natgillin/translations-raw huggingface dataset:
However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Toda zaradi nezadostnih podatkov in zaradi negotovosti glede ekstrapolacije podatkov ex vivo na klinično uporabo ni mogoče narediti nobenih trdnih sklepov, ki bi se nanašali na redno uporabo ibuprofena; klinično pomemben učinek v primeru občasne uporabe ibuprofena ni verjeten.
However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Toda zaradi nezadostnih podatkov in zaradi negotovosti glede ekstrapolacije podatkov ex vivo na klinično uporabo ni mogoče narediti nobenih trdnih sklepov ki bi se nanašali na redno uporabo ibuprofena; klinično pomemben učinek v primeru občasne uporabe ibuprofena ni verjeten.
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Vendar pa dolgoročni vpliv cepiva proti noricam na pojavnost pasavca trenutno ni znan.
However, the long- term effects of the medicine will need to be further investigated.
Vendar pa bo treba dolgoročne učinke zdravila nadalje raziskati.
However, the long-term effects of Neulasta have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Vendar dolgoročni učinki zdravila Neulasta pri akutni mieloični levkemiji niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
However, the magnitude of effect of these covariates on trastuzumab emtansine exposure, suggests that these covariates are unlikely to have any clinically meaningful effect on trastuzumab emtansine exposure.
Vendar velikost njihovega učinka na izpostavljenost trastuzumabu emtanzinu kaže, da ni verjetno, da bi te sospremenljivke kakor koli klinično pomembno vplivale na izpostavljenost trastuzumabu emtanzinu.
However, the magnitude of the effect seems unlikely to result in clinically important drug-drug interactions.
Vendar se zdi, da obseg učinka ni takšen, da bi prišlo do klinično pomembnih interakcij med učinkovinami.
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Pogosti neželeni učinki so bili večinoma blagi do zmerni, običajno so se pojavljali v zgodnjem obdobju zdravljenja in večina jih je minila, četudi so bolniki zdravljenje nadaljevali.
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e.g. nausea).
Vendar je bila večina najpogostejših neželenih učinkov blagih do zmernih in so minili v 30 dneh od pojava (npr. slabost).
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Vendar pa mora imetnik dovoljenja za promet za to zdravilo predložiti redno posodobljena poročila o varnosti zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Vendar pa bo imetnik dovoljenja za promet z zdravilom vlagal redna posodobljena poročila o varnosti tega zdravila v primeru uvrstitve zdravila na seznam referenčnih datumov unije (seznam EURD) po členu 107c(7) Direktive 2001/83/EC in objavljenih na spletnem portalu Evropske agencije za zdravila.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Vendar pa mora imetnik dovoljenja za promet predloži redna poročila o varnosti tega zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), predvidenih na podlagi člena 107c (7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Vendar pa mora imetnik dovoljenja za promet za to zdravilo predložiti redno posodobljena poročila o varnosti zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
However, the mean single dose MPAG AUC was 3 – 6 fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Pri bolnikih s hudo ledvično okvaro je bil srednji AUC mikofenolglukuronida po enkratnem odmerku od 3- do 6- krat večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
However, the mean single dose MPAG AUC was 3 – 6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Pri bolnikih s hudo ledvično okvaro je bil srednji AUC mikofenolglukuronida po enkratnem odmerku od 3- do 6- krat večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
However, the mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Pri bolnikih s hudo ledvično okvaro je bil srednji AUC mikofenolglukuronida po enkratnem odmerku od 3- do 6-krat večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
However, the measurement of dabigatran related anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additional risk factors.
Toda merjenje dabigatranovega antikoagulacijskega učinka je lahko v pomoč pri preprečevanju prevelike izpostavljenosti dabigatranu, kadar so prisotni dodatni dejavniki tveganja.
However, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, should be considered.
Pretehtati je treba tudi uporabo najbolj dokončne preiskave antraciklinske poškodbe miokarda, to je endomiokardne biopsije.
However, the need for this dose is currently not established.
Kljub temu pa potreba po tem odmerku trenutno ni dokazana.
However, the number of bleeding events was lower for Pradaxa than for warfarin.
