natgillin/translations-raw huggingface dataset:
The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl &gt; 80 ml/min; mild impairment with CrCl = 50 – 79 ml/min; moderate impairment with CrCl = 30 – 49 ml/min and severe impairment with CrCl = 10 – 29 ml/min).
Stopnja ledvične okvare je bila določena glede na začetno vrednost očistka kreatinina (ClCr) (normalna ledvična funkcija je pri ClCr &gt; 80 ml/min; blaga ledvična okvara pri ClCr = 50-79 ml/min; zmerna ledvična okvara pri ClCr = 30-49 ml/min in huda ledvična okvara pri ClCr = 10- 29 ml/min).
The degree of renal impairment was defined according to baseline creatinine clearance (CrCL) (normal renal function when CrCL &gt; 80 mL/min; mild impairment with CrCL = 50-79 mL/min; moderate impairment with CrCL = 30-49 mL/min and severe impairment with CrCL = 10-29 mL/min).
Stopnja ledvične okvare je bila določena glede na začetno vrednost očistka kreatinina (CLCr) (normalna ledvična funkcija je pri CLCr &gt; 80 ml/min; blaga ledvična okvara pri CLCr = 50-79 ml/min; zmerna ledvična okvara pri CLCr = 30-49 ml/min in huda ledvična okvara pri CLCr = 10-29 ml/min).
The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms; notably, approximately 50% of the patients enrolled in each arm had the following characteristics; ISS Stage III, and creatinine clearance &lt; 60 mL/min.
Demografske značilnosti in z boleznijo povezane izhodiščne značilnosti bolnikov so bile uravnovešene v vseh 3 skupinah; pomembno je, da je imelo približno 50 % bolnikov, vključenih v vsako skupino, naslednje značilnosti: ISS stadij III in očistek kreatinina &lt; 60 ml/min.
The denominator for relapse is the number of patients with HCV RNA &lt; LLOQ at their last on-treatment assessment.
Denominator za relaps je število bolnikov z HCV RNK &lt; LLOQ ob zadnji oceni med zdravljenjem.
The denominator for relapse is the number of patients with HCV RNA &lt; LLOQ at their last on-treatment assessment.
Denominator za relaps je število bolnikov z RNA HCV &lt; LLOQ ob zadnji oceni med zdravljenjem.
The denominator for relapse is the number of subjects with HCV RNA &lt; LLOQ at their last on-treatment assessment.
Denominator za relaps je število oseb z RNA HCV &lt; LLOQ ob zadnji oceni med zdravljenjem.
The denominator is the number of patients with HCV RNA &lt; 25 IU/ml at planned end of treatment or a missing HCV RNA assessment at planned end of treatment and HCV RNA &lt; 25 IU/ml during follow-up from planned end of treatment onwards.
Imenovalec je število bolnikov s HCV RNK &lt; 25 i.e./ml ali pri katerih ni podatka o koncentraciji HCV RNK ob načrtovanem zaključku zdravljenja in, ki so imeli koncentracijo HCV RNK &lt; 25 i.e./ml v obdobju spremljanja po zaključku zdravljenja.
The denominator when calculating the relapse rate represents the number of patients with end-of-treatment response (HCV RNA &lt; 25 IU/ml).
Število bolnikov z odzivom ob zaključku zdravljenja (HCV RNA &lt; 25 IU/ml) predstavlja imenovalec pri izračunu stopnje relapsa.
The desired haemoglobin concentration level in two studies was &gt; 13 g/dl (8.1 mmol/l); in the remaining three studies it was 12 to 14 g/dl (7.5 to 8.7 mmol/l).
V dveh študijah je bila želena raven koncentracije hemoglobina &gt; 13 g/dl (8,1 mmol/l), v preostalih dveh pa 12 do 14 g/dl (7,5 do 8,7 mmol/l).
The difference between both vaccines in terms of percentage of subjects with OPA titres  8 was &lt; 5% for all serotypes in common, including 6B and 23F. Post-primary and post-booster OPA antibody geometric mean titres (GMTs) elicited by Synflorix were lower than those elicited by 7-valent Prevenar for the seven shared serotypes, except for serotype 19F.
Kar zadeva odstotek preiskovancev s titrom OPA  8, je bila razlika med cepivoma &lt; 5 % za vse skupne serotipe, vključno s 6B in 23F. Postprimarna in poobnovitvena geometrijska sredina titrov (GMT- geometric mean titres) protiteles OPA, ki jih je proti sedmim skupnim serotipom izzvalo cepivo Synflorix, je bila – z izjemo serotipa 19F – nižja kot s 7-valentnim cepivom Prevenar.
