natgillin/translations-raw huggingface dataset:
The safety profile of co-administered alogliptin and pioglitazone was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for pioglitazone.
Varnostni profil sočasno uporabljenih alogliptina in pioglitazona je bil konsistenten s tistim pri posameznih učinkovinah, kot je bil dokazan v kliničnih preskušanjih z alogliptinom in na osnovi izčrpnih podatkov, ki so na voljo za pioglitazon.
The safety profile of Coagadex was considered satisfactory based on available data, with side effects that were manageable and of mild or moderate intensity.
Varnostni profil zdravila Coagadex je bil ocenjen za sprejemljiv glede na razpoložljive podatke in neželene učinke, ki so bili obvladljivi in ocenjeni kot blagi ali zmerni.
The safety profile of Cyramza is in line with what is expected for other medicines blocking VEGFR activity and considered manageable.
Varnostni profil zdravila Cyramza je skladen s tistim, ki ga je mogoče pričakovati pri drugih zdravilih, ki zavirajo delovanje receptorja za VEGF, in je bil ocenjen kot sprejemljiv.
The safety profile of DUTREBIS is based on the safety data from the individual components of DUTREBIS (lamivudine and raltegravir).
Varnostni profil zdravila DUTREBIS temelji na podatkih o varnosti vsake od obeh posameznih učinkovin zdravila DUTREBIS (lamivudina in raltegravirja).
The safety profile of emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat in 50 adolescent patients was similar to that in adults (see section 5.1).
Varnostni profil emtricitabina in alafenamidtenofovirata v kombinaciji z elvitegravirjem in kobicistatom pri 50 mladostnikih je bil podoben kot pri odraslih (glejte poglavje 5.1).
The safety profile of emtricitabine and tenofovir disoproxil fumarate in these studies was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Varnostni profil emtricitabina in dizoproksiltenofovirijevega fumarata v teh študijah je bil skladen s predhodnimi izkušnjami s tema učinkovinama, ko so bolniki vsako od njiju prejemali z drugimi protiretrovirusnimi zdravili.
The safety profile of emtricitabine and tenofovir disoproxil fumarate in this study was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Varnostni profil emtricitabina in dizoproksiltenofovirijevega fumarata v tej študiji je bil skladen s predhodnimi izkušnjami s tema učinkovinama, ko so bolniki vsako od njiju prejemali z drugimi protiretrovirusnimi zdravili.
The safety profile of Epclusa has been evaluated in one open-label study in which patients with CPT Class B cirrhosis received Epclusa for 12 weeks (n = 90), Epclusa + RBV for 12 weeks (n = 87) or Epclusa for 24 weeks (n = 90).
Profil varnosti zdravila Epclusa so ocenili v eni odprti študiji, v kateri so bolniki s cirozo stopnje B po CPT prejemali zdravilo Epclusa 12 tednov (n = 90), zdravilo Epclusa + RBV 12 tednov (n = 87) ali zdravilo Epclusa 24 tednov (n = 90).
The safety profile of Feraccru is considered acceptable, with side effects which are mostly mild to moderate in intensity and in line with those of other iron preparations.
Varnostni profil zdravila Feraccru velja za sprejemljivega, z večinoma blagimi do zmernimi neželenimi učinki, ki so v skladu z neželenimi učinki drugih železovih pripravkov.
The safety profile of filgrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Varnostni profil filgrastima, ki so ga opazili v teh kliničnih študijah, je bil v skladu s profilom referenčnega zdravila, ki je bilo uporabljeno v teh študijah.
The safety profile of Genvoya in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Varnostni profil zdravila Genvoya pri bolnikih z blago do zmerno ledvično okvaro je bil podoben kot pri bolnikih z normalnim delovanjem ledvic (glejte poglavje 5.1).
The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial BO22227 in EBC was overall similar to the known safety profile of the intravenous formulation.
Varnostni profil subkutane oblike zdravila Herceptin (ocenjen s podatki 298 bolnikov, zdravljenih z intravensko obliko, in 297 bolnikov, zdravljenih s subkutano obliko zdravila Herceptin) v ključnem preskušanju BO22227 pri zgodnjem raku dojk je bil celokupno podoben znanemu varnostnemu profilu intravenske oblike.
