FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Febuxostat Krka - if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke febuxostat Krka - hvis du er allergisk over for febuxostat eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Febuxostat Krka is available as either an 80 mg tablet or a 120 mg tablet.
Danish: Febuxostat Krka udleveres som enten en 80 mg tablet eller en 120 mg tablet.
English: 62% of patients required no dose adjustment to maintain sUA <6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose.
Danish: 62 % af patienterne behøvede ikke dosisjustering for at opretholde et serumurinsyreniveau < 6 mg/dl, mens 38 % af patienterne havde behov for dosisjustering for at opnå en endelig stabil dosis.
English: These tophi may cause joint and bone damage.
Danish: Disse tophi kan beskadige led og knogler.
English: Start taking Febuxostat Krka two days before chemotherapy and continue its use according to your doctor's advice.
Danish: Begynd at tage Febuxostat Krka to dage før kemoterapien og fortsæt i henhold til lægens anvisninger.
English: Patients with an overdose should be managed by symptomatic and supportive care.
Danish: I tilfælde af overdosering bør patienten have symptomatisk og understøttende behandling.
English: Pancytopenia, thrombocytopenia, agranulocytosis*
Danish: Sjældne Pancytopeni, trombocytopeni, agranulocytose*
English: Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.
Danish: Når niveauet af urinsyre holdes tilstrækkelig lavt i tilstrækkelig lang tid, kan det også få de dannede tophi til at svinde ind.
English: The safety and efficacy of Febuxostat Krka in children below the age of 18 years have not been established.
Danish: Febuxostat Krkas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Left untreated, larger deposits called tophi may form in and around joints.
Danish: Hvis det ikke behandles, kan der dannes større aflejringer, kaldet tophi, i og omkring leddene.
English: 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.
Danish: Hvis du i øjeblikket har et anfald af urinsyregigt (en pludselig, kraftig smerte, ømhed, rødme, varme og hævelse i et led), skal du vente, indtil anfaldet fortager sig, inden du starter på behandlingen med Febuxostat Krka.
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.
Danish: Hvis du har fået Stevens-Johnsons syndrom i forbindelse med brug af febuxostat, må du ikke begynde at tage Febuxostat Krka igen på et senere tidspunkt.
English: BL=baseline SEM=standard error of the mean
Danish: BLbaseline SEMstandard error of the mean
English: This has not been observed in the pivotal clinical study with febuxostat in the Tumor Lysis Syndrome.
Danish: Dette blev ikke observeret i det pivotale kliniske studie af febuxostat ved tumorlysesyndrom.
English: Keeping uric acid levels low by taking Febuxostat Krka once every day stops crystals building up, and over time it reduces symptoms.
Danish: Når niveauet af urinsyre holdes lavt ved brug af Febuxostat Krka én gang om dagen, standser opbygningen af krystaller, og efterhånden mindskes symptomerne.
English: Continue to take Febuxostat Krka every day even when you are not experiencing gout flare or attack.
Danish: Fortsæt med at tage Febuxostat Krka hver dag, selv om du ikke oplever udbrud eller anfald af urinsyregigt.
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).
Danish: Febuxostat Krka er indiceret til behandling af kronisk hyperurikæmi, hvor der allerede er urataflejringer (herunder en anamnese med eller tilstedeværelse af tophus og/eller arthritis urica).
English: Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation.
Danish: Tumorlysesyndrom: I det pivotale fase 3-studie (FLORENCE) blev kun patienter med alvorligt leversvigt ekskluderet fra deltagelse i forsøget.
English: Oral use Febuxostat Krka should be taken by mouth and can be taken with or without food.
Danish: Febuxostat Krka skal tages gennem munden og kan tages med eller uden mad.
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.
Danish: I det randomiserede, dobbeltblindede, pivotale fase 3-studie FLORENCE (FLO-01), der sammenlignede febuxostat med allopurinol (346 patienter i kemoterapi for hæmatologiske maligniteter og en middel til høj risiko for tumorlysesyndrom), fik kun 22 (6,4 %) patienter bivirkninger, nemlig 11 (6,4 %) patienter i hver behandlingsgruppe.
English: In patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Danish: Hos patienter, hvor hastigheden af uratdannelsen er kraftigt forøget (f.eks. malign sygdom og dens behandling, Lesch-Nyhan-syndrom), kan den absolutte koncentration af xanthin i urinen i sjældne tilfælde stige så meget, at der sker aflejring i urinvejene.
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.
Danish: I FLORENCE-studiet viste febuxostat en overlegen kontrol af serumurinsyreniveauet sammenlignet med allopurinol hos patienter, som var planlagt til at skulle have sidstnævnte lægemiddel.
