natgillin/translations-raw huggingface dataset:
No dosing recommendations can be made regarding the use of Tybost with oral contraceptives.
Priporočil glede sočasne uporabe zdravila Tybost s peroralnimi kontraceptivi ni mogoče dati.
No drug interaction studies have been performed with Feraccru.
Študij medsebojnega delovanja z zdravilom Feraccru niso izvedli.
No drug interaction studies have been performed.
Študij medsebojnih interakcij z drugimi zdravili niso izvedli.
No drug interaction study has been performed for the co- administration of nelfinavir with benzodiazepines.
Študije medsebojnega delovanja benzodiazepinov in nelfinavirja niso bile izvedene.
No drug interaction study has been performed for the co- administration of REYATAZ with benzodiazepines.
Študije medsebojnega delovanja pri sočasni uporabi zdravila REYATAZ in benzodiazepinov niso bile izvedene.
No drug interactions were observed in field studies where oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and anti- inflammatories.
V preskušanjih na terenu niso opazili medsebojnega delovanja pri sočasni uporabi oklacitiniba in drugih zdravil za uporabo v veterinarski medicini – zdravil proti endo- in ektoparazitom, protimikrobnih ter protivnetnih zdravil.
No drug-drug interaction studies have been performed with amlodipine/valsartan and other medicinal products.
Študij medsebojnega delovanja z amlodipinom/valsartanom in drugimi zdravili niso izvedli.
No drug-drug interaction studies have been performed.
Študij medsebojnega delovanja z drugimi zdravili niso izvajali.
No drug-drug interactions were observed between Portrazza and gemcitabine/cisplatin.
Med zdravilom Portrazza in gemcitabinom/cisplatinom niso opazili medsebojnega delovanja.
No drug-drug interactions were observed between ramucirumab and paclitaxel.
Med ramucirumabom in paklitakselom niso opazili medsebojnega delovanja.
No DRV use
Brez uporabe DRV
no duct
dovolj
No effect (↔) equals a decrease in mean ratio estimate of ≤20% or increase in mean ratio estimate of
Brez vpliva (↔) ustreza zmanjšanju povprečnega odstotka za ≤ 20 % ali zvečanju povprečnega odstotka za
No effect = 1.00
Ni učinka = 1,00
No effect = 1.00.
Ni učinka = 1,00
No effect = 1.00.
Ni učinka = 1,00.
no effect is expected.
Koncentracija efavirenza ni bila merjena,
no effect is expected.
Vpliva nanje ne pričakujemo.
No effect of bosentan on time to healing of digital ulcers was observed in either study.
Učinka bosetana na čas ozdravljenja razjed prstov niso opazili v nobeni študiji.
No effect of Ceplene and interleukin-2 was seen in patients in second or later remission.
Pri bolnikih v drugi ali kasnejši remisiji niso opazili nikakršnega učinka zdravila Ceplene in interlevkina-2.
No effect of inhaled nitric oxide has been documented in newborn babies with a malformation where the diaphragm is not fully complete, so called ‘congenital diaphragmatic hernia’.
Pri novorojenčkih s prirojeno diafragmalno hernijo, malformacijo, pri kateri diafragma ni popolnoma razvita, niso dokumentirali nobenega učinka zdravljenja z vdihavanjem dušikovega oksida.
No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Opazili niso nobenih učinkov prednizona na farmakokinetiko docetaksela.
No effect of race was identified in the population analysis.
Populacijska analiza ni pokazala vpliva rase.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablet.
20-miligramski odmerek vardenafila v filmsko obloženih tabletah ni vplival na znižanje krvnega tlaka, če so zdravi moški vzeli nitroglicerin 24 ur po zaužitju enkratnega odmerka vardenafila v filmsko obloženih tabletah.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablet.
20-miligramski odmerek vardenafila v filmsko obloženih tabletah ni vplival na znižanje krvnega tlaka, če so zdravi moški vzeli nitroglicerin 24 ur po zaužitju enkratnega odmerka vardenafila.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablets.
20-miligramski odmerek vardenafila v filmsko obloženih tabletah ni vplival na znižanje krvnega tlaka, če so zdravi moški vzeli nitroglicerin 24 ur po zaužitju enkratnega odmerka vardenafila.
No effect on fertility has been observed in animal studies.
Pri študijah na živalih niso opazili vpliva na plodnost.
