Изменилась инструкция по применению препарата-транквилизатора
2 декабря 2019
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№191, декабрь 2019
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Изменилась инструкция по применению препарата-транквилизатора
Министерство здравоохранения сообщает о необходимости внести изменения в инструкции по применению препаратов с действующим веществом тофизопам, основанные на новой информации об опыте клинического применения таких ЛС. Изменения касаются разделов «Показания к применению», «Противопоказания» и «Влияние на способность управлять транспортными средствами». Соответствующее письмо Минздрава опубликовано 29 ноября в Государственном реестре лекарственных средств.
Раздел «Показания к применению» необходимо привести в редакции, что тофизопам применяется для «лечения психических (невротических) и психосоматических расстройств, сопровождающихся эмоциональным напряжением, беспокойством, вегетативными расстройствами, апатией, усталостью и подавленным настроением, а также алкогольного абстинентного синдрома».
Раздел «Противопоказания» представить следующим образом:
«Повышенная чувствительность к тофизопаму, другим производным группы бензодиазепина, а также другим компонентам препарата. Детский возраст до 19 лет. Беременность. Период грудного вскармливания. Состояния, сопровождающиеся выраженным психомоторным возбуждением, агрессией или выраженной депрессией. Декомпенсированная дыхательная недостаточность. Синдром обструктивного апноэ. Кома. Одновременное применение с такролимусом, сиролимусом, циклоспорином».
Раздел «Влияние на способность управлять транспортным средством, механизмами» привести в редакции:
«В период применения препарата запрещено вождение транспортных средств и/или работа со сложными механизма, требующая повышенной концентрации внимания».
Ранее изменения в инструкцию по применению получил комбинированный антибактериальный препарат «Изокомб».
Катрен Стиль
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