English: Hepatitis, jaundice*, liver injury*
Danish: Hepatitis, gulsot*, leverskader*
English: A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
Danish: Der sås en numerisk højere forekomst af investigator-indberettede kardiovaskulære APTC-hændelser (definerede endepunkter fra Anti-Platelet Trialists' Collaboration (APTC), der inkluderer kardiovaskulær død, ikke-letalt myokardieinfarkt, ikke-letal apopleksi) i den samlede febuxostatgruppe sammenlignet med allopurinolgruppen i APEX- og FACT-studierne (1,3 versus 0,3 hændelser pr. 100 patientår), men ikke i CONFIRMS-studiet (se pkt.
English: Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production; ATC code: M04AA03.
Danish: Farmakoterapeutisk klassifikation: Midler mod arthritis urica, midler der hæmmer urinsyreproduktionen, ATC-kode: M04AA03.
English: Febuxostat Krka works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Danish: Febuxostat Krka virker tilstrækkeligt hurtigt til, at serumurinsyren kan testes igen efter to uger.
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).
Danish: Sikkerhed og virkning er ikke fuldstændig klarlagt hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min, se pkt.
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.
Danish: CONFIRMS-studiet: CONFIRMS-studiet var et randomiseret, kontrolleret, 26-ugers, fase 3-studie til evaluering af sikkerhed og virkning af febuxostat 40 mg og 80 mg ved sammenligning med allopurinol 300 mg eller 200 mg hos patienter med arthritis urica og hyperurikæmi.
English: Atrial fibrillation, palpitations, ECG abnormal Rare
Danish: Atrieflimren, palpitationer, unormalt EKG Sjældne
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.
Danish: Forekomsten af investigator-indberettede kardiovaskulære APTC-hændelser i de kombinerede fase 3-studier (APEX, FACT og CONFIRMS), var 0,7 versus 0,6 hændelser pr. 100 patientår.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter
English: Rare Blurred vision
Danish: Sjældne Sløret syn
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.
Danish: Febuxostat Krka 120 mg tabletter anvendes også til at behandle og forebygge forhøjet indhold af urinsyre i blodet, som kan forekomme, når du begynder at få kemoterapi mod blodkræft.
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.
Danish: FOCUS studiet (TMX-01-005) var et 5-årigt, åbent, forlænget, fase 2-multicenterstudie til evaluering af sikkerheden hos patienter, som havde gennemført studie TMX-00-004 med 4 ugers febuxostatbehandling i et dobbeltblindt design.
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).
Danish: Serumuratniveauerne blev opretholdt over tid (dvs. 91 % og 93 % af de patienter, der fik initial behandling med henholdsvis febuxostat 80 mg og 120 mg, havde serumurat < 6 mg/dl ved måned 36).
English: Thus, febuxostat may be taken without regard to food.
Danish: Febuxostat kan derfor tages uden hensyntagen til fødeindtagelse.
English: Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy Febuxostat Krka is available as a 120 mg tablet.
Danish: Forebyggelse og behandling af høje urinsyreniveauer hos patienter i kemoterapi mod kræft Febuxostat Krka fås som en 120 mg tablet.
English: 14 film-coated tablets: EU/1/18/1347/001 28 film-coated tablets: EU/1/18/1347/002 56 film-coated tablets: EU/1/18/1347/003 84 film-coated tablets: EU/1/18/1347/004
Danish: 14 filmovertrukne tabletter: EU/1/18/1347/001 28 filmovertrukne tabletter: EU/1/18/1347/002 56 filmovertrukne tabletter: EU/1/18/1347/003 84 filmovertrukne tabletter: EU/1/18/1347/004
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.
Danish: Reduktionen i serumurinsyreniveauerne til < 6 mg/dl (357 μmol/l) blev observeret ved uge 2-besøget og blev vedligeholdt gennem hele behandlingen.
English: 14 film-coated tablets: EU/1/18/1347/005 28 film-coated tablets: EU/1/18/1347/006 56 film-coated tablets: EU/1/18/1347/007 84 film-coated tablets: EU/1/18/1347/008
Danish: 14 filmovertrukne tabletter: EU/1/18/1347/005 28 filmovertrukne tabletter: EU/1/18/1347/006 56 filmovertrukne tabletter: EU/1/18/1347/007 84 filmovertrukne tabletter: EU/1/18/1347/008
English: Excipient(s) with known effect - lactose: 73 mg
Danish: Hjælpestof, som behandleren skal være opmærksom på - lactose: 73 mg
English: Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn.