No effect on male or female fertility has been observed in rats following intravenous verteporfin doses of up to 10 mg/kg/day (approximately 60 and 40-fold human exposure at 6 mg/m2 based on AUCinf in male and female rats, respectively).
Pri podganah po intravenskem vnosu odmerkov do 10 mg/kg/dan (kar pomeni približno 60-krat oziroma 40-krat večjo izpostavljenost kot pri ljudeh po odmerjanju 6 mg/m2 glede na AUCinf pri podganjih samcih oziroma samicah) niso opažali vpliva na plodnost samcev ali samic.
No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
V študijah na živalih po subkutani aplikaciji zdravila niso opažali vpliva na plodnost samic ali samcev (glejte poglavje 5.3).
No effect on the bioavailability of MPA was observed.
Vplivov na biološko uporabnost mikofenolne kisline niso opazili.
No effect on the metabolite profile of piperaquine in human hepatocytes was observed when piperaquine was co-incubated withartenimol.
Učinkov na profil presnovkov piperakina pri človeških hepatocitih pri sočasni inkubaciji piperakina z artenimolom niso opazili.
No effect on umeclidinium AUC or Cmax was observed at a 8-fold higher dose.
Pri 48-krat večjem odmerku niso opazili vpliva na AUC ali Cmax umeklidinija.
No effect on unbound
Ni vpliva na koncentracije
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature, ki izjemoma lahko traja pet dni.
No effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the QTc interval.
Amifampridinfosfat ni imel opaznega učinka na repolarizacijo srca, ocenjeno z uporabo intervala QTc.
No effects are known.
Ni znanih učinkov.
No effects of Hizentra on the ability to drive and use machines are expected.
Pri zdravilu Hizentra ni pričakovati nobenega vpliva na sposobnost vožnje in upravljanja strojev.
No effects on ability to drive and use machines have been observed.
Niso opaženi nobeni učinki na sposobnost vožnje in upravljanja s stroji.
No effects on ability to drive or use machines have been observed.
Vpliva na sposobnost vožnje in upravljanja s stroji niso opazili.
No effects on ability to drive or use machines have been observed.
Vpliva na sposobnost vožnje in upravljanja strojev niso opazili.
No effects on ability to drive or use machines have been observed.
Vplivov na sposobnost vožnje ali upravljanja s stroji niso opazili.
No effects on ability to drive or use of machines have been observed.
Vpliva na sposobnost vožnje ali upravljanja s stroji niso opazili.
No effects on fertility or early embryonic development were noted in animals (see section 5.3).
Učinki na plodnost ali zgodnji razvoj ploda pri živalih niso bile zabeležene (glejte poglavje 5.3).
No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (Human Equivalent Dose [HED]16 mg/kg/day) (see section 5.3).
Niso opazili učinkov na plodnost ali sposobnost razmnoževanja pri podganjih samcih ali samicah, ki so prejemali odmerke do največ 100 mg/kg/dan (odmerek, ekvivalenten odmerku 16 mg/kg/dan pri ljudeh) (glejte poglavje 5.3).
No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (Human Equivalent Dose [HED]16 mg/kg/day).
Niso opazili učinkov na plodnost ali sposobnost razmnoževanja pri podganjih samcih ali samicah, ki so prejemali odmerke do največ 100 mg/kg/dan (odmerek, ekvivalenten odmerku 16 mg/kg/dan pri ljudeh).
No effects on fertility were seen at sub-lethal doses (human equivalent dose was 19-fold higher than the maximum human recommended dose (MHRD)).
Med uporabo subletalnih odmerkov (ekvivalent človeškega odmerka je bil več kot 19-krat večji od največjega priporočenega odmerka pri človeku (MHRD – maximum human recommended dose)) niso opazili nobenega vpliva na plodnost.
No effects on male fertility were seen in reproductive studies in male rats.
V študijah o vplivu na sposobnost razmnoževanja, opravljenih na podganjih samcih, niso opazili vpliva na plodnost samcev.
No effects on male fertility were seen in reproductive studies in male rats.
V študijah vpliva na sposobnost razmnoževanja pri samcih podgan niso opazili vpliva na plodnost.
No effects on male or female fertility and reproductive performance indices were observed at ≤100 mg/kg/day (see section 5.3).
Pri odmerku ≤100 mg/kg/dan niso ugotovili učinkov na indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan (glejte poglavje 5.3).
