FrancophonIA/ELRC3.0 huggingface dataset:
English: After repeated doses of 75 mg clopidogrel per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.
Danish: Efter gentagen dosering med clopidogrel 75 mg dagligt i 10 dage svarede den ADP-inducerede trombocytaggregation hos patienter med alvorligt nedsat leverfunktion til den, der blev set hos raske forsøgspersoner.
English: Excipient:
Danish: Filmovertræk:
English: (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Danish: Det blev ikke observeret nogen betydende forskelle i eksponering for den aktive metabolit og gennemsnitlig hæmning af trombocytfunktionen (IPA) mellem ultrahurtige, extensive, eller intermediate metabolisers.
English: Blister of OPA/Al/PVC-Al containing 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in the box.
Danish: Blisterkort af OPA/Al/PVC-Al i æsker med 7, 14, 28, 30, 50, 56, 84, 90 og 100 filmovertrukne tabletter.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: Clopidogrel Qualimed 75 mg film-coated tablets Clopidogrel
Danish: Clopidogrel Qualimed 75 mg filmovertrukne tabletter Clopidogrel
English: Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.
Danish: Æsker med 7, 14, 28, 30, 50, 56, 84, 90 og 100 filmovertrukne tabletter i blisterpakning.
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to
Danish: I overensstemmelse med resultaterne ovenfor, blev det vist i en metaanalyse af 6 studier med 335 clopidogrelbehandlede ved steady state, at eksponeringen for den aktive metabolit blev nedsat med 28 % hos personer med intermediate metabolisme, og med 72 % hos personer med poor metabolisme.
English: Boxes of 7, 14, 28, 56, 84 film-coated tablets in calendar blisters are available.
Danish: Æsker med 7, 14, 28, 56 eller 84 filmovertrukne tabletter i kalenderblisterpakning.
English: Breastfeeding
Danish: Propylenglycol
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget anden medicin, bør De oplyse Deres læge eller apotek herom, også hvis der er tale om ikke-receptpligtig medicin.
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Danish: Efter gentagen dosering med clopidogrel 75 mg daglig var hæmningen af ADP-induceret trombocytaggregation lavere (25%) hos forsøgspersoner med alvorlig nyresygdom (kreatininclearance 5-15 ml/min) end der, der blev set hos raske forsøgspersoner.
English: Bruising
Danish: Amning
English: Calendar Blister of OPA/Al/PVC-Al containing 7, 14, 28, 56, 84 film-coated tablets in the box.
Danish: Kalenderblisterpakning af OPA/PVC aluminium eller aluminium i kartonæsker der indeholder 7, 14, 28, 56 eller 84 filmovertrukne tabletter.
English: 100 film-coated tablets: EU/1/09/559/009
Danish: 100 filmovertrukne tabletter: EU/1/09/559/009
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Danish: Blødning i luftvejene (hæmoptyse, pulmonær blødning), bronkospasmer, interstitiel pneumoni
English: • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: • kan det vare lidt længere end normalt, før blødningen ophører, hvis de skærer Dem eller kommer til skade.
English: • if you have a medical condition that is currently causing bleeding such as a stomach ulcer or
Danish: • hvis De har en aktiv blødning såsom et mavesår eller en blødning i hjernen;
English: Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Danish: Der er begrænset erfaring med behandling af patienter med nedsat nyrefunktion.
English: What Clopidogrel Qualimed looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Danish: De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
English: - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Danish: - en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår)
English: - For more than 12 hours: patients should take the next dose at the regular scheduled time
Danish: - MVed mere end 12 timer efter planlagt administration: patienten børskal tage næste dosis som planlagt og ikke tage dobbelt dosis.
English: 50x1 film-coated tablets EU/1/09/559/011
Danish: 50x1 filmovertrukne tabletter: EU/1/09/559/011
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Danish: Clopidogrel metaboliseres først til en 2-oxo-clopidogrel-metabolit, der derefter metaboliseres til den aktive metabolit, et tiolderivat af clopidogrel.
English: 30x1 film-coated tablets EU/1/09/559/010
Danish: 30x1 filmovertrukne tabletter: EU/1/09/559/010
English: Very rare aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
Danish: Trombotisk trombocytopenisk purpura (TTP) (se pkt.4.4), aplastisk anæmi, pancytopeni, agranulocytose, alvorlig trombocytopeni, granulocytopeni, anæmi
English: - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy, - ticlopidine, other antiplatelet agent.