The safety profile of Ilaris appeared similar to that in patients aged 2 years and above.
Pokazalo se je, da so bile varnostne lastnosti zdravila Ilaris podobne kot pri bolnikih, ki so stari 2 leti ali več.
The safety profile of ipilimumab 3 mg/kg in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials (N= 75; treated) and in treatment-naive patients in two retrospective observational studies (N= 273 and N= 157) was similar to that in previously-treated advanced melanoma.
Pri bolnikih, ki se še niso zdravili s kemoterapijo (združeni podatki iz kliničnih preskušanj 2. in 3. faze [N= 75; zdravljeni]), in pri predhodno nezdravljenih bolnikih (podatki iz dveh retrospektivnih opazovalnih študij [N= 273 in N= 157]) je bil varnostni profil ipilimumaba v odmerku 3 mg/kg podoben kot pri bolnikih s predhodno zdravljenim napredovalim melanomom.
The safety profile of Izba seemed more favourable than that of the higher-strength solution, as side effects were less frequent with Izba.
Varnostni profil zdravila Izba je bil videti ugodnejši od profila raztopine z višjo koncentracijo, saj so bili neželeni učinki pri njem manj pogosti.
The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of docetaxel.
Varnostni profil zdravila Keytruda pri bolnikih s pljučnim rakom je podoben kot pri bolnikih z melanomom in splošno varnost je primerljiva z docetakselom.
The safety profile of LAVENTAIR is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Varnostne značilnosti zdravila LAVENTAIR temeljijo na izkušnjah z varnostjo kombinacije umeklidinij/vilanterol in s posameznima sestavinama iz programa kliničnega razvoja, ki je zajel 6.855 bolnikov s KOPB, in iz spontanega poročanja.
The safety profile of MabThera in patients with moderate to severe rheumatoid arthritis (RA) is summarized in the sections below.
Varnostni profil zdravila MabThera pri bolnikih z zelo aktivnim revmatoidnim artritisom je povzet v spodnjem besedilu.
The safety profile of maraviroc is based on 1,374 HIV-1 infected patients who has received at least one dose of maraviroc during Phase 2b/3 clinical studies.
Varnostni profil maraviroka temelji na izkušnjah pri 1.374 bolnikih, okuženih s HIV-1, ki so med kliničnimi študijami faze 2b/3 dobili vsaj en odmerek maraviroka.
The safety profile of maraviroc is based on 1,374 HIV-1 infected patients who received at least one dose of maraviroc during Phase 2b/3 clinical studies.
Varnostni profil maraviroka temelji na izkušnjah pri 1.374 bolnikih, okuženih s HIV-1, ki so med kliničnimi študijami faze 2b/3 dobili vsaj en odmerek maraviroka.
The safety profile of naltrexone / bupropion (NB) presented below is based on clinical studies performed with the fixed-dose combination (adverse reactions at an incidence of at least 0.1% and twice that of placebo).
Spodaj prikazani varnostni profil kombinacije naltrekson/bupropion (NB) temelji na kliničnih študijah, izvedenih s fiksno kombinacijo odmerkov (neželeni učinki s pojavnostjo najmanj 0,1 % in dvakrat toliko za placebo).
The safety profile of NovoEight was also considered similar to other factor VIII products.
Tudi varnostni profil zdravila NovoEight je podoben kot pri drugih zdravilih za nadomeščanje faktorja VIII.
The safety profile of Nuwiq was also considered similar to other factor VIII products.
Tudi varnostni profil zdravila Nuwiq je podoben kot pri drugih zdravilih, ki vsebujejo faktor VIII.
The safety profile of pasireotide intramuscular use was consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Varnostni profil zdravila Signifor za intramuskularno uporabo je bil podoben kot pri drugih zdravilih iz skupine analogov somatostatina, z izjemo povečane stopnje in pogostnosti hiperglikemije, ki so jo opažali pri intramuskularni uporabi pasireotida.
The safety profile of prucalopride in this 24 week study was consistent with that seen in the previous 12 week studies.
Varnostni profil zdravila Resolor v tej 24-tedenski študiji je skladen s tistim v prejšnjih, 12-tedenskih študijah.
The safety profile of Rasilamlo presented below is based on clinical studies performed with Rasilamlo and the known safety profile of the individual components aliskiren and amlodipine.
