natgillin/translations-raw huggingface dataset:
There have been cases of non-specific interstitial pneumonitis, including fatal reports, occurring in patients who received weekly intravenous Torisel.
Opisani so bili primeri nespecifične intersticijske pljučnice, tudi smrti, pri bolnikih, ki so vsak teden intravensko dobivali zdravilo Torisel.
There have been cases of patients who, while taking one or more medications for the treatment of Parkinson’s disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others.
Znani so primeri, ko so se bolniki med jemanjem enega ali več zdravil za zdravljenje Parkinsonove bolezni bili nezmožni upirati nagibom, željam ali skušnjavam, da bi izvajali določene dejavnosti, ki bi lahko bile škodljive za njih same ali za druge.
There have been cases of patients who, while taking one or more medications for the treatment of Parkinson’s disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others.
Znani so primeri, ko so se bolniki, ki so med jemanjem enega ali več zdravil za zdravljenje Parkinsonove bolezni, bili nezmožni upirati nagibom, željam ali skušnjavam, da bi izvajali določene dejavnosti, ki so lahko škodljive za vas ali druge.
There have been cumulatively 2179 Adverse Drug Reactions (ADR) reports from post-marketing sources.
V obdobju po prihodu zdravila na trg je bilo skupno 2179 poročil o neželenih učinkih.
There have been eight (8) cases of pancreatitis reported during the period under review, and 18 cases cumulatively.
V zadnjem obdobju, ki je bil pod pregledom, je bilo opisanih osem primerov pankreatitisa, kar je skupno 18 primerov.
There have been fatal cases of inadvertent intrathecal administration of Bortezomib Hospira.
Nenamerno intratekalno dajanje bortezomiba se je končalo s smrtnimi primeri.
There have been fatal cases of inadvertent intrathecal administration of bortezomib.
Nenamerna intratekalna uporaba bortezomiba je privedla do smrtnih primerov.
There have been fatal cases of inadvertent intrathecal administration of VELCADE.
Nenamerno intratekalno dajanje zdravila VELCADE se je končalo s smrtnimi primeri.
There have been few reported events of acute pancreatitis.
Opisanih je bilo le nekaj primerov akutnega pankreatitisa.
There have been few reports, some fatal, of subjects presenting with seizures and radiological evidence of RPLS (see also section 4.4).
Poročali so o primerih preskušancev s konvulzijami in radiološkimi znaki sindroma RPLS, v nekaterih primerih s smrtnim izidom (glejte tudi poglavje 4.4).
There have been isolated post-marketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis.
V obdobju trženja zdravila so opisani posamezni primeri tromboze zaklopke pri nosečnicah z mehaničnimi umetnimi srčnimi zaklopkami, ki so preventivno prejemale enoksaparin za preprečitev tromboze.
There have been isolated reports of fatal outcomes.
Poročali so o posameznih primerih s smrtnim izidom.
There have been isolated reports of formation of pseudocysts (up to four months after the last treatment).
V posameznih primerih so poročali o tvorbi psevdociste (do štiri mesece po zadnjem zdravljenju).
There have been no adverse reactions related to anti-asfotase alfa antibody status in clinical trials.
V kliničnih preskušanjih niso opazili neželenih učinkov, povezanih s statusom protiteles proti asfotazi alfa.
There have been no clinical trials in severe sepsis specifically studying drotrecogin alfa (activated) re- administration.
Kliničnih preskušanj hude sepse, ki bi podrobno preučevala ponovno dajanje drotrekogin alfa (aktiviranega) ni bilo.
There have been no formal clinical trials undertaken in children or adolescents.
Formalnih kliničnih preskušanj pri otrocih ali mladostnikih niso izvedli.
There have been no formal interaction studies for Eucreas.
Formalnih študij medsebojnega delovanja zdravila Eucreas z drugimi zdravili niso opravili.
There have been no formal studies with Cyramza in patients with renal impairment.
Formalnih študij z zdravilom Cyramza pri bolnikih z okvarjenim delovanjem ledvic niso izvedli.
There have been no formal studies with ZALTRAP in patients with hepatic impairment (see section 5.2).
Formalnih študij z zdravilom ZALTRAP pri bolnikih z okvaro jeter niso izvedli (glejte poglavje 5.2).
There have been no observed differences in pharmacokinetic parameters noted in these subpopulations of aHUS patients.
Pri teh subpopulacijah bolnikov z aHUS niso opazovali razlik v farmakokinetičnih parametrih.
There have been no observed effects with Nespo on the ability to drive and use machines.
