Магнитно-резонансная томография (МРТ) головного и спинного мозга (опухоли, инсульты, рубцы, патология сосудов) и всего тела.
Противопоказания
Повышенная чувствительность к Омнискану и к его компонентам. Почечная недостаточность (скорость клубочковой фильтрации менее 30 мл/мин), детский возраст (до 6 мес).
В 1 мл. препарата содержится Активный ингредиент: гадодиамид (Ш-ВТРА-ВМА), эквивалентно 0,5 ммоль. 287 мг. Вспомогательные вещества: натрия кальдиамид, натрия гидроксид 1М или хлористоводородная кислота 1М и вода для инъекций.
Описание
Омнискан является неионным парамагнитным контрастным средством для магнитно- резонансной томографии (МРТ).
Фармакологические свойства
Парамагнитные свойства обуславливают контрастное усиление при выполнении магнитно-резонансной томографии (МРТ). Введение Омнискана вызывает усиление сигнала от областей, где имеется дисфункция гематоэнцефалического барьера вследствие его повреждения патологическим процессом, что может обеспечивать большую информативность изображений по сравнению с данными МРТ до контрастного усиления. Оптимальное контрастное усиление обычно наблюдается в течение первых минут после введения (зависит от типа патологического процесса/ткани). Контрастное усиление обычно сохраняется до 45 мин после введения Омнискана.
Показания к применению
Магнитно-резонансная томография (МРТ) головного и спинного мозга (опухоли, инсульты, рубцы, патология сосудов) и всего тела.
Противопоказания
Повышенная чувствительность к Омнискану и к его компонентам. Почечная недостаточность (скорость клубочковой фильтрации менее 30 мл/мин), детский возраст (до 6 мес).
Применение при беременности и в период грудного вскармливания
Отсутствует опыт применения Омнискана у людей во время беременности. Не следует использовать препарат для обследования беременных женщин, за исключением тех случаев, когда проведение МРТ с контрастным усилением представляется крайне необходимым и не имеется возможности заменить это обследование другими методиками. Степень экскреции препарата в материнское молоко неизвестна. Кормление грудью должно быть прекращено перед введением препарата и его возобновление возможно не ранее, чем через 24 ч после инъекции Омнискана.
Способ применения и дозы
Внутривенно струйно, однократно. Омнискан должен быть набран в шприц непосредственно перед использованием. За 2 часа до процедуры пациент должен прекратить прием пищи. При введении препарата больной должен находиться в горизонтальном положении. В течение 30 минут после окончания процедуры осуществляют врачебный контроль за пациентом, т.к. большинство побочных реакций возникает именно в этот период. Контрастирование ЦНС Дозировка для взрослых и детей в возрасте старше 6 месяцев Рекомендуемая дозировка - 0,1 ммоль/кг массы тела (0,2 мл/кг массы тела) при массе тела до 100 кг, более 100 кг - 20 мл обычно достаточно для обеспечения диагностически адекватного контрастирования. Необходимая доза должна быть введена однократно внутривенно. Для обеспечения полноты введения препарата можно промыть внутривенный катетер 0,9% раствором натрия хлорида. Для взрослых пациентов При подозрении на наличие метастатических поражений головного мозга возможно введение препарата в двойной или тройной дозе до 0,3 ммоль/кг (0,6 мл/кг массы тела) при массе тела обследуемого до 100 кг, более 100 кг - 60 мл обычно достаточно для обеспечения диагностически адекватного контрастирования. В случаях неоднозначных результатов исследования после контрастного усиления Омнисканом в дозе 0,1 ммоль/кг повторная болюсная инъекция препарата в течение последующих 20 мин в дозе 0,2 ммоль/кг (0,4 мл/кг) может помочь получить дополнительную диагностическую информацию. Контрастирование всего тела Для взрослых пациентов Рекомендуемая дозировка составляет обычно 0,1 ммоль/кг (0,2 мл/кг) или, при необходимости (0,6 мл/кг). При массе тела обследуемого более 100 кг 20-60 мл препарата обычно достаточно для обеспечения диагностически адекватного контрастирования. Для детей старше 2 лет Рекомендуемая дозировка составляет 0,1 ммоль/кг (0,2 мл/кг). Как для взрослых, так и для детей необходимая доза должна быть введена однократно внутривенно. Для обеспечения полноты введения препарата можно промыть внутривенный катетер 0,9% раствором натрия хлорида. Магнитно-резонансное исследование MP исследование при контрастном усилении должно быть начато через несколько минут после введения препарата, в зависимости от используемых импульсных последовательностей и протокола исследования. Для MP- исследований с контрастным усилением Омнисканом оптимальными являются Т1-взвешенные импульсные последовательности. В диапазоне используемых напряженностей магнитного поля томографов - от 0,15 до 1,5 Тесла - не выявлена зависимость контрастности изображения от величины поля прибора.
