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Минздрав анонсировал важные изменения в инструкции к препаратам с кальцитонином
Минздрав анонсировал важные изменения в инструкции к препаратам с кальцитонином
Ведомство сообщило о необходимости внесения изменений в инструкции по применению лекарственных препаратов с действующим веществом кальцитонин в лекарственной форме раствор для инъекций. Эти ЛС регулируют обмен кальция и метаболизм костной ткани. Изменения касаются показаний для применения лекарства. Информационное письмо об этом опубликовано 16 октября на портале Государственного реестра лекарственных средств.
Согласно Государственному реестру лекарственных средств, следующие торговые наименования содержат кальцитонин в лекарственной форме раствор для инъекций:
«Миакальцик», «Остеовер».
Минздрав обязывает всех производителей препаратов с кальцитонином в форме раствора для инъекций изложить раздел «Показания» в следующем виде:
«Профилактика острой потери костной массы вследствие иммобилизации. Лечение болезни Педжета продолжительностью не более 3 месяцев у пациентов, не отвечающих на иную терапию, или в случае невозможности ее применения. Гиперкальциемия при онкологических заболеваниях».
Кроме этого, Минздрав в своем письме приводит последнюю информацию о безопасности применению кальцитонина в форме назального спрея. Согласно исследованиям Европейского медицинского агентства, длительная терапия такими препаратами может повышать риск развития рака. В 17 проведенных исследованиях применение кальцитонина было связано с повышением риска развития новообразований на 2,36 % в сравнении с плацебо. Так образом, специалисты Минздрава оценивают соотношение пользы от применения препарата и вероятность развития побочных реакций как неблагоприятное.
17 октября 2018
Выпуск: №177, октябрь 20182329 просмотров
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