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Баннер
Market
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Описание
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Флексотрон Соло имплантат стерильный для внутрисуставных инъекций 2,2% 22 мг/мл 2 мл шприц 1 шт

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Артикул Market
103544168673
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Тип препарата
Назначение
Страна-производитель
Германия
Все характеристики
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Нет в продаже у продавца
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Флексотрон Соло импл. вязкоэластич. стер. для в/суст. ин.
Флексотрон Соло имплантат стерильный для внутрисуставных инъекций 2,2% 22 мг/мл 2 мл шприц 1 шт
2 вопроса
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Нет в продаже
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ЕАПТЕКА
ЕАПТЕКА
Магазин•4.8 136.7K оценок
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О товаре

ФЛЕКСОТРОН® Соло – протез синовиальной жидкости, стерильный, прозрачный вязкоэластичный гель, содержащий гиалуронат натрия, получаемый методом бактериальной ферментации, в фосфатном буфере. Имплантат не содержит лекарственного средства для медицинского применения, материалов животного и (или) человеческого происхождения.
Артикул Market
103544168673
Бренд
Albomed GmbH
Количество штук в упаковке
1 шт.
Объем
2 мл
Тип препарата
изделие медицинского назначения
Органы и системы
опорно-двигательная система
Назначение
временное восполнение или замещение синовиальной жидкости, остеоартрит, остеоартроз
Показания к применению
Вязкоэластичное протезирование синовиальной жидкости у пациентов с дегенеративно-дистрофическими и посттравматическими поражениями суставов, а также у лиц, имеющих повышенные нагрузки на поврежденные суставы.- остеоартрит / остеоартроз (ОА) и другие дегенеративно-дистрофические и посттравматические поражения коленных, тазобедренных и других синовиальных суставов.- восстановление свойств синовиальной жидкости при ортопедической хирургии суставов, а также у лиц, имеющих повышенные нагрузки на поврежденные суставы. Введение продукта должно выполняться в асептических условиях процедурных и манипуляционных кабинетов медицинскими работниками, владеющими техникой интраартикулярных инъекций. Объем одного имплантата приближен к безопасному объему средних и больших суставов взрослого человека. Нет каких-либо ограничений по антропометрическим и анатомическим особенностям целевого пациента.
Противопоказания
Изделие не должно использоваться при лечении пациентов: - имеющих повышенную чувствительность к одному из компонентов изделия; - страдающих септическим артритом; - страдающих инфекциями кожи или дерматологическими заболеваниями в области инъекции; - принимающих антикоагулянты, такие как, например, Фенопрокумон или Варфарин.
Состав
В 1 мл содержится:Гиалуронат натрия 2,2% / 22 мгХлорид натрия 8,500 мгДигидрат гидрофосфата натрияNa2HPO4 * 2H2O 0,563 мгДигидрат дигидрофосфата натрияNaH2PO4 * 2H2O 0,045 мгВода для инъекций до объема 1 мл
Способ применения и дозы
Инъекции проводятся врачами-специалистами в асептических условиях. Перед введением имплантата содержимое шприца должно быть визуально оценено на прозрачность и однородность. Помутнение, кристаллизация, появление окраски и/или инородных включений может свидетельствовать о нарушении правил транспортировки и хранения изделия. При появлении вышеуказанных признаков введение имплантата запрещено. Применение изделия включает в себя снятие колпачка с насадки Люэра предзаполненного шприца и привинчивание к насадке соответствующей стерильной иглы с острым концом. Для инъекции необходимо использовать одноразовые стерильные иглы размером 21G (не входят в комплект поставки). Необходимо продезинфицировать кожу антисептиком. Препарат вводятся точно в полость сустава по стандартным методикам, учитывая анатомические особенности пациента. Введение в полость сустава должно быть прекращено при возрастании боли во время инъекции. Неиспользованное средство не подлежит хранению. Возможно одновременное лечение нескольких суставов. В случае возникновения внутрисуставного отека перед введением гиалуроновой кислоты необходимо удалить жидкость методом аспирации. Допускаются повторные циклы лечения. Предварительно заполненный шприц объемом 2 мл предназначен для лечения коленного, тазобедренного, плечевого и голеностопного суставов. На цикл лечения может быть рекомендована следующая периодичность введения: ФЛЕКСОТРОН СОЛО: 1 инъекция, повторное введение через несколько месяцев (по индивидуальному состоянию)
Побочные действия
