natgillin/translations-raw huggingface dataset:
No clinical studies with NovoMix 70 have been carried out in children and adolescents under the age of 18 years.
Pri otrocih in mladostnikih do 18. leta starosti klinične študije z zdravilom NovoMix 70 niso bile izvedene.
No clinical studies with Toujeo have been conducted in the paediatric population.
V pediatrični populaciji ni bilo izvedenih kliničnih študij z zdravilom Toujeo.
No clinical study has been conducted to evaluate the effect of pH on dabrafenib pharmacokinetics.
Kliničnih študij za oceno vpliva pH na farmakokinetiko dabrafeniba niso izvedli.
No clinical trials have been conducted with duloxetine in paediatric populations.
Pri pediatričnih skupinah niso opravili kliničnih preskušanj z duloksetinom.
No clinical trials have been made with KIOVIG in pregnant or breast-feeding women.
Ni bilo kliničnih preskušanj z zdravilom KIOVIG pri nosečnicah ali doječih materah.
No clinical trials in subjects with a creatinine clearance <10 mL/min or in patients undergoing dialysis have been conducted.
Kliničnih preskušanj pri osebah z očistkom kreatinina < 10 ml/min ali pri bolnikih na dializi niso izvedli.
No clinically important adverse reactions were observed in healthy kittens aged 7 weeks or more, topically treated 7 times at 2 week intervals and with up to 4 times the highest recommended dose except transient oedema or dry skin at the application site.
Razen prehodnega edema ali suhe kože na mestu nanosa, ni bilo opaženih neželenih učinkov pri zdravih mladičih starih 7 tednov ali več, ki so jim dali sredstvo topikalno 7 krat v dvotedenskih razmikih in v najvišjem priporočenem odmerku.
No clinically important pharmacokinetic difference due to ethnicity has been identified.
Ni bilo identificirane klinično pomembne farmakokinetične razlike glede na etnično pripadnost.
No clinically important pharmacokinetic differences due to ethnicity have been identified.
Klinično pomembnih farmakokinetičnih razlik glede na etnično pripadnost niso ugotovili.
No clinically important pulmonary haemodynamic, systemic haemodynamic, or ECG changes were observed.
Opažene niso bile nobene klinično pomembne spremembe pljučne hemodinamike, sistemske hemodinamike ali EKG-ja.
No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
Pri večini starejših bolnikov po povečanju odmerka na 300 mg ni opaznega klinično pomembnega dodatnega znižanja krvnega tlaka.
No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
V razponu preučevane starosti (40–80) niso opazili klinično pomembnih razlik v farmakokinetiki ospemifena.
No clinically meaningful differences in safety were observed between these patients and younger patients.
Klinično pomembnih razlik v varnosti med temi in mlajšimi bolniki niso opazili.
No clinically relevant changes in dasabuvir, paritaprevir, and ombitasvir exposures (based on comparison with historical data) were observed during the co- administration.
Med sočasno uporabo niso opazili klinično pomembnih sprememb izpostavljenosti dasabuvirju, paritaprevirju in ombitasvirju (na podlagi primerjave historičnih podatkov).
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose ketoconazole and erythromycin interaction trials.
V preskušanjih medsebojnih delovanj z večkratnimi odmerki ketokonazola in eritromicina niso ugotovili klinično pomembnih sprememb koncentracije desloratadina v plazmi.
No clinically relevant changes in desloratadine plasma concentrations were observed in multiple-dose, ketoconazole and erythromycin interaction trials.
V kliničnih preskušanjih interakcij s ketokonazolom ali eritromicinom niso opažali nobenih klinično pomembnih sprememb plazemske koncentracije desloratadina pri večkratnem odmerjanju.
No clinically relevant differences in aprepitant pharmacokinetics is expected due to age and gender.
Klinično pomembnih razlik v farmakokinetiki aprepitanta zaradi starosti ali spola ne pričakujemo.
No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between patients with moderate impairment and healthy subjects.
