natgillin/translations-raw huggingface dataset:
The regimen 3 mg/kg/day during 6 months (selected at the end of the phase II part of the study) presented 60.4% of success versus 3.6% in the placebo arm (p value &lt; 0.0001).
Režim 3 mg/kg/dan v 6 mesecih (izbran ob koncu II. faze študije) je bil uspešen v 60,4 % v primerjavi s 3,6-odstotnim uspehom pri placebu (vrednost p &lt; 0,0001).
The relative contribution of the inhibitors to inactivation of reteplase decreases as follows: C1-inactivator &gt; 2- antiplasmin &gt; 2-antitrypsin.
Relativni prispevki zaviralcev k inaktivaciji reteplaze se nižajo v naslednjem vrstnem redu: C1- inaktivator &gt; α2-antiplazmin &gt; α2-antitripsin.
The renal excretion of verteporfin and its metabolite is minimal ( &lt; 1% of the verteporfin dose) and thus, clinically significant changes in verteporfin exposure in patients with renal impairment are unlikely.
Obseg izločanja verteporfina in njegovega presnovka preko ledvic je majhen ( &lt; 1 % odmerka verteporfina), tako da pri bolnikih z okvaro ledvic klinično pomembne spremembe v izpostavljenosti verteporfinu niso zelo verjetne.
The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations ( &lt; 1%).
Dogodki, o katerih so poročali, so bili večinoma prehodni, blago do zmerno izraženi in so povzročili zelo malo prekinitev zdravljenja ( &lt; 1 %).
The reported incidence of life-threatening (grade 4) cases was &lt; 1%.
Incidenca smrtno nevarnih (4. stopnje) primerov je bila &lt; 1%.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to
Po stopnji poročanja so razvrščeni 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
The reporting rate is classified as 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 form the available data).
Neželeni učinki se po poročani pogostosti ocenjujejo 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 reporting rate is classified as 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).
Neželeni učinki se po poročani pogostosti ocenjujejo 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 reporting rate is classified as 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).
Neželeni učinki se po poročani pogostosti ocenjujejo 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 response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p &lt; 0.001; Table 1).
V skupini, ki je dobivala 0,1% takrolimus, je bil delež odziva (71,6%) značilno večji kot v skupini, zdravljeni z lokalnim kortikosteroidom (50,8%; p &lt; 0,001; preglednica 1).
The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p &lt; 0.001; Table 1).
V skupini, ki je dobivala 0,1% takrolimus, je bil delež odziva (71,6%) značilno večji kot v skupini, zdravljeni z lokalnim kortikosteroidom (50,8%; p &lt; 0,001; tabela 1).
The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates &lt; 36%).
Stopnja odziva v kraku Pbo/PR je bila, v primerjavi z drugimi kliničnimi študijami dvojnega zdravljenja s peginterferonom (pretekle stopnje SVR &lt; 36%), višja.
The response rates observed for patients ≥ 65 years of age were similar to that of patients &lt; 65 years of age, across treatment groups.
Stopnje odziva, ki so jih opazili pri bolnikih, starih ≥ 65 let, so bile podobne kot pri bolnikih, starih &lt; 65 let, v vseh skupinah zdravljenja.
The results from both clinical studies demonstrated that Mirvaso was significantly more effective (p &lt; 0.001) in the reduction of facial erythema of rosacea than vehicle gel when applied once daily for 29 days (primary endpoint, see Table 2).
Rezultati obeh kliničnih študij so pokazali, da je bilo zdravilo Mirvaso, naneseno enkrat na dan 29 dni, značilno učinkovitejše (p &lt; 0,001) pri zmanjšanju obraznega eritema zaradi rozacee kot vehikel (primarni opazovani dogodek, glejte preglednico 2).
The results indicate that as renal function decreases ( &lt; 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
Rezultati kažejo, da se z zmanjšanjem delovanja ledvic ( &lt; 50 ml/min) sorazmerno manjša skupni očistek lenalidomida, zaradi česar se poveča vrednost AUC.
