natgillin/translations-raw huggingface dataset:
There is no relevant use of Provenge in the paediatric population in children and adolescents less than 18 years of age in the indication of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Zdravilo Provenge ni primerno za uporabo pri pediatrični populaciji pri otrocih in mladostnikih, starih manj kot 18 let, za indikacijo asimptomatskega ali minimalno simptomatskega metastatskega (nevisceralnega), na kastracijo odpornega raka prostate pri odraslih moških, pri katerih kemoterapija še ni klinično indicirana.
There is no relevant use of PUREGON in children.
Pri otrocih zdravilo Puregon nima ustrezne uporabe.
There is no relevant use of Puregon in the paediatric population for the approved indication.
Ustrezne uporabe zdravila Puregon v pediatrični populaciji za odobreno indikacijo ni.
There is no relevant use of Raloxifene in the paediatric population.
Uporaba zdravila Raloksifen Teva ni primerna pri pediatrični populaciji.
There is no relevant use of ramucirumab in the paediatric population for the indications of advanced gastric cancer or gastro-oesophageal adenocarcinoma, adenocarcinoma of the colon and rectum and lung carcinoma.
Smotrne uporabe ramucirumaba v pediatrični populaciji za indikacijo napredovali rak želodca ali adenokarcinom gastro-ezofagealnega prehoda, adenokarcinom kolona in rektuma ter pljučni rak ni.
There is no relevant use of Relvar Ellipta in the paediatric population for the indication of COPD.
Zdravilo Relvar Ellipta ni primerno za uporabo v pediatrični populaciji za indikacijo KOPB.
There is no relevant use of Removab in the paediatric population in the granted indication.
Zdravilo Removab ni primerno za uporabo pri pediatrični populaciji za odobreno indikacijo.
There is no relevant use of Rivastigmine 1 A Pharma in the paediatric population in the treatment of Alzheimer’s disease.
V pediatrični populaciji ni ustrezne uporabe zdravila Rivastigmin 1 A Pharma za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer’s disease.
Zdravila Rivastigmin 3M Health Care Ltd. ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer’s disease.
Zdravila Rivastigmin Actavis ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of Rivastigmine HEXAL in the paediatric population in the treatment of Alzheimer’s disease.
V pediatrični populaciji ni ustrezne uporabe zdravila Rivastigmin HEXAL za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.
Rivastigmina ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.
Zdravilo Rivastigmin 1 A Pharma ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.
Zdravilo Rivastigmin HEXAL ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.
Zdravilo Rivastigmin ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.
Zdravilo Rivastigmin Sandoz ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of Rivastigmine Sandoz in the paediatric population in the treatment of Alzheimer’s disease.
V pediatrični populaciji ni ustrezne uporabe zdravila Rivastigmin Sandoz za zdravljenje Alzheimerjeve bolezni.
There is no relevant use of Seebri Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Zdravilo Seebri Breezhaler ni primerno za uporabo pri pediatrični populaciji (v starosti pod 18 let) za indikacijo KOPB.
There is no relevant use of SIFROL in the paediatric population for the indication of Parkinson’s Disease.
Zdraviloa SIFROL ni namenjeno za uporabo pri pediatrični populaciji za indikacijo Parkinsonova bolezen.
There is no relevant use of SIFROL prolonged-release tablets in the paediatric population for the indication of Parkinson’s Disease.
Zdravilo SIFROL ni namenjeno za uporabo pri pediatrični populaciji za indikacijo Parkinsonova bolezen.
There is no relevant use of Silodyx in the paediatric population in the indication.
Zdravilo Silodyx ni primerno za uporabo pri pediatrični populaciji za navedeno indikacijo.
There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction.
Zdravilo Spedra ni namenjeno za uporabo pri pediatrični populaciji za indikacijo erektilne disfunkcije.
There is no relevant use of Stivarga in children and adolescents in the indication of colon or rectal cancer that has spread to other parts of the body.
Zdravilo Stivarga ni primerno za uporabo pri otrocih in mladostnikih za indikacijo raka debelega črevesa ali danke, ki se je razširil na druge dele telesa.
There is no relevant use of Stivarga in the paediatric population in the indication of metastatic colorectal cancer.
Uporaba zdravila Stivarga za indikacijo metastatskega kolorektalnega raka ni primerna pri pediatrični populaciji.
