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[title] => HALMED poslao važno upozorenje: pojavile su se kopije lijeka kojeg koriste mnogi, valja dobro pripaziti
[alias] => halmed-poslao-vazno-upozorenje-pojavile-su-se-kopije-lijeka-kojeg-koriste-mnogi-valja-dobro-pripaziti
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Agencija za lijekove i medicinske proizvode (HALMED) zaprimila je putem sustava žurnog uzbunjivanja obavijest o pojavi krivotvorine lijeka Ozempic 1 mg nositelja odobrenja Novo Nordisk A/S na tržištu Europske unije. Slučajevi krivotvorine zabilježeni su u pojedinim veleprodajama lijekova u Europskoj uniji i Ujedinjenom Kraljevstvu. Zahvaćena pakiranja lijeka označena su na njemačkom jeziku te potječu od veleprodaja u Austriji i Njemačkoj.
---
---
Vanjsko pakiranje krivotvorenog lijeka identično je pakiranju originalnog lijeka, dok se krivotvorina može prepoznati uvidom u unutarnje pakiranje. Na fotografijama u nastavku prikazan je izgled brizgalice originalnog lijeka opremljenog za njemačko tržište (Slika 1.) te izgled brizgalice krivotvorenog lijeka (Slika 2.), koje je objavila Njemačka agencija za lijekove (BfArM). Brizgalica krivotvorenog lijeka može imati i drugi, različiti izgled od prikazanog na Slici 2.
---
---
Nije zaprimljena nijedna prijava slučaja distribucije krivotvorina lijeka Ozempic 1 mg pacijentima putem ovlaštenih ljekarni, niti su zabilježene bilo kakve negativne posljedice za pacijente povezane s upotrebom krivotvorenog lijeka.
Jednako tako, u Republici Hrvatskoj do sada nije zaprimljena nijedna prijava sumnje na krivotvorinu predmetnog lijeka, kao ni prijava neispravnosti u kakvoći ili sumnje na nuspojavu na temelju koje bi se posumnjalo da se radi o krivotvorenom lijeku.
Iako navedeni slučajevi krivotvorina nisu zabilježeni u RH, kao mjera predostrožnosti upozoravaju se veleprodaje, zdravstveni radnici i pacijenti da obrate posebnu pozornost pri nabavi, rukovanju i primjeni ovih lijekova:
Upućujemo veleprodaje da obrate posebnu pozornost pri zaprimanju lijeka Ozempic 1 mg, da izbjegavaju povoljne ponude neprovjerenih dobavljača te da prilikom odabira svojih dobavljača provjere pridržava li se dobavljač načela dobre prakse u prometu lijekova na veliko i posjeduje li dozvolu za promet na veliko lijekovima.
Upućujemo ljekarnike da primijene povećan oprez prilikom izdavanja lijeka Ozempic 1 mg te da, u slučaju sumnje na autentičnost lijeka, pred pacijentom provjere izgled unutarnjeg pakiranja. Zdravstveni radnici se također upućuju da savjetuju pacijente kako prepoznati krivotvoreni lijek. Izgled lijeka ne smije odudarati od gore navedene Slike 1., odnosno od slike u uputi o lijeku.
Upućujemo pacijente da obrate osobitu pozornost prilikom nabavke lijeka Ozempic 1 mg te da lijekove, iz sigurnosnih razloga, nabavljaju isključivo iz provjerenih, ovlaštenih izvora. U slučaju da izgled brizgalice lijeka kojim raspolažu odudara od izvornog lijeka, upućujemo pacijente da lijek ne primjenjuju te da ga odnesu u svoju ljekarnu.
U slučaju bilo kakve sumnje u pojavu krivotvorenog lijeka, potrebno je obavijestiti HALMED putem adrese elektroničke pošte krivotvorine@halmed.hr.
Lijek Ozempic sadrži djelatnu tvar semaglutid i odobren je za liječenje dijabetesa tipa 2. Povećana potražnja za lijekom dovela je do njegove smanjene dostupnosti u Europskoj uniji. Na tržištu Republike Hrvatske lijek Ozempic u jačini 1 mg trenutačno se nalazi u nestašici s očekivanim trajanjem do 30. studenog 2023. godine, međutim dostupan je Ozempic u jačini 0,5 mg i 0,25 mg.
HALMED nastavlja intenzivno pratiti situaciju te će o svim novim saznanjima javnost biti pravovremeno obaviještena.