Vendar pa je bilo število epizod krvavitve pri uporabi zdravila Pradaxa manjše kot pri uporabi varfarina.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Nevtropenija 3. ali 4. stopnje (ANC < 1,0 x 109/l) in trombocitopenija (koncentracija trombocitov < 50 x 109/l) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59–64 % in trombocitopenija 44–63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
However, the OHSS will only occur if hCG is also administered [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Vendar pa se lahko OHSS pojavi samo, če se uporabi tudi hCG [glejte tudi poglavje 2 "Sindrom hiperstimulacije jajčnikov (OHSS)"].
However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0% - 0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
Vendar je bil odstotek bolnikov, ki so zaradi navedenih neželenih učinkov prenehali jemati zdravilo, majhen (suha usta: 0 % - 0,9 % in zapeka: 0,6 % - 2,2 % ob darifenacinu v odvisnosti od odmerka, ob placebu pa 0 % zaradi suhih ust in 0,3 % zaradi zapeke).
However, the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Toda koncentracija v plazmi, dosežena v teh študijah, je bila manjša, kot je dosežena pri človeku v priporočenih odmerkih (glejte poglavje 5.3).
However, the possibility of anaphylactic reaction related to PEG 400 cannot be excluded.
Vendar možnosti anafilaksijske reakcije, povezane s PEG 400, ni mogoče izključiti.
However, the possibility of anaphylactic reaction related to PEG400 cannot be excluded.
Vendar možnosti anafilaksijske reakcije, povezane s PEG 400, ni mogoče izključiti.
However, the possibility of interactions with gonadotropins or products that may induce histamine release in susceptible individuals, cannot be totally excluded.
Vendar možnosti medsebojnega delovanja z gonadotropini ali zdravili, ki pri občutljivih posameznikih lahko sprožijo sproščanje histamina, ni mogoče popolnoma izključiti.
However, the possibility that haemolytic anaemia could occur in association with Zavicefta treatment cannot be ruled out.
Vendar v povezavi z zdravljenjem z zdravilom Zavicefta ni mogoče izključiti možnosti za hemolitično anemijo.
However, the potential for severe allergic reactions cannot be excluded.
Kljub temu ni mogoče izključiti možnosti nastanka resnih alergijskih reakcij.
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Morebitnega vpliva jetrnega odpovedovanja na farmakokinetiko pramipeksola niso raziskovali.
However, the PRAC considered unclear if the day of negative pregnancy test is counted as day 0 or as day 1.
Po mnenju PRAC ni bilo jasno, ali dan negativnega testa nosečnosti štejemo kot dan 0 ali dan 1.
However, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied when extrapolating animal data directly to man.
Vendar pa natančen prispevek posameznih ciljnih receptorjev v opazovanem farmakodinamičnem profilu ostaja nejasen in otrebna je previdnost pri ekstrapolaciji podatkov iz živali neposredno na človeka.
However, the predicted amount of metabolite accumulation at steady state is not pharmacodynamically important because the terminal elimination half-life is only 1–2 hours in these subjects.
Vendar pa predvidena količina nakopičenega presnovka v stanju dinamičnega ravnovesja ni farmakodinamično pomembna, saj je končna eliminacijska razpolovna doba pri teh osebah le ena do dve uri.
However, the prepared syringe can be stored in a refrigerator (between 2°C and 8°C) for up to 6 hours before you inject.
Vendar pa pripravljeno injekcijsko brizgo lahko shranjujete v hladilniku (med 2 °C in 8 °C) do 6 ur pred injiciranjem.
However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Vendar pa blažja okužba, kot je prehlad, ni razlog za odložitev cepljenja.
However, the presence of a minor infection, such as a mild upper respiratory tract infection or low- grade fever, is not a contraindication for immunisation.
Vendar pa blažja okužba, kot sta blaga okužba zgornjih dihal ali rahlo zvišana telesna temperatura, ni kontraindikacija za cepljenje.
However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low.
Vendar pa je količina zdravila EndolucinBeta, ki jo je treba uporabiti, zelo majhna, zato je tudi to tveganje majhno.
However, the reconstituted solution can be stored at 2°C - 8°C for up to six hours, prior to injection.
Vendar pa lahko rekonstituirano raztopino shranjujemo pri temperaturi 2 °C – 8 °C do 6 ur pred injiciranjem.
However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15 to 30ºC).
