекомендуемая разовая доза Имурон-вак 50-100 мг 1 раз в неделю.\u003Cb\u003EИндукционный курс иммунотерапии состоит из 6 еженедельных инстилляций препарата. При достижении полной регрессии опухоли целесообразно проведение поддерживающей иммунотерапии в такой же или уменьшенной дозе с интервалами 3-6 месяцев на протяжении 1-3 лет. Схему поддерживающей терапии определяет лечащий врач.\u003Cb\u003EРазведение вакцины\u003Cb\u003EАмпулы/флаконы с вакциной перед вскрытием тщательно просматривают.\u003Cb\u003EПрепарат не подлежит применению при:\u003Cb\u003E- отсутствии маркировки на ампуле/флаконе или неправильном ее заполнении;\u003Cb\u003E- истекшем сроке годности;\u003Cb\u003E- при наличии трещин и насечек на ампуле/флаконе;\u003Cb\u003E- при изменении физических свойств препарата (сморщенная таблетка, изменение цвета и т.д.).\u003Cb\u003EСухой препарат разводят непосредственно перед употреблением раствором натрия хлорида 0,9 % для инъекций.\u003Cb\u003E1) Ампулы. Шейку и головку ампулы обтирают спиртом, место запайки ампулы (головку) надпиливают и осторожно, с помощью пинцета отламывают. Затем надпиливают и отламывают шейку ампулы, завернув надпиленный конец в стерильную марлевую салфетку. В ампулы с препаратом переносят стерильным шприцем с длинной иглой по 3-4 мл раствора натрия хлорида 0,9% для инъекций.\u003Cb\u003E2) Флаконы. Снимают защитную пластиковую накладку колпачка Flip-off, резиновую пробку обтирают спиртом. Во флакон с препаратом вводят стерильным шприцем с длинной иглой 5-6 мл раствора натрия хлорида 0,9 % для инъекций.\u003Cb\u003EПосле экспозиции в течение 3-5 мин с последующим 2-4-х кратным перемешиванием с помощью шприца, должна образоваться густая грубодисперсная суспензия белого с сероватым или желтым оттенком цвета. Видимые макрочастицы не влияют на эффективность и безопасность препарата.\u003Cb\u003EСодержимое ампул/флаконов тем же шприцем переносят во флакон с раствором натрия хлорида 0,9% для инъекций (общий объем - 50 мл) и тщательно перемешивают.\u003Cb\u003EРазведенный препарат необходимо предохранять от действия солнечного света и употреблять сразу после разведения. Ампулы, флаконы из-под препарата, катетер после процедуры погружают в дезинфицирующей раствор, (следуя режимам дезинфекции, указанным в инструкции по применению). Допускается дезинфекция инструментария кипячением в течение 40 мин"},{"name":"Побочные действия","value":"Побочные реакции\u003Cb\u003Eа) Локальные\u003Cb\u003E- Дизурия отмечается у 80%, макрогематурия - у 40% больных. Появляются после 2-3 введений БЦЖ, начинаются через 2-3 ч после инстилляции и продолжаются в течение 1-2 сут. С увеличением количества инсталляций выраженность побочных реакций может нарастать. Проходят, как правило, самостоятельно или может быть проведено симптоматическое лечение.\u003Cb\u003Eб) Системные\u003Cb\u003E- Повышение температуры тела, не превышающее 38,5 °С, отмечается у 40 % больных в день инстилляции. Обычно продолжительность лихорадки составляет не более 48 ч. Специального лечения не требует или могут быть применены жаропонижающие препараты.\u003Cb\u003EОсложнения\u003Cb\u003Eа) Локальные\u003Cb\u003E- Острый цистит, не проходящий к моменту следующей инстилляции, отмечается у 20% больных. В таких случаях лечение с помощью Имурон-вак должно быть прервано. После исключения бактериального цистита немикобактериальной этиологии назначается терапия противотуберкулезными препаратами до исчезновения симптомов и в течение 2 недель после нормализации состояния. БЦЖ-терапия может быть продолжена в дозе, составляющей от 10 до 30% от первоначальной.\u003Cb\u003E- Симптоматические грануломатозные циститы, простатиты, эпидидимиты у 3-5% больных. При развитии подобных осложнений БЦЖ- терапия прерывается. Проводят терапию изониазидом (300 мг в сут) и рифампицином (600 мг в сут) в течение 3 месяцев. У ряда больных развитие грануломатозных инфильтратов в области устьев мочеточников может привести к нарушению пассажа мочи из верхних мочевых путей и потребовать временного их дренирования.\u003Cb\u003E- Грануломатозное поражение паренхимы почки наблюдается редко. Дальнейшая БЦЖ-терапия этим больным противопоказана. Проводят терапию изониазидом (300 мг в сут), рифампицином (600 мг в сут) и этамбутолом (1200 мг в сут) до 6 месяцев.\u003Cb\u003Eб) Системные\u003Cb\u003EВ развитии системных осложнений ведущее значение принадлежит гематогенному распространению БЦЖ. Как правило, они развиваются при введении БЦЖ после грубых травматичных катетеризаций мочевого пузыря. Генерализации инфекции способствует ослабление иммунитета, обусловленное ВИЧ-инфекцией, приемом иммунодепрессантов и другими причинами.