FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no significant difference between etoricoxib and diclofenac in the rate of complicated events.
Danish: Der var ingen signifikant forskel mellem etoricoxib og diclofenac med hensyn til hyppigheden af komplicerede hændelser.
English: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
Danish: Symptomlindring i behandling af osteoarthrose (OA), rheumatoid arthritis (RA), ankylosis spondylitis samt ved smerter og tegn på inflammation i forbindelse med akut arthritis urica.
English: In March 2006, the marketing authorisation holders (MAH) for Arcoxia (etoricoxib) submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Danish: I marts 2006 indsendte indehaverne af markedsføringstilladelse for Arcoxia (etoricoxib) en ansøgning om udvidelse af den godkendte indikation, så denne kom til at omfatte behandling af ankyloserende spondylit (AS) ved en anbefalet daglig dosis på 90 mg. Under vurdering af proceduren blev der udtrykt betænkeligheder ved den langsigtede sikkerhed ved etoricoxib 90 mg til patienter med AS.
English: Confirmed Peripheral Vascular Events Per-protocol
Danish: Bekræftede perifere vaskulære hændelser Per-protocol
English: In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
Danish: Hos patienter med moderat leverdysfunktion (Child-Pugh score 7-9) bør dosis på 60 mg hver anden dag ikke overskrides uanset indikationen; administration af 30 mg én gang dagligt kan også overvejes.
English: White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two1-gram desiccant containers or 90 tablets and one1-gram desiccant container.
Danish: Hvid, rund, HDPE-beholder med hvid polypropylenlukning indeholdende 30 tabletter og to 1-grams beholdere med tørremiddel eller 90 tabletter og en 1-grams beholder med tørremiddel.
English: MEDAL Program Gastrointestinal Tolerability Results:
Danish: MEDAL - Gastrointestinale toleranceresultater:
English: The incidence of confirmed congestive heart failure adverse events (events that were serious and resulted in hospitalisation or a visit to an emergency department) was non-significantly higher with etoricoxib than diclofenac 150 mg, and this effect was dose-dependent.
Danish: Incidensen af bekræftede bivirkninger med venstresidigt hjertesvigt (hændelser, som var alvorlige og resulterede i hospitalsindlæggelse eller besøg på en skadestue) var ikke-signifikant højere med etoricoxib end diclofenac 150 mg; denne effekt var dosisafhængig.
English: Effect of etoricoxib on drugs metabolised by sulfotransferases
Danish: Etoricoxisb effekt på lægemidler, der metaboliseres via sulfotransferaser
English: The incidence of adverse experiences in EDGE and EDGE II and of adverse experiences considered serious or resulting in discontinuation in the MEDAL study was higher with etoricoxib than diclofenac.
Danish: Incidensen af bivirkninger i EDGE og EDGE II samt incidensen af bivirkninger, der blev anset for alvorlige eller som resulterede i afbrydelse af deltagelse i MEDAL-undersøgelsen, var højere for etoricoxib end for diclofenac.
English: Rare: blood sodium decreased.
Danish: Sjælden: Nedsat natrium i blodet.
English: Oral contraceptives: Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 micrograms ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%.
Danish: Oral antikonception: Ved samtidig indtagelse af etoricoxib 60 mg og et oralt antikonceptionsmiddel, som indeholder 35 mikrogram ethinyløstradiol (EØ) og 0,5-1 mg norethindron i 21 dage øgedes steady-state AUC0-24t af EØ med 37 %.
English: In a cardiovascular safety outcomes program of pooled data from three active comparator controlled trials, 17, 412 patients with OA or RA were treated with etoricoxib (60 mg or 90 mg) for a mean duration of approximately 18 months.
Danish: I et kardiovaskulært "safety outcomes"-program med poolede data fra tre aktive komparatorkontrollerede undersøgelser blev 17.412 patienter med OA eller RA behandlet med etoricoxib (60 mg eller 90 mg) i en gennemsnitlig periode på ca. 18 måneder.
English: Effect of etoricoxib on drugs metabolised by CYP isoenzymes
Danish: Etoricoxibs effekt på lægemidler, der metaboliseres via CYP-isoenzymer
English: • If you have moderate liver disease, you should not take more than 60 mg every other day or 30 mg a day.
Danish: • Hvis De har moderat nedsat leverfunktion, bør De højst tage 60 mg hver anden dag eller 30
English: Osteoarthritis The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Danish: Den anbefalede dosis er 30 mg én gang dagligt, som kan øges til højst 60 mg én gang dagligt, hvis det er nødvendigt.
