FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no dose adjustment is necessary in patients with mild or moderate renal impairment.
Slovenian: Kljub temu pri bolnikih z blago ali zmerno ledvično okvaro odmerka ni treba prilagajati.
English: The proportion of patients with serum urate levels of < 6.0 mg/dL (357 µmol/L) at the final visit, was 45% for 40 mg febuxostat, 67% for febuxostat 80 mg and 42% for allopurinol 300/200 mg, respectively.
Slovenian: Delež bolnikov z nivojem sečne kisline v serumu na končnem pregledu < 6,0 mg/dl (357 µmol/l) je bil 45 % pri odmerku 40 mg febuksostata, 67% pri 80 mg febuksostata oziroma 42 % pri 300/200 mg alopurinola.
English: Febuxostat 80 mg
Slovenian: Febuksostat 80 mg
English: Febuxostat Mylan 120 mg
Slovenian: Febuksostat Mylan 120 mg
English: Tumor Lysis Syndrome The recommended oral dose of Febuxostat Mylan is 120 mg once daily without regard to food.
Slovenian: Priporočeni peroralni odmerek zdravila Febuksostat Mylan je 120 mg enkrat na dan, ne glede na uživanje hrane.
English: Gout flares during the last 4 weeks of the study (Weeks 49-52) were observed in 6-8% (febuxostat 80 mg, 120 mg) and 11% (allopurinol 300 mg) of subjects.
Slovenian: Izbruhe protina so opazili tudi v zadnjih 4 tednih študije (tedni od 49 do 52) pri 6-8 % (80 mg, 120 mg febuksostata) in 11 % (300 mg alopurinola) oseb.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience Blood and lymphatic system disorders
Slovenian: Preglednica 1: Neželeni učinki v kombiniranih študijah 3. faze, dolgoročnih podaljšanih študijah in v obdobju trženja
English: (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.
Slovenian: (n=519) za analize so bili zbrani podatki bolnikov, ki so prejemali bodisi 100 mg enkrat na dan (n=10: bolniki s serumskim kreatininom > 1,5 in  2,0 mg/dl) ali 300 mg enkrat na dan (n=509) * p < 0,001 v primerjavi z alopurinolom,
English: Reproductive system and breast disorder
Slovenian: Motnje reprodukcije in dojk
English: Febuxostat Mylan is available as either an 80 mg tablet or a 120 mg tablet.
Slovenian: Zdravilo Febuksostat Mylan je na voljo v obliki 80 mg tablet ali 120 mg tablet.
English: In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively.
Slovenian: Raziskovalci so v dolgotrajnih podaljšanih študijah poročali o pojavnosti dogodka APTC 1,2 za febuksostat in 0,6 dogodka za alopurinol na 100 bolniških let, vendar pa statistično pomembnih razlik niso potrdili.
English: • muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm
Slovenian: • mišični krči, mišična oslabelost, bolečine v mišicah ali sklepih, burzitis ali artritis (vnetje sklepov, ki ga običajno spremlja bolečina, oteklost ali otrdelost), bolečine v udih in hrbtenici, občutek nelagodja v prsnem košu,
English: Common side effects (may affect up to 1 in 10 people) are:
Slovenian: Pogosti neželeni učinki (pojavijo se pri 1 od 10 bolnikov) so:
English: Febuxostat 120 mg
Slovenian: Febuksostat 120 mg
English: The primary MACE endpoint occurred at similar rates in the febuxostat and allopurinol treatment groups (10.8% vs. 10.4% of patients, respectively; hazard ratio [HR] 1.03; two-sided repeated 95% confidence interval [CI] 0.87-1.23).
Slovenian: Stopnja primarnega opazovanega dogodka MACE je bila v skupini, ki je prejemala febuksostat podobna kot v skupini, ki je prejemala alopurinol (10,8% v primerjavi z 10,4% bolnikov; razmerje ogroženosti [HR] 1,03; dvostranski ponavljajoči se 95% interval zaupanja [IZ] 0,87-1,23).
