Парамагнитный контрастный препарат для МРТ. Контрастирующий... Инструкция
Показания к применению
Для усиления контрастности изображения при проведении МРТ головного и спинного мозга (краниальной и спинальной МРТ):
Для обнаружения опухолей, в т.ч. небольших и плохо визуализируемых, рецидивов опухоли после оперативного вмешательства или лучевой терапии, метастазов
Для дифференциальной диагностики при подозрении на менингиому, невриному слухового нерва, опухоли с инфильтративным ростом в близлежащие ткани (например, глиома)
Для дифференциальной диагностики некоторых редких опухолей (гемангиобластома, эпендимома, небольшие аденомы гипофиза)
В 1 мл раствора содержится: гадопентетат димеглюмина 469.01 мг (0.5 ммоль); осмоляльность при 37°C - 1.96 Осм/кг Н2О; вязкость при 20°C - 4.9 мПа×сек, при 37°C - 2.9 мПа×сек; плотность при 20°C - 1.21 г/мл, при 37°C - 1.195 г/мл; рН 7.0-7.9. Вспомогательные вещества: меглюмин (соответствует 196.21 мг общего меглюмина) - 0.99 мг, пентетовая кислота (ДТПА) - 0.4 мг, вода д/и - 738.5 мг.
Фармакологические свойства
Парамагнитный контрастный препарат для МРТ. Контрастирующий эффект обусловлен ди-N-метилглюкаминовой солью гадопентетата - комплексом гадолиния с пентетовой кислотой (диэтилентриаминпентауксусной кислотой - ДТПК). При использовании соответствующей последовательности сканирования (например, метод Т1-взвешенного спинового эха) для получения протонной магнитно-резонансной визуализации гадолиниевый ион укорачивает время спин-решеточной релаксации возбужденных ядер атомов, что увеличивает интенсивность сигнала и повышает контрастность изображения определенных тканей. Гадопентетовой кислоты димеглюминовая соль практически не связывается с белками и не ингибирует активность ферментов (например, миокардиальную Na+-K+-АТФ-азу). Магневист; не активирует систему комплемента и, следовательно, имеет очень низкую потенциальную способность вызывать анафилактоидные реакции.
Показания к применению
Для усиления контрастности изображения при проведении МРТ головного и спинного мозга (краниальной и спинальной МРТ):
Для обнаружения опухолей, в т.ч. небольших и плохо визуализируемых, рецидивов опухоли после оперативного вмешательства или лучевой терапии, метастазов
Для дифференциальной диагностики при подозрении на менингиому, невриному слухового нерва, опухоли с инфильтративным ростом в близлежащие ткани (например, глиома)
Для дифференциальной диагностики некоторых редких опухолей (гемангиобластома, эпендимома, небольшие аденомы гипофиза)
Для улучшения визуализации интракраниального распространения внемозговых опухолей. Дополнительно при проведении спинальной МРТ:
Для дифференциальной диагностики интрамедуллярных и экстрамедуллярных опухолей
Для определения размеров солидных опухолей в спинном мозге
Для оценки распространенности интрамедуллярных опухолей. Для усиления контрастности изображения при проведении МРТ всего тела (включая исследования лицевого черепа, области шеи, грудной и брюшной полости, молочных желез, органов таза, опорно-двигательного аппарата и получение изображения сосудов всего тела):
Для выявления опухоли, воспалительного процесса, повреждений сосудов
Для определения распространенности и границ опухоли, воспалительного процесса, повреждений сосудов
Для дифференциальной диагностики структуры патологических изменений
Для оценки кровоснабжения нормальных и патологически измененных тканей
Для дифференциальной диагностики опухолей и рубцовой ткани после терапии
Для выявления рецидива выпадения межпозвонкового диска после хирургического вмешательства
Для одновременной полуколичественной оценки функции и их визуализации
Противопоказания
Повышенная чувствительность к компонентам препарата.
Применение при беременности и в период грудного вскармливания
Безопасность Магневиста при беременности не изучена. При необходимости применения препарата следует соблюдать осторожность. При в/в введении гадопентетовая кислота в очень ограниченных количествах выделяется с грудным молоком (приблизительно 0.04% введенной дозы). Имеющийся опыт свидетельствует об отсутствии опасности для детей, находящихся на грудном вскармливании.
