Chrípkové obdobie bez paralenu | Medicínske právo


Chrípkové obdobie bez paralenu

 | 4.10.2013 | komentárov: 287

Štátny ústav pre kontrolu liečiv (ďalej len ŠUKL) na základe oznámenia liekovej agentúry SÚKL Praha vydal 18.9.2013 rozhodnutie, ktorým stiahol z predaja liek PARALEN GRIP chrípka a bolesť tbl flm lx24 držiteľa registrácie Zentiva ak. s., Česká republika, z úrovne distribútorov a lekární.

Obrazok Dôvodom je nesúlad so špecifikáciou. U niektorých šarží lieku sa totižto prejavila klesajúca tendencia výsledkov v skúške disolúcie po 30 minútach. Čo znamená, že účinná látka obsiahnutá v lieku sa uvoľňuje pomalšie ako je uvedené v príbalových dokumentáciách. Podľa ŠUKL má stiahnutie z trhu preventívny charakter.
Konkrétne sa jedná o tieto čísla šarže: 2050912, 2060912, 2080912, 2090912.
Rozhodnutie je klasifikované v III. triede urgentnosti čo znamená, že opatrenie je potrebné vykonať do 5 dní.
Paralen Grip je voľnopredajný liek, ktorým si väčšina z nás snaží vyliečiť chrípku bez pomoci lekára doma. Napriek stiahnutiu z trhu sú stále na voľný predaj dostupné lieky s rovnakým alebo podobným účinkom a taktiež možnosť tradičnej a bezpečnejšej liečby začínajúcej návštevou lekára.

Celé znenie rozhodnutia je dostupné na stránke ŠUKL.

spracovala: Veronika Miková

 Obrazok Pošli do  |   Obrazok Zdieľať odkaz na Facebook




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