natgillin/translations-raw huggingface dataset:
No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa- 2b on growth, development, sexual maturation, and behaviour (see section 4.4 and Rebetol SPC if Viraferon is to be administered in combination with ribavirin).
Študije za proučevanje učinkov zdravljenja z interferonom alfa-2b na rast, razvoj, spolno zorenje in vedenje živali niso bile opravljene pri mladih živalih (če boste zdravilo Viraferon uporabljali v kombinaciji z ribavirinom, glejte poglavje 4.4 in SPC za zdravilo Rebetol).
No studies have been conducted in paediatric patients.
Študij pri pediatričnih bolnikih niso izvedli.
No studies have been conducted in patients with hepatic impairment.
Študij pri bolnikih z okvarjenim delovanjem jeter niso izvajali.
No studies have been conducted in patients with renal insufficiency.
Študij pri bolnikih z ledvično insuficienco niso izvajali.
No studies have been conducted in women older than 26 years of age.
Pri ženskah, starejših od 26 let, niso izvedli nobenih študij.
No studies have been conducted to assess the impact of mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child.
Študij za oceno vpliva mirabegrona na nastajanje mleka pri človeku, njegove prisotnosti v materinem mleku pri človeku in njegovih vplivov na dojenega otroka niso izvedli.
No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin.
Študije, ki bi določile vpliv okvare jeter na farmakokinetiko mekazermina, niso bile izvedene.
No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Študij za določitev učinka TMZ na presnovo ali izločanje drugih zdravil niso izvedli.
No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Študij, s katerimi bi ugotovili učinek temozolomida na presnovo ali izločanje drugih zdravil, niso opravili.
No studies have been conducted to evaluate carcinogenicity or mutagenicity of aflibercept.
Študij za oceno kancerogenosti in mutagenosti aflibercepta niso izvedli.
No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with hepatic impairment since the systemic exposure is expected to be very low after intravitreal administration.
Študij za preučitev farmakokinetike okriplazmina pri bolnikih z okvaro jeter niso izvedli, saj je pričakovana sistemska izpostavljenost po intravitrealni uporabi zdravila nizka.
No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with renal impairment since the systemic exposure is expected to be very low after intravitreal administration.
Študij za preučitev farmakokinetike okriplazmina pri bolnikih z okvaro ledvic niso izvedli, saj je pričakovana sistemska izpostavljenost po intravitrealni uporabi zdravila nizka.
No studies have been conducted to investigate the pharmacokinetics of dabrafenib in paediatric patients.
Študij za preučitev farmakokinetike dabrafeniba pri pediatričnih bolnikih niso izvedli.
No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients.
Študij farmakokinetike olapariba pri pediatričnih bolnikih niso izvedli.
No studies have been conducted to investigate the pharmacokinetics of riociguat in paediatric patients.
Študij farmakokinetike riociguata pri pediatričnih bolnikih niso izvedli.
No studies have been conducted to investigate the pharmacokinetics of vemurafenib in paediatric patients.
Študij farmakokinetike vemurafeniba pri pediatričnih bolnikih niso izvedli.
No studies have been conducted with conversion of patients from Advagraf to Envarsus; however, data from healthy volunteers would suggest that the same conversion rate is applicable as with the conversion from Prograf to Envarsus.
Študij prehoda bolnikov z zdravila Advagraf na zdravilo Envarsus niso opravili, vendar podatki pri zdravih prostovoljcih kažejo, da velja enaka stopnja prehoda kot pri prehodu z zdravila Prograf na zdravilo Envarsus
No studies have been conducted with DuoTrav or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment.
Študije z zdravilom DuoTrav ali s timololom 5 mg/ml kapljice za oko pri bolnikih z jetrno ali ledvično okvaro niso bile opravljene.
No studies have been conducted with Translarna in patients with renal or hepatic impairment.
Študije z zdravilom Translarna pri bolnikih z okvaro ledvic ali jeter niso bile izvedene.
No studies have been conducted.
Študij niso izvedli.