English: 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
Slovenian: Redki toksična epidermalna nekroliza*, Stevens-Johnsonov sindrom*, angioedem*, reakcija na zdravilo z eozinofilijo in sistemskimi simptomomi*, generaliziran izpuščaj (resen)*, eritem, eksfoliativni izpuščaj, folikularni izpuščaj, vezikularni izpuščaj, pustulozni izpuščaj, srbeč izpuščaj*, eritematozni izpuščaj, morbiliformni izpuščaj, alopecija, čezmerno znojenje
English: • 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)
Slovenian: • če se zdravite zaradi visokih ravni sečne kisline, ki so posledica Lesch-Nyhanovega sindroma
English: Following an 80 mg oral dose of C-labeled febuxostat, approximately 49% of the dose was recovered in the urine as unchanged febuxostat (3%), the acyl glucuronide of the active substance (30%), its known oxidative metabolites and their conjugates (13%), and other unknown metabolites (3%).
Slovenian: C označenega febuksostata se je približno 49 % odmerka izločilo z urinom, 3% v obliki nespremenjenega febuksostata, 30 % v obliki acil-glukuronida učinkovine, 13 % v obliki znanih oksidativnih presnovkov in njihovih konjugatov ter 3 % v obliki drugih neznanih presnovkov.
English: • dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort
Slovenian: • suha usta, bolečine/nelagodje v trebuhu ali napenjanje, zgaga/slaba prebava, zaprtost, pogostejše izločanje blata, bruhanje, občutek nelagodja v trebuhu,
English: No dose adjustment is necessary for febuxostat when administered with hydrochlorothiazide.
Slovenian: Prilagoditev odmerka febuksostata, če se daje sočasno s hidroklorotiazidom, ni potrebna.
English: (PVC/oPA/Alu)/Alu blisters of 14, 28, 42 tablets, calendar blisters of 28 tablets and perforated unit dose blisters of 28 x 1 tablets and multipacks of 84 (2 packs of 42) tablets.
Slovenian: Pretisni omoti iz (PVC/oPA/Alu)/Alu s po 14, 28, 42 tabletami, koledarski pretisni omoti s po 28 tabletami in perforirani pretisni omoti za posamezne odmerke z 28 x 1 tableto ter večkratno pakiranje s 84 (2 pakiranji po 42) tabletami.
English: Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the postmarketing experience.
Slovenian: V obdobju trženja so se pojavile redke resne preobčutljivostne reakcije na febuksostat, vključno s Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo in anafilaktično reakcijo/šokom.
English: Febuxostat has been shown to potently inhibit both the oxidized and reduced forms of XO. At therapeutic 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 transferaza, orotat fosforibozil transferaza, orotidin monofosfat dekarboksilaze ali purin nukleozid fosforilaza.
English: The active substance is febuxostat.
Slovenian: Zdravilna učinkovina je febuksostat.
English: Febuxostat can be co-administered with naproxen with no dose adjustment of febuxostat or naproxen being necessary.
Slovenian: Febuksostat se lahko uporablja skupaj z naproksenom, pri čemer odmerka febuksostata ali naproksena ni treba prilagoditi.
English: Following multiple oral 80 mg once daily doses or a single 120 mg dose with a high fat meal, there was a 49% and 38% decrease in Cmax and a 18% and 16% decrease in AUC, respectively.
Slovenian: Pri ponavljajočih se peroralnih odmerkih 80 mg enkrat na dan ali enkratnem odmerku 120 mg z obrokom, bogatim z maščobami, se je vrednost Cmax znižala za 49 % oz. 38 %, AUC pa za 18 % oz.
English: 4.8 Undesirable effects
Slovenian: 4.8 Neželeni učinki Povzetek varnostnega profila
English: Allopurinol
Slovenian: Alopurinol
English: During the CONFIRMS study, the percentages of patients who required treatment for gout flares (Day 1 through Month 6) were 31% and 25% for the febuxostat 80 mg and allopurinol groups, respectively.
Slovenian: Med študijo CONFIRMS je bil delež bolnikov, ki so potrebovali zdravljenje zaradi izbruhov protina (od 1. dne do 6. meseca) 31 % oziroma 25 % pri skupini z 80 mg febuksostata oziroma alopurinolom.
English: Gout flares during the last 4 weeks of the study (Weeks 24-28) were observed in 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) and 20% (placebo) of subjects.
Slovenian: Odstotki izbruhov protina pri preiskovancih v zadnjih 4 tednih študije (tedni od 24 do 28), so bili 15 % (80, 120 mg febuksostata), 14 % (300 mg alopurinola) in 20 % (placebo).
English: A total of 1,086 patients were enrolled: Febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145).
Slovenian: Skupaj je bilo vključenih 1.086 bolnikov in sicer: 80 mg febuksostata enkrat na dan (n = 649), 120 mg febuksostata enkrat na dan (n = 292) in 300/100 mg alopurinola enkrat na dan (n = 145).
