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Tvrtka Belupo lijekovi i kozmetika d.d., nositelj odobrenja za stavljanje u promet lijekova Lorsilan 1 mg tablete i Lorsilan 2,5 mg tablete (lorazepam), u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) provodi povlačenje sljedećih serija lijekova:

Lorsilan 1 mg tablete

27533041, 27534041, 28273081, 28890111, 29392022, 20153052, 20357062, 20358062, 20780092, 21368112, 21370112

Lorsilan 2,5 mg tablete

25879090, 25878090, 26272100, 26271100, 26678011, 26677011, 26676011, 27331031, 27330031, 27951061, 28556091, 28833111, 28834111, 29432022, 29431022, 29721032, 29720032, 20755082, 21000102, 21344112, 21343112.

Povlačenje se provodi iz preventivnih razloga, do razine ljekarni. Navedene serije lijekova povlače se temeljem sumnje u neispravnost u kakvoći koja se odnosi na promjenu izgleda tablete u pojedinim pakiranjima lijeka prilikom provjere stabilnosti u dugoročnim uvjetima. Nisu utvrđeni eventualni sigurnosni rizici povezani s navedenom neispravnošću.

Na tržištu u Republici Hrvatskoj u prometu nisu dostupne druge serije lijeka koje nisu zahvaćene navedenom sumnjom u neispravnost, ni drugi lijekovi s djelatnom tvari lorazepam. Stoga upućujemo sve korisnike predmetnog lijeka da se obrate svom liječniku vezano uz nastavak terapije. U prometu su dostupni lijekovi iz iste terapijske skupine te se dodatno poduzimaju mjere kako bi se u što kraćem roku osigurala dostupnost lijeka s istom djelatnom tvari.

- 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., poručili su iz Agencije za lijekove. 

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Tvrtka Belupo lijekovi i kozmetika d.d., nositelj odobrenja za stavljanje u promet lijekova Lorsilan 1 mg tablete i Lorsilan 2,5 mg tablete (lorazepam), u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) provodi povlačenje sljedećih serija lijekova:

Lorsilan 1 mg tablete

27533041, 27534041, 28273081, 28890111, 29392022, 20153052, 20357062, 20358062, 20780092, 21368112, 21370112

Lorsilan 2,5 mg tablete

25879090, 25878090, 26272100, 26271100, 26678011, 26677011, 26676011, 27331031, 27330031, 27951061, 28556091, 28833111, 28834111, 29432022, 29431022, 29721032, 29720032, 20755082, 21000102, 21344112, 21343112.

Povlačenje se provodi iz preventivnih razloga, do razine ljekarni. Navedene serije lijekova povlače se temeljem sumnje u neispravnost u kakvoći koja se odnosi na promjenu izgleda tablete u pojedinim pakiranjima lijeka prilikom provjere stabilnosti u dugoročnim uvjetima. Nisu utvrđeni eventualni sigurnosni rizici povezani s navedenom neispravnošću.

Na tržištu u Republici Hrvatskoj u prometu nisu dostupne druge serije lijeka koje nisu zahvaćene navedenom sumnjom u neispravnost, ni drugi lijekovi s djelatnom tvari lorazepam. Stoga upućujemo sve korisnike predmetnog lijeka da se obrate svom liječniku vezano uz nastavak terapije. U prometu su dostupni lijekovi iz iste terapijske skupine te se dodatno poduzimaju mjere kako bi se u što kraćem roku osigurala dostupnost lijeka s istom djelatnom tvari.

- 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., poručili su iz Agencije za lijekove. 

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Nikša Stipaničev/Cropix
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StoryEditorOCM
KalelargaPILULE ZA LILULE

S tržišta se povlače serije poznatog lijeka za smirenje kojeg možda i vi imate u ladicama: sumnja se na neispravnost, evo detalja

Piše Vijesti SD
12. travnja 2023. - 08:34
&lt;p&gt;Ilustracija&lt;/p&gt;
IlustracijaNikša Stipaničev/Cropix

Tvrtka Belupo lijekovi i kozmetika d.d., nositelj odobrenja za stavljanje u promet lijekova Lorsilan 1 mg tablete i Lorsilan 2,5 mg tablete (lorazepam), u suradnji s Agencijom za lijekove i medicinske proizvode (HALMED) provodi povlačenje sljedećih serija lijekova:

Lorsilan 1 mg tablete

27533041, 27534041, 28273081, 28890111, 29392022, 20153052, 20357062, 20358062, 20780092, 21368112, 21370112

Lorsilan 2,5 mg tablete

25879090, 25878090, 26272100, 26271100, 26678011, 26677011, 26676011, 27331031, 27330031, 27951061, 28556091, 28833111, 28834111, 29432022, 29431022, 29721032, 29720032, 20755082, 21000102, 21344112, 21343112.

Povlačenje se provodi iz preventivnih razloga, do razine ljekarni. Navedene serije lijekova povlače se temeljem sumnje u neispravnost u kakvoći koja se odnosi na promjenu izgleda tablete u pojedinim pakiranjima lijeka prilikom provjere stabilnosti u dugoročnim uvjetima. Nisu utvrđeni eventualni sigurnosni rizici povezani s navedenom neispravnošću.

Na tržištu u Republici Hrvatskoj u prometu nisu dostupne druge serije lijeka koje nisu zahvaćene navedenom sumnjom u neispravnost, ni drugi lijekovi s djelatnom tvari lorazepam. Stoga upućujemo sve korisnike predmetnog lijeka da se obrate svom liječniku vezano uz nastavak terapije. U prometu su dostupni lijekovi iz iste terapijske skupine te se dodatno poduzimaju mjere kako bi se u što kraćem roku osigurala dostupnost lijeka s istom djelatnom tvari.

- 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., poručili su iz Agencije za lijekove. 

#LIJEKOVI#POVLAČENJE S TRŽIŠTA
13. svibanj 2024 02:14