natgillin/translations-raw huggingface dataset:
The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6505 adult patients with stable chronic CHF (for  4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF  35%) and a resting heart rate  70 bpm.
Študija SHIFT je bila obsežno multicentrično, mednarodno, randomizirano, dvojno slepo, s placebo nadzorovano preskušanje izida, ki je zajelo 6505 odraslih bolnikov s stabilnim kroničnim srčnim popuščanjem (≥ 4 tedne) II. do IV. razreda po funkcijski razvrstitvi Newyorškega društva za srce (NYHA) z zmanjšanim iztisnim deležem levega prekata (LVEF ≤ 35 %) in srčno frekvenco v mirovanju ≥ 70 utripov na minuto.
The short duration of the studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Incruse on COPD exacerbation rate.
Kratkotrajnost teh študij in majhno število poslabšanj onemogočajo sklepanje o dodatnem učinku zdravila Incruse na delež poslabšanj KOPB.
The shorter-acting Humalog should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin.
V injekcijsko brizgo je treba najprej potegniti zdravilo Humalog s hitrejšim delovanjem, da preprečimo onesnaženje viale z insulinom z dolgotrajnejšim delovanjem.
The shorter-acting Liprolog should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin.
V injekcijsko brizgo je treba najprej potegniti zdravilo Liprolog s hitrejšim delovanjem, da preprečimo onesnaženje viale z insulinom z dolgotrajnejšim delovanjem.
The side buttons should be facing left and right.
Če je v kapsuli še prašek:
The side effects are listed below, grouped by how likely they are to happen.
Neželeni učinki so razvrščeni po pogostnosti pojavljanja.
The side effects are listed below, grouped by how likely they are to happen.
Neželeni učinki so razvrščeni po pogostnosti pojavljanja:
The side effects are similar in adolescents, but somnolence, sedation, extrapyramidal disorder, akathisia and fatigue were reported very commonly (in more than 1 in 10 patients).
Pri mladostnikih so neželeni učinki podobni, vendar so zelo pogosto (pri 1 bolniku od 10) poročali o zaspanosti, dremavosti, ekstrapiramidalnih motnjah, akatiziji in utrujenosti.
The side effects described below have been experienced by patients given nevirapine: Very common (may affect more than 1 in 10 people): rash
Našteti neželeni učinki so se pojavili pri bolnikih, ki so jemali nevirapin: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): izpuščaj;
The side effects described below have been experienced by patients given Viramune: Very common (may affect more than 1 in 10 people): rash
Našteti neželeni učinki so se pojavili pri bolnikih, ki so jemali zdravilo Viramune: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): izpuščaj.
The side effects described below have been experienced by patients given Viramune: Very common (may affect more than 1 in 10 people): rash
Našteti neželeni učinki so se pojavili pri bolnikih, ki so jemali zdravilo Viramune: Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov): izpuščaj.
The side effects dizziness and diarrhoea have been reported more frequently in men over 75 years of age taking tadalafil.
O neželenih učinkih omotici in diareji so pogosteje poročali pri moških nad 75. leti starosti, ki so jemali tadalafil.
The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults with rheumatoid arthritis, with the following differences:
Neželeni učinki o katerih so poročali pri otrocih in mladostnikih s poliartikularnim juvenilnim idiopatskim artritisom so podobni kot pri odraslih z revmatoidnim artritisom, z naslednjimi izjemami:
The side effects listed below have happened after Pandemrix (H1N1)v came on the market:
Neželeni učinki, našteti spodaj, so se pojavili po začetku trženja cepiva Pandemrix (H1N1)v.:
The side effects listed below have happened in the days or weeks after vaccination with other vaccines given routinely every year to prevent flu.
Neželeni učinki, ki so navedeni spodaj, so se pojavili v dnevih ali tednih po cepljenju z drugimi cepivi, s katerimi se vsako leto cepi proti gripi.
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Spodaj navedeni neželeni učinki so se pojavljali v dneh ali tednih po cepljenju s cepivi, ki so jih rutinsko uporabili vsako leto za preprečevanje gripe.
