ангиопатии с повышенным риском тромбообразования, в том числе и после перенесённого инфаркта миокарда;
нарушение мозгового кровообращения, включая острый период ишемического инсульта и период раннего восстановления; дисциркуляторная энцефалопатия, обусловленная атеросклерозом, сахарным диабетом, гипертонической болезнью; сосудистая деменция;
окклюзионные поражения периферических артерий как атеросклеротического, так и диабетического генеза;
Каждая ампула (2 мл) содержит:
Активное вещество: сулодексид 600 ЛЕ*
Вспомогательные вещества: хлорид натрия 18 мг, вода для инъекций до 2 мл.
* – липопротеинлипазная единица
Описание
Вессел® Дуэ Ф (сулодексид) является биологическим лекарственным препаратом, представляющим собой естественную смесь гликозаминогликанов (ГАГ): гепариноподобной фракции с молекулярной массой 8000 дальтон (80 %) и дерматансульфата (20 %).
Механизм действия сулодексида обусловлен двумя основными свойствами:
быстродействующая гепариноподобная фракция обладает сродством к антитромбину III (АТIII), а дерматановая – к кофактору II гепарина (КГII).
ангиопатии с повышенным риском тромбообразования, в том числе и после перенесённого инфаркта миокарда;
нарушение мозгового кровообращения, включая острый период ишемического инсульта и период раннего восстановления; дисциркуляторная энцефалопатия, обусловленная атеросклерозом, сахарным диабетом, гипертонической болезнью; сосудистая деменция;
окклюзионные поражения периферических артерий как атеросклеротического, так и диабетического генеза;
флебопатии, тромбозы глубоких вен;
микроангиопатии (нефропатия, ретинопатия, нейропатия) и макроангиопатии при сахарном диабете (синдром диабетической стопы, энцефалопатия, кардиопатия);
тромбофилические состояния, антифосфолипидный синдром (назначают совместно с ацетилсалициловой кислотой, а также вслед за низкомолекулярными гепаринами);
лечение гепарининдуцированной тромботической тромбоцитопении, поскольку не вызывает и не усугубляет её.
Противопоказания
гиперчувствительность;
геморрагический диатез и заболевания, сопровождающиеся пониженной свертываемостью крови;
беременность I триместр.
Применение при беременности и в период грудного вскармливания
При беременности назначается под строгим наблюдением врача. Имеется положительный опыт применения препарата с целью лечения и профилактики сосудистых осложнений у пациенток с диабетом типа I во II и III триместрах беременности, при развитии позднего токсикоза беременных.
Способ применения и дозы
По 1 ампуле в день, внутримышечно или внутривенно, в течение 15-20 дней.
Затем терапию следует продолжить в течение 30-40 дней, принимая препарат внутрь в виде лекарственной формы – капсулы. Назначают по 1-2 капсулы 2 раза в день до приёма пищи.
Полный курс лечения следует повторять не менее 2 раз в год.
В зависимости от результатов клинико-диагностического обследования пациента, по усмотрению врача режим дозирования может быть изменён.
Побочное действие
По данным клинических исследований
Данные о частоте развития нежелательных лекарственных реакций, связанных с применением сулодексида, были получены в ходе клинических исследований с участием пациентов, проходивших лечение стандартными дозами препарата при обычной продолжительности курса терапии.
Нежелательные реакции, связанные с применением сулодексида, были классифицированы по системно-органному классу и распределены по частоте возникновения в следующем порядке: очень часто (≥ 1/10), часто (≥ 1/100 до < 1/10), нечасто (≥ 1/1000 до < 1/100), редко (≥ 1/10000 до < 1/1000), очень редко (< 1/10000).
Нервная система: нечасто – головная боль, очень редко – потеря сознания.
Орган слуха: часто – головокружение.
Желудочно-кишечный тракт: часто – боль в верхней части живота, диарея, тошнота, нечасто – ощущение дискомфорта в животе, диспепсия, метеоризм, рвота, очень редко – желудочное кровотечение.
Аллергические реакции: часто – кожная сыпь различной локализации, нечасто – экзема, эритема, крапивница.
Общие расстройства и нарушения в месте введения: нечасто – боль в месте инъекции, гематома в месте инъекции, очень редко – периферический отёк.
По данным пострегистрационных наблюдений.
В ходе пострегистрационного применения сулодексида были зарегистрированы дополнительные нежелательные явления. Частота данных нежелательных эффектов не может быть оценена в связи с тем, что информация о них поступает в виде спонтанных сообщений. Соответственно, частота этих нежелательных явлений классифицируется как «неизвестная» (не может быть рассчитана на основании имеющихся данных).
Со стороны психики: дереализация.
Со стороны нервной системы: судороги, тремор.
Со стороны органа зрения: зрительные нарушения.
Со стороны сердечно-сосудистой системы: ощущение сердцебиения, приливы.
Со стороны дыхательной системы, органов грудной клетки и средостения: кровохарканье.
Со стороны кожи и подкожных тканей: кожный зуд, пурпура, генерализованная эритема.
Со стороны мочевыделительной системы: стеноз шейки мочевого пузыря, дизурия.
Общие расстройства и нарушения в месте введения: боль в груди, боль, жжение в месте инъекции.
Передозировка
Кровотечение является единственным явлением, которое может возникнуть при передозировке. В случае развития кровотечения необходимо введение протамина сульфата (1 % раствор), применяющегося при кровотечениях, вызываемых гепарином.
Взаимодействие с другими лекарственными средствами
Значимого взаимодействия препарата Вессел® Дуэ Ф с другими препаратами не установлено. При применении сулодексида не рекомендуется одновременно использовать препараты, влияющие на систему гемостаза в качестве антикоагулянтов (прямых и непрямых).
Особые указания
В начале и конце лечения целесообразно определить следующие показатели: активированное частичное тромбопластиновое время, антитромбин III, время кровотечения и время свёртывания.
Вессел® Дуэ Ф увеличивает нормальные показатели активированного частичного тромбопластинового времени приблизительно в полтора раза.
Условия хранения
5 лет
Не использовать по истечении срока годности!
Срок годности
При температуре не выше 30С.
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Условия отпуска
По рецепту.
Для описания товара использована информация от партнера 36.6
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