natgillin/translations-raw huggingface dataset:
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 tumorlyse-syndrom), fik kun 22 (6,4%) patienter bivirkninger, nemlig 11 (6,4%) patienter i hver behandlingsgruppe. 
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.
Patienterne bør monitoreres nøje, og dosen af mercaptopurin/azathioprin bør efterfølgende reguleres ud fra en vurdering af den terapeutiske effekt og indtrædelse af eventuelle toksiske virkninger. 
The patients should be closely monitored and the dose of mercaptopurine/azathioprine should be subsequently adjusted based on the evaluation of the therapeutic response and the onset of eventual toxic effects.
Der skal udvises forsigtighed, når febuxostat anvendes hos patienter med ændring i thyroideafunktionen (se pkt. 
Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1).
Urinsyre er slutproduktet af purinmetabolismen hos mennesker, og den genereres i følgende trin: hypoxanthin → xanthin → urinsyre. 
Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Febuxostat er et 2-arylthiazolderivat, der opnår terapeutiske effekt i form af nedsættelse af serumurinsyren ved selektivt at hæmme XO. Febuxostat er en potent, ikke-purin selektiv XO-hæmmer (non-purine selective inhibitor of XO (NP-SIXO)) med en Ki-værdi for in vitroinhibering, der er mindre end én nanomolær. 
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.
I alt deltog 346 patienter, der var i kemoterapi for hæmatologiske maligniteter og havde en middel/høj risiko for tumorlyse-syndrom. 
Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate/high risk of Tumor Lysis Syndrome were included.
Hypertension, flushing, hedeture, hæmoragi (se afsnittet Tumorlyse-syndrom) 
Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome)
Febuxostat bør ikke anvendes under graviditet. 
Febuxostat should not be used during pregnancy.
Febuxostat Mylan 120 mg tabletter anvendes også til at behandle og forebygge forhøjet indhold af urinsyre i blodet, som kan forekomme, når De begynder at få kemoterapi mod blodkræft. 
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.
Den anbefalede dosis til patienter med let nedsat leverfunktion er 80 mg. Der er kun begrænset information tilgængelig vedrørende patienter med moderat nedsat leverfunktion. 
The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Ikke almindelige Erektil dysfunktion 
Uncommon Erectile dysfunction
I de langvarige forlængelsesstudier var forekomsten af investigator-indberettede APTChændelser 1,2 og 0,6 hændelser pr. 100 patientår for henholdsvis febuxostat og allopurinol. 
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.
Organtransplanterede patienter 
Organ transplant recipients
Der foreligger ingen data for febuxostat 120 mg. 
No data is available for febuxostat 120 mg.
Da der ikke er erfaring med febuxostat, frarådes brug af febuxostat til patienter med Lesch-Nyhans syndrom. 
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended.
Der blev anvendt en dosis på 240 mg febuxostat (to gange den højst anbefalede dosis) til evaluering af sikkerheden. 
Two hundred and forty mg febuxostat (2 times the recommended highest dose) was used as a safety evaluation dose.
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. 
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.
Rabdomyolyse*, stive led, muskuloskeletal stivhed 
Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness
Febuxostats sikkerhed og virkning er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C). 
The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
• hedeture eller flushing (rødme i ansigt eller på hals), forhøjet blodtryk, blødning (kun hos patienter, der er i kemoterapi mod blodsygdomme) 
• 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)
Vægttab, øget appetit, anoreksi 
Weight decrease, increase appetite, anorexia
Forebyggelse og behandling af hyperurikæmi hos patienter med risiko for tumorlyse-syndrom 
Prevention and treatment of hyperuricaemia in patients at risk of TLS
Kemoterapi dræber kræftcellerne, hvorved indholdet af urinsyre i blodet stiger, medmindre det forebygges, at der dannes urinsyre. 
When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented.
Multipakning: 84 filmovertrukne tabletter (2 pakker med 42) 
Multipack: 84 (2 packs of 42) film-coated tablets
Nervøsitet 
Nervousness
• unormale resultater af leverfunktionsundersøgelser 
• abnormal liver test results
Udbruddet bør behandles sideløbende tilpasset den enkelte patient. 