Klinično pomembnih razlik v farmakokinetičnih lastnostih elvitegravirja ali kobicistata med bolniki z zmerno jetrno okvaro in zdravimi osebami niso opazili.
No clinically relevant differences in elvitegravir, cobicistat, tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 but < 30 mL/min) in studies of cobicistat-boosted elvitegravir or of tenofovir alafenamide, respectively.
Klinično pomembnih razlik v farmakokinetičnih lastnostih elvitegravirja, kobicistata, alafenamidtenofovirata ali tenofovirja med zdravimi osebami in bolniki s hudo ledvično okvaro (ocenjeni CrCl > 15, toda < 30 ml/min) v študijah z elvitegravirjem, ojačanim s kobicistatom, oz. z alafenamidtenofoviratom, niso opazili.
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and subjects with severe renal impairment (estimated CrCl from 15 to < 30 mL/min) in studies of cobicistat-boosted elvitegravir or of tenofovir alafenamide, respectively.
Klinično pomembnih razlik v farmakokinetičnih lastnostih alafenamidtenofovirata ali tenofovirja med zdravimi osebami in bolniki s hudo ledvično okvaro (ocenjeni CrCl od 15 do < 30 ml/min) v študijah s elvitegravirjem, ojačanim s kobicistatom, oz. z alafenamidtenofoviratom, niso opazili.
No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Med moškimi in ženskami niso opažali klinično pomembnih razlik v farmakokinetiki rilpivirina.
No clinically relevant drug interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Klinično pomembnih interakcij med zdravilom SANCUSO in emetogenimi kemoterapevtiki za zdravljenje raka niso ugotovili.
No clinically relevant drug-drug interaction is expected.
Klinično pomembnih interakcij med zdravili ni pričakovati.
No clinically relevant drug-drug interaction is expected.
Ni pričakovati klinično pomembnih medsebojnih delovanj.
No clinically relevant drug-drug interaction is expected.
Pričakuje se pomembno
No clinically relevant drug-drug interaction was observed when simvastatin and Entresto were co- administered.
Pri sočasni uporabi simvastatina in zdravila Entresto niso opažali nobenih klinično pomembnih interakcij.
No clinically relevant drug-drug interaction was observed when simvastatin and Neparvis were co- administered.
Pri sočasni uporabi simvastatina in zdravila Neparvis niso opažali nobenih klinično pomembnih interakcij.
No clinically relevant ECG morphological changes following administration of amifampridine phosphate were observed in a study of healthy volunteers (see section 5.1).
Po dajanju amifampridinfosfata v študiji z zdravimi prostovoljci niso opazili nobenih klinično pomembnih morfoloških sprememb EKG-ja (glejte poglavje 5.1).
No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the population pharmacokinetic analysis.
Populacijska farmakokinetična analiza ni pokazala, da bi starost klinično pomembno vplivala na farmakokinetiko enzalutamida.
No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl estradiol are co-administered with Possia.
Med sočasno uporabo levonorgestrela in etinilestradiola z zdravilom Possia ni pričakovati klinično pomembnega vpliva na učinkovitost peroralnih kontraceptivov.
No clinically relevant effect was observed during steady-state lithium exposure following co- administration with multiple doses of vortioxetine in healthy subjects.
Klinično pomembnega učinka niso opazili v dinamičnem stanju izpostavljenosti litiju po sočasni uporabi večkratnih odmerkov vortioksetina pri zdravih osebah.
No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials.
Pri kliničnih preskušanjih niso opazili klinično pomembnih učinkov na delovanje srca in krvni tlak.
No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Med sočasno uporabo tablet posakonazola in antacidov, antagonistov receptorjev H2 in zaviralcev protonske črpalke niso opazili klinično pomembnih učinkov.
No clinically relevant ethnic differences among Caucasians, Afrian-American, Hispanic, Japanese or Chinese patients were observed.
Med belci, Afroameričani, Latinoameričani, Japonci ali Kitajci ni bilo klinično pomembnih razlik.