No effects on male or female fertility and reproductive performance indices were observed at ≤100 mg/kg/day (yielding exposures approximately 8 times those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 100 mg/kg/day in the 6-month repeat-dose toxicity study in this species).
Pri odmerkih ≤100 mg/kg/dan (ki so povzročili izpostavljenosti, ki so približno 8-krat presegle tiste, ki so bile dosežene z največjim priporočenim odmerkom ivakaftorja (učinkovina zdravila Orkambi) za človeka na podlagi seštetih AUC ivakaftorja in njegovih presnovkov, ekstrapoliranih iz izpostavljenosti 90. dne pri odmerku 100 mg/kg/dan v 6-mesečni študiji toksičnosti ponavljajočih se odmerkov pri tej živalski vrsti) niso ugotovili učinkov na indekse plodnosti samcev ali samic ali indekse reproduktivne uspešnosti.
No effects on QT interval (corrected using either the Fridericia or Bazett method or individually- corrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
Pri dajanju aklidinijevega bromida (200 µg ali 800 µg) enkrat na dan 3 dni zdravim osebam niso opazili nobenih učinkov na interval QT (korigirano po metodi Fridericia ali Bazett ali korigirano individualno) v trajanju celotne študije QT.
No effects on reproductive organs have been seen in non-clinical studies.
V nekliničnih študijah niso ugotovili vplivov na reproduktivne organe.
No effects on the ability to drive or use machines are expected.
Vpliv na sposobnost vožnje in upravljanja s stroji ni pričakovan.
No effects on the breastfed child are anticipated.
Učinkov na dojenega otroka ni pričakovati.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to IXIARO is negligible.
Ni pričakovati učinkov na dojenega otroka, saj je sistemska izpostavljenost doječe ženske cepivu IXIARO zanemarljiva.
No effects on the reproductive performance were observed in both species.
Pri obeh živalskih vrstah niso ugotovili učinkov na reprodukcijsko sposobnost.
No effects other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature , ki izjemoma lahko traja pet dni.
No effects were observed on males and females fertility in animal studies.
V študijah na živalih niso opazili učinkov na plodnost moških in žensk.
No efficacy data are available concerning the use of the vaccine in male animals.
Glede uporabe cepiva COXEVAC pri samcih ni na voljo podatkov o učinkovitosti cepiva.
No embryonal/foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of decreased foetalbody weights in rats at doses associated with maternal toxicities (see section 5.3).
V študijah na brejih podganah in kunkah niso opazili embrionalnih/fetalnih toksičnih učinkov, razen zmanjšane telesne mase plodov pri podganah ob odmerkih, ki so jih spremljali toksični učinki pri samicah-materah (glejte poglavje 5.3).
No embryotoxicity or malformations were observed following intramuscular administration of paliperidone palmitate to pregnant rats up to the highest dose (160 mg/kg/day) corresponding to 4.1 times the exposure level in humans at the maximum recommended dose of 150 mg.
Po intramuskularnem injiciranju paliperidonijevega palmitata brejim podganam, pri čemer je bil največji odmerek (160 mg/kg/dan), kar ustreza 4,1-kratni izpostavljenosti pri največjem priporočenem odmerku (150 mg) pri človeku, niso opazili toksičnosti za zarodek ali malformacij.
No emesis
Brez bruhanja
No emesis (no emetic episodes regardless of use of rescue therapy)
Brez bruhanja (brez bruhanja ne glede na rešilno zdravljenje)
No entry
Jih ni
NO ENTRY
kolonij govejih
NO ENTRY
Navedba ni smiselna.
NO ENTRY
NI VPISA
NO ENTRY
Noben vpis
No environmental impact is anticipated from the clinical use of pioglitazone.
Pri klinični uporabi pioglitazona ni pričakovati vpliva na okolje.
No epidemiological data on the risk of cervical cancer in users of IOA are available.
Epidemiološki podatki o tveganju za nastanek raka materničnega vratu pri uporabnicah zdravila IOA niso na voljo.
No episodes of major hypoglycaemia were observed in the trial with liraglutide used as monotherapy.
V preskušanju monoterapije z liraglutidom ni bilo opisanih primerov hude hipoglikemije.
No episodes of major hypoglycaemia were reported, and no subject discontinued the study treatment due to hypoglycaemia (see sections 4.4 and 4.5).
O primerih hude hipoglikemije niso poročali in noben bolnik ni prenehal uporabljati raziskovanega zdravila zaradi hipoglikemije (glejte poglavji 4.4 in 4.5).