Danish: − carbamazepin eller oxcarbazepin, medicin der anvendes mod bestemte former for epilepsi
English: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Danish: Hvis en dosis glemmes: - MInden for mindre end 12 timer efter planlagt administration: patienten børskal straks tage den glemte dosis og tage den næste dosis som planlagt.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: It also contains hydrogenated castor oil.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder hydrogeneret ricinusolie.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Qualimed:
Danish: Vær ekstra forsigtig med at tage Clopidogrel Qualimed Hvis nogen af følgende situationer gælder for Dem, skal De oplyse det til Deres læge, før De tager Clopidogrel Qualimed:
English: Very rare erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Danish: Bulløs dermatitis (toksisk epidermal nekrolyse, Stevens Johnson Syndrom, erythema multiforme), angioødem erytematøst udslæt, urticaria, eksem, lichen planus
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of
Danish: Hvis De har taget for mange Clopidogrel Qualimed filmovertrukne tabletter Kontakt Deres læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: CALENDAR BLISTER (boxes of 7, 14, 28, 56 or 84 tablets)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT KALENDER (ÆSKER MED 7, 14, 28, 56 og 84)
English: Before you take Clopidogrel Qualimed
Danish: SÅDAN SKAL DE TAGE CLOPIDOGREL QUALIMED
English: 7 film-coated tablets - calendar blister 14 film-coated tablets - calendar blister 28 film-coated tablets - calendar blister
Danish: 7 filmovertrukne tabletter - kalenderblisterpakning 14 filmovertrukne tabletter 14 filmovertrukne tabletter - kalenderblisterpakning 28 filmovertrukne tabletter 28 filmovertrukne tabletter - kalenderblisterpakning 30 filmovertrukne tabletter 30x1 filmovertrukne tabletter 50 filmovertrukne tabletter 50x1 filmovertrukne tabletter 56 filmovertrukne tabletter 56 filmovertrukne tabletter - kalenderblisterpakning 84 filmovertrukne tabletter 84 filmovertrukne tabletter - kalenderblisterpakning 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Qualimed 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel Qualimed 75 mg filmovertrukne tabletter
English: Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Danish: Før planlagt kirurgi og før ordination af nye lægemidler bør patienter informere deres læge og tandlæge om, at de tager clopidogrel.
English: 4.7 Effects on ability to drive and use machines Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Danish: Som forholdsregel frarådes samtidig anvendelse af stærke eller intermediate CYP2C19-hæmmere (se pkt.
English: A. THE MANUFACTURING AUTHORISATION HOLDER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: Common side effects: Diarrhoea, abdominal pain, indigestion or heartburn.
Danish: Øvrige bivirkninger der er rapporteret for Clopidogrel Qualimed: Almindelige bivirkninger: Diarré, mavesmerter, fordøjelsesbesvær eller halsbrand.
English: Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Danish: Dette øgedes progressivt og nåede steady state mellem dag 3 og dag 7.
English: The incidence of severe cases was similar for clopidogrel and ASA.
Danish: Forekomsten af alvorlige tilfælde var 1,4% for clopidogrel og 1,6% for ASA.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Qualimed 75 mg film-coated tablets Clopidogrel
Danish: LÆGEMIDLETS NAVN Clopidogrel Qualimed 75 mg filmovertrukne tabletter Clopidogrel
English: - fever, signs of infection or extreme tiredness.
Danish: Kontakt Deres læge med det samme, hvis De oplever: - feber, tegn på infektion eller udtalt træthed.
English: - heparin, or any other injectable medicine used to reduce blood clotting, -omeprazole, esomeprazole or cimetidine, medicines to treat for upset stomach,
Danish: − heparin eller anden medicin til indsprøjtning, for at nedsætte dannelse af blodpropper
English: What Clopidogrel Qualimed contains
Danish: Clopidogrel Qualimed.
English: Hepatic impairment
Danish: Psykiske forstyrrelser
English: This medicinal product contains hydrogenated castor oil which may cause stomach upset and
Danish: Hjælpestoffer Clopidogrel Qualimed indeholder hydrogeneret ricinusolie, der kan give maveproblemer og diarré.
English: Musculoskeletal, connective tissue and bone
Danish: Knogler, led, muskler og bindevæv
English: • Severe hepatic impairment.
Danish: • Stærkt nedsat leverfunktion.
English: A. THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: If you take more Clopidogrel Qualimed than you should:
Danish: Hvis De vil have yderligere oplysninger om Clopidogrel Qualimed, skal De henvende Dem til den lokale repræsentant:
English: This leaflet was last approved in MM/YYYY.
Danish: DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ>
English: You should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory
Danish: − en type smertestillende medicin (nonsteroide antiinflammatoriske lægemidler, NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led,
English: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
Danish: Erfaringen med behandling af patienter med moderate leversygdomme, der kan have blødningstendens, er begrænset.
