natgillin/translations-raw huggingface dataset:
Based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Izkušnje z drugimi zdravili, ki zavirajo delovanje renin- angiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).
Based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Izkušnje z drugimi zdravili, ki zavirajo delovanje renin-angiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).
Based on the extent of
Glede na obseg zavrtja z
Based on the FACT-Lym questionnaire and EQ-5D index scale collected during the treatment and during follow-up periods, health-related quality of life was generally maintained in the pivotal study with no significant difference between the arms.
Na podlagi vprašalnika FACT-Lym in indeksne lestvice EQ-5D, uporabljenih med zdravljenjem in obdobjem spremljanja, se je zdravstvena kakovost življenja v ključni študiji na splošno ohranila; med skupinama ni bilo značilnih razlik.
Based on the final PK model trial simulation results, taking into account all the covariates effects, a sunitinib dose of 25 mg/m2/day in paediatric patients (ages 6-11 and 12-17 years) with GIST is predicted to achieve comparable sunitinib plasma exposures to those in adult patients with GIST treated at 50 mg/day, on Schedule 4/2.
Končni rezultati simulacije farmakokinetičnega modela preskušanja, ob upoštevanju učinkov vseh sospremenljivk, kažejo da sunitinib v odmerku 25 mg/m2/dan pri pediatričnih bolnikih (starih 6-11 in 12-17 let) z GIST predvidoma zagotovi izpostavljenosti sunitinibu v plazmi, ki so primerljive s tistimi pri odraslih bolnikih z GIST, ki se zdravijo s 50 mg/dan po shemi 4/2.
Based on the findings from a single-dose pharmacokinetic study, patients with mild, moderate or severe hepatic impairment may receive the recommended starting dose (see sections 4.2 and 5.2).
Glede na ugotovitve farmakokinetične študije z enkratnim odmerkom se pri bolnikih z blago, zmerno ali s hudo okvaro jeter zdravljenje lahko uvede s priporočenim začetnim odmerkom (glejte poglavji 4.2 in 5.2).
Based on the findings in studies BREATHE-3, FUTURE 1 and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients.
Na podlagi izsledkov študij BREATHE-3, FUTURE 1 in FUTURE-3 kaže, da doseže izpostavljenost bosentanu vrhunec pri pediatričnih bolnikih z nižjimi odmerki kot pri odraslih in da odmerki, višji od 2 mg/kg dvakrat na dan (4 mg/kg dvakrat dnevno ali 2 mg/kg trikrat dnevno) pri pediatričnih bolnikih ne bodo povzročili večje izpostavljenosti bosentanu.
Based on the findings in studies BREATHE-3, FUTURE 1, and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients.
Na podlagi izsledkov študij BREATHE-3, FUTURE 1 in FUTURE-3 kaže, da doseže izpostavljenost bosentanu vrhunec pri pediatričnih bolnikih z nižjimi odmerki kot pri odraslih in da odmerki višji od 2 mg/kg dvakrat na dan (4 mg/kg dvakrat dnevno ali 2 mg/kg trikrat dnevno) pri pediatričnih bolnikih ne bodo povzročili večje izpostavljenosti bosentanu.
Based on the findings of the studies, Loxicom was considered to be bioequivalent to the reference medicinal product.
Na podlagi izsledkov študije je bilo ugotovljeno, da je zdravilo Loxicom biološko enakovredno referenčnemu zdravilu.
Based on the findings of the studies, Rheumocam was considered to be bioequivalent to the reference medicine.
V študijah je bilo ugotovljeno, da je zdravilo Rheumocam biološko enakovredno referenčnemu zdravilu.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila ARICLAIM preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Cymbalta preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Duloxetine Lilly before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Duloxetine Lilly preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Xeristar before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja zdravila Xeristar preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping YENTREVE before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina mora po prenehanju jemanja zdravila YENTREVE preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4.3).
Based on the high inter-individual variability of exposure these effects are not considered clinically relevant.