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme:
Neželeni učinki, navedeni v nadaljevanju, so se pojavili pri podobnem cepivu proti gripi (Celvapan) pri odraslih in otrocih v programu cepljenja proti pandemski gripi H1N1:
The side effects listed below have occurred with Celvapan (H1N1)v in adults and children during the pandemic flu vaccination program.
Spodaj navedeni neželeni učinki so se pojavljali pri uporabi cepiva Celvapan (H1N1)v pri odraslih osebah in otrocih v programu cepljenja proti pandemski gripi.
The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly: Very common (affects more than 1 user in 10):
Neželeni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom Focetria v kliničnih študijah:
The side effects listed below were observed in arthritis patients who took medicines with the same active ingredient as Onsenal:
Spodaj navedene neželene učinke so zabeležili pri bolnikih z artritisom, ki so jemali zdravila z isto učinkovino, kot jo vsebuje zdravilo Onsenal:
The side effects marked with an asterisk (*) have led to death in some cases, either in clinical trials or during the marketing of the product.
Neželeni učinki, označeni z zvezdico (*). so povzročili smrt v nekaterih primerih bodisi med kliničnimi preskušanji ali v času trženja zdravila.
The side effects observed in children and adolescents are the same as observed in adults.
Neželeni učinki pri otrocih in mladostnikih so enaki kot pri odraslih.
The side effects of EQUIOXX are typical for those seen with other medicines in this class (NSAIDs) such as oral lesions (tissue damage) in the mouth of horses, soft faeces/diarrhoea or lethargy (unresponsiveness).
Neželeni učinki zdravila EQUIOXX, kot so oralne lezije (vrsta poškodb tkiva) v ustni votlini konj, mehko blato ali driska in letargija (neodzivanje), so značilni za vsa zdravila iz tega razreda zdravil (NSAID).
The side effects of medicines are classified as follows:
Neželeni učinki zdravil so razvrščeni na naslednji način:
The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhea) and the kidneys or lethargy.
Neželeni učinki zdravila Quadrisol so značilni za to skupino zdravil (NSAID), in sicer so to poškodbe (lezije) v ustni votlini, želodcu, črevesju (vključno z mehkim blatom ali drisko) in ledvicah ter letargija.
The side effects of Ravicti affected mainly the gut and were considered manageable.
Stranski učinki zdravila Ravicti so predvsem vplivali na črevo in so se šteli za obvladljive.
The side effects only rarely resulted into having to stop taking Viracept.
Zaradi neželenih učinkov je bilo le redko potrebno zaključiti zdravljenje z zdravilom Viracept.
The side effects reported with Orkambi and ivacaftor alone (one of the active substances of Orkambi) are listed below and may occur with the use of Orkambi.
Neželeni učinki, o katerih poročajo pri zdravilu Orkambi in pri ivakaftorju samem (ena od zdravilnih učinkovin zdravila Orkambi), so navedeni v nadaljevanju in se lahko pojavijo pri jemanju zdravila Orkambi.
The side effects seen in children are similar to those seen in adults.
Neželeni učinki pri otrocih so podobni tistim pri odraslih.
The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
Najpogostejši neželeni stranski učinki (opaženi pri več kot 1 od 10 bolnikov) so slabokrvnost (nizka koncentracija rdečih krvničk), trombocitopenija (nizka koncentracija krvnih ploščic), levkocitoza (visoka koncentracija levkocitov, vrste belih krvničk) ter povišane ravni jetrnih encimov v krvi (bilirubina, alanin-aminotransferaze, aspartat- aminotransferaze, gamaglutamil-transferaze in amilaze).
The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
Neželeni učinki zdravila Fampyra so večinoma nevrološki (povezani z možgani ali živci) in vključujejo epileptične napade (krči), nespečnost, tesnobo, motnje ravnotežja, omotico, parestezijo (nenavadna občutja, kot zbadanje z iglami), tremor, glavobol in astenijo (šibkost).
The side effects seen with Omnitrope were similar in type and severity to those seen with the reference medicine Genotropin.
Neželeni učinki, ki so jih opazili pri uporabi zdravila Omnitrope, so bili tako po vrsti kot po resnosti podobni učinkom, opaženim pri uporabi referenčnega zdravila Genotropin.
The side effects seen with the medicine were typical for this class of medicines and are considered manageable.
