Гадовист 7.5 мл

Гадовист — Gadovist (Гадобутрол) 7.5 мл

Категория:

Описание

Гадовист препарат, который применим у взрослых, подростков и детей всех возрастов (включая доношенных новорожденных). Его относят к группе противоопухолевых препаратов, который содержит активное вещество Гадобутрол.

Гадовист может быть применим для увеличения контрастности при проведении МРВ всего тела. Он способствует обнаружению патологических структур или изменений и помогает в дифференциации между здоровой и патологической тканью. Гадовист применяют только в случае необходимости диагностики, если магнитно-резонансной визуализация (МРВ) невозможна без контрастного усиления.

Свойства гадобутрола в организме сходны со свойствами других гидрофильных биологически инертных веществ, выделяемых почками (например, маннитола или инулина). Гадобутрол быстро распределяется во внеклеточном пространстве. Связывание с белками плазмы незначительно. При дозе гадобутрола 0,1 ммоль/кг массы тела через 2 минуты после инъекции его уровень в плазме составлял 0,59 ммоль/л, а через 60 минут после инъекции — 0,3 ммоль/л.

Состав

В 1 мл раствора содержится:

  • Активное вещество: гадобутрол 604,720 мг (1,0 ммоль).
  • Вспомогательные вещества: калкобутрол натрия, хлористоводородная кислота 1н, трометамол, вода для инъекций.

 

Показания к применению

Гадовист используют только с диагностической целью у взрослых, подростков и детей старше 2 лет

  • повышение контрастности при проведении магнитно-резонансной томографии (МРТ) области головы и позвоночника (краниальной и спинальной МРТ)
  • увеличение контрастности при проведении МРТ других частей тела, в т.ч. печени и почек
  • повышение контрастности при проведении магнитно-резонансной ангиографии (МРА)
  • проведение дифференциального диагноза между интра- и экстрамедуллярными опухолями,
  • определение границ крупных опухолей в спинномозговом канале и определение распространенности интрамедуллярной опухоли.
  • для определения мелких повреждений и для визуализации поражений, трудно контрастируемых обычными средствами.
  • применяют для перфузионных исследований: при диагностике инсульта, распознавании очаговой ишемии мозга и оценки кровоснабжения опухоли.

 

Фармакодинамика

Гадовист — это парамагнитное контрастное вещество для магнитно-резонансной визуализации (МРВ). Увеличение контрастности, связано с его активным веществом гадобутролом, который являет собой нейтральный (неионный) комплекс гадолиния (III) с макроциклическим лигандом — дигидрокси-гидроксиметилпропилтетраазациклододекантриуксусной кислотой (бутролом). Энтерогепатической циркуляции гадобутрола не наблюдалось. Гадобутрол не метаболизируется в организме. Период полувыведения вещества из плазмы крови равен 1,81 часов (в пределах 1,33 — 2,13 часов).

Клиническая эффективность

В контрольном исследовании печени III фазы при комбинированной пре- и постконтрастной МРТ у пациентов получавших Гадовист средняя чувствительность составила 79%, а специфичность — 81% применительно к детектированию и классификации подозреваемых злокачественных повреждений печени (анализ, учитывающий отдельных пациентов).

В контрольном исследовании почек III фазы при комбинированной пре- и постконтрастной МРТ показатели средней чувствительности составили 91% (анализ, учитывающий отдельных пациентов) и 85% (анализ, учитывающий очаг поражения) применительно к классификации злокачественных и доброкачественных повреждений почек. Средняя специфичность в анализе, учитывающем отдельных пациентов, составила 52%, а в анализе, учитывающем очаг поражения, — 82%.

