Гормональный контрацептив получил изменения в инструкцию
31 октября 2019
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№189, октябрь 2019
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Гормональный контрацептив получил изменения в инструкцию
Компания ООО «МСД Фармасьютикалс» сообщает о внесении изменений в инструкцию по применению препарата «Импланон НКСТ» (МНН: этоногестрел), содержащих новые данные по безопасности применения ЛС. Информационное письмо об этом опубликовано 30 октября на сайте Росздравнадзора.
«Импланон НКСТ» представляет собой не подверженный биологическому распаду одностержневой гормональный контрацептив пролонгированного действия для подкожного применения.
Введение имплантата более глубоко, чем подкожно, может вызвать повреждение нервов или сосудов. Глубокое или неправильное введение может осложниться миграцией имплантата и в редких случаях — внутрисосудистым введением, которое может привести к миграции имплантата в легочную артерию.
В связи с такими рисками производитель изменил в инструкции по применению информацию о процедуре введения: чтобы убедиться, что имплантат введен под кожу, врач должен находиться в положении, позволяющем увидеть перемещение иглы и наблюдать за аппликатором со стороны, а не сверху. При наблюдении за аппликатором со стороны место введения и движение иглы непосредственно под кожей отчетливо видны.
Также обновлена информация о рекомендуемом положении руки женщины при введении и удалении имплантата: следует согнуть руку в локте так, чтобы ладонь была расположена под головой (или как можно ближе).
Соответствующее обновление было добавлено в инструкции и иллюстрации по введению и удалению имплантата, а также в инструкции по удалению непальпируемых имплантатов.
Ранее производитель препарата «Мезавант» внес в инструкцию изменения, касающиеся новых побочных действий ЛС, выявленных во время клинических исследований.
Катрен Стиль
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