There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.
Smotrne uporabe tadalafila pri pediatrični populaciji v zvezi z zdravljenjem erektilne disfunkcije ni.
There is no relevant use of tafamidis in the paediatric population.
Tafamidis ni namenjen uporabi pri pediatrični populaciji.
There is no relevant use of Tecfidera in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.
Zdravilo Tecfidera ni primerno za uporabo za indikacijo recidivno- remitentne multiple skleroze pri otrocih, starih manj kot 10 let.
There is no relevant use of temsirolimus in the paediatric population for the indication: treatment of renal cell carcinoma and mantle cell lymphoma.
Temsirolimus ni primeren za uporabo pri pediatrični populaciji za indikacijo: zdravljenje karcinoma ledvičnih celic in limfoma plaščnih celic.
There is no relevant use of this medicinal product in the paediatric population in the indication of prostate cancer.
Uporaba tega zdravila pri pediatrični populaciji za indikacijo raka prostate ni primerna.
There is no relevant use of Thymanax in children from birth to 2 years for treatment of major depressive episodes.
Zdravilo Thymanax ni primerno za uporabo pri otrocih, od rojstva do starosti 2 let, za zdravljenje velikih depresivnih epizod.
There is no relevant use of Urorec in the paediatric population in the indication.
Zdravilo Urorec ni primerno za uporabo pri pediatrični populaciji za navedeno indikacijo.
There is no relevant use of Valdoxan in children from birth to 2 years for treatment of major depressive episodes.
Zdravilo Valdoxan ni primerno za uporabo pri otrocih, od rojstva do starosti 2 let, za zdravljenje velikih depresivnih epizod.
There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
V pediatrični populaciji zdravilo Vectibix nima relevantne uporabe za indikacijo zdravljenja kolorektalnega raka.
There is no relevant use of VIZAMYL in the paediatric population.
Smotrne uporabe zdravila VIZAMYL pri pediatrični populaciji ni.
There is no relevant use of Xiapex in children and adolescents aged 0-18 years for the treatment of Dupuytren’s contracture or Peyronie’s disease.
Zdravilo Xiapex ni primerno za uporabo pri otrocih in mladostnikih, starih 0-18 let, za zdravljenje Dupuytrenove kontrakture ali Peyroniejeve bolezni.
There is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Dupuytren’s contracture.
Zdravilo Xiapex ni primerno za uporabo pri pediatrični populaciji, stari od 0-18 let, za zdravljenje Dupuytrenove kontrakture.
There is no relevant use of Xultophy in the paediatric population.
Uporaba zdravila Xultophy pri pediatrični populaciji ni smiselna.
There is no relevant use of ZYTIGA in the paediatric population.
Uporaba zdravila ZYTIGA pri otrocih ni smiselna.
There is no restriction on treatment with Actrapid during breast-feeding.
Omejitev za zdravljenje z zdravilom Actrapid med dojenjem ni.
There is no restriction on treatment with Protaphane during breast-feeding.
Omejitev za zdravljenje z zdravilom Protaphane med dojenjem ni.
There is no risk of becoming dependent on Selincro.
Tveganje, da bi postali odvisni od zdravila Selincro, ne obstaja.
There is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration.
Podatkov o varnosti uporabe vardenafila pri bolnikih z motnjami krvavitve ali aktivno peptično razjedo ni.
There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e., not alfa-2b).
Ni podatkov o varnosti ali učinkovitosti uporabe ribavirina z ostalimi oblikami interferonov (tj. ne alfa-2b).
There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e., not alfa-2b).
Ni podatkov o varnosti ali učinkovitosti uporabe zdravila Ribavirin skupaj z drugimi oblikami interferona (to je ne alfa-2b).
There is no significant difference in pharmacokinetic parameters between patients with moderate or severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml.min-1) and healthy volunteers after a single oral dose of 50 mg riluzole.
Po enkratnem peroralnem odmerku 50 mg riluzola ni značilnih razlik v farmakokinetičnih parametrih med bolniki z zmerno ali hudo ledvično odpovedjo (očistek kreatinina med 10 in 50 ml.min–1) in zdravimi prostovoljci.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs.
V farmakokinetiki benazeprilata ni opazne razlike, če se benazeprilijev klorid daje nahranjenim ali teščim psom.
