Препарат с дексмедетомидином получил новое показание к применению
11 апреля 2019
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№183, апрель 2019
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Препарат с дексмедетомидином получил новое показание к применению
Компания «Орион Фарма», производитель седативного лекарственного средства «Дексдор» (МНН: дексмедетомидин), сообщает о внесении изменений в инструкции по применению ЛС. В нее добавили новые показания к применению, а также актуальные сведения о безопасности препарата. Соответствующее информационное письмо опубликовано на сайте Росздравнадзора 10 апреля.
В раздел «Показания к применению» внесено новое показание: «Седация у неинтубированных взрослых пациентов до и/или во время проведения диагностических или хирургических вмешательств, т. е. седация при проведении анестезиологического пособия / седация в сознании».
В связи с этим в инструкции обновились разделы «Фармакодинамика», «Применение при беременности и в период лактации», «Способ применения и дозы», «Побочное действие», «Особые указания» и «Влияние на способность управлять транспортными средствами».
Среди побочных действий указано, что при седации в сознании применение препарата может вызывать гипотензию, угнетение дыхания или брадикардию. Также пациентам рекомендуется отказаться от управления транспортными средствами (или выполнения других опасных задач) на время приема дексмедетомидина.
Более подробное описание внесенных изменений в инструкцию по применению препарата «Дексдор» доступно в информационном письме по ссылке.
По данным ГРЛС, «Дексдор» — это единственный зарегистрированный в России препарат с действующим веществом дексмедетомидин.
Ранее Минздрав обратился к производителям ингибиторов АПФ и препаратов с менадиона натрия бисульфитом с требованием о внесении в инструкции информации о новых противопоказаниях к применению.
Катрен Стиль
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