natgillin/translations-raw huggingface dataset:
In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo. 
V študiji na zdravih prostovoljcih sočasno jemanje 120 mg febuksostata enkrat na dan in enkratnega 4 mg peroralnega odmerka rosiglitazona ni imelo nobenega učinka na farmakokinetiko rosiglitazona in njegovih N-demetilrosiglitazon presnovkov, kar nakazuje, da febuksostat ni zaviralec encima CYP2C8 in vivo.
The proportion of patients with serum urate levels of <6.0 mg/dL (357 μmol/L) at the final visit was greater than 80% (81-100%) at each febuxostat dose. 
Delež bolnikov z vrednostmi uratov v serumu < 6,0 mg/dl (357 mol/l) je bil na zaključnem obisku večji kot 80 % (81-100 %) neodvisno od odmerka febuksostata.
hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate in the tablet core and poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172) - only for 120 mg film-coated tablets and red iron oxide (E172) - only for 80 mg film-coated tablets in the film coating. 
- Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, hidroksipropilceluloza, premreženi natrijev karmelozat, koloidni hidratirani silicijev dioksid in magnezijev stearat v jedru tablete ter polivinilalkohol, makrogol 3350, titanov dioksid (E171), smukec, rumeni železov oksid (E172) - samo za 120 mg filmsko obložene tablete, in rdeči železov oksid (E172) - samo za 80 mg filmsko obložene tablete, v filmski oblogi.
Monitoring of serum uric acid is therefore recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation. 
Zato se 1-2 tedna po uvedbi zdravljenja z močnimi induktorji glukuronidacije priporoča nadzor sečne kisline v serumu.
Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity . 
Zaviranje ksantinske oksidaze s febuksostatom lahko povzroči povečane plazemske koncentracije teh zdravil, kar vodi do toksičnosti.
Febuxostat Krka is for adults. 
Zdravilo Febuksostat Krka je za odrasle.
concentrations febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, namely, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase or purine nucleoside phosphorylase. 
Febuksostat v terapevtskih koncentracijah ne zavira drugih encimov, ki so udeleženi pri presnovi purina ali pirimidina, kot so gvanin deaminaza, hipoksantin gvanin fosforibozil transferaze, orotat fosforibozil transferaza, orotidin monofosfat dekarboksilaza ali purin nukleozid fosforilaza.
Febuxostat Krka tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. 
Tablete Febuksostat Krka vsebujejo učinkovino febuksostat in jih uporabljamo za zdravljenje protina, ki je povezan z izločanjem substance, ki se imenuje sečna kislina (urati) v telesu.
Continue to take Febuxostat Krka every day even when you are not experiencing gout flare or attack. 
Z jemanjem zdravila Febuksostat Krka nadaljujte vsak dan, tudi ko pri vas ne pride do izbruha ali poslabšanja protina.
The effect of Febuxostat Krka on human fertility is unknown. 
Učinek zdravila Febuksostat Krka na plodnost pri človeku ni znan.
Oral use Febuxostat Krka should be taken by mouth and can be taken with or without food. 
Način uporabe peroralna uporaba Zdravilo Febuksostat Krka se jemlje peroralno, s hrano ali brez hrane.
The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals). 
Delež bolnikov, pri katerih je bilo treba zdraviti izbruh protina (v študijah APEX in FACT), je bil številčno nižji v skupinah, ki so glede na izhodiščno vrednost dosegle povprečno vrednost urata v serumu < 6,0 mg/dl, < 5,0 mg/dl ali < 4,0 mg/dl, v primerjavi s skupino, ki je dosegla povprečne vrednosti urata v serumu ≥ 6,0 mg/dl v obdobju zadnjih 32 tednov zdravljenja (v intervalih teden 2024 do teden 49-52).
Following multiple doses of 80 mg of febuxostat in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function. 
Po večkratnih odmerkih febuksostata 80 mg pri bolnikih z blago (razred A po Child-Pughu) ali zmerno (razred B po Child-Pughu) okvaro jeter se Cmax in AUC febuksostata in njegovih presnovkov nista pomembneje spremenili v primerjavi z osebami z normalnim delovanjem jeter.
