FrancophonIA/ELRC3.0 huggingface dataset:
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 StevensJohnsonovim sindromom, saj je z zgodnjo ukinitvijo zdravljenja povezana boljša prognoza.
English: These rates were similar to the rates reported on allopurinol (4.2%) (see section 4.4).
Slovenian: O podobnem deležu so poročali tudi za alopurinol (4,2 %) (glejte poglavje 4.4).
English: Flares increased following the prophylaxis period and gradually decreased over time.
Slovenian: Izbruhi so se povečali po obdobju preventivnega zdravljenja in so se postopoma zniževali skozi daljše časovno obdobje.
English: Febuxostat Mylan 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.
Slovenian: Z zdravljenjem z zdravilom Febuksostat Mylan je potrebno začeti dva dni pred pričetkom terapije s citotoksičnimi kemoterapevtiki in nadaljevati z zdravilom Febuksostat Mylan za najmanj 7 dni; vendar se lahko zdravljenje podaljša do 9 dni odvisno od trajanja kemoterapije kot tudi klinične presoje.
English: Pharmacotherapeutic group: Antigout preparation, 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: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2).
Slovenian: Učinkovitosti in varnosti pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/min, glejte poglavje 5.2) niso povsem ovrednotili.
English: No interaction studies have been performed in humans.
Slovenian: Na ljudeh ni bilo izvedene nobene študije medsebojnega delovanja zdravil.
English: FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004.
Slovenian: Študija FOCUS (TMX-01-005), faze 2, odprta, multicentrična, podaljšane varnosti za bolnike, je potekala 5 let pri bolnikih, ki so zaključili 4 tedne trajajočo dvojno slepo študijo TMX-00-004 zdravljenja s febuksostatom.
English: A standard battery of test for genotoxicity did not reveal any biologically relevant genotoxic effects for febuxostat.
Slovenian: Pri vrsti standardnih testov za ugotavljanje genotoksičnosti biološko pomembnih genotoksičnih učinkov febuksostata niso ugotovili.
English: Start taking Febuxostat Mylan two days before chemotherapy and continue its use according to your doctor's advice.
Slovenian: Začnite jemati zdravilo Febuksostat Mylan dva dni pred kemoterapijo in z jemanjem nadaljujte v skladu z zdravnikovimi navodili.
English: • blurred vision, change in vision
Slovenian: • motnje vida, spremembe vida,
English: Uncommon Erectile dysfunction
Slovenian: Občasni erektilna disfunkcija
English: If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Mylan at any time.
Slovenian: Če se je pri vas po jemanju febuksostata razvil Stevens-Johnsonov sindrom, ne smete nikoli ponovno začeti jemati zdravila Febuksostat Mylan.
English: • hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, seen only in patients taking chemotherapy for blood disorders)
Slovenian: • vročinski oblivi (npr. pordelost obraza ali vratu), zvišan krvni tlak, krvavitev (hemoragija, opažena samo pri bolnikih, zdravljenih s kemoterapijo zaradi bolezni krvi),
English: Read the package leaflet before use.
Slovenian: peroralna uporaba Pred uporabo preberite priloženo navodilo!
English: It is important to keep taking Febuxostat Mylan even if you have a flare, as Febuxostat Mylan is still working to lower uric acid.
Slovenian: Pomembno je, da z jemanjem zdravila Febuksostat Mylan nadaljujete tudi, če pride do izbruha protina, saj zdravilo Febuksostat Mylan še vedno znižuje raven sečne kisline.
English: • changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results)
Slovenian: • spremembe v krvni sliki ali v številu krvnih celic ali levkocitov (nenormalni rezultati krvnih preiskav),
English: Absolute bioavailability of the febuxostat tablet formulation has not been studied.
Slovenian: Absolutne biološke uporabnosti tablet febuksostata niso raziskovali.
English: In total, 6,190 patients were followed for a median of 32 months and the median duration of exposure was 728 days for patients in febuxostat group (n 3098) and 719 days in allopurinol group (n 3092).
Slovenian: Skupno so spremljali 6190 bolnikov v povprečnem obdobju 32 mesecev, mediana trajanja izpostavljenosti je bila 728 dni za skupino bolnikov zdravljenih s febuksostatom (n=3098) in 719 dni za skupino, ki je prejemala alopurinol (n=3092).
