natgillin/translations-raw huggingface dataset:
• treatment of recurrent episodes of genital herpes in immunocompromised adults; 
• zdravljenje nadaljnjih ponovitev genitalnega herpesa pri imunsko kompromitiranih odraslih;
For the suppression of the recurrence of genital herpes, the recommended dose is 250 mg twice a day in immunocompetent adults and 500 mg twice a day in immunocompromised adults. 
Pri supresiji ponovitev genitalnega herpesa je priporočeni odmerek 250 mg dvakrat dnevno pri imunsko kompetentnih odraslih oziroma 500 mg dvakrat dnevno pri imunsko kompromitiranih odraslih.
Famvir was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)). 
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Famvir potrebno usklajevanje.
For recurrent genital herpes in immunocompromised adults, the recommended dose is 500 mg twice a day for seven days. 
Pri ponovitvah genitalnega herpesa pri imunsko kompromitiranih odraslih je priporočeni odmerek 500 mg dvakrat dnevno sedem dni.
• treatment of first and recurrent episodes of genital herpes in immunocompetent adults; 
• zdravljenje prvega pojava in nadaljnjih ponovitev genitalnega herpesa pri imunsko kompetentnih
Subcutaneous use pre-filled syringe (glass) in prefilled pen (VarioJect) 
45 mg/0,45 ml raztopina za injiciranje v napolnjeni brizgi napolnjen injekcijski peresnik (steklo) (VarioJect)
The treatment is usually short-term. 
Po navadi je zdravljenje kratkoročno.
Your doctor will have prescribed the strength most suitable for you. 
Zdravnik vam bo predpisal za vas ustrezno jakost.
BLISTER (PVC/PVDC/PVC//Alu) 
PRETISNI OMOT (PVC/PVDC/PVC//Al)
Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established. 
Otroci in mladostniki Zdravila ne dajajte otrokom, starim manj kot 18 let, saj varnost in učinkovitost nista bili dokazani.
Blister (PVC/PVDC/PVC//Alu): 14, 28, 56 or 84 film-coated tablets, in a box. 
Pretisni omot (PVC/PVDC/PVC//Al): 14, 28, 56 ali 84 filmsko obloženih tablet, v škatli.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni "brez natrija".
Not everyone gets flares, but you could get a flare-up even if you are taking Febuxostat Krka, and especially during the first weeks or months of treatment. 
Do izbruha ne pride pri vseh ljudeh, vendar se lahko pojavi tudi, če jemljete zdravilo Febuksostat Krka, še zlasti v prvih tednih ali mesecih zdravljenja.
BL 2 4 6 8 12 16 20 24 28 32 36 40 44 48 52 
BL 2 4 6 8 12 16 20 24 28 32 36 4b 44 48 52
Prophylaxis against gout flares was obligatory over the 26-week period. 
Preventivno zdravljenje zagonov protina je bilo obvezno v času 26 tednov.
* p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg 
* p < 0,001 v primerjavi z alopurinolom, # p < 0,001 v primerjavi z 80 mg
Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Krka every day. 
Čez čas se bodo izbruhi protina pojavljali manj pogosto in bodo manj boleči, če boste nadaljevali z jemanjem zdravila Febuksostat Krka vsak dan.
Rare (may affect up to 1 in 1,000 people): - muscle damage, a condition which on rare occasions can be serious. 
Redki (pojavijo se pri 1 od 1.000 bolnikov) so: - okvara mišic, stanje, ki je lahko v redkih primerih resno.
Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint). 
Zdravnik vam bo pogosto predpisal druga zdravila, če bodo potrebna za preprečevanje ali zdravljenje simptomov izbruhov protina (kot so bolečine in oteklost sklepov).
Long-term, open label extension studies 
Dolgotrajne, odprte podaljšane raziskave
*** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies. 
*** Glejte poglavje 5.1 za incidenco izbruhov protina v posameznih randomiziranih kontroliranih študijah 3. faze
The patients should be closely monitored and the dose of mercaptopurine/azathioprine should be subsequently adjusted based on the evaluation of the therapeutic response and the onset of eventual toxic effects. 