The gout flare should be managed concurrently as appropriate for the individual patient.
Dog var Cmax og AUC det samme for begge køn, når der blev korrigeret for vægt. 
However, weight-corrected Cmax and AUC were similar between the genders.
Det terapeutiske mål er at nedsætte og fastholde serumurinsyre på under 6 mg/dl (357 μmol/l). 
The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Studie TMX-01-005 (FOCUS) var et femårigt 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. 
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.
Febuxostat Mylans virkning og anvendelse Det skal De vide, før De begynder at tage Febuxostat Mylan Sådan skal De tage Febuxostat Mylan Bivirkninger 
What Febuxostat Mylan is and what it is used for What you need to know before you take Febuxostat Mylan How to take Febuxostat Mylan Possible side effects
• Theophyllin (anvendes til behandling af astma) 
• Theophylline (used to treat asthma)
14 filmovertrukne tabletter 28 filmovertrukne tabletter 42 filmovertrukne tabletter 84 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 28 filmovertrukne tabletter (kalender) 84 filmovertrukne tabletter (kalender) 
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)
Disse krystaller kan medføre pludselig, kraftig smerte, rødme, varme og hævelse i et led (anfald af urinsyregigt). 
These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack).
Vær opmærksom på, at De kan blive svimmel eller søvnig, få uskarpt syn eller opleve en følelsesløs eller prikkende fornemmelse under behandlingen. 
Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
I det pivotale studie af tumorlyse-syndrom blev der administreret 120 mg dagligt til patienter i flere forskellige kemoterapiregimer, herunder monoklonale antistoffer. 
In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Jernoxid, sort (E172) 
Iron oxide black (E172)
Hos hanrotter blev der kun fundet en statistisk signifikant stigning i urinblæretumorer (transitiocellulært papillom og karcinom) i forbindelse med xanthinsten i højdosisgruppen ved cirka 11 gange den humane eksponering. 
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.
Aflejring af xanthin 
Xanthine deposition
Administration of febuxostat (80 mg eller 120 mg en gang dagligt) sammen med warfarin påvirkede ikke warfarins farmakokinetik hos raske forsøgspersoner. 
Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects.
Sjældne Anafylaktisk reaktion*, lægemiddeloverfølsomhed 
Rare Anaphylactic reaction*, drug hypersensitivity*
Diabetes mellitus, hyperlipidæmi, nedsat appetit, vægtstigning Sjældne 
Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase
Febuxostats virkning og sikkerhed er ikke blevet klarlagt hos patienter med svært akut tumorlysesyndrom, f.eks. hos patienter, hvor andre former for uratsænkende behandling ikke havde nogen virkning. 
The efficacy and safety of febuxostat has not been established in patients with acute severe TLS, e.g. in patients who failed on other urate lowering therapies.
• kløe, nældefeber, betændelse i huden, misfarvning af huden, små røde eller rødviolette pletter på huden, små, flade, røde pletter på huden, fladt, rødt område på huden dækket af små sammenflydende buler, udslæt, områder med pletter og rødme, andre former for hudproblemer 
• 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
Patienterne bør informeres om symptomerne på allergiske reaktioner og overfølsomhedsreaktioner og monitoreres nøje for disse symptomer (se pkt. 
Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions (see section 4.8).
Stevens-Johnsons syndrom og toksisk epidermal nekrolyse kendetegnes ved progredierende hududslæt forbundet med blærer eller slimhindelæsioner og øjenirritation. 
Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation.
LÆGEMIDDELFORM OG INDHOLD 
PHARMACEUTICAL FORM AND CONTENTS
• øget forekomst af gigtsymptomer 
• increase in gout symptoms
Mylan Denmark ApS Tlf: + 45 28 11 69 32 
Mylan Denmark ApS Tel: +45 28 11 69 32
I tilfælde af overdosering bør patienten modtage symptomatisk og understøttende behandling. 