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 za človeka) in brejih kunčjih samicah (pri približno 13-kratni izpostavljenosti človeka) niso pokazale teratogenih učinkov.
English: CONFIRMS Study: The CONFIRMS study was a Phase 3, randomized, controlled, 26-week study to evaluate the safety and efficacy of febuxostat 40 mg and 80 mg, in comparison with allopurinol 300 mg or 200 mg, in patients with gout and hyperuricaemia.
Slovenian: Študija CONFIRMS: študija CONFIRMS je randomizirana, kontrolirana, 26-tedenska študija 3. faze, v kateri se je ocenjevalo varnost in učinkovitost 40 mg in 80 mg odmerkov febuksostata v primerjavi s 300 mg ali 200 mg odmerki alopurinola pri bolnikih s protinom in hiperurikemijo.
English: There was no evidence of impaired fertility, teratogenic effects, or harm to the foetus due to febuxostat.
Slovenian: Znakov vpliva na plodnost, teratogenih učinkov ali škodljivih učinkov na plod zaradi febuksostata niso ugotovili.
English: What you need to know before you take Febuxostat Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Febuksostat Mylan
English: 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.
Slovenian: V študiji FLORENCE se je pri febuksostatu pokazalo boljše uravnavanje vrednosti sečne kisline v primerjavi z alopurinolom pri bolnikih, ki so bili predvideni za prejem slednjega zdravila.
English: Febuxostat should not be used during pregnancy.
Slovenian: Febuksostata med nosečnostjo ne smete uporabljati.
English: Desipramine/CYP2D6 substrates
Slovenian: Dezipramin/substrati CYP2D6
English: Mylan Denmark ApS Tel: +45 28 11 69 32
Slovenian: Danmark Mylan Denmark ApSTel: +45 28 11 69 32
English: If you stop taking Febuxostat Mylan 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 Mylan, se lahko ravni sečne kisline znova povišajo in pride do poslabšanja simptomov zaradi nastajanja novih kristalov urata v sklepih in ledvicah.
English: Mylan Healthcare Sp. z o.o.
Slovenian: Polska Mylan Healthcare Sp. z o.o.
English: However, no clinically significant change in the percent decrease in serum uric acid concentration was observed where tested (80 mg multiple dose).
Slovenian: Vendar pa klinično pomembnih sprememb znižanja sečne kisline v serumu niso opazili (ponavljajoči se odmerek 80 mg).
English: Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat.
Slovenian: Močni induktorji encimov UGT lahko pospešijo presnovo febuksostata in zmanjšajo učinkovitost zdravljenja.
English: CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease.
Slovenian: Študija CARES je bila multicentrična, randomizirana, dvojno slepo preskušanje neinferiornosti, kjer so primerjali srčno-žilne izide pri febuksostatu v primerjavi z alopurinolom pri bolnikih s protinom in hudimi srčno-žilnimi boleznimi vključno z miokardnim infarktom (MI), hospitalizacijo zaradi nestabilne angine pektoris, koronarnega ali cerebralnega revaskularizacijskega postopka, možgansko kapjo, hospitalizacijo zaradi prehodnega ishemičnega napada, periferno vaskularno boleznijo ali sladkorno boleznijo z dokazi mikrovaskularne ali makrovaskularne bolezni.
English: • localised swelling due to retention of fluids in tissues (oedema)
Slovenian: • lokalizirana oteklina zaradi zastajanja tekočine v tkivu (edem).
English: Excipient with known effect Each tablet contains 236.0 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 236,0 mg laktoze.
English: Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Slovenian: Sečna kislina je končni produkt presnove purina pri ljudeh in nastaja v kaskadi hipoksantin → ksantin → sečna kislina.
English: This has not been observed in the pivotal clinical study with febuxostat in the Tumor Lysis Syndrome.
Slovenian: Tega v pilotski klinični študiji s febuksostatom pri sindromu tumorske lize ni bilo opaženo.
English: Mylan Ireland Limited Tel: +353 (0) 87 1694982
Slovenian: Mylan Ireland Tel: +353 (0) 87 1694982
English: Febuxostat Mylan 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 Mylan 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: • Periodic Safety Update Reports
Slovenian: • Redna posodobljena poročila o varnosti zdravila (PSUR)
English: Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase
Slovenian: Občasni diabetes mellitus, hiperlipidemija, zmanjšanje apetita, povečanje telesne mase
English: • Theophylline (used to treat asthma)
Slovenian: • teofilin (uporablja se za zdravljenje astme)
English: Rare Blurred vision
Slovenian: Redki zamegljen vid
English: Patients with an overdose should be managed by symptomatic and supportive care.