What Febuxostat Krka is and what it is used for 
Kaj je zdravilo Febuksostat Krka in za kaj ga uporabljamo
- if you have or have had liver disease or liver function test abnormalities, - if you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood), - if you have thyroid problems. 
- če imate ali ste imeli bolezen jeter ali nenormalne rezultate jetrnih testov, - če se zdravite zaradi visokih ravni sečne kisline, ki so posledica Lesch-Nyhanovega sindroma
Off pink, oval, biconvex, film-coated tablets scored on one side. 
Umazano roza, ovalne, izbočene, filmsko obložene tablete z razdelilno zarezo na eni strani.
If you miss a dose of Febuxostat Krka take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time. 
Če ste pozabili vzeti zdravilo Febuksostat Krka Če pozabite vzeti odmerek zdravila Febuksostat Krka, ga vzemite takoj, ko se spomnite, razen če je skoraj čas za naslednji odmerek.
Primary endpoint in the sub group of patients with sUA ≥ 10 mg/dL Approximately 40% of patients (combined APEX and FACT) had a baseline sUA of ≥ 10 mg/dL. 
Primarni izid v podskupini bolnikov z vrednostmi sečne kisline v serumu ≥ 10 mg/dl Približno 40 % bolnikov (iz obeh študij APEX in FACT) je imelo izhodiščno vrednost sečne kisline v serumu ≥ 10 mg/dl.
Serum urate levels were maintained over time (i.e. 91% and 93% of patients on initial treatment with febuxostat 80 mg and 120 mg, respectively, had sUA <6 mg/dL at Month 36). 
Nivo serumskih uratov se je ohranil skozi celotno obdobje zdravljenja (tj. 91 % in 93 % bolnikov, ki so bili na začetnem zdravljenju s febuksostatom 80 mg in 120 mg je imelo po 36 mesecih nivo sUA < 6 mg/dl.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 
- Običajni odmerek je ena tableta na dan. Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na dva enaka odmerka.
Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) and patients with allopurinol (5.8%) in the long term open label extension studies (see section 4.4). 
V dolgoročnih odprtih podaljšanih študijah so povišane vrednosti TSH (> 5,5 µi.e./ml) opazili pri bolnikih, ki so se dolgoročno zdravili s febuksostatom (5,5 %), in pri bolnikih, ki so se zdravili z alopurinolom (5,8 %) (glejte poglavje 4.4).
It is not known if Febuxostat Krka may pass into human breast milk. 
Ni znano, ali zdravilo Febuksostat Krka prehaja v materino mleko.
With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in febuxostat and allopurinol arm, respectively; relative risk: 0.875 [95% confidence interval: 0.4408; 1.7369]; p=0.8488) nor of clinical TLS (1.7% and 1.2% in febuxostat and allopurinol arm, respectively; relative risk: 0.994 [95% confidence interval: 0.9691; 1.0199]; p=1.0000). 
Pri sekundarnih izidih ni bilo izmerjenih pomembnih razlik glede incidence laboratorijske TLS (8,1 % pri febuksostatu oziroma 9,2 % pri alopurinolu; relativno tveganje: 0,875 [95% interval zaupanja: 0,4408; 1,7369]; p = 0,8488) in klinične TLS (1,7% pri febuksostatu oziroma 1,2 % pri alopurinolu; relativno tveganje: 0,994 [95 % interval zaupanja: 0,9691; 1,0199]; p = 1,0000).
Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow: - anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”) - potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens- Johnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2) - generalised skin rashes. 
Prenehajte jemati zdravilo in nemudoma pokličite zdravnika ali pojdite na oddelek za nujno medicinsko pomoč najbližje bolnišnice, če se pojavijo naslednji redki (pojavijo se pri 1 od 1.000 bolnikov) neželeni učinki, saj jim lahko sledijo resne alergijske reakcije: - anafilaktične reakcije, preobčutljivost na zdravilo (glejte tudi poglavje 2, "Opozorila in previdnostni ukrepi"), - potencialno življenjsko nevarni kožni izpuščaji, za katere je značilna tvorba mehurčkov, luščenje kože in notranjih površin telesnih votlin, npr. ust in spolovil, boleče razjede v območju ust in/ali spolovil, ki jih spremlja povišana telesna temperatura, boleče grlo in utrujenost (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza) ali povečane bezgavke, povečanje jeter, hepatitis (vse do jetrne odpovedi), povečanje števila belih krvničk v krvi (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi - sindrom DRESS) (glejte poglavje 2), - kožni izpuščaji po vsem telesu.