\u003Cb\u003E- Аллергические реакции. Отмечаются в виде кожной сыпи, артритов, артралгий менее чем у 1% больных. Иммунотерапия Имурон-вак этим больным должна быть прекращена. Назначают нестероидные противовоспалительные средства, антигистаминные препараты.\u003Cb\u003E- БЦЖ-сепсис отмечается крайне редко (единичные случаи). Характеризуется острым началом: повышением температуры тела выше 38,5 °С, ознобом, резким ухудшением общего состояния. Иногда отмечается падение артериального давления. Быстро развивается печеночная и почечная недостаточность. При рентгенографии грудной клетки могут выявляться очаговые изменения и инфильтраты в легких. После взятия проб для бактериологических исследований на наличие возбудителя, начинают лечение. Иммунотерапия Имурон-вак должна быть прекращена.\u003Cb\u003EНазначают терапию тремя противотуберкулезными препаратами: изониазид (300 мг в сут), рифампицин (600 мг в сут) и этамбутол (1200 мг в сут). В обязательном порядке добавляют антибиотик широкого спектра действия для лечения возможного уросепсиса не туберкулезной этиологии. Антибактериальную терапию сочетают с применением кортикостероидов: гормональная терапия предотвращает угрожающую жизни гиперэргическую реакцию. Описаны летальные исходы БЦЖ-сепсиса.\u003Cb\u003EБольной должен быть предупрежден о возможных осложнениях.\u003Cb\u003EЕсли любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты, не указанные в инструкции, сообщите об этом врачу."},{"name":"Фармакологическое действие","value":"Имурон-вак представляет собой культуру микробных клеток вакцинного штамма БЦЖ-1 (М.bovis ВСG -1, Russia), лиофилизированную в 1,5 % растворе натрия глутамата моногидрата.\u003Cb\u003EИмурон-вак стимулирует иммунную систему и обладает противоопухолевой активностью.\u003Cb\u003EПри внутрипузырной инсталляции БЦЖ действует как неспецифический иммуномодулятор, вызывая целый комплекс иммунных реакций, в которые вовлекаются ряд клеток иммунной системы, включающий Т и В лимфоциты, макрофаги, целый ряд цитокинов."},{"name":"Фармакологическая группа","value":"иммуномодулирующее средство"},{"name":"Форма выпуска","value":"лиофилизат для приготовления суспензии для внутрипузырного введения"},{"name":"Способ применения/введения","value":"парентеральный","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["35947170:36763748"]}}},{"name":"Минимальный возраст применения","value":"от 18 лет"},{"name":"Условия хранения","value":"Транспортируют по СП 3.3.2.1248-03 при температуре от 0 до 8 °С."},{"name":"Передозировка","value":"Отсутствуют данные, что передозировка может вызвать иные симптомы, чем описанные побочные реакции."},{"name":"Применение при беременности и кормлении грудью","value":"Не рекомендуется (клинических исследований не проводилось)."},{"name":"Влияние на способность управлять транспортом и механизмами","value":"Локальные и системные проявления токсичности могут оказывать влияние на выполнение потенциально опасных видов деятельности (управление автомобилем, работа с движущимися механизмами и т.п.)."},{"name":"Особые указания","value":"Имурон-вак хранят в специально выделенной комнате в холодильнике под замком. В этой же комнате проводят обработку катетеров и разведение вакцины. Посуду и инструменты, применяемые для БЦЖ-иммунотерапии, категорически запрещается использовать в других целях. Их хранят в отдельном шкафу под замком.\u003Cb\u003EРекомендуется работать в перчатках.\u003Cb\u003EПролившуюся разведенную вакцину удаляют салфеткой, смоченной дезинфицирующим средством."},{"name":"Взаимодействие","value":"Во время курса внутрипузырных инсталляций Имурон-вак следует избегать одновременного назначения средств, к которым чувствительны микобактерии БЦЖ: противотуберкулезные препараты, фторхинолоны, доксициклин или гентамицин."},{"name":"Регистрационный номер","value":"Р N001970/01"},{"name":"Дата государственной регистрации","value":"17.07.2018"},{"name":"Владелец регистрационного удостоверения","value":"ФГБУ \"НИЦЭМ им. Н.Ф. Гамалеи\" Минздрава России","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["34324371:35649313","7893318:17921131"]}}},{"name":"Изготовитель","value":"ФГБУ НИЦЭМ им. Н.Ф. Гамалеи"},{"name":"Фасовщик","value":"ФГБУ НИЦЭМ им. Н.