natgillin/translations-raw huggingface dataset:
Serious cardiovascular reactions, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post-marketing in temporal association with another medicinal product in this class.
V postmarketinških študijah z drugimi zdravili iz te skupine so opazili hude srčno-žilne dogodke, tudi cerebrovaskularno krvavitev, nenadno srčno smrt, tranzitoren ishemični napad, nestabilno angino pektoris in prekatno aritmijo, ki so bili včasih povezani z vzetim zdravilom.
Serious cardiovascular reactions, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post-marketing in temporal association with another medicinal product in this class.
V postmarketinških študijah z drugimi zdravili iz te skupine so opazili hude srčno-žilne dogodke, tudi cerebrovaskularno krvavitev, nenadno srčno smrt, tranzitoren ishemični napad, nestabilno angino pektoris in prekatno aritmijo, ki so bili časovno povezani z vzetim zdravilom.
Serious cases of haemorrhage have been reported in patients treated with lenvatinib (see section 4.8 Description of selected adverse reactions).
Pri bolnikih, zdravljenih z lenvatinibom, so poročali o primerih resnih krvavitev (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting.
Med uporabo v obdobju trženja so bili redko opisani resni primeri keratitisa in ulcerativnega keratitisa.
Serious cutaneous reactions
resne kožne reakcije
Serious disease that destroys skeletal muscle characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine (Rhabdomyolysis), increase in blood creatine phosphokinase.
Resna bolezen, ki uniči skeletne mišice in se kaže s prisotnostjo mioglobina (razgradni produkt mišičnih celic) v urinu (rabdomioliza), povišana koncentracija kreatin fosfokinaze v krvi.
Serious events of ITP have been observed in approximately 1% of patients treated in controlled clinical trials in MS.
Resne pojave ITP so opazili pri približno 1 % bolnikov, zdravljenih v kontroliranih kliničnih preskušanjih pri MS.
Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures and will only form part of the report if an issue of concern arises.
Resne pričakovane neželene učinke bo pregledal imetnik dovoljenja za promet kot del postopkov ugotavljanja signala in bodo tvorili del poročila le v primeru nastanka zadevnih vprašanj.
Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili resne gastrointestinalne perforacije in fistule, ki so včasih bile smrtne.
serious GI events*.
krvavitvijo.
Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of <5 g/dL or a decrease of >4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Resno hemolizo označujejo ravni LDH v serumu, višje od ravni pred zdravljenjem, v povezavi s katerimkoli od naslednjih znakov: absolutno zmanjšanje velikosti klona PNH za več kot 25 % (ob odsotnosti razredčenja zaradi transfuzije) v času enega tedna ali manj; raven hemoglobina <5 g/dl ali zmanjšanje za >4 g/dl v času enega tedna ali manj; angina; sprememba duševnega stanja; 50 % zvišanje ravni serumskega kreatinina; ali tromboza.
Serious haemorrhage, haemorrhage of
krvavitve v dihalih (hemoptiza, pljučna krvavitev), bronhospazem,
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
resne krvavitve, krvavitev operacijske rane, vaskulitis, hipotenzija
Serious hepatobiliary disorders, including nodular regenerative hyperplasia (NRH) of the liver and some with a fatal outcome due to drug-induced liver injury have been observed in patients treated with trastuzumab emtansine.
Pri bolnikih, zdravljenih s trastuzumabom emtanzinom, so opažali resne hepatobiliarne zaplete, vključno z nodularno regenerativno hiperplazijo jeter in nekaterimi primeri smrti zaradi medikamentozne poškodbe jeter.
Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Lahko se pojavijo resne preobčutljivostne reakcije (redke, vendar hude akutne reakcije, kot je bronhospazem, anafilaksija in urtikarija).
Serious hypersensitivity reactions (severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Lahko pride do resnih preobčutljivostnih reakcij (hude akutne reakcije, kot je bronhospazem, anafilaksa in urtikarija).
Serious hypersensitivity reactions and their management
resne preobčutljivostne reakcije in njihovo zdravljenje,
Serious hypersensitivity reactions have been reported as a rare complication of treatment with interferon beta, including Plegridy.
Pri zdravljenju z interferonom beta, vključno z zdravilom Plegridy, so poročali o preobčutljivostnih reakcijah kot o redkem zapletu, povezanim z zdravljenjem.