The results of summary of PID at 60 minutes (SPID0-60) showed that all strengths of Instanyl had significantly higher mean SPID0-60 scores compared with placebo (p0.001) demonstrating better pain relief of Instanyl compared to placebo during 60 minutes.
Skupni rezultati PID po 60 minutah (SPID0-60) so pokazali, da so imele vse jakosti zdravila Instanyl pomembno višje vrednosti SPID0-60 v primerjavi s placebom (p &lt; 0,001), kar pomeni, da zdravilo Instanyl v 60 minutah učinkoviteje lajša bolečino od placeba.
The results of these simulations indicate that at least 95% of patients will reach concentrations that are &lt; 1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije &lt; 1 μg/ml (približno 3 % Cmin, ss predvidene za populacijo ali približno 97-% izpiranje).
The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p &lt; 0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Rezultati te multicentrične, dvojno slepe randomizirane raziskave so pokazali, da je mazilo s takrolimusom (tako 0,03% kot 0,1%) značilno učinkovitejše (p &lt; 0,001 za oba) kot 1% mazilo s hidrokortizonacetatom (preglednica 2).
The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p &lt; 0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Rezultati te multicentrične, dvojno slepe randomizirane raziskave so pokazali, da je mazilo s takrolimusom (tako 0,03% kot 0,1%) značilno učinkovitejše (p &lt; 0,001 za oba) kot 1% mazilo s hidrokortizonacetatom (tabela 2).
The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of &gt; 10 msec with a 90% CI upper limit &gt; 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method, and at greater than therapeutic concentration (Day 9) using both baseline correction methods.
Rezultati te študije so pokazali, da sunitinib vpliva na interval QTc (opredeljeno kot povprečna, glede na placebo korigirana sprememba za &gt; 10 milisekund in z zgornjo mejo 90 % intervala zaupanja &gt; 15 milisekund); vpliv se je izkazal pri terapevtski koncentraciji (3. dan) z uporabo znotrajdnevnega postopka korekcije glede na izhodišče ter v več kot terapevtski koncentraciji (9. dan) z uporabo obeh postopkov korekcije glede na izhodišče.
The results with pitolisant were significantly superior to those in the placebo group (mean difference: -3.33; 95%CI [-5.83 to -0.83]; p &lt; 0.05) but did not differ significantly from the results in the modafinil group (mean difference: 0.12; 95%CI [-2.5 to 2.7]).
Rezultati v skupini s pitolizantom so bili znatno boljši kot v skupini s placebom (povprečna razlika: –3,33; 95-odstotni IZ [–5,83 do –0,83]; p &lt; 0,05), niso pa se bistveno razlikovali od rezultatov v skupini z modafinilom (povprečna razlika: 0,12; 95-% IZ [–2,5 do 2,7]).
The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score &gt; 9), relative to healthy volunteers.
V primerjavi z zdravimi prostovoljci je bila AUC retigabina pri prostovoljcih z zmerno okvaro jeter (7 do 9 po Child-Pughu) približno 50 % večja in pri prostovoljcih s hudo okvaro jeter ( &gt; 9 po Child-Pughu) približno 100 % večja.
The REYATAZ/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA &lt; 50 copies/ml at week 48 (Table 5).
V skupini, ki je prejemala zdravilo REYATAZ/ritonavir, je bila protivirusna učinkovitost podobna (ni bila manjša) kot v skupini, ki je prejemala lopinavir/ritonavir, kar je bilo ovrednoteno z deležem bolnikov z vrednostjo HIV RNA &lt; 50 kopij/ml v 48. tednu (preglednica 5).
The risk of hepatic damage in patients with severely reduced renal function (i.e. eGFR &lt; 20) may be increased; these patients should be carefully monitored for hepatic toxicity.
