natgillin/translations-raw huggingface dataset:
There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitorof CYP2C8 in vivo.
Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax repaglinida za 1,7-krat in njegove povprečne AUC za 2,4-krat; to kaže, da A771726 in vivo zavira CYP2C8.
There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo.
Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (1,7-krat) in AUC (2,4-krat) repaglinida, kar nakazuje, da je teriflunomid zaviralec CYP2C8 in vivo.
There was an increase in median PFS of 1.5 months in favour of the Cyramza plus docetaxel arm: 4.5 months in the Cyramza plus docetaxel arm and 3 months in the placebo plus docetaxel arm.
Opazili so porast medianega preživetja brez napredovanja bolezni za 1,5 meseca v korist skupine z zdravilom Cyramza in docetaksel: 4,5 meseca v skupini z zdravilom Cyramza in docetaksel in 3 mesece v skupini s placebom in docetaksel.
There was an increase in median survival of 1.4 months in favour of the Cyramza plus docetaxel arm:
Opazili so porast medianega preživetja za 1,4 meseca v korist skupine z zdravilom Cyramza in docetaksel: 10,5 meseca v skupini z zdravilom Cyramza in docetaksel in
There was an increase in rivaroxaban exposure correlated to decrease in renal function, as assessed via creatinine clearance measurements.
Povečanje koncentracije rivaroksabana v plazmi je bilo povezano z zmanjšanim delovanjem ledvic, ocenjenim z očistkom kreatinina.
There was an increased incidence of cardiac toxicity, but these events were comparable in nature and severity to those reported from the lapatinib clinical programme (see section 4.4 – cardiac toxicity).
Incidenca kardiotoksičnih učinkov se je povečala, vendar so bili ti dogodki po naravi in izrazitosti primerljivi tistim, ki so bili opisani v kliničnem programu lapatiniba (glejte poglavje 4.4 - kardiotoksičnost).
There was an increased incidence of SAEs (40% vs.
V kombinacijskem kraku s trastuzumabom je prišlo do povečane incidence resnih neželenih učinkov (40
There was brain penetration, with accumulation over time with repetitive treatment, and effective reduction of levels of phospho-S6, a downstream marker of mTORC1.
Everolimus je prehajal v možgane in se sčasoma pri večkratnem odmerjanju v njih kopičil, prišlo je do učinkovitega znižanja koncentracije fosforiliranega proteina S6, ki je označevalec kaskade, sprožene s kompleksom mTORC1.
There was continuous improvement up to 36 months in the clinical outcome measure KOOS (the Knee Injury and Osteoarthritis Outcome Score) in both treatment arms.
Po kliničnem izidu KOOS (Knee Injury and Osteoarthritis Outcome Score – merjenje izida ob poškodbi kolena in osteoartritisu) se je stanje neprestano izboljševalo 36 mesecev pri obeh zdravljenih rokah.
There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)].
Podatki dokazujejo korist zdravljenja s telmisartanom v primerjavi s placebom glede na vnaprej opredeljeni sekundarni sestavljeni opazovani dogodek, in sicer smrt zaradi srčnožilnega dogodka, neusodni miokardni infarkt in neusodno možgansko kap [0,87 (95-odstotni interval zaupanja 0,76 - 1,00, p
There was evidence of attenuation with repeated doses of voriconazole.
Obstajali so dokazi o njihovem zmanjševanju s ponavljajočimi odmerki vorikonazola.
There was faster normalisation of corrected serum calcium at day 4 for zoledronic acid 8 mg and at day 7 for zoledronic acid 4 mg and 8 mg.
Korigirani serumski kalcij se je hitreje normaliziral 4. dne (8 mg zoledronske kisline) in 7. dne (4 mg in 8 mg zoledronske kisline).
There was generally no change in the concentration-time profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG).
V splošnem ni bilo sprememb v profilih koncentracija- čas za endogene označevalce estradiol, progesteron, luteinizirajoči hormon (LH), folikle stimulirajoči hormon (FSH), in globulin, ki se veže na spolne hormone (SHBG).
There was high between- patient variability in plasma imatinib AUC levels after an oral dose.