Serious hypersensitivity reactions have been reported with the use of oritavancin.
Pri uporabi oritavancina so poročali o resnih preobčutljivostnih reakcijah.
Serious hypersensitivity reactions, including some cases of angioedema, urticaria and, rarely, late (10- 14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported.
Poročali so o resnih preobčutljivostnih reakcijah, vključno z nekaj primeri angioedema, urtikarije in, redko, resnih zapoznelih (10–14 dni po injiciranju) preobčutljivostnih reakcij, ki so vključevale široko razširjeno urtikarijo, dispnejo in visoke titre protiteles.
Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Resna preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. Klinično pomembne aktivne okužbe (npr. aktivna tuberkuloza, glejte poglavje 4.4).
Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Huda hipoglikemija lahko povzroči srčni infarkt ali poškodbo možganov in je lahko smrtno nevarna.
Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening.
Resna hipoglikemija lahko povzroči srčno kap ali poškodbe možgan in lahko ogroža življenje.
Serious hypoglycaemia may cause brain damage and may be life- threatening.
Huda hipoglikemija lahko povzroči poškodbo možganov in je lahko smrtno nevarna.
Serious infection including infection in the blood (sepsis)
resne okužbe, vključno z okužbo krvi (sepso),
Serious infection-related adverse drug reactions, with potentially fatal outcome, such as septic shock, sepsis, pneumonia, and other infections (viral, bacterial and fungal) were reported in patients receiving Dacogen.
Pri bolnikih, ki so prejemali zdravilo Dacogen, so v povezavi z okužbami poročali o resnih neželenih učinkih z možnim smrtnim izidom, kot so septični šok, sepsa, pljučnica in druge okužbe (virusne, bakterijske in glivične).
Serious infections
resne okužbe;
Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); rash; inflammation or scarring of the lungs; inflammation of the blood vessels affecting multiple organs.
Resne okužbe (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov, okužbo krvi in okužbami na različnih mestih); nizko število krvnih ploščic; kožni rak (razen melanoma); lokalizirano otekanje kože (angioedem); koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo); očesno vnetje; luskavica (na novo nastala ali poslabšanje obstoječe); izpuščaj; vnetje ali brazgotinjenje pljuč; vnetje krvnih žil, ki negativno vpliva na več organov.
Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit.
V kliničnih študijah so pri sočasni uporabi anakinre in nekega drugega zaviralca TNF, t.j. etanercepta, opazili resne okužbe in nevtropenijo, ni pa bilo nobene dodatne klinične koristi njegove sočasne uporabe.
Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
V kliničnih študijah, v katerih so sočasno uporabljali anakinro in drug zaviralec TNF-etanercept, so opažali resne okužbe in nevtropenijo, ni pa bilo nikakršnih dodatnih koristnih kliničnih učinkov v primerjavi z uporabo samega etanercepta.
Serious infections at least possibly related to treatment were reported in 1.8% of abatacept-treated patients and 1.1% of placebo-treated patients.
O resnih okužbah, ki bi lahko bile povezane z zdravljenjem, so poročali pri 1,8% bolnikov, ki so prejemali abatacept, in 1,1% bolnikov, ki so prejemali placebo.
Serious infections can happen with NULOJIX treatment and can lead to death.
Med zdravljenjem z zdravilom NULOJIX se lahko pojavijo resne okužbe, ki se lahko končajo s smrtjo.
Serious infections can include
Resne okužbe, ki se lahko pojavijo, so:
Serious infections have been observed in patients taking Ilaris.
Pri bolnikih, ki so jemali zdravilo Ilaris, so bili opažene resne okužbe.
Serious infections have been observed.
Opažali so tudi resne okužbe.
Serious infections in the LEMTRADA group included: appendicitis, gastroenteritis, pneumonia, herpes zoster, and tooth infection.
Resne okužbe v skupini bolnikov, ki so prejemali zdravilo LEMTRADA, so vključevale: apendicitis, gastroenteritis, pljučnico, pasovec in zobno okužbo.
Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving Humira.
Pri bolnikih, ki so dobivali zdravilo Humira, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioza, legioneloza in pnevmocistična okužba.
Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Med resne okužbe, ki so jih opazili pri bolnikih, zdravljenih z golimumabom, so sodile tuberkuloza, bakterijske okužbe, vključno s sepso in pljučnico, invazivne glivne in ostale oportunistične okužbe.
Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Tveganje hudih okužb, vključno z oportunističnimi bakterijskimi, virusnimi in glivnimi okužbami pri bolnikih, ki prejemajo zdravilo Simponi.
Serious infections occurred at the rate of 0.03 per patient-year of follow-up in ustekinumab-treated patients (27 serious infections in 829 patient-years of follow-up) and 0.03 in placebo-treated patients (11 serious infections in 385 patient-years of follow-up) (see section 4.4).
Resne okužbe so se pojavljale s pogostnostjo 0,01 na bolnikov-let spremljanja pri bolnikih, zdravljenih z ustekinumabom (5 resnih okužb na 616 bolnikov-let spremljanja), in s pogostnostjo 0,01 pri bolnikih, ki so prejemali placebo (4 resne okužbe na 287 bolnikov-let spremljanja) (glejte poglavje 4.4).
Serious infections occurred in 0.14% of patients treated with Cosentyx and in 0.3% of patients treated with placebo (see section 4.4).
Do resnih okužb je prišlo pri 0,14% bolnikov, ki so prejemali zdravilo Cosentyx, in pri 0,3% bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
Serious infections occurred in 2.7% of patients treated with LEMTRADA as compared to 1% of patients treated with IFNB-1a in controlled clinical trials in MS.
V kontroliranih kliničnih preskušanjih pri MS so se resne okužbe pojavile pri 2,7 % bolnikov, zdravljenih z zdravilom LEMTRADA, in 1 % bolnikov, zdravljenih z IFNB 1a.
Serious infections occurred in 5% of patients receiving Benlysta or placebo.
Resne okužbe so se pojavile pri 5 % bolnikov, ki so prejemali zdravilo Benlysta ali placebo.
Serious infections reported in at least one patient treated with abatacept (0.05% of patients) included the following: pneumonia, cellulitis, localised infection, urinary tract infection, bronchitis, diverticulitis, pyelonephritis acute, sepsis, abscess, arthritis bacterial, bacteraemia, bronchopneumonia, bronchopulmonary aspergillosis, bursitis infective, cellulitis staphylococcal, empyema, gastrointestinal infection, hepatitis E, infected skin ulcer, peridiverticular abscess, pneumonia bacterial, pneumonia haemophilus, pneumonia influenzal, sinusitis, streptococcal sepsis, tuberculosis, urosepsis (see section 4.4).
Resne okužbe, ki so se pojavile pri vsaj enem bolniku, ki je prejemal abatacept (0,05% bolnikov) so naslednje: pljučnica, flegmona, lokalne okužbe, okužbe sečil, bronhitis, divertikulitis, akutni pielonefritis, sepsa, absces, bakterijski artritis, bakteriemija, bronhialna pljučnica, bronhialno-pljučna aspergiloza, infekcijski burzitis, stafilokokna flegmona, empiem, okužbe v prebavilih, hepatitis E, okužba razjede na koži, peridivertikularni absces, bakterijska pljučnica, hemofilna pljučnica, pljučnica povzročena z Influenza virusi, sinuzitis, sepsa povzročena s streptokoki, tuberkuloza in urosepsa (glejte poglavje 4.4).
Serious infections such as pneumonia (a chest infection) or infections of the skin can occur during Kineret treatment.
Med zdravljenjem z zdravilom Kineret se lahko pojavijo resne okužbe, na primer pljučnica (okužba v prsnem košu) ali okužbe kože.
Serious infections were reported in 1.2% of patients treated with Cosentyx (0.015 per patient-year of follow-up).
O resnih okužbah so poročali pri 1,2% bolnikov, ki so prejemali zdravilo Cosentyx (0,015 na enoto bolnik-leto spremljanja).
Serious infections were reported in 1.6 % of patients treated with Taltz (1.5 per 100 patient years).
Pri 1,6 % bolnikov, zdravljenih z zdravilom Taltz (1,5 na 100 bolnikov-let), so poročali o resnih okužbah.
Serious infections, including pneumonia and sepsis, were observed during clinical studies (see section 4.8).
V kliničnih študijah so opažali pojav resnih okužb, med drugim pljučnice in sepse (glejte poglavje 4.8).
Serious infections.
Resne okužbe.