Ni ugotovljeno, da bi Nespa vplival na sposobnost vožnje in upravljanja s stroji.
There have been no observed effects with Nespo on the ability to drive and use machines.
Ni ugotovljeno, da bi Nespo vplival na sposobnost vožnje in upravljanja s stroji.
There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines.
Ni poročil, ki bi izrecno govorila o učinkih zdravljenja z zdravilom DepoCyte na sposobnost vožnje ali upravljanja s stroji.
There have been no reports of overdose with Pixuvri.
Poročil o prevelikem odmerjanju zdravila Pixuvri ni.
There have been no reports of serious harmful effects from taking too many IOA tablets at one time.
Ni nobenih poročil o resnih škodljivih učinkih zaradi zaužitja prevelikega števila tablet zdravila IOA naenkrat.
There have been no reports of serious harmful effects from taking too many Zoely tablets at one time.
Ni nobenih poročil o resnih škodljivih učinkih zaradi zaužitja prevelikega števila tablet zdravila Zoely naenkrat.
There have been no studies in patients with hepatic impairment (see section 5.2).
Študij pri bolnikih z okvaro jeter ni bilo (glejte poglavje 5.2).
There have been no studies performed in children with ADHD under the age of 6 years with Intuniv.
Pri otrocih z ADHD, mlajših od 6 let, študij z zdravilom Intuniv niso izvedli.
There have been no studies performed with other routes of administration.
Za druge oblike dajanja ni bilo opravljenih študij.
There have been no studies to investigate the effect of dolutegravir on driving performance or the ability to operate machines.
Vpliva dolutegravirja na sposobnost vožnje ali upravljanja s stroji niso raziskovali.
There have been no therapeutic clinical trials conducted with Eucreas.
Terapevtskih kliničnih preskušanj z zdravilom Eucreas niso izvajali.
There have been occasional post-marketing reports of contraceptive failure with etonogestrel in efavirenz-exposed patients.
V obdobju trženja zdravila so pri bolnikih, ki so prejemali etonogestrel in efavirenz, občasno poročali o nezadostnem delovanju kontraceptiva.
There have been occasional reports of administration of twice the recommended dose of trivalent Fluenz in the post-marketing setting.
Obstajajo občasna poročila o uporabi dvakratnega priporočenega odmerka trivalentnega cepiva Fluenz v obdobju po začetku trženja.
There have been post- marketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Po prihodu zdravila na trg so poročali o intersticijski bolezni pljuč (vključno s pnevmonitisom in pljučno fibrozo), v nekaterih primerih s smrtnim izidom.
There have been post-marketing reports of pancytopaenia, leucopaenia, neutropaenia, aplastic anaemia, and thrombocytopaenia in patients receiving TNF-blockers.
Obstajajo poročila iz obdobja trženja o pojavu pancitopenije, levkopenije, nevtropenije, aplastične anemije in trombocitopenije pri bolnikih, ki so prejemali zaviralce TNF.
There have been post-marketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving dapagliflozin and other SGLT2 inhibitors.
V obdobju trženja zdravila so pri bolnikih, ki so prejemali dapagliflozin in druge zaviralce SGLT2, poročali o resnih okužbah sečil, vključno z urosepso in pielonefritisom, ki so zahtevali sprejem v bolnišnico.
There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Iz obdobja trženja obstajajo poročila iz obdobja trženja o poslabševanju srčnega popuščanja pri bolnikih, ki so jemali infliksimab, z ali brez ugotovljivih dejavnikov, ki bi lahko poslabšali stanje.
There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Obstajajo poročila iz obdobja trženja o poslabševanju srčnega popuščanja pri bolnikih, ki so jemali infliksimab, z ali brez ugotovljivih dejavnikov, ki bi lahko poslabšali stanje.
There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Objavljeni so bili primeri bronhiektaze pri odraslih in otrocih, ki so prejeli zdravilo CellCept v kombinaciji z drugimi imunosupresivi.
There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Pri bolnikih, ki so se zdravili z zdravilom Avastin, so redko poročali o pojavu znakov in simptomov, povezanih s sindromom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome), redko nevrološko motnjo, ki se lahko kaže tudi z naslednjimi znaki in simptomi: epileptični napad, glavobol, spremenjeni mentalni status, motnje vida ali kortikalna slepota s sočasno hipertenzijo ali brez nje.
There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Pri bolnikih, ki so se zdravili z zdravilom Avastin, so redko poročali o pojavu znakov in simptomov, povezanih s sindromom posteriorne reverzibilne encefalopatije, redko nevrološko motnjo.