Po peroralnem odmerku so med posameznimi bolniki opazili veliko variabilnost plazemske AUC imatiniba.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medications (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease related medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, ki so se zdravili z docetakselom v odmerku 75 mg/m2, so potrebovali manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in obsevanja (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was no apparent impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety or efficacy (SABRINA).
Očitnega vpliva prisotnosti protiteles proti rituksimabu ali protiteles proti rHuPH20 na varnost in učinkovitost ni bilo (SABRINA).
There was no apparent relationship with respect to occurrence of adverse events in the clinical studies for patients receiving various categories of the most common concomitant medications.
V kliničnih preskušanjih pri bolnikih, ki so sočasno prejemali običajno najbolj predpisane kombinacije zdravil, niso ugotovili očitne povezave s pojavom neželenih učinkov.
There was no association of the presence of anti-alemtuzumab or inhibitory anti-alemtuzumab antibodies with a reduction in efficacy, change in pharmacodynamics, or the occurrence of adverse reactions, including infusion associated reactions.
Prisotnosti protiteles proti alemtuzumabu ali zaviralnih protiteles proti alemtuzumabu nista bili povezani z z zmanjšanjem učinkovitosti, spremembo farmakodinamike ali pojavnostjo neželenih učinkov, vključno z reakcijami, povezanimi z infuzijo.
There was no attenuation of the bronchodilator effect over time in the 6- and 12-month studies.
Tako v 6-mesečni kot v 12-mesečni študiji se bronhodilatatoren učinek s časom ni zmanjševal.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Pri ponovnem odmerjanju se kinetika imatiniba ni spreminjala, kopičenje pa je bilo pri enem odmerku na dan v stanju dinamičnega ravnovesja 1,5–2,5-kratno.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5–2.5-fold at steady state when dosed once daily.
Pri ponavljajočem se odmerjanju se kinetika imatiniba ni spreminjala, kopičenje pa je bilo pri enem odmerku na dan v stanju dinamičnega ravnovesja 1,5–2,5-kratno.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5–2.5-fold at steady state when dosed once daily.
Pri ponovnem odmerjanju se kinetika imatiniba ni spreminjala, kopičenje pa je bilo pri enem odmerku na dan v stanju dinamičnega ravnovesja 1,5–2,5-kratno.
There was no clear relationship between decreases in neutrophils below 1 x 109/L and the occurrence of serious infections.
Jasne povezave med zmanjšanjem števila nevtrofilcev pod 1 x 109/l in pojavov resnih okužb ni bilo.
There was no clinical evidence in the vehicle-controlled studies of interactions with systemic antiretroviral agents, including protease inhibitors; macrolide antibiotics and azole antifungals.
Kliničnih izsledkov v nadzorovanih študijah medsebojnega delovanja zdravila s sistemskimi antiretrovirusnimi učinkovinamikot so inhibitorji proteaze, makrolidni antibiotiki in azolni antimikotiki ni bilo.
There was no clinically meaningful drug-drug interaction between ketoconazole and apremilast.
Med ketokonazolom in apremilastom ni bilo klinično pomembnih interakcij.
There was no clinically meaningful effect of age on raltegravir pharmacokinetics over the age range studied (19 to 71 years, with few (8) subjects over the age of 65).
V preiskovanih starostnih skupinah (od 19 do 71 let, z manjšim številom (8) oseb, starejših od 65 let) starost ni imela klinično pomembnega vpliva na farmakokinetiko raltegravirja.
There was no clinically relevant difference in pharmacokinetics of Levemir between older and young subjects.
Klinično pomembne razlike v farmakokinetiki zdravila Levemir med starejšimi in mlajšimi bolniki niso bile ugotovljene.
There was no clinically relevant difference in pharmacokinetics of Levemir between subjects with renal or hepatic impairment and healthy subjects.
Klinično pomembne razlike v farmakokinetiki zdravila Levemir med bolniki z ledvično ali jetrno okvaro in zdravimi ljudmi niso bile ugotovljene.
There was no clinically relevant effect of age (18-64 years) or gender on the pharmacokinetics of lomitapide.
Klinično pomembnega učinka starosti (18–64 let) ali spola na farmakokinetiko lomitapida ni bilo.
