Катрен Стиль25 августа 2021
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Выпуск: №212, август 20213939 просмотров
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Серия отечественного препарата вернулась в обращение спустя полгода карантина
24 августа Федеральная служба по надзору в сфере здравоохранения сообщила о возобновлении реализации серии лекарственного препарата «Натальсид» (МНН — натрия алгинат). Ранее в партии этого ЛС нашли суппозитории разного цвета.
Речь идёт о препарате «Натальсид®, суппозитории ректальные, 250 мг 5 шт., контурная ячейковая упаковка (2), пачка картонная» производства АО «Нижфарм» (Россия), серии 871020.
Росздравнадзор разрешил возобновить реализацию препарата «при условии соответствия его качества установленным требованиям». Решение было принято на основании результатов «проведённых производителем мероприятий».
По данным ГРЛС, «Натальсид» является гемостатическим средством для местного применения. Препарат применяется для лечения хронических анальных трещин и кровоточащего геморроя.
О приостановлении реализации указанной серии препарата ранее сообщалось в письме Росздравнадзора № 01И-171/21 от 10 февраля 2021 года. Эти меры были предприняты из‑за несоответствия препарата требованиям качества по показателю «Описание» (суппозитории были неоднородными по окраске).
Напомним, что согласно требованиям п. 30 Правил надлежащей практики хранения и перевозки лекарственных препаратов для медицинского применения (Приказ Минздрава России от 31.08.2016 г. № 646н) такие препараты должны быть помещены в отдельное помещение (зону) или изолированы с применением системы электронной обработки данных, обеспечивающей разделение.
Ранее в августе Министерство здравоохранения РФ заявило о возобновлении применения антикоагулянта «Вессел Дуэ Ф» и анестетика «Маркаин Спинал».
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