There have been rare reports of cholestasis, icterus, hepatic cell necrosis and hepatic failure with fatal outcome.
Poročali so o redkih primerih holestaze, ikterusa, nekroze jetrnih celic in jetrne odpovedi s smrtnim izidom.
There have been rare reports of CNS demyelinating disorders in patients treated with etanercept (see section 4.8).
Poročali so o redkih primerih demielinizirajočih obolenj centralnega živčnega sistema (CŽS) pri bolnikih, zdravljenih z etanercept (glejte poglavje 4.8).
There have been rare reports of lactic acidosis in patients receiving lamivudine for hepatitis B.
Redko so o laktacidozi poročali tudi pri bolnikih, ki so se proti hepatitisu B zdravili z lamivudinom.
There have been rare reports of other immune-mediated conditions; the causal relationship to Cimzia is not known.
V redkih primerih so poročali o stanjih, ki so posredovana preko imunskega sistema, vendar njihova vzročna povezanost z zdravilom Cimzia ni znana.
There have been rare reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xtandi (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Xtandi so redko poročali o sindromu posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (glejte poglavje 4.8).
There have been rare reports of PRES, a rare, reversible condition involving the brain, in patients treated with XTANDI.
Pri bolnikih, ki so jemali zdravilo Xtandi so redko poročali o PRES, redkem, reverzibilnem stanju, ki vključuje možgane.
There have been rare reports of TLS in patients with MM treated with lenalidomide, and no reports in patients with MDS treated with lenalidomide.
O sindromu tumorske lize pri bolnikih z DP, zdravljenih z lenalidomidom, so poročali redko, pri bolnikih z MDS, zdravljenih z lenalidomidom, pa nikoli.
There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation).
Pri uporabi bimatoprosta 0,3 mg/ml, kapljic za oko, raztopine (večodmerna oblika), so redko spontano poročali o reaktivaciji predhodnih infiltratov roženice ali očesnih okužbah.
There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/ml eye drops, solution.
Pri uporabi bimatoprosta 0,3 mg/ml, kapljic za oko, raztopine, so redko spontano poročali o reaktivaciji predhodnih infiltratov roženice ali očesnih okužbah.
There have been reported adverse reactions of pancreatitis.
Poročali so o pankreatitisu kot neželenem učinku.
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV patients when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once-daily regimen.
Obstajajo poročila o visoki stopnji virološkega neuspeha in pojavu rezistence, v obeh primerih v zgodnji fazi okužbe z virusom HIV, pri zdravljenju s kombinacijo dizoproksiltenofovirijevega fumarata z lamivudinom in abakavirom kakor tudi z lamivudinom in didanozinom pri odmerjanju enkrat na dan.
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV-1 infected patients when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Obstajajo poročila o visoki stopnji virološkega neuspeha in pojavu rezistence v obeh primerih v zgodnji fazi, kadar se je dizoproksiltenofovirijev fumarat kombiniral z lamivudinom in abakavirjem kakor tudi z lamivudinom in didanozinom kot režim zdravljenja enkrat na dan.
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Poročali so o velikem deležu virološkega neuspeha in pojava rezistence v zgodnji fazi, ko so dizoproksiltenofovirat fumarat kombinirali z lamivudinom in abakavirjem ter lamivudinom in didanozinom z režimom odmerjanja enkrat na dan.
There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Opisani so primeri akutne odpovedi ledvic pri bolnikih, ki se jim pojavi driska in dehidracija (glejte poglavje 4.4).
There have been reports of agglutination of red blood cells in the tube/syringe with the administration of BeneFIX.
Obstajajo poročila o aglutinaciji rdečih krvničk v infuzijskem sistemu/brizgi ob dajanju zdravila BeneFIX.
There have been reports of aplastic anaemia and bone marrow depression in patients treated with CellCept, some of which have been fatal.
Pri bolnikih, ki so se zdravili z zdravilom CellCept, so poročali o primerih aplastične anemije in depresije kostnega mozga, nekateri od teh so bili smrtni.
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Pri selektivnih zaviralcih prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selective noradrenaline reuptake inhibitors, SNRI), vključno z duloksetinom, so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Pri selektivnih zaviralcih prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selectivenoradrenaline reuptake inhibitors, SNRI), vključno z duloksetinom, so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related anti-epileptics drugs like carbamazepine and oxcarbazepine.
Pri uporabi strukturno sorodnih antiepileptikov, kot sta karbamazepin in okskarbazepin, so poročali o motnjah kosti, vključno z osteopenijo in osteoporozo (tanjšanjem kosti), ter o zlomih.