The difference between Enbrel alone and methotrexate alone was also significant (p &lt; 0.05).
Pomembna je bila tudi razlika med monoterapijo z zdravilom Enbrel in monoterapijo z metotreksatom (p &lt; 0,05).
The difference between etanercept alone and methotrexate alone was also significant (p &lt; 0.05).
Pomembna je bila tudi razlika med monoterapijo z etanerceptom in monoterapijo z metotreksatom (p &lt; 0,05).
The difference between methylnaltrexone bromide 12 mg once daily and placebo of 1.6 RFBMs per week is statistically significant (p &lt; 0.001) and clinically meaningful.
Razlika med metilnaltreksonijevim bromidom 12 mg enkrat na dan in placebom, ki je 1,6 iztrebljanja brez rešilnega odvajala na teden, je statistično značilna (p &lt; 0,001) in klinično pomembna.
The difference between the change from baseline for Feraccru compared to placebo at week 12 was 2.25 g/dL (p &lt; 0.0001).
Razlika v spremembi od izhodišča do 12. tedna med zdravilom Feraccru in placebom je bila 2,25 g/dl (p &lt; 0,0001).
The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI
Razlika med povprečno spremembo od izhodišča do 26 tedna/zaključka (Zadnje opazovanje preneseno vnaprej; Last Observation Carried Forward - LOCF) je bila statistično pomembna (UPDRS, deli I-III: za razagilin 1 mg v primerjavi s placebom -4,2, 95% CI [-5,7, -2,7]; p &lt; 0,0001; za razagilin 2 mg v primerjavi s placebom -3,6, 95% CI [-5,0, -2,1]; p &lt; 0,0001; UPDRS
The difference in clearance between Fabry patients ≥ 65 years and those &lt; 65 years was 20%, which was not considered clinically significant.
Razlika v očistku pri bolnikih s Fabryjevo boleznijo, starih 65 let ali več, in mlajših od 65 let, je znašala 20 %, kar ni klinično pomembno.
The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p &lt; 0.001).
Razlika v povprečni spremembi telesne mase med prejemniki 20 mg rimonabanta in prejemniki placeba je bila 3,8 kg (IZ95 % –5,0, –2,6, p &lt; 0,001).
The difference in ORR was 22.9 % (p-value &lt; 0.0001).
Razlika v ORR je bila 22,9 % (vrednost p &lt; 0,0001).
The difference in the proportion of patients who maintained &lt; 400 copies/ml at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil fumarate treatment group.
Na razliko v deležu bolnikov, ki so ohranili &lt; 400 kopij/ml v 48. tednu, je v glavnem vplivalo večje število prekinitev v skupini zdravljenja z dizoproksiltenofovirijevim fumaratom.
The difference was 5.28 points and statistically significant (p &lt; 0.0001).
Razlika je bila 5,28 točke in je bila statistično pomembna (p &lt; 0,0001).
The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p &lt; 0.001).
Razlika je bila statistično značilna (razlika – 13,3 %, IZ95 % –16,5 %, –10,2 %; p &lt; 0,001).
The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p &lt; 0.001).
Razlika je bila statistično značilna (razlika 7,9 %, IZ95 % 6,6 %, 9,2 %; p &lt; 0,001).
The differences observed were &lt; 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see section 4.5).
Razlike so bile &lt; 10 %, v večini primerov pa je šlo za neželene učinke blage do zmerne intenzivnosti (glejte poglavje 4.5).
The differences were statistically significant (p &lt; 0.001 and p=0.003, respectively).
Razlike so bile statistično pomembne (p &lt; 0,001 v prvi skupini in p=0,003 v drugi).
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p &lt; 0.001).
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom Enbrel, v primerjavi s placebom (p &lt; 0,001).
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p &lt; 0.001).
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z etanerceptom, v primerjavi s placebom (p &lt; 0,001).
the disease to which the product is intended to confer immunity is largely absent from the territory in question.
bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna. &gt;
The displayed frequency categories use the following convention: very common (1/10), common (1/100 to &lt; 1/10), uncommon (1/1,000 to &lt; 1/100), rare (1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1000), zelo redki ( &lt; 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The displayed frequency categories use the following convention: very common (1/10), common (1/100 to &lt; 1/10), uncommon (1/1,000 to &lt; 1/100), rare (1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom:: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do &lt; 1/10), občasni (≥ 1/1000 do &lt; 1/100), redki (≥ 1/10.000 do &lt; 1/1000), zelo redki ( &lt; 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The displayed frequency categories use the following convention: very common (1/10); common (1/100 to &lt; 1/10); uncommon (1/1000 to &lt; 1/100); rare (1/10,000 to &lt; 1/1000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available clinical trial data).