Na podl agi velike variabilnosti izpostavljenosti med posamezniki, našteti učinki ne veljajo za klinično pomembne.
Based on the high plasma protein binding riociguat is not expected to be dialysable.
Zaradi visoke stopnje vezave na plazemske proteine ni pričakovati, da bi se riociguat dializiral.
Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of TOBI Podhaler is not recommended with other medicinal products with nephrotoxic or ototoxic potential.
Glede na profil interakcij tobramicina pri intravenski in aerosolni uporabi sočasna in/ali zaporedna uporaba zdravila TOBI Podhaler z drugimi zdravili, ki imajo nefrotoksičen ali ototoksičen potencial, ni priporočena.
Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of Vantobra is not recommended with other medicinal products with nephrotoxic or ototoxic potential, such as: amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); platinum compounds (risk of increased nephrotoxicity and ototoxicity);
Glede na profil interakcij tobramicina pri intravenski uporabi in uporabi v obliki aerosola, sočasna in/ali zaporedna uporaba zdravila Vantobra z drugimi zdravili, ki imajo nefrotoksičen ali ototoksičen potencial, ni priporočena: amfotericin B, cefalotin, ciklosporin, takrolimus, polimiksini (tveganje za povečano nefrotoksičnost); zdravila, ki vsebujejo platino (tveganje za povečano nefrotoksičnost in ototoksičnost);
Based on the Kaplan- Meier estimates, 87% (95% CI: [78%–92%]) of CP-CML (median duration of treatment: 866 days) patients who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months.
Na podlagi ocene Kaplan-Meier se projicira, da bo 87 % (95-% IZ: [78 %–92 %]) bolnikov s CP-KML (mediana trajanja zdravljenja: 866 dni), ki so dosegli MCyR in 66 % (95-% IZ: [55 %–75%]) bolnikov s CP-KML, ki so dosegli MMR, ohranilo odgovor še v 24. mesecu.
Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI: [85%-97%]) for dasatinib and 73% (95% CI: [54%-91%]) for imatinib.
Na osnovi Kaplan-Meierjeve ocene je bil pri zdravljenju z dasatinibom delež bolnikov z 1-letnim preživetjem brez progresije bolezni 91% (95% interval zaupanja: [85% - 97%]), pri zdravljenju z imatinibom pa 73% (95% interval zaupanja: [54% - 91%]).
Based on the known interaction of voriconazole with low dose ritonavir (see voriconazole SmPC) the co-administration of tipranavir/r and voriconazole should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
vorikonazolom in majhnimi odmerki ritonavirja (glejte Povzetek glavnih značilnosti vorikonazola) se je treba sočasnega dajanja tipranavirja/r in vorikonazola izogibati, razen če je uporaba vorikonazola upravičena glede na oceno razmerja med koristjo in tveganjem za bolnika.
Based on the large reduction in bosutinib exposure that occurred when bosutinib was co-administered with rifampicin, increasing the dose of Bosulif when co-administering with strong or moderate CYP3A inducers is unlikely to sufficiently compensate for the loss of exposure.
Na podlagi velikega zmanjšanja izpostavljenosti bosutinibu, do katerega je prišlo pri sočasni uporabi z rifampicinom, povečanje odmerka zdravila Bosulif pri sočasni uporabi z močnimi ali zmernimi induktorji CYP3A najverjetneje ne bo v zadostni meri nadomestilo zmanjšane izpostavljenosti.
Based on the limited amount of available information, in case of an exposure to hydroxycarbamide of pregnant female patients or pregnant partners of male patients, treated by hydroxycarbamide, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered.
Na podlagi omejenih razpoložljivih podatkov o primerih izpostavljenosti nosečih bolnic hidroksikarbamidu ali nosečih partneric bolnikov, zdravljenih s hidroksikarbamidom, je treba razmisliti o skrbnem nadziranju z ustreznimi kliničnimi, biološkimi in ultrazvočnimi preiskavami.
