Examples of using
Patients with normal hepatic function
in English and their translations into Slovenian
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Treat with same doses as patients with normal hepatic function.
Zdravite jih z enakimi odmerki kot bolnike z normalnim delovanjem jeter.
Stavudine pharmacokinetics in patients with hepatic impairment were similar to those in patients with normal hepatic function.
Farmakokinetika stavudina pri bolnikih z okvaro jeter je bila podobna kot pri bolnikih z normalnim delovanjem jeter.
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose- normalised bortezomib AUC.
Ob primerjavi z bolniki z normalnim delovanjem jeter pri bolnikih z blago jetrno okvaro ni bilo sprememb v povprečnem, na odmerek normaliziranem AUC bortezomiba.
Ledipasvir plasma exposure(AUCinf)was similar in patients with severe hepatic impairment and control patients with normal hepatic function.
Izpostavljenost ledipasvirja v plazmi(AUCinf)je bila pri bolnikih s hudo jetrno okvaro podobna kot pri kontrolnih bolnikih z normalnim delovanjem jeter.
The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles(see sections 4.4 and 5.2).
Zmanjšani odmerek lahko spet zvečate na odmerek za bolnike z normalnim delovanjem jeter, če bolnik prenaša zdravljenje vsaj dva cikla(glejte poglavji 4.4 in 5.2).
No clinically important differences in the clearance of Empliciti werefound between patients with mild hepatic impairment and patients with normal hepatic function.
Pri bolnikih z blago okvaro jeter niso ugotovili klinično pomembnihrazlik v očistku zdravila Empliciti v primerjavi z bolniki z normalnim delovanjem jeter.
Compared to patients with normal hepatic function(n=6), eribulin exposure increased 1.8-fold and 3-fold in patients with mild and moderate hepatic impairment.
V primerjavi z bolniki z normalnim delovanjem jeter(n= 6) se je izpostavljenost eribulinu povečala za 1,8-krat pri bolnikih z blago okvarjenim in 3-krat pri bolnikih z zmerno okvarjenim delovanjem jeter..
The exposure of regorafenib and its metabolites M-2 andM-5 is comparable in patients with mild hepatic impairment(Child-Pugh A) and patients with normal hepatic function.
Izpostavljenost regorafenibu in njegovima presnovkoma M-2 inM-5 je podobna pri bolnikih z blago okvaro jeter(Child-Pugh A) in pri bolnikih z normalnim delovanjem jeter.
Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
V primerjavi z bolniki z normalnim delovanjem jeter je bila vrednost AUC0-24 za sofosbuvir za 126% višja pri zmerni jetrni okvari in za 143% višja pri hudi jetrni okvari, medtem ko je bila vrednost AUC0-24 za GS-331007 višja za 18% oz. 9%.
Hepatic impairment: pharmacokinetic parameters in patients with moderate orsevere hepatic impairment were similar to those in patients with normal hepatic function.
Okvara jeter: pri bolnikih z zmerno alihudo okvaro jeter so bili farmakokinetični parametri enaki kot pri bolnikih z normalnim delovanjem jeter.
The study included acontrol group consisting of 7 HIV-infected patients with normal hepatic function matched with the hepatically impaired patients for age, gender, weight and tobacco use.
V kontrolno skupino v preskušanju je bilo vključenih 7 bolnikov,ki so bili okuženi s HIV in so imeli normalno jetrno funkcijo ter so se ujemali z bolniki z jetrno okvaro v starosti, spolu, telesni masi in uporabi tobačnih izdelkov.
No modification of vinflunine and DVFL pharmacokinetics was observed in 25 patients presenting varying degrees of hepatic impairment,compared to patients with normal hepatic function.
Pri 25 bolnikih z različnimi stopnjami okvare jeter niso ugotovili razlik v farmakokinetiki vinflunina inDVFL v primerjavi z bolniki z normalno jetrno funkcijo.
This analysis included patients with normal hepatic function(n=130), and pre-existing mild(n=8), moderate(n=7), or severe(n=5) hepatic impairment(according to NCI Organ Dysfunction Working Group criteria).
V to analizo so bili vključeni bolniki z normalnim delovanjem jeter(n=130) in s predobstoječo blago(n=8), zmerno(n=7) ali hudo(n=5) okvaro jeter(po merilih delovne skupine za disfunkcijo organov Nacionalnega inštituta za raka(NCI Organ Dysfunction Working Group)).
Patients with severe hepatic impairment may have increased plasma concentrations of unbound cobimetinib compared to patients with normal hepatic function(see section 5.2).
Bolniki s hudo okvaro jeter imajo lahko v primerjavi z bolniki z normalnim delovanjem jeter zvišane koncentracije prostega kobimetiniba v plazmi(glejte poglavje 5.2).