Ф. Гамалеи"},{"name":"Страна бренда","value":"Россия"},{"name":"Страна-производитель","value":"Россия"},{"name":"Название препарата","value":"Имурон-вак","transition":{"type":"catalog","params":{"categorySlug":"vaktsiny-syvorotki-fagi-toksiny","categoryId":"15756921","navnodeId":"72514","glfilters":["17796364:18302732"]}}},{"name":"Срок годности","value":"1 г."}]}},"fullSpecsGrouped":{"13419614176640180843":{"groups":[{"name":"Общие характеристики","items":[{"name":"Тип препарата","value":"лекарственный препарат, вакцина"},{"name":"Рецептурный препарат","value":"да"},{"name":"Органы и системы","value":"мочевой пузырь"},{"name":"Назначение","value":"иммунотерапия поверхностного рака мочевого пузыря или профилактика его рецидивов после трансуретрального удаления опухолей"},{"name":"Показания к применению","value":"Препарат предназначен для иммунотерапии поверхностного (Та, Тl, Тis) рака мочевого пузыря или профилактики его рецидивов после трансуретрального удаления опухолей."},{"name":"Противопоказания","value":"1. Ранее перенесенный туберкулез.\u003Cb\u003E2. Размер местной реакции на внутрикожное введение туберкулина в дозе 2 ТЕ (проба Манту) 17 мм и более.\u003Cb\u003E3. Иммунодефицитные состояния.\u003Cb\u003E4. Острый цистит или макрогематурия (до исчезновения клинических проявлений).\u003Cb\u003E5. Тяжелые сопутствующие заболевания в стадии декомпенсации. Травматическая катетеризация или появление крови после катетеризации мочевого пузыря являются противопоказаниями для инстилляции БЦЖ в данный день.\u003Cb\u003EИмурон-вак не рекомендуется для применения у детей в связи с отсутствием данных по эффективности и безопасности."},{"name":"Состав","value":"Активное вещество:\u003Cb\u003EВ одной ампуле Имурон-вак содержится:\u003Cb\u003E- 25 мг микробных клеток БЦЖ (не менее 2x108 и не более 3,75x108 жизнеспособных клеток БЦЖ)\u003Cb\u003E- 30 мг микробных клеток БЦЖ (не менее 2,4x108 и не более 4,5x108 жизнеспособных клеток БЦЖ)\u003Cb\u003EВ одном флаконе Имурон-вак содержится:\u003Cb\u003E- 25 мг микробных клеток БЦЖ (не менее 2x108 и не более 3,75x108 жизнеспособных клеток БЦЖ)\u003Cb\u003E- 50 мг микробных клеток БЦЖ (не менее 4x108 и не более 7,5x108 жизнеспособных клеток БЦЖ)\u003Cb\u003EВспомогательные вещества: стабилизатор - натрия глутамат моногидрат."},{"name":"Действующее вещество","value":"Вакцина БЦЖ для иммунотерапии рака мочевого пузыря"},{"name":"Способ применения и дозы","value":"За 3-11 сут. до проведения иммунотерапии больному ставят внутрикожную пробу Манту с 2 ТЕ очищенного туберкулина в стандартном разведении.\u003Cb\u003EПостановку пробы и учет ответной реакции проводят в соответствии с инструкцией по применению туберкулина. Пробу Манту выполняют в противотуберкулезном диспансере или сотрудник, имеющий специальную справку-допуск для постановки туберкулиновых проб. Применение Имурон-вак разрешается при размере папулы менее 17 мм в диаметре.\u003Cb\u003EРазовая терапевтическая доза (50-100 мг микробных клеток БЦЖ) содержится в двух-четырех ампулах/флаконах по 25 мг или одном-двух флаконах по 50 мг препарата.\u003Cb\u003EИмурон-вак применяют внутрипузырно.\u003Cb\u003EВнутрипузырные инстилляции рекомендуется начинать не ранее чем через 3 недели после проведения биопсии при лечении поверхностного рака мочевого пузыря или после трансуретрального удаления опухоли.\u003Cb\u003EПри наличии пиурии, бактериурии, дизурии до начала лечения необходимо провести антибактериальную терапию до полной ликвидации клинических симптомов цистита.\u003Cb\u003EПациенту не следует пить за 4 часа до процедуры и в течение 2 часов после инстилляции. Катетеризацию мочевого пузыря производят эластичным катетером, не травмируя слизистую уретры и мочевого пузыря. После опорожнения мочевого пузыря его следует промыть раствором натрия хлорида 0,9 % для инъекций и убедиться, что в промывной жидкости отсутствует примесь крови. После этого разовую терапевтическую дозу препарата разводят в 50 мл раствора натрия хлорида 0,9 % для инъекций и вводят по катетеру в мочевой пузырь. Больного просят удерживать раствор в мочевом пузыре в течение 2 ч. Желательно, чтобы в течение этого времени пациент двигался, менял положение тела каждые 15 минут для равномерного контакта препарата со стенками мочевого пузыря. Через 2 ч мочевой пузырь опорожняется в емкость, содержащую не менее 500 мл аттестованного дезинфицирующего раствора (следуя режимам дезинфекции, указанным в инструкции по применению). После каждой инстилляции рекомендуется гипергидратация в течение 48 часов (при отсутствии противопоказаний).\u003Cb\u003EРекомендуемая разовая доза Имурон-вак 50-100 мг 1 раз в неделю.