natgillin/translations-raw huggingface dataset:
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zoledronic acid medac (see section 4.4).
Predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, kot je zdravilo Zoledronska kislina medac, so poročali o primerih osteonekroze čeljustnic (glejte poglavje 4.4).
Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported.
Poročali so o primerih prevelikega odmerjanja (nekaj tednov z odmerki, ki so 2 do 3-krat presegali predpisani odmerek).
Cases of overdose have been reported; the maximum dose of Pelzont taken was
Poročali so o primerih prevelikega odmerjanja; največji zaužiti odmerek zdravila Pelzont je bil
Cases of overdose have been reported; the maximum dose of Tredaptive taken was 5,000 mg/100 mg.
Poročali so o primerih prevelikega odmerjanja; največji zaužiti odmerek zdravila Tredaptive je bil
Cases of overdose with GlaxoSmithKline’s combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance.
Med obdobjem postmarketinškega spremljanja so bili opisani primeri prevelikega odmerjanja kombiniranega cepiva proti hepatitisu A in hepatitisu B družbe GlaxoSmithKline.
Cases of overdose with Viramune immediate- release at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Poročajo o dajanju prevelikih odmerkov zdravila Viramune s takojšnim sproščanjem v razponu od 800 do 6000 mg na dan do 15 dni.
Cases of pancreatitis have occurred rarely in patients treated with abacavir, lamivudine and zidovudine.
Pri bolnikih, ki so se zdravili z abakavirjem, lamivudinom in zidovudinom so bili primeri pankreatitisa redki.
Cases of PCP, some with fatal outcomes, have been reported (see section 4.4).
Poročali so o primerih pljučnice zaradi PCP, nekaterih s smrtnim izidom (glejte poglavje 4.4).
Cases of peripheral neuropathy have been reported in patients receiving Leflunomide Teva.
Pri bolnikih, ki so jemali zdravilo Leflunomid Teva, so poročali o primerih periferne nevropatije.
Cases of peripheral neuropathy have been reported in patients receiving leflunomide.
Pri bolnikih, ki so jemali zdravilo Leflunomid ratiopharm, so poročali o primerih periferne nevropatije.
Cases of peripheral neuropathy have been reported in patients receiving leflunomide.
Pri bolnikih, ki so jemali zdravilo Leflunomid Winthrop, so poročali o primerih periferne nevropatije.
Cases of PML have been reported from clinical trials, post-marketing observational studies and post- marketing passive surveillance.
O primerih PML so poročali iz kliničnih preskušanj in iz opazovalnih študij ter pasivnega opazovanja po začetku trženja zdravila.
Cases of Pneumocystis carinii pneumonia have been reported in patients not receiving antimicrobial prophylaxis.
Pri bolnikih, ki niso prejemali protimikrobne profilakse, so poročali o primerih pljučnice, ki jo je povzročila Pneumocystis carinii.
Cases of Pneumocystis jiroveci pneumonia (PCP) some with fatal outcomes, have been reported in patients who received temsirolimus, many of whom also received corticosteroids or other immunosuppressive agents.
Pri bolnikih, ki so prejeli temsirolimus in med katerimi so številni prejeli tudi kortikosteroide ali druge imunosupresivne učinkovine, so poročali o primerih pljučnice, ki jo povzroča Pneumocystis jiroveci (PCP), od katerih so se nekateri končali s smrtnim izidom.
Cases of pneumonitis have been reported in clinical studies with idelalisib.
V kliničnih študijah z idelalizibom so poročali o primerih pnevmonitisa.
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome – PRES) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (reversible posterior leukoencephalopathy syndrome – RPLS).
Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis.
Med zdravljenjem z zdravilom Kyprolis so poročali o primerih sindroma posteriorne reverzibilne encefalopatije (PRES – Posterior Reversible Encephalopathy Syndrome).
Cases of PRES have been observed after administration of vinflunine.