Bolnike je treba skrbno nadzirati, odmerek merkaptopurina/azatioprina pa mora biti posledično prilagojen glede na oceno terapevtskega odgovora in pojava morebitnih toksičnih učinkov.
Treatment of chronic hyperuricaemia 
Zdravljenje kronične hiperuikemije
Do not take Febuxostat Krka - if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 
Ne jemljite zdravila Febuksostat Krka - če ste alergični na febuksostat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events. 
V kliničnih študijah uporaba naproksena ali drugih NSAID/zaviralcev COX-2 ni bila povezana z nobenim klinično pomembnim povečanjem neželenih učinkov.
Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation. 
Sindrom tumorske lize: v ključni študiji 3. faze (FLORENCE) so bili samo bolniki s hudo jetrno insuficienco izključeni iz študije.
Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed. 
Pokazalo se je, da sočasno zaužitje antacida, ki vsebuje magnezijev hidroksid in aluminijev hidroksid, zakasni absorpcijo febuksostata (za približno 1 uro) in povzroči 32 % znižanje Cmax, toda značilne spremembe AUC niso opazili.
Excipient(s) with known effect - lactose: 73 mg 
Pomožna snov z znanim učinkom: - laktoza: 73 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. 
Če ste vzeli večji odmerek zdravila Febuksostat Krka, kot bi smeli V primeru nenamerno vzetega prevelikega odmerka se o tem, kaj morate storiti, posvetujte z zdravnikom ali pojdite v najbližji urgentni oddelek za nezgode in nujne primere.
Incidence of overall treatment-emergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with febuxostat and allopurinol respectively. 
Incidenca z zdravljenjem povezanih znakov in simptomov ter neželenih učinkov je bila 67,6 % proti 64,7 % in 6,4 % za febuksostat v primerjavi s 6,4 % pri alopurinolu.
Febuxostat Krka should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment. 
Zdravljenje z zdravilom Febuksostat Krka je treba začeti dva dni pred pričetkom terapije s citotoksičnimi kemoterapevtiki in ga nadaljevati najmanj 7 dni; vendar se lahko zdravljenje podaljša do 9 dni, odvisno od trajanja kemoterapije kot tudi klinične presoje.
Excipient(s) with known effect - lactose: 109 mg 
Pomožna snov z znanim učinkom: - laktoza: 109 mg
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. 
Triletni podatki so pokazali zmanjšanje napadov protina in manj kot 4 % bolnikov je potrebovalo nadaljnjo zdravljenje izbruhov protina (tj. več kot 96 % bolnikov ni bilo potrebno zdraviti zaradi izbruhov protina) v mesecih 16 - 24 in v mesecih 30 - 36.
Gout flares were commonly observed soon after the start of treatment and during the first months. 
Izbruh protina se je pogosto pojavil takoj po začetku zdravljenja in v prvih mesecih.
Rosiglitazone/CYP2C8 substrates 
Rosiglitazon/substrati CYP2C8
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with Febuxostat Krka. 
Če imate trenutno izbruh protina (nenadni občutek hude bolečine, napetosti, pordelosti, toplote in oteklosti sklepa), počakajte, da izbruh protina mine, preden začnete zdravljenje z zdravilom Febuksostat Krka.
Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn. 
Bolnike, ki so imeli 3 zaporedne vrednosti sUA na ravni > 6,0 mg/dl, so iz raziskave izključili.
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. 
Učinkovitost febuksostata je bila dokazana v treh ključnih študijah 3. faze (dve ključni študiji APEX in FACT ter dodatna študija CONFIRMS, ki so opisane v nadaljevanju) pri 4.101 bolnikih s hiperurikemijo in protinom.
See section 2 "Febuxostat Krka contains lactose and sodium". 
Glejte poglavje 2 "Zdravilo Febuksostat Krka vsebuje laktozo in natrij".
What you need to know before you take Febuxostat Krka 
Kaj morate vedeti, preden boste vzeli zdravilo Febuksostat Krka
Keeping uric acid levels low by taking Febuxostat Krka once every day stops crystals building up, and over time it reduces symptoms. 