Способ применения и дозы
Магневист; следует вводить только в/в. МРТ с контрастированием следует начинать сразу же после введения. Магневист; не применяется для введения под оболочки мозга. В диапазоне от 0.14 до 1.5 Тл рекомендации по применению Магневиста не зависят от напряженности магнитного поля. Магневист; следует набирать в шприц непосредственно перед применением. Неиспользованные при обследовании остатки контрастного средства должны быть уничтожены. При краниальной и спинальной МРТ для взрослых и детей (в т.ч. новорожденных и грудных) и подростков рекомендуемая доза составляет 0.2 мл/кг массы тела. В случаях, когда остается подозрение на наличие патологического очага, возможно проведение повторного контрастного исследования. Повторное введение в дозе 0.2 мл/кг или 0.4 мл/кг (взрослым) следует проводить через 30 мин после первого введения с незамедлительным проведением МРТ. Введение взрослым пациентам повышенной дозы Магневиста 0.6 мл/кг повышает достоверность диагностики при метастатических поражениях или рецидивах опухолей. При МРТ всего тела взрослым и детям старше 2 лет рекомендуют введение Магневиста в дозе 0.2 мл/кг. При расположении объекта исследования в области с бедной васкуляризацией и/или с небольшим внеклеточным пространством для получения адекватного контрастирующего эффекта может потребоваться введение препарата в дозе 0.4 мл/кг, особенно при использовании коротких Т1-взвешенных последовательностей при сканировании. Введение в дозе 0.6 мл/кг может повысить достоверность диагностики при ряде патологических повреждений или рецидивах опухолей. Для визуализации сосудов в зависимости от области исследования и используемой методики МРТ может потребоваться введение взрослым дозы Магневиста 0.6 мл/кг. Опыт применения Магневиста при проведении МРТ всего тела у детей младше 2 лет пока ограничен. В таких случаях врач должен тщательно взвешивать соотношение предполагаемой пользы и потенциального риска от проведения исследования с Магневистом. Подготовка пациентаДля в/в введения целесообразно использовать гибкий катетер. Препарат применяют только в условиях стационара при наличии оборудования для проведения реанимационных мероприятий. Необходимо соблюдать общепринятые меры предосторожности при проведении МРТ (в т.ч. отсутствие у больных кардиостимуляторов, ферромагнитных имплантатов). Во время внутрисосудистого введения контрастного средства пациент должен находиться в горизонтальном положении. После инъекции следует наблюдать за пациентом в течение 30 мин. У взрослых и детей старше 2 лет в/в введение Магневиста следует осуществлять ручным способом или с помощью автоматического инжектора. У новорожденных и у детей в возрасте до 2 лет требуемую дозу следует вводить ручным способом. Для исследований с применением контрастирования при сканировании обычно используют Т1-взвешенные последовательности.
Побочное действие
Побочные эффекты, связанные с применением Магневиста, обычно выражены слабо, умеренно и носят преходящий характер. Однако сообщалось о развитии тяжелых и угрожающих жизни реакциях. Определение частоты побочных эффектов: часто >(1/100); иногда (≤1/100, но >1/1000); редко - (≤1/1000). Частота побочных реакций по данным пострегистрационных клинических исследований и по данным спонтанных сообщений. Со стороны организма в целом: иногда - чувство жара, головная боль; редко - боль в спине, боль в груди или в суставах, недомогание, повышенное потоотделение, обморок, повышение температуры тела. Местные реакции: редко при экстравазации - локальная боль, ощущение тепла или холода, отек, воспалительный процесс, некроз тканей, флебит, тромбофлебит. Аллергические реакции: редко - ангионевротический отек, конъюнктивит, кашель, ринит, чиханье, бронхоспазм, ларингоспазм, отек гортани/глотки, артериальная гипотензия, шок, кожные реакции (крапивница). Со стороны ЦНС и периферической нервной системы: иногда - головокружение, головные боли, парестезии; редко - возбуждение (ажитация), спутанность сознания, судороги, тремор, астения, кома, сонливость, нарушения речи. Со стороны органов чувств: редко - слезотечение, боль в глазах, боль в ушах, нарушение зрения, слуха, обоняния. Со стороны сердечно-сосудистой системы: редко - снижение АД, аритмия, остановка сердца, периферическая вазодилатация, артериальная гипотензия, обморок, рефлекторная тахикардия, цианоз. Со стороны дыхательной системы: редко - одышка, дыхательная недостаточность, кашель, остановка дыхания, отек легких. Со стороны пищеварительной системы: иногда - тошнота, рвота; редко - боли в животе, диарея, извращение вкуса, сухость во рту, гиперсаливация, транзиторное повышение активности печеночных ферментов и билирубина в крови. Со стороны мочевыделительной системы: редко - недержание мочи, частые позывы к мочеиспусканию; у пациентов с предшествующей патологией почек - увеличение уровня креатинина и острая почечная недостаточность. Дерматологические реакции: редко - кожный зуд, покраснение кожи (за счет вазодилатации), сыпь, отек. Прочие: редко - транзиторное повышение содержания железа в сыворотке крови.