Based on the limited clinical information from the Phase 1/2 study, some evidence of clinical activity was observed in patients with Bcr-Abl mutations (see Table 4).
Na osnovi omejenih kliničnih podatkov iz študije 1./2. faze so določene znake klinične aktivnosti opazili pri bolnikih z mutacijami Bcr-Abl (glejte preglednico 4).
Based on the limited data currently available the development of ADA seems to occur more frequently in infants.’
Na podlagi omejenih podatkov se zdi, da ADA razvije pogosteje pri dojenčkih.
Based on the limited data currently available, Kaletra should not be administered once daily in paediatric patients (see section 5.1).
Na podlagi omejenih podatkov, ki so trenutno na razpolago, se zdravila Kaletra ne sme odmerjati enkrat na dan pri pediatričnih bolnikih (glejte poglavje 5.1).
Based on the limited data currently available, Kaletra should not be administered once daily in paediatric patients (see section 5.1).
Na podlagi omejenih podatkov, ki so trenutno na razpolago, se zdravila Kaletra ne sme odmerjati enkrat na dan pri pediatričnih bolnikih.
Based on the limited data currently available, lopinavir/ritonavir should not be administered once daily in paediatric patients (see section 5.1).
Ker so podatki za to starostno skupino omejeni, lopinavirja/ritonavija pri pediatričnih bolnikih ni dovoljeno dajati enkrat na dan (glejte poglavje 5.1).
Based on the local epidemiological situation and the decision of the prescribing veterinarian, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Glede na lokalne epidemiološke okoliščine in po presoji odgovornega veterinarja se lahko to zdravilo v priporočenih odmerkih daje v mesečnih intervalih ves čas sezone, kakor je opisano spodaj.
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj zdravil, če je kombinacija umeklidinij/vilanterol uporabljena sočasno z zaviralci CYP2D6 ali pri bolnikih z genetskim pomanjkanjem CYP2D6 (slabi metabolizatorji).
Based on the main measure of effectiveness 116 out of 139 cats (84%) were considered to be treated successfully.
Glede na glavno merilo učinkovitosti se ocenjuje, da je bilo zdravljenje uspešno pri 116 mačkah od 139 (84 %).
Based on the mechanism of action of MabThera and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following MabThera therapy (see section 5.1).
Glede na mehanizem delovanja zdravila MabThera in dejstvo, da imajo celice B pomembno vlogo pri vzdrževanju normalnega imunskega odziva, imajo lahko bolniki, ki se zdravijo z zdravilom MabThera, povečano tveganje za okužbe (glejte poglavje 5.1).
Based on the mechanism of action, trifluridine is suspected to cause congenital malformations when administered during pregnancy.
Glede na mehanizem delovanja trifluridina obstaja sum, da povzroča prirojene nepravilnosti, če ga jemljejo nosečnice.
Based on the metabolic profiles of
Zaradi presnovnih lastnosti
Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Na podlagi načina delovanja zdravilne učinkovine ni teoretičnih razlogov, ki bi narekovali zmanjšanje odmerka za starejše bolnike.
Based on the non-clinical study (see section 5.3) it is not recommended to combine NovoThirteen and rFVIIa.
Na podlagi neklinične študije (glejte poglavje 5.3) ni priporočljivo, da bi zdravilo NovoThirteen in rFVIIa uporabljali v kombinaciji.
Based on the observed data in study BO22227, steady state with the intravenous formulation was reached at Cycle 8.
Glede na opažene podatke v študiji BO22227 je bilo stanje dinamičnega ravnovesja pri intravenski obliki doseženo v 8. ciklu.
Based on the Patient Global Assessment of Treatment Satisfaction, more than 85% of subjects in the CORD I and CORD II studies reported either being quite satisfied or very satisfied with their treatment with Xiapex versus approximately 30% treated with placebo (p<0.001).