No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Med belci, Afroameričani, Latinoameričani, Japonci ali Kitajci ni bilo klinično pomembnih razlik.
No clinically relevant gender differences were observed in clinical studies.
V kliničnih študijah niso opazili klinično pomembnih razlik med spoloma.
No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding rivaroxaban pharmacokinetics and pharmacodynamics.
Med belci, Afroameričani, hispani, Japonci in Kitajci niso opazili klinično pomembnih medetničnih razlik v farmakokinetiki in farmakodinamiki rivaroksabana.
No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co- administered interferon alpha 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Klinično pomembnega medsebojnega delovanja bevacizumaba na farmakokinetiko sočasno danega interferona alfa-2a, erlotiniba (in njegovega aktivnega presnovka OSI-420), kemoterapevtika irinotekana (in njegovega aktivnega presnovka SN38), kapecitabina, oksaliplatina (kot je dokazano z merjenjem proste in celokupne platine) in cisplatina niso opazili.
No clinically relevant interactions have been observed when mirabegron was co-administered with therapeutic doses of solifenacin, tamsulosin, warfarin, metformin or a combined oral contraceptive medicinal product containing ethinylestradiol and levonorgestrel.
Med sočasno uporabo mirabegrona s terapevtskimi odmerki solifenacina, tamsulozina, varfarina, metformina ali kombiniranih peroralnih kontraceptivov z etinilestradiolom in levonorgestrelom niso opazili klinično pomembnih medsebojnih delovanj.
No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
V kliničnih preskušanjih sočasne uporabe tablet desloratadina ter eritromicina ali ketokonazola niso zabeležili klinično pomembnih medsebojnih delovanj (glejte poglavje 5.1).
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
Po hkratni uporabi z rosiglitazonom niso opazili klinično pomembnega medsebojnega delovanja z digoksinom, substratom CYP2C9 varfarinom in substrati CYP3A4 nifedipinom, etinilestradiolom oz. noretindronom.
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, or tenofovir alafenamide.
Za emtricitabin ali alafenamidtenofovirat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na starost, spol ali etnično pripadnost.
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide.
Za emtricitabin, rilpivirin ali alafenamidtenofovirat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na starost, spol ali etnično pripadnost.
No clinically relevant pharmacokinetic differences due to ethnicity have been identified for boosted elvitegravir.
Za ojačan elvitegravir ni bilo identificirane klinično pomembne farmakokinetične razlike glede na etnično pripadnost.
No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil fumarate.
Za elvitegravir, ojačan s kobicistatom, emtricitabin in dizoproksiltenofovirijev fumarat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na etnično pripadnost.
No clinically relevant pharmacokinetic differences due to gender have been identified for boosted elvitegravir.
Za ojačan elvitegravir ni bilo identificirane klinično pomembne farmakokinetične razlike glede na spol.
No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil fumarate.
Za elvitegravir, ojačan s kobicistatom, emtricitabin in dizoproksiltenofovirijev fumarat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na spol.
No clinically relevant pharmacokinetic differences due to gender or ethnicity have been identified for cobicistat-boosted elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide.
Za elvitegravir, ojačan s kobicistatom, kobicistat, emtricitabin ali alafenamidtenofovirat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na spol ali etnično pripadnost.
No clinically significant
Ni klinično pomembne
No clinically significant
Ni klinično pomembnih
No clinically significant alterations of either saquinavir or efavirenz concentration were noted in studies in healthy volunteers or in HIV- infected patients (see section 4.5).
V študijah z zdravimi prostovoljci ali s HIV okuženimi bolniki niso opazili klinično pomembnih sprememb v koncentracijah sakvinavirja ali efavirenza (glejte poglavje 4.5).
No clinically significant change is observed in tipranavir PK parameters.
Ni pomembne spremembe tipranavirjevih farmakokinetičnih parametrov.
No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation.
Pokazale se niso nikakršne klinično pomembne spremembe srčne frekvence, atrioventrikularnega (AV) prevajanja in repolarizacije srca.
No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarization.