Po dajanju zdravila vinflunin so bili opaženi primeri PRES-a.
Cases of PRES/ RPLS have been reported.
Poročali so o primerih PRES/ RPLS.
Cases of prolonged neutropenia (3% in the G+B arm) and late onset neutropenia (7% in the G+B arm) were also reported (See section 4.4).
Poročali so tudi o primerih dolgotrajne nevtropenije (3 % s kombinacijo zdravila Gazyvaro in bendamustina) in primerih zakasnjene nevtropenije (7 % s kombinacijo zdravila Gazyvaro in bendamustina) (glejte poglavje 4.4).
Cases of pulmonary embolism were observed in approximately 3.1% of patients with GIST and in approximately 1.2% of patients with MRCC, who received sunitinib in phase 3 studies (see section 4.4 - Venous thromboembolic events).
Primere pljučne embolije so opazili pri približno 3,1 % bolnikov z GIST in približno 1,2 % bolnikov z MRCC, ki so prejemali sunitinib v študijah 3. faze (glejte poglavje 4.4 – Venski trombembolični dogodki).
Cases of pulmonary haemorrhage, some with a fatal outcome, have been observed in clinical trials and have been reported in post-marketing experience in patients treated with sunitinib for MRCC, GIST and lung cancer.
V kliničnih preskušanjih in v obdobju trženja zdravila so poročali o primerih krvavitev v pljučih, nekaterih s smrtnim izidom, pri bolnikih, zdravljenih s sunitinibom pri MRCC, GIST in pljučnem raku.
Cases of pulmonary hypertension, some fatal, have been reported in patients treated with thalidomide.
Pri bolnikih, zdravljenih z talidomidom, so poročali o primerih pljučne hipertenzije, ki se je včasih končala s smrtjo.
Cases of pulmonary oedema have been reported with vasodilating medicinal products, such as ERAs, when used in patients with pulmonary veno-occlusive disease.
Med uporabo vazodilatacijskih zdravil, kakršna so ERA , so bili pri bolnikih s pljučno venookluzivno boleznijo opisani primeri pljučnega edema.
Cases of pure red cell aplasia (a very severe reduction in red blood cell counts),
primeri čiste aplazije rdečih krvnih celic (zelo resno zmanjšanje števila rdečih krvnih celic)
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressants.
Pri zdravljenju z zdravilom CellCept v kombinaciji z drugimi imunosupresivi so poročali o primerih čiste aplazije rdečih krvnih celic (PRCA).
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressants.
Pri zdravljenju z mofetilmikofenolatom v kombinaciji z drugimi imunosupresivi so poročali o primerih čiste aplazije rdečih krvnih celic (PRCA).
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus.
Pri bolnikih, zdravljenih s takrolimusom, so poročali o primerih čiste aplazije rdečih krvnih celic (PRCA, pure red cell aplasia).
Cases of radiation pneumonitis have been reported in patients receving concomitant radiotherapy.
Pri bolnikih, ki so sočasno dobivali radioterapijo, so bili opisani primeri radiacijskega pnevmonitisa.
Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy.
Poročali so o primerih radiacijske pljučnice pri bolnikih, ki so jih zdravili z obsevanjem pred, med ali po zdravljenju s pemetreksedom.
Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
psevdomem- branski kolitis (glej poglavje 4.4)
Cases of RAS-driven malignancies have been seen with dabrafenib as monotherapy and in combination with trametinib.
Med uporabo dabrafeniba tako v monoterapiji kot v kombinaciji s trametinibom so opazili primere malignomov pod vplivom RAS.
Cases of recurrence of inhibitors (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Pri zamenjavi zdravila z rekombinantnim faktorjem VIII z drugim zdravilom s faktorjem VIII pri predhodno zdravljenih bolnikih, ki so bili že več kot 100 dni izpostavljeni zdravilu in so imeli nastanek inhibitorjev v anamnezi, so opazili primere ponovnega nastanka inhibitorjev (nizek titer).