V skladu z dogovorom so neželeni učinki opredeljeni po pogostnosti kot: zelo pogosti ( 1/10), pogosti ( 1/100 do &lt; 1/10), občasni ( 1/1.000 do &lt; 1/100), redki ( 1/10.000 do &lt; 1/1.000), zelo redki ( &lt; 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. and Varicella Vaccine live (Oka/Merck)).
Zdravnik ima podrobnejši seznam neželenih učinkov cepiva ProQuad in posameznih komponent, ki sestavljajo cepivo ProQuad (cepivo proti ošpicam, mumpsu in rdečkam, izdelovalca Merck &amp; Co., Inc., in cepivo z živim virusom noric (Oka/Merck)).
The dosage may be increased every 4 weeks by 3 x 20 IU/kg and week if the increase of Hb is not adequate ( &lt; 0.25 g/dl per week).
Kadar ne dosežemo ustreznega povečanja koncentracije hemoglobina ( &lt; 0,25 g/dl na teden), lahko odmerek vsake 4 tedne povečamo za 3 x 20 i.e./kg na teden.
The dosage should therefore be reduced for patients with a creatinine clearance of &lt; 50 ml/minute.
Tako je treba pri bolnikih, ki imajo očistek kreatinina &lt; 50 ml/minuto, odmerek zmanjšati.
The dosage should, therefore, be reduced for patients with a creatinine clearance of &lt; 50 ml/minute.
Tako je treba pri bolnikih z očistkom kreatinina &lt; 50 ml/minuto odmerek zmanjšati.
The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate ( &lt; 1 g/dl [0.62 mmol/l] within 4 weeks).
Po štirih tednih se lahko odmerek poveča na 40 i.e./kg trikrat na teden, če povečanje vrednosti hemoglobina ni zadostno ( &lt; 1 g/dl [0,62 mmol/l] v štirih tednih).
The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade &gt; 2 peripheral neuropathy (see section 4.2).
V primeru dolgotrajne periferne nevropatije &gt; 2. stopnje, je treba odmerek kabazitaksela zmanjšati s 25 mg/m2 na 20 mg/m2 (glejte poglavje 4.2).
The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains &gt; 1 nmol hemicystine/mg protein.
Odmerek je treba povečati, če je prenašanje primerno dobro in koncentracija cistina v levkocitih vztraja pri vrednosti
The dose should be raised if there is adequate tolerance and the WBC cystine level remains &gt; 1 nmol hemicystine/mg protein.
Odmerek je treba povečati, če je prenašanje primerno dobro in koncentracija cistina v belih krvnih celicah vztraja pri vrednosti &gt; 1 nmol hemicistina/mg beljakovin.
The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50%, of the total lesion area.
Z zdravljenjem je treba prenehati in se ga ne sme ponovno začeti prej kot ob naslednjem načrtovanem odmerku v naslednjih primerih: zmanjšana najboljša korigirana ostrina vida (BCVA) &gt; 30 črk v primerjavi z zadnjo oceno ostrine vida, krvavitev pod mrežnico, tudi v vidni jamici (fovea centralis), ali če je velikost krvavitve &gt; 50 % celotne lezije.
The dose should not be &lt; 2.2 mg/kg.
Odmerek ne sme biti &lt; 2.2 mg/kg.
The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw &gt; 24 kg or dose volume in ml = 0.117 x bw (kg) if bw &lt; 24 kg)).
Velikost odmerka v mililitrih je treba za vsakega bolnika izračunati glede na telesno maso po naslednji formuli: velikost odmerka v ml = 0,042 x bolnikova telesna masa (v kg), če je telesna masa &gt; 24 kg ali velikost odmerka v ml = 0,117 x telesna masa (kg), če je telesna masa &lt; 24 kg).
The dose-response curve for tocilizumab flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in tocilizumab concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with &gt; 800 mg of tocilizumab.