Febuxostat Krka is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). 
Zdravilo Febuksostat Krka je indicirano za preventivo in zdravljenje hiperurikemije pri odraslih bolnikih, pri katerih poteka zdravljenje hematološkega malignega obolenja s srednje visokim do visokim tveganjem nastanka sindroma tumorske lize (TLS - Tumor Lysis Syndrome) s kemoterapijo.
What Febuxostat Krka looks like and contents of the pack Febuxostat Krka 80 mg film-coated tablets (tablets) are off pink, oval, biconvex, film-coated tablets scored on one side. 
Izgled zdravila Febuksostat Krka in vsebina pakiranja Filmsko obložene tablete Febuksostat Krka 80 mg (tablete) so umazano roza, ovalne, izbočene, filmsko obložene tablete z razdelilno zarezo na eni strani.
Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome) Rare 
Občasni atrijska fibrilacija, palpitacije, nenormalni EKG, levokračni blok, (glejte poglavje Sindrom tumorske lize), sinusna tahikardija (glejte poglavje Sindrom tumorske lize) Redki nenadna kardialna smrt*
The results of the study showed that the co-administration of febuxostat 80 mg QD with theophylline 400 mg single dose has no effect on the pharmacokinetics or safety of theophylline. 
Rezultati študije na zdravih prostovoljcih so pokazali, da sočasno jemanje 80 mg febuksostata enkrat na dan in 400 mg teofilina v enkratnem odmerku, nima učinka na farmakokinetiko ali varnost teofilina.
Each film-coated tablet contains 80 mg febuxostat. 
Ena filmsko obložena tableta vsebuje 80 mg febuksostata.
Febuxostat Krka 120 mg film-coated tablets (tablets) are brownish yellow, slightly biconvex, capsule shaped film-coated tablets scored on both sides. 
Filmsko obložene tablete Febuksostat Krka 120 mg (tablete) so rjavkasto rumene, rahlo izbočene, filmsko obložene tablete v obliki kapsule z razdelilno zarezo na obeh straneh.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino ali katerokoli pomožno snov navedeno v poglavju 6.1 (glejte tudi poglavje 4.8).
The proportion of patients with serum urate levels of < 6.0 mg/dL (357 μmol/L) at the final visit, was 45% for 40 mg febuxostat, 67% for febuxostat 80 mg and 42% for allopurinol 300/200 mg, respectively. 
Delež bolnikov z nivojem sečne kisline v serumu na končnem pregledu < 6,0 mg/dl (357 µmol/l) je bil 45 % pri odmerku 40 mg febuksostata, 67 % pri 80 mg febuksostata oziroma 42 % pri 300/200 mg alopurinola.
62% of patients required no dose adjustment to maintain sUA <6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose. 
Vključenih je bilo 116 bolnikov, ki so prejemali prvotni odmerek febuksostat 80 mg enkrat na dan. 62 % bolnikov ni potrebovalo prilagajanja odmerka za vzdrževanje sUA < 6 mg/dl, 38 % bolnikov pa je potrebovalo prilagoditev odmerjanja za dosego končnega ciljnega stabilnega odmerka.
FLORENCE was a randomized (1:1), double blind, phase III, pivotal trial comparing febuxostat 120 mg once daily with allopurinol 200 to 600 mg daily (mean allopurinol daily dose [± standard deviation]: 349.7 ± 112.90 mg) in terms of control of serum uric acid level. 
V študiji FLORENCE, ki je bila randomizirana (1 : 1), dvojno slepa, ključna študija 3. faze, so primerjali, kako febuksostat 120 mg enkrat na dan in alopurinol 200 do 600 mg dnevno (povprečni dnevni odmerek alopurinola [± standardna deviacija]: 349,7 ± 112,90 mg), vplivata na serumske vrednosti sečne kisline.
In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit. 
V dodatni študiji 3. faze CONFIRMS, za katero so bili rezultati na voljo po prvi pridobitvi dovoljenja za promet s febuksostatom, je bil primarni izid učinkovitosti delež bolnikov, pri katerih je bil nivo sečne kisline v serumu na končnem pregledu < 6,0 mg/dl. Bolniki s presajenimi organi niso bili vključeni v študiji (glejte poglavje 4.2).
