FrancophonIA/ELRC3.0 huggingface dataset:
English: There is little direct comparative safety data for individual NSAIDs other than diclofenac and naproxen and it is therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Danish: Der foreligger kun få direkte sammenlignelige sikkerhedsdata for bestemte NSAID'er ud over diclofenac og naproxen, og det er derfor vanskeligt at vurdere risiciene for etoricoxib sammenlignet med ibuprofen, ketoprofen eller andre mindre gængse NSAID'er.
English: If necessary, monitor blood lithium closely and adjust the lithium dosage while the combination is being taken and when the NSAID is withdrawn.
Danish: Om nødvendigt bør lithiumkoncentrationerne monitoreres tæt, og lithiumdosis justeres, når kombinationen tages, og når NSAID seponeres.
English: Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Danish: Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: 7 Film-coated tablets 28 Film-coated tablets
Danish: 7 filmovertrukne tabletter 28 filmovertrukne tabletter
English: Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Danish: Meget sjælden: Urticaria, Steven-Johnsons syndrom, toksisk epidermisk nekrolyse.
English: Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Danish: Ældre patienter: Farmakokinetikken hos ældre patienter (65 år og derover) svarer til den hos yngre patienter.
English: Dizziness and sleepiness have been reported in some patients taking <ARCOXIA>.
Danish: Svimmelhed og søvnighed er rapporteret hos nogle patienter, der har taget ARCOXIA.
English: Rare (occurring in greater than 1 out of 10,000 and less than 1 out of 1000 people) Low blood levels of sodium.
Danish: Sjældne (forekommer hos mere end 1 ud af 10.000 og færre end 1 ud af 1000 patienter) Lavt indhold af natrium i blodet.
English: • if you have serious liver disease
Danish: • hvis De har alvorlig leversygdom
English: • if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of <ARCOXIA> (see Further information, section 6)
Danish: • hvis De er overfølsom (allergisk) over for etoricoxib eller et af de øvrige indholdsstoffer i ARCOXIA (se Yderligere oplysninger, pkt.
English: If you are not sure if any of the above apply to you, talk to your doctor before taking <ARCOXIA> to see if this medicine is suitable for you.
Danish: Hvis De er i tvivl om, hvorvidt noget af ovenstående passer på Dem, skal De tale med lægen, før De tager ARCOXIA, for at finde ud af, om denne medicin er passende for Dem.
English: Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
Danish: Baseret på in vitro-undersøgelser forventes etoricoxib ikke at hæmme cytokrom P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 eller 3A4.
English: The CHMP assessed efficacy data submitted for AS and safety data collected regarding AS, and also in the rheumatoid arthritis population for which the same dose is approved for treatment.
Danish: CHMP vurderede de indsendte data for effektivitet mod AS og de indsamlede sikkerhedsdata i forbindelse med AS samt data fra gruppen af patienter med reumatoid artritis, hvortil samme dosis er godkendt til behandling.
English: However no treatment-related external or skeletal foetal malformations were observed.
Danish: Hos kaniner sås ingen behandlingsrelaterede eksterne eller skeletale føtale misdannelser.
English: There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases.
Danish: Der har været rapporter om akut overdosering med etoricoxib, selvom der i de fleste af tilfældene ikke blev rapporteret om bivirkninger.
English: These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Danish: Den gavnlige effekt blev observeret så tidligt som på anden behandlingsdag og blev opretholdt i op til 52 uger.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Danish: COX-2 er isoformen af det enzym, som induceres af proinflammatoriske stimuli, og som man mener hovedsageligt har ansvaret for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
English: If you are using <ARCOXIA>, you must not breastfeed.
Danish: Hvis De tager ARCOXIA, bør De ikke amme.
English: Do not drive if you experience dizziness or sleepiness.
Danish: Kør ikke bil, hvis De oplever svimmelhed eller søvnighed.
English: In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking <ARCOXIA>:
Danish: Især hvis De tager et eller flere af følgende lægemidler, vil Deres læge følge Dem for at kontrollere, at Deres medicin virker, som den skal, efter at De er begyndt at tage ARCOXIA:
English: In the pooled MEDAL Program, 0.3% of patients on etoricoxib and 2.7% of patients on diclofenac discontinued due to hepatic-related adverse experiences.