No episodes of torsade de pointes were observed.
Epizod “torsade de pointes” niso opažali.
No eRVR
eRVR ni dosežena
No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony- stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Ni dokazov, ki kažejo na medsebojno delovanje med epoetinom alfa in granulocitne kolonije stimulirajočim faktorjem (G-CSF) ali granulocitne/makrofagne kolonije stimulirajočim faktorjem (GM-CSF) glede na in vitro hematološko diferenciacijo ali proliferacijo vzorcev tumorjev, ki so bili pridobljeni z biopsijo.
No evidence of altered toxicity profile was identified in the patient who developed antibodies to siltuximab.
Pri bolniku s protitelesi proti siltuksimabu niso odkrili sprememb v profilu toksičnosti zdravila.
No evidence of an altered safety profile was found in patients who tested positive for antibodies to Vectibix.
Pri bolnikih, ki so imeli pozitiven izvid protiteles proti zdravilu Vectibix, niso ugotovili spremenjenih varnostnih značilnosti.
No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
V študijah toksičnosti ponavljajočih se odmerkov pri podganah in opicah niso ugotovili znakov nevarnosti, povezanih z zdravilom.
No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian- cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Pri Amesovem testu mutagenosti na mikrobih, testu genskih mutacij v celicah sesalcev in testu celične transformacije embrionalnih celic sirijskega hrčka niso odkrili znakov genotoksičnosti.
No evidence of leukaemia
nobenih znakov levkemije
No evidence of leukaemia (NEL)
nobenih znakov levkemije (NEL)
No evidence of leukaemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm3 and less than 100,000/mm3) and/or neutropenia (ANC greater than or equal to 0.5×109/L and less than 1.0×109/L).
Ni nobenega dokaza za levkemijo: izpolnjena so vsa druga merila za CHR, z izjemo tega, da je lahko prisotna trombocitopenija (število trombocitov večje od ali enako 20.000/mm3 in manjše od 100.000/mm3) in/ali nevtropenija (ANC večje od ali enako 0,5 x 109/l in manjše od 1,0 x 109/l).
No evidence of MAO-A inhibition was observed in Phase 1 studies specifically designed to investigate the potential for this interaction.
V študijah 1. faze, posebej zasnovanih za raziskavo možnosti tega medsebojnega delovanja, niso opazili dokazov o zaviranju MAO-A.
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Thymanax in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
V kliničnih preskušanjih faze I niso opazili dokazov o farmakokinetičnem ali famakodinamičnem medsebojnem delovanju zdravila Vadoxan z zdravili, ki jih sočasno predpisujemo pri ciljni skupini bolnikov: benzodiazepini, litijem, paroksetinom, flukonazolom in teofilinom.
No experience exists for the treatment of BCC and Bowen’s disease, which should therefore not be treated with the product.
Ni izkušenj z zdravljenjem karcinoma bazalnih celic (BCC) in Bowenove bolezni, zato se to zdravilo pri zdravljenju teh bolezni ne sme uporabljati.
No experience exists for the use of Ameluz in patients with inherited or acquired coagulation defects or in immunosuppressed patients.
Ni izkušenj z uporabo zdravila Ameluz pri bolnikih z dednimi ali pridobljenimi motnjami strjevanja krvi ali pri bolnikih z oslabljenim imunskim sistemom.
No experience exists in patients with hepatic impairment from causes other than
Izkušenj pri bolnikih z okvarjenim delovanjem jeter, ki ni posledica pomanjkanja
No experience exists in patients with hepatic impairment from causes other than 3β-
Izkušenj pri bolnikih z okvarjenim delovanjem jeter, ki ni posledica pomanjkanja
No explanation can be given to this higher number of PE.
Večjega števila primerov pljučne embolije ni mogoče pojasniti.
No fatal case was observed during the study.
V študiji ni bilo smrtnih primerov.
No fertility data are available.
Podatki glede plodnosti niso na voljo.
No fertility data are available.
Podatkov o ploodnosti ni.
No fertility studies have been performed (see section 5.3).
Študij plodnosti niso izvedli (glejte poglavje 5.3).
No fertility studies have been performed with ingenol mebutate.
Študij plodnosti z ingenol mebutatom niso izvedli.
No fertility studies have been performed.
Študij plodnosti niso opravili.
No fertility studies have been performed.
