natgillin/translations-raw huggingface dataset:
No data are available for H2- receptor antagonists in combination with tipranavir and low dose ritonavir.
Zaenkrat ni podatkov o kombinaciji antagonistov receptorjev H2 in tipranavirja z majhnimi odmerki ritonavirja.
No data are available for hepatic transplant patients with severe chronic renal impairment.
Za bolnike z jetrnim presadkom in hudo ledvično okvaro podatki niso znani.
No data are available for NovoMix 30 in children below 6 years of age.
Za uporabo zdravila NovoMix 30 pri otrocih do 6. leta starosti podatkov ni na voljo.
No data are available for paediatric cardiac transplant patients.
Za otroke s srčnim presadkom podatki niso znani.
No data are available for paediatric cardiac transplant patients.
Za otroke s srčnim presadkom podatkov ni.
No data are available for paediatric hepatic transplant patients.
Za otroke in mladostnike z jetrnim presadkom podatki niso znani.
No data are available for paediatric hepatic transplant patients.
Za otroke in mladostnike z jetrnim presadkom podatkov ni.
No data are available for these patients.
Podatkov za te bolnike ni na voljo.
No data are available from clinical studies of Odefsey in HIV-1 infected patients.
Ni podatkov iz kliničnih študij zdravila Odefsey pri bolnikih, okuženih z virusom HIV-1.
No data are available in children below 3 years of age.
Podatkov pri otrocih, mlajših od 3 let ni na voljo.
No data are available in children below the age of 2 years.
Podatki niso na voljo pri otrocih, mlajših od 2 let.
No data are available in children under the age of 8 months.
Podatkov za otroke, mlajše od 8 mesecev, ni na voljo
No data are available in elderly people treated with Latuda 148 mg.
Pri starostnikih ni podatkov o uporabi zdravila Latuda v odmerku 148 mg.
No data are available in humans regarding overdose by accidental or deliberate ingestion.
Podatkov o prevelikem odmerjanju zdravila zaradi nezgodnega ali namernega zaužitja pri človeku ni.
No data are available in older children (see sections 4.8 and 5.1) Method of administration
Podatki za starejše otroke niso na voljo (glejte poglavji 4.8 in 5.1) Način uporabe
No data are available in patients with a creatinine clearance below 10 ml/min.
Za bolnike z očistkom kreatinina, manjšim od 10 ml/min ni podatkov.
No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Za bolnike s hudo okvaro jeter (razred C po Child-Pughu) ni podatkov.
No data are available in patients with severe hepatic impairment.
Za bolnike s hudo okvaro jeter podatkov ni na voljo.
No data are available in subjects with severe hepatic impairment (Child-Pugh class C).
Podatki o bolnikih s hudo okvaro jeter (Child–Pugh razred C) niso na voljo.
No data are available on administration of pomalidomide to paediatric or adolescent patients (< 18 years of age).
Podatki o dajanju pomalidomida pediatričnim ali mladostniškim bolnikom (< 18 let starosti) niso na voljo.
No data are available on concomitant use of ticagrelor with other active substances that also are potent P-gp inhibitors and moderate CYP3A4 inhibitors (e.g. verapamil, quinidine) that also may increase ticagrelor exposure.
Ni podatkov o sočasni uporabi ticagrelorja z drugimi zdravilnimi učinkovinami, ki so prav tako močni zaviralci P-gp in zmerni zaviralci CYP3A4 (npr. verapamil, kinidin) in lahko prav tako povečajo izpostavljenost ticagrelorju.
No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving Ilaris.
O vplivu na cepljenje z živimi cepivi ali na sekundarni prenos okužb z živimi cepivi pri bolnikih, ki so prejemali zdravilo Ilaris, ni podatkov.
No data are available on male and female fertility as well as on peri- and postnatal development.
Podatkov o plodnosti pri samcih in samicah ter o peri- in postnatalnem razvoju ni.
No data are available on neurodevelopment.
O nevrološkem razvoju ni podatkov.
No data are available on patients with severe (CLCR < 30 mL/min) renal impairment or end-stage renal disease.
Za bolnike s hudo ledvično okvaro ali odpovedjo ledvic (očistek kreatinina < 30 ml/min) ni podatkov.
No data are available on re-treating actinic keratoses that have cleared after one or two courses of treatment and subsequently recur, and any such use is therefore not recommended.
Ni podatkov o ponovnem zdravljenju aktiničnih keratoz, ki so se pojavile potem, ko so izginile po enem ali dveh postopkih zdravljenja, zato uporaba imikvimod kreme v takšnih primerih ni priporočljiva.
