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[alias] => poznati-lijek-protiv-kaslja-povlaci-se-s-trzista-jer-moze-biti-izrazito-opasan-kupuje-se-i-u-hrvatskoj-a-djeluje-izravno-u-mozgu
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Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) pri Europskoj agenciji za lijekove (EMA) završilo je ocjenu lijekova s djelatnom tvari folkodin, koji se primjenjuju u liječenju neproduktivnog (suhog) kašlja u odraslih i djece, te je preporučilo ukidanje odobrenja za stavljanje u promet u Europskoj uniji (EU) za navedene lijekove.
Folkodin je opioidni lijek koji se primjenjuje u liječenju neproduktivnog (suhog) kašlja u odraslih i djece. Djeluje izravno u mozgu, potiskujući refleks kašlja na način da smanjuje živčane signale koji se šalju mišićima koji su uključeni u kašljanje.
Folkodin se primjenjuje od 1950-ih godina kao lijek koji potiskuje kašalj te je nacionalno odobren u sedam država članica EU-a. U Republici Hrvatskoj folkodin je dostupan u Pholcodin Alkaloid 10 mg tvrdim kapsulama.
Tijekom ovog postupka, stručnjaci su ocijenili sve dostupne dokaze, uključujući konačne rezultate iz ispitivanja ALPHO1, podatke o sigurnosti ovih lijekova nakon njihovog stavljanja u promet te informacije zaprimljene od trećih strana, poput zdravstvenih radnika. Dostupni podaci pokazali su da je primjena folkodina u razdoblju do 12 mjeseci prije opće anestezije provedene uz neuromuskularne blokatore rizični faktor za razvoj anafilaktičke reakcije (nagla, teška i životno ugrožavajuća alergijska reakcija) na neuromuskularne blokatore. Budući da nije bilo moguće identificirati učinkovite mjere za minimizaciju navedenog rizika, niti identificirati skupinu bolesnika za koju prednosti primjene folkodina nadmašuju njegove rizike, EMA je preporučila da se lijekovi koji sadrže folkodin povuku iz prometa u EU-u te više ne budu dostupni na tržištu.
Zdravstveni radnici trebaju razmotriti prikladne terapijske alternative i savjetovati bolesnicima da prestanu uzimati lijekove koji sadrže folkodin.
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Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) pri Europskoj agenciji za lijekove (EMA) završilo je ocjenu lijekova s djelatnom tvari folkodin, koji se primjenjuju u liječenju neproduktivnog (suhog) kašlja u odraslih i djece, te je preporučilo ukidanje odobrenja za stavljanje u promet u Europskoj uniji (EU) za navedene lijekove.
Folkodin je opioidni lijek koji se primjenjuje u liječenju neproduktivnog (suhog) kašlja u odraslih i djece. Djeluje izravno u mozgu, potiskujući refleks kašlja na način da smanjuje živčane signale koji se šalju mišićima koji su uključeni u kašljanje.
Folkodin se primjenjuje od 1950-ih godina kao lijek koji potiskuje kašalj te je nacionalno odobren u sedam država članica EU-a. U Republici Hrvatskoj folkodin je dostupan u Pholcodin Alkaloid 10 mg tvrdim kapsulama.
Tijekom ovog postupka, stručnjaci su ocijenili sve dostupne dokaze, uključujući konačne rezultate iz ispitivanja ALPHO1, podatke o sigurnosti ovih lijekova nakon njihovog stavljanja u promet te informacije zaprimljene od trećih strana, poput zdravstvenih radnika. Dostupni podaci pokazali su da je primjena folkodina u razdoblju do 12 mjeseci prije opće anestezije provedene uz neuromuskularne blokatore rizični faktor za razvoj anafilaktičke reakcije (nagla, teška i životno ugrožavajuća alergijska reakcija) na neuromuskularne blokatore. Budući da nije bilo moguće identificirati učinkovite mjere za minimizaciju navedenog rizika, niti identificirati skupinu bolesnika za koju prednosti primjene folkodina nadmašuju njegove rizike, EMA je preporučila da se lijekovi koji sadrže folkodin povuku iz prometa u EU-u te više ne budu dostupni na tržištu.
Zdravstveni radnici trebaju razmotriti prikladne terapijske alternative i savjetovati bolesnicima da prestanu uzimati lijekove koji sadrže folkodin.
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11. svibanj 2024 07:30