Danish: Patienter, som fik målt 3 konsekutive serumurinsyreniveauer > 6,0 mg/dl, udgik af studiet.
English: Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of febuxostat.
Danish: Der er rapporteret døsighed, svimmelhed, paræstesi og sløret syn i forbindelse med anvendelse af febuxostat.
English: In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Danish: I det pivotale studie af tumorlysesyndrom blev der administreret 120 mg dagligt til patienter i flere forskellige kemoterapiregimer, herunder monoklonale antistoffer.
English: Febuxostat Krka is available in boxes containing 14, 28, 56 or 84 film-coated tablets in blisters.
Danish: Febuxostat Krka leveres i æsker med 14, 28, 56 eller 84 filmovertrukne tabletter i blisterpakninger.
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).
Danish: Det primære effektmål i APEX- og FACT-studierne var den andel af patienterne, hvis sidste tre månedlige serumurinsyreniveauer var < 6,0 mg/dl (357 μmol/l).
English: Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Danish: Febuxostat metaboliseres i stort omfang ved konjugering via uridindiphosphat-glukuronosyltransferase (UDPGT)-enzymsystemet og oxidation via cytochrom P450 (CYP) -systemet.
English: If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Krka 120 mg once daily may be considered.
Danish: Hvis serumurinsyre er > 357 μmol/l (6 mg/dl) efter 2-4 uger, bør det overvejes at give Febuxostat Krka 120 mg én gang dagligt.
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 μmol/L) Last Three Monthly Visits
Danish: Tabel 2 Andel patienter med serumurinsyreniveauer < 6 mg/dl (357 μmol/l) Sidste tre månedlige besøg
English: Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment with this medicine and should not drive or operate machines if affected.
Danish: Vær opmærksom på, at du kan blive svimmel eller søvnig, få sløret syn eller opleve en følelsesløs eller prikkende fornemmelse under behandlingen med dette lægemiddel.
English: Excipient(s) with known effect - lactose: 109 mg
Danish: Hjælpestof, som behandleren skal være opmærksom på - lactose: 109 mg
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.
Danish: Hos patienter, hvis urinsyreniveau er meget højt (f.eks. hvis man er i kemobehandling), kan behandling med urinsyresænkende medicin medføre, at der ophobes xanthin i urinvejene, evt. med dannelse af nyresten, selvom dette ikke er blevet observeret hos patienter, der behandles med febuxostat mod tumorlysesyndrom.
English: What Febuxostat Krka contains - The active substance is febuxostat.
Danish: Febuxostat Krka indeholder - Aktivt stof: febuxostat.
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.
Danish: Efter enkelte eller gentagne orale doser på 80 og 120 mg én gang dagligt er Cmax henholdsvis cirka 2,8-3,2 μg/mL og 5,0-5,3 μg/mL.
English: APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study.
Danish: APEX-studiet: APEX-studiet (Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat) var et fase 3, randomiseret, dobbeltblindet, multicenterstudie over 28 uger.
English: Febuxostat has been shown to potently inhibit both the oxidized and reduced forms of XO. At therapeutic
Danish: Febuxostat har vist sig at inhibere både de oxiderede og reducerede former af XO kraftigt.
English: Febuxostat treatment should not be started until an acute attack of gout has completely subsided.
Danish: Behandlingen med febuxostat bør ikke påbegyndes, før et akut anfald af arthritis urica har fortaget sig fuldstændig.
English: Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase Rare
Danish: Diabetes mellitus, hyperlipidæmi, nedsat appetit, vægtstigning
English: What you need to know before you take Febuxostat Krka
Danish: Det skal du vide, før du begynder at tage Febuxostat Krka
English: In a study in healthy subjects, 120 mg febuxostat QD resulted in a mean 22% increase in AUC of desipramine, a CYP2D6 substrate indicating a potential weak inhibitory effect of febuxostat on the CYP2D6 enzyme in vivo.
Danish: I et studie med raske forsøgspersoner resulterede 120 mg febuxostat en gang dagligt i en gennemsnitlig stigning på 22 % i AUC for desipramin, et CYP2D6-substrat, hvilket indikerer, at febuxostat har en potentiel, svag hæmmende virkning på CYP2D6-enzymet in vivo.
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate
Danish: Lactosemonohydrat Cellulose, mikrokrystallinsk Hydroxypropylcellulose Croscarmellosenatrium Silica, kolloid
English: 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.
Danish: I tilfælde af en utilsigtet overdosering skal du spørge din læge om, hvad du skal gøre, eller du skal henvende dig på den nærmeste skadestue.
English: España KRKA Farmacéutica, S.L.
Danish: KRKA Farmacéutica, S.L.