No data are available on re-treating actinic keratosis that have cleared after two cycles of treatment and subsequently recur.
Ni podatkov o ponovnem zdravljenju aktiničnih keratoz, ki so se pojavile potem, ko so že izginile po dveh ciklusih zdravljenja.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Podatki o uporabi TMZ pri bolnikih s hudo okvaro jeter (razred C po Child- Pughu) ali okvaro ledvic niso na voljo.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child’s Class C) or with renal impairment.
O uporabi TMZ pri bolnikih s hudo okvaro jeter (razred C po Childu) ali okvaro ledvic ni podatkov.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child’s Class C) or with renal impairment.
Podatki o uporabi TMZ pri bolnikih s hudo jetrno okvaro (razred C po Child-u) ali ledvično okvaro niso na voljo.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child’s Class C) or with renal impairment.
Podatki o uporabi TMZ pri bolnikih s hudo jetrno okvaro (razred C po Childu) ali ledvično okvaro, niso na voljo.
No data are available on the concomitant use of nitromidazoles with Teysuno in combination with cisplatin.
Podatki o sočasni uporabi nitroimidazolov in zdravila Teysuno v kombinaciji s cisplatinom niso na voljo.
No data are available on the effect of azilsartan medoxomil on human fertility.
Podatkov o vplivu medoksomilazilsartanata na plodnost pri ljudeh ni.
No data are available on the effect of Ipreziv on human fertility.
Podatkov o vplivu zdravila Ipreziv na plodnost pri ljudeh ni.
No data are available on the efficacy of ellaOne when taken more than 120 hours (5 days) after unprotected intercourse.
Na voljo ni podatkov o učinkovitosti zdravila ellaOne pri ženskah, ki so ga zaužile več kot 120 ur (5 dni) po nezaščitenem spolnem odnosu.
No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years).
Podatki o varnosti in učinkovitosti zdravila BindRen pri otrocih in mladostnikih niso razpoložljivi (starih manj kot 18 let).
No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
Ni podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki prejemajo zdravilo Enbrel.
No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept.
Ni podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki prejemajo etanercept.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih z zdravilom Humira, ni.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Trudexa.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih s Trudexo, ni.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ORENCIA.
Podatkov o sekundarnem prenosu okužbe z oseb, ki so bile cepljene z živimi cepivi na bolnike, ki prejemajo zdravilo ORENCIA, ni na voljo.
No data are available on the use of deferiprone in HIV positive or in other immune-compromised patients.
Ni podatkov o uporabi deferiprona pri bolnikih, ki so HIV pozitivni oziroma imajo drugače prizadet imunski sistem.
No data are available on the use of Rilonacept Regeneron in children with CAPS under 12 years of age, therefore it is not recommended in this paediatric age group.
O uporabi zdravila Rilonacept Regeneron pri otrocih s CAPS, mlajših od 12 let, podatkov ni na voljo, zato ga za to starostno skupino otrok ne priporočajo.
No data are available that can be used to exclude the risk that lenvatinib could be an inducer of CYP3A4 or P-gp in the gastrointestinal tract.
Podatkov, ki bi jih lahko uporabili zato, da bi izključili tveganje, da bi lenvatinib lahko induciral CYP3A4 ali P-gp v prebavilih, ni na voljo.
No data are available to assess the potential influence of BindRen on fertility.
Podatkov za oceno možnega vpliva zdravila BindRen na sposobnost razmnoževanja ni.
No data are available to assess the safety and efficacy in pregnant women.
Podatkov za oceno varnosti in učinkovitosti pri nosečnicah ni.
No data are available to evaluate whether Episalvan is excreted into human milk.
Ni na voljo podatkov, iz katerih bi ugotovili, ali se zdravilo Episalvan izloča v materino mleko.
No data are available to make a dose recommendation.
Ker podatkov ni na voljo, ne moremo podati priporočila glede
No data are available to make recommendations on the use of atazanavir/cobicistat or darunavir/cobicistat with combined or progestagen-only oral or implanted contraceptives.
Podatkov za priporočila o uporabi atazanavirja/kobicistata ali darunavirja/kobicistata s kombiniranimi ali samo progestagenskimi peroralnimi ali vsajenimi kontraceptivi ni na voljo.
No data are available with regard to overdose of Eucreas.
Podatkov o primerih prevelikega odmerjanja zdravila Eucreas ni.
No data are available with regard to overdose of Glubrava.
Podatki glede prevelikega odmerjanja zdravila Glubrava niso na voljo.
