natgillin/translations-raw huggingface dataset:
Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g., 10 kg) than in adult patients (150 mg dose).
Na podlagi analize populacijskega farmakokinetičnega modeliranja so bile pričakovane izpostavljenosti po odmerjanju 2 mg/kg primerljive med vsemi starostnimi skupinami pediatričnih bolnikov s CAPS, pri tem pa so bile pri pediatričnih bolnikih z zelo majhno telesno maso (na primer 10 kg) približno za 40 % manjše kot pri odraslih bolnikih (z odmerkom 150 mg).
Based on the population pharmacokinetics analysis (range 19 to 92 years), age had no relevant clinical effect on trametinib pharmacokinetics.
Na podlagi populacijske farmakokinetične analize (razpon starosti: od 19 do 92 let) starost nima pomembnega kliničnega vpliva na farmakokinetiko trametiniba.
Based on the population PK analysis the exposure to daratumumab was similar between white (n = 197) and non-white (n = 26) subjects.
Po podatkih analize populacijske farmakokinetike sta bili farmakokinetika daratumumaba in izpostavljenost daratumumabu približno enaki pri belcih (n=197) in pripadnikih drugih ras (n=26).
Based on the population PK analysis, liver function parameters including alkaline phosphatase (ALP, 36-2322 U/L), aspartate aminotransferase (AST, 11-197 U/L), alanine aminotransferase (ALT, 5-182 U/L) , and total bilirubin (0.17-3.20 mg/dL) were not significant covariates for PK parameters of either trifluridine or tipiracil hydrochloride.
Na podlagi populacijske farmakokinetične analize parametri spremljanja delovanja jeter, vključno z alkalno fosfatazo (AF, 36 – 2322 U/l), aspartat-aminotransferazo (AST, 11 – 197 U/l), alanin-aminotransferazo (ALT, 5 – 182 U/l) in celotnim bilirubinom (0,17 – 3,20 mg/dl), niso bili hkratne spremenljivke farmakokinetičnih parametrov niti trifluridina niti tipiracilijevega klorida.
Based on the population- pharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Na podlagi farmakokinetičnega modela populacije je volumen porazdelitve (V/F) približno 349 l (SE: ± 2,73 %).
Based on the population- pharmacokinetic (PK) model, the volume of distribution (Vz) is approximately 319 L (SE: ± 2.7%).
Na podlagi farmakokinetičnega modela populacije je volumen porazdelitve Vz) približno 349 l (SE: ± 2,7 %).
Based on the published literature, in vitro studies of binding to human serum proteins, (using paclitaxel at concentrations ranging from 0.1 to 50 µg/ml), indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Kot je navedeno v objavljeni literaturi, in vitro raziskave o vezavi na beljakovine človeškega seruma (ob uporabi paklitaksela v koncentracijah, ki so segale od 0,1 do 50 µg/ml), kažejo, da prisotnost cimetidina, ranitidina, deksametazona ali difenhidramina ni vplivala na vezavo paklitaksela na beljakovine.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Hemofilija A je pri ženskah zelo redka in izkušenj z uporabo faktorja VIII med nosečnostjo in obdobjem dojenja ni.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate
Hemofilija A je pri ženskah zelo redka.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast- feeding is not available.
Na podlagi redke pojavnosti hemofilije B pri ženskah, podatki o izkušnjah glede uporabe faktorja IX med nosečnostjo in dojenjem niso na voljo.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast- feeding is not available.
Na podlagi redkega pojavljanja hemofilije B pri ženskah, izkušenj v zvezi z uporabo faktorja IX med nosečnostjo in dojenjem ni.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Na podlagi redkega pojavljanja hemofilije B pri ženskah, izkušenj v zvezi z uporabo faktorja IX med nosečnostjo in dojenjem ni.
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81 % of the dose was recovered within 7 days in faeces (68 % of dose) and urine (13 % of dose).
