natgillin/translations-raw huggingface dataset:
In patients ≥ 75 years the observed incidence of the primary efficacy composite end point for the pharmaco-invasive strategy and primary PCI were as follows: before dose reduction 11/37 (29.7%) (95% CI: 15.9- 47.0) versus 10/32 (31.3%) (95% CI: 16.1-50.0), after dose reduction: 25/97 (25.8%) (95% CI: 17.4-35.7) versus 25/88 (24.8%) (95% CI: 19.3-39.0).
Pri bolnikih, starih ≥ 75 let, je bila pojavnost primarnega učinkovitostnega sestavljenega opazovanega dogodka pri farmakoinvazivni strategiji in primarni perkutani koronarni intervenciji naslednja: pred zmanjšanjem odmerka 11/37 (29,7 %) (95-odstotni IZ: 15,9–47,0) v primerjavi z 10/32 (31,3 %) (95-odstotni IZ: 16,1–50,0) po zmanjšanju odmerka: 25/97 (25,8 %) (95-odstotni IZ: 17,4–35,7) v primerjavi s 25/88 (24,8 %) (95-odstotni IZ: 19,3–39,0).
In patients ≥60 kg and age <75 years, non-CABG-related TIMI major or minor bleeding rates were 3.6% for prasugrel and 2.8% for clopidogrel; rates for fatal bleeding were 0.2% for prasugrel and 0.1% for clopidogrel.
Pri bolnikih ≥ 60 kg in starih < 75 let, so bile stopnje večjih in manjših krvavitev po TIMI, nepovezanih s CABG, 3,6 % za prasugrel in 2,8 % za klopidogrel; stopnje smrtnih krvavitev so bile 0,2 % za prasugrel in 0,1 % za klopidogrel.
In patients  11 years of age not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
Ko je z odmerjanjem enkrat na dva tedna dosežen ciljni hemoglobin, lahko bolniki, stari  11 let, ki niso na dializi, zdravilo Aranesp dobivajo subkutano enkrat na mesec; začetni odmerek naj bo dvakrat tolikšen, kot ga je bolnik pred tem dobival enkrat na dva tedna.
In patients 75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4).
Pri bolnikih, starih 75 let ali več, je treba fondaparinuks uporabljati previdno, ker se delovanje ledvic s starostjo zmanjšuje (glejte poglavje 4.4).
In patients, as well as in healthy volunteers, the maximum concentration (Cmax) and area-under-the-concentration time curve (AUC) increase proportionally with increases in dose.
Pri bolnikih in zdravih prostovoljcih se največja koncentracija (Cmax) in površina pod krivuljo koncentracije po času (AUC) večata sorazmerno z večanjem odmerka.
In patients, baseline factor Xa and PT were influenced by the surgery resulting in a difference in the concentration-PT slope between the day post- surgery and steady state.
Pri bolnikih vplivajo na izhodiščne vrednosti faktorja Xa in PČ kirurški posegi, kar se kaže v različnih krivuljah koncentracija-PČ med dnevom po kirurškem posegu in dinamičnim ravnovesjem.
In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Pri otrocih in odraslih bolnikih s hudo prirojeno, ciklično ali idiopatsko nevtropenijo z absolutnim številom nevtrofilcev (ANC - Absolute Neutrophil Count) ≤ 0,5 x 109/L in s hudimi ali ponavljajočimi se okužbami v anamnezi je indicirana dolgotrajna uporaba zdravila Grastofil za povečanje števila nevtrofilcev in zmanjšanje pogostnosti pojavljanja in trajanja z okužbami povezanih zapletov.
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Bolnikom, otrokom ali odraslim s hujšo obliko kongenitalne, ciklične ali idiopatične nevtropenije z absolutnim številom nevtrofilcev (ANC) ≤ 0,5 x 109/l in s hujšimi ali ponavljajočimi se okužbami, se dolgotrajno jemanje zdravila Biograstim predpiše zato, da se poveča število nevtrofilcev in zmanjša pogostost nastanka in trajanja z okužbami povezanih pojavov.