No data are available with regard to overdose of Jentadueto.
O prevelikem odmerjanju zdravila Jentadueto ni podatkov.
No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Podatkov o sildenafilu pri bolnikih s pljučno arterijsko hipertenzijo, povezano s pljučno venookluzivno boleznijo, ni.
No data are available, therefore, the combination of boceprevir with these medicines is not-recommended (see section 4.4).
Podatkov ni na voljo, zato kombinacija boceprevirja in teh zdravil ni priporočljiva (glejte poglavje 4.4).
No data are available.
Podatki niso na voljo (glejte poglavji 4.2 in 5.2).
No data are available.
Podatkov ni na voljo..
No data are available. (see section 5.1 and 5.2).
Podatki niso na voljo (glejte poglavji 5.1 in 5.2).
No data are available. (see section 5.1 and section 5.2).
Podatki niso na voljo (glejte poglavji 5.1 in 5.2).
No data are available. b In case of delay, the booster should not be given later than 24 months. c See section 5.1. The need for, and timing of, further booster doses has not yet been determined. d See section 5.1.
Podatkov ni na voljo. b V primeru zamika poživitvenega odmerka ne smete dati pozneje kot pri 24 mesecih. c Glejte poglavje 5.1. Potreba po nadaljnjih poživitvenih odmerkih in ustrezni čas zanje še nista ugotovljena. d Glejte poglavje 5.1.
No data are currently available from clinical studies with Atripla in treatment-naïve or in heavily pretreated patients.
Podatkov iz kliničnih študij z zdravilom Atripla pri bolnikih, ki se še niso zdravili ali pa so se zdravili že z veliko zdravili, trenutno ni na voljo.
No data are currently available on interactions of tipranavir, co- administered with low dose ritonavir, with protease inhibitors other than those listed above.
Za zdaj ni na voljo podatkov o interakcijah tipranavirja ob hkratnih majhnih odmerkih ritonavirja z drugimi zaviralci proteaze.
No data are currently available on interactions of tipranavir, co-administered with low dose ritonavir, with protease inhibitors other than those listed above.
Zaenkrat ni podatkov o medsebojnem delovanju tipranavirja, ob hkratnih majhnih odmerkih ritonavirja, z drugimi zaviralci proteaze, razen navedenimi.
No data available (see section 5.2).
Podatkov ni na voljo (glejte poglavje 5.2).
No data available.
Podatki niso na voljo.
No data exist regarding the possible effects of FLUENZ on male and female fertility.
Podatkov o morebitnem vplivu cepiva FLUENZ na plodnost pri moških in ženskah ni.
No data exist regarding the possible effects of Pandemic influenza vaccine H5N1 MedImmune on male and female fertility.
O možnih vplivih Cepiva proti pandemski gripi H5N1 MedImmune na plodnost moških in žensk ni podatkov.
No data exist regarding the safety of intranasal administration of Pandemic influenza vaccine H5N1 MedImmune in children with unrepaired craniofacial malformations.
Podatkov o varnosti intranazalne uporabe Cepiva proti pandemski gripi H5N1 MedImmune pri otrocih z nepopravljenimi kraniofacialnimi malformacijami ni.
No data from animal studies with netupitant are available regarding placental transfer and lactation.
Podatkov iz živalskih študij z netupitantom o prehajanju skozi placento in laktaciji ni.
No data have been generated with Foclivia in pregnant women.
Podatkov o uporabi zdravila Foclivia pri nosečnicah ni.
No data in humans are available on excretion of empagliflozin into milk.
Podatkov o izločanju empagliflozina v mleko pri ljudeh ni.
No data is available
Nobenih podatkov ni na voljo.
No data is available for patients weighing 140 kg and more.
Za bolnike s telesno maso 140 kg ali več podatki niso na voljo.
No data is available in the event of an overdose.
Podatkov o prevelikem odmerjanju ni.
No data is available of the effect of Intrinsa on fertility.
Ni podatkov o vplivu zdravila Intrinsa na sposobnost razmnoževanja.
No data is available of the effect of Livensa on fertility.
Ni podatkov o vplivu zdravila Livensa na sposobnost razmnoževanja.
No data is available on safety in lactating animals.
Podatkov glede varnosti pri živalih v laktaciji ni.
No data is available on safety in lactating animals.
Varnost cepiva v obdobju laktacije ni bila ugotovljena.
No data is available regarding the safety of febuxostat during cytotoxic therapy.
Podatkov o varnosti uporabe febuksostata med zdravljenjem s citotoksini ni.