Mean AUC sUA1-8 (mgxh/dl) was significantly lower with febuxostat (514.0 ± 225.71 vs 708.0 ± 234.42; least square means difference: -196.794 [95% confidence interval: -238.600; -154.988]; p <.0001). 
Srednja AUC sUA1-8 (mgxh/dl) je bila značilno manjša pri uporabi febuksostata (514,0 ± 225,71 proti 708,0 ± 234,42; razlika povprečne vrednosti najmanjšega kvadrata: -196,794 [95 % interval zaupanja: -238,600 ; -154.988]; p < 0,0001).
Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary. 
Febuksostat se lahko daje sočasno s kolhicinom ali indometacinom brez prilagoditve odmerka febuksostata ali učinkovine, ki se daje hkrati.
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema. 
Neželeni učinki, o katerih so najpogosteje poročali v kliničnem preskušanju (4.072 bolnikov, zdravljenih z odmerkom zdravila od 10 mg do 300 mg) in v obdobju trženja pri bolnikih s protinom, so zagoni protina, nenormalnosti delovanja jeter, driska, navzea, glavobol, izpuščaj in edem.
Each film-coated tablet contains 120 mg febuxostat. 
Ena filmsko obložena tableta vsebuje 120 mg febuksostata.
14 film-coated tablets: EU/1/18/1347/005 28 film-coated tablets: EU/1/18/1347/006 56 film-coated tablets: EU/1/18/1347/007 84 film-coated tablets: EU/1/18/1347/008 
14 filmsko obloženih tablet: EU/1/18/1347/005 28 filmsko obloženih tablet: EU/1/18/1347/006 56 filmsko obloženih tablet: EU/1/18/1347/007 84 filmsko obloženih tablet: EU/1/18/1347/008
14 film-coated tablets: EU/1/18/1347/001 28 film-coated tablets: EU/1/18/1347/002 56 film-coated tablets: EU/1/18/1347/003 84 film-coated tablets: EU/1/18/1347/004 
14 filmsko obloženih tablet: EU/1/18/1347/001 28 filmsko obloženih tablet: EU/1/18/1347/002 56 filmsko obloženih tablet: EU/1/18/1347/003 84 filmsko obloženih tablet: EU/1/18/1347/004
If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Krka 120 mg once daily may be considered. 
Če je po 2-4 tednih koncentracija sečne kisline v serumu > 6 mg/dl (357 µmol/l), je smiselno razmisliti o jemanju zdravila Febuksostat Krka v odmerku 120 mg enkrat na dan.
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema. 
Neželeni učinki, o katerih so najpogosteje poročali v kliničnem preskušanju (4.072 bolnikov, zdravljenih z odmerkom zdravila od 10 mg do 300 mg) in v obdobju trženja, so zagoni protina, nenormalnosti delovanja jeter, driska, navzea, glavobol, izpuščaj in edem.
In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies. 
V ključni študiji sindroma tumorske lize so bolniki, pri katerih poteka zdravljenje s kemoterapevtiki z različnim režimom zdravljenja, vključno z monoklonskimi protitelesi, prejemali febuksostat 120 mg dnevno.
Thus, coadministration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds. 
Zato ni pričakovati, da bi bilo treba pri sočasnem dajanju febuksostata z drugimi substrati za CYP2D6 prilagoditi odmerek učinkovin.
Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) in the long term open label extension studies. 
V dolgoročnih odprtih podaljšanih študijah so pri bolnikih, ki so bili na dolgotrajnem zdravljenju s febuksostatom (5,5 %), opazili povišane vrednosti TSH (> 5,5 µi.e./ml).
Febuxostat Krka 80 mg 
Febuksostat Krka 80 mg
Clinical Outcomes: proportion of patients requiring treatment for a gout flare APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%). 
Klinični izidi: Delež bolnikov, pri katerih je bilo treba zdraviti izbruh protina Študija APEX: V času 8 tedenskega preventivnega zdravljenja je večji delež oseb potreboval zdravljenje zagona protina v skupini s 120 mg febuksostata (36 %), kot v skupini s febuksostatom 80 mg (28 %), skupini z alopurinolom 300 mg (23 %) in placebo skupini (20 %).