Передозировка
Симптомы: возможны проявления гиперосмотичности препарата - увеличение давления в легочной артерии, увеличение диуреза, гиперволемия, дегидратация. Лечение: необходимо контролировать функцию почек (особенно у пациентов с почечной недостаточностью). Гадопентетат димеглюмина может быть удален при помощи гемодиализа.
Особые указания
Для уменьшения риска аспирации за 2 ч до исследования пациенту следует воздерживаться от приема пищи. На фоне применения Магневиста возможно развитие серьезных аллергических реакций (включая анафилактический шок), большинство из которых возникают в течение 30 мин после введения препарата, однако в редких случаях возможно развитие отсроченных реакций (от нескольких часов до нескольких дней). Перед назначением препарата следует внимательно собрать аллергологический анамнез пациентов на наличие сенной лихорадки, крапивницы, аллергических реакций на морепродукты и реакций на контрастные вещества, бронхиальной астмы. Этой категории пациентов рекомендуется провести премедикацию (ГКС и блокаторы гистаминовых H1-рецепторов). У пациентов с бронхиальной астмой имеется повышенный риск развития бронхоспазма или реакций повышенной чувствительности. При внутричерепных опухолях или метастазах, а также при эпилепсии в анамнезе возможно повышение частоты возникновения судорог после введения контрастных средств. При определении содержания железа в сыворотке крови комплексонометрическими методами (например, с помощью батофенантролина) в течение первых 24 ч количественный показатель может быть снижен, что объясняется наличием в растворе контрастного средства свободной ДТПК. Влияние на способность к вождению автотранспорта и управлению механизмамиНе обнаружено влияние препарата Магневист; на способность к вождению автотранспорта и другой деятельности, требующей высокой концентрации внимания и скорости психомоторных реакций.
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раствора содержится: гадопентетат димеглюмина 469.01 мг (0.5 ммоль); осмоляльность при 37°C - 1.96 Осм/кг Н2О; вязкость при 20°C - 4.9 мПа×сек, при 37°C - 2.9 мПа×сек; плотность при 20°C - 1.21 г/мл, при 37°C - 1.195 г/мл; рН 7.0-7.9. Вспомогательные вещества: меглюмин (соответствует 196.21 мг общего меглюмина) - 0.99 мг, пентетовая кислота (ДТПА) - 0.4 мг, вода д/и - 738.5 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Парамагнитный контрастный препарат для МРТ. Контрастирующий эффект обусловлен ди-N-метилглюкаминовой солью гадопентетата - комплексом гадолиния с пентетовой кислотой (диэтилентриаминпентауксусной кислотой - ДТПК). При использовании соответствующей последовательности сканирования (например, метод Т1-взвешенного спинового эха) для получения протонной магнитно-резонансной визуализации гадолиниевый ион укорачивает время спин-решеточной релаксации возбужденных ядер атомов, что увеличивает интенсивность сигнала и повышает контрастность изображения определенных тканей. Гадопентетовой кислоты димеглюминовая соль практически не связывается с белками и не ингибирует активность ферментов (например, миокардиальную Na+-K+-АТФ-азу). Магневист; не активирует систему комплемента и, следовательно, имеет очень низкую потенциальную способность вызывать анафилактоидные реакции."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Для усиления контрастности изображения при проведении МРТ головного и спинного мозга (краниальной и спинальной МРТ):"}},{"type":"list","data":{"style":"unordered","items":["Для обнаружения опухолей, в т.ч. небольших и плохо визуализируемых, рецидивов опухоли после оперативного вмешательства или лучевой терапии, метастазов","Для дифференциальной диагностики при подозрении на менингиому, невриному слухового нерва, опухоли с инфильтративным ростом в близлежащие ткани (например, глиома)","Для дифференциальной диагностики некоторых редких опухолей (гемангиобластома, эпендимома, небольшие аденомы гипофиза)","Для улучшения визуализации интракраниального распространения внемозговых опухолей. 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Для усиления контрастности изображения при проведении МРТ всего тела (включая исследования лицевого черепа, области шеи, грудной и брюшной полости, молочных желез, органов таза, опорно-двигательного аппарата и получение изображения сосудов всего тела):","Для выявления опухоли, воспалительного процесса, повреждений сосудов","Для определения распространенности и границ опухоли, воспалительного процесса, повреждений сосудов","Для дифференциальной диагностики структуры патологических изменений","Для оценки кровоснабжения нормальных и патологически измененных тканей","Для дифференциальной диагностики опухолей и рубцовой ткани после терапии","Для выявления рецидива выпадения межпозвонкового диска после хирургического вмешательства","Для одновременной полуколичественной оценки функции и их визуализации"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Безопасность Магневиста при беременности не изучена. При необходимости применения препарата следует соблюдать осторожность. При в/в введении гадопентетовая кислота в очень ограниченных количествах выделяется с грудным молоком (приблизительно 0.04% введенной дозы). Имеющийся опыт свидетельствует об отсутствии опасности для детей, находящихся на грудном вскармливании."