Фармакокинетика

Распределение

После внутривенного введения гадобутрол быстро распределяется во внеклеточном пространстве. Связывание с белками плазмы незначительное. Показатели фармакокинетики у человека пропорциональны вводимой дозе гадобутрола. Если доза гадобутрола не превышает 0,4 ммоль на 1 кг массы тела, происходит двухфазное снижение его концентрации в плазме крови. При дозе гадобутрола 0,1 ммоль/кг веса тела через 2 минуты после инъекции его уровень в плазме составлял 0,59 ммоль/л, а через 60 минут после инъекции — 0,3 ммоль/л.

Биотрансформация

Никаких метаболитов в плазме и моче обнаружить не удалось.

Выведение

Гадобутрол в неизмененном виде выводится почками. В течение двух часов с мочой выводится более 50 % введенной дозы, а в течение 12 часов — более 90 %. Почечный клиренс гадобутрола у здоровых лиц составляет от 1,1 до 1,7 мл/мин-кг; таким образом, он сравним с клиренсом инулина, что показывает о выведении гадобутрола в основном путем клубочковой фильтрации. Гадобутрол выводится полностью в течение 24 часов. Менее 0,1% введенного вещества выводится из организма с калом.

Фармакокинетика в особых группах пациентов

Педиатрическая популяция

Были проведены два однодозовых клинических исследования I/III фазы с участием 130 пациентов в возрасте младше 18 лет и с участием 43 пациентов в возрасте младше 2 лет (включая доношенных новорожденных).

По данным проведенным исследованиям различия среди педиатрических возрастных групп не были выявлены , также, как не были обнаружены различия в сравнении с взрослыми пациентами. Гадовист в указанных исследованиях хорошо переносился, полученный профиль безопасности был таким же, как и у взрослых.

Пациенты пожилого возраста (≥ 65 лет)

Вследствие физиологических возрастных изменений почечной функции системная экспозиция у здоровых добровольцев пожилого возраста (старше 65 лет) увеличивается примерно на 33% у мужчин и примерно на 54% у женщин, а конечный период полувыведения уменьшается примерно на 25% у мужчин и на 35% у женщин. Введенная доза полностью выводилась через 24 часа с мочой, у всех добровольцев, по данному показателю не были выявлены различия между пожилыми и более молодыми здоровыми добровольцами.

Почечная недостаточность

У больных с нарушенной функцией почек период полувыведения гадобутрола из сыворотки увеличивается вследствие снижения клубочковой фильтрации. Среднее значение конечного периода полувыведения увеличивается до 5,8 часов у больных с нарушением функции почек средней степени и до 17,6 часов у больных с нарушением функции почек тяжелой степени, не находящихся на диализе.

У пациентов с нарушением функции почек легкой и средней степени вещество выводится с мочой в течение 72 часов. У больных с нарушением почечной функции тяжелой степени примерно 80% введенной дозы выводится с мочой в течение 5 дней.

Гадобутрол практически полностью выводится из сыворотки, у пациентов, нуждающихся в диализе, после третьего сеанса.

Фармацевтические характеристики

Прозрачная, бесцветная или слегка желтоватая жидкость, свободная от частиц

Упаковка, срок годности,

условия хранения

Раствор для внутривенного введения 1 ммоль/мл.

  • По 15 мл или 30 мл во флаконе из бесцветного стекла типа I, закрытого резиновой черной пробкой, обжатого алюминиевым колпачком с пластмассовой крышкой. По 1 флакону по 30 мл или по 5 флаконов по 15 мл вместе с инструкцией помещают в картонную пачку.
  • По 5 мл или 7,5 мл в стеклянный шприц из бесцветного стекла вместимостью 10 мл и оснащён адаптером Люэра. По 1 шприцу в герметично укупоренный блистер из ПВХ и ламинированной бумаги. По пять блистеров с инструкцией по применению размещают в картонной пачке.
  • По 15 мл или 30 млв пластиковые картриджи вместимостью 65 мл. По пять картриджей с инструкцией по применению размещают в картонной пачке.

Хранение: в недоступном для детей месте и при температуре не выше 30°С.

Срок годности 3 года.

 

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Детали

Страна производитель

Великобритания
Тип

Жидкость, Таблетки

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