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Pri otrocih ali odraslih bolnikih s hudo prirojeno, ciklično ali idiopatsko nevtropenijo z absolutnim številom nevtrofilcev (ANC - Absolute Neutrophil Count) ≤ 0,5 x 109/l in s hudimi ali ponavljajočimi se okužbami v anamnezi je indicirana dolgotrajna uporaba filgrastima za povečanje števila nevtrofilcev in zmanjšanje pogostnosti pojavljanja in trajanja z okužbami povezanih zapletov.
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of  0.5 x 109 /l and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Pri bolnikih - otrocih ali odraslih s hudo prirojeno, ciklično ali idiopatsko nevtropenijo z absolutnim številom nevtrofilcev (»absolute neutrophil count« - ANC)  0,5 x 109 /l in hudimi ali ponavljajočimi se okužbami v anamnezi je indicirana dolgotrajna uporaba filgrastima za povečanje števila nevtrofilcev in zmanjšanje pojavnosti in trajanja z okužbami povezanih dogodkov.
In patients, dasatinib has a large apparent volume of distribution (2,505 l) suggesting that the medicinal product is extensively distributed in the extravascular space.
Dasatinib ima pri bolnikih velik navidezni volumen porazdelitve (2.505 l), kar kaže na ekstenzivno porazdelitev zdravila v ekstravaskularni prostor.
In patients, HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil fumarate.
Pri bolnikih, pri katerih je HIV-1 izražal tri ali več mutacij, povezanih z analogom timidina (TAM, thymidine-analogue associated mutations), ki so vsebovale ali M41L ali L210W mutacijo reverzne transkriptaze, se je kazala zmanjšana občutljivost za zdravljenje z dizoproksiltenofovirijevim fumaratom.
In patients, the mean peak plasma concentration (Cmax) was 79.6 μg/ml (CV 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Pri bolnikih je bila največja koncentracija v plazmi (Cmax) takoj po injiciranju 79,6 μg/ml (C.V. 61%, razpon 39-222), pri prostovoljcih pa je bil Cmax 40 μg/ml in AUCinf 2400 μg/h/ml.
In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Pri bolnikih je mediani navidezni porazdelitveni volumen (Vz/F) prvega odmerka segal od 50,5 l do 92 l in je bil na splošno skladen v skupinah odmerkov od 3,2 mg do 32 mg.
In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Pri bolnikih je mediani navidezni porazdelitveni volumen (Vz/F) prvega odmerka segal od 50,5 l do 92 l in je bil na splošno skladen v vseh skupinah odmerkov od 3,2 mg do 32 mg.
In patients, the nelfinavir AUC0-24 with 1250 mg BID administration was 52.8  15.7 µgh/ml (n=10) and with 750 mg TID administration was 43.6  17.8 µgh/ml (n=11).
Pri bolnikih, ki so prejemali 1250 mg nelfinavirja dvakrat na dan je bila AUC0-24 nelfinavirja 52,8 ± 15,7 μg•h/ml (n = 10), pri jemanju 750 mg trikrat na dan pa je bila 43,6 ± 17,8 μg•h/ml (n = 11).
In patients, the nelfinavir AUC0-24 with 1250 mg BID administration was 52.8  15.7 µgh/ml (n=10) and with 750 mg TID administration was 43.6  17.8 µgh/ml (n=11).
Pri bolnikih, ki so prejemali 1250 mg nelfinavirja dvakrat na dan, je bila AUC0-24 nelfinavirja 52,8 ± 15,7 μg•h/ml (n = 10), pri jemanju 750 mg trikrat na dan pa je bila 43,6 ± 17,8 μg•h/ml (n = 11).
In patients,the mean peak plasma concentration (Cmax) was 79.6 μg/ml (C.V. 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Pri bolnikih je bila največja /koncentracija v plazmi (Cmax) takoj po injiciranju 79,6 μg/ml (C.V. 61%, razpon 39-222), pri prostovoljcih pa je bil Cmax 40 μg/ml in AUCinf 2400 μg/h/ml..