Побочное действие
Организм в целом: лихорадка, озноб. Анафилактоидные реакции, редко (>0,01% -<0,10%) - анафилактический шок. Со стороны ЖКТ - снижение аппетита, отрыжка, боль в животе, диарея, тошнота, рвота. Со стороны нервной системы - головокружение, головная боль, изменение вкуса и обоняния, тревожность, психические нарушения, атаксия, нарушение координации движений, парестезии, тремор, нарушения зрения, потеря сознания (вплоть до развития глубокой комы), шум в ушах, сонливость, редко (>0,01% - <0,10%) судороги (вплоть до развития эпилептического статуса). Нарушения функции почек. Со стороны органов кроветворения - бессимптомное снижение содержания сывороточного железа (в сроки от 8 до 48 ч после введения препарата). Местные реакции: локальная болезненность или ощущение распирания в месте введения. Прочие - идиосинкразия, артралгия, миалгия, гиперемия кожи лица, повышенное потоотделение.
Передозировка
Симптомы: возможно усиление проявлений описанных побочных эффектов. Лечение симптоматическое. Удаляется путем гемодиализа.
Особые указания
С связи с возможностью развития анафилактического шока во время введения препарата необходимо создать все условия для проведения немедленной, интенсивной терапии. Перед каждым применением контрастного средства необходимо получить точную информацию о пациенте, включая важные лабораторные данные (например, уровень креатинина в сыворотке крови, электрокардиограмма, аллергия в анамнезе, наличие беременности). Перед исследованием у пациента следует устранить нарушения водно-элетролитного баланса и обеспечить достаточное поступление жидкости и электролитов. Это особенно касается пациентов с множественной миеломой, сахарным диабетом, полиурией или подагрой, а также новорожденных, грудных детей и детей раннего возраста, пожилых пациентов. Отсутствие контрастного усиления не является однозначным свидетельством отсутствия патологии, т.к. некоторые виды новообразований или неконтрастные бляшки при атеросклерозе не контрастируются. Наличие или отсутствие контрастного усиления может быть использовано для дифференциального диагноза. Флаконы предназначены для использования только у одного пациента. При введении других препаратов необходимо использовать отдельные шприц и иглу. Неиспользованные остатки препарата должны быть уничтожены. Каждый флакон или одноразовый шприц рассчитан на введение препарата одному пациенту. Не рекомендуется проводить предварительное тестирование индивидуальной чувствительности с использованием малых доз препарата, ввиду риска возникновения тяжелых реакций гиперчувствительности. Пациентам, испытывающим страх ожидания перед процедурой необходима премедикация успокаивающими средствами. Омнискан искажает результаты измерения концентрации кальция и сывороточного железа в крови при использовании некоторых колориметрических (комплексометрических) методов, обычно применяющихся в лечебных учреждениях. (Не рекомендуется использовать эти методы в течение 12-24 ч после введения Омнискана). Если подобные исследования необходимы, следует использовать другие методы анализа. При изменении окраски раствора или наличии крупных частиц препарат нельзя использовать. Влияние на способность водить машину и использовать механизмы: Не описаны
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Омнискан должен быть набран в шприц непосредственно перед использованием. За 2 часа до процедуры пациент должен прекратить прием пищи. При введении препарата больной должен находиться в горизонтальном положении. В течение 30 минут после окончания процедуры осуществляют врачебный контроль за пациентом, т.к. большинство побочных реакций возникает именно в этот период. Контрастирование ЦНС Дозировка для взрослых и детей в возрасте старше 6 месяцев Рекомендуемая дозировка - 0,1 ммоль/кг массы тела (0,2 мл/кг массы тела) при массе тела до 100 кг, более 100 кг - 20 мл обычно достаточно для обеспечения диагностически адекватного контрастирования. Необходимая доза должна быть введена однократно внутривенно. Для обеспечения полноты введения препарата можно промыть внутривенный катетер 0,9% раствором натрия хлорида. 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Как для взрослых, так и для детей необходимая доза должна быть введена однократно внутривенно. Для обеспечения полноты введения препарата можно промыть внутривенный катетер 0,9% раствором натрия хлорида. Магнитно-резонансное исследование MP исследование при контрастном усилении должно быть начато через несколько минут после введения препарата, в зависимости от используемых импульсных последовательностей и протокола исследования. Для MP- исследований с контрастным усилением Омнисканом оптимальными являются Т1-взвешенные импульсные последовательности. В диапазоне используемых напряженностей магнитного поля томографов - от 0,15 до 1,5 Тесла - не выявлена зависимость контрастности изображения от величины поля прибора."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Организм в целом: лихорадка, озноб. Анафилактоидные реакции, редко (\u003e0,01% -\u003c0,10%) - анафилактический шок. Со стороны ЖКТ - снижение аппетита, отрыжка, боль в животе, диарея, тошнота, рвота. Со стороны нервной системы - головокружение, головная боль, изменение вкуса и обоняния, тревожность, психические нарушения, атаксия, нарушение координации движений, парестезии, тремор, нарушения зрения, потеря сознания (вплоть до развития глубокой комы), шум в ушах, сонливость, редко (\u003e0,01% - \u003c0,10%) судороги (вплоть до развития эпилептического статуса). Нарушения функции почек. Со стороны органов кроветворения - бессимптомное снижение содержания сывороточного железа (в сроки от 8 до 48 ч после введения препарата). Местные реакции: локальная болезненность или ощущение распирания в месте введения. Прочие - идиосинкразия, артралгия, миалгия, гиперемия кожи лица, повышенное потоотделение."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: возможно усиление проявлений описанных побочных эффектов. 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