Krivulja odmerek-odziv za tocilizumab je pri večji izpostavljenosti bolj položna, kar pomeni manjše poraste učinkovitosti pri vsakem nadaljnjem povečanju koncentracije tocilizumaba; tako pri bolnikih, zdravljenih z več kot 800 mg tocilizumaba, niso dokazali klinično pomembnih porastov učikovitosti.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Zdravljenje je trajalo 48 tednov, bolnike pa so spremljali 6 mesecev, razen tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme &lt; 800.000 i.e./ml (Amplicor) - te so zdravili 24 tednov in jih spremljali 6 mesecev.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Zdravljenje je trajalo 48 tednov, z nadaljnjim 6-mesečnim obdobjem spremljanja bolnikov, razen pri tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme &lt; 800.000 i.e./ml (Amplicor) - njih so zdravili 24 tednov z nadaljnjim 6-mesečnim obdobjem spremljanja.
The duration of therapy with olaparib in patients who developed MDS/AML varied from &lt; 6 months to &gt; 2 years.
Pri bolnicah, ki so zbolele za MDS/AML, je zdravljenje z olaparibom trajalo od &lt; 6 mesecev do &gt; 2 leti.
The duration of treatment should be based upon maintenance of response (serum uric acid levels &lt; 6 mg/dl) and clinical judgment.
Trajanje zdravljenja mora temeljiti na vzdrževanju odziva (ravni sečne kisline v serumu &lt; 6 mg/dl) in na klinični presoji.
The effect of being homozygote (UGT1A9*3/*3, frequency &lt; 0.1%) is probably more marked, but has not been investigated.
Verjetno je učinek večji, če je posameznik homozigot (UGT1A9*3/*3, pogostnost &lt; 0,1%), vendar tega niso preiskovali.
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 AST &gt; 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 AST &gt; 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).
The effect of Lonsurf on overall survival was similar in patients &lt; 65 years and ≥65 years of age.
Učinek zdravila Lonsurf na podaljšanje celokupnega preživetja je bil pri bolnikih &lt; 65 let in bolnikih ≥ 65 let podoben.
The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA &gt; 1500 microns (see section 5.1).
Učinek okriplazmina (zlasti pri induciranju odprave vitreomakularne adhezije ali povzročitvi popolnega posteriornega odstopa steklovine [PVD – Posterior Vitreous Detachment]) je manjši pri bolnikih z epiretinalno membrano (ERM) ali premerom vitreomakularne adhezije &gt; 1500 mikronov (glejte poglavje 5.1).
The effect of OPTISON on pulmonary haemodynamics was studied in a prospective, open-label study of 30 patients scheduled for pulmonary artery catheterisation, including 19 with an elevated baseline pulmonary arterial systolic pressure (PASP) ( &gt; 35 mmHg; mean 70.1±33.0 mmHg; range 36.0-176.0 mmHg) and 11 with a normal PASP (≤35 mmHg; mean 29.3±4.6 mmHg; range 22.0-35.0 mmHg).
Učinek zdravila OPTISON na pljučno hemodinamiko so preučevali v perspektivni, odprti študiji na 30 bolnikih, naročenih na kateterizacijo pljučne arterije, vključno z 19 bolniki s povišanim sistolnim tlakom v pljučni arteriji (PASP) glede na izhodišče ( &gt; 35 mmHg; povprečje 70,1 ± 33,0 mmHg; obseg 36,0-176,0 mmHg) in 11 bolniki z normalnim PASP (≤ 35 mmHg; povprečje 29,3 ± 4,6 mmHg; obseg 22,0-35,0 mmHg).
The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR &lt; 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR &lt; 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR &lt; 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
Vpliv okvare ledvic na očistek nivolumaba so v analizah populacijske farmakokinetike ovrednotili pri bolnikih z blago (GFR &lt; 90 in ≥ 60 ml/min/1,73 m2; n = 379), zmerno (GFR &lt; 60 in ≥ 30 ml/min/1,73 m2; n = 179) ali s hudo (GFR &lt; 30 in ≥ 15 ml/min/1,73 m2; n = 2) okvaro ledvic v primerjavi z bolniki z normalnim delovanjem ledvic (GFR ≥ 90 ml/min/1,73 m2; n = 342).
The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl &gt; 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl &lt; 30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl &lt; 30 mL/min; N = 9).
Vpliv okvare ledvic na farmakokinetiko elotuzumaba so ovrednotili pri bolnikih z normalnim delovanjem ledvic (CrCl &gt; 90 ml/min; N = 8), bolnikih s hudo okvaro ledvic, ki niso potrebovali zdravljenja z dializo (CrCl &lt; 30 ml/min; N = 9) in bolnikih s končno odpovedjo ledvic, ki so potrebovali zdravljenje z dializo (CrCl &lt; 30 ml/min; N = 9).
