Бета-лактамный антибиотик получил изменения в инструкции по применению
16 июля 2019
Фото: depositphotos.com
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№186, июль 2019
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Бета-лактамный антибиотик получил изменения в инструкции по применению
Росздравнадзор в своем официальном письме от 12 июля 2019 года сообщил о необходимости внести изменения в инструкции всех препаратов с действующим веществом меропенем в лекарственной форме порошок для приготовления раствора для внутривенного введения.
Ведомство обращается ко всем держателям регистрационных удостоверений и производителям лекарственных препаратов с указанным действующим веществом. Необходимость изменений в инструкциях обусловлена опытом клинического применения препарата.
В частности, раздел «Противопоказания» следует представить в следующей редакции:
«Гиперчувствительность к меропенему, к вспомогательным веществам или другим препаратам группы карбапенемов в анамнезе. Выраженная гиперчувствительность (анафилактические реакции, тяжелые кожные реакции) к любому антибактериальному средству, имеющему бета-лактамную структуру (т. е. к пенициллинам или цефалоспоринам). Детский возраст до 3‑х месяцев».
Меропенем — β-лактамный антибиотик класса карбапенемов. Согласно данным ГРЛС, меропенем показан при лечении нозокомиальных пневмоний, а также инфекций мочевыводящих путей, брюшной полости, кожи и ее структур. Кроме того, в списке показаний препарата эндометрит, менингит и септицемия.
Напомним, что ранее Росздравнадзор сообщил о внесении изменений в инструкции по применению препаратов «Дексдор» (дексмедетомидин), «Ибмрувика» (ибрутиниб), «Фурадонин авексима» (нитрофурантоин) и «Резолор» (прукалоприд).
Катрен Стиль
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