Гемостатический препарат для местного применения. Тахокомб® содержит фибриноген и тромбин в виде сухого покрытия поверхности коллагеновой губки.
При контакте с физиологическими жидкостями (кровью, лимфой или растворами электролитов) компоненты покрытия губки растворяются и частично диффундируют на раневую поверхность. Это сопровождается реакцией фибриногена и тромбина, инициирующей последнюю фазу физиологического свертывания крови.
Фибриноген превращается в фибрин-мономер, который затем полимеризуется с образованием фибринового сгустка (тромба), плотно удерживающего коллаген губки на поверхности раны. С помощью фактора свертывания крови XIII происходит сшивание фибрин-полимеров с формированием твердой, механически прочной сетчатой структуры с хорошими адгезивными свойствами, что обеспечивает надежное закрытие раны.
Фармакокинетика
В организме компоненты препарата подвергаются прогрессивной биодеградации. Фибриновый сгусток метаболизируется так же, как эндогенный фибрин, претерпевая фибринолиз и фагоцитоз. Коллаген губки претерпевает деградацию под действием резорбтивной грануляционной ткани.
Показания к применению
Для вспомогательного применения у взрослых при хирургических вмешательствах:
с целью улучшения гемостаза;
для обеспечения соединения тканей;
для укрепления швов в сосудистой хирургии тогда, когда результаты стандартных методов недостаточны;
Для создания герметичности при хирургических вмешательствах на легких.
Противопоказания
детский и подростковый возраст до 18 лет (в связи с недостаточностью данных о безопасности и эффективности);
повышенная чувствительность к любому из компонентов препарата.
Способ применения и дозы
Тахокомб® предназначен только для местного применения. Не следует использовать препарат интраваскулярно.
Тахокомб® находится в стерильной упаковке и готов к применению. Можно использовать препарат только из неповрежденной упаковки.
После вскрытия упаковки повторная стерилизация препарата Тахокомб® невозможна. Наружный упаковочный алюминиевый пакет может быть вскрыт в нестерильной зоне операционной. Внутренний стерильный блистер следует вскрывать в стерильной зоне. Тахокомб® следует использовать сразу после вскрытия внутренней стерильной упаковки.
Препарат следует наносить на хирургические раневые поверхности в стерильных условиях. Перед наложением губки раневую поверхность необходимо очистить от крови, дезинфицирующих и других жидкостей.
После извлечения препарата Тахокомб® из внутренней стерильной упаковки, губку следует смочить 0.9% раствором натрия хлорида и применить немедленно.
Сторону, покрытую активными веществами и помеченную желтым цветом, накладывают на раневую поверхность и слегка прижимают в течение 3-5 мин. Прижимание осуществляют увлажненными перчатками или увлаженной подушечкой.
Губка Тахокомб® может прилипать к испачканным кровью перчаткам или инструментам. Этого можно избежать с помощью предварительного увлажнения хирургических инструментов и перчаток 0.9% раствором натрия хлорида.
По окончании прижимания губки Тахокомб® к ране следует аккуратно убрать подушечку или перчатку. Во избежание отставания губки от поверхности, она может быть удержана на месте за один конец, например, с помощью пары зажимов.
В случае сильного кровотечения Тахокомб® можно использовать без предварительного увлажнения. Губку накладывают на раневую поверхность и слегка прижимают в течение 3-5 мин.
Размер и количество губок Тахокомб® зависят от величины раневой поверхности. Края раны должны быть перекрыты губкой на 1-2 см. Если для закрытия раневой поверхности требуется более одной губки, то при наложении на рану их края должны перекрывать друг друга.
Губку можно резать для получения желаемого размера. Неиспользованные фрагменты губки подлежат уничтожению.
Побочное действие
Также как и любой белковый продукт, губка Тахокомб® может вызывать у пациентов аллергические реакции, например, крапивницу (в т.ч. генерализованные формы), обструкцию дыхательных путей, снижение АД и анафилактический шок. В случае развития подобных симптомов применение препарата Тахокомб® следует прекратить немедленно.
Классификация нежелательных побочных реакций по частоте развития: очень часто (>1/10); часто (>1/100, <1/10); нечасто (>1/1000, <1/100); редко (>1/10 000, <1/1000); очень редко (1/10 000, включая отдельные сообщения); частота неизвестна (невозможно оценить на основании имеющихся данных).
Аллергические реакции: нечасто - реакции гиперчувствительности; очень редко - анафилактический шок.
Со стороны сердечно-сосудистой системы: очень редко - тромбоэмболии (при внутрисосудистом применении).
Прочие: часто - гипертермия; редко - образование антител к фибрину/гемостатическим продуктам.