In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderatehepatic impairment were similar to those observed in patients with normal hepatic function.
V ločeni farmakokinetični študiji so bili plazemski farmakokinetični profili pri bolnikih zblago do zmerno okvaro jeter podobni kot pri bolnikih z normalnim delovanjem jeter.
Limited data in patients with moderate hepatic impairment(Child-Pugh B)indicate similar exposure as compared to patients with normal hepatic function after a single 100 mg dose of regorafenib.
Omejeni podatki po uporabi enkratnega odmerka 100 mg regorafenibapri bolnikih z zmerno okvaro jeter(Child-Pugh B) kažejo podobno izpostavljenost kot pri bolnikih z normalnim delovanjem jeter.
In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderatehepatic impairment were similar to those observed in patients with normal hepatic function.
V ločeni študiji farmakokinetike so bili plazemski farmakokinetični profili pri bolnikih z blago do zmernookvaro jeter podobni tistim, ki so jih opazili pri bolnikih z normalnim delovanjem jeter.
The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderatehepatic impairment were compared with those of HIV-infected patientswith normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Farmakokinetične parametre lopinavirja v stanju dinamičnega ravnovesja pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaroso primerjali s tistimi pri s HIV okuženih bolnikih z normalno jetrno funkcijo v študiji z večkratnimi odmerki lopinavirja/ritonavirja 400/100 mg dvakrat dnevno.
Trastuzumab emtansine exposure(AUC) at Cycle 3 after repeated dosing in patients with mild ormoderate hepatic dysfunction was within the range observed in patients with normal hepatic function.
Izpostavljenost trastuzumabu emtanzinu(AUC) v 3. ciklusu po dajanju ponavljajočih se odmerkov bolnikom z blago ali zmernookvarjenim delovanjem jeter je bila v območju, ki so ga opazili pri bolnikih z normalnim delovanjem jeter.
Even with these dose adjustments for adults, some patients with hepatic impairment may have higher or lower than anticipated amprenavir and/ orritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability(see section 5.2), therefore a close monitoring of safety and virologic response is warranted.
Zaradi večje variabilnosti med bolniki so kljub takšni prilagoditvi odmerka pri nekaterih bolnikih z jetrno okvaro lahko dosežene višje ali nižje plazemske koncentracijeamprenavirja in/ ali ritonavirja od pričakovanih, v primerjavi z bolniki, ki imajo normalno jetrno funkcijo,(glejte poglavje 5. 2), zato je treba te bolnike skrbno nadzirati glede varnosti in virološkega odziva.
Patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared withpatients with normal hepatic function.
Bolniki z izhodiščno okvaro jeter so imeli večjo incidenco hipertenzije in PPE in večjo incidenco hipertenzije, astenije, utrujenosti in hipokalciemije stopnje 3 ali 4 kot bolniki z normalno funkcijo jeter.
The pharmacokinetics of trastuzumab emtansine and DM1-containing catabolites were evaluated afterthe administration of 3.6 mg/kg of trastuzumab emtansine to metastatic HER2+ breast cancer patients with normal hepatic function(n=10), mild(Child-Pugh A; n=10) and moderate(Child-Pugh B; n=8) hepatic impairment.
Farmakokinetika trastuzumaba emtanzina in DM1 vsebujočih presnovkov je bila ocenjena po dajanju 3,6 mgtrastuzumaba emtanzina na kg telesne mase bolnikoms HER2+ metastatskim rakom dojk z normalnim delovanjem jeter(n= 10), blago(razred A po Child-Pughovi lestvici; n= 10) in zmerno(razred B po Child-Pughovi lestvici, n= 8) jetrno okvaro.
The effect of hepatic impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild hepatic impairment(as defined using the US National Cancer Institute criteria of hepatic dysfunction)compared to patients with normal hepatic function.
Vpliv okvare jeter na očistek pembrolizumaba so ocenili s populacijskimi farmakokinetičnimi analizami pri bolnikih z blago okvaro jeter(opredeljeno po merilih ameriškega Nacionalnega onkološkega inštituta za moteno delovanje jeter)v primerjavi z bolniki z normalnim delovanjem jeter.
Overall, even with these dose adjustments for adults with hepatic impairment, some patients may have higher or lower than anticipated amprenavirand/or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability(see section 5.2), therefore close monitoring of safety and virologic response is warranted.
Gledano v celoti, so zaradi večje variabilnosti med bolniki, kljub takšni prilagoditvi odmerka za odrasle z jetrno okvaro, pri nekaterih bolnikih lahko dosežene višjeali nižje plazemske koncentracije amprenavirja in/ali ritonavirja od pričakovanih, v primerjavi z bolniki, ki imajo normalno jetrno funkcijo(glejte poglavje 5.2), zato je treba te bolnike skrbno nadzirati glede varnosti in virološkega odziva.
