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S tržišta se povlači poznati lijek za djecu zbog onečišćenja jer su u njemu pronađeni tragovi druge djelatne tvari.

Kako navode u Agenciji za lijekove, riječ je o lijeku Sabril 500 mg djelatne tvari vigabatrin kojom se liječi epilepsija kod djece. No, osim vigabatrina, u lijeku je poronađena i tvar tiaprid koja liječi različite psihoze te se deklarira kao antipsihotik, odnosno sedativ ili neka vrsta lijeka za smirenje.

Problem s povlačenjem lijeka Sabril je u tome da na hrvatskom tržištu nema drugih lijekova s djelatnom tvari vigabatrin, pa je pokrenuta procedura hitnog uvoza. Lijek proizvodi farmaceutska kompanija Sanofi.

“Phoenix Farmacija i Medika, distributeri lijekova Sabril 500 mg tablets i Sabril 500 mg sachets (vigabatrin), u suradnji s Agencijom za lijekove provode povlačenje serija 2006B i 2987A tih lijekova. Povlačenje se provodi do razine ljekarni.

Postupak povlačenja provodi se temeljem neispravnosti u kakvoći koja se odnosi na onečišćenje djelatne tvari vigabatrin, u kojoj su detektirani tragovi druge djelatne tvari koja je identificirana kao tiaprid, prenosi Danica.

Detektirane količine tiaprida znatno su niže od maksimalne dopuštene dnevne doze, međutim eventualni sigurnosni rizici za pacijente odnose se na moguće nuspojave djelatne tvari tiaprid.

Budući da u Hrvatskoj u promet nije stavljen nijedan lijek s djelatnom tvari vigabatrin, navedeni lijekovi nabavljaju se postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept.

Bolesnici se trebaju obratiti svome liječniku ili ljekarniku u slučaju bilo kakvih pitanja u vezi trenutačne terapije”, rekli su u petak u Agenciji za lijekove.

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S tržišta se povlači poznati lijek za djecu zbog onečišćenja jer su u njemu pronađeni tragovi druge djelatne tvari.

Kako navode u Agenciji za lijekove, riječ je o lijeku Sabril 500 mg djelatne tvari vigabatrin kojom se liječi epilepsija kod djece. No, osim vigabatrina, u lijeku je poronađena i tvar tiaprid koja liječi različite psihoze te se deklarira kao antipsihotik, odnosno sedativ ili neka vrsta lijeka za smirenje.

Problem s povlačenjem lijeka Sabril je u tome da na hrvatskom tržištu nema drugih lijekova s djelatnom tvari vigabatrin, pa je pokrenuta procedura hitnog uvoza. Lijek proizvodi farmaceutska kompanija Sanofi.

“Phoenix Farmacija i Medika, distributeri lijekova Sabril 500 mg tablets i Sabril 500 mg sachets (vigabatrin), u suradnji s Agencijom za lijekove provode povlačenje serija 2006B i 2987A tih lijekova. Povlačenje se provodi do razine ljekarni.

Postupak povlačenja provodi se temeljem neispravnosti u kakvoći koja se odnosi na onečišćenje djelatne tvari vigabatrin, u kojoj su detektirani tragovi druge djelatne tvari koja je identificirana kao tiaprid, prenosi Danica.

Detektirane količine tiaprida znatno su niže od maksimalne dopuštene dnevne doze, međutim eventualni sigurnosni rizici za pacijente odnose se na moguće nuspojave djelatne tvari tiaprid.

Budući da u Hrvatskoj u promet nije stavljen nijedan lijek s djelatnom tvari vigabatrin, navedeni lijekovi nabavljaju se postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept.

Bolesnici se trebaju obratiti svome liječniku ili ljekarniku u slučaju bilo kakvih pitanja u vezi trenutačne terapije”, rekli su u petak u Agenciji za lijekove.

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Hrvatska i svijethitno se uvozi novi

Povlači se lijek za djecu, u njemu je pronađena tvar koja može izazvati nuspojave. Evo što pacijenti trebaju napraviti

Piše Šibenski.hr
13. srpnja 2023. - 19:19
24646533
Nikša Stipaničev/ilustracija/Cropix

S tržišta se povlači poznati lijek za djecu zbog onečišćenja jer su u njemu pronađeni tragovi druge djelatne tvari.

Kako navode u Agenciji za lijekove, riječ je o lijeku Sabril 500 mg djelatne tvari vigabatrin kojom se liječi epilepsija kod djece. No, osim vigabatrina, u lijeku je poronađena i tvar tiaprid koja liječi različite psihoze te se deklarira kao antipsihotik, odnosno sedativ ili neka vrsta lijeka za smirenje.

Problem s povlačenjem lijeka Sabril je u tome da na hrvatskom tržištu nema drugih lijekova s djelatnom tvari vigabatrin, pa je pokrenuta procedura hitnog uvoza. Lijek proizvodi farmaceutska kompanija Sanofi.

“Phoenix Farmacija i Medika, distributeri lijekova Sabril 500 mg tablets i Sabril 500 mg sachets (vigabatrin), u suradnji s Agencijom za lijekove provode povlačenje serija 2006B i 2987A tih lijekova. Povlačenje se provodi do razine ljekarni.

Postupak povlačenja provodi se temeljem neispravnosti u kakvoći koja se odnosi na onečišćenje djelatne tvari vigabatrin, u kojoj su detektirani tragovi druge djelatne tvari koja je identificirana kao tiaprid, prenosi Danica.

Detektirane količine tiaprida znatno su niže od maksimalne dopuštene dnevne doze, međutim eventualni sigurnosni rizici za pacijente odnose se na moguće nuspojave djelatne tvari tiaprid.

Budući da u Hrvatskoj u promet nije stavljen nijedan lijek s djelatnom tvari vigabatrin, navedeni lijekovi nabavljaju se postupkom izvanrednog unošenja temeljem izjave zdravstvene ustanove o potrebi za nabavkom lijeka ili za nužne slučajeve liječenja na pojedinačni recept.

Bolesnici se trebaju obratiti svome liječniku ili ljekarniku u slučaju bilo kakvih pitanja u vezi trenutačne terapije”, rekli su u petak u Agenciji za lijekove.

#SABRIL#POVLAČENJE LIJEKA#AGENCIJA ZA LIJEKOVE#EPILEPSIJA
14. svibanj 2024 02:05