natgillin/translations-raw huggingface dataset:
If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylactic reaction/shock, febuxostat must not be re-started in this patient at any time. 
Ako se u bolesnika pojavila alergijska reakcija/reakcija preosjetljivosti, uključujući Stevens-Johnsonov sindrom i akutnu anafilaktičku reakciju/šok, više se nikada ne smije ponovno započeti liječenje tog bolesnika febuksostatom.
Abdominal pain, abdominal distension, gastrooesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort Rare 
Bol u abdomenu, distenzija abdomena, bolest gastroezofagealnog refluksa, povraćanje, suha usta, dispepsija, konstipacija, česte stolice, flatulencija, gastrointestinalna nelagoda Rijetko
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. 
Povećane vrijednosti TSH-a (>5,5 µIU/ml) uočene su u bolesnika dugotrajno liječenih febuksostatom (5,5%) tijekom dugoročnih produljenih otvorenih ispitivanja.
Elderly No dose adjustment is required in the elderly (see section 5.2). 
Nije potrebna prilagodba doze u starijih bolesnika (vidjeti dio 5.2).
No dose adjustment is necessary for warfarin when administered with febuxostat. 
Nije potrebna prilagodba doze varfarina kad se primjenjuje zajedno s febuksostatom.
Off pink, oval, biconvex, film-coated tablets scored on one side. 
Prljavo ružičaste, ovalne, bikonveksne, filmom obložene tablete s urezom na jednoj strani.
Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production; ATC code: M04AA03. 
Lijekovi koji inhibiraju stvaranje urične kiseline, ATK oznaka: M04AA03
Teratology studies, performed in pregnant rats at approximately 4.3 times and pregnant rabbits at approximately 13 times human exposure did not reveal any teratogenic effects. 
U ispitivanjima teratogenosti, provedenima na gravidnim štakoricama uz dozu od oko 4,3 puta veću od izloženosti u ljudi i na gravidnim zečicama uz dozu oko 13 puta veću od izloženosti u ljudi, nisu otkriveni teratogeni učinci.
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 može primjenjivati istodobno s kolhicinom i indometacinom, bez potrebe prilagodbe doze febuksostata ili istodobno primijenjene djelatne tvari.
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%). 
Uz izlučivanje putem urina, oko 45% doze nalazi se u stolici u obliku nepromijenjenog febuksostata (12%), acil glukuronida djelatne tvari (1%), poznatih oksidacijskih metabolita i njihovih konjugata (25%) te drugih nepoznatih metabolita (7%).
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. 
Krka tablete sadrže djelatnu tvar febuksostat i koriste se za liječenje uloga (gihta), uzrokovanih povećanim nakupljanjem tvari koja se zove mokraćna kiselina (urati) u organizmu.
The rate of all-cause mortality was also higher with febuxostat than allopurinol (7.8% vs. 6.4% of patients; HR 1.22; 95% CI 1.01-1.47), which was mainly driven by the higher rate of CV deaths in that group (see section 4.4). 
Stopa smrtnosti zbog bilo kojeg uzroka također je bila viša u skupini febuksostata nego u skupini alopurinola (7,8% u odnosu na 6,4% bolesnika; HR 1,22; 95% CI 1,01-1,47), što je uglavnom bilo uzrokovano višom stopom KV smrti u toj skupini (vidjeti dio 4.4).
Febuxostat Krka is for adults. 
Krka namijenjen je za odrasle osobe.
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). 
Povećane vrijednosti TSH-a (>5,5 µIU/ml) uočene su kod bolesnika na dugotrajnom liječenju febuksostatom (5,5%) i kod bolesnika liječenih alopurinolom (5,8%) u dugoročnim, otvorenim, produljenim ispitivanjima (vidjeti dio 4.4).
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 filmom obloženih tableta: EU/1/18/1347/005 28 filmom obloženih tableta: EU/1/18/1347/006 56 filmom obloženih tableta: EU/1/18/1347/007 84 filmom obložene tablete: EU/1/18/1347/008
In male rats, a statistically significant increase in urinary bladder tumours (transitional cell papilloma and carcinoma) was found only in association with xanthine calculi in the high dose group, at approximately 11 times human exposure. 
U mužjaka štakora nađeno je statistički značajno povećanje incidencije pojave tumora mokraćnog mjehura (papiloma prijelaznih stanica i karcinoma), što je povezano samo sa ksantinskim kamencima u skupini koja je primala visoke doze, otprilike 11 puta veće od izloženosti u ljudi.
(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) rezultati ispitanika koji su primali 100 mg jednom dnevno (n=10: bolesnici s kreatininom u serumu >1,5 i ≤2,0 mg/dl) ili 300 mg jednom dnevno (n=509) su zbrojeni za potrebe analize.