Na podlagi izločenih spojin(e) po peroralnem odmerku imatiniba, označenega s 14C, se je približno 81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Na podlagi izločenih spojin po peroralnem odmerku imatiniba, označenega s 14C, se je približno 81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Na podlagi izločenih spojin(e) po peroralnem odmerku imatiniba, označenega s 14C, se je približno 81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
Based on the reported cases and the suggested mechanism of action, it is deemed appropriate to include the risk of renal failure and acute renal failure as a new warning and as a new adverse drug reaction in the summary of product characteristics.
Na podlagi zabeleženih primerov in domnevnega mehanizma delovanja se zdi primerno, da se tveganje za odpoved ledvic in akutno odpoved ledvic vključi v povzetek glavnih značilnosti zdravila kot novo opozorilo in nov neželen učinek zdravila.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Glede na odmerek (izražen v mg), ki ga potrebuje bolnik, aseptično izvlecite ustrezno količino osnovne raztopine z 10 mg docetaksela/ml iz ustreznega števila vial z osnovno raztopino; uporabite graduirane injekcijske brizge z iglo.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle.
Glede na zahtevan odmerek za bolnika, izražen v mg, aseptično odvzemite potreben volumen koncentrata za raztopino, ki vsebuje 20 mg/ml docetaksela z graduirano brizgo z iglo 21 G iz ustreznega števila vial.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle.
Glede na zahtevan odmerek za bolnika, izražen v mg, aseptično odvzemite potreben volumen koncentrata za raztopino, ki vsebuje 20 mg/ml docetaksela z graduirano brizgo z iglo iglo 21G iz ustreznega števila vial.
Based on the required dose for the patient, withdraw the necessary volume of ZALTRAP concentrate from the vial.
Glede na odmerek, ki ga potrebuje bolnik, izvlecite iz viale potrebno količino koncentrata zdravila ZALTRAP.
Based on the results from clinical trials with other authorized erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Na osnovi kliničnih preskušanj z drugimi eritropoetini z dovoljenjem za prometje pričakovati, da bo do neželenih učinkov prišlo pri približno 8% bolnikov, ki se jih zdravi z eritropoetinom.
Based on the results from this study, Aptivus oral solution might be expected to have a similar interaction profile as the capsules.
Na podlagi izsledkov te raziskave lahko pričakujemo, da ima zdravilo Aptivus peroralna raztopina podoben profil interakcij kot kapsule.
Based on the results of a Phase 3 study in mantle cell lymphoma, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopaenia, lymphopaenia, myalgia, arthralgia, taste loss, dizziness, upper respiratory infection, mucositis, and rhinitis.
Glede na rezultate študije 3. faze limfoma plaščnih celic so pri starejših bolnikih ( 65 let starosti) verjetnejši nekateri neželeni učinki, med drugim plevralni izliv, anksioznost, depresija, nespečnost, dispneja, levkopenija, limfopenija, mialgija, artralgija, izguba okušanja, omotica, okužba zgornjih dihal, vnetje sluznic in rinitis.
Based on the results of a Phase 3 study in renal cell carcinoma, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including oedema, diarrhoea, and pneumonia.
Rezultati študije 3. faze karcinoma ledvičnih celic so pokazali, da so pri starejših bolnikih ( 65 let starosti) verjetnejši nekateri neželeni učinki, med drugim edemi, diareja in pljučnica.
Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that co- administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Na podlagi rezultatov študije enkratnega odmerjanja priporočenih odmerkov peroralne oblike mofetilmikofenolata in intravenske oblike ganciklovirja in znanih učinkov ledvične okvare na farmakokinetiko mofetilmikofenolata (glejte poglavje 4.2) in ganciklovirja, je pričakovati, da bo sočasno dajanje obeh učinkovin, ki tekmujeta v mehanizmih renalne tubularne sekrecije, povzročilo zvišanje koncentracij mikofenolglukuronida in ganciklovirja.
