natgillin/translations-raw huggingface dataset:
Febuxostat Mylan film-coated tablets are yellow, capsule shaped, biconvex tablets. 
Febuxostat Mylan filmom obložene tablete žute su bikonveksne tablete u obliku kapsule.
• If you have thyroid problems. 
• ako imate problema sa štitnjačom.
HDPE bottle with polypropylene (PP) screw cap closure with desiccant containing 28 or 84 tablets. 
Boca od polietilena visoke gustoće s polipropilenskim (PP) navojnim čepom sa sredstvom za sušenje, koja sadržava 28 ili 84 tablete.
Lactose and Sodium content 
Sadržaj laktoze i natrija
Febuxostat Mylan is for adults. 
Mylan je za odrasle.
• increase in blood thyroid stimulating hormone (TSH) level 
• povišena razina tiroidnog stimulirajućeg hormona (TSH) u krvi
Treatment with febuxostat in patients with pre-existing major cardiovascular diseases (e.g. myocardial infarction, stroke or unstable angina) should be avoided, unless no other therapy options are appropriate. 
U bolesnika s postojećom težom kardiovaskularnom bolešću (npr. infarkt miokarda, moždani udar ili nestabilna angina) liječenje febuksostatom treba izbjegavati, osim u slučaju kada nijedno drugo liječenje nije prikladno.
Rare Blurred vision 
Rijetko Zamagljen vid
• dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia) 
• omaglica, utrnulost, trnci, smanjen ili promijenjen osjet (hipoestezija, hemipareza ili parestezija), promijenjen osjet okusa, smanjen osjet njuha (hiposmija)
EXCEL Study (C02-021): The Excel study was a three years Phase 3, open label, multicenter, randomised, allopurinol-controlled, safety extension study for patients who had completed the pivotal Phase 3 studies (APEX or FACT). 
EXCEL ispitivanja (C02-021): Excel ispitivanje bilo je otvoreno, multicentrično, randomizirano ispitivanje faze 3 kontrolirano alopurinolom, produljeno ispitivanje sigurnosti za bolesnike koji su završili pivotalna ispitivanja faze 3 (APEX ili FACT).
The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study, described below) that were conducted in 4101 patients with hyperuricaemia and gout. 
Djelotvornost febuksostata dokazana je u tri pivotalna ispitivanja faze 3 (niže su opisana dva pivotalna ispitivanja APEX i FACT, i dodatno CONFIRMS ispitivanje) koja su provedena na 4101 bolesniku s hiperuricemijom i gihtom.
The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). 
Djelotvornost i sigurnost febuksostata nije ispitivana kod bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 µmol/L). 
Primarni ishod djelotvornosti u ispitivanjima APEX i FACT bio je omjer bolesnika kod kojih su razine mokraćne kiseline u serumu u posljednja 3 mjeseca bile < 6,0 mg/dl (357 µmol/l).
After the 8-week prophylaxis period, the incidences of flares increased and gradually decreased over time (64% and 70% of subjects received treatment for gout flares from Week 8-52). 
Nakon 8 tjedana profilaktičkog razdoblja, incidencija akutnih napada gihta se povećavala i postupno smanjivala tijekom vremena (akutni napadi gihta liječeni su kod 64% i 70% ispitanika od 8. do 52. tjedna).
Gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits (see sections 4.8 and 5.1). 
Na početku liječenja mogu nastupiti akutni napadi gihta, zbog promjena razine mokraćne kiseline u serumu koja dovodi do mobilizacije urata nataloženih u tkivima (vidjeti dijelove 4.8 i 5.1).
(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.
Salomone Pharma Ltd Tel: + 356 21 22 01 74 
V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Flares increased following the prophylaxis period and gradually decreased over time. 
Akutni napadi gihta bili su češći u profilaktičkom razdoblju, a zatim su s vremenom postupno postali rjeđi.
14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 84 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets (calendar) 84 film-coated tablets (calendar) 
14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obložene tablete 84 filmom obložene tablete 28 × 1 filmom obložena tableta 28 filmom obloženih tableta (kalendar) 84 filmom obložene tablete (kalendar)
If a gout flare occurs during febuxostat treatment, it should not be discontinued. 
Javi li se napad gihta tijekom liječenja febuksostatom, njegovu primjenu ne treba prekinuti.
Rates of adjudicated hospitalization for heart failure, hospital admissions for arrhythmias not associated with ischemia, venous thromboembolic events and hospitalization for transient ischemic attacks were comparable for febuxostat and allopurinol. 