Pokazale se niso nikakršne klinično pomembne spremembe srčne frekvence, atrioventrikularnega (AV) prevajanja in repolarizacije srca.
No clinically significant differences in LVMi were observed during the initial 6-month placebo-controlled period.
V začetnem šestmesečnem s placebom nadzorovanem obdobju niso bile ugotovljene nobene klinično pomembne razlike glede LVMi.
No clinically significant differences in nateglinide pharmacokinetics were observed between men and women.
Med moškimi in ženskami niso opažene klinično pomembne razlike v farmakokinetiki nateglinida.
No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine- treated and placebo-treated patients.
Pri meritvah QT, PR, QRS ali QTcB niso opažali klinično pomembnih razlik med bolniki, zdravljenimi z duloksetinom, in bolniki, ki so prejemali placebo.
No clinically significant differences were seen when the safety data were analysed by gender or race.
Pri analizi podatkov o varnosti niso opazili nobenih klinično značilnih razlik glede na spol ali raso.
No clinically significant interaction is observed.
Ni klinično pomembne
No clinically significant interaction is observed.
Ni klinično pomembne interakcijje.
No clinically significant interaction observed.
Klinično signifikantne interakcije niso opažene.
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co- administered with atenolol, nifedipine, or both atenolol and nifedipine.
Pri sočasni uporabi klopidogrela z atenololom, nifedipinom, ali z obema - atenololom in nifedipinom - niso opazili nobenih klinično pomembnih farmakodinamičnih interakcij.
No clinically significant pharmacokinetic interaction
farmakokinetičnih interakcij.
No clinically significant pharmacokinetic interaction
Ni klinično pomembnih
No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/sulfamethoxazole.
Med sirolimusom in naslednjimi učinkovinami niso opazili klinično pomembnih farmakokinetičnih interakcij: aciklovirjem, atorvastatinom, digoksinom, glibenklamidom, metilprednizolonom, nifedipinom, prednizolonom in trimetoprimom/sulfametoksazolom.
No clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with entecavir.
Pri sočasni uporabi dizoproksiltenofovirijevega fumarata in entekavirja ni bilo klinično pomembnih farmakokinetičnih interakcij.
No clinically significant reductions in glimepiride AUC and Cmax were observed after repeat doses of rosiglitazone for eight days in healthy adult subjects.
Po uporabi večkratnih odmerkov rosiglitazona pri zdravih odraslih preiskovancih v obdobju osmih dni niso ugotovili klinično pomembnega zmanjšanja AUC in Cmax glimepirida.
NO Clumps, uniformly cloudy
BREZ grudic, enakomerno motna raztopina
No Combivir dosage adjustment necessary, unless patient has renal impairment (See Section 4.2).
Prilagoditev odmerjanja zdravila Combivir ni potrebna, razen če ima bolnik okvaro ledvic (glejte poglavje 4.2).
No common adverse reactions are attributable to netupitant, the new component of the fixed combination, since their frequency was similar with oral palonosetron alone.
Nobenega od pogostih neželenih učinkov ni mogoče pripisati netupitantu, ki je nova sestavina fiksne kombinacije, saj je bila njihova pogostnost podobna kot pri peroralnem palonosetronu samem.
No comparative studies versus salmeterol/FP or versus other ICS/LABA combinations have been conducted to appropriately compare the effects of asthma exacerbations.
Primerjalnih študij s salmeterolom/FP ali drugimi kombinacijami ICS/LABA za ustrezno primerjavo vpliva na poslabšanje astme niso izvedli.
No concerns in relation to the clinical use of the product.
Ne zadevajo klinične uporabe izdelka.
No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Iz teh ugotovitev o embrio- fetalni toksičnosti ni bilo mogoče podati zaključkov o teratogenem potencialu abakavirja.
No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Iz teh ugotovitev o embrio- fetalni toksičnosti se zaključki o teratogenem potencialu abakavirja ne morejo podati.