Jemanje zdravila Febuksostat Krka enkrat na dan ohranja nizko raven sečne kisline in prepreči nastanek kristalov, dolgoročno pa zmanjša simptome.
The safety and efficacy of Febuxostat Krka in children below the age of 18 years have not been established. 
Varnost in učinkovitost zdravila Febuksostat Krka pri otrocih, starih do 18 let, še nista bili dokazani.
In the randomized, double-blind, Phase 3 pivotal FLORENCE (FLO-01) study comparing febuxostat with allopurinol (346 patients undergoing chemotherapy for haematologic malignancies and at intermediate-to-high risk of TLS), only 22 (6.4%) patients overall experienced adverse reactions, namely 11 (6.4%) patients in each treatment group. 
V randomizirani, dvojno slepi, ključni študiji 3. faze FLORENCE (FLO-01), kjer so primerjali febuksostat z alopurinolom (346 bolnikov, zdravljenih s kemoterapijo zaradi hematološkega malignega obolenja in s srednje visokim do visokim tveganjem za TLS), je v celoti le 22 (6,4 %) bolnikov imelo neželene učinke, in sicer 11 (6,4 %) bolnikov v vsaki zdravljeni skupini.
Primary endpoints were serum uric acid area under the curve (AUCsUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8. 
Primarni cilji so bili površina serumske sečne kisline pod krivuljo (AUCsUA1-8) in sprememba vrednosti serumskega kreatinina (sC) na samem začetku in do dneva 8.
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 
14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet
Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. 
Presnova febuksostata je odvisna od encimov uridin glukoronoziltransferaze (UGT).
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat Krka and your doctor may wish to consider necessary measures: - Mercaptopurine (used to treat cancer) - Azathioprine (used to reduce immune response) - Theophylline (used to treat asthma) 
Zlasti pomembno je, da zdravnika ali farmacevta obvestite, če jemljete zdravila, ki vsebujejo katero od naslednjih učinkovin, da bo zdravnik ocenil, ali so potrebni ustrezni ukrepi, saj lahko pride do medsebojnega delovanja z zdravilom Febuksostat Krka: - merkaptopurin (uporablja se za zdravljenje raka), - azatioprin (uporablja se za zaviranje imunskega odziva), - teofilin (uporablja se za zdravljenje astme).
Start taking Febuxostat Krka two days before chemotherapy and continue its use according to your doctor's advice. 
Začnite jemati zdravilo Febuksostat Krka dva dni pred kemoterapijo in z jemanjem nadaljujte v skladu z zdravnikovimi navodili.
This has not been observed in the pivotal clinical study with febuxostat in the Tumor Lysis Syndrome. 
To v ključni klinični študiji s febuksostatom pri sindromu tumorske lize ni bilo opaženo.
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). 
Po 8 tednih preventivnega zdravljenja se je pojavnost napadov protina povečala in se nato postopoma zniževala (64 % in 70 % oseb je prejelo zdravljenje proti izbruhom protina v tednih od 8 do 52).
Thereafter, the frequency of gout flare decreases in a time-dependent manner. 
Zato pogostnost izbruhov protina pada v odvisnosti od časa.
If you stop taking Febuxostat Krka your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys. 
Če prenehate jemati zdravilo Febuksostat Krka, se lahko ravni sečne kisline znova povišajo in pride do poslabšanja simptomov zaradi nastajanja novih kristalov urata v sklepih in ledvicah.
Talk to your doctor or pharmacist before taking Febuxostat Krka: - if you have or have had heart failure or heart problems or stroke, - if you have or have had kidney disease and/or serious allergic reaction to Allopurinol (a medicine used for the treatment of gout), 
Pred začetkom jemanja zdravila Febuksostat Krka se posvetujte z zdravnikom ali farmacevtom: - če imate ali ste imeli srčno popuščanje, težave s srcem ali možgansko kap, - če imate ali ste imeli bolezen ledvic in/ali resne alergijske reakcije na alopurinol (zdravilo za zdravljenje protina),
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. 