English: • rare (affects 1 to 10 users in 10,000)
Danish: Hyppigheden af bivirkninger anført nedenfor er defineret ud fra følgende konvention: Meget almindelig (påvirker flere end 1 ud af 10 patienter) Almindelig (påvirker mellem 1 og 10 ud af 100 patienter) Ikke-almindelig (påvirker 1 til 10 ud af 1.000 patienter) Sjælden (påvirker 1 til 10 ud af 10.000 patienter)
English: As a precaution, concomitant use of omeprazole or esomeprozole should be
Danish: Som forholdsregel frarådes samtidig anvendelse af omeprazol eller esomeprazol (se pkt.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Danish: Samlet set var clopidogrel 75 mg/dag sammenligneligt med ASA 325 mg/dag i CAPRIE-studiet uafhængigt af alder, køn og race.De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY- og COMMIT-studierne beskrives nedenfor.. Ud over erfaringerne fra de kliniske studier, er der spontant blevet rapporteret bivirkninger.
English: Mylan Sp.z.o.o Tel: +48 22 5466400
Danish: Tel: +48 22 5466400
English: Vertigo
Danish: Metabolisme
English: If you forget to take Clopidogrel Qualimed:
Danish: Tag ikke Clopidogrel Qualimed:
English: Contact your doctor immediately if you experience:
Danish: Det er særlig vigtigt, at De fortæller det til Deres læge, hvis De tager
English: TAD Pharma GmbH
Danish: Greece Generics Pharma Hellas ΕΠΕ
English: Common***
Danish: Almindelige***
English: • The usual dose is one tablet daily.
Danish: • Den sædvanlige dosis er en tablet om dagen.
English: (10 patients out of 268 in APEX study).
Danish: (10 patienter ud af 268 i APEX-studiet).
English: The potential risk for human is unknown.
Danish: Den potentielle risiko for mennesket er ukendt.
English: Your doctor will have prescribed the strength most suitable for you.
Danish: Deres læge vil have ordineret den styrke, der er bedst egnet til Dem.
English: FACT (52 weeks)
Danish: FACT (52 uger)
English: Usually treatment is short-term.
Danish: Behandlingen er i reglen kortvarig.
English: H-2900 Komárom Hungary
Danish: H-2900 Komárom Ungarn
English: Date of first authorisation: 15 June 2017
Danish: Dato for første markedsføringstilladelse: 15 juni 2017
English: APEX (28 weeks)
Danish: APEX (28 uger)
English: Your doctor may ask you to have blood tests to check that your liver is working normally.
Danish: Deres læge vil muligvis bede Dem om at få taget blodprøver for at kontrollere, om Deres lever fungerer normalt.
English: Components of a multipack, can't be sold separately.
Danish: En del af en multipakning, må ikke sælges separat.
English: No interaction studies have been performed in humans.
Danish: Der er ikke udført interaktionsstudier hos mennesker.
English: Rare Tinnitus
Danish: Sjældne Tinnitus
English: Do not use this medicine after the expiry date which is stated on the packaging after ‘EXP.'
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ‘EXP'.
English: Combined Results
Danish: Kombinerede resultater
English: Not everyone gets flares, but you could get a flare-up even if you are taking Febuxostat Mylan, and especially during the first weeks or months of treatment.
Danish: Ikke alle får udbrud, men De kunne få et udbrud, selv om De tager Febuxostat Mylan og især i behandlingens første uger eller måneder.
English: Table 2 summarises the primary efficacy endpoint results:
Danish: Tabel 2 giver en oversigt over resultaterne for de primære effektmål:
English: (leukocytosis, with or without eosinophilia)
Danish: (leukocytose med eller uden eosinofili)
English: Four pharmacologically active hydroxyl metabolites have been identified, of which three occur in plasma of humans.
Danish: Der er identificeret fire farmakologisk aktive hydroxylmetabolitter, hvoraf tre optræder i human plasma.
English: Other side effects which are not mentioned above are listed below.
Danish: Andre bivirkninger, som ikke omtales ovenfor, er angivet i det følgende:
English: About 69% of patients required no treatment change to achieve a final stable treatment.
Danish: Hos ca. 69% af patienterne var det ikke nødvendigt at ændre behandlingen for at opnå en endelig og stabil behandling.
English: Effects in non-clinical studies were generally observed at exposures in excess of the maximum human exposure.
Danish: Virkningerne i prækliniske studier blev generelt observeret ved eksponeringer, der oversteg den maksimale humane eksponering.