Na osnovi globalne ocene zadovoljnosti z zdravljenjem je več kot 85 % preskušancev v študijah CORD I in CORD II poročalo, da so bodisi precej zadovoljni bodisi zelo zadovoljni s svojim zdravljenjem z zdravilom Xiapex v primerjavi s približno 30 %, zdravljenih s placebom (p < 0,001).
Based on the pharmacological actions of pertuzumab and anthracyclines an increased risk of cardiac toxicity might be expected from concomitant use of these agents compared with sequential use, although not seen in the TRYPHAENA study.
Na podlagi farmakološkega delovanja pertuzumaba in antraciklinov je mogoče pričakovati večje tveganje za srčno toksičnost ob sočasni uporabi teh učinkovin v primerjavi z zaporedno uporabo, čeprav tega v študiji TRYPHAENA ni bilo opaziti.
Based on the pharmacological mechanism of action of efalizumab, the use of Raptiva is not expected to affect patient’s ability to drive and use machines.
Na podlagi farmakološkega mehanizma delovanja efalizumaba, ni pričakovati, da bi uporaba Raptive vplivala na bolnikovo sposobnost vožnje in upravljanja s stroji.
Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Na osnovi farmakološkega mehanizma delovanja hidroklorotiazida lahko njegova uporaba v drugem in tretjem trimesečjem nosečnosti ogroža fetoplacentno perfuzijo in lahko pri plodu ali novorojenčku povzroči zlatenico, motnje elektrolitskega ravnovesja in trombocitopenijo.
Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foeto and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Na osnovi farmakološkega mehanizma delovanja hidroklorotiazida lahko njegova uporaba v drugem in tretjem trimesečju nosečnosti ogroža fetoplacentno perfuzijo in lahko pri plodu ali novorojenčku povzroči zlatenico, motnje elektrolitskega ravnovesja in trombocitopenijo.
Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman.
Glede na njegove farmakološke lastnosti bi aksitinib lahko škodoval plodu, če bi ga jemala nosečnica.
Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), eluxadoline is expected to have minimal abuse or dependence liability.
Na podlagi fizikalno-kemijskih in biofarmacevtskih lastnosti (zelo majhna peroralna biološka uporabnost) se pri eluksadolinu pričakuje minimalno tveganje za zlorabo ali odvisnost.
Based on the PK, safety, and efficacy trial simulation results, a starting dose of approximately 25 mg/m2/day on schedule 4/2 in paediatric patients with GIST (ages 6-11 and 12-17 years) is predicted to provide comparable sunitinib plasma exposures, and subsequently safety and efficacy to those in adult patients with GIST treated at 50 mg/day on schedule 4/2.
Rezultati simulacije študije farmakokinetike, varnosti in učinkovitosti kažejo, da začetni odmerek približno 25 mg/m2/dan po shemi 4/2 pri pediatričnih bolnikih (starih 6-11 in 12-17 let) z GIST predvidoma zagotovi izpostavljenosti sunitinibu v plazmi, ter posledično profil varnosti in učinkovitosti, primerljive s tistimi pri odraslih bolnikih z GIST, ki prejemajo odmerek 50 mg/dan po shemi 4/2.
Based on the planned date of your infusion of ALIMTA and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Na podlagi načrtovanega datuma vaše infuzije zdravila ALIMTA in/ali glede na delovanje vaših ledvic vam mora vaš zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
Based on the planned date of your infusion of Armisarte and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Na podlagi načrtovanega datuma vaše infuzije zdravila Armisarte in/ali glede na delovanje vaših ledvic vam mora vaš zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
Based on the planned date of your infusion of Pemetrexed Accord and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Na podlagi načrtovanega datuma vaše infuzije zdravila Pemetreksed Accord in/ali glede na delovanje vaših ledvic vam mora vaš zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
Based on the pooled analysis results, treatment with OZURDEX implants showed statistically significantly greater incidence of responders, defined as patients achieving a ≥ 15 letter improvement from baseline in Best Corrected Visual Acuity (BCVA) at 90 days following injection of a single implant, when compared with sham (p < 0.001).