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. 
U 62% bolesnika nije bila potrebna prilagodba doze kako bi se održala razina mokraćne kiseline u serumu ispod 6 mg/dl, a u 38% bolesnika bilo je potrebna prilagodba doze kako bi se postigla krajnja stabilna doza.
Uncommon Erectile dysfunction 
Manje često Erektilna disfunkcija
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 filmom obloženih tableta: EU/1/18/1347/001 28 filmom obloženih tableta: EU/1/18/1347/002 56 filmom obloženih tableta: EU/1/18/1347/003 84 filmom obložene tablete: EU/1/18/1347/004
The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 μg⋅h/mL in the normal renal function group to 13.2 μg.h/mL in the severe renal dysfunction group. 
Srednji ukupni AUC febuksostata povećao se za oko 1,8 puta, sa 7,5 g.h/ml u skupini s urednom funkcijom bubrega na 13,2 g.h/ml u skupini s teškim oštećenjem funkcije bubrega.
Each film-coated tablet contains 80 mg febuxostat. 
Jedna filmom obložena tableta sadrži 80 mg febuksostata.
If you forget to take Febuxostat Krka 
Ako ste zaboravili uzeti Febuxostat Krka
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. 
Prestanite uzimati ovaj lijek i odmah se javite svom liječniku ili otiđite u najbližu ustanovu hitne medicinske pomoći ako se pojave sljedeće rijetke nuspojave (mogu se pojaviti kod manje od 1 na 1000 osoba), jer ozbiljna alergijska reakcija može slijediti nakon toga: - anafilaktičke reakcije, preosjetljivost na lijek (vidjeti i dio 2. „Upozorenja i mjere opreza“) - kožni osipi koji mogu biti opasni po život, karakterizirani stvaranjem mjehura, ljuštenjem kože i sluznica, npr. usta i genitalija, bolnim čirevima u ustima i/ili na području genitalija, udruženim s vrućicom, grloboljom i umorom (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza) ili s povećanim limfnim čvorovima, povećanom jetrom, hepatitisom (sve do zatajenja jetre), povećanjem broja bijelih krvnih stanica (reakcija na lijek s eozinofilijom i sustavnim simptomima - DRESS) (vidjeti dio 2.) - generalizirani kožni osip.
One thousand and seventy-two (1072) patients were randomized: placebo (n=134), febxuostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 240 mg QD (n=134) or allopurinol (300 mg QD [n=258] for patients with a baseline serum creatinine ≤1.5 mg/dL or 100 mg QD [n=10] for patients with a baseline serum creatinine >1.5 mg/dL and ≤2.0 mg/dL). 
Tisuću i sedamdeset dva (1072) bolesnika su randomizirana te su primali: placebo (n=134), febuksostat 80 mg jednom dnevno (n=267), febuksostat 120 mg jednom dnevno (n=269), febuksostat 240 mg jednom dnevno (n=134) ili alopurinol (300 mg jednom dnevno [n=258] u bolesnika s početnom razinom kreatinina u serumu 1,5 mg/dl ili 100 mg jednom dnevno [n=10] u bolesnika s početnom razinom kreatinina u serumu >1,5 mg/dl i 2,0 mg/dl).
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). 
Što se tiče sekundarnih ishoda, nisu opažene značajne razlike u incidenciji laboratorijskog STL-a (8,1% u skupini na febuksostatu, 9,2% u skupini na alopurinolu; relativni rizik 0,875 [95%-tni interval pouzdanosti: 0,4408; 1,7369]; p=0,8488 niti kliničkog STL-a (1,7% u skupini na febuksostatu, 1,2% u skupini na alopurinolu; relativni rizik 0,994 [95%-tni interval pouzdanosti: 0,9691; 1,0199]; p=1,0000).
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, oko 49% doze je nađeno u urinu u obliku nepromijenjenog febuksostata (3%), acil glukuronida djelatne tvari (30%), poznatih oksidacijskih metabolita i njihovih konjugata (13%) te drugih nepoznatih metabolita (3%).
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. 
Udio bolesnika s razinom urata u serumu <6,0 mg/dl (357 µmol/l) na završnoj kontroli bio je 45% za febuksostat od 40 mg, 67% za febuksostat od 80 mg i 42% za alopurinol od 300/200 mg.
If you take more Febuxostat Krka than you should In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department. 
U slučaju slučajna predoziranja, pitajte svog liječnika za savjet ili se obratite najbližem odjelu za hitnu pomoć.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti i dio 4.8).
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. 
Udio bolesnika s razinom urata u serumu <6,0 mg/dl (357 µmol/l) na zadnjoj kontroli bio je veći od 80% (81-100%) kod svake doze febuksostata.
Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases. 
Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS), su u nekim slučajevima uključivale vrućicu, hematološke promjene, zahvaćanje bubrega ili jetre.
Toxic epidermal necrolysis*, Stevens-Johnson Syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalized rash (serious)*, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic*, rash erythematous, rash morbillifom, alopecia, hyperhidrosis Musculoskeletal and connective tissue disorders Uncommon Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis 
Toksična epidermalna nekroliza*, Stevens-Johnsonov sindrom*, angioedem*, reakcija na lijek s eozinofilijom i sustavnim simptomima*, generalizirani osip (ozbiljni)*, eritem, eksfolijativni osip, folikularni osip, vezikularni osip, pustularni osip, pruritični osip*, eritematozni osip, morbiliformni osip, alopecija, hiperhidroza
Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine. 
Povišena glukoza u krvi, produljeno aktivirano parcijalno tromboplastinsko vrijeme, smanjen broj crvenih krvnih stanica, povišena alkalna fosfataza u krvi, povišena kreatin fosfokinaza u krvi* * Nuspojave prijavljene nakon stavljanja lijeka u promet ** Neinfektivni proljev i abnormalni testovi jetrene funkcije vezani uz liječenje bili su učestaliji u kombiniranim ispitivanjima faze 3 kod bolesnika istodobno liječenih kolhicinom *** Vidjeti dio 5.1 za incidenciju napada gihta u pojedinim randomiziranim ispitivanjima faze 3
Febuxostat Krka contains lactose. 
Krka sadrži laktozu.
Primary endpoint in the sub-group of patients with renal impairment The APEX Study evaluated efficacy in 40 patients with renal impairment (i.e., baseline serum creatinine > 1.5 mg/dL and ≤2.0 mg/dL). 
U ispitivanju APEX procjenjivana je djelotvornost u 40 bolesnika s oštećenom funkcijom bubrega (tj. početna razina kreatinina u serumu >1,5 mg/dl i ≤2,0 mg/dl).
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). 
Krka je indiciran za prevenciju i liječenje hiperuricemije u odraslih bolesnika koji su podvrgnuti kemoterapiji za hematološke zloćudne bolesti i imaju srednje visoki do visoki rizik za nastajanje sindroma tumorske lize (STL).
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 AUCsMK1-8 (mgxh/dl) bila je značajno niža s febuksostatom (514,0 ± 225,71 naspram 708,0 ± 234,42; razlika srednjih vrijednosti procijenjena metodom najmanjih kvadrata: -196,794 [95%-tni interval pouzdanosti: -238,600; -154,988]; p<0,0001).
Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn. 
Bolesnici kojima je u tri uzastopna mjerenja razina mokraćne kiseline u serumu bila >6,0 mg/dl bili su isključeni iz ispitivanja.
Febuxostat Krka 120 mg film-coated tablets (tablets) are brownish yellow, slightly biconvex, capsule shaped film-coated tablets scored on both sides. 
Krka 120 mg filmom obložene tablete (tablete) su smećkasto-žute, blago bikonveksne, filmom obložene tablete oblika kapsule, s urezom na obje strane.
During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%). 
Tijekom faze 3 kombiniranih kliničkih ispitivanja, uočene su blage abnormalnosti testova funkcije jetre u bolesnika liječenih febuksostatom (5,0%).
During the phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%). 
Tijekom kliničkih ispitivanja faze 3, uočene su blage abnormalnosti testova funkcije jetre u bolesnika liječenih febuksostatom (5,0%).
Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate 
Jezgra tablete laktoza hidrat celuloza, mikrokristalična hidroksipropilceluloza hidroksipropilceluloza silicijev dioksid, koloidni, hidratizirani magnezijev stearat
Brownish yellow, slightly biconvex, capsule shaped film-coated tablets scored on both sides. 
Smećkasto-žute, blago bikonveksne, filmom obložene tablete oblika kapsule s urezom na obje strane.
Each film-coated tablet contains 120 mg febuxostat. 
Jedna filmom obložena tableta sadrži 120 mg febuksostata.
However, no dose adjustment is necessary in patients with mild or moderate renal impairment. 
Međutim, nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
In healthy subjects, maximum plasma concentrations (Cmax) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg to 120 mg. For doses between 120 mg and 300 mg, a greater than dose proportional increase in AUC is observed for febuxostat. 
U zdravih ispitanika maksimalne koncentracije u plazmi (Cmax) i područje ispod krivulje (AUC) febuksostata povećavali su se proporcionalno dozi nakon jednokratnih i ponovljenih doza od 10 mg do 120 mg.
Other medicines and Febuxostat Krka 
Drugi lijekovi i Febuxostat Krka
Febuxostat Krka 80 mg 
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%). 