English: No dose adjustment is necessary for warfarin when administered with febuxostat.
Slovenian: Prilagoditev odmerka varfarina, če se daje sočasno s febuksostatom, ni potrebna.
English: In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA <6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively.
Slovenian: V študiji CONFIRMS je bil delež bolnikov, pri katerih je bil dosežen primarni opazovani dogodek učinkovitosti (sUA < 6,0 mg/dl pri zadnjem pregledu) in z začetno vrednostjo sečne kisline ≥ 10 mg/dl, ki so bili zdravljeni z 40 mg febuksostata enkrat na dan 27% (66/249), 80 mg febuksostata enkrat na dan 49 % (125/254) v primerjavi z 31 % (72/230) bolnikov zdravljenih z 300 mg/200 mg alopurinola enkrat na dan.
English: Clinical Outcomes: proportion of patients requiring treatment for a gout flare APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%).
Slovenian: Klinični izidi: Delež bolnikov, pri katerih je bilo treba zdraviti izbruh protina Študija APEX: V času 8 tedenskega preventivnega zdravljenja je večji delež oseb potreboval zdravljenje zagona putike v skupini s 120 mg febuksostata (36 %), kot v skupini z 80 mg febuksostata (28 %), 300 mg alopurinola (23 %) in placebo (20 %) skupinah.
English: The 120 mg tablets are marked with M on one side of the tablet and FX4 on the other side.
Slovenian: 120-miligramske tablete so označene s »FX4« na eni strani.
English: Tablet coating
Slovenian: • Tableto pogoltnite.
English: How to take Febuxostat Mylan
Slovenian: Kako jemati zdravilo Febuksostat Mylan
English: Increased TSH values (>5.5 µIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) in the long term open label extension studies.
Slovenian: V dolgoročnih odprtih podaljšanih študijah so pri bolnikih, ki so bili na dolgotrajnem zdravljenju s febuksostatom (5,5 %), opazili povišane vrednosti TSH (> 5,0 µi.e./ml).
English: Rare reports of serious allergic/hypersensitivity reactions, including life-threatening StevensJohnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
Slovenian: Izkušnje v obdobju po trženju kažejo, da so se redko pojavile resne alergijske/preobčutljivostne reakcije, vključno z življenjsko nevarnim Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo in akutno anafilaktično reakcijo/šokom.
English: Abdominal pain, abdominal distension, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort Rare
Slovenian: Občasni: bolečine v trebuhu, distenzija trebuha, gastroezofagealni refluks, bruhanje, suha usta, dispepsija, zaprtost, pogosto odvajanje blata, flatulenca, nelagodje v prebavilih Redki pankreatitis, razjede v ustih
English: • severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals,
Slovenian: • hudo otekanje spodnjih slojev kože, predvsem v področju ustnic, oči, spolovil, dlani, stopal ali jezika, z možno nenadno otežitvijo dihanja.
English: The plasma protein binding of febuxostat is approximately 99.2%, (primarily to albumin), and is constant over the concentration range achieved with 80 and 120 mg doses.
Slovenian: Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vss/F) febuksostata je po peroralnih odmerkih 10-300 mg od 29 do 75 l. Delež vezave febuksostata na plazemske beljakovine je približno 99,2 %, (primarno na albumin) in je enak pri koncentracijah, doseženih z odmerki 80 mg in 120 mg.
English: Cardiac disorders: Uncommon: Left bundle branch block, sinus tachycardia
Slovenian: Občasni: levokračni blok, sinusna tahikardija
English: There were no significant changes observed in AUC of febuxostat or its metabolites following multiple oral doses of febuxostat in elderly as compared to younger healthy subjects.
Slovenian: Po večkratnih peroralnih odmerkih febuksotata se AUC febuksostata ali njegovih presnovkov pri starostnikih ni pomembneje spremenila v primerjavi z mlajšimi zdravimi osebami.
English: In this subgroup febuxostat achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0% in the placebo groups.
Slovenian: V tej podskupini je bil primarni opazovani dogodek učinkovitosti (sUA < 6,0 mg/dl pri zadnjih treh pregledih) dosežen pri 41 % (80 mg enkrat na dan), 48 % (120 mg enkrat na dan) in 66 % (240 mg enkrat na dan) bolnikov v skupinah, ki je jemala febuksostat, v primerjavi z 9 % v skupini, zdravljeni s 300 mg ali 100 mg alopurinola enkrat na dan, in 0 % v placebo skupini.
