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X. Международные указания по применению препарата
1.Торговое название лекарственного препарата
Esmeron® 25 мг = 2,5 мл
Esmeron® 50 мг = 5 мл
Esmeron® 100 мг = 10 мл
Esmeron® 250 мг = 25 мл
2.Качественный и количественный состав
Каждый мл Эсмерона содержит 10 мг рокурония бромида. Вспомогательные вещества – см. раздел 6.1.
3.Лекарственная форма
Раствор для внутривенного введения
4.Клинические характеристики
4.1. Терапевтические показания
Эсмерон применяется как дополнительное средство общей анестезии с целью облегчения эндотрахеальной интубации во время обычной и быстрой последовательной индукции, а также для обеспечения релаксации скелетной мускулатуры при хирургических вмешательствах. Эсмерон также используется как вспомогательное средство в ОИТ для облегчения интубации и искусственной вентиляции легких.
4.2. Дозировка и способ применения
Дозировка
Как и при использовании других миорелаксантов, дозировка Эсмерона подбирается индивидуально для каждого пациента. При подборе дозы следует учитывать такие моменты, как метод анестезии, предполагаемая продолжительность хирургического вмешательства, способ седации, ожидаемая продолжительность искусст-
99
венной вентиляции легких, возможное взаимодействие с другими, совместно назначаемыми препаратами, а также общее состояние пациента. Для оценки эффективности блокады нервно-мышечного проведения и восстановления нервно-мышечной передачи рекомендуется использовать соответствующую технику мониторинга.
Ингаляционные анестетики потенциируют миорелаксирующее действие Эсмерона. Это потенцирование, тем не менее, становится клинически значимым лишь в случае, когда в тканях создается необходимая для взаимодействия концентрация анестетика. В связи с этим необходимо адаптировать схему назначения Эсмерона путем снижения поддерживающих доз, увеличения временных интервалов между их введениями или за счет снижения скорости инфузии при длительных операциях (более 1 ч) под ингаляционным наркозом (см. раздел Взаимодействия с другими препаратами и другие формы взаимодействия).
Приведенные ниже дозы Эсмерона у взрослых пациентов можно рассматривать как общие рекомендации для проведения интубации трахеи и мышечной релаксации при выполнении коротких по времени или продолжительных хирургических вмешательств, а также при использовании в ОИТ.
Хирургические вмешательства
Интубация трахеи
Стандартная интубационная доза рокурония бромида при проведении обычного анестезиологического пособия составляет 0,6 мг/кг; она позволяет в течение 60 с у большинства пациентов достичь приемлемых условий для интубации. Доза 1,0 мг/кг рекомендуется для облегчения процедуры интубации трахеи при быстрой последовательной индукции анестезии, при этом адекватные условия у большинства пациентов достигаются также в течение 60 с. Если при выполнении быстрой последовательной индукции анестезии рокуроний бромид применяется в дозе 0,6 мг/кг, то приступать к интубации трахеи рекомендуется через 90 с после введения препарата.
При кесаревом сечении рекомендуется использовать только дозу 0,6 мг/кг рокурония бромида, поскольку доза 1,0 мг/кг у данной категории пациенток не изучалась.
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