\u003Cb\u003EИндукционный курс иммунотерапии состоит из 6 еженедельных инстилляций препарата. При достижении полной регрессии опухоли целесообразно проведение поддерживающей иммунотерапии в такой же или уменьшенной дозе с интервалами 3-6 месяцев на протяжении 1-3 лет. Схему поддерживающей терапии определяет лечащий врач.\u003Cb\u003EРазведение вакцины\u003Cb\u003EАмпулы/флаконы с вакциной перед вскрытием тщательно просматривают.\u003Cb\u003EПрепарат не подлежит применению при:\u003Cb\u003E- отсутствии маркировки на ампуле/флаконе или неправильном ее заполнении;\u003Cb\u003E- истекшем сроке годности;\u003Cb\u003E- при наличии трещин и насечек на ампуле/флаконе;\u003Cb\u003E- при изменении физических свойств препарата (сморщенная таблетка, изменение цвета и т.д.).\u003Cb\u003EСухой препарат разводят непосредственно перед употреблением раствором натрия хлорида 0,9 % для инъекций.\u003Cb\u003E1) Ампулы. Шейку и головку ампулы обтирают спиртом, место запайки ампулы (головку) надпиливают и осторожно, с помощью пинцета отламывают. Затем надпиливают и отламывают шейку ампулы, завернув надпиленный конец в стерильную марлевую салфетку. В ампулы с препаратом переносят стерильным шприцем с длинной иглой по 3-4 мл раствора натрия хлорида 0,9% для инъекций.\u003Cb\u003E2) Флаконы. Снимают защитную пластиковую накладку колпачка Flip-off, резиновую пробку обтирают спиртом. Во флакон с препаратом вводят стерильным шприцем с длинной иглой 5-6 мл раствора натрия хлорида 0,9 % для инъекций.\u003Cb\u003EПосле экспозиции в течение 3-5 мин с последующим 2-4-х кратным перемешиванием с помощью шприца, должна образоваться густая грубодисперсная суспензия белого с сероватым или желтым оттенком цвета. Видимые макрочастицы не влияют на эффективность и безопасность препарата.\u003Cb\u003EСодержимое ампул/флаконов тем же шприцем переносят во флакон с раствором натрия хлорида 0,9% для инъекций (общий объем - 50 мл) и тщательно перемешивают.\u003Cb\u003EРазведенный препарат необходимо предохранять от действия солнечного света и употреблять сразу после разведения. Ампулы, флаконы из-под препарата, катетер после процедуры погружают в дезинфицирующей раствор, (следуя режимам дезинфекции, указанным в инструкции по применению). Допускается дезинфекция инструментария кипячением в течение 40 мин"},{"name":"Побочные действия","value":"Побочные реакции\u003Cb\u003Eа) Локальные\u003Cb\u003E- Дизурия отмечается у 80%, макрогематурия - у 40% больных. Появляются после 2-3 введений БЦЖ, начинаются через 2-3 ч после инстилляции и продолжаются в течение 1-2 сут. С увеличением количества инсталляций выраженность побочных реакций может нарастать. Проходят, как правило, самостоятельно или может быть проведено симптоматическое лечение.\u003Cb\u003Eб) Системные\u003Cb\u003E- Повышение температуры тела, не превышающее 38,5 °С, отмечается у 40 % больных в день инстилляции. Обычно продолжительность лихорадки составляет не более 48 ч. Специального лечения не требует или могут быть применены жаропонижающие препараты.\u003Cb\u003EОсложнения\u003Cb\u003Eа) Локальные\u003Cb\u003E- Острый цистит, не проходящий к моменту следующей инстилляции, отмечается у 20% больных. В таких случаях лечение с помощью Имурон-вак должно быть прервано. После исключения бактериального цистита немикобактериальной этиологии назначается терапия противотуберкулезными препаратами до исчезновения симптомов и в течение 2 недель после нормализации состояния. БЦЖ-терапия может быть продолжена в дозе, составляющей от 10 до 30% от первоначальной.\u003Cb\u003E- Симптоматические грануломатозные циститы, простатиты, эпидидимиты у 3-5% больных. При развитии подобных осложнений БЦЖ- терапия прерывается. Проводят терапию изониазидом (300 мг в сут) и рифампицином (600 мг в сут) в течение 3 месяцев. У ряда больных развитие грануломатозных инфильтратов в области устьев мочеточников может привести к нарушению пассажа мочи из верхних мочевых путей и потребовать временного их дренирования.\u003Cb\u003E- Грануломатозное поражение паренхимы почки наблюдается редко. Дальнейшая БЦЖ-терапия этим больным противопоказана. Проводят терапию изониазидом (300 мг в сут), рифампицином (600 мг в сут) и этамбутолом (1200 мг в сут) до 6 месяцев.\u003Cb\u003Eб) Системные\u003Cb\u003EВ развитии системных осложнений ведущее значение принадлежит гематогенному распространению БЦЖ. Как правило, они развиваются при введении БЦЖ после грубых травматичных катетеризаций мочевого пузыря. Генерализации инфекции способствует ослабление иммунитета, обусловленное ВИЧ-инфекцией, приемом иммунодепрессантов и другими причинами.