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[title] => Iz ljekarni se povlače neke serije Peptorana i Gastrobel
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Hrvatska agencija za lijekove (HALMED) objavila je u utorak na svojoj web stranici priopćenje koje prenosimo u cijelosti:
Nositelj odobrenja za stavljanje u promet lijekova Peptoran 150 mg filmom obložene tablete, Peptoran 75 mg filmom obložene tablete i Peptoran MAX 150 mg filmom obložene tablete, Pliva Hrvatska d.o.o. u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED), pokreće postupak povlačenja svih serija navedenih lijekova.
Povlačenje se provodi do razine ljekarni te se odnosi na sljedeće serije:
Peptoran 150 mg filmom obložene tablete, 20 tableta u blisteru
Serije: 107890, 121920, 16207, 123240, 119470, 122262, 113040, 122630, 92640, 122500, 103970, 120650
Peptoran 75 mg filmom obložene tablete, 10 tableta u blisteru
Serija 51540
Peptoran MAX 150 mg filmom obložene tablete, 10 tableta u blisteru
Serije: 14700, 29760, 9940, 9340, 54610, 35140
Nositelj odobrenja za stavljanje u promet lijeka Gastrobel 150 mg šumeće tablete, Belupo lijekovi i kozmetika d.d. u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) pokreće postupak povlačenja navedenog lijeka. Povlačenje se provodi do razine ljekarni te se odnosi na seriju 190892 predmetnog lijeka, koja je jedina dostupna u prometu u Republici Hrvatskoj.
Navedeni postupak povlačenja provodi se temeljem sumnje u neispravnost u kakvoći djelatne tvari ranitidin proizvođača Solara Active Pharma Sciences Limited, koja se odnosi na prisutnost tvari pod nazivom N-nitrozodimetilamin (NDMA).
Nakon što su ispitivanja pokazala da neki od lijekova s djelatnom tvari ranitidin sadrže onečišćenje NDMA-om, Europska agencija za lijekove (EMA) je na zahtjev Europske komisije započela ocjenu lijekova koji sadrže djelatnu tvar ranitidin. EMA će proučiti podatke kako bi procijenila jesu li bolesnici koji koriste ranitidin pod bilo kakvim rizikom od NDMA te će obavijestiti javnost čim informacije budu dostupne.
U prometu u Republici Hrvatskoj dostupni su drugi odobreni lijekovi iz iste terapijske skupine - lijekovi za liječenje peptičkog ulkusa i GERB-a. Bolesnici se trebaju obratiti svome liječniku ili ljekarniku u slučaju bilo kakvih pitanja u vezi trenutačne ili zamjenske terapije.
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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Hrvatska agencija za lijekove (HALMED) objavila je u utorak na svojoj web stranici priopćenje koje prenosimo u cijelosti:
Nositelj odobrenja za stavljanje u promet lijekova Peptoran 150 mg filmom obložene tablete, Peptoran 75 mg filmom obložene tablete i Peptoran MAX 150 mg filmom obložene tablete, Pliva Hrvatska d.o.o. u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED), pokreće postupak povlačenja svih serija navedenih lijekova.
Povlačenje se provodi do razine ljekarni te se odnosi na sljedeće serije:
Peptoran 150 mg filmom obložene tablete, 20 tableta u blisteru
Serije: 107890, 121920, 16207, 123240, 119470, 122262, 113040, 122630, 92640, 122500, 103970, 120650
Peptoran 75 mg filmom obložene tablete, 10 tableta u blisteru
Serija 51540
Peptoran MAX 150 mg filmom obložene tablete, 10 tableta u blisteru
Serije: 14700, 29760, 9940, 9340, 54610, 35140
Nositelj odobrenja za stavljanje u promet lijeka Gastrobel 150 mg šumeće tablete, Belupo lijekovi i kozmetika d.d. u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) pokreće postupak povlačenja navedenog lijeka. Povlačenje se provodi do razine ljekarni te se odnosi na seriju 190892 predmetnog lijeka, koja je jedina dostupna u prometu u Republici Hrvatskoj.
Navedeni postupak povlačenja provodi se temeljem sumnje u neispravnost u kakvoći djelatne tvari ranitidin proizvođača Solara Active Pharma Sciences Limited, koja se odnosi na prisutnost tvari pod nazivom N-nitrozodimetilamin (NDMA).
Nakon što su ispitivanja pokazala da neki od lijekova s djelatnom tvari ranitidin sadrže onečišćenje NDMA-om, Europska agencija za lijekove (EMA) je na zahtjev Europske komisije započela ocjenu lijekova koji sadrže djelatnu tvar ranitidin. EMA će proučiti podatke kako bi procijenila jesu li bolesnici koji koriste ranitidin pod bilo kakvim rizikom od NDMA te će obavijestiti javnost čim informacije budu dostupne.
U prometu u Republici Hrvatskoj dostupni su drugi odobreni lijekovi iz iste terapijske skupine - lijekovi za liječenje peptičkog ulkusa i GERB-a. Bolesnici se trebaju obratiti svome liječniku ili ljekarniku u slučaju bilo kakvih pitanja u vezi trenutačne ili zamjenske terapije.
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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18. svibanj 2024 16:31