Slovenian: Pri bolnikih, ki vzamejo prevelik odmerek, je treba uvesti simptomatsko in podporno zdravljenje.
English: • abnormal liver test results
Slovenian: • nenormalni izvidi testov delovanja jeter,
English: What Febuxostat Mylan is and what it is used for
Slovenian: Kaj je zdravilo Febuksostat Mylan in za kaj ga uporabljamo
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-Nyhan sindromom, se njegova uporaba ne priporoča.
English: Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172).
Slovenian: Filmska obloga: hipromeloza, titanov dioksid (E171), etil celuloza, rumeni železov oksid (E172), triacetin in črni železov oksid (E172).
English: 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.
Slovenian: 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 od 16 do 24 in v mesecih od 30 do 36.
English: Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation.
Slovenian: Stevens-Johnsonov sindrom in toksična epidermalna nekroliza sta opisani kot progresiven kožni izpuščaj z mehurčki ali razjedami na sluznici in draženjem oči.
English: Eligible patients had to be candidates for allopurinol treatment or have no access to rasburicase.
Slovenian: Bolniki, ki so lahko prisostvovali študiji, so bili kandidati za zdravljenje z alopurinolom ali pa niso imeli na voljo razburikaze.
English: • Azathioprine (used to reduce immune response)
Slovenian: • azatioprin (uporablja se za zaviranje imunskega odziva),
English: • rash (including various types of rash, please see below under “uncommon” and “rare”
Slovenian: • izpuščaj (vključno z različnimi tipi izpuščajev, ki so našteti spodaj med »občasnimi« in
English: Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn.
Slovenian: Bolnike, ki so imeli 3 zaporedne vrednosti sUA na ravni > 6,0 mg/dl, so izključili iz raziskave.
English: Febuxostat Mylan is for adults.
Slovenian: Zdravilo Febuksostat Mylan je za odrasle.
English: Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28.
Slovenian: Pri od 46 % do 55 % zdravljenih oseb pride do izbruhov protina med 8. in 28 tednom.
English: The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Slovenian: Terapevtski cilj je zmanjšati in vzdrževati koncentracijo sečne kisline v serumu pod 6 mg/dl (357 /l).
English: 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.
Slovenian: Stopnja odobrenih hospitalizacij zaradi srčnega popuščanja, bolnišničnih sprejemov zaradi aritmij, ki niso povezani z ishemijo, venoznih tromboemboličnih dogodkov in hospitalizacij zaradi prehodnih ishemičnih napadov, so bili primerljivi v skupini, ki je prejemala febuksostat in alopurinol.
English: Hepatitis, jaundice*, liver injury*
Slovenian: Redki hepatitis, zlatenica*, poškodba jeter*
English: • nervousness
Slovenian: • živčnost,
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 z zdravilom Febuksostat Mylan zaradi sindroma tumorske lize.
English: The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Slovenian: Učinkovitosti in varnosti febuksostata pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) niso raziskovali.
English: Febuxostat Mylan film-coated tablets are yellow, capsule shaped, biconvex tablets.
Slovenian: Filmsko obložene tablete Febuksostat Mylan so rumene bikonveksne tablete v obliki kapsul.
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 has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours.
Slovenian: Povprečen navidezni končni razpolovni čas izločanja (t1/2) febuksostata je približno 5 do 8 ur.
English: • 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
Slovenian: • srbenje, izpuščaj, vnetje ali sprememba barve kože, rdečkasto ali škrlatno obarvane pike na koži, drobne, sploščene rdeče pike na koži, rdečkaste lise na koži, pokrite z majhnimi izboklinami, izpuščaj, rdečkasta in pikasta področja na koži, druge vrste kožnih težav,
English: Tumor Lysis Syndrome
Slovenian: Sindrom tumorske lize
English: Drug interaction studies of febuxostat with other cytotoxic chemotherapy have not been conducted.
Slovenian: Študij medsebojnega delovanja febuksostata z drugimi citotoksičnimi kemoterapevtiki niso izvedli.
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 opazovani dogodek 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: • abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation)
Slovenian: • nenormalnosti izvidov EKG, neenakomeren ali hiter srčni utrip, občutek bitja srca (palpitacija),
English: 0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000).