Based on the results of Analysis of Variance (ANOVA), body weight is the main covariate of exposure (by Cmax and AUC) in relapsing remitting multiple sclerosis (RRMS) subjects, but did not affect safety and efficacy measures evaluated in the clinical studies.
Na podlagi rezultatov analize variance (ANOVA, analysis of variance), je telesna masa glavna sospremenljivka izpostavljenosti (po Cmax in AUC) pri osebah z recidivno remitentno multiplo sklerozo (RRMS), vendar ni vplivala na ukrepe glede varnosti in učinkovitosti, ki so jih ovrednotili v kliničnih študijah.
Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the Pom + LD-Dex arm.
Na podlagi rezultatov obeh končnih ciljev PFS in celokupnega preživetja je Odbor za spremljanje podatkov (Data Monitoring Committee) za to študijo priporočil, da se zaključi, bolnike iz skupine VO- deks pa se priključi skupini POM + NO-deks.
Based on the results of drug-drug clinical interaction studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Na osnovi rezultatov študij medsebojnega delovanja z drugimi učinkovinami (npr. escitalopram, zolpidem, etinilestradiol), ne moremo izključiti indukcije presnovnih encimov s telapravirjem.
Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir is low.
Na podlagi rezultatov in vitro preskušanj, ter znanih glavnih presnovnih poti abakavirja obstaja le majhna verjetnost, da bo prišlo do s P450 povezanih interakcij z drugimi zdravili.
Based on the results of population pharmacokinetic analyses that included Caucasian, African American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically meaningful effect on the pharmacokinetics of Eperzan clearance.
Na podlagi rezultatov populacijskih farmakokinetičnih analiz, ki so vključile belce, Afroameričane/Afričane, Azijce in bolnike hispanskega/nehispanskega porekla, rasa in etnična pripadnost nista klinično pomembno vplivali na farmakokinetiko zdravila Eperzan.
Based on the results of study BM 16549, ibandronic acid 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Glede na rezultate BM 16549 pričakujemo, da je ibandronska kislina v odmerku 150 mg enkrat mesečno najmanj enako učinkovita v preprečevanju zlomov kakor ibandronska kislina v odmerku 2,5 mg dnevno.
Based on the results of the cumulative evaluations and considering the pharmacological plausibility of anticholinergic effect on urinary function, there is sufficiently robust evidence to warrant an update of the Product Information with ‘urinary retention, bladder outlet obstruction and dysuria" as ADRs associated to UMEC/VI.
Glede na rezultate kumulativnih ocen in farmakološko prepričljivost antiholinergičnega učinka na delovanje sečil je dovolj trdnih dokazov za dopolnitev informacij o zdravilu z "zastojem urina, obstrukcijo iztočnega dela sečnega mehurja in dizurijo" kot neželenimi učinki kombinacije UMEK/VI.
Based on the results of the phase 3 studies, elderly patients may be more likely to experience certain adverse reactions, including face oedema, pneumonia, pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopaenia, lymphopaenia, myalgia, arthralgia, ageusia, dizziness, upper respiratory infection, mucositis, and rhinitis.
Na osnovi rezultatov študij 3. faze je pri starejših bolnikih verjetneje, da se bodo pojavili nekateri neželeni učinki, vključno z edemom obraza, pljučnico, plevralnim izlivom, anksioznostjo, depresijo, nespečnostjo, dispnejo, levkopenijo, limfopenijo, mialgijo, artralgijo, izgubo okušanja, omotico, okužbo zgornjih dihal, vnetjem sluznic in rinitisom.
Based on the results of the population pharmacokinetic analysis, Perjeta exposure in patients with mild (creatinine clearance [CLcr] 60 to 90 ml/min, N=200) and moderate renal impairment (CLcr 30 to 60 ml/min, N=71) was similar to that in patients with normal renal function (CLcr greater than 90 ml/min, N=200).