Spodaj opisane varnostne lastnosti zdravila Rasilamlo temeljijo na kliničnih študijah, ki so jih opravili z zdravilom Rasilamlo, in na znanih varnostnih lastnostih posameznih učinkovin zdravila - aliskirena in amlodipina.
The safety profile of Rasitrio presented below is based on clinical studies performed with Rasitrio and the known safety profile of the individual components aliskiren, amlodipine and hydrochlorothiazide.
Spodaj opisane varnostne lastnosti zdravila Rasitrio temeljijo na kliničnih študijah, ki so jih opravili z zdravilom Rasitrio, in na znanih varnostnih lastnostih posameznih učinkovin zdravila - aliskirena, amlodipina in hidroklorotiazida.
The safety profile of Ratiograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Varnostni profil zdravila Ratiograstim v kliničnih študij se je ujemal z varnostnim profilom referenčnega zdravila, prav tako uporabljenega v teh študijah.
The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Varnostni profil sildenafila temelji na 9570 bolnikih v 74 dvojno slepih s placebom nadzorovanih kliničnih študijah.
The safety profile of SIMBRINZA was similar to that of the individual components (brinzolamide 10 mg/mL and brimonidine 2 mg/mL).
Varnostni profil zdravila SIMBRINZA je bil podoben varnostnim profilom posameznih učinkovin (brinzolamida 10 mg/ml in brimonidina 2 mg/ml).
The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and ribavirin.
Varnostni profil simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom pri bolnikih, okuženih s HCV genotipa 1, temelji na združenih podatkih iz študij faze 2 in študij faze 3 (študije C205, C206, C208, C216 in HPC3007), v katerih je sodelovalo 924 bolnikov, ki so prejemali 150 mg simeprevirja enkrat na dan 12 tednov in 540 bolnikov, ki so prejemali placebo s peginterferonom alfa in z ribavirinom.
The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected subjects was similar to that observed in mono-infected HCV subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Profil varnosti sofosbuvirja in ribavirina pri osebah, sočasno okuženih z virusoma HCV in HIV, je bil podoben tistemu, ki so ga opazili pri osebah, okuženih samo z virusom HCV, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
The safety profile of Spedra is based on 2436 subjects exposed to avanafil during the clinical development program.
Varnostni profil zdravila Spedra temelji na podatkih 2.436 posameznikov, ki so bili izpostavljeni avanafilu med programom kliničnega razvoja zdravila.
The safety profile of Tevagrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Varnostni profil zdravila Tevagrastim v kliničnih študij se je ujemal z varnostnim profilom referenčnega zdravila, prav tako uporabljenega v teh študijah.
The safety profile of these subjects was not different from that of the general population.
Varnostne značilnosti se pri teh preiskovancih niso razlikovale od tistih v splošni populaciji.
The safety profile of Zinforo was similar to that observed in previous pooled Phase III studies with the exception of both a greater incidence of rash in Asian patients (see below) and a greater incidence of DAGT seroconversion (see section 4.4).
Varnostni profil zdravila Zinforo je bil podoben kot so ga ugotavljali kumulativno v predhodnih študijah III. faze, z izjemo večje incidence izpuščaja pri azijskih bolnikih (glejte spodaj) in večje incidence serokonverzije DAGT (glejte poglavje 4.4).
The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320).
Prikazan varnostni profil je osnovan na skupni analizi dogodkov na odmerek pri več kot 6.000 osebah, ki so bile cepljene po standarni shemi (0, 1, 6 mesec) (n=5,683) ali pospešeni shemi (0, 7, 21 dan) cepljenja (n=320).
The safety profile presented below is based on a pooled analysis on 9,621 subjects who have been vaccinated with one dose of Nimenrix in clinical studies.
Spodaj predstavljen varnostni profil temelji na kumulativni analizi podatkov 9.621 oseb, cepljenih z enim odmerkom cepiva Nimenrix v kliničnih študijah.
The safety profile presented below is based on data from approximately 800 subjects.
Prikazan varnostni profil je osnovan na pridobljenih podatkih približno 800 oseb.