Stope slučajeva u kojima je određena hospitalizacija zbog srčanog zatajenja, prijema u bolnicu zbog aritmija koje nisu povezane s ishemijom, venskih tromboembolijskih događaja i hospitalizacije zbog tranzitorne ishemijske atake bile su usporedive za skupinu febuksostata i skupinu alopurinola.
No data comparing febuxostat with rasburicase are currently available. 
Trenutno nema dostupnih podataka o usporedbi febuksostata i razburikaze.
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. 
Kod 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 kod ljudi.
In a study in healthy subjects, 120 mg febuxostat QD resulted in a mean 22% increase in AUC of desipramine, a CYP2D6 substrate indicating a potential weak inhibitory effect of febuxostat on the CYP2D6 enzyme in vivo. 
Tijekom ispitivanja na zdravim ispitanicima primjena 120 mg febuksostata jednom dnevno dovela je do srednjeg povećanja od 22% površine ispod krivulje (AUC-a) desipramina, supstrata CYP2D6, što upućuje na moguće blago inhibicijsko djelovanje febuksostata na enzim CYP2D6 in vivo.
Thus, febuxostat may be taken without regard to food. 
Dakle, febuksostat se može uzimati neovisno o hrani.
Pharmacotherapeutic group: Antigout preparation, preparations inhibiting uric acid production, ATC code: M04AA03 
Lijekovi koji inhibiraju stvaranje urične kiseline, ATK oznaka: M04AA03
No data is available regarding the safety of febuxostat during other cytotoxic therapy. 
Ne postoje podaci o sigurnosti febuksostata tijekom liječenja ostalim citotoksičnim lijekovima.
Dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia 
Omaglica, parestezija, hemipareza, somnolencija, promjena osjeta okusa, hipoestezija, hiposmija
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. 
FLORENCE je bilo randomizirano (1:1), dvostruko slijepo pivotalno ispitivanje faze 3 u kojem se uspoređivao febuksostat 120 mg jednom dnevno s alopurinolom 200 do 600 mg dnevno (srednja dnevna doza alopurinola [± standardna devijacija]: 349,7 ± 112,90 mg) s obzirom na kontrolu razine mokraćne kiseline u serumu.
Endocrine disorders 
Endokrini poremećaji
No dose adjustment is necessary for febuxostat when administered with hydrochlorothiazide. 
Nije potrebno prilagođavanje doze febuksostata kad se primjenjuje zajedno s hidroklorotiazidom.
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. 
Kod 62% bolesnika nije bilo potrebno prilagođavanje doze kako bi se održala razina mokraćne kiseline u serumu ispod 6 mg/dl, a kod 38% bolesnika bilo je potrebno prilagođavanje doze kako bi se postigla krajnja stabilna doza.
240 mg febuxostat was used to evaluate the safety of febuxostat at twice the recommended highest dose. 
Za procjenu sigurnosti febuksostata korištena je doza od 240 mg febuksostata, što je dvostruko od najviše preporučene doze.
You should not use Febuxostat Mylan if you are breast-feeding, or if you are planning to breast-feed. 
Nemojte uzimati Febuxostat Mylan ako dojite ili planirate dojiti.
Drug interaction studies of febuxostat with other cytotoxic chemotherapy have not been conducted. 
Nisu provedena ispitivanja interakcija febuksostata s ostalim citotoksičnim kemoterapeuticima.
The incidence of investigator-reported cardiovascular APTC events in the combined Phase 3 studies (APEX, FACT and CONFIRMS studies) was 0.7 vs. 0.6 events per 100 PYs. 
Incidencija APTC kardiovaskularnih događaja koje su prijavili ispitivači tijekom faze 3 kombiniranih ispitivanja (APEX, FACT i CONFIRMS) bila je 0,7, u odnosu na 0,6 događaja na 100 bolesnik/godina.
• muscle and/or joint stiffness 
• ukočenost mišića i/ili zglobova
In the FLORENCE study febuxostat demonstrated a superior control of serum uric acid level compared to allopurinol in patients scheduled to receive the latter drug. 
U FLORENCE ispitivanju febuksostat je pokazao superiornu kontrolu razine mokraćne kiseline u serumu u odnosu na bolesnike na alopurinolu kod bolesnika koji su bili planirani za liječenje alopurinolom.
Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase 
Povišene amilaze u krvi, smanjen broj trombocita, smanjen broj bijelih krvnih stanica, smanjen broj limfocita, povišen kreatin u krvi, povišen kreatinin u krvi, snižen hemoglobin, povišena ureja u krvi, povišeni trigliceridi u krvi, povišen kolesterol u krvi, snižen hematokrit, povišena laktat dehidrogenaza u krvi, povišen kalij u krvi
Febuxostat Mylan 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. 