No concurrent elevations of ALT (> 3 times the upper limit of normal [ULN]) and bilirubin (> 2 times the ULN) were observed.
Sočasno prisotnih zvišanj ravni ALT (> 3-kratnik zgornje meje normalnih vrednosti [ZMN]) in bilirubina (> 2-kratnik ZMN) niso opažali.
No consistent effect was seen with cyclophosphamide after netupitant co- administration.
Pri ciklofosfamidu po sočasnem dajanju netupitanta niso opazili konsistentnih učinkov.
No consistent inhibition of any transporter was observed with the exception of BCRP, which was inhibited by tedizolid.
Pri nobenem prenašalcu niso opazili doslednega zaviranja, razen pri prenašalcu BCRP, ki ga je tedizolid zaviral.
No controlled clinical data are available on the use of Rasilez HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi zdravila Rasilez HCT ni na voljo podatkov iz kontroliranih kliničnih študij.
No controlled clinical data are available on the use of Rasilez in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi zdravila Rasilez ni na voljo podatkov iz kontroliranih kliničnih študij.
No controlled clinical data are available on the use of Riprazo HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi zdravila Riprazo HCT ni na voljo podatkov iz kontroliranih kliničnih študij.
No controlled clinical data are available on the use of Sprimeo HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi zdravila Sprimeo HCT ni na voljo podatkov iz kontroliranih kliničnih študij.
No correlation of antibody development to clinical response or adverse events was observed.
Povezave med tvorbo protiteles in kliničnim odzivom ali neželenimi učinki ni bilo.
No corresponding information is available for dogs.
Za pse ustreznih informacij ni.
No CRESEMBA dose adjustment necessary.
Prilagoditev odmerka zdravila CRESEMBA ni potrebna.
No CRESEMBA dose adjustment necessary; caution is advised as adverse drug reactions may increase.
CRESEMBA ni potrebno; potrebna je previdnost, saj se lahko neţeleni učinki zdravila povečajo.
No CRESEMBA dose adjustment necessary; caution is advised as adverse drug reactions may increase.
Prilagajanje odmerkov za zdravilo CRESEMBA ni potrebno; potrebna je previdnost, saj se lahko neţeleni učinki zdravila povečajo.
No CRESEMBA dose adjustment necessary; caution is advised as adverse drug reactions may increase.
Prilagajanje odmerkov zdravila CRESEMBA ni potrebno; potrebna je previdnost, saj se
No CRESEMBA dose adjustment necessary; caution is advised as adverse drug reactions may increase.
Prilagajanje odmerkov zdravila CRESEMBA ni potrebno; potrebna je previdnost, saj se lahko neţeleni učinki zdravila povečajo.
No cytochrome P 450 catalysed metabolism has been detected in vitro.
In vitro niso zaznali presnove preko citokroma P 450.
No cytochrome P 450 catalysed metabolism has been detected in vitro.
In vitro niso zaznali presnove preko citokroma P450.
No data
ni podatkov
No data allowing a dose recommendation for premature children (< 36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje za nedonošene otroke (<36 tednov postkoncepcijske starosti), trenutno niso na voljo.
No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje za nedonošene otroke (< 36 tednov postkoncepcijske starosti), trenutno niso na voljo.
No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje za nedonošene otroke (<36 tednov postkoncepcijske starosti), trenutno niso na voljo.
No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje, za nedonošene otroke (<36 tednov postkoncepcijske starosti), trenutno niso na voljo.
No data are available (see section 5.1 and 5.2).
Podatki niso na voljo.
No data are available .
Podatkov ni na voljo.
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 at present on reactogenicity after a second half adult (i.e.
Trenutno ni podatkov o reaktogenosti po drugi uporabi polovičnega odmerka (tj.
No data are available beyond the age of years.
Za otroke po 2. letu starosti ni podatkov.
No data are available for children below 18 years of age.
Podatkov za otroke, stare do 18 let, ni na voljo.
No data are available for children below the age of 2 months.
Podatkov pa ni na voljo za otroke, mlajše od 2 mesecev.