The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Varnostni profil, katerega so poročali pri osebah, ki so prejele priporočeni odmerek zdravila Tamiflu za preprečevanje (75 mg enkrat na dan do 6 tednov) je kakovostno podoben tistemu, ki so ga opazili v študijah zdravljenja, kljub dolgotrajnemu odmerjanju v študijah preprečevanja.
The safety profile represented by approximately 1,500 patients for the combination of Victrelis with peginterferon alfa-2b and ribavirin was based on pooled safety data in two clinical trials: one in patients who were previously untreated, and one in patients who had failed prior therapy (see section 5.1).
Varnostni profil pri približno 1.500 bolnikih, zdravljenih s kombinacijo zdravila Victrelis, peginterferona alfa-2b in ribavirina, temelji na kumulativnih podatkih o varnosti iz dveh kliničnih preskušanj: enega pri predhodno nezdravljenih bolnikih in enega pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno (glejte poglavje 5.1).
The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable.
Varnostni profil je bil v primerjavi z drugimi oblikami zdravljenja, vključno z ipilimumabom in kemoterapijo, pozitiven, neželeni učinki pa obvladljivi.
The safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
Varnostni profil je bil na splošno podoben kot v podštudiji spremljanja neželenih učinkov študije SPS.
The safety profile was generally similar to that seen in the aprepitant table above.
Varnostni profil je bil na splošno podoben tistemu za aprepitant, ki je opisan v preglednici zgoraj.
The safety profile was similar across the different treatment populations mentioned above.
Varnostni profil pri vseh zgoraj navedenih različno zdravljenih populacijah je bil podoben.
The safety profile was similar to non-HIV infected subjects in other studies.
Varnostni profil je bil podoben kot pri s HIV neokuženih osebah iz drugih študij.
The safety profile was similar when comparing patients receiving intravenous Sivextro alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Varnostni profil je bil podoben pri bolnikih, ki so zdravilo Sivextro prejemali kot samostojno zdravljenje intravensko, in tistih, ki so zdravilo prejemali kot samostojno zdravljenje peroralno.
The safety report prepared by the Innovator MAH contained several cases very suggestive of a causal association between levetiracetam and encephalopathy.
Poročilo o varnosti, ki ga je pripravil imetnik dovoljenja za promet z inovativnim zdravilom vsebuje nekaj primerov, ki močno nakazujejo na vzročno povezavo med levetiracetamom in encefalopatijo.
The safety results for 29 paediatric patients (those  17 years old) included in the PID studies were evaluated.
Ovrednotili so rezultate varnosti pri 29 pediatričnih bolnikih (starih  17 let), ki so sodelovali v študijah PID.
The safety results for 4 paediatric patients (those  17 years old) included in the PID study and the results for the 12 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Ovrednotili so rezultate varnosti pri 4 pediatričnih bolnikih (starih  17 let), ki so sodelovali v študiji PID, in rezultate pri 12 otrocih (starih od 3 do 16 let), ki so sodelovali v študiji ITP.
The safety shield will remain in the position you set (see picture 4)
Varnostni pokrovček ostane v nastavljenem položaju (glejte sliko 4).
The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin.
Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri več kot 2.600 preiskovancih, ki so prejemali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax and dasabuvir with or without ribavirin.
Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri več kot 2.600 preiskovancih, ki so prejemali zdravili Viekirax in dasabuvir z ribavirinom ali brez njega.
The safety, efficacy and pharmacokinetics of nintedanib have not been investigated in patients with severe hepatic impairment (Child Pugh C).
Varnosti in učinkovitosti nintedaniba niso proučili pri bolnikih z jetrno okvaro, razvrščeno kot B ali C po Child Pughovi lestvici.
The safety, efficacy and population pharmacokinetics of Kuvan were studied in a multicentre, open-label, randomised, controlled study in children <4 years old with a confirmed diagnosis of PKU.
Varnost, učinkovitost in populacijsko farmakokinetiko zdravila Kuvan so preučili v multicentrični, odprti, randomizirani, nadzorovani študiji pri otrocih, starih < 4 leta, s potrjeno diagnozo PKU.
The safety, efficacy and quality of life of pazopanib versus sunitinib has been evaluated in a randomised, open-label, parallel group Phase III non-inferiority study (VEG108844).