Neželeni učinki, ki so jih opazili pri uporabi zdravila, so značilni za zdravila iz tega razreda in veljajo za obvladljive.
The side effects seen with treatment involving Yttriga will therefore depend largely on the medicine being labelled and will be described in that medicine’s package leaflet.
Neželeni učinki, opaženi pri zdravljenju z zdravilom Yttriga, so zato odvisni predvsem od označenega zdravila in so opisani v navodilu za uporabo tega zdravila.
The side effects seen, such as bleeding, were considered manageable and it was not possible to determine with certainty whether they were caused by Defitelio.
Odbor je menil, da so opaženi neželeni učinki, kakršen je npr. krvavenje, obvladljivi in da ni mogoče zagotovo potrditi, da jih je povzročilo zdravilo Defitelio.
The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low white blood cells (leucopenia), redness or blushing (flushing), viral infections, low neutrophils which are white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Pri otrocih so se pogosteje pojavili naslednji neželeni učinki: nizka vrednost rdečih krvnih celic (anemija), kri v blatu, nizka vrednost belih krvnih celic (levkopenija), rdečina ali zardevanje (navali vročine), virusne okužbe, nizka vrednost nevtrofilcev (to so bele krvne celice, ki se borijo proti okužbi) (nevtropenija), zlom kosti, bakterijska okužba in alergijske reakcije v dihalih.
The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low white blood cells (leucopenia), redness or blushing (flushing), viral infections, low neutrophils which are white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Pri otrocih so se pogosteje pojavili naslednji neželeni učinki: nizko število rdečih krvnih celic (anemija), kri v blatu, nizko število belih krvnih celic (levkopenija), rdečina ali zardevanje, virusne okužbe, nizko število nevtrofilcev (to so bele krvne celice, ki se borijo proti okužbi) (nevtropenija), zlom kosti, bakterijska okužba in alergijske reakcije v dihalih.
The side effects that have been reported in children treated with STAYVEER are the same as those in adults.
Neželeni učinki, o katerih so poročali pri otrocih, zdravljenih z zdravilom STAYVEER, so enaki kot pri odraslih.
The side effects were also similar to other medicines of its class, with the exception of hyperglycaemia, which was more frequent and severe in acromegaly patients treated with Signifor.
Neželeni učinki so bili poleg tega podobni kot pri drugih zdravilih istega razreda, z izjemo hiperglikemije, ki je bila pogostejša in hujša pri bolnikih z akromegalijo, zdravljenih z zdravilom Signifor.
The side effects were considered acceptable and manageable with appropriate measures.
Neželeni učinki veljajo za sprejemljive in jih je mogoče obvladati z ustreznimi ukrepi.
The side effects with EndolucinBeta depend largely on the medicine it is used with and will be described in that medicine’s package leaflet.
Neželeni učinki zdravila EndolucinBeta so odvisni predvsem od zdravila, s katerim se uporablja, in so opisani v navodilu za uporabo tega zdravila.
The side effects with Lumark depend largely on the medicine it is used with and will be described in that medicine’s package leaflet.
Neželeni učinki pri uporabi zdravila Lumark so odvisni predvsem od zdravila, s katerim se uporablja, in so opisani v navodilu za uporabo tega zdravila.
The side- effects are generally similar to those related to the seasonal flu vaccine.
Neţeleni učinki so bili na splošno podobni kot pri cepivu proti sezonski gripi.
The signal was considered potentially serious and the marketing authorisation holder performed a cumulative review of high level term amyloidosis.
Signal je bil obravnavan kot potencialno resen in imetnik dovoljenja za promet z zdravilom je izvedel kumulativen pregled amiloidoze, zavedene po najmanj specifičnem izrazu klasifikacije neželenega učinka.
The significance of these data for the use of Intrinsa in patients is not known.
Pomen teh podatkov za uporabo zdravila Intrinsa pri bolnicah ni znan.
The significance of these data for the use of Livensa in patients is not known.
Pomen teh podatkov za uporabo zdravila Livensa pri bolnicah ni znan.
The significance of these data in pregnant women is not known; therefore the use of AMMONAPS is contra-indicated during pregnancy (see section 4.3).
Pomen tega pojava za nosečnice ni znan, zato je uporaba zdravila AMMONAPS v nosečnosti kontraindicirana (glejte poglavje 4.3).