Применение внутрисуставных форм гиалуроновой кислоты при дегенеративно-дистрофических и посттравматических поражениях суставов является хорошо изученным методом с установленным профилем безопасности, применяющимся на протяжении нескольких десятилетий. В крайне редких случаях возможно проявление местных временных воспалительных симптомов (боль, повышение температуры, покраснение и отечность, увеличение содержания экссудата в полости сустава). После внутрисуставной инъекции могут возникать такие обратимые местные реакции, как кратковременное ограничение подвижности (скованность), чувство дискомфорта или тяжести в суставе, гематомы. Проявление данных симптомов можно уменьшить прикладыванием льда к месту инъекции в течение 5-10 минут. Имеются сообщения о единичных случаях аллергических реакций (например, зуд, сыпь, крапивница) и анафилактических реакций, септического артрита, внутритканевых кровотечениях или кровоизлияниях в полость сустава, тенденитах, флебитах, парестезиях, головокружениях, головных болях, мышечных спазмах, чувстве жара, общем недомогании, периферических отеков при внутрисуставном введении растворов гиалуроновой кислоты. При появлении местных или общих симптомов следует проконсультироваться с врачом. Биодеградация Гиалуроновая кислота деградируется семейством ферментов, называемых гиалуронидазами, большинство из которых лизосомальные, с образованием мономерных нетоксичных продуктов деградации (первичными продуктами деградации являются олигосахариды и гиалуронаты с низкой молекулярной массой). В организме человека существуют по меньшей мере семь типов гиалуронидазоподобных ферментов. Скорость биодеградации зависит от состояния и особенностей метаболизма конкретного пациента. Деградация высокомолекулярного внеклеточного гиалуроната происходит в виде ряда отдельных этапов, генерирующих гиалуроновые цепи уменьшающихся размеров. Данных о негативном влиянии продуктов деградации на имплант или об каких-либо их системных эффектах в теле человека, нет. Некоторые продукты деградации могут быть использованы в процессах эндогенного ресинтеза. Удаление импланта В случае выраженных проявлений может быть рекомендовано удаление импланта из полости сустава, в том числе с применением лаважа согласно действующим клиническим рекомендациям. Если реакция на имплантат не была связана с индивидуальной непереносимостью компонентов изделия, возможно повторное введение имплантата спустя 3 недели после стихания воспалительных явлений.
Фармакологическое действие
Гиалуроновая кислота представляет собой поли-(2-ацетамидо-2-дезокси-D-глюко)-D- глюкуроногликан, то есть полимер, состоящий из остатков D-глюкуроновой кислоты и N-ацетил-D- глюкозамина, соединённых поочерёдно β-1,4- и β-1,3-гликозидными связями. Благодаря такой полимерной трехмерной структуре формируются крупные отрицательно заряженные агрегаты, удерживающие воду. Эти агрегаты отвечают за влагосодержание, упругость и эластичность хрящевой ткани (устойчивость её к компрессии). Внутрисуставное обогащение синовиальной жидкости инъекциями гиалуроната натрия способствует улучшению или восстановлению вязкоупругих свойств естественной синовиальной жидкости. Гиалуронат натрия отвечает за вязкоупругие свойства синовиальной жидкости, таким образом вязкоэластичное протезирование позволяет компенсировать недостаточность гиалуроновой кислоты в синовиальной жидкости или снижение её вязкости, смягчить внешние нагрузки на сустав, обеспечивает смазывание, восстановление упругости и вязкости, амортизацию, увлажнение и обволакивание суставных поверхностей, покрывая смазывающим защитным слоем хрящ и рецепторы синовии. Это помогает увеличить объём движений и обеспечивает механическую защиту тканей полости сустава, что в свою очередь может улучшать течение остеоратроза / остеоартрита и других дегенеративно-дистрофических и посттравматических патологий суставов. На основании клинических сведений об особенностях биодеградации и продолжительности лечебных эффектов внутрисуставного введения гиалуроновой кислоты предполагается, что биодеградация каждого варианта исполнения вязкоэластичного имплантата ФЛЕКСОТРОН СОЛО происходит в срок от 12 до 24 недель. Клинический эффект лечения сохраняется в течение не менее 6 месяцев.
Способ применения/введения
внутрисуставной
Подробная комплектация
имплантат (жидкая смесь компонентов) в предварительно заполненном шприце в блистерной упаковке; 3 имплантационных стикера; инструкция по применению
Условия хранения
От 2 °C до 25 °C в оригинальной упаковке,при относительной влажности 30-60%. Защищать от света, не замораживать, избегать ударов и резких встряхиваний. Хранить в недоступном для детей месте. Данное медицинское изделие транспортируется всеми видами транспорта в крытых транспортных средствах в соответствии с требованиями, правилами и нормативными документами перевозки грузов, действующих на транспорте каждого вида.