No data is available that can be used to exclude the risk that lenvatinib could be an inducer of CYP3A4 or Pgp in the gastrointestinal tract.
Podatkov, ki bi jih lahko uporabili zato, da bi izključili tveganje, da bi lenvatinib lahko spodbujal CYP3A4 ali Pgp v prebavilih, ni na voljo.
No data is available.
Podatki niso na voljo.
No data on antibody persistence are currently available.
Podatki o prisotnosti protiteles trenutno niso na voljo.
No data on cardiovascular mortality and morbidity are available for aliskiren in patients with heart failure (see section 5.1).
Pri uporabi aliskirena pri bolnikih s srčnim popuščanjem ni na voljo nobenih podatkov glede kardiovaskularne umrljivosti in obolevnosti (glejte poglavje 5.1).
No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Podatki o sočasnem dajanju cepiva Ambirix in specifičnih imunoglobulinov proti hepatitisu A ali imunoglobulinov proti hepatitisu B niso bili pridobljeni.
No data on efficacy and safety are available in adolescents below 18 years.
Podatki o učinkovitosti in varnosti pri mladostnicah do 18. leta starosti niso na voljo.
No data on fertility are available.
Podatki o plodnosti niso razpoložljivi.
No data on re-administration of Glybera are available, therefore Glybera should not be re-administered.
Podatkov o ponovni uporabi zdravila Glybera ni, zato se zdravilo Glybera ne sme ponovno uporabiti.
No data on the effect of catumaxomab on fertility are available.
Podatkov o učinkih katumaksomaba na plodnost ni.
No data on the interaction of rufinamide with alcohol are available.
O medsebojnem delovanju rufinamida z alkoholom podatkov ni na voljo.
No data on the pharmacokinetics of eluxadoline in patients with renal impairment are available (see section 5.2).
O farmakokinetiki eluksadolina pri bolnikih z okvaro ledvic ni na voljo nobenih podatkov (glejte poglavje 5.2).
No data on the possible effect of this medicinal product on male and female fertility are available.
Podatki o možnih učinkih tega zdravila na plodnost samcev in samic niso na voljo.
No data were available from patients with severe renal impairment (CLcr 15-29 mL/min).
Podatki o bolnikih s hudo okvaro ledvic (CLcr 15–29 ml/min) niso bili na voljo.
No deaths resulted from these events, and none of the hospitalized children required mechanical ventilation or admission to an intensive care unit.
Smrti zaradi teh dogodkov ni bilo in noben otrok, sprejet v bolnišnico, ni potreboval mehanične ventilacije ali sprejema na oddelek za intenzivno nego.
No decline (FVC change >0%)
Ni zmanjšanja (sprememba forsirane vitalne kapacitete > 0 %)
No decrease in OCS/lack of asthma control/ withdrawal from treatment
Brez zmanjšanja PKS/odsotnost urejenosti astme/umik iz zdravljenja
No dedicated clinical studies have been conducted to evaluate pharmacokinetics of lenalidomide in the elderly.
Posebnih kliničnih študij za ocenjevanje farmakokinetike lenalidomida pri starejših niso opravili.
No dedicated hepatic impairment study has been conducted with ONIVYDE.
Z zdravilom ONIVYDE niso izvedli posebne študije pri jetrni okvari.
No dedicated pharmacokinetic studies have been completed in patients with hepatic impairment (see section 4.4).
Namenskih farmakokinetičnih študij pri bolnikih z okvaro jeter niso izvedli (glejte poglavje 4.4).
No dedicated renal impairment study has been conducted with ONIVYDE.
Z zdravilom ONIVYDE niso izvedli posebne študije pri ledvični okvari.
No dedicated renal impairment trial for Perjeta has been conducted.
Posebne študije za zdravilo Perjeta pri bolnikih z ledvično okvaro niso izvedli.
No definite interactions between DepoCyte delivered intrathecally and other medicinal products have been established.
Med intratekalno uporabljenim zdravilom DepoCyte in drugimi zdravili niso bile ugotovljene interakcije.
No definitive conclusion can be drawn on the benefit/risk balance.
O razmerju med koristmi in tveganji zdravila ne moremo dokončno sklepati.
No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study, but given the lack of binding of vedolizumab to male reproductive tissue in monkey and human, and the intact male fertility observed in β7 integrin-knockout mice, it is not expected that vedolizumab will affect male fertility.