There was no consistent difference in mean Cmax between orodispersible tablets and film coated tablets.
Očitne razlike v povprečni Cmax med orodisperzibilnimi in filmsko obloženimi tabletami ni.
There was no correlation of antibody activity with either clinical efficacy or safety.
Korelacije med aktivnostjo protiteles in bodisi klinično učinkovitostjo bodisi varnostjo ni bilo.
There was no detectable plasma protein binding following administration of [14C]-migalastat hydrochloride in the concentration range between 1 and 100 M.
Po aplikaciji [14C]-migalastatijevega klorida v koncentracijskem razponu od 1 do 100 M ni bilo zaznavne vezave na plazemske proteine.
There was no difference between ataluren 20-, 20-, 40 mg/kg and placebo.
Med atalurenom v odmerkih 20, 20 in 40 mg/kg ter placebom ni bilo razlike.
There was no difference between the atosiban and beta- mimetic groups with regard to this parameter.
Skupini, ki sta prejemali atosiban in beta-mimetik, se v tem pogledu nista razlikovali.
There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
Skupini, ki sta prejemali atosiban in beta-mimetik, se v tem pogledu nista razlikovali.
There was no difference between the combination and the individual components in severity for any observed adverse reactions.
Glede resnosti opazovanih neželenih učinkov ni bilo nobenih razlik med kombinacijo in posameznimi komponentami.
There was no difference in ORR between the treatment arms in patients with non-squamous histology (N=602, 26% vs 25%, p=0.808).
Razlike v ORR med zdravljenima skupinama pri bolnikih z neploščatocelično histologijo ni bilo (N=602, 26 % proti 25 %, p=0,808).
There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil fumarate.
Razlike v spremembi od začetne vrednosti BMD ali BMC za rilpivirin v primerjavi s kontrolno skupino, splošno populacijo ali bolniki z osnovno shemo zdravljenja, vključno z dizoproksiltenofovirijevim fumaratom, ni bilo.
There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7% in antibody positive patients compared to 2.5% in antibody-negative patients during the entire treatment period).
Varnostne značilnosti se med bolniki v celoti niso razlikovale ne glede na izvid protiteles, z izjemo večje incidence reakcij na mestu injiciranja (4,7 % pri bolnikih s pozitivnim izvidom protiteles v primerjavi s 2,5 % pri bolnikih z negativnim izvidom protiteles med celotnim obdobjem zdravljenja) .
There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7% in antibody-positive patients compared to 2.5% in antibody-negative patients during the entire treatment period).
Varnostne značilnosti se med bolniki v celoti niso razlikovale ne glede na izvid protiteles, z izjemo večje incidence reakcij na mestu injiciranja (4,7 % pri bolnikih s pozitivnim izvidom protiteles v primerjavi s 2,5 % pri bolnikih z negativnim izvidom protiteles med celotnim obdobjem zdravljenja) .
There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7%in antibody positive patients compared to 2.5% in antibody negative patients during the entire treatment period).
Varnostne značilnosti se med bolniki v celoti niso razlikovale ne glede na izvid protiteles, z izjemo večje incidence reakcij na mestu injiciranja (4,7 % pri bolnikih s pozitivnim izvidom protiteles v primerjavi s 2,5 % pri bolnikih z negativnim izvidom protiteles med celotnim obdobjem zdravljenja).
There was no difference in the pharmacokinetic profile of alglucosidase alfa in these juvenile late- onset patients compared to infantile-onset patients.
V farmakokinetičnem profilu alglukozidaze alfa ni bilo razlike med temi mladimi bolniki s poznim nastopom bolezni v primerjavi z bolniki z zgodnjim nastopom bolezni.
There was no dose- response effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg to 1.0 mg.
Pri odmerkih protiteles v razponu od 0,1 mg do 1,0 mg velikost odmerka ni vplivala na učinkovitost slikanja (občutljivost ali specifičnost).
There was no drug-related increase in tumour incidence in any other organ.
Drugih z zdravilom povezanih povišanj incidenc tumorjev kateregakoli organa ni bilo.
There was no effect of anti-ipilimumab antibodies on the CL of ipilimumab.