The effect on red blood cell (RBC) ( &lt; 2%) and platelet counts ( &lt; 10%) was less pronounced.
Učinek na eritrocite ( &lt; 2 %) in trombocite ( &lt; 10 %) je bil manj izrazit.
The effect size of pitolisant compared with placebo based on a model for WRC based on BOCF with centre as a fixed effect was 0.581, 95%CI [0.493 to 0.686]; p &lt; 0.0001.
Velikost učinka pitolizanta v primerjavi s placebom na podlagi modela za WRC, ki temelji na BOCF s središčem kot fiksnim učinkom, je bila 0,581, 95-% IZ (0,493 do 0,686); p &lt; 0,0001.
The effects of desloratadine in poor metabolisers &lt; 2 years of age have not been studied.
Učinkov zdravila desloratadin pri otrocih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
The effects of desloratadine in poor metabolizers &lt; 2 years of age have not been studied.
Učinkov zdravila desloratadin pri bolnikih, mlajših od 2 let, ki slabo presnavljajo zdravilo, niso raziskovali.
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min, see section 5.2).
Učinkovitosti in varnosti pri bolnikih s hudo okvaro ledvic (kreatininski očistek &lt; 30 ml/min, glejte poglavje 5.2) niso povsem ovrednotili.
The efficacy and safety of a daily dose of 0.25 mg/kg to 10 mg adefovir dipivoxil in children (aged from 2 to &lt; 18 years) were examined in a double-blind, randomised, placebo-controlled study in 173 paediatric patients (115 on adefovir dipivoxil, 58 on placebo) who had HBeAg positive chronic hepatitis B, serum ALT levels ≥ 1.5 x upper limit of normal (ULN) and compensated liver disease.
Učinkovitost in varnost dnevnega odmerka 0,25 mg/kg do 10 mg dipivoksiladefovirata pri otrocih (starih od 2 do &lt; 18 let) so raziskali v dvojno slepi, randomizirani, s placebom kontrolirani študiji na 173 pediatričnih bolnikih (115 jih je prejemalo dipivoksiladefovirat, 58 pa placebo), ki so imeli HBeAg pozitivni kronični hepatitis B, serumske vrednosti ALT ≥ 1,5 krat zgornja referenčna vrednost (ULN) in kompenzirano bolezen jeter.
The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients ( &lt; 75years).
Učinkovitost in varnost agomelatina (25 do 50 mg/dan) sta bili dokazani pri starejših bolnikih z depresijo ( &lt; 75 let).
The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients ( &lt; 75years).
Učinkovitost in varnost agomelatina (25 do 50 mg/dan) sta bili dokazani pri starejših bolnikih z depresijo ( 75 let).
The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multi- center, multi-national, double-blind, placebo-controlled studies (Studies 1 &amp; 2).
Učinkovitost in varnost eluksadolina pri bolnikih z IBS-D sta bili ugotovljeni v dveh randomiziranih, multicentričnih, multinacionalnih, dvojno slepih, s placebom nadzorovanih študijah (študiji 1 in 2).
The efficacy and safety of inhaled human insulin in patients with baseline FEV1 &lt; 70% predicted have not been established and the use of inhaled human insulin in this population is not recommended A follow-up lung function measurement is recommended after the first 6 months of therapy.
Učinkovitost in varnost humanega insulina za inhaliranje pri bolnikih z izhodiščnim FEV1 &lt; 70 % nista bili določeni in uporaba humanega insulina za inhaliranje pri tej populaciji ni priporočljiva.Po prvih 6 mesecih zdravljenja je priporočljiva ponovna ocena pljučne funkcije.
The efficacy and safety of inhaled human insulin in patients with baseline FEV1 &lt; 70% predicted have not been established and the use of inhaled human insulin in this population is not recommended.
Učinkovitost in varnost humanega insulina za inhaliranje pri bolnikih z izhodiščnim FEV1 &lt; 70 % nista bili določeni in uporaba humanega insulina za inhaliranje pri tej populaciji ni priporočljiva.
The efficacy and safety of Lonsurf was compared between a high-exposure group ( &gt; median) and a low-exposure group (≤median) based on the median AUC value of trifluridine.
Učinkovitost in varnost zdravila Lonsurf so primerjali med skupino z veliko izpostavljenostjo ( &gt; mediana) in skupino z majhno izpostavljenostjo (≤ mediana) na osnovi mediane vrednosti AUC trifluridina.