SD Dojavi
OSMRTNICE
PRETPLATA
PREMIUM
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Tvrtke Medical Intertrade d.o.o i Pharma One d.o.o., distributeri lijeka Benzetacil 2,400.000 UI polvo y disolvente para suspensión inyectable, (bencilpenicilla benzatina), pakiranje 1 bočica i 1 ampula s otapalom, u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) provode povlačenje serije T008 predmetnog lijeka. Povlačenje se provodi do razine ljekarni - javlja N1.

Navedeni postupak povlačenja provodi se zbog sumnje u neispravnost u kakvoći koja se odnosi na mogućnost pogrešnog označivanja vanjskog pakiranja lijeka, pri čemu postoji mogućnost da je lijek označen jačinom 1.200,000 UI umjesto ispravnom jačinom 2.400,000 UI.

Budući da odobrenje za stavljanje u promet u Republici Hrvatskoj nema niti jedan lijek s djelatnom tvari benzilpenicilinbenzatin, navedeni lijek se nabavlja postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept.

Podsjećamo da su zdravstveni radnici obvezni prijaviti HALMED-u svaku nuspojavu lijeka, kao i neispravnost u kakvoći lijeka. Pacijenti koji su razvili neku nuspojavu na lijek također mogu nuspojavu prijaviti izravno HALMED-u, uz preporuku da se za svaku nuspojavu koju zapaze obrate svom liječniku ili ljekarniku radi savjetovanja o načinu nastavka terapije.

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HALMED poslao objavu... 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ILUSTRACIJA

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ILUSTRACIJA

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Tvrtke Medical Intertrade d.o.o i Pharma One d.o.o., distributeri lijeka Benzetacil 2,400.000 UI polvo y disolvente para suspensión inyectable, (bencilpenicilla benzatina), pakiranje 1 bočica i 1 ampula s otapalom, u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) provode povlačenje serije T008 predmetnog lijeka. Povlačenje se provodi do razine ljekarni - javlja N1.

Navedeni postupak povlačenja provodi se zbog sumnje u neispravnost u kakvoći koja se odnosi na mogućnost pogrešnog označivanja vanjskog pakiranja lijeka, pri čemu postoji mogućnost da je lijek označen jačinom 1.200,000 UI umjesto ispravnom jačinom 2.400,000 UI.

Budući da odobrenje za stavljanje u promet u Republici Hrvatskoj nema niti jedan lijek s djelatnom tvari benzilpenicilinbenzatin, navedeni lijek se nabavlja postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept.

Podsjećamo da su zdravstveni radnici obvezni prijaviti HALMED-u svaku nuspojavu lijeka, kao i neispravnost u kakvoći lijeka. Pacijenti koji su razvili neku nuspojavu na lijek također mogu nuspojavu prijaviti izravno HALMED-u, uz preporuku da se za svaku nuspojavu koju zapaze obrate svom liječniku ili ljekarniku radi savjetovanja o načinu nastavka terapije.

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Jens Buttner/Dpa Picture-alliance Via Afp
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HrvatskaDO RAZINE LJEKARNI

Povlači se antibiotik zbog sumnje u neispravnost u kakvoći. HALMED poslao objavu...

Piše VIJESTI SD
1. srpnja 2023. - 11:07
&lt;p&gt;ILUSTRACIJA&lt;/p&gt;
ILUSTRACIJAJens Buttner/Dpa Picture-alliance Via Afp

Tvrtke Medical Intertrade d.o.o i Pharma One d.o.o., distributeri lijeka Benzetacil 2,400.000 UI polvo y disolvente para suspensión inyectable, (bencilpenicilla benzatina), pakiranje 1 bočica i 1 ampula s otapalom, u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) provode povlačenje serije T008 predmetnog lijeka. Povlačenje se provodi do razine ljekarni - javlja N1.

Navedeni postupak povlačenja provodi se zbog sumnje u neispravnost u kakvoći koja se odnosi na mogućnost pogrešnog označivanja vanjskog pakiranja lijeka, pri čemu postoji mogućnost da je lijek označen jačinom 1.200,000 UI umjesto ispravnom jačinom 2.400,000 UI.

Budući da odobrenje za stavljanje u promet u Republici Hrvatskoj nema niti jedan lijek s djelatnom tvari benzilpenicilinbenzatin, navedeni lijek se nabavlja postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept.

Podsjećamo da su zdravstveni radnici obvezni prijaviti HALMED-u svaku nuspojavu lijeka, kao i neispravnost u kakvoći lijeka. Pacijenti koji su razvili neku nuspojavu na lijek također mogu nuspojavu prijaviti izravno HALMED-u, uz preporuku da se za svaku nuspojavu koju zapaze obrate svom liječniku ili ljekarniku radi savjetovanja o načinu nastavka terapije.

#LJEKARNE#ANTIBIOTIK#BENZETACIL
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12. svibanj 2024 14:58