Взаимодействие с другими лекарственными средствами
Компоненты препарата могут изменять свои свойства при одновременном применении с растворами этанола, йода или тяжелых металлов (например, антисептические растворы). Подобные вещества следует тщательно удалить перед применением препарата.
Особые указания
Внутрисосудистое применение препарата недопустимо. При случайном попадании внутрь сосуда возможно развитие угрожающих жизни тромбоэмболических осложнений.
В случае развития анафилактического шока следует проводить неотложную терапию по стандартным алгоритмам.
Характеристика вирусной безопасности
К стандартным мерам профилактики инфекций, передающихся с лекарственными средствами, изготовленными из человеческой крови или плазмы, относятся: отбор доноров, скрининг получаемого от доноров материала на специфические маркеры инфекций, а также специальные технологические процедуры по инактивации/элиминации вирусов. Несмотря на вышесказанное, при назначении препаратов, приготовленных из крови или плазмы человека, существует вероятность передачи инфекционных агентов. Это относится также к вновь выявляемым или неизвестным ранее вирусам и другим патогенам.
Принимаемые профилактические меры считаются эффективными в отношении оболочечных вирусов: ВИЧ, вирус гепатита В и вирус гепатита С, а также в отношении безоболочечных вирусов, например, вирус гепатита А.
Эффективность принимаемых мер ограничена в отношении таких безоболочечных вирусов, как парвовирус В19. Инфицирование парвовирусом В19 может быть опасным для беременных женщин (инфекция плода) и для людей с иммунодефицитом или состояниями, характеризующимися повышением эритропоэза (например, гемолитические анемии).
Каждый раз при применении препарата Тахокомб® настоятельно рекомендуется записывать название и номер серии препарата, чтобы в последующем, при необходимости, можно было провести анализ.
Влияние на способность к управлению транспортными средствами и механизмами
Не изучалось.
Срок годности
Срок годности - 3 года.
После извлечения губки Тахокомб® из внутренней стерильной упаковки препарат применяют немедленно.
Для описания товара использована информация от партнера 36.6
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С помощью фактора свертывания крови XIII происходит сшивание фибрин-полимеров с формированием твердой, механически прочной сетчатой структуры с хорошими адгезивными свойствами, что обеспечивает надежное закрытие раны."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"В организме компоненты препарата подвергаются прогрессивной биодеградации. Фибриновый сгусток метаболизируется так же, как эндогенный фибрин, претерпевая фибринолиз и фагоцитоз. Коллаген губки претерпевает деградацию под действием резорбтивной грануляционной ткани."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Для вспомогательного применения у взрослых при хирургических вмешательствах:"}},{"type":"list","data":{"style":"ordered","items":["с целью улучшения гемостаза;","для обеспечения соединения тканей;","для укрепления швов в сосудистой хирургии тогда, когда результаты стандартных методов недостаточны;"]}},{"type":"paragraph","data":{"text":"Для создания герметичности при хирургических вмешательствах на легких."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["детский и подростковый возраст до 18 лет (в связи с недостаточностью данных о безопасности и эффективности);","повышенная чувствительность к любому из компонентов препарата."]}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Тахокомб\u003csup\u003e®\u003c/sup\u003e предназначен только для местного применения. Не следует использовать препарат интраваскулярно."}},{"type":"paragraph","data":{"text":"Тахокомб\u003csup\u003e®\u003c/sup\u003e находится в стерильной упаковке и готов к применению. Можно использовать препарат только из неповрежденной упаковки."}},{"type":"paragraph","data":{"text":"После вскрытия упаковки повторная стерилизация препарата Тахокомб\u003csup\u003e®\u003c/sup\u003e невозможна. Наружный упаковочный алюминиевый пакет может быть вскрыт в нестерильной зоне операционной. Внутренний стерильный блистер следует вскрывать в стерильной зоне. Тахокомб\u003csup\u003e®\u003c/sup\u003e следует использовать сразу после вскрытия внутренней стерильной упаковки."}},{"type":"paragraph","data":{"text":"Препарат следует наносить на хирургические раневые поверхности в стерильных условиях. Перед наложением губки раневую поверхность необходимо очистить от крови, дезинфицирующих и других жидкостей."}},{"type":"paragraph","data":{"text":"После извлечения препарата Тахокомб\u003csup\u003e®\u003c/sup\u003e из внутренней стерильной упаковки, губку следует смочить 0.9% раствором натрия хлорида и применить немедленно."}},{"type":"paragraph","data":{"text":"Сторону, покрытую активными веществами и помеченную желтым цветом, накладывают на раневую поверхность и слегка прижимают в течение 3-5 мин. Прижимание осуществляют увлажненными перчатками или увлаженной подушечкой."