\u003Cb\u003E- Аллергические реакции. Отмечаются в виде кожной сыпи, артритов, артралгий менее чем у 1% больных. Иммунотерапия Имурон-вак этим больным должна быть прекращена. Назначают нестероидные противовоспалительные средства, антигистаминные препараты.\u003Cb\u003E- БЦЖ-сепсис отмечается крайне редко (единичные случаи). Характеризуется острым началом: повышением температуры тела выше 38,5 °С, ознобом, резким ухудшением общего состояния. Иногда отмечается падение артериального давления. Быстро развивается печеночная и почечная недостаточность. При рентгенографии грудной клетки могут выявляться очаговые изменения и инфильтраты в легких. После взятия проб для бактериологических исследований на наличие возбудителя, начинают лечение. Иммунотерапия Имурон-вак должна быть прекращена.\u003Cb\u003EНазначают терапию тремя противотуберкулезными препаратами: изониазид (300 мг в сут), рифампицин (600 мг в сут) и этамбутол (1200 мг в сут). В обязательном порядке добавляют антибиотик широкого спектра действия для лечения возможного уросепсиса не туберкулезной этиологии. Антибактериальную терапию сочетают с применением кортикостероидов: гормональная терапия предотвращает угрожающую жизни гиперэргическую реакцию. Описаны летальные исходы БЦЖ-сепсиса.\u003Cb\u003EБольной должен быть предупрежден о возможных осложнениях.\u003Cb\u003EЕсли любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты, не указанные в инструкции, сообщите об этом врачу."},{"name":"Фармакологическое действие","value":"Имурон-вак представляет собой культуру микробных клеток вакцинного штамма БЦЖ-1 (М.bovis ВСG -1, Russia), лиофилизированную в 1,5 % растворе натрия глутамата моногидрата.\u003Cb\u003EИмурон-вак стимулирует иммунную систему и обладает противоопухолевой активностью.\u003Cb\u003EПри внутрипузырной инсталляции БЦЖ действует как неспецифический иммуномодулятор, вызывая целый комплекс иммунных реакций, в которые вовлекаются ряд клеток иммунной системы, включающий Т и В лимфоциты, макрофаги, целый ряд цитокинов."},{"name":"Фармакологическая группа","value":"иммуномодулирующее средство"},{"name":"Форма выпуска","value":"лиофилизат для приготовления суспензии для внутрипузырного введения"},{"name":"Способ применения/введения","value":"парентеральный"},{"name":"Минимальный возраст применения","value":"от 18 лет"}]},{"name":"Дополнительно","items":[{"name":"Условия хранения","value":"Транспортируют по СП 3.3.2.1248-03 при температуре от 0 до 8 °С."},{"name":"Передозировка","value":"Отсутствуют данные, что передозировка может вызвать иные симптомы, чем описанные побочные реакции."},{"name":"Применение при беременности и кормлении грудью","value":"Не рекомендуется (клинических исследований не проводилось)."},{"name":"Влияние на способность управлять транспортом и механизмами","value":"Локальные и системные проявления токсичности могут оказывать влияние на выполнение потенциально опасных видов деятельности (управление автомобилем, работа с движущимися механизмами и т.п.)."},{"name":"Особые указания","value":"Имурон-вак хранят в специально выделенной комнате в холодильнике под замком. В этой же комнате проводят обработку катетеров и разведение вакцины. Посуду и инструменты, применяемые для БЦЖ-иммунотерапии, категорически запрещается использовать в других целях. Их хранят в отдельном шкафу под замком.\u003Cb\u003EРекомендуется работать в перчатках.\u003Cb\u003EПролившуюся разведенную вакцину удаляют салфеткой, смоченной дезинфицирующим средством."},{"name":"Взаимодействие","value":"Во время курса внутрипузырных инсталляций Имурон-вак следует избегать одновременного назначения средств, к которым чувствительны микобактерии БЦЖ: противотуберкулезные препараты, фторхинолоны, доксициклин или гентамицин."},{"name":"Регистрационный номер","value":"Р N001970/01"},{"name":"Дата государственной регистрации","value":"17.07.2018"},{"name":"Владелец регистрационного удостоверения","value":"ФГБУ \"НИЦЭМ им. Н.Ф. Гамалеи\" Минздрава России"},{"name":"Изготовитель","value":"ФГБУ НИЦЭМ им. Н.Ф. Гамалеи"},{"name":"Фасовщик","value":"ФГБУ НИЦЭМ им. Н.Ф. Гамалеи"},{"name":"Страна бренда","value":"Россия"},{"name":"Страна-производитель","value":"Россия"},{"name":"Название препарата","value":"Имурон-вак"},{"name":"Срок годности","value":"1 г."}]}],"transitionId":"tr_9025211593901320251"}}}}
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    Анатоксин столбнячный (ас-анатоксин) сусп. для п/к введ. дозы, 10 шт.