English: Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
Danish: Filmovertræk: Carnaubavoks, lactosemonohydrat, hypromellose, titandioxid (E171), glyceroltriacetat.
English: 60, 90, 120 mg: Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets in blisters; or 30 and 90 tablets in bottles.
Danish: Blisterpakninger à 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 eller 100 tabletter; eller 30 og 90 tabletter i flasker.
English: MEDAL Program Gastrointestinal Safety Results:
Danish: MEDAL - Gastrointestinale sikkerhedsresultater:
English: Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30, 60 and 90 mg daily.
Danish: Der er rapporteret stigninger i ALAT og/eller ASAT (ca. 3 gange eller mere end den øvre normalgrænse) hos ca. 1% af patienterne i kliniske undersøgelser, behandlet i op til 1 år med etoricoxib 30, 60 eller 90 mg dagligt.
English: As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.
Danish: Som med andre lægemidler der hæmmer prostaglandinsyntesen, er der set væskeretention, ødem og hypertension hos patienter i behandling med etoricoxib.
English: • medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan
Danish: • ACE-hæmmere og angiotensin-II-receptorantagonister (mod forhøjet blodtryk og nedsat hjertefunktion), f.eks. enalapril og ramipril og losartan og valsartan.
English: The incidence of discontinuations due to edema-related adverse events was higher for etoricoxib than diclofenac 150 mg, and this effect was dose-dependent (statistically significant for etoricoxib 90 mg, but not for etoricoxib 60 mg).
Danish: Incidensen af seponering på grund af ødemrelaterede bivirkninger var højere for etoricoxib end diclofenac 150 mg; denne effekt var dosisafhængig (statistisk signifikant for etoricoxib 90 mg, men ikke for etoricoxib 60 mg).
English: Acetylsalicylic Acid: In a study in healthy subjects, at steady state, etoricoxib 120 mg once daily had no effect on the anti-platelet activity of acetylsalicylic acid (81 mg once daily).
Danish: Acetylsalicylsyre: I en undersøgelse med raske frivillige, havde etoricoxib 120 mg én gang dagligt, ved steady-state ingen effekt på den anti-thrombotiske effekt af acetylsalicylsyre (81 mg én gang dagligt).
English: In patients with osteoarthritis (OA), etoricoxib 60 mg once daily provided significant improvements in pain and patient assessments of disease status.
Danish: Hos patienter med osteoarthrose (OA) gav etoricoxib 60 mg én gang dagligt signifikant forbedring af smerter og patientens vurdering af sygdomsstatus.
English: It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects.
Danish: Den forårsager smerter, stivhed, hævelse og tiltagende tab af funktionen i de led, der er angrebet, samt betændelse i andre af kroppens organer.
English: 30 mg Aluminum/aluminium blisters in packs containing 7 and 28 tablets.
Danish: Aluminium/aluminiumblister i pakninger à 7 og 28 tabletter.
English: Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Danish: Etoricoxib er en selektiv hæmmer af COX-2 (cyclooxygenase 2), der er indiceret til symptomlindring ved osteoartrose (OA, 30-60 mg én gang daglig), reumatoid artritis (RA, 90 mg én gang daglig) og smerter og tegn på inflammation i forbindelse med akut artritis urica (120 mg én gang daglig).
English: Uncommon: anxiety, depression, mental acuity decreased.
Danish: Ikke almindelig: Angst, depression, nedsat koncentration.
English: In a clinical study for acute gouty arthritis, patients were treated with etoricoxib 120 mg once daily for eight days.
Danish: I en klinisk undersøgelse af akut arthritis urica blev patienterne behandlet med etoricoxib 120 mg én gang dagligt i 8 dage.
English: In the study, the incidence of discontinuations due to hypertension-related adverse events was statistically significantly higher for etoricoxib than for diclofenac.
Danish: I undersøgelsen var incidensen af seponering på grund af hypertensionsrelaterede bivirkninger statistisk signifikant højere for etoricoxib end for diclofenac.
English: Pack sizes of 7 and 28 tablets in blisters.
Danish: Pakningsstørrelser à 7 og 28 tabletter.
English: No clinical data on exposed pregnancies are available for etoricoxib.
Danish: Der foreligger ikke kliniske data om brugen af etoricoxib hos gravide kvinder.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] MSD
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis.