Varnost, učinkovitost in kakovost življenja s pazopanibom v primerjavi s sunitinibom so ocenili v randomizirani, odprti študiji neinferiornosti III. faze z vzporednimi skupinami (VEG108844).
The safety, efficacy, and pharmacokinetics of ALPROLIX was evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Varnost, učinkovitost in farmakokinetiko zdravila ALPROLIX so ocenili v dveh multinacionalnih, odprtih, osrednjih študijah; v študiji faze 3, imenovani študija I, in pediatrični študiji faze 3, imenovani študija II (glejte Pediatrična populacija).
The safety, efficacy, and pharmacokinetics of ELOCTA was evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Varnost, učinkovitost in farmakokinetiko zdravila ELOCTA so ocenili v dveh multinacionalnih, odprtih, osrednjih študijah; v študiji faze 3, imenovani študija I, in pediatrični študiji faze 3, imenovani študija II (glejte Pediatrična populacija).
The safety, including potential immune responses, and effectiveness of repeated administration have not been evaluated in dogs.
Varnosti vključno z morebitnimi imunskimi reakcijami in učinkovitosti pri ponavljajočem se dajanju zdravila pri psih niso ocenili.
The safety/efficacy of mannitol in patients with asthma has not been properly studied.
Varnost in učinkovitost manitola pri bolnikih z astmo nista bili ustrezno raziskani.
The same adverse reactions may occur in the paediatric population.
Enaki neželeni učinki se lahko pojavijo pri pediatrični populaciji.
The same area of skin should not be used for two consecutive patches.
Obliža nikoli ne namestimo dvakrat zaporedno na isto mesto na koži.
The same dose adjustments, which are based on pharmacokinetic data in volunteers including PK modelling results, are recommended for patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
Za bolnike na hemodializi (HD) ali kontinuirani ambulantni peritonealni dializi (CAPD) je priporočeno enako prilagajanje odmerjanja, ki temelji na farmakokinetskih podatkih, pridobljenih pri prostovoljcih, vključno z rezultati farmakokinetskih modelov.
The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Enak odmerek je priporočen tudi za ljudi, ki so stari več kot 65 let, če njihove ledvice dobro delujejo.
The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for:
Enak postopek spremljanja kot ob prvi uvedbi zdravljenja je priporočen v primeru, da je bilo zdravljenje prekinjeno:
The same indications, dose and frequency of infusion as for adults apply for children and adolescents (0-18 years).
Za otroke in mladostnike (0–18 let) veljajo enake indikacije, odmerek in pogostnost infundiranja kot za odrasle.
The same interactions may occur in the elderly population.
Enaka medsebojna delovanja se lahko pojavijo pri starejši populaciji.
The same interactions may occur in the paediatric population.
Enaka medsebojna delovanja se lahko pojavijo pri pediatrični populaciji.
The same oral syringe should be used for all doses taken each day.
Ista peroralna brizga je namenjena za vse odmerke za vsak dan.
The same place must not be used again until two weeks later.
V prihodnjih dveh tednih se ne sme namestiti
The same proportion of subjects (3/9) receiving placebo and mepolizumab intravenously reported clinically significant exacerbations; no exacerbations were reported in those receiving mepolizumab subcutaneously.
Klinično pomembna poslabšanja je navedel enak delež preiskovancev (3/9), ki so dobivali placebo, kot tistih, ki so dobivali mepolizumab intravensko; med prejemniki mepolizumaba subkutano niso zabeležili poslabšanj.
The same recommendations apply as in adults (see above).
Uporablja se ista priporočila kot pri odraslih (glejte zgoraj).
The same recommendations apply to re- introduction of STAYVEER after treatment interruption (see section 4.4).
Enaka priporočila veljajo ob ponovni uvedbi zdravila STAYVEER po prekinitvi zdravljenja (glejte poglavje 4.4).
The same recommendations apply to re- introduction of Tracleer after treatment interruption (see section 4.4).
Enaka priporočila veljajo ob ponovni uvedbi zdravila Tracleer po prekinitvi zdravljenja (glejte poglavje 4.4).
The same recommendations apply to re-introduction of STAYVEER after treatment interruption (see section 4.4).
Enaka priporočila veljajo ob ponovni uvedbi zdravila STAYVEER po prekinitvi zdravljenja (glejte poglavje 4.4).