The significance of these data in pregnant women is not known; therefore the use of PHEBURANE is contra-indicated during pregnancy (see section 4.3).
Pomen tega pojava za nosečnice ni znan, zato je uporaba zdravila PHEBURANE v nosečnosti kontraindicirana (glejte poglavje 4.3).
The significance of this finding is unknown.
Ni znano, ali je bil ta izsledek posledica učinkov zdravila na samce in/ali na samice.
The significant dose related cortisol suppression noticed during therapy is a result of effective doses suppressing the hypothalamo-pituitreal adrenal axis.
Precejšnje znižanje ravni kortizola, povezano z odmerkom, ki so ga opazili med zdravljenjem, povzročijo terapevtski odmerki, ki zavirajo os hipotalamus–hipofiza–nadledvična žleza.
The significant increase in triglycerids noticed can be a part of possible iatrogenic hyperadrenocorticism (Cushings disease) involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in body weight, muscle weakness and wastage and osteoporosis may result.
Opaženo precejšnje zvišanje ravni trigliceridov je lahko del možnega iatrogenega hiperadrenokorticizma (Cushingove bolezni), za katerega so značilne precejšnje spremembe v presnovi maščob, ogljikovih hidratov, beljakovin in mineralov; pojavijo se lahko na primer prerazporeditev telesnih maščob, povečanje telesne mase, šibkost mišic in zmanjšanje mišične mase ter osteoporoza.
The significant increase in triglycerids noticed can be a part of possible iatrogenic hyperadrenocorticism (Cushing’s disease) involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in body weight, muscle weakness and wastage and osteoporosis may result.
Opaženo precejšnje zvišanje ravni trigliceridov je lahko del možnega iatrogenega hiperadrenokorticizma (Cushingove bolezni), za katerega so značilne precejšnje spremembe v presnovi maščob, ogljikovih hidratov, beljakovin in mineralov; pojavijo se lahko na primer prerazporeditev telesnih maščob, povečanje telesne mase, šibkost mišic in zmanjšanje mišične mase ter osteoporoza.
The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia.
Pričakovati je, da bodo znaki in simptomi akutnega prevelikega odmerjanja pretirani farmakološki učinki: zvišanje koncentracij natrija v serumu, poliurija, žeja in dehidracija/hipovolemija.
The signs and symptoms of hypoglycaemia.
Znaki in simptomi hipoglikemije.
The signs and symptoms of infection and the need to report these immediately to the prescriber during and up to two months after treatment with GILENYA.
Opis znakov in simptomov okužbe in pomembnost takojšnjega obveščanja lečečega zdravnika, če pride do njih v času zdravljenja in še najmanj dva meseca po prekinitvi zdravljenja z zdravilom GILENYA.
The signs and symptoms of liver problems include:
Znaki in simptomi težav z jetri so:
The signs and symptoms of Peyronie’s disease are caused by a collagen plaque.
Znaki in simptomi Peyroniejeve bolezni so posledica kolagenskega plaka.
the signs and symptoms of sepsis/severe infection and what action to take
znake in simptome sepse/resne okužbe in kaj morajo storiti v takem primeru,
The signs include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Med njenimi znaki so hitro izgubljanje telesne mase, slabost ali bruhanje, bolečine v trebuhu, hitro in globoko dihanje, zaspanost, sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja.
The signs include rapid weight loss, feeling sick or being sick;
Znaki vključujejo hitro izgubljanje telesne mase, občutek siljenja na bruhanje ali bruhanje;
The signs include shortness of breath and pain in the chest or in the legs.
Znaki vključujejo zasoplost in bolečino v prsih ali nogah.
The signs include unusual bruising or bleeding (see section 2).
Znaki vključujejo neobičajne modrice ali krvavitve (glejte
The signs include:
Znaki vključujejo:
The signs may include reddening, unusually intense pain on injection, itching, hives, swelling or inflammation.
Znaki so lahko pordelost, nenavadno močna bolečina pri injiciranju, srbenje, koprivnica, otekanje ali vnetje.
The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Znaki so lahko pordelost, nenavadno močna bolečina pri injiciranju, srbenje, koprivnica, otekanje ali vnetje.