Na osnovi rezultatov farmakokinetične populacijske analize je bila izpostavljenost zdravilu Perjeta pri bolnikih z blago ledvično okvaro (očistek kreatinina [Clcr] = 60 do 90 ml/min, n = 200) ter bolnikih z zmerno ledvično okvaro (Clcr = 30 do 60 ml/min, n = 71) podobna kot pri bolnikih z normalno ledvično funkcijo (Clcr večji kot 90 ml/min, n = 200).
Based on the results of the studies, the Committee decided that Ozurdex’s benefits are greater than its risks in patients with uveitis or macular oedema related to blocked veins, and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Ozurdex pri bolnikih z uveitisom ali makularnim edemom, povezanim z zaporo ven, večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Based on the results of transporter inhibition studies drug-drug interactions related to dextromethorphan inhibition of P-gp, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 or BSEP are not expected during treatment withNUEDEXTA.
Na podlagi rezultatov študij medsebojnega delovanja s prenašalci, se medsebojno delovanje zdravil, povezano z zaviranjem P-glikoproteina, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 in BSEP, ki bi ga povzročal dekstrometorfan, pri zdravljenju z zdravilom NUEDEXTA ne pričakuje.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zoledronic Acid Teva therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zdravilom Zoledronska kislina Teva, opisane primere hipokalciemije in posledičen razvoj aritmije.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zdravilom zolendronska kislina, opisane primere hipokalciemije in posledičen razvoj aritmije.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali v obdobju trženja zdravila, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zdravilom Zoledronska kislina Mylan, opisane primere hipokalciemije in posledičen razvoj aritmije.
Based on the short half-life of axitinib, steady state is expected within 2 to 3 days of the initial dose.
Glede na kratek razpolovni časa aksitiniba je vzpostavitev stanja dinamičnega ravnovesja mogoče pričakovati v 2 do 3 dneh po začetnem odmerku.
Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at Week 16.
Na podlagi zasnove študij so v 16. tednu bolnike, pri katerih se število občutljivih in oteklih sklepov ni izboljšalo vsaj za 20 %, smatrali kot neodzivne na zdravljenje.
Based on the three cases of SJS and the potentially life-threatening and severe consequences of the event SJS/TEN an update of section 4.8 of the SmPC is recommended.
Na podlagi teh treh primerov SJS in potencialno življenje ogrožajočih in težkih posledic dogodka SJS/TEN se priporoča posodobitev poglavja 4.8 Povzetka glavnih značilnosti zdravila.
Based on the Visual Symptom Assessment Questionnaire (VSAQ-ALK), patients treated with crizotinib in Study 1007 and Study 1014 reported a higher incidence of visual disturbances compared to patients treated with chemotherapy.
Glede na vprašalnik za oceno simptomov, povezanih z vidom (VSAQ-ALK - Visual Symptom Assessment Questionnaire), so bolniki, ki so jih v Študijah 1007 in 1014 zdravili s krizotinibom, poročali o večji incidenci motenj vida kot bolniki, zdravljeni s kemoterapijo.
Based on their pharmacokinetic properties, no interaction is expected with other beta-lactams, clindamycin, metronidazole, or fluoroquinolones.
Na osnovi njihovih farmakokinetičnih značilnosti ni pričakovati interakcije z ostalimi betalaktami, klindamicinom, metronidazolom ali fluorokinoloni.
Based on their pharmacological properties it can be expected that the following medicinal product may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Zdravili, ki lahko zaradi svojih farmakoloških lastnosti povečata hipotenzivne učinke vseh antihipertenzivov, tudi telmisartana, sta baklofen in amifostin.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, amifostine, neuroleptics or antidepressants.
Zdravila, ki zaradi svojih farmakoloških lastnosti lahko povečajo hipotenzivne učinke vseh antihipertenzivov, tudi zdravilaOnduarp, so na primer baklofen, amifostin, nevroleptiki ali antidepresivi.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants.