Klinički ishodi: udio bolesnika koji zahtijevaju liječenje akutnog napada gihta APEX ispitivanje: Tijekom razdoblja provođenja profilakse u trajanju od 8 tjedana zabilježen je veći udio ispitanika kojima je bilo potrebno liječenje akutnog napada gihta u skupini na febuksostatu 120 mg (36%), u odnosu na skupinu na febuksostatu 80 mg (28%), alopurinolu 300 mg (23%) i placebu (20%).
No significant difference in mean serum creatinine change (%) occurred between febuxostat and allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 respectively; least square means difference: 4.0970 [95% confidence interval: -0.6467; 8.8406]; p=0.0903). 
Nije bilo značajne razlike u promjeni srednje vrijednosti serumskog kreatinina (%) između febuksostata i alopurinola (-0,83 ± 26,98 odnosno -4,92 ± 16,70); razlika srednjih vrijednosti procijenjena metodom najmanjih kvadrata: 4,0970 [95%-tni interval pouzdanosti: -0,6467; 8,8406]; p=0,0903).
Febuxostat Krka 120 mg 
Krka 120 mg
Reduction in serum uric acid level to <6.0 mg/dL (357 μmol/L) was noted by the Week 2 visit and was maintained throughout treatment. 
Snižavanje razine mokraćne kiseline u serumu na <6,0 mg/dl (357 µmol/l) uočena je do kontrole bolesnika nakon 2 tjedna i zadržalo se tijekom cijelog liječenja.
Allopurinol 300 / 100 mg QD 
Alopurinol 300 / 100 mg jednom dnevno
- abnormal liver test results - diarrhoea - headache - rash (including various types of rash, please see below under “uncommon” and “rare” sections) - nausea - increase in gout symptoms - localised swelling due to retention of fluids in tissues (oedema). 
Česte nuspojave (mogu se javiti kod manje od 1 na 10 osoba) su: - abnormalni rezultati jetrenih pretraga - proljev - glavobolja - osip (uključujući razne vrste osipa, molimo pogledajte niže u tekstu u dijelovima „manje česte nuspojave“ i „rijetke nuspojave“) - mučnina - pojačani simptomi gihta - lokalizirano oticanje radi zadržavanja tekućina u tkivima (edem).
Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment with this medicine and should not drive or operate machines if affected. 
Imajte na umu da tijekom liječenja možete osjetiti omaglicu, pospanost, zamućeni vid i utrnulost ili trnce.
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). 
Ispitivanje APEX pokazalo je statistički značajnu superiornost liječenja, kako febuksostatom 80 mg jednom dnevno tako i febuksostatom 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg (n=258)/100 mg (n=10), s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l) (vidjeti tablicu 2 i sliku 1).
Gout: The recommended oral dose of Febuxostat Krka is 80 mg once daily without regard to food. 
Giht: preporučena peroralna doza lijeka Febuxostat Krka je 80 mg jednom dnevno, neovisno o unosu 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). 
Udio bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (ispitivanja APEX i FACT) bio je brojčano manji u skupinama kod kojih je nakon početka liječenja postignuta prosječna razina urata u serumu <6,0 mg/dl, <5,0 mg/dl ili <4,0 mg/dl, u usporedbi sa skupinom kod koje je nakon početka liječenja postignuta prosječna razina urata u serumu ≥6,0 mg/dl tijekom posljednja 32 tjedna liječenja (u intervalima od 20. - 24. tjedna do 49. - 52. tjedna).
How to take Febuxostat Krka 
Kako uzimati Febuxostat Krka
Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate 
Ukupno je bilo uključeno 346 bolesnika s hematološkim zloćudnim bolestima koji su podvrgnuti kemoterapiji i imaju srednje visoki/visoki rizik od nastajanja sindroma tumorske lize.
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. 
Nakon višekratnih doza od 80 mg febuksostata u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre, Cmax i AUC febuksostata i njegovih metabolita nije bio značajno promijenjen u odnosu na ispitanike s urednom funkcijom jetre.
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). 
Ispitivanje FACT pokazalo je statistički značajnu superiornost liječenja, kako febuksostatom 80 mg tako i febuksostatom 120 mg jednom dnevno u odnosu na liječenje uobičajeno korištenim dozama alopurinola 300 mg, s obzirom na snižavanje razine mokraćne kiseline u serumu ispod 6 mg/dl (357 µmol/l).
How to store Febuxostat Krka 
Kako čuvati Febuxostat Krka
Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience. 
Nakon stavljanja lijeka u promet pojavile su se rijetke ozbiljne reakcije preosjetljivosti na febuksostat, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i anafilaktičku reakciju/šok.