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Магневист; следует вводить только в/в. МРТ с контрастированием следует начинать сразу же после введения. Магневист; не применяется для введения под оболочки мозга. В диапазоне от 0.14 до 1.5 Тл рекомендации по применению Магневиста не зависят от напряженности магнитного поля. Магневист; следует набирать в шприц непосредственно перед применением. Неиспользованные при обследовании остатки контрастного средства должны быть уничтожены. При краниальной и спинальной МРТ для взрослых и детей (в т.ч. новорожденных и грудных) и подростков рекомендуемая доза составляет 0.2 мл/кг массы тела. В случаях, когда остается подозрение на наличие патологического очага, возможно проведение повторного контрастного исследования. Повторное введение в дозе 0.2 мл/кг или 0.4 мл/кг (взрослым) следует проводить через 30 мин после первого введения с незамедлительным проведением МРТ. Введение взрослым пациентам повышенной дозы Магневиста 0.6 мл/кг повышает достоверность диагностики при метастатических поражениях или рецидивах опухолей. При МРТ всего тела взрослым и детям старше 2 лет рекомендуют введение Магневиста в дозе 0.2 мл/кг. При расположении объекта исследования в области с бедной васкуляризацией и/или с небольшим внеклеточным пространством для получения адекватного контрастирующего эффекта может потребоваться введение препарата в дозе 0.4 мл/кг, особенно при использовании коротких Т1-взвешенных последовательностей при сканировании. Введение в дозе 0.6 мл/кг может повысить достоверность диагностики при ряде патологических повреждений или рецидивах опухолей. Для визуализации сосудов в зависимости от области исследования и используемой методики МРТ может потребоваться введение взрослым дозы Магневиста 0.6 мл/кг. Опыт применения Магневиста при проведении МРТ всего тела у детей младше 2 лет пока ограничен. В таких случаях врач должен тщательно взвешивать соотношение предполагаемой пользы и потенциального риска от проведения исследования с Магневистом. Подготовка пациентаДля в/в введения целесообразно использовать гибкий катетер. Препарат применяют только в условиях стационара при наличии оборудования для проведения реанимационных мероприятий. Необходимо соблюдать общепринятые меры предосторожности при проведении МРТ (в т.ч. отсутствие у больных кардиостимуляторов, ферромагнитных имплантатов). Во время внутрисосудистого введения контрастного средства пациент должен находиться в горизонтальном положении. После инъекции следует наблюдать за пациентом в течение 30 мин. У взрослых и детей старше 2 лет в/в введение Магневиста следует осуществлять ручным способом или с помощью автоматического инжектора. У новорожденных и у детей в возрасте до 2 лет требуемую дозу следует вводить ручным способом. Для исследований с применением контрастирования при сканировании обычно используют Т1-взвешенные последовательности."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Побочные эффекты, связанные с применением Магневиста, обычно выражены слабо, умеренно и носят преходящий характер. Однако сообщалось о развитии тяжелых и угрожающих жизни реакциях. Определение частоты побочных эффектов: часто \u003e(1/100); иногда (≤1/100, но \u003e1/1000); редко - (≤1/1000). Частота побочных реакций по данным пострегистрационных клинических исследований и по данным спонтанных сообщений. Со стороны организма в целом: иногда - чувство жара, головная боль; редко - боль в спине, боль в груди или в суставах, недомогание, повышенное потоотделение, обморок, повышение температуры тела. Местные реакции: редко при экстравазации - локальная боль, ощущение тепла или холода, отек, воспалительный процесс, некроз тканей, флебит, тромбофлебит. Аллергические реакции: редко - ангионевротический отек, конъюнктивит, кашель, ринит, чиханье, бронхоспазм, ларингоспазм, отек гортани/глотки, артериальная гипотензия, шок, кожные реакции (крапивница). Со стороны ЦНС и периферической нервной системы: иногда - головокружение, головные боли, парестезии; редко - возбуждение (ажитация), спутанность сознания, судороги, тремор, астения, кома, сонливость, нарушения