Zdravila, ki zaradi svojih farmakoloških lastnosti lahko povečajo hipotenzivne učinke vseh antihipertenzivov, tudi tega zdravila, so na primer baklofen, amifostin, nevroleptiki ali antidepresivi.
Based on theoretical considerations
Po presoji na teoretični podlagi
Based on theoretical considerations,
Po presoji na teoretični podlagi se
Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase cisapride concentrations.
Teoretično bi lahko tipranavir ob sočasni uporabi majhnih odmerkov ritonavirja povečal koncentracijo cisaprida.
Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase tolterodine concentrations.
Teoretično bi lahko tipranavir ob sočasni uporabi majhnih odmerkov ritonavirja povečal koncentracijo tolterodina.
Based on these data and because cobicistat is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co- administration of EVOTAZ with these medicinal products is not expected to significantly alter the exposure of the co-administered medicinal products.
Na osnovi teh podatkov in ker pomembnejšega vpliva kobicistata na farmakokinetiko NRTI-jev ne pričakujemo, pri sočasni uporabi zdravila EVOTAZ s temi zdravili ne pričakujemo, da bi se izpostavljenost sočasno uporabljenim zdravilom pomembneje spremenila.
Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of REYATAZ/ritonavir with these medicinal products is not expected to significantly alter the exposure of the co- administered medicinal products.
Na osnovi teh podatkov in ker pomembnejšega vpliva ritonavirja na farmakokinetiko NRTI-jev ne pričakujemo, pri sočasni uporabi zdravila REYATAZ/ritonavirja s temi zdravili ne pričakujemo, da bi se izpostavljenost sočasno uporabljenim zdravilom pomembneje spremenila.
Based on these data and the extent of reversal of the anticoagulant effect of dabigatran in patients, renal impairment does not appear to impact the reversal effect of idarucizumab, although the conclusion for patients with severe renal impairment is drawn from only a small subset of patients.
Na osnovi teh podatkov in obsegu izničenja antikoagulacijskega učinka dabigatrana pri bolnikih kaže, da ledvična okvara nima vpliva na izničevalni učinek idarucizumaba, čeprav so zaključki pri bolnikih s hudo okvaro ledvic izpeljani samo iz majhne podskuine bolnikov.
Based on these data concomitant treatment with tacrolimus is not recommended.
Na podlagi teh podatkov sočasno zdravljenje s takrolimusom ni priporočeno.
Based on these data lamivudine/zidovudine may be administered with or without food.
Na osnovi teh podatkov se lahko zdravilo Lamivudin/zidovudin Teva vzame s hrano ali brez nje.
Based on these data, it is unlikely that clinically significant interactions involving tenofovir disoproxil fumarate and medicinal products metabolised by CYP450 would occur.
Na podlagi teh podatkov ni verjetno, da bi prišlo do klinično pomembnih interakcij med dizoproksiltenofovirijevim fumaratom in zdravili, ki jih presnavlja CYP450.
Based on these data, no dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment.
Na podlagi teh podatkov bolnikom z okvaro jeter ni treba prilagajati odmerka, razen v primeru sočasnega oslabljenega delovanja ledvic.
Based on these data, the onset of steady state is predicted to be approximately 49 – 56 days.
Na podlagi teh podatkov je predviden čas do nastopa stanja dinamičnega ravnovesja približno 49 – 56 dni.
Based on these issues, the CHMP was of the opinion that one additional five-year renewal on the basis of pharmacovigilance grounds is required.
Na podlagi zgornjih ugotovitev odbor CHMP meni, da je v obdobju petih let potrebno dodatno podaljšanje dovoljenja za promet z zdravilom na osnovi farmakovigilance.
Based on these limited data no recommendation on dose adjustment can be made.
Na podlagi teh omejenih podatkov ni mogoče dati priporočil o prilagajanju odmerka.