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Opazili so primere recidivov inhibitorjev (nizek titer) po prehodu z enega faktorja VIII na drugega pri predhodno zdravljenih bolnikih z izpostavljenostjo, daljšo od 100 dni, ki imajo anamnezo razvoja inhibitorjev.
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Po prehodu z enega zdravila s faktorjem VIII na drugega so opazili primere ponovnega pojava zaviralcev (nizek titer) pri predhodno zdravljenih bolnikih z izpostavljenostjo, daljšo od 100 dni, ki so imeli v anamnezi pojav zaviralcev.
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Pri prehodu z zdravila, ki vsebuje en faktor VIII, na zdravilo, ki vsebuje drugega, so pri predhodno zdravljenih bolnikih, ki so bili izpostavljeni več kot 100 dni in so imeli razvoj inhibitorjev v anamnezi, opazili primere ponavljajoče se inhibicije (nizkega titra).
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Pri zamenjavi enega zdravila z rekombinantnim faktorjem VIII z drugim so pri predhodno zdravljenih bolnikih, ki so bili že več kot 100 dni izpostavljeni zdravilu in so imeli v anamnezi nastanek zaviralcev, opazili primere ponovnega nastanka zaviralcev (nizek titer).
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Primere ponavljajočega se pojavljanja inhibitorjev (nizek titer) so opazili po prehodu z enega zdravila FVIII na drugega pri predhodno zdravljenih bolnikih z več kot 100 dnevi izpostavljenosti, ki imajo razvoj inhibitorjev v anamnezi.
Cases of renal impairment, renal failure and/or acute renal failure, in some cases with fatal outcome, have been reported.
Poročali so o primerih zmanjšanega delovanja ledvic, odpovedi ledvic in/ali akutni odpovedi ledvic, v nekaterih primerih s smrtnim izidom.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions have been observed with human normal immunoglobulin including Privigen.
Pri humanem polispecifičnem imunoglobulinu, vključno z zdravilom Privigen, so opazili primere reverzibilnega aseptičnega meningitisa in redke primere prehodnih kožnih reakcij.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions have been observed with human normal immunoglobulin.
Pri uporabi humanega polispecifičnega imunoglobulina so opažali primere reverzibilnega aseptičnega meningitisa in redke primere prehodnih kožnih reakcij.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions have been observed with human normal immunoglobulin.
Pri uporabi humanih polispecifičnih immunoglobulinov so opažali primere reverzibilnega aseptičnega meningitisa in redke primere prehodnih kožnih reakcij.
Cases of Reye’s syndrome have occurred following the use of salicylates during varicella infections (see section 4.4).
Po uporabi salicilatov med okužbo z noricami so poročali o pojavu Reyevega sindroma (glejte poglavje 4.4)
Cases of serious hepatic dysfunction occurred uncommonly (see section 4.4).
Občasno so se pojavili primeri resnih motenj v delovanju jeter (glejte poglavje 4.4).
Cases of serious hypotension have been reported during and immediately following BRINAVESS infusion.
Med infundiranjem in takoj po infundiranju zdravila BRINAVESS so poročali o primerih resne hipotenzije.
Cases of serious infection (with or without neutropoenia), including cases with fatal outcome, have been reported.
Poročali so o primerih resnih okužb (z nevtropenijo ali brez nje), vključno s primeri s smrtnim izidom.
Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis, …) associated with the presence of sevelamer crystals have been reported in literature.
V literaturi so bili opisani primeri resnih vnetnih bolezni različnih delov prebavil (vključno z resnimi zapleti, kot so npr. krvavitev, perforacija, ulceracija, nekroza, colitis, …), povezanih s prisotnostjo kristalov sevelamerja.
Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis, …) associated with the presence of sevelamer crystals have been reported in literature.