Dodatne informacije vezane uz pojavu krivotvorine lijeka Ozempic 1 mg u Europskoj uniji dostupne su u obavijesti Europske agencije za lijekove.
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Agencija za lijekove i medicinske proizvode (HALMED) zaprimila je putem sustava žurnog uzbunjivanja obavijest o pojavi krivotvorine lijeka Ozempic 1 mg nositelja odobrenja Novo Nordisk A/S na tržištu Europske unije. Slučajevi krivotvorine zabilježeni su u pojedinim veleprodajama lijekova u Europskoj uniji i Ujedinjenom Kraljevstvu. Zahvaćena pakiranja lijeka označena su na njemačkom jeziku te potječu od veleprodaja u Austriji i Njemačkoj.
---
---
Vanjsko pakiranje krivotvorenog lijeka identično je pakiranju originalnog lijeka, dok se krivotvorina može prepoznati uvidom u unutarnje pakiranje. Na fotografijama u nastavku prikazan je izgled brizgalice originalnog lijeka opremljenog za njemačko tržište (Slika 1.) te izgled brizgalice krivotvorenog lijeka (Slika 2.), koje je objavila Njemačka agencija za lijekove (BfArM). Brizgalica krivotvorenog lijeka može imati i drugi, različiti izgled od prikazanog na Slici 2.
---
---
Nije zaprimljena nijedna prijava slučaja distribucije krivotvorina lijeka Ozempic 1 mg pacijentima putem ovlaštenih ljekarni, niti su zabilježene bilo kakve negativne posljedice za pacijente povezane s upotrebom krivotvorenog lijeka.
Jednako tako, u Republici Hrvatskoj do sada nije zaprimljena nijedna prijava sumnje na krivotvorinu predmetnog lijeka, kao ni prijava neispravnosti u kakvoći ili sumnje na nuspojavu na temelju koje bi se posumnjalo da se radi o krivotvorenom lijeku.
Iako navedeni slučajevi krivotvorina nisu zabilježeni u RH, kao mjera predostrožnosti upozoravaju se veleprodaje, zdravstveni radnici i pacijenti da obrate posebnu pozornost pri nabavi, rukovanju i primjeni ovih lijekova:
Upućujemo veleprodaje da obrate posebnu pozornost pri zaprimanju lijeka Ozempic 1 mg, da izbjegavaju povoljne ponude neprovjerenih dobavljača te da prilikom odabira svojih dobavljača provjere pridržava li se dobavljač načela dobre prakse u prometu lijekova na veliko i posjeduje li dozvolu za promet na veliko lijekovima.
Upućujemo ljekarnike da primijene povećan oprez prilikom izdavanja lijeka Ozempic 1 mg te da, u slučaju sumnje na autentičnost lijeka, pred pacijentom provjere izgled unutarnjeg pakiranja. Zdravstveni radnici se također upućuju da savjetuju pacijente kako prepoznati krivotvoreni lijek. Izgled lijeka ne smije odudarati od gore navedene Slike 1., odnosno od slike u uputi o lijeku.
Upućujemo pacijente da obrate osobitu pozornost prilikom nabavke lijeka Ozempic 1 mg te da lijekove, iz sigurnosnih razloga, nabavljaju isključivo iz provjerenih, ovlaštenih izvora. U slučaju da izgled brizgalice lijeka kojim raspolažu odudara od izvornog lijeka, upućujemo pacijente da lijek ne primjenjuju te da ga odnesu u svoju ljekarnu.
U slučaju bilo kakve sumnje u pojavu krivotvorenog lijeka, potrebno je obavijestiti HALMED putem adrese elektroničke pošte krivotvorine@halmed.hr.
Lijek Ozempic sadrži djelatnu tvar semaglutid i odobren je za liječenje dijabetesa tipa 2. Povećana potražnja za lijekom dovela je do njegove smanjene dostupnosti u Europskoj uniji. Na tržištu Republike Hrvatske lijek Ozempic u jačini 1 mg trenutačno se nalazi u nestašici s očekivanim trajanjem do 30. studenog 2023. godine, međutim dostupan je Ozempic u jačini 0,5 mg i 0,25 mg.
HALMED nastavlja intenzivno pratiti situaciju te će o svim novim saznanjima javnost biti pravovremeno obaviještena.
Dodatne informacije vezane uz pojavu krivotvorine lijeka Ozempic 1 mg u Europskoj uniji dostupne su u obavijesti Europske agencije za lijekove.
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16. svibanj 2024 07:29