Študije plodnosti niso bile opravljene.
No fertility studies in humans have been conducted.
Študij plodnosti na ljudeh niso izvedli.
No fertility studies in humans have been conducted.
Študije plodnosti na ljudeh niso izvedli.
No fibrosis or minimal fibrosis
brez fibroze ali minimalna fibroza
No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which is 19 times the exposure in humans at the highest clinically tested dose (10 mg/kg).
Toksikološko pomembnih ugotovitev ni bilo, koncentracija, pri kateri niso opazili neželenih učinkov (no observed adverse effect level - NOAEL), je bila v obeh študijah ≥ 200 mg/kg; kar je 19-kratnik izpostavljenosti pri človeku ob največjem klinično testiranem odmerku (10 mg/kg).
No food should be consumed for 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.
Hrane se ne sme uživati 2 uri pred zaužitjem odmerka in vsaj eno uro po zaužitju odmerka.
No food should be eaten for at least two hours before and two hours after the dose is taken.
Bolnik ne sme zaužiti nobene hrane najmanj dve uri pred odmerjanjem zdravila in najmanj dve uri po njem.
No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine’s effects.
Uživanje hrane hkrati z zdravilom Sonata ali tik pred tem ni priporočljivo, saj lahko zmanjša učinke zdravila.
No food should be eaten with or shortly before taking Zerene, because it can reduce the medicine’s effects.
Uživanje hrane hkrati z zdravilom Zerene ali tik pred tem ni priporočljivo, saj lahko zmanjša učinke zdravila.
No force is required.
Ne potiskajte je na silo.
No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have been conducted.
Formalnih raziskav farmakokinetskih interakcij med zdravilom DepoCyte in drugimi učinkovinami niso opravili.
No formal carcinogenicity studies of arsenic trioxide have been performed.
Uradnih študij karcinogenosti arzenovega trioksida niso opravili.
No formal clinical studies have been conducted in children or teenagers.
Formalnih kliničnih preskušanj pri otrocih ali mladostnikih niso izvedli.
No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also section 4.4).
O učinkih bosentana na učinkovitost protiretrovirusnih zdravil ni bilo mogoče sklepati (glejte tudi poglavje 4.4).
No formal drug-drug interaction studies have been conducted for Repatha.
Formalnih študij medsebojnega delovanja zdravil z zdravilom Repatha niso izvedli.
No formal evaluation has been conducted to investigate the potential differences in ketoconazole pharmacokinetics between males and females and data evaluating the effect of weight on pharmacokinetics of ketoconazole are very limited.
Morebitnih razlik v farmakokinetiki ketokonazola med moškimi in ženskami niso uradno ocenili, podatki o oceni telesne mase na farmakoinetiko ketokonazola pa so zelo omejeni.
No formal evaluation of the effect of age on the pharmacokinetics of Ketoconazole HRA has been performed.
Opravili niso nobene uradne ocene učinka starosti na farmakokinetiko zdravila Ketokonazol HRA.
No formal in vivo drug-drug interaction studies have been conducted.
Opravili niso nobenih formalnih študij medsebojnega delovanja zdravil in vivo.
No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic product interactions with other medicinal products.
Niso bile opravljene nobene predpisane raziskave o medsebojnem delovanju s PhotoBarrom, ki bi preučevale farmakokinetične interakcije z drugimi zdravili.
No formal interaction studies with other medicinal products have been conducted.
Formalne študije o medsebojnem delovanju z drugimi zdravili niso bile izvedene.
No formal interaction studies with other medicinal products have been conducted.
Študije o medsebojnem delovanju z drugimi zdravili niso bile izvedene.
No formal interaction studies with Praxbind and other medicinal products have been performed.
Formalnih študij medsebojnega delovanja zdravila Praxbind z drugimi zdravili niso izvedli.
No formal interaction studies with tenecteplase and medicinal products commonly administered in patients with AMI have been performed.
S tenekteplazo in zdravili, ki jih običajno dajemo bolnikom z akutnim miokardnim infarktom, niso izvajali uradnih raziskav o medsebojnem delovanju.
No formal interaction study has been
Uradnih študij medsebojnega delovanja niso
No formal interactions studies with other medicinal products were conducted, .
Formalnih raziskav medsebojnega delovanja z drugimi zdravili ni bilo.
No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Opravili niso nobenih uradnih predkliničnih varnostnih študij, vendar podatki v literaturi na podlagi študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.