Tveganje za poškodovanje jeter pri bolnikih z močno zmanjšanim delovanjem ledvic (tj. ocenjena stopnja glomerularne filtracije [eGFR] &lt; 20) je lahko povečano; te bolnike je treba skrbno spremljati zaradi jetrne toksičnosti.
The risk of PAH related death or hospitalisation for PAH up to EOT was reduced by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p &lt; 0.0001) in patients receiving macitentan 10 mg (50 events) compared to placebo (84 events).
Tveganje smrti zaradi PAH ali hospitalizacije zaradi PAH do konca zdravljenja se je pri bolnikih, ki so prejemali macitentan 10 mg (50 dogodkov) v primerjavi s placebom (84 dogodkov), zmanjšalo za 50 % (HR 0,50; 97,5 % IZ: 0,34 do 0,75; logrank vrednost p &lt; 0,0001).
The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl &lt; 50 ml/min) or in patients on haemodialysis.
Varnost in učinkovitost pri bolnikih z zmerno ali hudo ledvično okvaro (CrCl &lt; 50 ml/min) in pri bolnikih, ki se zdravijo s hemodializo, ni bila dokazana.
The safety and efficacy of ATryn in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila ATryn pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of axitinib in children and adolescents &lt; 18 years have not been established.
Varnost in učinkovitost aksitiniba pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of cabozantinib in children aged &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila kabozantiniba pri otrocih, starih &lt; 18 let, še nista bili dokazani.
The safety and efficacy of cabozantinib in children and adolescents aged &lt; 18 years have not yet been established.
Varnost in učinkovitost kabozantiniba pri otrocih, starih &lt; 18 let, še nista bili dokazani.
The safety and efficacy of Cyramza in children and adolescents ( &lt; 18 years) has not been established.
Varnost in učinkovitost zdravila Cyramza pri otrocih in mladostnikih (starih &lt; 18 let) nista bili dokazani.
The safety and efficacy of dabrafenib have not yet been established in children and adolescents ( &lt; 18 years).
Varnost in učinkovitost dabrafeniba pri otrocih in mladostnikih ( &lt; 18 let) še nista ugotovljeni.
The safety and efficacy of Dacogen in children aged &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Dacogen pri otrocih, starih &lt; 18 let, nista bili dokazani.
The safety and efficacy of Daklinza in children and adolescents aged &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Daklinza pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of dalbavancin in children aged from birth to &lt; 18 years has not yet been established.
Varnost in učinkovitost dalbavancina pri otrocih v starosti od rojstva do &lt; 18 let še nista ugotovljeni.
The safety and efficacy of dapagliflozin in children aged 0 to &lt; 18 years have not yet been established.
Varnost in učinkovitost dapagliflozina pri otrocih, starih 0 do &lt; 18 let še nista bili ugotovljeni.
The safety and efficacy of Descovy in children younger than 12 years of age, or weighing &lt; 35 kg, have not yet been established.
Varnost in učinkovitost zdravila Descovy pri otrocih, mlajših od 12 let, ali s telesno maso &lt; 35 kg, še nista bili dokazani.
The safety and efficacy of Ebymect in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Ebymect pri otrocih in mladostnikih v starosti od 0 do &lt; 18 let nista ugotovljeni.
The safety and efficacy of Edarbi in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Edarbi pri otrocih in mladostnikih, starih 0 do &lt; 18 let še nista bili dokazani.
The safety and efficacy of EDURANT in children aged &lt; 12 years have not yet been established.
Varnost in učinkovitost zdravila EDURANT pri otrocih, mlajših od 12 let, še nista bili dokazani.
The safety and efficacy of Efficib in children and adolescents from birth to &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila Efficib pri otrocih in mladostnikih, od rojstva do starosti &lt; 18 let, nista bili dokazani.
The safety and efficacy of eltrombopag has not been established in children and adolescents ( &lt; 18 years) with chronic HCV related thrombocytopenia or SAA.