Влияние на способность управлять транспортом и механизмами
Продукт не влияет на способность человека управлять автотранспортом, заниматься другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Особые указания
В течение первых 2 суток после проведения процедуры рекомендуется не перегружать сустав, особенно следует избегать длительной нагрузки. При получении аспирационной жидкости перед проведением вискосаплиментарной терапии следует провести соответствующие исследования для исключения бактериальной этиологии артрита. Вязкоэластичные имплантаты совместимы для использования в условиях магнитно-резонансных исследований при индукции магнитного поля по меньшей мере до 3 Тесла. Радиационные, электромагнитные и магнитные поля не оказывают прямого эффекта на имплантаты ФЛЕКСОТРОН СОЛО и их свойства, а также не вызывают каких-либо известных соответствующих последующих эффектов в теле человека. Вязкоэластичные имплантаты не поддаются визуализации посредством радиологических, ультразвуковых и других сканирующих процедур вследствие близости своих физических свойств к естественным компонентам тканей человека. Меры предосторожности По причине того, что септический артрит является серьезным побочным эффектом, необходимо соблюдать все стандартные меры предосторожности для хирургических вмешательств. Изделие предназначено для внутрисуставного введения. Необходимо избегать внутрисосудистого или внутритканевого введения изделия. Ввиду отсутствия клинических данных по применению гиалуроновой кислоты при лечении детей, беременных или кормящих женщин, избегать использования изделия у данных групп пациентов. Изделие следует использовать до истечения срока годности, указанного на упаковке. В первые дни после инъекции может быть полезным пероральный прием анальгетиков или противовоспалительных лекарственных средств. Применение изделия совместно с четвертичными соединениями аммония запрещено. Повторная стерилизация и применение изделия запрещены по причине наличия риска возникновения инфекции, перекрестной инфекции и (или) дефекта изделия. Только для одноразового использования. Не использовать шприц из открытой и/или поврежденной стерильной упаковки. Не использовать шприц с открытым или поврежденным колпачком стерильного шприца. При нарушении стерильности или подозрении о нарушении стерильности импланта изделие должно быть утилизировано.
Взаимодействие
Имплантаты линейки ФЛЕКСОТРОН СОЛО успешно прошли доклинические испытания и подтвердили совместимость с биологическими тканями, клетками и жидкостями организма, с которыми они контактируют в имплантируемом состоянии. Не следует применять дезинфицирующие средства, содержащие соли четвертичного аммония, поскольку гиалуроновая кислота осаждается в присутствии этих веществ. Сведения о несовместимости с другими лекарствами, веществами и внутрисуставными инъекционными продуктами на данный момент отсутствуют, однако, медицинский специалист должен внимательно ознакомиться с информацией в инструкциях к данным лекарствам/веществам/продуктам и пользоваться с осторожностью.
Бренд
Albomed GmbH
Изготовитель
Albomed GmbH
Фасовщик
Albomed GmbH
Страна бренда
Германия
Страна-производитель
Германия
Номер документа о соответствии
РЗН 2020/10487
Дата документа о соответствии
01.06.2020
Название препарата
Флексотрон
Срок годности
1461 дн.
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Отзывы

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220 оценок•48 отзывов
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Достоинства:Препарат действительно работает, я доволен! Помог при начальной стадии артроза коленного сустава - процедура ввода препарата ощущаемая, но уже через неделю стало намного легче. В целом требуется 2 укола (это два тюбика) по одному с разницей в неделю, затем через полгода-год повторно. Хруст практически ушёл, боль ушла полностью. Травмы будто и не было. Лично для себя я доволен, буду наблюдать дальше. В целом, могу рекомендовать, но обязательно консультируйтесь с врачом
Недостатки:Недостатков не обнаружил, своих денег препарат явно стоит
Комментарий:Рекомендую к покупке! Данный препарат на Маркете был у нескольких продавцов, взял здесь у еаптеки, забирал у них самовывозом, выдали оригинал, Ростест, все оригинальные прозрачные пломбы на месте, срок годности до 2027 года, фото прикладываю (кусок лишнего скотча - это я вскрывал для проверки в аптеке)
Достоинства:помогает ,продлить жизнь суставам
Недостатки:цена,если бы не она данный препарат был бы востребован в разы большем количеством страждущими,но у нас у вы капитализм -счастье помолись 🙏"ежели купить не можешь нужное лекарство, а молитва твоя горяча спасет тебя лучше любого врача!!"©Духоскрепный Батюшка
Достоинства:эффективное лекарство,хорошо смазывает суставы. прописал врач после травмы колена, после серии сеансов увт и укола флексотроном боль ушла и я снова могу бегать
Недостатки:цена препарата конечно кусается
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Войдите в аккаунтИ тогда откроется корзина, а цены на Market могут стать ниже
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