Na podlagi rezultatov analize zbranih podatkov so pri zdravljenju z vsadki OZURDEX pokazali statistično pomembno večjo incidenco bolnikov z odzivom, ki so bili opredeljeni kot bolniki, ki so dosegli izboljšanje ≥ 15 črk od izhodiščne vrednosti pri najboljši vidni ostrini s korekcijo (Best Corrected Visual Acuity – BCVA) 90 dni po injiciranju enega vsadka, v primerjavi s skupino, ki je prejela placebo (p < 0,001).
Based on the poor aqueous solubility and high erythrocyte and plasma protein binding of Rapamune, it is anticipated that Rapamune will not be dialysable to any significant extent.
Zaradi slabe vodotopnosti sirolimusa in precejšnje vezave na eritrocite in plazemske beljakovine se predvideva, da zdravila Rapamune ni mogoče odstraniti z dializo, vsaj ne v pomembnejši meri.
Based on the population estimate for plasma clearance of trabectedin (30.9 l/h) and blood/plasma ratio (0.89), the clearance of trabectedin in whole blood is approximately 35 l/h.
Na podlagi populacijske ocene plazemskega očistka trabektedina (30,9 l/h) in razmerje kri/plazma (0,89) je očistek trabektedina v polni krvi približno 35 l/h.
Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260,
Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 v stanju dinamičnega ravnovesja za sofosbuvir (n = 982), GS-331007 (n = 1.428) in velpatasvir (n = 1.425), kot sledi: 1.260, 13.970 oz.
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted steady-state AUC (95% CI) was 23%-37% higher in Asian patients (N=523) than in non- Asian patients (N=691).
Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 je bila predvidena vrednost AUC v stanju dinamičnega ravnovesja (95 % IZ) za 23 %-37 % večja pri azijskih bolnikih (n = 523) kot pri bolnikih, ki niso bili azijskega porekla (n = 691).
Based on the population pharmacokinetic analysis, 12 to 14 year old adolescents weighing less than 50 kg should receive children’s doses (sees ection4.2).
Na osnovi populacijske farmakokinetične analize morajo bolniki, stari od 12 do 14 let, s telesno maso manj kot 50 kg, prejemati odmerke za otroke (glejte poglavje 4.2).
Based on the population pharmacokinetic analysis, 12- to 14- year-old adolescents weighing less than 50 kg should receive children's doses (see section 4.2).
Na osnovi populacijske farmakokinetične analize morajo bolniki, stari od 12 do 14 let, s telesno maso manj kot 50 kg, prejemati odmerke za otroke (glejte poglavje 4.2).
Based on the population pharmacokinetic analysis, 12- to 14- year-old adolescents weighing less than 50 kg should receive children’s doses (see section 4.2).
Na osnovi populacijske farmakokinetične analize morajo bolniki, stari od 12 do 14 let, s telesno maso manj kot 50 kg, prejemati odmerke za otroke (glejte poglavje 4.2).
Based on the population pharmacokinetic analysis, 12- to 14-year-old adolescents weighing less than 50 kg should receive children’s doses (see section 4.2).
Na osnovi populacijske farmakokinetične analize morajo bolniki, stari od 12 do 14 let, s telesno maso manj kot 50 kg, prejemati odmerke za otroke (glejte poglavje 4.2).
Based on the population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of Perjeta between patients < 65 years (n=306) and patients ≥ 65 years (n=175).
Na osnovi populacijske farmakokinetične analize niso ugotovili pomembnih farmakokinetičnih razlik za zdravilo Perjeta med bolniki, ki so bili mlajši od 65 let (n = 306), in bolniki, ki so bili stari 65 let ali več (n = 175).
Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Na osnovi podatkov populacijske farmakokinetične študije, ki je zajela bolnike z velikim razponom v letih (27 do 86 let) in 234 bolnikov (46 %), starih 65 let ali starejših, so ugotovili, da starost ne vpliva na farmakokinetiko 5'-DFUR in 5-FU.