The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives).
Znaki lahko vključujejo otekanje ustnic, obraza, jezika ali žrela, oteženo dihanje ali kolaps, lahko opazite tudi srbeč izbokel izpuščaj (koprivnico).
The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Znaki lahko vključujejo: izpuščaj, težko požiranje ali dihanje, otekanje ustnic, obraza, grla in jezika.
The signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (signs include paleness and coldness of skin, rapid heartbeat), feeling dizzy and sweating.
Med znaki so lahko koprivnica, srbečica, otekanje, težave pri dihanju, nizek krvni tlak (bledost in hladnost kože, pospešen srčni utrip), vrtoglavica in potenje.
The signs of dehydration are not specific, but may include:
Znaki dehidracije niso specifični, vendar lahko vključujejo:
The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements
občutkom slabosti (navzeo) in bruhanjem poslabšanje znakov Parkinsonove bolezni ali pojav podobnih znakov, na primer togih mišic ali težav pri izvajanju gibov
The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements
Poslabšanje znakov Parkinsonove bolezni ali pojav podobnih znakov – na primer togih mišic ali težav pri izvajanju gibov
The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, difficulty in carrying out movements and muscle weakness
Poslabšanje znakov Parkinsonove bolezni ali pojav podobnih znakov – na primer togih mišic ali težav pri izvajanju gibov in mišične šibkosti
The signs of urinary tract infection are:
Znaki okužbe sečil so:
The signs or symptoms of bleeding and when to seek attention
o znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč;
The signs or symptoms of bleeding and when to seek attention from a healthcare provider
znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč,
The signs, symptoms and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 Management of bleeding).
Znaki, simptomi in resnost (vključno s smrtnim izidom) so odvisni od mesta, stopnje ali obsežnosti krvavitve in/ali anemije (glejte poglavje 4.9 Ukrepi pri krvavitvah).
The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18 % (95 %CI: 2 % to 32 %) and 27 % (95 %CI: 14 % to 39 %), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2 %).
Tako v skupini, ki je prejemala srednji odmerek, kot tudi v skupini, ki je prejemala velik odmerek sildenafila, so ugotovili zmanjšanje žilnega upora v pljučih v primerjavi s placebom, in sicer za 18 % (95 % IZ: 2 % do 32 %) oziroma 27 % (95 % IZ: 14 % do 39 %); medtem ko v skupini, ki je prejemala majhen odmerek, niso opazili nobene pomembne razlike v primerjavi s placebom (razlika v obsegu 2 %).
The Sileo oral syringe is capable of delivering the product in 0.25 ml increments.
Z oralno brizgo za zdravilo Sileo se lahko zdravilo odmerja v korakih po 0,25 ml.
The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Podobnosti v vzorcu malformacij, ki so jih opazili pri drugih antagonistih receptorjev ET in pri ET “knock-out” miših, kažejo, da gre za učinek skupine zdravil.
The simultaneous oral administration of 10 mg of Rapamune oral solution and 120 mg of diltiazem significantly affected the bioavailability of sirolimus.
Sočasna uporaba 10 mg peroralne raztopine zdravila Rapamune in 120 mg diltiazema bistveno spremeni biološko uporabnost sirolimusa.
The single and multiple dose pharmacokinetics of vedolizumab have been studied in healthy subjects and in patients with moderate to severely active ulcerative colitis or Crohn’s disease.
Farmakokinetiko enkratnega in ponavljajočih se odmerkov vedolizumaba so raziskali pri zdravih osebah in bolnikih z zmerno do močno aktivnim ulceroznim kolitisom ali Crohnovo boleznijo.
The single dose pharmacokinetic parameters of NovoEight are listed in Table 4 for the clotting assay and in Table 5 for the chromogenic assay.
Farmakokinetični parametri enkratnega odmerka zdravila NovoEight s preizkusom strjevanja so našteti v preglednici 4, s kromogenim preizkusom pa v preglednici 5.
The single injection will be
Ena injekcija bo vsebovala
The single- dose pharmacokinetics of aripiprazole was linear and dose-proportional.
Farmakokinetika posamičnih odmerkov aripiprazola je bila linearna in sorazmerna odmerku.