речи. Со стороны органов чувств: редко - слезотечение, боль в глазах, боль в ушах, нарушение зрения, слуха, обоняния. Со стороны сердечно-сосудистой системы: редко - снижение АД, аритмия, остановка сердца, периферическая вазодилатация, артериальная гипотензия, обморок, рефлекторная тахикардия, цианоз. Со стороны дыхательной системы: редко - одышка, дыхательная недостаточность, кашель, остановка дыхания, отек легких. Со стороны пищеварительной системы: иногда - тошнота, рвота; редко - боли в животе, диарея, извращение вкуса, сухость во рту, гиперсаливация, транзиторное повышение активности печеночных ферментов и билирубина в крови. Со стороны мочевыделительной системы: редко - недержание мочи, частые позывы к мочеиспусканию; у пациентов с предшествующей патологией почек - увеличение уровня креатинина и острая почечная недостаточность. Дерматологические реакции: редко - кожный зуд, покраснение кожи (за счет вазодилатации), сыпь, отек. Прочие: редко - транзиторное повышение содержания железа в сыворотке крови."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: возможны проявления гиперосмотичности препарата - увеличение давления в легочной артерии, увеличение диуреза, гиперволемия, дегидратация. Лечение: необходимо контролировать функцию почек (особенно у пациентов с почечной недостаточностью). Гадопентетат димеглюмина может быть удален при помощи гемодиализа."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Для уменьшения риска аспирации за 2 ч до исследования пациенту следует воздерживаться от приема пищи. На фоне применения Магневиста возможно развитие серьезных аллергических реакций (включая анафилактический шок), большинство из которых возникают в течение 30 мин после введения препарата, однако в редких случаях возможно развитие отсроченных реакций (от нескольких часов до нескольких дней). Перед назначением препарата следует внимательно собрать аллергологический анамнез пациентов на наличие сенной лихорадки, крапивницы, аллергических реакций на морепродукты и реакций на контрастные вещества, бронхиальной астмы. Этой категории пациентов рекомендуется провести премедикацию (ГКС и блокаторы гистаминовых H1-рецепторов). У пациентов с бронхиальной астмой имеется повышенный риск развития бронхоспазма или реакций повышенной чувствительности. При внутричерепных опухолях или метастазах, а также при эпилепсии в анамнезе возможно повышение частоты возникновения судорог после введения контрастных средств. При определении содержания железа в сыворотке крови комплексонометрическими методами (например, с помощью батофенантролина) в течение первых 24 ч количественный показатель может быть снижен, что объясняется наличием в растворе контрастного средства свободной ДТПК. Влияние на способность к вождению автотранспорта и управлению механизмамиНе обнаружено влияние препарата Магневист; на способность к вождению автотранспорта и другой деятельности, требующей высокой концентрации внимания и скорости психомоторных реакций."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Парамагнитный контрастный препарат для МРТ. Контрастирующий эффект обусловлен ди-N-метилглюкаминовой солью гадопентетата - комплексом гадолиния с пентетовой кислотой (диэтилентриаминпентауксусной кислотой - ДТПК). При использовании соответствующей последовательности сканирования (например, метод Т1-взвешенного спинового эха) для получения протонной магнитно-резонансной визуализации гадолиниевый ион укорачивает время спин-решеточной релаксации возбужденных ядер атомов, что увеличивает интенсивность сигнала и повышает контрастность изображения определенных тканей. Гадопентетовой кислоты димеглюминовая соль практически не связывается с белками и не ингибирует активность ферментов (например, миокардиальную Na+-K+-АТФ-азу). Магневист; не активирует систему комплемента и, следовательно, имеет очень низкую потенциальную способность вызывать анафилактоидные реакции.","substance":[{"id":881,"title":"Гадопентетовая кислота","title_latin":null,"slug":"gadopentetovaya_kislota_881"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Магневист - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/1349/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/1349/share_default/"}},"diseases":[{"id":"1366","title":"Медицинское наблюдение и оценка при подозрении на заболевание или патологическое состояние","slug":"1366-meditsinskoe_nablyudenie_i_otsenka_pri_podozrenii_na_zabolevanie_ili_patologicheskoe_sostoyanie"}],"other_packages":[{"id":95700,"title":"Магневист","subtitle":{"full":"Раствор, 10 шт, 15 мл","short":"Раствор, 10 шт, 15 мл","package":"10 шт, 15 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