Danish: Ikke almindelig: Abdominal udspilning, syrerefluks, ændringer i tarmmotilitetsmønstret, obstipation, tør mund, gastroduodenal ulcera, colon irritabile, esophagitis, orale ulcera, opkastning, gastritis.
English: Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Danish: Tabletkerne: Calciumhydrogenfosfat (vandfri), croscarmellosenatrium, magnesiumstearat, mikrokrystallinsk cellulose.
English: Safety and effectiveness of etoricoxib in paediatric patients have not been established (see section
Danish: Sikkerhed og effekt af etoricoxib hos børn er ikke undersøgt (se pkt.
English: 3 avenue Hoche 75114 Paris Cedex 8 France
Danish: Merck Sharp Dohme Chibret 3 avenue Hoche 75114 Paris Cedex 8
English: The rates per hundred patient-years of confirmed complicated and uncomplicated upper GI clinical events (perforations, ulcers and bleeds (PUBs)) were 0.67 (95% CI 0.57, 0.77) with etoricoxib and 0.97 (95% CI 0.85, 1.10) with diclofenac, yielding a relative risk of 0.69 (95% CI 0.57, 0.83).
Danish: Hyppigheden af bekræftede komplicerede og ukomplicerede øvre GI-hændelser (perforation, mavesår og blødning (PUBs)) pr. hundrede patientår var 0,67 (95 % konfidensinterval 0,57; 0,77) for etoricoxib og 0,97 (95 % konfidensinterval 0,85; 1,10) for diclofenac, hvilket gav en relativ risiko på 0,69 (95 % konfidensinterval 0,57, 0,83).
English: Uncommon: dysgeusia, insomnia, paresthaesia/hypaesthesia, somnolence.
Danish: Ikke almindelig: Smagsforstyrrelser, søvnløshed, paræstesi/hypæstesi, somnolens.
English: Stomach or bowel bloating, chest pain, heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection, high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers, taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable bowel syndrome, inflammation of the esophagus, blurred vision, eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight gain, muscle cramp/spasm, muscle pain/stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety, depression,
Danish: Oppustet mave eller tarm, brystsmerter, nedsat hjertefunktion, hjerteanfald, slagtilfælde, forbigående iskæmisk anfald (kortere varighed af mangel på blodtilførsel til hjernen), unormal hjerterytme (atrieflimren), infektion i de øvre luftveje, højt kaliumindhold i blodet, ændringer i blod- eller urinprøver vedrørende nyrerne, ændrede tarmbevægelser herunder forstoppelse, tør mund, sår i munden, smagsforstyrrelser, mave-tarm-katar, mavesår, opkastning, irritabel tyktarm, spiserørsbetændelse, sløret syn, irriterede og røde øjne, næseblod, ringen for ørerne, svimmelhed, øget eller nedsat appetit, vægtøgning, muskelkramper/spasmer, muskelsmerter/stivhed, problemer med at sove, søvnighed, følelsesløshed eller prikken i huden, angst, depression, nedsat koncentration, kortåndethed, hoste, hævelse af ansigtet, rødmen, hududslæt eller kløe, urinvejsinfektion.
English: Confirmed Cerebrovascular Events Per-protocol
Danish: Bekræftede cerebrovaskulære hændelser Per-protocol
English: • <ARCOXIA> helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Danish: • ARCOXIA medvirker til at mindske smerte og hævelse (betændelse) i led og muskler hos personer, der har slidgigt, leddegigt, ankyloserende spondylitis (særlig form for leddegigt) og urinsyregigt.
English: Etoricoxib 120 mg given with the same oral contraceptive concomitantly or separated by 12 hours, increased the steady state AUC0-24hr of EE by 50 to 60%.
Danish: Etoricoxib 120 mg, som blev givet, enten samtidig med eller 12 timer forskudt, med det samme orale antikonceptionsmiddel, øgede steady-state AUC0-24t af EØ med 50- 60%.
English: Gastrointestinal and hepatic adverse events were observed significantly more frequently with diclofenac than etoricoxib.
Danish: Gastrointestinale og hepatiske bivirkninger observeredes signifikant hyppigere med diclofenac end med etoricoxib.
English: Common: ecchymosis.
Danish: Almindelig: Ekkymoser.
English: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2).
Danish: Nyreinsufficiens: Dosisjustering er ikke nødvendig hos patienter med creatininclearance ≥30 ml/min (se pkt.
English: For information regarding a dose related response for etoricoxib see section 5.1.
