Results for licensee event report translation from English to Slovenian

creatinine increases of >50% from baseline.) and not crude adverse event report frequency.
zvišanje kreatinina za > 50 % od izhodiščne vrednosti.) in ne groba poročana pogostnost neželenih dogodkov.

(e) preparing the adverse event reports referred to in article 76;
(e) priprava poročil o neželenih dogodkih iz člena 76;

(f) ensuring that collected adverse event reports are recorded in the pharmacovigilance database;
(f) zagotavljanje, da se zbrana poročila o neželenih dogodkih evidentirajo v zbirki podatkov o farmakovigilanci;

marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report.
imetniki dovoljenj za promet v 30 dneh od prejema poročila o neželenem dogodku v zbirki podatkov o farmakovigilanci evidentirajo vse neželene dogodke, o katerih so poročali zdravstveni delavci in imetniki živali in ki so se v zvezi z njihovimi odobrenimi zdravili za uporabo v veterinarski medicini zgodili v uniji ali tretji državi.

cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post marketing adverse event reports.
poročali so tudi o primerih akutne jetrne okvare pri osebah, zasvojenih z opioidi, tako v kliničnih preskušanjih kot v postmarketinških poročilih o neželenih učinkih.

as young people attending music festivals and electronic dance events report higher levels of drug use than the general or school populations, users of hallucinogenic mushrooms are likely to be found in these settings.
ker je med mladimi, ki se udeležujejo glasbenih festivalov in prireditev z elektronsko plesno glasbo, stopnja uporabe drog višja kot v splošni ali šolski populaciji, bomo uporabnike halucinogenih gob najverjetneje našli v teh okoljih.

the frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy.
v nadaljevanju navedena pogostnost hematoloških in nehematoloških neželenih dogodkov se nanaša na poročila o neželenih dogodkih, ki so bili ali bi lahko bili povezani z zdravljenjem s topotekanom.

the frequencies associated with the haematological and non-haematological adverse events listed below, represent the adverse event reports considered to be related/possibly related to topotecan therapy.
spodaj navedene pogostnosti hematoloških in nehematoloških neželenih dogodkov se nanašajo na poročila o neželenih dogodkih, ki so bili ali bi lahko bili povezani z zdravljenjem s topotekanom.

a pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini zdravljeni s pioglitazonom in 7400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do 3, 5 let.