    Цена 890 ₽
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  • Превенар 13 сусп. для в/м введ., 0.5 мл/доза, 0.5 мл, 1 шт.
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    Превенар 13 сусп. для в/м введ., 0.5 мл/доза, 0.5 мл, 1 шт.

    Рейтинг товара: 5 из 5
    на основе 2 оценки
    Цена 1 782 ₽
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  • Гардасил сусп. для в/м введ. фл., 0.5 мл/доза, 0.5 мл, 1 шт.
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    Гардасил сусп. для в/м введ. фл., 0.5 мл/доза, 0.5 мл, 1 шт.

    Рейтинг товара: 4.6 из 5
    на основе 7 оценок
    Цена 9 402 ₽
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  • Лонгидаза лиоф. д/приг. р-ра д/ин., 3000 МЕ, 5 шт.
    –11 %
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    Лонгидаза лиоф. д/приг. р-ра д/ин., 3000 МЕ, 5 шт.

    Рейтинг товара: 5 из 5
    на основе 6 оценок
    Цена 3 840 ₽ вместо 4 315
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  • Протамина сульфат р-р для в/в введ. введ., 10 мг/мл, 5 мл, 10 шт.
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    Протамина сульфат р-р для в/в введ. введ., 10 мг/мл, 5 мл, 10 шт.