No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera.
Študije, ki bi ocenjevale učinkovitost in varnost zdravila Tecfidera pri prehodu zdravljenja bolnikov z drugih zdravljenj, ki spreminjajo potek bolezni, na zdravljenje z zdravilom Tecfidera, niso bile izvedene.
No studies have been performed in paediatric patients.
Študij pri pediatričnih bolnikih niso izvajali.
No studies have been performed in paediatric patients.
Študij pri pediatričnih bolnikih niso opravili.
No studies have been performed in patients with hepatic impairment and therefore Inovelon should not be administered to patients with severe hepatic impairment(see section 4.2).
Pri bolnikih z okvarami jeter študij niso opravili, zato pri bolnikih s težkimi okvarami jeter zdravila Inovelon ne smemo uporabljati (glejte poglavje 4.2).
No studies have been performed in patients with hepatic impairment.
Pri bolnikih z jetrno okvaro študije niso bile opravljene.
No studies have been performed in patients with impaired renal function and use in such patients is not recommended (see section 4.4).
Zdravilo ni preučeno pri bolnikih z okvaro ledvic, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavje 4.4).
No studies have been performed in sick or convalescent cats, therefore this veterinary medicinal product should only be used based on the benefit-risk assessment of the responsible veterinarian.
Študije niso bile opravljene pri bolnih mačkah ali mačkah med okrevanjem po bolezni, zato uporabljajte to zdravilo le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
No studies have been performed in sick or convalescent dogs, therefore the product should only be used based on a benefit-risk assessment of the responsible veterinarian.
Z bolnimi ali okrevajočimi psi niso izvedli nobenih študij, zato se sme zdravilo uporabljati samo na podlagi ocene koristi in tveganj, ki jo opravi odgovorni veterinar.
No studies have been performed in the paediatric population (see section 4.2).
Pri otrocih študij niso opravili (glejte poglavje 4.2).
No studies have been performed on patients with hepatic impairment.
Pri bolnikih z okvaro jeter niso opravili nobene študije.
No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Študij, s katerimi bi raziskovali farmakokinetiko zdravila SANCUSO pri pediatričnih bolnikih, niso izvedli.
No studies in lactating animals have been conducted with the combined active substances of this medicinal product.
Študij s kombinacijo zdravilnih učinkovin tega zdravila na doječih živalih niso opravili.
No studies in pregnant women have been conducted.
Študij na nosečnicah niso izvedli.
No studies investigating the effect of pegaspargase on fertility have been performed.
Študije učinka pegaspargaze na plodnost niso bile opravljene.
No studies of Certifect in the treatment of lice were presented, as field studies previously presented for the medicine containing fipronil and (S)- methoprene were considered sufficient.
Predstavljene niso bile nobene študije glede uporabe zdravila Certifect za zatiranje uši, saj se je štelo, da zadostujejo predhodno izvedene terenske študije, ki so bile predstavljene za zdravila, ki vsebujejo fipronil in (S)-metopren.
No studies of interaction with other medicinal products have been performed.
Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
No studies of reproductive toxicity were conducted with pegaspargase.
Študije škodljivih učinkov pegaspargaze na sposobnost razmnoževanja niso bile opravljene.
No studies of the effects of Emselex on the ability to drive and use machines have been performed.
Študij o vplivu zdravila Emselex na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies of the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
No studies on fertility have been performed.
Študije plodnosti niso bile opravljene.
No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid-lowering drugs other than statins and ezetimibe have been conducted.
Študij o farmakokinetičnih in farmakodinamičnih medsebojnih delovanjih med zdravilom Repatha in drugimi zdravili za zniževanje lipidov (razen statinov in ezetimiba) niso izvedli.
No studies on the ability to drive and use machines have been conducted.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effect on human fertility have been conducted for Eucreas (see section 5.3).
Študij o vplivu zdravila Eucreas na plodnost pri ljudeh niso izvajali (glejte poglavje 5.3).
No studies on the effect on human fertility have been conducted for Jentadueto.