Danish: I det poolede MEDAL-program stoppede 0,3 % af de patienter, der fik etoricoxib, og 2,7 % af de patienter, der fik diclofenac på grund af leverrelaterede hændelser.
English: Renal function should be monitored when etoricoxib and either of these drugs is used in combination.
Danish: Nyrefunktionen bør monitoreres, når etoricoxib og et af disse stoffer bruges i kombination.
English: In a dose ranging study, etoricoxib 60 mg demonstrated significantly greater improvement than 30 mg for all 3 primary endpoints over 6 weeks of treatment.
Danish: I en undersøgelse med forskellige doser viste etoricoxib 60 mg signifikant større forbedringer end 30 mg for alle 3 primære endepunkter over en 6 ugers behandlingsperiode.
English: The effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has not been studied.
Danish: Effekten af de anbefalede doser ved kronisk behandling med etoricoxib (30, 60 og 90 mg) er ikke undersøgt.
English: Studies with etoricoxib 30 mg once daily demonstrated efficacy superior to placebo over a 12 week treatment period (using similar assessments as the above studies).
Danish: Undersøgelser med etoricoxib 30 mg én gang dagligt viste bedre effekt i forhold til placebo over en 12 ugers behandlingsperiode (vurderet på samme måde som ovennævnte undersøgelser).
English: The subset of overall upper GI events considered complicated included perforations, obstructions, and complicated bleeding; the subset of upper GI events considered uncomplicated included uncomplicated bleeds and uncomplicated ulcers.
Danish: Undergruppen af samlede øvre GI-hændelser, der blev anset for komplicerede, omfattede perforation, obstruktion og kompliceret blødning; Undergruppen af øvre GI-hændelser, der blev anset for ikke-komplicerede, omfattede ukompliceret blødning og ukompliceret mavesår.
English: • You have a history of heart failure, heart attack or any other form of heart disease.
Danish: • De har tidligere haft nedsat hjertefunktion, hjerteanfald eller anden form for hjertesygdom.
English: Gender: The pharmacokinetics of etoricoxib are similar between men and women.
Danish: Køn: Etoricoxibs farmakokinetik er sammenlignelig hos mænd og kvinder.
English: Aluminum/aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Danish: Aluminum/aluminiumblister (enkeltdoser) i pakninger à 50 eller 100 tabletter.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.
Danish: Hvis der er kliniske tegn på forværring i disse patienters tilstand, bør der tages relevante forholdsregler, herunder seponering af behandling med etoricoxib.
English: Uncommon (occurring in greater than 1 out of 1000 and less than 1 out of 100 people)
Danish: Ikke almindelige (forekommer hos mere end 1 ud af 1.000 og hos færre end 1 ud af 100 patienter)
English: Ear and labyrinth disorders: Uncommon: tinnitus, vertigo.
Danish: Øre og labyrint: Ikke almindelig: Tinnitus, vertigo.
English: The CHMP concluded on 26 June 2008 that the data confirm the known relatively adverse renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure), but similar CV thrombotic risk as diclofenac and some degree of upper GI safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Danish: CHMP konkluderede den 26. juni 2008, at dataene bekræfter den kendte relativt ugunstige renovaskulære sikkerhedsprofil for etoricoxib (hypertension, ødem og kongestiv hjerteinsufficiens), men med tilsvarende kardiovaskulær tromboembolisk risiko som diclofenac og med en lidt gunstigere øvre GI-sikkerhedsprofil end naproxen og diclofenac (men ingen nævneværdig fordel med hensyn til nedre GI-sikkerhed).
English: While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended (see section 4.2).
Danish: Selvom denne information kan indikere en dosisøgning, er etoricoxibdoser højere end de, der er anført for de respektive indikationer, ikke undersøgt i kombination med rifampicin, og kan derfor ikke anbefales (sepkt.
English: Both referral procedures pertained to the safety of the COX-2 inhibitor products, including etoricoxib, with a particular focus on gastrointestinal (GI) and cardiovascular (CV) safety.
Danish: Begge indbringelsesprocedurer omhandlede sikkerheden af COX-2-hæmmere, heriblandt etoricoxib, med særligt fokus på gastrointestinal (GI) og kardiovaskulær (CV) sikkerhed.
English: This information should inform healthcare professionals on the cardiorenal risks associated with Arcoxia and should be in line with the DHPC endorsed by the CHMP.