    Рейтинг товара: 5 из 5
    на основе 1 оценка
    Цена 1 371 ₽
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  • Сыворотка противостолбнячная р-р для ин. амп., 3000 МЕ, 5 шт.
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    Сыворотка противостолбнячная р-р для ин. амп., 3000 МЕ, 5 шт.

    Рейтинг товара: 5 из 5
    на основе 1 оценка
    Цена 915 ₽
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  • Димефосфон р-р д/вн. приема и нар. прим., 15 %, 100 мл
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    Димефосфон р-р д/вн. приема и нар. прим., 15 %, 100 мл

    Рейтинг товара: 5 из 5
    на основе 6 оценок
    Цена 476 ₽
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  • Сыворотка противоботулиническая типа B лошадиная очищенная конц. жидкая р-р д/ин. амп., 5000 ме, 1 мл, 5 шт.
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    Сыворотка противоботулиническая типа B лошадиная очищенная конц. жидкая р-р д/ин. амп., 5000 ме, 1 мл, 5 шт.

    Рейтинг товара: 5 из 5
    на основе 1 оценка
    Цена 863 ₽
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  • Вианвак р-р для в/м введ. амп., 0,5 мл, 0.5 мл, 10 шт.
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    Вианвак р-р для в/м введ. амп., 0,5 мл, 0.5 мл, 10 шт.

    Цена 5 387 ₽
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  • Натрия тиосульфат р-р для в/в введ. амп., 300 мг/мл, 10 мл, 10 шт.
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    Натрия тиосульфат р-р для в/в введ. амп., 300 мг/мл, 10 мл, 10 шт.

    Рейтинг товара: 4.9 из 5
    на основе 12 оценок
    Цена 93 ₽
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  • Менактра р-р для в/м введ. введ. фл., 0.5 мл, 1 шт.
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    Менактра р-р для в/м введ. введ. фл., 0.5 мл, 1 шт.

    Рейтинг товара: 5 из 5
    на основе 1 оценка
    Цена 4 012 ₽
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  • Налоксон р-р д/ин. амп., 0.4 мг/мл, 1 мл, 10 шт.
    –18 %
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    Налоксон р-р д/ин. амп., 0.4 мг/мл, 1 мл, 10 шт.

    Цена 234 ₽ вместо 284
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Инструкция

Показания к применению

Препарат предназначен для иммунотерапии поверхностного (Та, Тl, Тis) рака мочевого пузыря или профилактики его рецидивов после трансуретрального удаления опухолей.

Противопоказания

1. Ранее перенесенный туберкулез.2. Размер местной реакции на внутрикожное введение туберкулина в дозе 2 ТЕ (проба Манту) 17 мм и более.3. Иммунодефицитные состояния.4. Острый цистит или макрогематурия (до исчезновения клинических проявлений).5. Тяжелые сопутствующие заболевания в стадии декомпенсации. Травматическая катетеризация или появление крови после катетеризации мочевого пузыря являются противопоказаниями для инстилляции БЦЖ в данный день.Имурон-вак не рекомендуется для применения у детей в связи с отсутствием данных по эффективности и безопасности.