Febuxostat Mylan tablete sadrže djelatnu tvar febuksostat i koriste se za liječenje uloga (gihta), uzrokovanih povećanim nakupljanjem tvari koja se zove mokraćna kiselina (urati) u organizmu.
Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience Blood and lymphatic system disorders 
Tablica 1: Nuspojave u fazi 3 dugoročnih produžetaka ispitivanja i nakon stavljanja lijeka u promet Poremećaji krvi i limfnog sustava Rijetko
Hypersensitivity reactions to febuxostat can be associated to the following symptoms: skin reactions characterised by infiltrated maculopapular eruption, generalised or exfoliative rashes, but also skin lesions, facial oedema, fever, haematologic abnormalities such as thrombocytopenia and eosinophilia, and single or multiple organ involvement (liver and kidney including tubulointerstitial nephritis) (see section 4.4). 
Reakcije preosjetljivosti na febuksostat mogu uključivati sljedeće simptome: kožne promjene karakterizirane infiltrativnim makulopapuloznim eruptivnim osipom, generaliziranim ili eksfolijativnim osipom, ali i kožnim lezijama, edemom lica, vrućicom, hematološkim abnormalnostima poput trombocitopenije i eozinofilije, te zahvaćenošću jednog ili više organa (jetra i bubreg, uključujući tubulointersticijski nefritis) (vidjeti dio 4.4).
BOTTLE LABEL 
NALJEPNICA NA BOCI
If you miss a dose of Febuxostat Mylan 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. 
Ako ste zaboravili uzeti tabletu lijeka Febuxostat Mylan, uzmite je čim se sjetite, osim ako je uskoro vrijeme za sljedeću tabletu.
Three years data showed a decrease in the incidence of gout flares with less than 4% of patients requiring treatment for a flare (i.e. more than 96% of patients did not require treatment for a flare) at Month 16-24 and at Month 30-36. 
Podaci dobiveni tijekom tri godine pokazali su sniženje incidencije akutnih napada gihta s manje od 4% bolesnika kojima je bilo potrebno liječenje akutnog napada gihta (tj. kod više od 96% bolesnika nije bilo potrebno liječenje akutnih napada gihta) od 16. do 24. i od 30. do 36. mjeseca ispitivanja.
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 kod 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.
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting 
• upala gušterače: česti simptomi su bol u trbuhu, mučnina i povraćanje
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 kod bolesnika liječenih febuksostatom (5,0%).
Thus, co-administration of febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds. 
Prema tome, nije očekivano da će istodobna primjena febuksostata s roziglitazonom ili drugim CYP2C8 supstratom zahtijevati prilagodbu doze ovih lijekova.
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 kod bolesnika liječenih febuksostatom (5,0%).
The primary endpoint in CARES was the time to first occurrence of MACE, a composite of nonfatal MI, non-fatal stroke, CV death and unstable angina with urgent coronary revascularization. 
Primarna mjera ishoda u CARES-u bilo je vrijeme do prve pojave velikog kardiovaskularnog štetnog događaja (MACE), što je uključivalo nefatalni infarkt miokarda, nefatalni moždani udar, KV smrt i nestabilnu anginu s hitnom koronarnom revaskularizacijom.
• itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin conditions 
• svrbež, urtikarija, upalne promjene kože, promjena boje kože, male, crvene ili ljubičaste mrlje na koži, male, plosnate, crvene kožne mrlje, plosnato, crveno područje kože prekriveno malim ispupčenjima koji se spajaju, osip, područja crvenila kože i kožnih mrlji, druge vrste kožnih promjena
Inducers of glucuronidation 
Induktori glukuronidacije
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). 
Razine urata u serumu bile su održavane tijekom vremena (to jest 91% i 93% bolesnika koji su inicijalno liječeni febuksostatom 80 mg, odnosno 120 mg imali su mokraćnu kiselinu u serumu nižu od 6 mg/dl u 36. mjesecu).
The recommended oral dose of Febuxostat Mylan is 80 mg once daily without regard to food. 
Preporučena peroralna doza lijeka Febuxostat Mylan je 80 mg jednom dnevno, neovisno o unosu hrane.
Following multiple doses of 80 mg of febuxostat in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function. 
Nakon višekratnih doza od 80 mg febuksostata kod bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega, Cmax febuksostata nije bio promijenjen u odnosu na ispitanike s urednom funkcijom bubrega.