Patients with an overdose should be managed by symptomatic and supportive care.
I reproduktionsstudier hos dyr med doser på op til 48 mg/kg/dag sås ingen dosisafhængig påvirkning af fertiliteten (se pkt. 
In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3).
Induktorer af glukuronidering 
Inducers of glucuronidation
Disse bivirkninger var for det meste af let til moderat sværhedsgrad. 
These adverse reactions were mostly mild or moderate in severity.
Derfor forventes samtidig administration af febuxostat og andre CYP2D6-substrater ikke at kræve dosisjustering af disse stoffer. 
Thus, co-administration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Der er rapporteret døsighed, svimmelhed, paræstesi og uskarpt syn i forbindelse med anvendelse af febuxostat. 
Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of febuxostat.
28 filmovertrukne tabletter 84 filmovertrukne tabletter 
28 film-coated tablets 84 film-coated tablets
Tumorlyse-syndrom 
Tumor Lysis Syndrome
Den anbefalede orale dosis af Febuxostat Mylan er 80 mg én gang dagligt uden hensyntagen til fødeindtagelse. 
The recommended oral dose of Febuxostat Mylan is 80 mg once daily without regard to food.
Efter enkelte eller gentagne orale doser på 80 og 120 mg én gang dagligt er Cmax henholdsvis cirka 2,8-3,2 mikrog/ml og 5,05,3 mikrog/ml. 
After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.05.3 µg/mL, respectively.
Hold op med at tage medicinen, hvis De får allergiske reaktioner på Febuxostat Mylan (se også punkt 4). 
Should you experience allergic reactions to Febuxostat Mylan, stop taking this medicine (see also section 4).
62% af patienterne behøvede ikke dosisjustering for at opretholde et serumurinsyreniveau < 357 µmol/l (6 mg/dl), mens 38% af patienterne havde behov for dosisjustering for at opnå en endelig stabil dosis. 
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.
Omfanget af bekræftede hospitalsindlæggelser pga. hjertesvigt, indlæggelser pga. arytmi uden sammenhæng med iskæmi, venøse tromboemboliske hændelser samt indlæggelse for transiente iskæmiske attacks var sammenlignelige for febuxostat og allopurinol. 
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.
Reduktionen i serumurinsyreniveauerne til <357 µmol/l (6,0 mg/dl) blev observeret ved uge 2-besøget og blev vedligeholdt gennem hele behandlingen. 
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.
Desipramin/CYP2D6-substrater 
Desipramine/CYP2D6 substrates
• stigning i blodets indhold af det hormon, der stimulerer skjoldbruskkirtlen (TSH) 
• increase in blood thyroid stimulating hormone (TSH) level
Mikrokrystallinsk cellulose Magnesiumstearat Hydroxypropylcellulose Croscarmellosenatrium Hydratiseret kolloid silica Vandfri kolloid silica Crospovidon 
Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Colloidal hydrated silica Colloidal anhydrous silica Crospovidone Talc
Hypromellose Titandioxid (E171) Ethylcellulose Jernoxid, gul (E172) Triacetin 
Hypromellose Titanium dioxide (E171) Ethylcellulose Iron oxide yellow (E172) Triacetin
Bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactase deficiency eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
I en 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. 
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.
FACT-studiet: FACT-studiet (Febuxostat Allopurinol Controlled Trial) var et fase 3, randomiseret, dobbeltblind, multicenterstudie over 52 uger. 
FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study.
Behandlingen med febuxostat bør omgående seponeres i tilfælde af alvorlige reaktioner pga. allergi/overfølsomhed inklusive Stevens-Johnsons syndrom, da prognosen er bedre ved hurtig seponering. 
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.
Hvis en patient udvikler allergiske reaktioner eller overfølsomhedsreaktioner, inklusive Stevens-Johnsons syndrom og akut anafylaksi/shock, må denne patient ikke på noget tidspunkt genoptage behandlingen med febuxostat. 