Способ применения и дозы

За 3-11 сут. до проведения иммунотерапии больному ставят внутрикожную пробу Манту с 2 ТЕ очищенного туберкулина в стандартном разведении.Постановку пробы и учет ответной реакции проводят в соответствии с инструкцией по применению туберкулина. Пробу Манту выполняют в противотуберкулезном диспансере или сотрудник, имеющий специальную справку-допуск для постановки туберкулиновых проб. Применение Имурон-вак разрешается при размере папулы менее 17 мм в диаметре.Разовая терапевтическая доза (50-100 мг микробных клеток БЦЖ) содержится в двух-четырех ампулах/флаконах по 25 мг или одном-двух флаконах по 50 мг препарата.Имурон-вак применяют внутрипузырно.Внутрипузырные инстилляции рекомендуется начинать не ранее чем через 3 недели после проведения биопсии при лечении поверхностного рака мочевого пузыря или после трансуретрального удаления опухоли.При наличии пиурии, бактериурии, дизурии до начала лечения необходимо провести антибактериальную терапию до полной ликвидации клинических симптомов цистита.Пациенту не следует пить за 4 часа до процедуры и в течение 2 часов после инстилляции. Катетеризацию мочевого пузыря производят эластичным катетером, не травмируя слизистую уретры и мочевого пузыря. После опорожнения мочевого пузыря его следует промыть раствором натрия хлорида 0,9 % для инъекций и убедиться, что в промывной жидкости отсутствует примесь крови. После этого разовую терапевтическую дозу препарата разводят в 50 мл раствора натрия хлорида 0,9 % для инъекций и вводят по катетеру в мочевой пузырь. Больного просят удерживать раствор в мочевом пузыре в течение 2 ч. Желательно, чтобы в течение этого времени пациент двигался, менял положение тела каждые 15 минут для равномерного контакта препарата со стенками мочевого пузыря. Через 2 ч мочевой пузырь опорожняется в емкость, содержащую не менее 500 мл аттестованного дезинфицирующего раствора (следуя режимам дезинфекции, указанным в инструкции по применению). После каждой инстилляции рекомендуется гипергидратация в течение 48 часов (при отсутствии противопоказаний).Рекомендуемая разовая доза Имурон-вак 50-100 мг 1 раз в неделю.Индукционный курс иммунотерапии состоит из 6 еженедельных инстилляций препарата. При достижении полной регрессии опухоли целесообразно проведение поддерживающей иммунотерапии в такой же или уменьшенной дозе с интервалами 3-6 месяцев на протяжении 1-3 лет. Схему поддерживающей терапии определяет лечащий врач.Разведение вакциныАмпулы/флаконы с вакциной перед вскрытием тщательно просматривают.Препарат не подлежит применению при:- отсутствии маркировки на ампуле/флаконе или неправильном ее заполнении;- истекшем сроке годности;- при наличии трещин и насечек на ампуле/флаконе;- при изменении физических свойств препарата (сморщенная таблетка, изменение цвета и т.д.).Сухой препарат разводят непосредственно перед употреблением раствором натрия хлорида 0,9 % для инъекций.1) Ампулы. Шейку и головку ампулы обтирают спиртом, место запайки ампулы (головку) надпиливают и осторожно, с помощью пинцета отламывают. Затем надпиливают и отламывают шейку ампулы, завернув надпиленный конец в стерильную марлевую салфетку. В ампулы с препаратом переносят стерильным шприцем с длинной иглой по 3-4 мл раствора натрия хлорида 0,9% для инъекций.2) Флаконы. Снимают защитную пластиковую накладку колпачка Flip-off, резиновую пробку обтирают спиртом. Во флакон с препаратом вводят стерильным шприцем с длинной иглой 5-6 мл раствора натрия хлорида 0,9 % для инъекций.После экспозиции в течение 3-5 мин с последующим 2-4-х кратным перемешиванием с помощью шприца, должна образоваться густая грубодисперсная суспензия белого с сероватым или желтым оттенком цвета. Видимые макрочастицы не влияют на эффективность и безопасность препарата.Содержимое ампул/флаконов тем же шприцем переносят во флакон с раствором натрия хлорида 0,9% для инъекций (общий объем - 50 мл) и тщательно перемешивают.Разведенный препарат необходимо предохранять от действия солнечного света и употреблять сразу после разведения. Ампулы, флаконы из-под препарата, катетер после процедуры погружают в дезинфицирующей раствор, (следуя режимам дезинфекции, указанным в инструкции по применению). Допускается дезинфекция инструментария кипячением в течение 40 мин
Полная инструкция
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Имурон-вак лиоф. д/приг. сусп. для в/пузырного введ.фл.
Имурон-вак лиоф. д/приг. сусп. для в/пузырного введ.фл., 50 мг, 2 шт.
5.0
(1)
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2 вопроса
Инструкция

2 612 ₽

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