V literaturi so bili opisani primeri resnih vnetnih bolezni različnih delov prebavil (vključno z resnimi zapleti, kot so npr. krvavitev, perforacija, ulceracija, nekroza, kolitis, …), povezanih s prisotnostjo kristalov sevelamerja.
Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis, colitis, …) associated with the presence of sevelamer crystals have been reported in literature.
V literaturi so bili opisani primeri resnih vnetnih bolezni različnih delov prebavil (vključno z resnimi zapleti, kot so npr. krvavitev, perforacija, ulceracija, nekroza, kolitis,, ...), povezanih s prisotnostjo kristalov sevelamerja.
Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Pri uporabi zdravila Daklinza v kombinaciji s sofosbuvirjem in sočasni uporabi amiodarona in/ali drugih zdravil, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4 in 4.5).
Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another DAA (including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Pri uporabi sofosbuvirja v kombinaciji z drugim zdravilom z direktnim delovanjem na viruse (vključno z daklatasvirjem, simeprevirjem in ledipasvirjem) in sočasni uporabi amiodarona in/ali drugih zdravil, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4 in 4.5).
Cases of severe bradycardia and heart block have been observed when sofosbuvir used in combination with another direct acting antiviral (DAA), is used with concomitant amiodarone with or without other medicinal products that lower heart rate.
Pri uporabi sofosbuvirja v kombinaciji z drugim zdravilom z direktnim delovanjem na viruse sočasno z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
Cases of severe bradycardia and heart block have been observed when sofosbuvir used in combination with another direct acting antiviral, is used with concomitant amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Pri uporabi sofosbuvirja v kombinaciji z drugim zdravilom z direktnim delovanjem na viruse s sočasno uporabo amiodarona in/ali drugih zdravil, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4 in 4.5).
Cases of severe hypersensitivity syndromes, including DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and TEN (toxic epidermal necrolysis), sometimes fatal, have been reported with the use of INTELENCE (see section 4.8).
Pri uporabi zdravila INTELENCE so poročali o primerih hudih preobčutljivostnih sindromov, vključno s sindromom DRESS (Drug Rash with Eosinophilia and Systemic Symptoms - kožni izpuščaj z eozinofilijo in s sistemskimi simptomi kot posledica zdravljenja) in toksično epidermalno nekrolizo (TEN – Toxic Epidermal Necrolysis), ki so lahko tudi smrtni (glejte poglavje 4.8).
Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
V obdobju po prihodu zdravila na trg so pri uporabi teriflunomida poročali o hudih kožnih reakcijah (glejte poglavje 4.4).
Cases of skin laceration requiring skin graft after finger extension procedures have been reported post-marketing.
V obdobju trženja zdravila so po postopkih iztegovanja prstov poročali o primerih raztrganin kože, zaradi katerih je bilo treba kožo presaditi.
Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim.
Po dajanju filgrastima so občasno poročali o primerih splenomegalije in raztrganja vranice.
Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim.
Po uporabi filgrastima so občasno poročali o primerih splenomegalije in raztrganja vranice.
Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim.
Po uporabi filgrastima so občasno poročali o splenomegaliji in rupturi vranice.
Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim.
Po uporabi filgrastima so poročali o občasnih primerih splenomegalije in raztrganja vranice.
Cases of splenomegaly have been reported commonly following administration of filgrastim.
Po uporabi filgrastima so pogosto poročali o primerih splenomegalije.
Cases of splenomegaly have been reported commonly following administration of filgrastim.
Po uporabi filgrastima so poročali o pogostih primerih splenomegalije.
Cases of splenomegaly have been reported very commonly and cases of splenic rupture have been reported commonly following administration of filgrastim.
Po uporabi filgrastima so poročali o zelo pogostih primerih splenomegalije in pogostih primerih raztrganja vranice.
Cases of splenomegaly have been reported very commonly and cases of splenic rupture have been reported commonly following administration of filgrastim.
Po uporabi filgrastima so zelo pogosto poročali o primerih splenomegalije in pogosto o primerih raztrganja vranice.