Danish: Dette brev skal informere lægefaglige personer om de kardiorenale risici, der er forbundet med Arcoxia, og brevets indhold skal være i overensstemmelse med CHMP's anbefaling.
English: Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indications; however, some data are available to indicate that lower doses might also show effect.
Danish: Dataene fra de kliniske undersøgelser viste klinisk betydningsfuld behandlingseffekt af 90 mg etoricoxib én gang daglig ved AS-indikationerne, men der foreligger dog data, som indikerer, at den lavere dosis muligvis også viser effekt.
English: The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome; hepatotoxicity including hepatic failure, jaundice and pancreatitis.
Danish: Følgende alvorlige bivirkninger er rapporteret i forbindelse med brug af NSAID og kan ikke udelukkes for etoricoxib: Nefrotoksicitet, herunder interstitiel nefritis og nefrotisk syndrom; hepatotoksicitet, herunder leversvigt, icterus og pancreatitis.
English: In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing.
Danish: I undersøgelser specielt designet til at måle indsættelse af etoricoxibs virkning, indtrådte denne så tidligt som 24 minutter efter dosering.
English: • if you have a current stomach ulcer or bleeding in your stomach or intestines
Danish: • hvis De har aktivt mavesår eller blødning i maven eller tarmene
English: As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Danish: Da de kardiovaskulære risici ved anvendelse af etoricoxib kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingstid og den laveste effektive daglige dosis anvendes.
English: Renal effects
Danish: Renal effekt
English: Rifampicin: Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations.
Danish: Rifampicin: Samtidig administration af etoricoxib og rifampicin, en potent CYP-enzyminduktor, medførte et fald på 65% i etoricixibs plasmakoncentration.
English: Gastrointestinal effects
Danish: Gastrointestinal effekt
English: However, patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.
Danish: Patienter der oplever svimmelhed, vertigo eller søvnighed, når de anvender etoricoxib, bør ikke køre bil eller betjene maskiner.
English: Overall upper GI events were defined as perforations, ulcers and bleeds.
Danish: Samlet blev de øvre GI-hændelser defineret som perforation, mavesår og blødning.
English: Based on the review of the available data, the CHMP considers that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis.
Danish: På baggrund af gennemgangen af de tilgængelige data anser CHMP, at fordelene ved etoricoxib til behandling af ankyloserende spondylit er større end risiciene.
English: The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Danish: Beslutningen om at ordinere en selektiv COX-2 hæmmer bør bero på en vurdering af den samlede risiko for den enkelte patient (se pkt.
English: Common: palpitations.
Danish: Almindelig: Palpitation.
English: An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g., venous thrombo-embolic events in women at risk).
Danish: En øgning i EØ-eksponering kan øge bivirkningsfrekvensen i forbindelse med oral antikonception (f.eks. venøse thromboemboliske tilfælde hos kvinder i risikogruppen).
English: The clinical benefit of etoricoxib was observed as early as the second day of therapy after initiation of treatment and was maintained throughout the 52-week treatment period.
Danish: Den kliniske gavn af etoricoxib sås allerede på dag to efter behandlingsstart og blev opretholdt gennem hele perioden på 52 uger.
English: However, concomitant administration of low-dose acetylsalicylic acid with etoricoxib may result in an increased rate of GI ulceration or other complications compared to use of etoricoxib alone.
Danish: Samtidig administration af lav-dosis acetylsalicylsyre og etoricoxib kan dog medføre øget risiko for GI-ulceration eller andre komplikationer sammenlignet med anvendelse af etoricoxib alene.
English: • severe or continual stomach pain or your stools become black
Danish: • alvorlige eller hyppige mavesmerter eller afføringen bliver sort
English: Total number of patients randomised, n= 17412 on etoricoxib and 17289 on diclofenac.
Danish: Samlet antal randomiserede patienter, n = 17.412 på etoricoxib og 17.289 på diclofenac.
English: The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, cardiorenal events).
Danish: De hyppigst observerede bivirkninger var i overensstemmelse med etoricoxibs sikkerhedsprofil (f.eks. gastrointestinale hændelser, kardiorenale hændelser).
English: All Nonsteroidal Antiinflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure.
Danish: Alle nonsteroide antiinflammatoriske midler (NSAID), herunder etoricoxib, kan associeres med debut af eller tilbagevendende venstresidigt hjertesvigt.