Študij o učinku zdravila Jentadueto na plodnost pri človeku niso izvajali.
No studies on the effect on the ability to drive and use machines have been performed.
Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvajali.
No studies on the effects of AVONEX on the ability to drive and use machines have been performed.
Študij o vplivu zdravila AVONEX na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects of cobicistat on the ability to drive and use machines have been performed.
Študij o vplivu kobicistata na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects of LEMTRADA on the ability to drive and use machines have been performed.
Študij o vplivu zdravila LEMTRADA na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects of MabThera on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that MabThera would have no or negligible influence on the ability to drive and use machines.
Študij o vplivu zdravila MabThera na sposobnost za vožnjo in upravljanje s stroji niso izvedli, čeprav opisano farmakološko delovanje in neželeni učinki kažejo, da vpliva na to ni ali je le zanemarljiv.
No studies on the effects of Nimenrix on the ability to drive and use machines have been performed.
Študij o vplivih cepiva Nimenrix na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects of Ranexa on the ability to drive and use machines have been performed.
Študij o vplivu zdravila Ranexa na sposobnost vožnje in upravljanja strojev niso izvedli.
No studies on the effects of tacrolimus (Envarsus) on the ability to drive and use machines have been performed.
Študij o vplivu takrolimusa (zdravilo Envarsus) na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects of Tasmar on the ability to drive and use machines have been performed.
Študije o vplivu zdravila Tasmar na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
No studies on the effects of the ability to drive and to use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects of the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects on the ability to drive and use machines have been performed with IOA.
Študij vpliva zdravila IOA na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects on the ability to drive and use machines have been performed.
Raziskave o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
No studies on the effects on the ability to drive and use machines have been performed.
Raziskave o vplivu zdravila na sposobnost vožnje in upravljanje s stroji niso bile izvedene.
No studies on the effects on the ability to drive and use machines have been performed.
Specifične študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost upravljanja vozil in strojev niso izvedli.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost voţnje in uporabe strojev niso opravili.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvajali.
No studies on the effects on the ability to drive and use machines have been performed.
Študij učinkov filgrastima na sposobnost vožnje in upravljanja s stroji niso opravili.
No studies on the effects on the ability to drive and use machines have been performed.
Študij, ki bi preučevale učinke na zmožnost vožnje in uporabo strojev, niso izvedli.
No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroiji niso bile izvedene.
No studies on the effects on the ability to drive or use machinery have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies on the effects on the ability to drive or use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies to establish the effects of enzalutamide on the ability to drive and use machines have been conducted.
Študij za ugotavljanje vplivov enzalutamida na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies to establish the effects of vandetanib on ability to drive and use machines have been conducted.
Študij o vplivu vandetaniba na sposobnost vožnje in upravljanja s stroji niso izvedli.
No studies were performed on animals to evaluate the effects on reproduction with the CE/bazedoxifene combination.
Študij na živalih, pri katerih bi ugotavljali učinke kombinacije CE/bazedoksifena na razmnoževanje, niso izvedli.
No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of IOA.
Študij za oceno vpliva ledvičnih bolezni na farmakokinetiko zdravila IOA niso izvedli.
No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of Zoely.
Študij za oceno vpliva ledvičnih bolezni na farmakokinetiko zdravila Zoely niso izvedli.
No studies were performed with albumin bound nanoparticules.
Z nanodelci, ki se vežejo na albumin, niso izvedli nobenih študij.
No studies with Januvia have been performed in paediatric patients.
Pri otrocih študij z zdravilom Januvia niso izvedli.
No studies with Ristaben have been performed in paediatric patients.
Pri otrocih študij z zdravilom Ristaben niso izvedli.
No studies with sitagliptin have been performed in paediatric patients.
Pri otrocih študij s sitagliptinom niso izvedli.
No studies with TESAVEL have been performed in paediatric patients.
Pri otrocih študij z zdravilom TESAVEL niso izvedli.
No studies with the proposed regimen have been conducted in patients with liver dysfunction.