English: - If you get any side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Theophylline
Slovenian: Teofilin
English: Febuxostat Mylan works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Slovenian: Zaradi hitrega nastopa učinka zdravila Febuksostat Mylan se lahko preverjanje sečne kisline v serumu izvede že po 2 tednih.
English: Each tablet contains 80 mg febuxostat.
Slovenian: Ena tableta vsebuje 80 mg febuksostata.
English: Talk to your doctor before taking Febuxostat Mylan:
Slovenian: Ne jemljite zdravila Febuksostat Mylan:
English: • liver damage
Slovenian: • poškodba jeter,
English: Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Febuxostat is a potent, nonpurine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar.
Slovenian: Febuksostat je derivat 2-ariltiazola, ki svoj terapevtski učinek zmanjšanja sečne kisline v serumu doseže s selektivnim zaviranjem ksantinske oksidaze.
English: Rare Pancytopenia, thrombocytopenia, agranulocytosis*
Slovenian: Bolezni krvi in limfnega sistema Redki pancitopenija, trombocitopenija, agranulocitoza*
English: The APEX study showed statistically significant superiority of both the febuxostat 80 mg QD and the febuxostat 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n = 258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 µmol/L) (see Table 2 and Figure 1).
Slovenian: Študija APEX je pokazala statistično pomembno prednost obeh oblik zdravljenja s febuksostatom v odmerku 80 mg enkrat na dan in s 120 mg febuksostata enkrat na dan v primerjavi z običajno uporabljenim odmerkom alopurinola 300 mg (n=258) /100 mg (n=10) pri zmanjšanju koncentracije sečne kisline v serumu pod 6 mg/dl (357 µmol/l) (glejte preglednico 2 in sliko 1).
English: The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 µmol/L).
Slovenian: Študija FACT je pokazala statistično pomembno prednost obeh oblik zdravljenja z 80 mg febuksostata in s 120 mg febuksostata enkrat na dan v primerjavi z običajno uporabljenim odmerkom 300 mg alopurinola pri zmanjšanju in vzdrževanju ravni sečne kisline v serumu pod 6 mg/dl (357 µmol/l).
English: 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.
Slovenian: Pri zaključnem obisku je bilo 46 % oziroma 38 % bolnikov stabilnih pri zdravljenju z 80 mg oziroma 120 mg febuksostata enkrat na dan s popolnim razkrojem primarno tipljivega tofa.
English: Two thousand and two hundred-sixty nine (2269) patients were randomized: febuxostat 40 mg QD (n=757), febuxostat 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756).
Slovenian: Skupno je bilo vključenih 2.269 bolnikov: 40 mg febuksostata na dan (n=757), 80 mg febuksostata na dan (n=756) ali 300/200 mg alopurinola na dan (n=756).
English: Two hundred and forty mg febuxostat (2 times the recommended highest dose) was used as a safety evaluation dose.
Slovenian: febuksostata (dvakratni najvišji priporočeni odmerek).
English: Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with febuxostat 40-240 mg QD.
Slovenian: Analize populacijske farmakokinetike/farmakodinamike so bile izvedene pri 211 bolnikih s hiperurikemijo in protinom, zdravljenih s 40-240 mg febuksostata enkrat na dan. Na splošno se parametri farmakokinetike febuksostata, ocenjeni v teh analizah, ujemajo s tistimi, ki so jih pridobili pri zdravih osebah, kar kaže, da so zdrave osebe ustrezne za oceno farmakokinetike/farmakodinamike pri bolnikih s protinom.
English: Respiratory system disorders
Slovenian: Motnje delovanja jeter
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.87-1.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Slovenian: V preskušanju CARES iz obdobja trženja (glejte poglavje 5.1 za bolj podroben opis študije), je bila stopnja MACE (Major Adverse Cardiovascular Events) v skupini, ki je prejemala febuksostat podobna kot v skupini, ki je prejemala alopurinol (razmerje ogroženosti [HR - hazard ratio] 1,03; 95% interval zaupanja [IZ] 0,87-1,23), vendar je bil delež srčno-žilnih smrti večji v skupini zdravljeni s febuksostatom (4,3% v primerjavi z 3,2% bolnikov; HR 1,34; 95% IZ 1,03-1,73).
English: Possible symptoms of allergic reactions might be: - rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness - swelling of limbs or face - difficulties in breathing - fever with enlarged lymph nodes - but also serious life threatening allergic conditions with cardiac and circulatory arrest.