Cases of splenomegaly have been reported very commonly and cases of splenic rupture have been reported commonly following administration of filgrastim.
Po uporabi filgrastima so zelo pogosto poročali o splenomegaliji in pogosto o rupturi vranice.
Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Poročali so o primerih spontanih splavov pri bolnicah izpostavljenih mofetilmikofenolatu, pretežno v prvem trimesečju, glejte poglavje 4.6.
Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Poročali so o primerih spontanih splavov pri bolnicah, izpostavljenih mofetilmikofenolatu, pretežno v prvem trimesečju, glejte poglavje 4.6.
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with fatal outcomes have been reported when idelalisib was administered concomitantly with other medicinal products associated with these syndromes.
Poročali so o Stevens-Johnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN) s smrtnimi izidi, ko so idelalizib dajali sočasno z drugimi zdravili, povezanimi s tema sindromoma.
Cases of Sweet's syndrome (acute febrile dermatosis) have been reported in the post-marketing setting.
V obdobju trženja so poročali o primerih Sweetovega sindroma (akutni febrilni dermatozi).
Cases of symptomatic hypoglycaemia have been reported in children with ALL receiving 6- mercaptopurine (see section 4.8).
Pri otrocih z ALL, ki so prejemali 6-merkaptopurin, so poročali o primerih simptomatske hipoglikemije (glejte poglavje 4.8).
Cases of systemic lupus erythematosus (SLE) in relation to Xolair treatment, including two cases with positive dechallenge and one case with positive dechallenge /rechallenged, were reported.
Poročali so o primerih sistemskega eritematoznega lupusa (SLE) v povezavi z uporabo zdravila Xolair, med drugim o dveh primerih z okrevanjem po prekinitvi zdravljenja in o enem primeru okrevanja po prekinitvi zdravljenja ter ponovitvi SLE po ponovni uvedbi zdravila.
Cases of TB have been reported in patients treated with Flixabi, even in patients who have been treated with medicines for TB.
Pri bolnikih, zdravljenih z zdravilom Flixabi, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so bili zdravljeni z zdravili proti TBC.
Cases of TB have been reported in patients treated with Inflectra, in rare occasions even in patients who have been treated with medications for TB.
Pri bolnikih, zdravljenih z zdravilom Inflectra, so poročali o primerih tuberkuloze, v redkih primerih tudi pri bolnikih, ki so bili zdravljeni z zdravili proti TBC.
Cases of TB have been reported in patients treated with Remicade, even in patients who have been treated with medications for TB.
Pri bolnikih, zdravljenih z zdravilom Remicade, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so bili zdravljeni z zdravili proti TBC.
Cases of TB have been reported in patients treated with Remsima, even in patients who have been treated with medications for TB.
Pri bolnikih, zdravljenih z zdravilom Remsima, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so bili zdravljeni z zdravili proti TBC.
Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB.
Pri bolnikih, zdravljenih z zdravilom Simponi, so poročali o primerih TB, v redkih primerih celo pri bolnikih, ki so prejemali zdravila za zdravljenje TB.
Cases of temporary meningitis (which symptoms or signs are headache, fear or intolerance of light, stiff neck).
Primeri prehodnega meningitisa (simptomi in znaki so lahko glavobol, strah pred svetlobo ali neprenašanje svetlobe, otrpel tilnik).
Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/haemolysis).
Primeri prehodnega zmanjšanja števila rdečih krvničk v krvi (reverzibilna hemolitična anemija/hemoliza).
Cases of thrombocytopenia have been spontaneously reported, frequency unknown.
Spontano so poročali o primerih trombocitopenije, pogostnost ni znana.
Cases of thrombotic microangiopathy, in some cases with fatal outcome, have been reported (see also section 4.4).
Poročali so o primerih trombotične mikroangiopatije, v nekaterih primerih s smrtnim izidom (glejte tudi poglavje 4.4).