Pri bolnikih z motenim delovanjem jeter niso izvajali študij s predlaganim režimom.
No studies with Xelevia have been performed in paediatric patients.
Pri otrocih študij z zdravilom Xelevia niso izvedli.
No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.
Opazili niso nobenih neželenih učinkov, povezanih z raziskovanim zdravilom, ali klinično pomembnih laboratorijskih nepravilnosti.
No study has been performed comparing AUC or Cmax of naltrexone / bupropion prolonged-release tablets with bupropion PR or naltrexone IR administered as single agents in the multiple dose setting (i.e., under steady state conditions).
V nobeni študiji niso vrednosti AUC ali Cmax za tablete kombinacije naltrekson/bupropion s podaljšanim sproščanjem primerjali z uporabo tablet bupropiona s podaljšanim sproščanjem ali tablet naltreksona s takojšnjim sproščanjem kot samostojnih zdravil v shemi večkratnega odmerjanja (tj. v stanju dinamičnega ravnovesja).
No study has been performed with DUTREBIS in subjects with hepatic insufficiency.
Pri bolnikih z insuficienco jeter študije z zdravilom DUTREBIS niso bile izvedene.
No study has been performed with DUTREBIS in subjects with renal insufficiency.
Pri bolnikih z insuficienco ledvic študije z zdravilom DUTREBIS niso bile izvedene.
No study related adverse reactions with paritaprevir, ritonavir, or ombitasvir were observed.
S paritaprevirjem, ritonavirjem ali ombitasvirjem niso opažali s študijo povezanih neželenih učinkov.
No study was conducted with Prometax transdermal patches in subjects with hepatic impairment.
Pri osebah z okvaro jeter niso opravili nobene študije s transdermalnimi obliži Prometax.
No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Pri osebah z okvaro ledvic niso opravili nobene študije s transdermalnimi obliži Prometax.
No subject developed the tenofovir-associated resistance substitution K65R or any primary resistance substitution associated with protease inhibitors.
Noben bolnik ni razvil s tenofovirjem povezane rezistenčne substitucije K65R ali katerekoli primarne rezistenčne substitucije, povezane z zaviralci proteaz.
No subject discontinued the study due to an adverse event.
Noben preiskovanec ni prekinil študije zaradi kakega neželenega dogodka.
No subject experienced an increase in QTcF of  60 msec from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 msec.
Nobenemu preiskovancu se QTcF ni podaljšal za  60 msec v primerjavi z izhodiščem, dolžina intervala QTcF pa ni pri nobenem presegla potencialno klinično pomembnega praga 500 msec.
No subject had a QTcF >450 msec.
Pri nobenem od prostovoljcev trajanje QTcF ni preseglo 450 milisekund.
No subject in any group had an increase in QTc of ≥ 60 msec from baseline.
Pri nobenem izmed preskušancev v vseh skupinah ni prišlo do podaljšanja QTc za ≥ 60 milisekund od izhodišča.
No subject in any group had an increase in QTc of ≥60 msec from baseline.
Pri nobenem izmed preiskovancev v vseh skupinah ni prišlo do podaljšanja QTc za ≥ 60 milisekund od izhodišča.
No subject in any group had an increase in QTc of ≥60 msec from baseline.
Pri nobenem izmed preskušancev v vseh skupinah ni prišlo do podaljšanja QTc za ≥ 60 milisekund od izhodišča.
No subject received a blood transfusion.
Noben preiskovanec ni dobil transfuzije krvi.
No subjects developed new clinically relevant ECG morphological changes following administration of amifampridine phosphate.
Po uporabi amifampridinfosfata niso pri nobenem preskušancu nastopile nove klinično pomembne morfološke spremembe EKG-ja.
No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0).
Pri nobenem preskušancu niso ugotovili učinka na interval QTc, ki bi bil večji od stopnje 2 (CTCAE, različica 3.0).
No subjects reported varicella- like or herpes zoster-like rashes.