In PBPC mobilisation in normal donors the most commonly reported undesirable effect was musculoskeletal pain.
Neželeni učinek, o katerem so najpogosteje poročali pri izplavljanju PBPC pri zdravih darovalcih, je bila mišično-skeletna bolečina.
In PBPC mobilisation in normal donors the most commonly reported undesirable effect was musculoskeletal pain.
Pri izplavljanju PBPC pri zdravih darovalcih je bil neželeni učinek, o katerem so najpogosteje poročali, mišično-skeletna bolečina.
In PBPC mobilisation in normal donors, the most commonly reported undesirable effect was musculoskeletal pain.
Pri izplavljanju matičnih celic v periferno kri pri zdravih dajalcih je bil najpogosteje poročan neželen učinek mišično-skeletna bolečina.
In PBPC mobilization in normal donors the most commonly reported undesirable effect was musculoskeletal pain.
Neželeni učinek, o katerem so najpogosteje poročali pri izplavljanju PBPC pri zdravih dajalcih, je bila mišično-skeletna bolečina.
In PEGASUS, patients on ticagrelor had a higher incidence of discontinuation due to adverse events compared to ASA therapy alone (16.1% for ticagrelor 60 mg with ASA vs.
V preskušanju PEGASUS je bila incidenca prekinitev zaradi neželenih učinkov med bolniki s ticagrelorjem večja kot med tistimi, ki so prejemali samo ASA (16,1 % s 60 mg ticagrelorja in 8,5 % s samo ASA).
In Pegasys, the interferon alfa-2a has been ‘pegylated’ (attached to a chemical called polyethylene glycol).
V zdravilu Pegasys je interferon alfa-2a „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
In PegIntron, the interferon alfa-2b has been ‘pegylated’ (attached to a chemical called polyethylene glycol).
V zdravilu PegIntron je interferon alfa-2b „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
In people who have problems with their bone marrow, medicines like Revolade could make the problems worse.
Pri bolnikih, ki imajo težave s kostnim mozgom, lahko zdravila, kot je zdravilo Revolade, težave še poslabšajo.
In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks’ treatment.
Pri celoletnem alergijskem rinitisu je bil v času 4-tedenskega zdravljenja profil učinkovitosti flutikazonfuroata v obliki pršila za nos v odmerku 55 mikrogramov enkrat na dan doslednejši kot pri uporabi flutikazonfuroata v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan.
In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks’ treatment.
Pri celoletnem alergijskem rinitisu je bil v času 4-tedenskega zdravljenja profil učinkovitosti flutikazonfuroata v obliki pršila za nos v odmerku 55 mikrogramov enkrat na dan stanovitnejši kot pri uporabi flutikazonfuroata v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan.
In Period A, patients received placebo or Humira at an initial dose of 160 mg at Week 0 and 80 mg at Week 2 and 40 mg every week starting at Week 4 to Week 11.
Bolniki so dobivali placebo, začetni odmerek 7,5 mg metotreksata z nadaljnjim povečevanjem odmerka do 12. tedna; do največjega odmerka 25 mg, ali začetni odmerek 80 mg zdravila Humira in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
In Period A, patients received placebo or Humira at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11.
V obdobju A so bolniki dobivali placebo ali zdravilo Humira v začetnem odmerku 80 mg in potem 40 mg vsak drugi teden, začenši en teden po začetnem odmerku.
In Period A, patients received placebo or Humira at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11.
V obdobju A so bolniki prejemali placebo ali zdravilo Humira v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od vključno 4. tedna do 11. tedna.
In peripheral tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, respectively, than that of healthy subjects.
V perifernih tkivih so pomalidomid najraje privzemali tumorji z navideznim perifernim porazdelitvenim očistkom (Q/F) in navideznim perifernim volumnom porazdelitve (V3/F), ki sta bila 3,7- krat oziroma 8-krat večja kot pri zdravih osebah.