Poročila raziskovalcev o srčno-žilnih dogodkih APTC v kombiniranih študijah 3. faze (študijah APEX, FACT in CONFIRMS) so bila 0,7 v primerjavi z 0,6 dogodka na 100 bolniških let.
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. 
Študije na brejih podganjih samicah (pri približno 4,3-kratni izpostavljenosti človeka) in brejih kunčjih samicah (pri približno 13-kratni izpostavljenosti človeka) niso pokazale teratogenih učinkov.
How to store Febuxostat Krka Contents of the pack and other information 
Shranjevanje zdravila Febuksostat Krka Vsebina pakiranja in dodatne informacije
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended. 
Ker ni izkušenj s febuksostatom pri bolnikih z Lesch-Nyhanovim sindromom, se njegova uporaba ne priporoča.
Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production; ATC code: M04AA03. 
Farmakoterapevtska skupina: zdravila za zdravljenje protina, Zdravila za zaviranje nastajanja sečne kisline; oznaka ATC: M04AA03.
In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with febuxostat for Tumor Lysis Syndrome. 
Pri bolnikih, ki imajo zelo visoke vrednosti sečne kisline (npr. tisti, ki prejemajo kemoterapijo zaradi rakavega obolenja), lahko zdravila za zniževanje sečne kisline vodijo v odlaganje ksantina v sečilih, z možnimi kamni, čeprav tega ni bilo opaženo pri bolnikih, ki so se zdravili s febuksostatom zaradi sindroma tumorske lize.
Your doctor might decide to permanently stop treatment with Febuxostat Krka. 
Zdravnik se lahko odloči, da za stalno prekine zdravljenje z zdravilom Febuksostat Krka.
Should you experience allergic reactions to Febuxostat Krka, stop taking this medicine (see also section 4). 
Če se med zdravljenjem z zdravilom Febuksostat Krka pojavijo alergijske reakcije, prenehajte jemati zdravilo (glejte tudi poglavje 4).
Febuxostat Krka 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. 
Zdravilo Febuksostat Krka 120 mg tablete uporabljamo tudi za zdravljenje in preprečevanje visokih ravni sečne kisline v krvi, ki se lahko pojavijo ob začetku zdravljenja krvnega raka s kemoterapijo.
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). 
Ob začetku zdravljenja se lahko pojavi izbruh protina zaradi spremenjene ravni sečne kisline v serumu, kar povzroči mobilizacijo urata iz depozitov v tkivih (glejte poglavji 4.8 in 5.1).
Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). 
Zdravilo Febuksostat Krka je indicirano za zdravljenje kronične hiperurikemije v primerih, ko je že prišlo do odlaganja kristalov urata (vključno s primeri, kjer so ali so kdaj prej bili prisotni tofi ali uratni artritis).
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). 
Primarni izid v podskupini bolnikov z okvaro delovanja ledvic V študiji APEX je bila ocenjena učinkovitost pri 40 bolnikih z okvaro delovanja ledvic (tj. izhodiščna vrednost kreatinina v serumu > 1,5 mg/dl in ≤ 2,0 mg/dl).
Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity. 
Uporabe febuksostata se ne priporoča pri bolnikih, ki se sočasno zdravijo z merkaptopurinom/azatioprinom, saj lahko febuksostat z inhibicijo ksantinske oksidaze povzroči povečano plazemsko koncentracijo merkaptopurina/azatioprina, kar lahko povzroči hudo toksičnost.
Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system. 
Večji del presnove febuksostata poteka s konjugacijo prek encimskega sistema uridin difosfat glukoronoziltransfaraze (UDPGT) in z oksidacijo s citokromi P450 (CYP).
Tumor Lysis Syndrome: 
Sindrom tumorske lize:
Drug interaction studies of febuxostat with drugs (except theophylline) that are metabolized by XO have not been performed in humans. 
Študij medsebojnega delovanja febuksostata z zdravili (razen s teofilinom), ki se presnavljajo s ksantinsko oksidazo na ljudeh niso izvedli.
If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Krka at any time. 