Danish: 5.1 angående information om dosisrelateret respons på etoricoxib.
English: 60, 90 and 120 mg Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Danish: Aluminum/aluminiumblister i pakninger à 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 eller 100 tabletter.
English: There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events.
Danish: Der var ingen signifikant forskel mellem etoricoxib og diclofenac i forekomsten af kardiovaskulære trombotiske hændelser.
English: A significantly lower rate of overall upper GI events was observed with etoricoxib compared to diclofenac.
Danish: Der blev observeret en signifikant lavere hyppighed totalt af øvre GI-hændelser for etoricoxib sammenlignet med diclofenac.
English: -do not take high dose aspirin or other anti-inflammatory medicines while taking <ARCOXIA>
Danish: tag ikke antiinflammatorisk medicin eller højere doser af acetylsalicylsyre, mens De tager
English: The incidence of congestive heart failure adverse events (discontinuations and serious events) occurred at similar rates on etoricoxib 60 mg compared to diclofenac 150 mg but was higher for etoricoxib 90 mg compared to diclofenac 150 mg (statistically significant for 90 mg etoricoxib vs. 150 mg diclofenac in MEDAL OA cohort).
Danish: Incidensen af bivirkninger med venstresidigt hjertesvigt (seponering og alvorlige hændelser) forekom med samme hyppighed for etoricoxib 60 mg sammenlignet med diclofenac 150 mg, men var højere for etoricoxib 90 mg sammenlignet med diclofenac 150 mg (statistisk signifikant for etoricoxib 90 mg versus diclofenac 150 mg i MEDAL-OA-kohorten).
English: Effects of other drugs on the pharmacokinetics of etoricoxib
Danish: Andre lægemidlers effekt på etoricoxibs farmakokinetik
English: Hepatic insufficiency: Patients with mild hepatic dysfunction (Child-Pugh score 5-6) administered etoricoxib 60 mg once daily had an approximately 16% higher mean AUC as compared to healthy subjects given the same regimen.
Danish: Leverinsufficiens: Patienter med mild leverdysfunktion (Child-Pugh score 5-6), der fik etoricoxib 60 mg én gang daglig, havde ca. 16% højere middel-AUC end raske frivillige i samme regime.
English: • If you have mild liver disease, you should not take more than 60 mg a day.
Danish: • Hvis De har let nedsat leverfunktion, bør De højst tage 60 mg per dag.
English: Do not take <ARCOXIA>:
Danish: Tag ikke ARCOXIA
English: Common (occurring in greater than 1 out of 100 and less than 1 out of 10 people) Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind, nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn, changes in blood tests related to your liver, swelling of the legs and/or feet due to fluid retention (oedema), increased blood pressure, palpitations, bruising.
Danish: Almindelige (forekommer hos mere end 1 ud af 100 og hos færre end 1 ud af 10 patienter) Svaghedsfølelse og træthed, svimmelhed, hovedpine, influenza-lignende sygdom, diarré, tarmluft, kvalme, fordøjelsesbesvær (dyspepsi), mavesmerter eller ubehag i maven, halsbrand, ændringer i blodprøver vedrørende leveren, hævede ben og/eller fødder på grund af væskeophobning (ødemer), forhøjet blodtryk, hjertebanken, blå mærker.
English: It is caused by deposits of mineral crystals in the joint.
Danish: Den forårsages af aflejringer af urinsyresalte i leddet.
English: Merck Sharp & Dohme de España, S.A. Josefa Valcárcel, 38
Danish: Merck Sharp & Dohme de España, S.A., Josefa Valcárcel, 38 28027 Madrid Spain
English: In patients experiencing attacks of acute gouty arthritis, etoricoxib 120 mg once daily over an eight-day treatment period, relieved moderate to extreme joint pain and inflammation comparable to indomethacin 50 mg three times daily.
Danish: Hos patienter, der oplevede anfald med arthritis urica, lindrede etoricoxib 120 mg én gang dagligt over en behandlingsperiode på 8 dage moderat til ekstrem ledsmerte og inflammation sammenlignet med indomethacin 50 mg 3 gange dagligt.
English: MEDAL Program Hepatic Safety Results:
Danish: MEDAL - Hepatiske sikkerhedsresultater
English: Across clinical pharmacology studies, <ARCOXIA> produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Danish: I alle kliniske, farmakologiske undersøgelser forårsagede ARCOXIA i doser op til 150 mg dagligt, dosisafhængig hæmning af COX-2 uden hæmning af COX-1.