Sicer lahko hranite pripravljeno raztopino v viali do 3 ure pri sobni temperaturi (med 15 in 30 ºC).
However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15ºC - 30ºC).
Sicer lahko pripravljeno (rekonstituirano) raztopino hranimo do 3 ure v viali pri sobni temperaturi (15 ºC – 30 ºC).
However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15ºC-30ºC).
Sicer lahko pripravljeno (rekonstituirano) raztopino hranimo do 3 ure v viali pri sobni temperaturi (15 ºC – 30 ºC).
However, the safety database in children is limited.
Vendar pa je varnostna zbirka podatkov pri otrocih omejena.
However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Vendar je druga študija pokazala, da so se simptomi ponovno pojavili pri 21 % (34 od 165) bolnikov, ki so 24 tednov jemali zdravilo Valdoxan, medtem ko je ta delež pri bolnikih, ki so jemali placebo, znašal 41 % (72 od 174).
However, the solution may be use for up to 6 hours when stored in the refrigerator (2 – 8C).
Lahko se uporabi tudi v 6 urah po pripravi, če je shranjena v hladilniku (2 C – 8 C).
However, the solution may be used for up to 6 hours if stored in the refrigerator (2C – 8C).
Raztopina je uporabna največ 6 ur, če jo hranite v hladilniku (2 C – 8 C).
However, the solution may be used for up to 6 hours when stored at a temperature up to 25C.
Raztopina je uporabna največ 6 ur, če jo hranite pri temperaturi do 25 °C.
However, the solution may be used for up to 6 hours when stored at temperatures of up to 25C.
Raztopina je uporabna največ 6 ur, če jo hranite pri temperaturi do 25 °C.
However, the spurious signal resulting from non-specific ‘bone uptake’ in the face could lead to incorrect image interpretation.
Vendar pa lahko lažen signal, ki je posledica nespecifičnega »privzema v kosti« obraza, povzroči nepravilno interpretacijo slike.
However, the subject’s HBsAg loss was ultimately confirmed at the subsequent visit.
Izguba HBsAg je bila dokončno potrjena ob naslednjem obisku.
However, the therapeutic experience in patients ≥ 75 years is very limited (see section 5.1), and in these patients 0.75 mg once weekly can be considered as a starting dose.
Vendar pa so izkušnje z zdravljenjem pri bolnikih, starih 75 let in več, zelo omejene (glejte poglavje 5.1) in pri teh bolnikih je odmerek 0,75 mg mogoče upoštevati kot začetni odmerek.
However, the time taken for the disease to get worse after treatment was the same in both groups (about 10 months).
Vendar pa je bil čas do poslabšanja bolezni po zdravljenju v obeh skupinah enak (približno 10 mesecev).
However, the transdermal patch may become partially unstuck.
Se pa transdermalni obliž lahko deloma odlepi.
However, the twice-daily dose was slightly more effective in patients who were at risk of a reduced response to HIV treatment, due to high viral load, low levels of immunity or few available treatment options.
Vendar pa je bil pri bolnikih s tveganjem zmanjšanega odziva na zdravljenje okužbe z virusom HIV zaradi visokega virusnega bremena, nizkih ravni imunosti ali malo razpoložljivih možnosti za zdravljenje odmerek dvakrat dnevno nekoliko učinkovitejši.
However, the upper limit of the confidence interval for creatinine remained within the reference range at all visits.
Vendar pa je zgornja meja intervala zaupanja za kreatinin ostala ob vseh obiskih znotraj referenčnega razpona.
However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions.
Dokazano je, da je cepivo učinkovito ob prisotnosti maternalnih protiteles za CDV, CAV in CPV proti virulentni izpostavitvi, ki jo navadno srečamo na terenu.
However, there are insufficient data available to make a dose recommendation for this patient group.
Vendar ni dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje v tej skupini bolnikov.
However, there are insufficient data available to make a dose recommendation for this patient group.
Vseeno za sedaj nimamo na voljo zadostne količine podatkov, da bi priporočili odmerek za to skupino bolnikov.
However, there are limited data regarding the long-term use of Kuvan.
Vendar pa o dolgotrajni uporabi zdravila Kuvan obstaja le malo podatkov.