Febuxostat Krka 120 mg 
Febuksostat Krka 120 mg
The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 μmol/L). 
Študija FACT je pokazala statistično pomembno prednost obeh oblik zdravljenja s febuksostatom 80 mg in febuksostatom 120 mg enkrat na dan v primerjavi z običajno uporabljenim odmerkom alopurinola 300 mg pri zmanjšanju in vzdrževanju ravni sečne kisline v serumu pod 6 mg/dl (357 µmol/l).
Brownish yellow, slightly biconvex, capsule shaped film-coated tablets scored on both sides. 
Rjavkasto rumene, rahlo izbočene, filmsko obložene tablete v obliki kapsule z razdelilno zarezo na obeh straneh.
In addition to the urinary excretion, approximately 45% of the dose was recovered in the faeces as the unchanged febuxostat (12%), the acyl glucuronide of the active substance (1%), its known oxidative metabolites and their conjugates (25%), and other unknown metabolites (7%). 
Približno 45 % odmerka se je izločilo z blatom, 12 % v obliki nespremenjenega febuksostata, 1 % v obliki acil-glukuronida, 25 % v obliki znanih oksidativnih presnovkov in njihovih konjugatov in 7 % v obliki drugih neznanih presnovkov.
Clabeled febuxostat, approximately 49% of the dose was recovered in the urine as unchanged febuxostat (3%), the acyl glucuronide of the active substance (30%), its known oxidative metabolites and their conjugates (13%), and other unknown metabolites (3%). 
C označenega febuksostata se je približno 49 % odmerka izločilo z urinom, 3 % v obliki nespremenjenega febuksostata, 30 % v obliki acil-glukuronida učinkovine, 13 % v obliki znanih oksidativnih presnovkov in njihovih konjugatov ter 3 % v obliki drugih neznanih presnovkov.
Do not stop taking Febuxostat Krka without the advice of your doctor even if you feel better. 
Če ste prenehali jemati zdravilo Febuksostat Krka Tudi če se počutite bolje, ne prenehajte jemati zdravila Febuksostat Krka, razen če vam je to svetoval zdravnik.
In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA < 6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively. 
V študiji CONFIRMS je bil delež bolnikov, pri katerih je bil dosežen primarni izid učinkovitosti (sUA < 6,0 mg/dl pri zadnjem pregledu) in z začetno vrednostjo sečne kisline ≥ 10 mg/dl, ki so bili zdravljeni z 40 mg febuksostata enkrat na dan 27 % (66/249), 80 mg febuksostata enkrat na dan 49 % (125/254) v primerjavi z 31 % (72/230) bolnikov, zdravljenih z 300 mg/200 mg alopurinola enkrat na dan.
(n=519) results from subjects receiving either 100 mg QD (n=10: patients with serum creatinine >1.5 and ≤2.0 mg/dL) or 300 mg QD (n=509) were pooled for analyses. 
(n = 519) za analize so bili zbrani podatki bolnikov, ki so prejemali bodisi 100 mg enkrat na dan (n = 10: bolniki s serumskim kreatininom > 1,5 in  2,0 mg/dl) ali 300 mg enkrat na dan (n = 509)
Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Febuxostat Krka does not adversely affect performance. 
Po uporabi febuksostata so poročali o neželenih učinkih, kot so zaspanost, omotica, parestezija in zamegljen vid. Bolniki morajo biti pred vožnjo, uporabo strojev ali udeležbo v tveganih dejavnostih previdni, dokler niso povsem prepričani, da zdravilo Febuksostat Krka ne vpliva negativno na opravljanje teh dejavnosti.
The APEX study showed statistically significant superiority of both the febuxostat 80 mg QD and the febuxostat 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n = 258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 μmol/L) (see Table 2 and Figure 1). 
Študija APEX je pokazala statistično pomembno prednost obeh oblik zdravljenja s febuksostatom v odmerku 80 mg enkrat na dan in s febuksostatom 120 mg enkrat na dan v primerjavi z običajno uporabljenim odmerkom alopurinola 300 mg (n = 258) /100 mg (n = 10) pri zmanjšanju koncentracije sečne kisline v serumu pod 6 mg/dl (357 µmol/l) (glejte preglednico 2 in sliko 1).