Slovenian: srbenje - otekanje okončin in obraza - oteženo dihanje - zvišana telesna temperatura s povečanimi limfatičnimi vozliči - in tudi resna, življenjsko nevarna alergijska stanja z zastojem srca in s krvožilnim zastojem.
English: Febuxostat is eliminated by both hepatic and renal pathways.
Slovenian: Izločanje Febuksostat se izloča tako preko jeter kot ledvic.
English: Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat 120 mg QD (n=251), or allopurinol 300 mg QD (n=253).
Slovenian: Naključno je bilo razvrščenih sedemsto šestdeset (760) bolnikov: 80 mg febuksostata enkrat na dan (n=256), 120 mg febuksostata enkrat na dan (n=251) ali 300 mg alopurinola enkrat na dan (n=253).
English: Febuxostat Mylan 80 mg film-coated tablets Febuxostat Mylan 120 mg film-coated tablets febuxostat
Slovenian: Febuksostat Mylan 80 mg filmsko obložene tablete Febuksostat Mylan 120 mg filmsko obložene tablete febuksostat
English: Each tablet contains 120 mg febuxostat.
Slovenian: Ena tableta vsebuje 120 mg febuksostata.
English: No dose adjustment is necessary in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati.
English: Gout: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Slovenian: Protin: Priporočeni odmerek pri bolnikih z blago okvaro jeter je 80 mg.
English: Cardio-vascular disorders
Slovenian: Srčno-žilne bolezni
English: For oral use.
Slovenian: Način uporabe Peroralna uporaba.
English: FACT study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for a gout flare compared to both the febuxostat 80 mg (22%) and allopurinol 300 mg (21%) treatment groups.
Slovenian: Študija FACT: V času 8 tedenskega preventivnega zdravljenja je večji delež oseb zdravljenih s 120 mg febuksostata (36 %) potreboval zdravljenje zaradi izbruha protina v kot v skupinah zdravljenih z 80 mg febuksostata (22 %) in 300 mg alopurinola (21 %).
English: • fatigue, chest pain, chest discomfort
Slovenian: • utrujenost, bolečine v prsih, nelagodnost v prsih,
English: Febuxostat Mylan 120 mg film-coated tablets
Slovenian: Febuksostat Mylan 120 mg filmsko obložene tablete
English: • nausea
Slovenian: *, navzea
English: When this happens, urate crystals may form in and around the joints and kidneys.
Slovenian: Ko pride do tega, se v sklepih in ledvicah začnejo odlagati uratni kristali.
English: • The tablets should be taken by mouth and can be taken with or without food.
Slovenian: Lahko jo jemljete s hrano ali brez nje.
English: OTHER
Slovenian: SRE
English: Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800
Slovenian: Deutschland Mylan dura GmbH Tel: + 49-(0) 6172 888 01
English: Febuxostat Mylan 120 mg film-coated tablets febuxostat
Slovenian: Febuksostat Mylan 120 mg filmsko obložene tablete febuksostat
English: 100 mg QD
Slovenian: 100 mg enkrat na dan
English: For bottles: After first opening use within 180 days
Slovenian: 2 leti Za plastenke: Po odprtju porabite v roku 180 dni.
English: One thousand and seventy-two (1072) patients were randomized: placebo (n=134), febuxostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 240 mg QD (n=134) or allopurinol (300 mg QD [n=258] for patients with a baseline serum creatinine ≤1.5 mg/dL or 100 mg QD [n=10] for patients with a baseline serum creatinine >1.5 mg/dL and ≤2.0 mg/dL).
Slovenian: Naključno je bilo razvrščenih tisoč dvainsedemdeset (1.072) bolnikov: placebo (n=134), 80 mg febuksostata enkrat na dan (n=267), 120 mg febuksostata enkrat na dan (n=269), 240 mg febuksostata enkrat na dan (n=134) ali alopurinol
English: Liver function abnormalities** Uncommon
Slovenian: Pogosti nenormalni rezutati jetrne funkcije** Občasni holelitiaza
English: Modelling and simulation analysis of data from a pre-clinical study in rats, indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose (see section 4.4 and 5.3).
Slovenian: Modeliranje in simulacija analiznih podatkov predklinične študije, izvedene na podganah, v primeru sočasnega jemanja s febuksostatom kažejo, da je potrebno odmerek merkaptopurina/azatioprina zmanjšati na 20 % ali manj prvotno predpisanega odmerka (glejte poglavji 4.4 in 5.3).