There is no significant effect of unboosted
indinavirjem/ritonavirjem, se
There is no specific antidote for extravasation of trabectedin.
Posebnega antidota za ekstravazacijo trabektedina ni.
There is no specific antidote for levetiracetam.
Specifičnega antidota za levetiracetam ni.
There is no specific antidote for overdose of vemurafenib.
Specifičnega antidota za preveliko odmerjanje vemurafeniba ni.
There is no specific antidote for overdose with brivaracetam.
Specifičnega antidota za preveliko odmerjanje brivaracetama ni.
There is no specific antidote for overdose with Eviplera.
Specifičnega antidota za preveliko odmerjanje zdravila Eviplera ni.
There is no specific antidote for overdose with INTELENCE.
Za preveliko odmerjanje zdravila INTELENCE ni specifičnega antidota.
There is no specific antidote for overdose with maraviroc.
Specifičnega antidota za preveliko odmerjanje maraviroka ni.
There is no specific antidote for overdose with Odefsey.
Specifičnega antidota za preveliko odmerjanje zdravila Odefsey ni.
There is no specific antidote for overdose with REYATAZ.
Specifičnega antidota za preveliko odmerjanje zdravila REYATAZ ni.
There is no specific antidote for tolvaptan intoxication.
Specifičnega antidota za zastrupitev s tolvaptanom ni.
There is no specific antidote or treatment for nintedanib overdose.
Specifičnega antidota ali zdravljenja za preveliko odmerjanje nintedaniba ni.
There is no specific clinical experience in patients undergoing dialysis.
Kliničnih izkušenj pri dializno odvisnih bolnikih ni.
There is no specific experience in the management of lenalidomide overdose in multiple myeloma patients, although in dose-ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg.
V skupini bolnikov z diseminiranim plazmocitomom ni izkušenj z obravnavanjem prevelikega odmerjanja lenalidomida, čeprav so bili v študijah intervalov odmerjanja nekateri bolniki izpostavljeni odmerkom do 150 mg, v študijah z enim odmerkom pa so bili nekateri bolniki izpostavljeni odmerkom do 400 mg.
There is no specific experience in the management of lenalidomide overdose in patients, although in dose- ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg.
Ni izkušenj z obravnavanjem prevelikega odmerjanja lenalidomida pri bolnikih, čeprav so bili v študijah intervalov odmerjanja nekateri bolniki izpostavljeni odmerkom do 150 mg, v študijah z enim odmerkom pa so bili nekateri bolniki izpostavljeni odmerkom do 400 mg.
There is no specific pharmacological treatment.
Specifičnega farmakološkega zdravljenja ni.
There is no specific treatment for Torisel overdose.
Za preveliko odmerjanje zdravila Torisel ni specifičnega zdravljenja.
There is no specific treatment in the event of overdose of gefitinib.
Specifičnega zdravljenja za preveliko odmerjanje gefitiniba ni.
There is no study in patients with hepatic impairment due to cirrhosis.
Študij pri bolnikih z okvarjenim delovanjem jeter zaradi ciroze ni.
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance below 30 ml/min).
Terapevtskih izkušenj pri bolnikih s hudo okvaro ledvic (očistek kreatinina pod 30 ml/min) ni.
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use Lyxumia in these populations (see section 5.2).
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali s končno odpovedjo ledvic terapevtskih izkušenj ni, zato zdravila Lyxumia v teh populacijah ni priporočljivo uporabljati (glejte poglavje 5.2).
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
Terapevtskih izkušenj pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali s končno odpovedjo ledvic ni.
There is no therapeutic experience with Eperzan in patients with type 1 diabetes mellitus and it should not be used in these patients.
Z zdravilom Eperzan ni terapevtskih izkušenj pri bolnikih s sladkorno boleznijo tipa 1; pri teh bolnikih se ga ne sme uporabljati.
There is no therapeutic experience with ulipristal acetate in patients with hepatic impairment.
Terapevtskih izkušenj z uporabo ulipristalacetata pri bolnicah z jetrno okvaro ni.
There is not conclusive data about the possible association between SYLVANT treatment and incidence of adverse events (AEs) and serious adverse events (SAEs).
Jasnih podatkov o povezavi med zdravljenjem z zdravilom SYLVANT in pojavnostjo neželenih učinkov ter resnih neželenih učinkov ni.