Protitelesa proti ipilimumabu niso vplivala na očistek ipilimumaba.
There was no effect of mild (50 mL/min ≤ CLcr ≤80 mL/min) or moderate (30 mL/min ≤ CLcr < 50 mL/min) renal insufficiency on the clearance of total MTP-PE, when compared with that observed in healthy adult subjects with normal renal function (CLcr > 80 mL/min).
Vpliva blage (50 ml/min ≤CLcr ≤80 ml/min) ali zmerne (30 ml/min ≤CLcr <50 ml/min) ledvične insuficience na očistek skupnega MTP-PE v primerjavi z očistkom pri zdravih odraslih osebah z normalnim delovanjem ledvic (CLcr >80 ml/min) niso opazili.
There was no effect on embryomortality and no increased incidence of malformations.
Vpliva na umrljivosti zarodkov in povečanja pojava malformacij ni bilo.
There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.
Enkratni peroralni odmerki 200 mg avanafila niso vplivali na gibljivost ali morfologijo semenčic zdravih prostovoljcev.
There was no effect on the clearance of safinamide in patients with PD receiving safinamide as adjunct to chronic L-dopa and/or DA-agonists and safinamide treatment did not change the pharmacokinetic profile of co-administered L-dopa.
Ni bilo učinka na očistek safinamida pri bolnikih s parkinsonovo boleznijo, ki so safinamid prejemali kot dodatek dolgotrajnemu zdravljenju z L-dopo in/ali DA-agonisti in zdravljenje s safinamidom ni spremenilo farmakokinetičnega profila sočasno dajane L-dope.
There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the maximum recommended human dose of 10 mg/day on an mg/m2 basis).
Peroralni odmerki amlodipinijevega maleata do 10 mg amlodipina na kilogram na dan (odmerek, ki je približno 10-krat večji od največjega priporočenega odmerka za ljudi 10 mg na dan na osnovi mg/m2) niso vplivali na plodnost podgan (samci 64 dni in samice 14 dni pred parjenjem).
There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m2 basis).
Pri podganah, ki so jim dajali amlodipin (samcem 64 dni, samicam pa 14 dni pred parjenjem) v odmerkih do 10 mg/kg/dan (8-kratnik* največjega priporočenega 10 mg odmerka za ljudi na podlagi mg/m2), ni bilo nikakršnega vpliva na plodnost.
There was no effect on the R- warfarin pharmacokinetics or on coagulation.
Učinka na farmakokinetiko R-varfarina ali na koagulacijo ni bilo.
There was no evidence for age to affect the pharmacokinetics of fluticasone furoate in subjects with COPD while there was an increase (37%) in AUC (0-24) of vilanterol over the observed age range of 41 to 84 years.
Izsledki niso pokazali, da bi starost pri preiskovancih s KOPB vplivala na farmakokinetiko flutikazonfuroata, so pa v starosti od 41 do 84 let ugotovili povečanje AUC(0-24) vilanterola za 37 %.
There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
= 0,048)], medtem ko korist pri srčnožilni umrljivosti ni bila dokazana (razmerje tveganja 1,03, 95- odstotni interval zaupanja 0,85 - 1,24).
There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females).
Populacijska farmakokinetična analiza podatkov III. faze pri 1213 preiskovancih z astmo (712 žensk) in 1255 preiskovancih s KOPB (392 žensk) ni pokazala, da bi spol, telesna masa ali ITM (indeks telesne mase) vplivali na farmakokinetiko flutikazonfuroata.
There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females).
Populacijska farmakokinetična analiza podatkov III. faze pri 1213 preiskovancih z astmo (712 žensk) in 1255 preiskovancih s KOPB (392 žensk) ni pokazala, da bi spol, telesna masa ali ITM (indeks telesne mase) vplivali na farmakokinetiko flutikazonfuroata.
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females).
Populacijska farmakokinetična analiza podatkov 856 preiskovancev z astmo (500 žensk) in 1091 preiskovancev s KOPB (340 žensk) ni pokazala, da bi spol, telesna masa ali ITM vplivali na farmakokinetiko vilanterola.
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).