Serious injection-related side effects (which have occurred in less than 1 in 2,200 injections) include blindness, endophthalmitis (inflammation inside the eye), cataract, increased intraocular pressure, vitreous haemorrhage (bleeding into the jelly- like fluid in the eye, causing temporary loss of vision) and vitreous or retinal detachment.
Resni neželeni učinki, povezani z injiciranjem (ki so se pojavili pri manj kot 1 na 2 200 injekcij), vključujejo slepoto, endoftalmitis (vnetje v očesu), katarakto, povečan tlak v očesu, krvavitev v steklovini (v želatini podobni snovi v očesu, ki povzroči začasno izgubo vida) in odstop steklovine ali mrežnice.
Serious injection/infusion reaction and their management
resne reakcije, povezane z injiciranjem/infundiranjem in njihovo zdravljenje,
Serious IRs were observed in clinical trials and included anaphylaxis, hypersensitivity and vomiting.
Med resnimi, z infuzijo povezanimi reakcijami, ki so jih opazili v kliničnih preskušanjih, so bili anafilaksa, preobčutljivost in bruhanje.
Serious kidney or liver problems
resne težave z ledvicami ali jetri,
Serious life-threatening infections including meningitis, endocarditis tuberculosis and atypical mycobacterial infection.
Resne življenjsko nevarne okužbe, vključno z meningitisom, endokarditisom, tuberkulozo in atipičnimi mikobakterijskimi okužbami.
Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Resne življenjsko nevarne okužbe, vključno z meningitisom, endokarditisom, tuberkulozo in atipičnimi mikobakterijskimi okužbami.
Serious liver problems
resne težave z jetri.
Serious lung infection (pneumonia)
resna okužba pljuč (pljučnica),
Serious lung infection (pneumonia), bronchitis
resna okužba pljuč (pljučnica), bronhitis
Serious lung problems (such as interstitial lung disease)
resne težave s pljuči (na primer intersticijska pljučna bolezen)
Serious lung problems (such as interstitial lung disease)
resne težave s pljuči (na primer intersticijska pljučna bolezen),
Serious ocular adverse reactions in the study eye related to the injection procedure have occurred in less than 1 in 1,900 intravitreal injections with Eylea and included blindness, endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous haemorrhage, , vitreous detachment, and intraocular pressure increased (see section 4.4).
Resni očesni neželeni učinki, povezani s postopkom injiciranja, ki so se pojavili v zdravljenem očesu, pri manj kot 1 od 1.900 intravitrealnih injekcij zdravila Eylea, so vključevali slepoto, endoftalmitis, odstop mrežnice, travmatsko katarakto, katarakto, krvavitev v steklovino, odstop steklovine in povišan intraokularni tlak (glejte poglavje 4.4).
Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.
V povezavi z zdravljenjem z zonisamidom so se pojavili resni izpuščaji, vključno s primeri Stevens-Johnsonovega sindroma.
Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
O resnih reakcijah (npr. anafilaktoidna reakcija v 0,2 %; 6/3028) so v času zdravljenja z mikafunginom poročali le občasno in samo pri bolnikih z resnimi sočasno prisotnimi boleznimi (npr. napredovali AIDS, maligna obolenja), ki so zahtevale sočasno zdravljenje z več zdravili.
Serious reactions occurred in 3% of patients including cases of pyrexia, urticaria, atrial fibrillation, nausea, chest discomfort, and hypotension.
Resne reakcije so se pojavile pri 3 % bolnikov, vključevale so primere pireksije, urtikarije, atrijske fibrilacije, navzee, nelagodnega občutka v prsnem košu in hipotenzije.
Serious reactions of the skin and/or mucous membranes which may include painful blisters and fever (Stevens-Johnson syndrome).
Resne reakcije kože in/ali sluznic, kar lahko vključuje boleče mehurje in vročino (Stevens-Johnsonov sindrom).
Serious reactions, including autoimmune hepatitis, hepatitis and jaundice, were observed in 1% of patients.
Pri 1 % bolnikov so opazili resne reakcije, vključno z avtoimunim hepatitisom, hepatitisom in zlatenico.