There is not enough evidence to substantiate that the absence of an increased risk for toxicity seen in pre- treated women initiating nevirapine with an undetectable viral load (less than 50 copies/ml of HIV-1 in plasma) and CD4 cell counts above 250 cells/mm3 also applies to pregnant women.
Na voljo ni dovolj dokazov za trditev, da odsotnost povečanega tveganja za toksičnost pri že zdravljenih ženskah, ki imajo ob uvedbi nevirapina neizmerljivo virusno breme (manj kot 50 kopij/ml HIV-1 v plazmi) in število celic CD4 nad 250 celic/mm3 velja tudi za nosečnice.
There is not enough evidence to substantiate that the absence of an increased risk for toxicity seen in pretreated women initiating nevirapine with an undetectable viral load (less than 50 copies/ml of HIV- 1 in plasma) and CD4 cell counts above 250 cells/mm3 also applies to pregnant women.
Na voljo ni dovolj dokazov za trditev, da odsotnost povečanega tveganja za toksičnost pri že zdravljenih ženskah, ki imajo ob uvedbi nevirapina neizmerljivo virusno breme (manj kot 50 kopij/ml HIV-1 v plazmi) in število celic CD4 nad 250 celic/mm3 velja tudi za nosečnice.
There is not enough insulin in the reservoir.
Razlika je 2 enoti.
There is not enough insulin in the reservoir.
V rezervoarju ni dovolj insulina.
There is not much experience with NeoRecormon in pregnant women or women who are breast- feeding.
O uporabi zdravila NeoRecormon pri nosečnicah in doječih ženskah ni ustreznih izkušenj.
There is now a new transdermal patch “Change Day” and a new “Day 1”.
Sedaj ima nov “dan zamenjave” in nov “1. dan”.
There is now a new “Day 1” and a new “Change Day”.
Sedaj ima nov “1. dan” in nov “dan zamenjave”.
There is only limited experience in the treatment of patients with DME due to type I diabetes. diabetics with very high average blood sugar values (HbA1c over 12%). diabetics with an eye disease caused by diabetes called proliferative diabetic retinopathy.
Izkušnje so omejene pri zdravljenju bolnikov z DME zaradi sladkorne bolezni tipa I, bolnikov s sladkorno boleznijo z zelo velikimi povprečnimi vrednostmi sladkorja v krvi (HbA1c več kot 12 %), bolnikov s sladkorno boleznijo z očesno boleznijo zaradi sladkorne bolezni, imenovano proliferativna diabetična retinopatija.
There is potential for immunogenicity.
Obstaja potencial za imunogenost.
There is practically no risk of adverse effects due to accidental oral ingestion.
Tveganja za pojav neželenih učinkov pri nenamernem zaužitju praktično ni.
There is reassuring clinical experience regarding the lack of hepatitis A or Parvovirus
Obstajajo pomirjujoče klinične izkušnje o tem, da se virus hepatitisa A in parvovirus B19 ne prenašata z imunoglobulini.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Lahko štejemo, da vsebnost protiteles pomembno prispeva k zaščiti pred virusi.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Obstajajo opogumljajoče klinične izkušnje o neprenašanju virusa hepatitisa tipa A ali parvovirusa B19 z imunoglobulini in domnevajo, da vsebnost protiteles predstavlja pomemben doprinos k virološki varnosti.
There is some evidence that ellaOne may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Obstaja nekaj dokazov, da se lahko učinkovitost zdravila ellaOne zmanjša s povečano telesno maso ali indeksom telesne mase (ITM), vendar so ti podatki omejeni in nedokončni.
There is some experience of Lucentis administered concomitantly with laser photocoagulation (see section 5.1).
Obstaja nekaj izkušenj z uporabo zdravila Lucentis sočasno z lasersko fotokoagulacijo (glejte poglavje 5.1).
There is some experience of Lucentis administered concomitantly with laser photocoagulation.
Obstaja nekaj izkušenj z uporabo zdravila Lucentis sočasno z lasersko fotokoagulacijo.
There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages.
max koncentraciji kot v plazmi, kar očitno kaže na njegovo obilno kopičenje v nevtrofilcih in alveolarnih makrofagih.