Populacijska farmakokinetična analiza podatkov 856 preiskovancev z astmo (500 žensk) in 1091 preiskovancev s KOPB (340 žensk) ni pokazala, da bi spol, telesna masa ali ITM vplivali na farmakokinetiko vilanterola.
There was no evidence for tachyphylaxis in the effect of ANORO over time.
Znakov postopnega zmanjšanja učinkovitosti (tahifilaksije) zdravila ANORO ni bilo.
There was no evidence for tachyphylaxis in the effect of Incruse over time.
Ni bilo znakov, da bi se skozi čas razvila tahifilaksija na učinek zdravila Incruse.
There was no evidence for tachyphylaxis in the effect of LAVENTAIR over time.
Znakov postopnega zmanjšanja učinkovitosti (tahifilaksije) zdravila LAVENTAIR ni bilo.
There was no evidence of adverse reactions of tafamidis on fertility, reproductive performance or mating behaviour in the rat at any dose level.
Pri podganah pri nobenem odmerku ni bilo dokazov o neželenih učinkih tafamidisa na plodnost, sposobnost razmnoževanja ali paritveno obnašanje.
There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding antibody development.
V primeru nastanka vežočih protiteles proti pembrolizumabu niso ugotovili spremenjenega farmakokinetičnega ali varnostnega profila.
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
O kancerogenem učinku klopidogrela v odmerkih do 77 mg/kg na dan (kar predstavlja najmanj 25- krat večjo izpostavljenost kot pri človeku ob jemanju kliničnega odmerka 75 mg na dan), ki so ga mišim dajali 78 tednov, podganam pa 104 tedne, ni bilo dokazov.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Dokazov o mutagenem in klastogenem delovanju kombinacije irbesartana in hidroklorotiazida ni.
There was no evidence of teratogenic effects or foetotoxicity due to enoxaparin.
Ugotovili niso nobenih znakov teratogenih ali fetotoksičnih učinkov enoksaparina.
There was no excess in major bleeds with Clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4% Clopidogrel+ASA vs.
Število velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot 5 dni pred kirurškim posegom (4,4 % klopidogrel in ASA proti 5,3 % placebo in ASA).
There was no formation of anti-ofatumumab antibodies in patients with CLL after treatment with Arzerra.
Pri bolnikih s KLL po zdravljenju z ofatumumabom niso nastajala protitelesa proti ofatumumabu.
There was no formation of anti-ofatumumab antibodies in patients with CLL after treatment with ofatumumab.
Pri bolnikih s KLL po zdravljenju z ofatumumabom niso nastajala protitelesa proti ofatumumabu.
There was no gender difference in severity or treatment discontinuation due to rash.
Kar zadeva izrazitost izpuščaja ali ukinitev zdravila zaradi izpuščaja med spoloma ni bilo razlik.
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric patients in study C213 (33 to 93 kg), similar to what was observed in adults.
V študiji C213 telesna masa (33 do 93 kg) ni vplivala na farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, kar je podobno ugotovitvam pri odraslih.
There was no improvement in terms of fibrosis observed in this study.
Glede fibroze v tej študiji niso opažali izboljšanja.
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
Po drugem odmerku ni bilo povečanja, ne glede na to, ali so otroci dobili polovični ali celotni odmerek za odrasle, razen nekaterih neželenih učinkov, ki so bili pogostejši po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, mlajših od 6 let.
There was no increased incidence of serious infections observed in patients with lymphocyte counts
Pri bolnikih s številom limfocitov < 0,8 x 109/l ali < 0,5 x 109/l niso opazili zvišanja incidence okužb in resnih okužb.
There was no increased rate in overall infections or serious infections in patients with low IgA, IgG or IgM.
Bolnikom z nizkimi IgA, IgG ali IgM se ni povečal delež vseh okužb ali resnih okužb.
There was no indication for a genotoxic potential of regorafenib tested in standard assays in vitro and in vivo in mice.
Standardni preskusi in vitro ter in vivo pri miših niso pokazali genotoksičnega potenciala regorafeniba.
There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section 5.1).
Imunski odziv na cepiva proti virusu japonskega encefalitisa ali hepatitisu A ali steklini ni bil moten (glejte poglavje 5.1).