The median steady-state pazopanib Cmax and AUC(0-24) in patients with mild abnormalities in hepatic parameters(defined as either normal bilirubin and any degree of ALT elevation or as an elevation of bilirubin up to 1.5 x ULN regardless of the ALT value) after administration of 800 mgonce daily are similar to the median in patients with normal hepatic function(see Table 7).
Mediani Cmax in AUC(0-24) v stanju dinamičnega ravnovesja pri bolnikih z blagimi nepravilnostmi jetrnih parametrov(opredeljenimi bodisi kot normalen bilirubin in kakršnokoli zvišanje alanin- aminotransferaze(ALT) bodisi kot zvišanje bilirubina do 1,5-kratne ZMN ne glede na vrednost ALT) po uporabi 800 mgenkrat na dan sta podobni medianama pri bolnikih z normalnim delovanjem jeter(glejte preglednico 7).
Hepatic Insufficiency The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderatehepatic impairment were compared with those of HIV-infected patientswith normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Farmakokinetične parametre lopinavirja v stanju dinamičnega ravnovesja pri s HIV okuženih bolnikih z blago do zmerno jetrno okvaroso primerjali s tistimi pri s HIV okuženih bolnikih z normalno jetrno funkcijo v študiji z večkratnimi odmerki lopinavirja/ritonavirja 400/100 mg dvakrat dnevno.
Systemic exposures(AUC) of trastuzumab emtansine at Cycle 1 in patients with mild and moderate hepatic impairmentwere approximately 38% and 67% lower than that of patients with normal hepatic function.
Sistemska izpostavljenost trastuzumabu emtanzinu(AUC) v 1. ciklusu je bila pri bolnikih z blago jetrno okvaro približno 38%,pri bolnikih z zmerno jetrno okvaro pa 67% nižja kot pri bolnikih z normalnim delovanjem jeter.
The effect of hepatic impairment on the CL of nivolumab was evaluated in patients with mild hepatic impairment(total bilirubin 1.0× to 1.5× ULN or ASTgt; ULN as defined using the National Cancer Institute criteria of hepatic dysfunction; n= 92)compared to patients with normal hepatic function(total bilirubin and AST≤ ULN; n= 804) in the population PK analyses.
Vpliv okvare jeter na očistek nivolumaba so v analizah populacijske farmakokinetike ovrednotili pri bolnikih z blago okvaro jeter(skupni bilirubin 1,0 × do 1,5 × ZMN ali ASTgt; ZMN po kriterijih ameriškega Nacionalnega onkološkega inštituta za disfunkcijo jeter; n= 92)v primerjavi z bolniki z normalnim delovanjem jeter(skupni bilirubin in AST ≤ ZMN; n= 804).
Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild(total bilirubin within upper limit of normal[ULN] and ASTgt; ULN, or total bilirubingt; 1.0-1.5 times ULN and any AST level, n= 16), or moderate(total bilirubingt; 1.5-3.0 times ULN, n= 1)hepatic impairment compared to patients with normal hepatic function(total bilirubin and AST≤ ULN, n= 126).
Analiza PopPK ni pokazala klinično pomembnih razlik med bolniki z blago(skupni bilirubin pod zgornjo mejo normale[ULN] in ASTgt; ULN ali skupni bilirubingt; 1,0- 1,5-krat ULN in katera koli raven AST, n= 16) ali zmerno(skupni bilirubingt; 1,5- 3,0-krat ULN, n= 1)okvaro jeter in bolniki z normalnim delovanjem jeter(skupni bilirubin in AST ≤ ULN, n= 126).
Based on PopPK, ramucirumab exposure in patients with mild hepatic impairment(total bilirubingt; 1.0-1.5 upper limit of normal(ULN) and any AST or total bilirubin≤1.0 ULN and ASTgt; ULN) or moderate hepatic impairment(total bilirubingt; 1.5-3.0 ULN and any AST)was similar to patients with normal hepatic function(total bilirubin and AST≤ ULN).
Na podlagi populacijske farmakokinetike je bila izpostavljenost ramucirumabu pri bolnikih z blago okvarjenim delovanjem jeter(celokupni bilirubingt; 1,0‒1,5-kratna zgornja meja normalne vrednosti(ULN) in kakršna koli vrednost AST ali celokupnega bilirubina ≤ 1,0 ULN in ASTgt; ULN) ali zmerno okvarjenim delovanjem jeter(celokupni bilirubingt; 1,5- 3,0 ULN in kakršna koli vrednost AST)podobna kot pri bolnikih z normalnim delovanjem jeter(celokupni bilirubin in AST ≤ ULN).
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