However, there has been no evidence of an increase in the occurrence of AIDS-related infections associated with the use of CELSENTRI in clinical studies
Vendar pa v kliničnih študijah ni bilo dokazov, da bi ob uporabi zdravila CELSENTRI prihajalo do povečane pojavnosti okužb, povezanih z aidsom.
However, there have also been post- marketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom pri bolnikih, ki so prejemali adalimumab.
However, there have also been post- marketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
However, there have also been post- marketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
However, there is currently no evidence that a dose reduction is required (see section 5.2).
Vendar pa trenutno ni nikakršnih dokazov, da je potrebno zmanjšati odmerke (glejte poglavje 5.2).
However, there is currently very limited clinical experience with the use of these products in individuals receiving rivaroxaban.
Do sedaj je zelo malo izkušenj z uporabo teh zdravil pri bolnikih, ki prejemajo rivaroksaban.
However, there is currently very limited clinical experience with the use of these products in individuals receiving rivaroxaban.
edaj je zelo malo izkušenj z uporabo teh zdravil pri bolnikih, ki prejemajo rivaroksaban.
However, there is limited clinical experience of the use of sevoflurane, after propofol induction, in bitches undergoing caesarean section, without any ill effects being detected in either the bitch or the puppies.
Vendar so z uporabo sevoflurana po uvodu v anestezijo s propofolom pri psicah po carskem rezu na voljo omejene klinične izkušnje, pri tem niso odkrili nikakršnih škodljivih učinkov niti pri psici niti pri kužkih.
However, there is some evidence on hepatotoxicity with increasing dose, since reversible increases of liver enzymes have been found in humans with therapeutic and higher doses (see section 4.4 and 4.8).
Vendar obstajajo dokazi o hepatotoksičnosti pri povečevanju odmerka, kajti pri osebah, ki so prejemale terapevtske in večje odmerke, so opazili reverzibilno povečanje jetrnih encimov (glejte poglavji 4.4 in 4.8).
However, there was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and soft-tissue infections.
Kljub temu ni bilo dovolj dokazov v podporo uporabi zdravila Cubicin za zdravljenje bakteremije pri bolnikih, ki niso imeli bodisi infektivnega endokarditisa desne strani bodisi zapletenih oblik okužbe kože ali mehkih tkiv.
However, there was no delay in neonatal development following exposure in utero or via milk.
Vendar pa ni bilo zakasnitve v neonatalnem razvoju po izpostavitvi in utero ali z mlekom.
However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Edistride did not show this risk.
Pri upoštevanju vseh vrst raka pa med skupinama ni bilo razlike in predklinične študije, ki so proučevale tveganje za razvoj raka zaradi zdravila Edistride, tovrstnega tveganja niso zabeležile.
However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Forxiga did not show this risk.
Pri upoštevanju vseh vrst raka pa med skupinama ni bilo razlike in predklinične študije, ki so preučevale tveganje za razvoj raka zaradi zdravila Forxiga, tovrstnega tveganja niso zabeležile.
However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p  0.03).
Vendar med odmerkoma ni bilo razlik v trajanju telesne vadbe (24 sekund v primerjavi s placebom; p  0,003).
However, there was no improvement of Revinty Ellipta 184/22 microgram over Revinty Ellipta 92/22 microgram.
Vendar se zdravilo Revinty Ellipta 184/22 mikrogramov ni pokazalo kot učinkovitejše od zdravila Revinty Ellipta 92/22 mikrogramov.
However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone- based therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Pri umrljivosti iz kateregakoli vzroka pa ni prišlo do statistično značilne razlike med zdravljenjem, ki je vključevalo amlodipin, in tistim, ki je vključevalo klortalidon (razmerje tveganj (RR) 0,96; 95-odstotni IZ: 0,89-1,02; p=0,20).
However, there were too few patients aged below six years to support the use of Telzir in this age group.
Vendar pa je bilo število bolnikov, mlajših od šest let, premajhno, da bi podatki teh študij podprli uporabo zdravila Telzir v tej starostni skupini.
However, there were too few patients in the study to prove whether or not such a schedule is as effective as deferoxamine taken on its own.
Vendar pa število bolnikov v študiji ni bilo zadostno, da bi bilo mogoče dokazati, ali je tak urnik res tako učinkovit kot samostojno jemanje deferoksamina ali ne.