English: In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provided significant improvements in spine pain, inflammation, stiffness and function.
Danish: Hos patienter med ankylosis spondylitis gav etoricoxib 90 mg én gang dagligt signifikant forbedring af spinalsmerter, inflammation, stivhed og funktion.
English: In patients with rheumatoid arthritis (RA), etoricoxib 90 mg once daily provided significant improvements in pain, inflammation, and mobility.
Danish: Hos patienter med rheumatoid arthritis (RA) gav etoricoxib 90 mg én gang dagligt signifikant forbedring af smerte, inflammation og mobilitet.
English: Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given etoricoxib 60 mg once daily; etoricoxib 30 mg once daily has not been studied in this population.
Danish: Patienter med moderat leverdysfunktion (Child-Pugh score 7-9), der fik etoricoxib 60 mg hver anden dag havde samme middel-AUC som raske frivillige, der fik etoricoxib 60 mg én gang dagligt; etoricoxib 30 mg én gang dagligt er ikke undersøgt i denne patientgruppe.
English: (95% CI)
Danish: Hyppighed† (95 % KI)
English: It is not known whether etoricoxib is excreted in human milk.
Danish: Det vides ikke, om etoricoxib udskilles i modermælk.
English: Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a dose of 60 mg once daily should not be exceeded.
Danish: Leverinsufficiens: Hos patienter med mild leverdysfunktion (Child-Pugh score 5-6) bør dosis på 60 mg én gang dagligt ikke overskrides uanset indikationen.
English: Diclofenac (N=16483) 24766 PatientYears
Danish: (N=16483)
English: Bottles Keep the container tightly closed in order to protect from moisture.
Danish: Flaske Hold beholderen tæt tillukket for at beskytte mod fugt.
English: The rates of confirmed lower GI clinical events (small or large bowel perforation, obstruction, or hemorrhage, (POBs)) were not significantly different between etoricoxib and diclofenac.
Danish: Hyppigheden af bekræftede kliniske hændelser i den nederste del af mave-tarmkanalen (perforation af tyndtarm eller tyktarm, obstruktion eller blødning (POBs)) var ikke signifikant forskellig for etoricoxib og diclofenac.
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular cramp/spasm, musculoskeletal pain/stiffness.
Danish: Knogler, led, muskler og bindevæv: Ikke almindelig: Muskelkramper/spasmer, smerter/stivhed i bevægeapparatet.
English: Women who use etoricoxib must not breast feed (see sections 4.3 and 5.3).
Danish: Kvinder der tager etoricoxib bør ikke amme (se pkt.
English: <ARCOXIA> Tablets should not be taken by children or adolescents under 16 years of age.
Danish: Børn og unge under 16 år bør ikke tage ARCOXIA.
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Danish: I langtidsundersøgelser er der ikke vist signifikant forskel på GI-sikkerheden mellem selektive COX-2 hæmmere + acetylsalicylsyre versus NSAID + acetylsalicylsyre (se pkt.
English: The recommended dose is 30 mg once daily.
Danish: Anbefalet dosis er 30 mg én gang dagligt.
English: Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate
Danish: Calciumhydrogenfosfat (vandfri) Croscarmellosenatrium Magnesiumstearat Mikrokrystallinsk cellulose
English: Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Danish: Hver filmovertrukken tablet indeholder 30, 60, 90 eller 120 mg etoricoxib.
English: It is not known if <ARCOXIA> is excreted in human milk.
Danish: Man ved ikke, om ARCOXIA udskilles i modermælk.
English: (See sections 4.3 and 4.4.)
Danish: 4.3 og 4.4).
English: If you take more <ARCOXIA> than you should You should never take more tablets than the doctor recommends.
Danish: Tag aldrig flere tabletter end Deres læge anbefaler.
English: In the individual MEDAL Program studies, for etoricoxib (60 mg or 90 mg), the absolute incidence of discontinuation in any treatment group was up to 2.6% for hypertension, up to 1.9% for edema, and up to 1.1% for congestive heart failure, with higher rates of discontinuation observed with etoricoxib 90 mg than etoricoxib 60 mg.
Danish: I de individuelle undersøgelser i MEDAL-programmet var den absolutte incidens for seponering for etoricoxib (60 mg eller 90 mg) i alle behandlingsgrupperne op til 2,6 % for hypertension, 1,9 % for ødem og 1,1 % for venstresidigt hjertesvigt.