}},{"type":"paragraph","data":{"text":"Губка Тахокомб\u003csup\u003e®\u003c/sup\u003e может прилипать к испачканным кровью перчаткам или инструментам. Этого можно избежать с помощью предварительного увлажнения хирургических инструментов и перчаток 0.9% раствором натрия хлорида."}},{"type":"paragraph","data":{"text":"По окончании прижимания губки Тахокомб\u003csup\u003e®\u003c/sup\u003e к ране следует аккуратно убрать подушечку или перчатку. Во избежание отставания губки от поверхности, она может быть удержана на месте за один конец, например, с помощью пары зажимов."}},{"type":"paragraph","data":{"text":"В случае сильного кровотечения Тахокомб\u003csup\u003e®\u003c/sup\u003e можно использовать без предварительного увлажнения. Губку накладывают на раневую поверхность и слегка прижимают в течение 3-5 мин."}},{"type":"paragraph","data":{"text":"Размер и количество губок Тахокомб\u003csup\u003e®\u003c/sup\u003e зависят от величины раневой поверхности. Края раны должны быть перекрыты губкой на 1-2 см. Если для закрытия раневой поверхности требуется более одной губки, то при наложении на рану их края должны перекрывать друг друга."}},{"type":"paragraph","data":{"text":"Губку можно резать для получения желаемого размера. Неиспользованные фрагменты губки подлежат уничтожению."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Также как и любой белковый продукт, губка Тахокомб\u003csup\u003e®\u003c/sup\u003e может вызывать у пациентов аллергические реакции, например, крапивницу (в т.ч. генерализованные формы), обструкцию дыхательных путей, снижение АД и анафилактический шок. В случае развития подобных симптомов применение препарата Тахокомб\u003csup\u003e®\u003c/sup\u003e следует прекратить немедленно."}},{"type":"paragraph","data":{"text":"Классификация нежелательных побочных реакций по частоте развития: очень часто (>1/10); часто (>1/100, <1/10); нечасто (>1/1000, <1/100); редко (>1/10 000, <1/1000); очень редко (1/10 000, включая отдельные сообщения); частота неизвестна (невозможно оценить на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e нечасто - реакции гиперчувствительности; очень редко - анафилактический шок."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e очень редко - тромбоэмболии (при внутрисосудистом применении)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e часто - гипертермия; редко - образование антител к фибрину/гемостатическим продуктам."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Компоненты препарата могут изменять свои свойства при одновременном применении с растворами этанола, йода или тяжелых металлов (например, антисептические растворы). Подобные вещества следует тщательно удалить перед применением препарата."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Внутрисосудистое применение препарата недопустимо. При случайном попадании внутрь сосуда возможно развитие угрожающих жизни тромбоэмболических осложнений."}},{"type":"paragraph","data":{"text":"В случае развития анафилактического шока следует проводить неотложную терапию по стандартным алгоритмам."}},{"type":"paragraph","data":{"text":"\u003ci\u003eХарактеристика вирусной безопасности\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"К стандартным мерам профилактики инфекций, передающихся с лекарственными средствами, изготовленными из человеческой крови или плазмы, относятся: отбор доноров, скрининг получаемого от доноров материала на специфические маркеры инфекций, а также специальные технологические процедуры по инактивации/элиминации вирусов. Несмотря на вышесказанное, при назначении препаратов, приготовленных из крови или плазмы человека, существует вероятность передачи инфекционных агентов. Это относится также к вновь выявляемым или неизвестным ранее вирусам и другим патогенам."}},{"type":"paragraph","data":{"text":"Принимаемые профилактические меры считаются эффективными в отношении оболочечных вирусов: ВИЧ, вирус гепатита В и вирус гепатита С, а также в отношении безоболочечных вирусов, например, вирус гепатита А."}},{"type":"paragraph","data":{"text":"Эффективность принимаемых мер ограничена в отношении таких безоболочечных вирусов, как парвовирус В19. Инфицирование парвовирусом В19 может быть опасным для беременных женщин (инфекция плода) и для людей с иммунодефицитом или состояниями, характеризующимися повышением эритропоэза (например, гемолитические анемии)."}},{"type":"paragraph","data":{"text":"Каждый раз при применении препарата Тахокомб\u003csup\u003e®\u003c/sup\u003e настоятельно рекомендуется записывать название и номер серии препарата, чтобы в последующем, при необходимости, можно было провести анализ."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Не изучалось."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"Срок годности - 3 года."}},{"type":"paragraph","data":{"text":"После извлечения губки Тахокомб\u003csup\u003e®\u003c/sup\u003e из внутренней стерильной упаковки препарат применяют немедленно."}}]}],"source":null},"description_toggle":false,"short_description":"Гемостатический препарат для местного применения. 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