Če se je pri vas po jemanju febuksostata razvil Stevens-Johnsonov sindrom, ne smete nikoli ponovno začeti jemati zdravila Febuksostat Krka.
Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis. 
Zdravljenje s febuksostatom je treba nemudoma prekiniti, če nastane resna alergijska/preobčutljivostna reakcija, vključno s Stevens-Johnsonovim sindromom, saj je z zgodnjo ukinitvijo zdravljenja povezana boljša prognoza.
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 izid učinkovitosti v študijah APEX in FACT je bil delež bolnikov, pri katerih je bil nivo sečne kisline v serumu v zadnjih 3 mesecih < 6,0 mg/dl (357 µmol/l).
Dyspnoea, bronchitis, upper respiratory tract infection, cough 
Občasni dispneja, bronhitis, okužba zgornjih dihal, kašelj
There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of febuxostat, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk. 
Redko so se pri jemanju febuksostata pojavili potencialno življenjsko nevarni kožni izpuščaji (Stevens-Johnsonov sindrom), ki so vidni na začetku kot rdečkaste, tarči podobne pike ali krožne lise, pogosto z mehurjem v sredini.
After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 μg/mL, and 5.0-5.3 μg/mL, respectively. 
Po enkratnem ali ponavljajočem se peroralnem odmerku 80 mg enkrat na dan je Cmax približno 2,8-3,2 µg/ml, pri odmerku 120 mg pa 5,0-5,3 µg/ml.
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. 
Povprečni skupni AUC febuksostata se je povišal za približno 1,8-krat od 7,5 gh/ml v skupini oseb z normalnim delovanjem ledvic na 13,2 gh/ml v skupini s hudo motnjo delovanja ledvic.
Febuxostat Krka is available in boxes containing 14, 28, 56 or 84 film-coated tablets in blisters. 
Zdravilo Febuksostat Krka je na voljo v škatlah po 14, 28, 56 ali 84 filmsko obloženih tablet v pretisnih omotih.
Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate 
laktoza monohidrat mikrokristalna celuloza hidroksipropilceluloza premreženi natrijev karmelozat koloidni hidratirani silicijev dioksid magnezijev stearat
It is important to keep taking Febuxostat Krka even if you have a flare, as Febuxostat Krka is still working to lower uric acid. 
Pomembno je, da z jemanjem zdravila Febuksostat Krka nadaljujete tudi, če pride do izbruha protina, saj zdravilo Febuksostat Krka še vedno znižuje raven sečne kisline.
Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience in gout patients. 
Preglednica 1: Neželeni učinki v kombiniranih študijah 3. faze, dolgoročnih podaljšanih študijah in v obdobju trženja pri bolnikih s protinom
Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 μmol/L) Last Three Monthly Visits 
Preglednica 2 Delež bolnikov s koncentracijo sečne kisline v serumu < 6,0 mg/dl (357 µmol/l) Zadnji trije mesečni obiski
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 študija (C02-021): Excel študija, študija podaljšanje varnosti 3. faze, je potekala tri leta in je bila odprta, multicentrična, randomizirana, s kontrolno skupino zdravljeno s alopurinolom, za bolnike, ki so zaključili ključne študije 3. faze (APEX in FACT).
What Febuxostat Krka is and what it is used for What you need to know before you take Febuxostat Krka How to take Febuxostat Krka Possible side effects 
Kaj je zdravilo Febuksostat Krka in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Febuksostat Krka Kako jemati zdravilo Febuksostat Krka Možni neželeni učinki
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. 
Znižanje vrednosti sečne kisline v serumu na < 6,0 mg/dl (357 µmol/l) so opazili pri obisku v 2. tednu, ohranilo pa se je ves čas zdravljenja.
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. 
Po večkratnih odmerkih febuksostata 80 mg pri bolnikih z blago, zmerno ali hudo ledvično okvaro, se vrednost Cmax febuksostata ni spremenila v primerjavi z osebami z normalnim delovanjem ledvic.
Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase Rare 
Občasni diabetes mellitus, hiperlipidemija, zmanjšanje apetita, povečanje telesne mase