English: Should you experience allergic reactions to Febuxostat Krka, stop taking this medicine (see also section 4).
Danish: Hold op med at tage medicinen, hvis du får allergiske reaktioner på Febuxostat Krka (se også punkt 4).
English: Febuxostat Krka is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
Danish: Febuxostat Krka er indiceret til forebyggelse og behandling af hyperurikæmi hos voksne patienter i behandling med kemoterapi for hæmatologiske maligniteter med en middel til høj risiko for tumorlysesyndrom.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience
Danish: Tabel 1: Bivirkninger i kombinerede langvarige fase 3- forlængelsesstudier og efter markedsføringen Blod og lymfesystem
English: Febuxostat showed a superior and faster urate lowering activity compared to allopurinol.
Danish: Febuxostat viste en overlegen og hurtigere evne til at sænke uratniveauet sammenlignet med allopurinol.
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.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, hydroxypropylcellulose, croscarmellosenatrium, kolloid silica og magnesiumstearat i tabletkernen og poly(vinylalkhol), macrogol 3350, titandioxid (E171), talcum, gul jernoxid (E172) - kun for 120 mg filmovertrukne tabletter og rød jernoxid (E172) - kun for 80 mg filmovertrukne tabletter i filmovertrækket.
English: In addition to the urinary excretion, approximately 45% of the dose was recovered in the faeces as the unchanged febuxostat (12%), the acyl glucuronide of the active substance (1%), its known oxidative metabolites and their conjugates (25%), and other unknown metabolites (7%).
Danish: Foruden renal udskillelse blev cirka 45 % af dosis genfundet i fæces som uændret febuxostat (12 %), det aktive stofs acyl-glukuronid (1 %), dets kendte oxidative metabolitter og deres konjugater (25 %) samt andre ukendte metabolitter (7 %).
English: At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2).
Danish: Det anbefales at give profylaktisk behandling mod anfald med et NSAID eller colchicin i mindst seks måneder i starten af behandlingen med febuxostat (se pkt.
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.
Danish: Febuxostats gennemsnitlige totale AUC steg cirka 1,8 gange fra 7,5 μg × time/ml hos gruppen med normal nyrefunktion til 13,2 μg × time/ml hos gruppen med svært nedsat nyrefunktion.
English: If you stop taking Febuxostat Krka
Danish: Hvis du holder op med at tage Febuxostat Krka
English: Thus, coadministration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Danish: Derfor forventes samtidig administration af febuxostat og andre CYP2D6-substrater ikke at kræve dosisjustering af disse stoffer.
English: Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro.
Danish: Febuxostat er påvist at være en svag CYP2D6-hæmmer in vitro.
English: Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome)
Danish: Hypertension, rødmen, hedeture, hæmoragi (se afsnittet Tumorlysesyndrom)
English: Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes.
Danish: Febuxostats metabolisme er afhængig af UDP-glukuronosyltransferaser (UGT-enzymer).
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.
Danish: Ved terapeutiske koncentrationer hæmmer febuxostat ikke andre enzymer, der medvirker i purin- eller pyrimidinmetabolismen, dvs. guanin-deaminase, hypoxanthinguanin-phosphoribosyltransferase, orotat-phosphoribosyltransferase, orotidinmonophosphatdecarboxylase eller purinnukleosid-phosphorylase.
English: (see also section 4.8).
Danish: (angivet i punkt 6).
English: Following an 80 mg oral dose of
Danish: Efter en oral dosis på 80 mg
English: Each film-coated tablet contains 80 mg febuxostat.
Danish: Hver filmovertrukket tablet indeholder 80 mg febuxostat.
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).
Danish: Udbruddene tog til efter den 8 ugers profylaktiske periode, hvorefter de aftog gradvist med tiden (henholdsvis 64 % og 70 % af deltagerne blev behandlet for udbrud af arthritis urica i perioden uge 8-52).
English: 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%).
Danish: C-mærket febuxostat blev cirka 49 % af dosis genfundet i urinen som uændret febuxostat (3 %), det aktive stofs acylglukuronid (30 %), dets kendte oxidative metabolitter og deres konjugater (13 %) og andre ukendte metabolitter (3 %).
English: Febuxostat Krka is indicated in adults.
Danish: Febuxostat Krka er indiceret til voksne.
English: Off pink, oval, biconvex, film-coated tablets scored on one side.
Danish: Lyserøde, ovale, bikonvekse, filmovertrukne tabletter med delekærv på den ene side.
English: Dyspnoea, bronchitis, upper respiratory tract infection, cough
Danish: Ikke almindelige Dyspnø, bronkitis, øvre luftvejsinfektion, hoste