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S hrvatskog tržišta povučen je poznati antibiotik s djelatnom tvari benzilpenicilin. Nema zamjenskoga pa je pokrenut postupak izvanredne nabave.

Lijek Benzetacil je antibiotik koji se ubrizgava i sadrži penicilin G benzathin. Može se koristiti za grlobolju, respiratorne infekcije i sifilis. Često se koristi za liječenje jače streptokokne upale. Nabavlja se na uputnicu.

"Tvrtke Medical Intertrade i Pharma One, distributeri lijeka Benzetacil 2,400.000 (bencilpenicilla benzatina), pakiranje 1 bočica i 1 ampula s otapalom, u suradnji s Agencijom za lijekove provode povlačenje serije T008 tog lijeka. Povlačenje se provodi do razine ljekarni.

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 RH nema niti jedan lijek s tom djelatnom tvari, lijek se nabavlja postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept", ističu u Agenciji.

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S hrvatskog tržišta povučen je poznati antibiotik s djelatnom tvari benzilpenicilin. Nema zamjenskoga pa je pokrenut postupak izvanredne nabave.

Lijek Benzetacil je antibiotik koji se ubrizgava i sadrži penicilin G benzathin. Može se koristiti za grlobolju, respiratorne infekcije i sifilis. Često se koristi za liječenje jače streptokokne upale. Nabavlja se na uputnicu.

"Tvrtke Medical Intertrade i Pharma One, distributeri lijeka Benzetacil 2,400.000 (bencilpenicilla benzatina), pakiranje 1 bočica i 1 ampula s otapalom, u suradnji s Agencijom za lijekove provode povlačenje serije T008 tog lijeka. Povlačenje se provodi do razine ljekarni.

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 RH nema niti jedan lijek s tom djelatnom tvari, lijek se nabavlja postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept", ističu u Agenciji.

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StoryEditorOCM
Hrvatska i svijetNEMA GA VIŠE

Iz ljekarni hitno povučen poznati antibiotik, nema zamjenskoga pa se kreće u izvanrednu nabavu

Piše PSD.
30. lipnja 2023. - 10:39
24646531
Niksa Stipanicev/cropix/Cropix

S hrvatskog tržišta povučen je poznati antibiotik s djelatnom tvari benzilpenicilin. Nema zamjenskoga pa je pokrenut postupak izvanredne nabave.

Lijek Benzetacil je antibiotik koji se ubrizgava i sadrži penicilin G benzathin. Može se koristiti za grlobolju, respiratorne infekcije i sifilis. Često se koristi za liječenje jače streptokokne upale. Nabavlja se na uputnicu.

"Tvrtke Medical Intertrade i Pharma One, distributeri lijeka Benzetacil 2,400.000 (bencilpenicilla benzatina), pakiranje 1 bočica i 1 ampula s otapalom, u suradnji s Agencijom za lijekove provode povlačenje serije T008 tog lijeka. Povlačenje se provodi do razine ljekarni.

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 RH nema niti jedan lijek s tom djelatnom tvari, lijek se nabavlja postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept", ističu u Agenciji.

#ANTIBIOTIK#POVUČEN LIJEK IZ PRODAJE
12. svibanj 2024 16:34