Гиперчувствительность (в т.ч. на др. мышиные белки), сепсис, клинически выраженное инфекционное заболевание или абсцесс, беременность, кормление грудью, детский возраст до 17 лет.
Инструкция
Торговое название препарата
Ремикейд
Лекарственная форма
Лиофилизат для приготовления раствора для инфузий.
Состав
Действующее вещество: инфликсимаб 100 мг.
Фармакотерапевтическая группа
Ремикейд - иммунодепрессивное.
Взаимодействует с растворимой и трансмембранной формами человеческого фактора некроза опухоли альфа (цитокин широкого биологического действия) и снижает его функциональную активность, вследствие образования устойчивого комплекса.
Гиперчувствительность (в т.ч. на др. мышиные белки), сепсис, клинически выраженное инфекционное заболевание или абсцесс, беременность, кормление грудью, детский возраст до 17 лет.
Применение при беременности и в период грудного вскармливания
Ремикейд противопкоазан при беременности, лактации.
Способ применения и дозы
Ремикейд вводят в/в капельно, в течение 2 ч со скоростью не более 2 мл/мин, с использованием инфузионной системы со встроенным стерильным апирогенным фильтром, обладающим низкой белковосвязывающей активностью. При ревматоидном артрите лечение проводят в комбинации с метотрексатом. Начальная разовая доза инфликсимаба - 3 мг/кг; через 2 и 6 нед вводят повторно в той же дозе, затем - каждые 8 нед (общее число введений - 5-6). При болезни Крона (тяжелое течение) - однократно 5 мк/кг. При болезни Крона с образованием свищей - разовая доза - 5 мг/кг, повторно вводят через 2 и 6 нед после первой инъекции. В случае рецидива заболевания препарат может быть снова назначен в течение 14 нед после введения последней дозы. Для приготовления инфузионного раствора содержимое флакона растворяют в 10 мл воды для инъекций и доводят общий объем до 250 мл 0.9% раствором NaCl. Полученный раствор должен быть бесцветным или светло-желтого цвета и опалесцирующим; в нем может присутствовать небольшое количество мелких полупрозрачных частиц (раствор, в котором присутствуют темные частицы или с измененным цветом, не применяется). В связи с отсутствием в препарате консерванта введение инфузионного раствора должно быть начато как можно скорее и не позже 3 ч после его приготовления. Неиспользованная часть инфузионного раствора дальнейшему применению не подлежит.
Побочное действие
Со стороны нервной системы: головная боль, головокружение, обморочные состояния, депрессия, психоз, тревожность, амнезия, апатия, нервозность, сонливость.
Со стороны ССС: "приливы" крови к коже лица, повышение или снижение АД, петехии, тромбофлебит, брадикардия, сердцебиение, спазм сосудов, цианоз, нарушения периферического кровообращения, аритмия.
Со стороны пищеварительной системы: тошнота, диарея, боль в животе, диспепсия, запоры, гастроэзофагеальный рефлюкс, хейлит, дивертикулит, нарушение функции печени, холецистит.
Со стороны мочевыделительной системы: инфекции мочевыводящих путей, пиелонефрит.
Со стороны мочеполовой системы: вагинит.
Со стороны опорно-двигательного аппарата: миалгия, артралгия.
Со стороны органов кроветворения: анемия, лейкопения, лимфоаденопатия, лимфоцитоз, лимфопения, нейтропения, тромбоцитопения.
Со стороны дыхательной системы: инфекции верхних дыхательных путей, бронхит, пневмония, одышка, синусит, носовое кровотечение, бронхоспазм, плеврит.
Со стороны органов чувств: конъюнктивит, кератоконъюнктивит, эндофтальмит.
Со стороны кожных покровов и подкожно-жировой клетчатки: крапивница, повышенное потоотделение, сухость кожи, экзема, себорея, периорбитальный отек, гиперкератоз, нарушение пигментации кожи, алопеция, буллезная сыпь.
Аллергические реакции (замедленного типа): миалгия и/или артралгия с лихорадкой, крапивница, зуд, отек лица, губ, кистей, дисфагия, головная боль.
Прочие: образование аутоантител, волчаночный синдром, чрезмерная утомляемость, боль в груди, отек, инфузионный синдром; вирусные инфекции (грипп, герпес), абсцесс, сепсис, бактериальные и грибковые инфекции (рожа, бородавки, фурункулез, онихомикоз, флегмона).
Взаимодействие с другими лекарственными средствами
У больных ревматоидным артритом и болезнью Крона одновременное применение метотрексата или других иммуномодуляторов снижает образование антител к Ремикейду и повышает концентрацию последнего в плазме.
ГКС практически не влияют на фармакокинетику Ремикейда.
Не рекомендуется комбинировать лечение Ремикейдом и анакинрой.
Данные о взаимодействии между инфликсимабом и другими лекарственными средствами отсутствуют.
Фармацевтическое взаимодействие
При проведении инфузии смешивать раствор Ремикейда с другими лекарственными препаратами не следует.
Особые указания
Проведение повторного лечения Ремикейд с интервалом более 15 нед не рекомендуется, женщины репродуктивного возраста в период лечения препаратом Ремикейд и затем в течение 6 мес должны использовать надежные методы контрацепции
Форма выпуска
Лиофилизат для приготовления раствора для инфузий.
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