In permanent AF, the AF has been present for a long time (at least during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion, if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
Pri permanentni (trajni) AF je AF prisotna že dolgo (vsaj 6 mesecev) in odločeno je bilo, da vašega srčnega ritma ne bodo znova vračali v normalen preddvorni ritem z zdravljenjem, ki ga imenujemo kardioverzija. če imate ali ste imeli težavo, pri kateri srce ne more po telesu črpati krvi tako dobro, kot bi moralo (to stanje imenujemo srčno popuščanje).
In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur.
Pri hišnih kuncih v zelo redkih primerih lahko pride do lokalnih reakcij, kot so nekroza, raste ali izpadanje dlake.
In pharmacokinetic studies with and without a charcoal blockage, BiResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
V farmakokinetičnih študijah z in brez blokade z ogljem so ocenjevali zdravilo BiResp Spiromax tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
In pharmacokinetic studies with and without a charcoal blockage, BiResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
V farmakokinetičnih študijah z in brez blokade z ogljem so ocenjevali zdravilo BiResp Spiromax tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno odmkombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
V farmakokinetičnih študijah z in brez blokade z ogljem so ocenjevali zdravilo Budezonid/formoterol Teva Pharma B.V. tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
V farmakokinetičnih študijah z in brez blokade z ogljem so ocenjevali zdravilo Budezonid/formoterol Teva Pharma B.V. tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno odmkombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
V farmakokinetičnih študijah z in brez blokade z ogljem so ocenjevali zdravilo Budezonid/formoterol Teva tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno odmkombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
In pharmacokinetic studies with and without a charcoal blockage, DuoResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
V farmakokinetičnih študijah z in brez blokade z ogljem so ocenjevali zdravilo DuoResp Spiromax tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
In Phase 1 studies, healthy volunteers have been administered single doses of up to 1500 mg, and cumulative doses up to 4500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.
V študijah 1.faze so zdravi prostovoljci prejeli enkratne odmerke do 1500 mg in kumulativne odmerke do 4500 mg v obdobju do osem tednov, brez znakov toksičnosti ali klinično pomembnih laboratorijskih rezultatov.
In Phase 1-4 studies the most commonly reported adverse reactions associated with DepoCyte were headache (23%), arachnoiditis (16%), pyrexia (14%), weakness (13%), nausea (13%), vomiting (12%), confusion (11%), diarrhoea (11%), thrombocytopenia (10%), and fatigue (6%).
V fazah I do IV kliničnih študij so najpogosteje poročali o sledečih neželenih učinkih v povezavi z zdravilom DepoCyte: glavobol (23%), arahnitis (16%), povišana telesna temperatura (14%), šibkost (13%), slabost (13%), bruhanje (12%), zmedenost (11%), diareja (11%), trombocitopenija (10%) in utrujenost (6%).
In Phase 2 / 3 clinical studies, 2,473 patients received dalbavancin administered as either a single infusion of 1500 mg or as 1000 mg followed one week later by 500 mg.
V fazi 2/3 kliničnih študij je 2473 pacientov prejelo dalbavancin z enkratnim infundiranjem 1500 mg ali infundiranjem 1000 mg, ki mu je po enem tednu sledilo še 500 mg.
In Phase 2 and 3 clinical trials of telaprevir, treatment-naïve and prior treatment-failure patients with predominant telaprevir-resistant variants at baseline (pre-treatment) were rare (V36M, T54A and R155K < 1% and T54S 2.7%).
V kliničnih preskušanjih telaprevirja faze II in III so bili še nezdravljeni bolniki in tisti, pri katerih je bilo predhodno zdravljenje neuspešno in so imeli prevladujoče za telaprevir rezistentne variante na začetku študije (t.j. še pred zdravljenjem), redki (V36M, T54A in R155K < 1% in T54S 2,7%).