If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylactic reaction/shock, febuxostat must not be re-started in this patient at any time.
Ikke almindelige Dyspnø, bronkitis, øvre luftvejsinfektion, hoste 
Uncommon Dyspnoea, bronchitis, upper respiratory tract infection, cough
Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
For forsøgspersoner med nedsat nyrefunktion, som var randomiseret til allopurinol, blev der lagt loft over dosen ved 100 mg en gang dagligt. 
For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100 mg QD.
• tab af sexlyst 
• loss of sex drive
Atrieflimren, palpitationer, unormalt ekg Sjældne 
Atrial fibrillation, palpitations, ECG abnormal Rare
Hvis De vil have yderligere oplysninger om febuxostat, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen. 
For any information about this medicine, please contact the local representative of the Marketing
Febuxostat kan administreres samtidig med colchicin eller indometacin, uden at det er nødvendigt at justere dosis af hverken febuxostat eller det samtidigt administrerede aktive stof. 
Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary.
Ikke almindelige Hypertension, flushing, hedeture 
Uncommon Hypertension, flushing, hot flush
Febuxostat Mylan anvendes til voksne. 
Febuxostat Mylan is for adults.
Filmbelægning: hypromellose, titandioxid (E171), ethylcellulose, gul jernoxid (E172), triacetin og sort jernoxid (E172). 
Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172).
Det primære effektmål i APEX- og FACT-studierne var den andel af patienterne, hvis sidste tre månedlige serumurinsyreniveauer var < 357 µmol/l (6,0 mg/dl). 
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).
Virkningen af febuxostat blev påvist i tre pivotale fase 3-studier (de to pivotale studier APEX og FACT og det supplerende CONFIRMS-studie beskrevet nedenfor), der blev gennemført med 4.101 patienter med hyperurikæmi og arthritis urica. 
The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
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 tumorlyse-syndrom. 
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.
Udbrud af arthritis urica sås hyppigt umiddelbart efter behandlingsstart og i de første måneder. 
Gout flares were commonly observed soon after the start of treatment and during the first months.
Febuxostat ved orale doser på op til 48 mg/kg/dag havde ingen virkning på fertilitet og reproduktion hos han- og hunrotter. 
Febuxostat at oral doses up to 48 mg/kg/day was found to have no effect on fertility and reproductive performance of male and female rats.
APEX-studiet: APEX-studiet (Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat) var et fase 3, randomiseret, dobbeltblind, multicenterstudie over 28 uger. 
APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study.
Der sås ingen forskel i andelen af patienter, der behøvede behandling for udbrud af arthritis urica, mellem grupperne, der fik hhv. febuxostat 80 mg og 40 mg. 
No difference in the proportion of patients requiring treatment for gout flares was observed between the febuxostat 80 mg and 40 mg groups.
Læs indlægssedlen for yderligere oplysninger. 
See leaflet for further information.
FLORENCE var et randomiseret (1:1), dobbeltblindet, pivotalt fase 3-studie, der sammenlignede febuxostat 120 mg en gang dagligt med allopurinol 200 til 600 mg dagligt (daglig gennemsnitsdosis allopurinol (± standard afvigelse): 349,7 ± 112,90 mg) i forhold til kontrol af serumurinsyreniveau. 
FLORENCE was a randomized (1:1), double blind, phase III, pivotal trial comparing febuxostat 120 mg once daily with allopurinol 200 to 600 mg daily (mean allopurinol daily dose [± standard deviation]: 349.7 ± 112.90 mg) in terms of control of serum uric acid level.
I det supplerende fase 3-studie CONFIRMS, hvis resultater blev offentliggjort efter den første udstedelse af markedsføringstilladelse for febuxostat, var det primære effektmål andelen af patienter med serumurat < 357 µmol/l (6,0 mg/dl) ved det sidste besøg. 
In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
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. 
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.
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. 
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).
• nervøsitet 
• nervousness
Naproxen og andre hæmmere af glukuronidering 
Naproxen and other inhibitors of glucuronidation