Varnost in učinkovitost eltrombopaga nista bili dokazani pri otrocih in mladostnikih, ki so stari manj kot 18 let in imajo trombocitopenijo zaradi okužbe z virusom hepatitisa C (HCV) ali hudo aplastično anemijo.
The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT &gt; 5 x ULN).
Varnosti in učinkovitosti erlotiniba pri bolnikih s hudo jetrno disfunkcijo (AST/SGOT in ALT/SGPT &gt; petkratna zgornja meja normalne vrednosti) niso proučevali.
The safety and efficacy of Eucreas in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila Eucreas pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t (8; 21), t (15; 17), and inv (16)] have not been established.
Varnost in učinkovitost uporabe filgrastima pri bolnikih z na novo nastalo akutno mieloično levkemijo, ki so mlajši od 55 let in imajo dobro citogenetiko [t(8; 21), t(15; 17) in inv (16)], nista bili dokazani.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Varnost in učinkovitost filgrastima pri bolnikih z de novo AML, mlajših od 55 let in z ugodno citogenetiko [t(8;21), t(15;17) in inv(16)], nista ugotovljeni.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Varnost in učinkovitost uporabe filgrastima pri bolnikih z na novo nastalo akutno mieloično levkemijo, ki so mlajši od 55 let in imajo dobro citogenetiko [t(8;21), t(15;17) in inv(16)] nista bili dokazani.
The safety and efficacy of filgrastim administration in de novo AML patients aged &lt; 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Varnost in učinkovitost uporabe filgrastima pri bolnikih z na novo nastalo AML, starih &lt; 55 let, in dobro citogenetiko [t(8;21), t(15;17), ter inv(16)] še nista bili ugotovljeni.
The safety and efficacy of filgrastim have not been assessed in normal donors &lt; 16 years or &gt; 60 years.
Varnosti in učinkovitosti uporabe filgrastima še niso ovrednotili pri normalnih darovalcih, mlajših od 16 let ali starejših od 60 let.
The safety and efficacy of Galvus in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila Galvus pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl &lt; 30 mL/min).
Varnost in učinkovitost zdravila Gazyvaro pri bolnikih s hudo ledvično okvaro (očistek kreatinina &lt; 30 ml/min) nista ugotovljeni.
The safety and efficacy of Genvoya in children younger than 12 years of age, or weighing &lt; 35 kg, have not yet been established.
Varnost in učinkovitost zdravila Genvoya pri otrocih, mlajših od 12 let, ali s telesno maso &lt; 35 kg, še nista bili dokazani.
The safety and efficacy of Humira was assessed in an open-label, multicenter study in 32 children (2 - &lt; 4 years old or aged 4 and above weighing &lt; 15 kg) with moderately to severely active polyarticular JIA.
Varnost in učinkovitost zdravila Humira so ocenili v odprti, multicentrični študiji pri 32 otrocih (starih od 2 do &lt; 4 leta ali starih 4 leta ali več in s telesno maso &lt; 15 kg) z zmernim do zelo aktivnim poliartikularnim JIA.
The safety and efficacy of Icandra in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila Icandra pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of INCIVO in children aged &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila INCIVO pri otrocih, starih &lt; 18 let, še nista ugotovljeni.
The safety and efficacy of INCIVO in children aged &lt; 18 years have not yet been established.
Varnosti in učinkovitosti zdravila INCIVO pri otrocih, starih &lt; 18 let niso ugotovili.
The safety and efficacy of Incresync in children and adolescents &lt; 18 years old have not been established.
Varnost in učinkovitost zdravila Incresync pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Ipreziv in children and adolescents 0 to &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Ipreziv pri otrocih in mladostnikih starih 0 do &lt; 18 let še nista bili dokazani.
The safety and efficacy of Jalra in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila Jalra pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of Janumet in children and adolescents from birth to &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila Janumet pri otrocih in mladostnikih, od rojstva do starosti &lt; 18 let, nista bili dokazani.