English: • muscle damage, a condition which on rare occasions can be serious.
Danish: • muskelskader, som af og til kan være alvorlige.
English: Overall 56.6% of patients discontinued trial treatment prematurely and 45% of patients did not complete all trial visits.
Danish: I alt 56,6 % af patienterne ophørte med forsøgsbehandlingen før tid, og 45 % af patienterne gennemførte ikke alle møder under forsøget.
English: There is no appreciable accumulation when doses of 10 mg to 240 mg are administered every 24 hours.
Danish: Der sker ingen væsentlig akkumulation, når der administreres doser på 10 mg til 240 mg hver 24. time.
English: Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that febuxostat does not adversely affect performance.
Danish: Patienterne bør udvise forsigtighed, inden de fører motorkøretøj, betjener maskiner eller deltager i farlige aktiviteter, indtil de er rimeligt sikre på, at febuxostat ikke nedsætter deres evne hertil.
English: In most cases, these reactions occurred during the first month of therapy with febuxostat.
Danish: I de fleste tilfælde indtraf disse reaktioner i løbet af den første måned af behandlingen med febuxostat.
English: However, drugdrug and drug-disease interactions were not explored during this study.
Danish: Interaktion mellem lægemiddellægemiddel og lægemiddel-sygdom blev ikke undersøgt i dette studie.
English: No dose adjustment is needed based on gender.
Danish: Der er ikke behov for dosisjustering baseret på køn.
English: Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow:
Danish: Hold op med at tage dette lægemiddel, og kontakt straks lægen eller nærmeste skadestue, hvis følgende sjældne bivirkninger opstår (kan forekomme hos op til 1 ud af 1.000 personer), da de kan være de første symptomer på en alvorlig allergisk reaktion:
English: Long-term, open label extension Studies
Danish: Langvarige åbne forlængelsesstudier
English: BL=baseline SEM=standard error of the mean
Danish: BL = baseline, SEM = standardfejl for middelværdi
English: Monitoring of serum uric acid is therefore recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation.
Danish: Monitorering af serumurinsyre anbefales derfor 1-2 uger efter behandlingsstart med en potent induktor af glukuronidering.
English: Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.
Danish: Giv ikke febuxostat til børn under 18 år, da sikkerhed og virkning endnu ikke er klarlagt hos denne aldersgruppe.
English: Both steps in the above transformations are catalyzed by xanthine oxidase (XO).
Danish: Begge trin i ovenstående transformationer katalyseres af xanthinoxidase (XO).
English: • The tablets should be taken by mouth and can be taken with or without food.
Danish: • Tabletterne skal tages gennem munden - med eller uden mad.
English: Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol.
Danish: Nogle af disse patienter, men ikke alle, rapporterede nedsat nyrefunktion og/eller tidligere overfølsomhed over for allopurinol.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid eller planlægger at blive gravid, skal De spørge Deres læge eller apoteket til råds, før De tager dette lægemiddel.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: Diarrhoea**, nausea
Danish: Diarre**, kvalme
English: A risk to a suckling infant cannot be excluded.
Danish: En risiko for et barn, der ammes, kan ikke udelukkes.
English: Furthermore, the mean serum uric acid level was significantly lower with febuxostat since the first 24 hours of treatment and at any following time point.
Danish: Desuden var middel serumurinsyreniveauet signifikant lavere med febuxostat efter de første 24 timers behandling og ethvert tidspunkt derefter.
English: It may cause muscle problems and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown.
Danish: Det kan give muskelproblemer, og hvis du samtidig føler dig utilpas eller har høj feber, kan det skyldes unormal nedbrydning af musklerne.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Medicinal products that inhibit glucuronidation, such as NSAIDs and probenecid, could in theory affect the elimination of febuxostat.
Danish: Lægemidler, der hæmmer glukuronidering, såsom NSAID og probenecid, kunne i teorien påvirke eliminationen af febuxostat.
English: Where the combination cannot be avoided, a reduction of the dose of mercaptopurine/azathioprine is recommended.
Danish: Hvis kombinationen ikke kan undgås, anbefales det at nedsætte dosen af mercaptopurin/azathioprin.
English: There was no significant increase in any other tumour type in either male or female mice or rats.
Danish: Der var ingen signifikant stigning i andre tumortyper hos hverken han- eller hunmus/rotter.
English: Febuxostat has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours.
Danish: Febuxostat har en tilsyneladende gennemsnitlig terminal eliminationshalveringstid (t1/2) på cirka 5 til 8 timer.
English: • If you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for febuxostat eller et af de øvrige indholdsstoffer i febuxostat (angivet i punkt 6).