Serious rise in creatinine
pomembno zvišanje koncentracije kreatinina,
Serious side effects
Hudi neželeni učinki
Serious side effects
Možni neželeni učinki
Serious side effects
Resni neželeni učinkie
Serious side effects Bleeding problems
Resni neželeni učinki Težave s krvavitvami
Serious side effects caused by the single treatment with Yondelis:
Resni neželeni učinki, ki jih povzroča zdravilo Yondelis kot monoterapija:
Serious side effects for Orkambi include raised levels of liver enzymes in the blood, liver injury, and confusion related to poor liver function.
Resni neželeni učinki zdravila Orkambi vključujejo zvišano raven jetrnih encimov v krvi, poškodbo jeter in zmedenost, ki je povezana z oslabljenim delovanjem jeter.
Serious side effects include hypersensitivity (allergic) reactions, eosinophilic pneumonia (infection of the lungs), drug rash with eosinophilia and systemic symptoms (DRESS, a severe skin reaction), angioedema (rapid swelling of deeper skin tissues) and rhabdomyolysis (breakdown of muscle fibres).
Resni neželeni učinki vključujejo preobčutljivostne (alergijske) reakcije, eozinofilno pljučnico (okužba pljuč), izpuščaj zaradi zdravila z eozinofilnimi in sistemskimi simptomi (sindrom DRESS – huda reakcija na koži), angioedem (hitro otekanje globokih krvnih žil) in rabdomiolizo (razgradnjo mišičnega tkiva).
Serious side effects include stomach (abdominal) ache and increased liver enzymes in the blood.
Med resnimi neželenimi učinki so bolečine v želodcu (trebuhu) in zvišane jetrne encime v krvi.
Serious side effects include:
Resni neželeni učinki vključujejo:
Serious side effects included liver problems such as raised liver enzymes, cholestatic hepatitis (build-up of bile leading to inflammation of the liver) and hepatic encephalopathy (a brain disease caused by liver problems).
Resni neželeni učinki so vključevali težave z jetri, kot so povišane vrednosti jetrnih encimov, holestatski hepatitis (kopičenje žolča, ki privede do vnetja jeter) in hepatično encefalopatijo (možgansko bolezen, ki jo povzročajo težave z jetri).
Serious side effects Infusion related reactions
Resni neželeni učinki Reakcije, povezane z infuzijo
Serious side effects reported with Adcetris include pneumonia (lung infection), other infections (including chickenpox and shingles), acute respiratory distress syndrome (a condition where inflammation and fluid in the lungs lead to difficulty breathing), headache, neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), constipation, diarrhoea, vomiting, fever, peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements) and peripheral sensory neuropathy (nerve damage affecting sensation in the hands and feet), hyperglycaemia (high blood glucose levels), demyelinating polyneuropathy (a neurological disorder characterized by slowly progressive weakness and a loss of sensation in the legs and arms), tumour lysis syndrome (a potentially fatal complication due to the breakdown of cancer cells) and Stevens- Johnson syndrome (a life-threatening type of allergic reaction affecting the skin and mucous membranes).
Resni neželeni učinki, o katerih so poročali v zvezi z zdravilom Adcetris, vključujejo: pljučnico (okužbo pljuč), druge okužbe (tudi norice in pasovec), sindrom akutne dihalne stiske (bolezni, kjer vnetje in tekočina v pljučih povzročita težave z dihanjem), glavobol, nevtropenijo (nizko število belih krvnih celic), trombocitopenijo (nizko število trombocitov), zaprtje, drisko, bruhanje, povišano telesno temperaturo, periferno motorično nevropatijo (poškodbe živcev, kar otežuje koordinacijo gibov) in periferno senzorično nevropatijo (poškodbe živcev, ki vplivajo na občutek v dlaneh in stopalih), hiperglikemijo (visoka raven glukoze v krvi), demielinizirajočo polinevropatijo (nevrološko motnjo, za katero sta značilni počasno napredovanje šibkosti in izguba občutka v nogah in rokah), sindrom tumorske lize (potencialno smrten zaplet zaradi razkrajanja rakastih celic) in Stevens-Johnsonov sindrom (smrtno nevarno vrsto alergijske reakcije, ki prizadene kožo in sluznice).
Serious side effects that may occur with the combination of Yondelis and PLD:
Resni neželeni učinki, ki se lahko pojavijo pri kombinaciji zdravila Yondelis s PLD:
Serious side effects which may affect more than 1 in 10 people
Resni neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov
Serious side effects with frequency not known (frequency cannot be estimated from the available data)
Resni neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)