Stanovisko ŠÚKL v súvislosti s liekom EPIPEN | Medicínske právo
              

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Stanovisko ŠÚKL v súvislosti s liekom EPIPEN


 | 15.4.2017 | komentárov: 422

Štátny ústav pre kontrolu liečiv dostal hlásenie o sťahovaní lieku Epipen a EpiPen Jr. v zahraničí v dôsledku zlyhania aktivácie pera. Toto zlyhanie bolo pozorované u šarže 5FA665H, ktorá sa však na slovenskom trhu nevyskytuje.

Obrazok

Zlyhanie aktivácie pera bolo v celom svete pozorované v dvoch prípadoch, jedná sa o mimoriadne zriedkavý jav. Pri šaržiach lieku EpiPen a EpiPen Jr., číslo šarží 6FA292D, 6FA293K, 5ED824Y, 5ED824AA, 6ED117AF a 6FA293M, ktoré sa nachádzajú na slovenskom trhu, táto chyba nebola hlásená. Očakáva  sa síce celosvetový výpadok tohto lieku na trhu, ale náhrady za uvedený liek na Slovensku nie sú dostačujúce. Práve preto ŠÚKL sa rozhodol o ponechaní lieku EpiPen na trhu. Táto chyba v nekvalite lieku sa netýka iba Slovenskej republiky ale celej Európy, Spojených štátov amerických, Kanady, Ázie a Austrálie. Vzhľadom k tomu, že ide o celosvetový problém, ŠÚKL intenzívne komunikuje s Európskou liekovou agentúrou a držiteľom registrácie lieku EpiPen. V prípade nových skutočností bude  ŠÚKL  pacientov ihneď informovať. Pri aplikácii lieku EpiPen  treba postupovať v súlade s  písomnou informáciou pre používateľov, to znamená, že pri použití je nutné pero prudko naraziť na vonkajšiu stranu stehna zo vzdialenosti približne 10 cm od stehna. Liek EpiPen a EpiPen Jr. obsahuje sterilný roztok adrenalínu. Je určený na naliehavú liečbu závažných alergických reakcií spôsobených alergénmi, napríklad jedlom, liekmi, žihadlami alebo po uštipnutí hmyzom.

Stiahnutie lieku TRALGIT 

Štátny ústav pre kontrolu liečiv informuje o stiahnutí lieku TRALGIT gtt, gto por 1x96 ml (fľ.skl.hnedá s pump. adaptérom), dvoch šarží č. 2040916 a 2020516 z úrovne distribučných spoločností a lekární. Dôvodom stiahnutia predmetných šarží lieku je nález vypadnutých častí plastového uzáveru vo vnútri roztoku, zistený v niekoľkých prípadoch. Tento nedostatok nemá vplyv na účinnosť a bezpečnosť lieku. V súvislosti s touto chybou lieku TRALGIT neboli hlásené žiadne podozrenia na vedľajšie účinky. Dostupnosť liečby pre pacientov týmto nariadením ohrozená nie je. Na trhu sú pacientom k dispozícii iné šarže tohto lieku.

 


Zdroj: http://www.sukl.sk/

 




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