Dokončnega zaključka o vplivu na moške reproduktivne organe na osnovi študije toksičnosti pri ponavljajočih se odmerkih pri opicah Cynomolgus ni mogoče podati, vendar pa zaradi odsotnosti vezave vedolizumaba na moško reproduktivno tkivo pri opicah in človeku in ohranjeni plodnosti samcev, opaženi pri miših z izbitim genom za integrin β7 (“β7 integrin-knockout mice”), vpliva vedolizumaba na moško plodnost ne pričakujemo.
No definitive recommendation on dosage reduction is possible in patients with mild hepatic impairment due to the substantial variability of abacavir exposure.
Zaradi znatne variabilnosti v izpostavljenosti abakavirju pri bolnikih z blago jetrno okvaro ni mogoče podati dokončnih priporočil o zmanjšanju odmerka.
No detrimental effects on such activities are predicted from the pharmacology of Benlysta.
Glede na farmakologijo zdravila Benlysta ni pričakovati škodljivih učinkov na takšne dejavnosti.
No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
Pri izpostavljenosti, ki je bila glede na AUC0-24 ur 3,4-kratna izpostavljenost kot pri človeku, ki prejema 400 mg dvakrat na dan, učinkov na razvoj niso opazili (glejte poglavje 4.6).
No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
Pri izpostavljenosti, ki je bila glede na AUC0-24ur 3,4-krat tolikšna kot izpostavljenost pri človeku med uporabo 400 mg dvakrat na dan, niso opazili učinkov na razvoj (glejte poglavje 4.6).
No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥0.9 times the AUC in patients administered the RDD).
Pri odmerku 1 mg/kg/dan (približna izpostavljenost ≥ 0,9-kratnik vrednosti AUC pri bolnikih, ki prejemajo RDD) niso opazili nobene razvojne toksičnosti.
No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined non- inferiority criterion of 1.20 (non-inferiority p = 0.02).
Ugotovili niso nobene razlike v številu presojenih dogodkov primarne končne točke za rosiglitazon (321/2220) v primerjavi s primerjalno učinkovino (323/2227) (razmerje ogroženost 0,99, 95 % IZ
No difference in the number of adjudicated primary endpoint events for rosiglitazone (321/2220) versus active control (323/2227) (HR 0.99, CI 0.85-1.16) was observed, meeting the pre-defined non- inferiority criterion of 1.20 (non-inferiority p = 0.02).
Ugotovili niso nobene razlike v številu presojenih dogodkov primarne končne točke za rosiglitazon (321/2220) v primerjavi s primerjalno učinkovino (323/2227) (razmerje ogroženost 0,99, 95 % IZ 0,85-1,16), s čimer je izpolnjeno vnaprej opredeljeno merilo neinferiornosti 1,20 (p za neinferiornost = 0,02).
No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups.
Razlik v deležih bolnikov, ki so potrebovali zdravljenje zaradi širjenja protina, v skupinah z 80 mg in 40 mg febuksostata niso opazili.
No difference was evident between the two arms as regards the proportion of patients who discontinued because of ADRs (2.5% on everolimus versus 2.6% on placebo).
Pri deležu bolnikov, ki so z zdravljenjem prenehali zaradi pojava neželenih učinkov (2,5 % pri bolnikih, ki so prejemali everolimus in 2,6 % pri bolnikih, ki so prejemali placebo) med obema skupinama ni bilo opaziti nobenih razlik.
No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
V času 2-letnega zdravljenja ni bilo razlik v incidenci in v naravi malignosti med bolniki zdravljenimi z natalizumabom in tistimi, ki so prejemali placebo.
No differences in safety or efficacy were observed between elderly ( 65 years) patients and younger patients.
Med starejšimi (≥ 65 let) bolniki in mlajšimi bolniki niso opazili nobenih razlik v varnosti in učinkovitosti.
No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Opazili niso nobenih razlik v presnovnih profilih granisetrona pri peroralni in transdermalni uporabi.
No differences were seen in the pharmacodynamic properties between adult and elderly study patients.
Med odraslimi in starejšo populacijo, zajeto v študiji, niso opazili razlik v farmakodinamičnih lastnostih.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Med odraslimi in pediatričnimi bolniki, zajetimi v študijo, niso opazili razlik v farmakodinamičnih lastnostih.
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Razlik v farmakodinamičnih lastnostih med odraslimi in pediatričnimi bolniki v študiji niso opazili.
No differences were seen in the pharmacokinetic parameters between adult and elderly study patients.
V farmakokinetičnih parametrih ni bilo opaznih razlik med odraslimi in starejšo populacijo bolnikov v študiji.
No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients.
V farmakokinetičnih parametrih ni bilo opaznih razlik med odraslimi in pediatričnimi bolniki v študiji.