The safety and efficacy of lenvatinib in children aged 2 to &lt; 18 years have not yet been established (see section 5.1).
Varnost in učinkovitost lenvatiniba pri otrocih, starih od 2 do &lt; 18 let, še nista bili dokazani (glejte poglavje 5.1).
The safety and efficacy of Lojuxta in children &lt; 18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Varnost in učinkovitost zdravila Lojuxta pri otrocih, starih do 18 let, nista bili dokazani, zato uporaba tega zdravila pri otrocih ni priporočljiva.
The safety and efficacy of naloxegol in children &lt; 18 years of age has not yet been established.
Varnost in učinkovitost naloksegola pri otrocih, mlajših od 18 let, še nista ugotovljeni.
The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing &lt; 35 kg, have not yet been established.
Varnost in učinkovitost zdravila Odefsey pri otrocih, mlajših od 12 let, ali s telesno maso &lt; 35 kg, še nista bili dokazani.
The safety and efficacy of Onglyza in children aged birth to &lt; 18 years have not yet been established.
Učinkovitost in varnost zdravila Onglyza pri otrocih od rojstva do starosti &lt; 18 let še nista ugotovljeni.
The safety and efficacy of oritavancin in children and adolescents ( &lt; 18 years) has not yet been established.
Varnost in učinkovitost oritavancina pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of Palonosetron i.v at single doses of 1µg/kg and 3µg/kg was compared in the first clinical study in 150 patients in the following age groups, &gt; 28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
Varnost in učinkovitost palonosetrona i.v. pri enojnem odmerku 1 µg/kg in 3 µg/kg so primerjali v prvi klinični študiji s 150 bolniki v naslednjih starostnih skupinah: &gt; 28 dni do 23 mesecev (7 bolnikov), 2 do 11 let (96 bolnikov) in 12 do 16 let (47 bolnikov) z elektivno operacijo.
The safety and efficacy of Palonosetron i.v at single doses of 3 µg/kg and 10 µg/kg was investigated in the first clinical study in 72 patients in the following age groups, &gt; 28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Varnost in učinkovitost palonosetrona i.v. pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: &gt; 28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
The safety and efficacy of Palonosetron i.v at single doses of 3µg/kg and 10µg/kg was investigated in the first clinical study in 72 patients in the following age groups, &gt; 28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Varnost in učinkovitost palonosetrona i.v. pri enojnem odmerku 3 µg/kg in 10 µg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: &gt; 28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
The safety and efficacy of palonosetron intravenously at single doses of 3 mcg/kg and 10 mcg/kg was investigated in the first clinical study in 72 patients in the following age groups, &gt; 28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Varnost in učinkovitost palonosetrona intravensko pri enojnem odmerku 3 mcg/kg in 10 mcg/kg so raziskovali v prvi klinični študiji z 72 bolniki v naslednjih starostnih skupinah: &gt; 28 dni do 23 mesecev (12 bolnikov), 2 do 11 let (31 bolnikov) in 12 do 17 let (29 bolnikov), ki so prejemali zelo ali zmerno emetogeno kemoterapijo.
The safety and efficacy of Pixuvri in children aged &lt; 18 years has not yet been established.
Varnost in učinkovitost zdravila Pixuvri pri otrocih, starih &lt; 18 let, še nista bili dokazani.
The safety and efficacy of prophylactic doses in obese patients (with BMI &gt; 30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Varnost in učinkovitost profilaktičnih odmerkov pri bolnikih s prekomerno telesno težo (z ITM &gt; 30 kg/m2) še nista v celoti dokazani, zato ni enotnega mnenja glede prilagajanja odmerka.
The safety and efficacy of prophylactic doses in obese patients (with BMI &gt; 30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Varnost in učinkovitost profilaktičnih odmerkov pri debelih bolnikih (z ITM &gt; 30 kg/m2) še nista v celoti dokazani, zato ni enotnega mnenja glede prilagajanja odmerka.