There have been reports of chronic overdose in patients taking Arava at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali zdravilo Arava v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
There have been reports of chronic overdose in patients taking leflunomide at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali zdravilo Leflunomid Teva v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka, in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
There have been reports of chronic overdose in patients taking Leflunomide Winthrop at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali zdravilo Leflunomid Winthrop v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
There have been reports of chronic overdose in patients taking Leflunomide Winthrop at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali zdravilo Leflunomid Winthrop v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka, in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
There have been reports of convulsions when taking Lyrica or shortly after stopping Lyrica.
Med jemanjem zdravila Lyrica ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking Pregabalin Mylan or shortly after stopping Pregabalin Mylan.
Med jemanjem zdravila Pregabalin Mylan ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking Pregabalin Mylan Pharma or shortly after stopping Pregabalin Mylan Pharma.
Med jemanjem zdravila Pregabalin Mylan Pharma ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking pregabalin or shortly after stopping pregabalin.
Med jemanjem pregabalina ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking Pregabalin Pfizer or shortly after stopping Pregabalin Pfizer.
Med jemanjem zdravila Pregabalin Pfizer ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking Pregabalin Sandoz GmbH or shortly after stopping Pregabalin Sandoz GmbH.
Med jemanjem zdravila Pregabalin Sandoz GmbH ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking Pregabalin Sandoz or shortly after stopping Pregabalin Sandoz.
Med jemanjem zdravila Pregabalin Sandoz ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of convulsions when taking this medicine or shortly after stopping this medicine.
Med jemanjem tega zdravila ali kmalu po prenehanju jemanja so poročali o primerih krčev.
There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G- CSF after allogeneic bone marrow transplantation (see section 4.8 and 5.1).
Poročali so o reakcijah presadka proti gostitelju (GvHD - Graft versus Host Disease) in o smrtnih primerih pri bolnikih, ki so G-CSF prejemali po alogenski presaditvi kostnega mozga (glejte poglavji 4.8 in 5.1).
There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.8 and 5.1)
Obstajajo poročila o reakcijah presadka proti gostitelju (»Graft versus Host Disease« - GvHD) in o smrtnih primerih pri bolnikih, ki so prejemali G-CSF po alogenski presaditvi kostnega mozga (glejte poglavji 4.8 in 5.1).
There have been reports of Graft versus Host Disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.8 and 5.1).
Poročali so o reakcijah presadka proti gostitelju (GvHD - Graft versus Host Disease) in o smrtnih primerih pri bolnikih, ki so granulocitne kolonije spodbujajoči faktor (G-CSF) prejemali po alogenski presaditvi kostnega mozga (glejte poglavji 4.8 in 5.1).
There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 5.1).
Obstajajo poročila o reakciji presadka proti gostitelju (graft versus host disease – GvHD) in o smrti bolnikov, ki so prejeli G-CSF po alogenski presaditvi kostnega mozga (glejte poglavje 5.1).
There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 5.1).
Obstajajo poročila o reakciji presadka proti gostitelju (GvHD – graft versus host disease) in o smrti bolnikov, ki so prejeli G-CSF po alogenski presaditvi kostnega mozga (glejte poglavje 5.1).
There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.4 and 5.1).
Pri bolnikih, ki so prejemali G-CSF po alogenski presaditvi kostnega mozga, so poročali o pojavu reakcij presadka proti gostitelju in o smrtnih primerih (glejte poglavji 4.4 in 5.1).
There have been reports of haemorrhagic events in patients treated with IMBRUVICA, both with and without thrombocytopenia.
Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o krvavitvah s trombocitopenijo ali brez nje.
There have been reports of heart failure in some patients when taking Lyrica; these patients were mostly elderly with cardiovascular conditions.
Pri nekaterih bolnikih, ki so jemali zdravilo Lyrica, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.
There have been reports of heart failure in some patients when taking Pregabalin Mylan Pharma; these patients were mostly elderly with cardiovascular conditions.
Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Mylan Pharma, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.
There have been reports of heart failure in some patients when taking Pregabalin Mylan; these patients were mostly elderly with cardiovascular conditions.
Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Mylan, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.
There have been reports of heart failure in some patients when taking Pregabalin Pfizer; these patients were mostly elderly with cardiovascular conditions.
Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Pfizer, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.
There have been reports of heart failure in some patients when taking Pregabalin Sandoz GmbH; these patients were mostly elderly with cardiovascular conditions.
Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Sandoz GmbH, so opisani primeri srčnega popuščanja; večinoma je šlo za starejše bolnike s srčnožilnimi boleznimi.