Pri nobeni osebi niso poročali o noricam ali herpesu zostru podobnem izpuščaju.
No substantial alteration of MPA pharmacokinetics is anticipated and mycophenolate mofetil dose adjustment is not required.
Znatnih sprememb v farmakokinetiki mikofenolne kisline ni pričakovati, zato prilagajanje odmerkov zdravila Myfenax ni potrebno.
No substantial alteration of MPA pharmacokinetics is anticipated and Mycophenolate mofetil Teva dose adjustment is not required.
Znatnih sprememb v farmakokinetiki mikofenolne kisline ni pričakovati, zato prilagajanje odmerkov zdravila Mofetilmikofenolat Teva ni potrebno.
No substantial differences were seen in safety and efficacy related to age (see section 5.1).
Ugotovili niso nobenih bistvenih s starostjo povezanih razlik glede varnosti in učinkovitosti (glejte poglavje 5.1).
No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66% respectively.
Takšnega podaljšanja tmax niso opazili, če je bil atorvastatin uporabljen zvečer in liksisenatid zjutraj, toda AUC atorvastatina se je zmanjšala za 27 %, njegova Cmax pa za 66 %.
No such reactions have been observed in pigs and sheep after intramuscular administration.
Teh reakcij pri prašičih in ovcah po intramuskularnem dajanju ni bilo opaziti.
No sudden discontinuation of anti-epileptic therapy should be undertaken as this may lead to breakthrough seizures which could have serious consequences for both mother and child.
Zdravljenje z antiepileptiki se ne sme prekiniti nenadoma, saj to lahko povzroči prebojne epileptične napade, ki imajo lahko resne posledice za mater in otroka.
No sudden discontinuation of anti-epileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child.
Antiepileptičnega zdravljenja ne smemo nenadoma prekiniti, ker bi to lahko povzročilo prekinitvene epileptične napade, ki bi lahko imeli tako za mater kot za otroka resne posledice.
No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)- IHC negative tumours (see section 5.1).
Koristnega vpliva na podaljšanje preživetja ali drugih klinično pomembnih učinkov zdravljenja niso dokazali pri bolnikih z EGFR-negativnimi tumorji (glede na rezultat imunohistokemije; EGFR - receptor za epidermalni rastni dejavnik) (glejte poglavje 5.1).
No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours (see section 5.1).
Koristnega vpliva na podaljšanje preživetja ali drugih klinično pomembnih učinkov zdravljenja niso dokazali pri bolnikih z EGFR-negativnimi tumorji (glede na rezultat imunohistokemije; EGFR - receptor za epidermalni rastni dejavnik) (glejte poglavje 5.1).
No sustained antibody formation to the tenecteplase molecule has been observed after treatment.
Po zdravljenju niso zasledili trejnega nastajanja protiteles proti molekuli tenekteplaze.
No symptoms of overdose have been reported.
Ni poročil o simptomih zaradi prevelikega odmerka.
No systemic absorption was detected at or above the lower limit of detection (0.1 ng/mL) when Picato 500 mcg/g from 4 tubes was applied to an area of 100 cm2 on the dorsal forearm in actinic keratosis patients once daily for 2 consecutive days.
Pri nanosu zdravila Picato 500 µg/g enkrat dnevno v 2 zaporednih dneh iz 4 tub na mesto velikosti 100 cm2 na hrbtni strani podlahti pri bolnikih z aktinično keratozo niso opazili sistemske absorpcije na meji zaznavnosti ali nad njo (0,1 ng/ml).
No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the three- months toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
Pri dvotedenskih študijah toksičnosti (pri podganah in psih) z intravenskimi odmerki, ki so bili približno 10-krat večji od terapevtskega odmerka pri človeku, in pri trimesečnih študijah toksičnosti pri podganah in psih (do 20 mg/kg/dan s.c.) niso ugotovili sistemskih toksičnih učinkov.
No teratogenic effect of Luveris has been observed in animal studies.
Študije na živalih ne kažejo teratogenih učinkov zdravila Luveris.