Slovenian: 4,0970 [95 % interval zaupanja: -0,6467 ; 8,8406]; p=0,0903).
English: At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2).
Slovenian: Ob začetku zdravljenja s febuksostatom se za preprečitev ponovnega izbruha priporoča preventivno zdravljenje z NSAID ali kolhicinom vsaj 6 mesecev (glejte poglavje 4.2).
English: No dose adjustment was required for enrolled patients on the basis of hepatic function.
Slovenian: Prilagajanje odmerka za bolnike, ki so sodelovali v študiji, na podlagi jetrnega delovanja ni bila potrebna.
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: Excipient with known effect Each tablet contains 354.0 mg of lactose
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 354,0 mg laktoze.
English: Weight decrease, increase appetite, anorexia
Slovenian: Redki zmanjšanje telesne mase, povečanje apetita, anoreksija
English: • If you have or have had liver disease or liver function test abnormalities
Slovenian: • če imate ali ste imeli bolezen jeter ali nenormalne rezultate jetrnih testov,
English: 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)
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 42 filmsko obloženih tablet 84 filmsko obloženih tablet 28 × 1 filmsko obložena tableta 28 filmsko obloženih tablet (koledarsko) 84 filmsko obloženih tablet (koledarsko)
English: There is no appreciable accumulation when doses of 10 mg to 240 mg are administered every 24 hours.
Slovenian: Za odmerke med 10 mg do 240 mg, ki se dajejo vsakih 24 ur, ni omembe vrednega kopičenja.
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 uridil difosfat glukuroniltransferaze (UDPGT) in z oksidacijo s citokromi P450 (CYP).
English: Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects.
Slovenian: Dajanje febuksostata (80 mg ali 120 mg enkrat na dan) z varfarinom ni imelo učinka na farmakokinetiko varfarina pri zdravih osebah.
English: Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes.
Slovenian: Presnova febuksostata je odvisna od encimov uridil-difosfat-glukuroniltransferaze (UGT).
English: Rare Anaphylactic reaction*, drug hypersensitivity*
Slovenian: Redki anafilaktične reakcije*, preobčutljivost na zdravilo*
English: Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Slovenian: Delež bolnikov s koncentracijo sečne kisline v serumu < 6,0 mg/dl (357 µmol/l) Zadnji trije mesečni obiski
English: Plasma protein binding of the active metabolites ranges from about 82% to
Slovenian: Delež vezave aktivnih presnovkov na plazemske beljakovine je približno 82 % do 91 %.
English: Continue to take Febuxostat Mylan every day even when you are not experiencing gout flare or attack.
Slovenian: Z jemanjem zdravila Febuksostat Mylan nadaljujte vsak dan, tudi ko pri vas ne pride do izbruha ali poslabšanja protina.
English: Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome)
Slovenian: Občasni hipertenzija, zardevanje, navali vročine, hemoragija (glejte poglavje Sindrom tumorske lize)
English: HDPE bottle with polypropylene (PP) screw cap closure with desiccant containing 28 or 84 tablets.
Slovenian: Plastenka iz HDPE s polipropilenskim (PP) navojnim pokrovčkom in sušilnim sredstvom, ki vsebuje 28 ali 84 tablet.
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 trupa.
English: Libido decreased, insomnia Rare
Slovenian: Občasni zmanjšanje libida, nespečnost Redki živčnost
English: • inflammation of the liver (hepatitis)
Slovenian: • vnetje jeter (hepatitis),
English: 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.
Slovenian: Pri podganjih samcih so opazili statistično pomembno večjo pojavnost tumorjev sečnega mehurja (prehodnocelični papilom in karcinom) samo v povezavi s ksantinskimi kamni pri skupini, ki je bila izpostavljena visokim odmerkom, približno 11-kratni izpostavljenosti človeka.
English: The back of the calendar blister pack is marked with the days of the week to help you check that you have taken a dose each day.
Slovenian: • Običajni odmerek je ena tableta na dan. Na hrbtni strani koledarskega pretisnega omota so oznake z dnevi v tednu, s pomočjo katerih lahko nadzirate vsakodnevno jemanje odmerka.
English: INR and Factor VII activity were also not affected by the co-administration of febuxostat.
Slovenian: Tudi INR in aktivnost faktorja VII se nista spremenili pri sočasnem dajanju febuksostata.
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 študije ključne 3. faze (APEX in FACT).