There is the potential for a drug-drug interaction with other agents which are also activated by sequential phosphorylation (via intracellular phosphokinase activities) and/or metabolized by enzymes implicated in the inactivation of decitabine (e.g., cytidine deaminase).
Obstaja možnost medsebojnega delovanja zdravil z drugimi učinkovinami, ki se aktivirajo s sekvenčno fosforilacijo (z intracelularnim delovanjem fosfokinaze) in/ali presnavljajo z encimi, vpletenimi v inaktivacijo decitabina (npr. citidin deaminaza).
There is the theoretical risk that the co-administration of the immunosuppressant regime leads to longer persistence of virus DNA in serum and as well to longer shedding in saliva, urine and semen.
Obstaja teoretično tveganje, da sočasna uporaba imunosupresivnega režima povzroči daljšo persistenco DNK virusa v serumu ter daljše razsejanje v slini, urinu in spermi.
There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology.
S priporočenim odmerjanjem je zelo malo kliničnih izkušenj pri bolnikih s telesno maso nižjo od 50 kg ali višjo od 110 kg.
There is very limited clinical experience in patients with severe renal impairment (estimated GFR
Izkušenj z bolniki s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije
There is very limited experience in patients with severe renal impairment (eGFR [by CKD-EPI]
Pri bolnikih s hujšo okvaro delovanja ledvic (eGFR [po CKD-EPI] < 30 ml/min/1,73 m2 ) ali z ledvično boleznijo v zadnjem stadiju so izkušnje zelo omejene.
There is very limited experience to date with deliberate overdose.
Izkušenj z namernim prevelikim odmerjanjem je doslej zelo malo.
There is very limited experience with blinatumomab in adults weighing less than 45 kg.
Zelo so omejene izkušnje z blinatumomabom pri odraslih s telesno maso manj kot 45 kg.
There is very limited experience with the use of thrombolytic agents for the treatment of acute ischemic stroke in patients administered apixaban.
Izkušnje z uporabo trombolitičnih učinkovin za zdravljenje akutne ishemične možganske kapi pri bolnikih, ki so prejemali apiksaban, so zelo omejene.
There is very limited information on the use of NexoBrid on areas where eschar remained after the first application.
Informacij o uporabi zdravila NexoBrid na predelih, kjer so eshare ostale po prvem nanosu, je malo..
There is very limited information on the use of NexoBrid on areas where eschar remained after the first application.
Informacije o uporabi zdravila NexoBrid na predelih, kjer so eshare ostale po prvem nanosu, je malo.
There is very little experience of using Visudyne in pregnant women.
Izkušenj z uporabo zdravila Visudyne pri nosečnicah je zelo malo.
There is very little information on the use of ritonavir (the active ingredient in Norvir) during pregnancy.
O uporabi ritonavirja (zdravilne učinkovine v zdravilu Norvir) med nosečnostjo je zelo malo podatkov.
There is visible evidence of contamination, such as change in appearance.
Obstajajo vidni znaki kontaminacije, na primer sprememba videza.
There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Tveganje prirojenih okvar pri novorojenčku obstaja tudi, če ribavirin jemlje bolnik, katerga partnerica zanosi.
There may also be bleeding, ulcers, swelling in the treated area like swelling of your face or tongue, and scarring.
Lahko se pojavijo tudi krvavitve, razjede, otekline v zdravljenem predelu, na primer oteklina obraza ali jezika, in brazgotine.
There may also be changes to the patient’s eyelashes, including increased length, thickness, colour or number of lashes.
Spremenijo se lahko tudi bolnikove trepalnice: te lahko postanejo daljše ali debelejše ali se spremeni njihova barva ali število.
There may also be other effects including nausea and a skin rash, hypersensitivity reactions (breathing difficulties, hypotension, urticarial and angioedema).
Lahko se pojavijo tudi drugi učinki, vključno s slabostjo, izpuščajem na koži in preobčutljivostnimi reakcijami (težave z dihanjem, hipotenzija, urtikarija in angioedem).
There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients.
Razpon odziva na zdravljenje z FSH/LH se lahko med bolnicami razlikuje, pri nekaterih bolnicah je odziv na dajanje FSH/LH zelo majhen.
There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.
Lahko se pojavi od odmerka odvisna hipertrofija nadledvične cone glomeruloze pri visokih odmerkih.