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ispitivanja kancerogenosti sa simeprevirom nisu bila provedena.
carcinogenicity studies with simeprevir have not been conducted.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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iskustvo u ljudi s predoziranjem simeprevirom je ograničeno.
human experience of overdose with simeprevir is limited.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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ne preporučuje se istodobna primjena pojačane preziste sa simeprevirom.
it is not recommended to co-administer boosted prezista and simeprevir.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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nema prikladnih i dobro kontroliranih ispitivanja sa simeprevirom u trudnica.
there are no adequate and well-controlled studies with simeprevir in pregnant women.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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uključuje 4 bolesnika liječena simeprevirom koji su doživjeli relaps nakon svr12.
includes 4 simeprevir-treated patients who experienced relapse after svr12.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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tablica 11: ispitivanja provedena sa simeprevirom + sofosbuvirom: populacija i sažetak dizajna ispitivanja
table 11: studies conducted with simeprevir + sofosbuvir: population and summary of study design
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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osip ili pruritus stupnja 3 pojavio se u 0,5% odnosno 0,1% bolesnika liječenih simeprevirom.
grade 3 rash or pruritus occurred in 0.5% and 0.1% of simeprevir-treated patients, respectively.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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nastale ns3 supstitucije aminokiselina bile su slične onima zabilježenim u bolesnika koji nisu postigli svr nakon liječenja simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom.
the emerging ns3 amino acid substitutions were similar to those observed in patients who did not achieve svr following treatment with simeprevir in combination with peginterferon alfa and ribavirin.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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obrasci supstitucija aminokiselina, specifični za podtip hcv genotipa 1, koji su proizašli iz liječenja simeprevirom bili su uočeni u bolesnika koji nisu postigli svr.
hcv genotype 1 subtype-specific patterns of simeprevir treatment-emergent amino acid substitutions were observed in patients not achieving svr.
Dernière mise à jour : 2017-04-26
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tablica 17: ispitivanja provedena sa simeprevirom + peginterferonom alfa + ribavirinom: populacija i sažetak dizajna ispitivanja
table 17: studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design
Dernière mise à jour : 2017-04-26
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poremećaji laboratorijskih nalaza koji su proizašli tijekom liječenja te su uočeni s većom incidencijom u bolesnika liječenih simeprevirom nego u bolesnika liječenih placebom, peginterferonom alfa i ribavirinom prikazani su u tablici 7.
treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are given in table 7.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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doza simeprevira u ovom ispitivanju interakcija bila je 50 mg kada se istodobno primjenjivao u kombinaciji s darunavirom/ritonavirom, u usporedbi sa 150 mg u skupini liječenoj samim simeprevirom.
the dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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populacijska farmakokinetika procjenjuje izloženost simeprevira što je usporedivo među bolesnicima bijele i crne/afro-američke rase inficiranima hcv-om liječenih simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom.
population pharmacokinetic estimates of exposure of simeprevir were comparable between caucasian and black/african american hcv infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Dernière mise à jour : 2017-04-26
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dob (18-73 godina) nije klinički značajno utjecala na farmakokinetiku simeprevira, temeljeno na populacijskoj farmakokinetičkoj analizi (n = 21, dob iznad 65 godina) bolesnika inficiranih hcv-om koji su liječeni simeprevirom.
age (18-73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis (n = 21, age above 65 years) of hcv infected patients treated with simeprevir.
Dernière mise à jour : 2017-04-26
Fréquence d'utilisation : 1
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