46% and 38%, of patients on final stable treatment of febuxostat 80 or 120 mg QD, respectively, had complete resolution of the primary palpable tophus from baseline to the Final Visit. 
Kod 46% i 38% bolesnika finalno liječenih stabilnim dozama febuksostata od 80 mg, odnosno 120 mg jednom dnevno došlo je do potpuna nestanka primarnoga palpabilnog tofa od početka ispitivanja do zadnje kontrole.
Rare side effects (may affect up to 1 in 1,000 people) are: 
Rijetke nuspojave (mogu se pojaviti kod manje od 1 na 1000 osoba) su:
For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. 
Kod nekih osoba napadi gihta mogu nastupiti na početku uzimanja određenih lijekova za kontrolu razine mokraćne kiseline.
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 
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
Hypromellose Titanium dioxide (E171) Ethylcellulose Iron oxide yellow (E172) Triacetin 
Ovojnica tablete hipromeloza titanijev dioksid (E171) etilceluloza željezov oksid, žuti (E172) triacetin željezov oksid, crni (E172)
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%) i drugih poznatih metabolita (7%).
Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome) 
Atrijska fibrilacija, palpitacije, abnormalni EKG, blok lijeve grane snopa (vidjeti dio Sindrom tumorske lize), sinusna tahikardija (vidjeti dio Sindrom tumorske lize) Rijetko
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 µgh/ml u skupini s urednom funkcijom bubrega na 13,2 µg.h/ml u skupini s teškim oštećenjem funkcije bubrega.
The active substance is febuxostat. 
Djelatna tvar je febuksostat.
28 film-coated tablets 84 film-coated tablets 
28 filmom obloženih tableta 84 filmom obložene tablete
It is not known if febuxostat may pass into human breast milk. 
Nije poznato može li febuksostat prijeći u majčino mlijeko.
No dose adjustment is necessary for warfarin when administered with febuxostat. 
Nije potrebno prilagođavanje doze varfarina kad se primjenjuje zajedno s febuksostatom.
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 nižom od 6,0 mg/dl (357 µmol/l) na zadnjoj kontroli bio je veći od 80% (81-100%) kod svake doze febuksostata.
Febuxostat 240 mg 
Febuksostat 240 mg
What Febuxostat Mylan contains 
Što Febuxostat Mylan sadrži
The frequencies are based on studies and post-marketing experience in gout patients. 
Učestalosti se temelje na ispitivanjima i iskustvu nakon stavljanja lijeka u promet kod bolesnika s gihtom.
Uncommon Erectile dysfunction 
• erektilna disfunkcija
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 kod 40 bolesnika s oštećenom funkcijom bubrega (tj. početna razina kreatinina u serumu >1,5 mg/dl i ≤2,0 mg/dl).
4.2 Posology and method of administration 
4.2 Doziranje i način primjene Doziranje
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 prilagođavanja doze febuksostata ili istodobno primijenjene djelatne tvari.
Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in blister packs of 14, 28, 42 and 84 tablets, calendar blister packs of 28 and 84 tablets, and perforated unit dose blister packs of 28 x 1 tablets and in multipacks of 84 film-coated tablets comprising 2 packs, each containing 42 film-coated tablets. 
Febuxostat Mylan 80 mg i 120 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 42 i 84 tablete, kalendarskim blister pakiranjima s 28 i 84 tablete i perforiranim blister pakiranjima s jediničnim dozama s 28 x 1 tabletom i u multipakiranjima s 84 filmom obložene tablete koja se sastoje od 2 pakiranja po 42 filmom obložene tablete.
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 kod 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.
At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2). 
Na početku liječenja febuksostatom preporučuje se profilaksa napada gihta nesteroidnim protuupalnim lijekom ili kolhicinom, u trajanju od najmanje 6 mjeseci (vidjeti dio 4.2).
Mercaptopurine/azathioprine 
Merkaptopurin/azatioprin
If you stop taking Febuxostat Mylan 
Ako prestanete uzimati Febuxostat Mylan
FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study. 
Ispitivanje FACT: Kontrolirano ispitivanje febuksostata i alopurinola (FACT) je bilo randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 u trajanju od 52 tjedna.
APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study. 
Ispitivanje APEX: Ispitivanje djelotvornosti febuksostata uz kontrolu alopurinolom i placebom (APEX) bilo je randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 u trajanju od 28 tjedana.
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). 
Liječenje kronične hiperuricemije, u stanjima kada je već došlo do taloženja urata (uključujući prisutnost tofa i/ili uričnog artritisa, trenutno ili u anamnezi).