FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet
English: Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes.
Slovenian: Presnova febuksostata je odvisna od encimov uridin glukoronoziltransferaze (UGT).
English: 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)
Slovenian: 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).
English: Start taking Febuxostat Krka two days before chemotherapy and continue its use according to your doctor's advice.
Slovenian: Začnite jemati zdravilo Febuksostat Krka dva dni pred kemoterapijo in z jemanjem nadaljujte v skladu z zdravnikovimi navodili.
English: This has not been observed in the pivotal clinical study with febuxostat in the Tumor Lysis Syndrome.
Slovenian: To v ključni klinični študiji s febuksostatom pri sindromu tumorske lize ni bilo opaženo.
English: 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).
Slovenian: 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).
English: Thereafter, the frequency of gout flare decreases in a time-dependent manner.
Slovenian: Zato pogostnost izbruhov protina pada v odvisnosti od časa.
English: 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.
Slovenian: 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.
English: 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),
Slovenian: 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),
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: How to store Febuxostat Krka Contents of the pack and other information
Slovenian: Shranjevanje zdravila Febuksostat Krka Vsebina pakiranja in dodatne informacije
English: As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended.
Slovenian: Ker ni izkušenj s febuksostatom pri bolnikih z Lesch-Nyhanovim sindromom, se njegova uporaba ne priporoča.
English: Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production; ATC code: M04AA03.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje protina, Zdravila za zaviranje nastajanja sečne kisline; oznaka ATC: M04AA03.
English: 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.
Slovenian: 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.
English: Your doctor might decide to permanently stop treatment with Febuxostat Krka.
Slovenian: Zdravnik se lahko odloči, da za stalno prekine zdravljenje z zdravilom Febuksostat Krka.
English: Should you experience allergic reactions to Febuxostat Krka, stop taking this medicine (see also section 4).
Slovenian: Če se med zdravljenjem z zdravilom Febuksostat Krka pojavijo alergijske reakcije, prenehajte jemati zdravilo (glejte tudi poglavje 4).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Slovenian: Večji del presnove febuksostata poteka s konjugacijo prek encimskega sistema uridin difosfat glukoronoziltransfaraze (UDPGT) in z oksidacijo s citokromi P450 (CYP).
English: Tumor Lysis Syndrome:
Slovenian: Sindrom tumorske lize:
English: Drug interaction studies of febuxostat with drugs (except theophylline) that are metabolized by XO have not been performed in humans.
Slovenian: Študij medsebojnega delovanja febuksostata z zdravili (razen s teofilinom), ki se presnavljajo s ksantinsko oksidazo na ljudeh niso izvedli.
English: If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Krka at any time.
Slovenian: Če se je pri vas po jemanju febuksostata razvil Stevens-Johnsonov sindrom, ne smete nikoli ponovno začeti jemati zdravila Febuksostat Krka.
English: 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.
Slovenian: 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.
English: España KRKA Farmacéutica, S.L.
Slovenian: KRKA Farmacéutica, S.L.
English: 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).
Slovenian: 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).
English: Dyspnoea, bronchitis, upper respiratory tract infection, cough
Slovenian: Občasni dispneja, bronhitis, okužba zgornjih dihal, kašelj
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Febuxostat Krka is available in boxes containing 14, 28, 56 or 84 film-coated tablets in blisters.
Slovenian: Zdravilo Febuksostat Krka je na voljo v škatlah po 14, 28, 56 ali 84 filmsko obloženih tablet v pretisnih omotih.
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate
Slovenian: laktoza monohidrat mikrokristalna celuloza hidroksipropilceluloza premreženi natrijev karmelozat koloidni hidratirani silicijev dioksid magnezijev stearat
English: It is important to keep taking Febuxostat Krka even if you have a flare, as Febuxostat Krka is still working to lower uric acid.
Slovenian: 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.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience in gout patients.
Slovenian: Preglednica 1: Neželeni učinki v kombiniranih študijah 3. faze, dolgoročnih podaljšanih študijah in v obdobju trženja pri bolnikih s protinom
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 μmol/L) Last Three Monthly Visits
Slovenian: Preglednica 2 Delež bolnikov s koncentracijo sečne kisline v serumu < 6,0 mg/dl (357 µmol/l) Zadnji trije mesečni obiski
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase Rare
Slovenian: Občasni diabetes mellitus, hiperlipidemija, zmanjšanje apetita, povečanje telesne mase
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: - 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.
English: Monitoring of serum uric acid is therefore recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation.
Slovenian: Zato se 1-2 tedna po uvedbi zdravljenja z močnimi induktorji glukuronidacije priporoča nadzor sečne kisline v serumu.
English: Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity .
Slovenian: Zaviranje ksantinske oksidaze s febuksostatom lahko povzroči povečane plazemske koncentracije teh zdravil, kar vodi do toksičnosti.
English: Febuxostat Krka is for adults.
Slovenian: Zdravilo Febuksostat Krka je za odrasle.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Continue to take Febuxostat Krka every day even when you are not experiencing gout flare or attack.
Slovenian: Z jemanjem zdravila Febuksostat Krka nadaljujte vsak dan, tudi ko pri vas ne pride do izbruha ali poslabšanja protina.
English: The effect of Febuxostat Krka on human fertility is unknown.
Slovenian: Učinek zdravila Febuksostat Krka na plodnost pri človeku ni znan.
English: Oral use Febuxostat Krka should be taken by mouth and can be taken with or without food.
Slovenian: Način uporabe peroralna uporaba Zdravilo Febuksostat Krka se jemlje peroralno, s hrano ali brez hrane.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: What Febuxostat Krka is and what it is used for
Slovenian: Kaj je zdravilo Febuksostat Krka in za kaj ga uporabljamo
English: - 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.
Slovenian: - 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
English: Off pink, oval, biconvex, film-coated tablets scored on one side.
Slovenian: Umazano roza, ovalne, izbočene, filmsko obložene tablete z razdelilno zarezo na eni strani.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Slovenian: - Običajni odmerek je ena tableta na dan. Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje in ne delitvi na dva enaka odmerka.
English: 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).
Slovenian: 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).
English: It is not known if Febuxostat Krka may pass into human breast milk.
Slovenian: Ni znano, ali zdravilo Febuksostat Krka prehaja v materino mleko.
English: 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).
Slovenian: 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).