In phase 2 and phase 3 clinical studies general infections (not wound related. e.g. urinary tract infections, viral infections) were reported more frequently in the NexoBrid group (0.147 events per patient) than in the group treated according to SOC (0.079 events per patient).
V kliničnih študijah 2. faze in 3. faze so o splošnih okužbah (nepovezano z rano, npr. okužbe sečil, virusne okužbe) pogosteje poročali v skupini, zdravljeni z zdravilom NexoBrid (0,147 dogodka na bolnika), kot v skupini, zdravljeni s standardno nego (0,079 dogodka na bolnika).
In phase 2 and phase 3 clinical studies, certain types of wound complications were reported more frequently in the NexoBrid group than in the group treated according to the study sites’ Standard of Care (SOC).
V kliničnih študijah 2. in 3. faze so o nekaterih vrstah zapletov z rano poročali pogosteje v skupini z zdravilom NexoBrid, kot pri skupini, zdravljeni v skladu s standardno terapijo.
In Phase 2/3 trials, 9 out of 2498 subjects treated with EXUBERA were discontinued from trials due to a decline in pulmonary function whose end of study FEV1 showed a decline of  15% from baseline.
V študijah 2. in 3. faze so zaradi poslabšanja pljučne funkcije (zmanjšanje FEV1 za 15 % ali več) prekinili terapijo pri devetih izmed 2498 oseb, ki so prejemali EXUBERO.
In Phase 3 ABSSSI clinical trials, more cases of osteomyelitis were reported in the oritavancin-treated arm than in the vancomycin-treated arm (see section 4.8).
V kliničnih preskušanjih ABSSSI faze 3 so poročali o več primerih osteomielitisa v kraku bolnikov, zdravljenih z oritavancinom, kot v kraku bolnikov, zdravljenih z vankomicinom (glejte poglavje 4.8).
In phase 3 clinical studies in MF, neither CTCAE grade 3 or 4 hypercholesterolaemia, raised aspartate aminotransferase nor CTCAE grade 4 raised alanine aminotransferase were observed.
V kliničnih študijah faze 3 pri bolnikih z mielofibrozo niso opažali niti hiperholesterolemije stopnje 3 ali 4 po CTCAE, zvišane vrednosti aspartat-aminotransferaze, niti zvišane vrednosti alanin-aminotransferaze stopnje 4 po CTCAE.
In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) received the recommended regimen (see section 4.2).
V kliničnih preskušanjih 3. faze je 1075 preiskovancev (vključno z 181 s kompenzirano cirozo) prejelo priporočeno shemo (glejte poglavje 4.2).
In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) with genotype 1 HCV infection received the recommended regimen (see section 4.2).
V kliničnih preskušanjih 3. faze je 1075 preiskovancev (vključno s 181 s kompenzirano cirozo), okuženih s HCV genotipa 1, prejelo priporočeno shemo (glejte poglavje 4.2).
In phase 3 studies with SBS patients who received Revestive for ≥2 years, 39% of patients developed anti-teduglutide antibodies and 21% of patients developed antibodies against E.coli protein (residual host cell protein from the manufacture).
V študijah 3. faze na bolnikih s SKČ, ki so prejemali zdravilo Revestive ≥ 2 leti, je 39 % bolnikov razvilo anti-teduglutidna protitelesa, 21 % bolnikov pa je razvilo protitelesa proti proteinu E. coli (protein gostiteljskih celic, ki ostane od proizvodnje).
In Phase 3 studies, patients have been administered single doses of up to 1500 mg.
V študijah 3.faze so bolniki prejemali enkratne odmerke do 1500 mg.
In phase 3 studies, pre-meal administration of canagliflozin 300 mg once daily provided a greater reduction in postprandial glucose excursion than observed with the 100 mg once daily dose.
V študijah faze III je odmerek 300 mg kanagliflozina pred obrokom enkrat na dan omogočil bolj obsežno zmanjšanje nihanja koncentracije glukoze v krvi po obroku kot odmerek 100 mg enkrat na dan.