English: In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Danish: I tilfælde af overdosering bør der tages de sædvanlige forholdsregler, f. eks. fjernelse af ikkeabsorberet materiale fra gastrointestinalkanalen samt instituering af understøttende behandling, hvis dette er påkrævet.
English: 90 mg film-coated tablets oral use
Danish: 90 mg filmovertrukne tabletter oral anvendelse
English: <ARCOXIA> tablets contain lactose.
Danish: ARCOXIA-tabletterne indeholder lactose..
English: • medicines that thin your blood (anticoagulants), such as warfarin
Danish: • Blodfortyndende medicin (antikoagulantia), f.eks. warfarin.
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed (see section 4.4).
Danish: Patienter, der får orale antikoagulantia, bør derfor monitoreres tæt for protrombin-tid INR især i de første par dage, hvor behandling med etoricoxib initieres eller etoricoxibdosis ændres (se pkt.
English: Cardiorenal adverse events were observed more frequently with etoricoxib than with diclofenac, and this effect was dose-dependent (see specific results below).
Danish: Kardiorenale hændelser observeredes hyppigere med etoricoxib end med diclofenac; denne effekt var dosisafhængig (se specifikke resultater nedenfor).
English: There are no clinical or pharmacokinetic data in patients with severe hepatic dysfunction (Child-Pugh score ≥10).
Danish: Der findes ingen kliniske eller farmakokinetiske data fra patienter med svær leverdysfunktion (Child-Pugh score ≥10) (se pkt.
English: Caution should be used when initiating treatment with etoricoxib in patients with dehydration.
Danish: Der bør udvises forsigtighed, når behandling med etoricoxib initieres hos patienter med dehydrering.
English: • if you have serious kidney disease
Danish: • hvis De har alvorlig nyresygdom
English: However, the rate of these events was higher in patients receiving etoricoxib comparedwith those receiving naproxen 500 mg twice daily.
Danish: Incidensen af disse hændelser var imidlertid højere hos patienter, der fik etoricoxib sammenlignet med dem, der fik naproxen 500 mg 2 gange dagligt.
English: The upper GI benefit for etoricoxib compared with diclofenac was not statistically significant in patients taking concomitant low-dose aspirin (approximately 33% of patients).
Danish: Øvre GI-fordel ved etoricoxib sammenlignet med diclofenac var ikke statistisk signifikant hos patienter, der samtidigt tog lavdosis acetylsalicylsyre (ca. 33 % af patienterne).
English: If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor.
Danish: Hvis De mener, at nogle af disse punkter passer på Dem, må De ikke tage tabletterne, før De har talt med Deres læge.
English: If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis De af Deres læge har fået at vide, at der er nogle sukkerarter, De ikke kan tåle, skal De rådføre Dem med Deres læge, før De tager dette lægemiddel.
English: Additional Gastrointestinal Safety Data
Danish: Supplerende gastrointestinale sikkerhedsdata
English: • if you have inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis
Danish: • hvis De har tarmbetændelse (såsom Crohns sygdom, colitis ulcerosa eller tyktarmsbetændelse)
English: Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock.
Danish: Meget sjælden: Overfølsomhedsreaktioner omfattende angioødem, anafylaktiske/anafylaktoide reaktioner, herunder shock.
English: Cardiovascular safety results:
Danish: Kardiovaskulære sikkerhedsresultater:
English: 90 Film coated tablets (HDPE bottles)
Danish: 90 filmovertrukne tabletter (HDPE-flasker)
English: What <ARCOXIA> is and what it is used for Before you take <ARCOXIA> How to take <ARCOXIB> Possible side effects
Danish: ARCOXIAs virkning og hvad De skal bruge det til Det skal De vide, før De begynder at tage ARCOXIA Sådan skal De tage ARCOXIA Bivirkninger
English: Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Danish: Diuretika, ACE-hæmmere og angiotensin-II-receptorantagonister: NSAID kan reducere effekten af diuretika og andre antihypertensiva.
English: In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
Danish: Hos nogle patienter med utilstrækkelig symptomlindring kan øgning af dosis til 60 mg én gang dagligt forbedre effekten.
English: If you are breast-feeding, or planning to breastfeed, consult your doctor before taking <ARCOXIA>.
Danish: Hvis De ammer eller planlægger at amme, skal De rådføre Dem med Deres læge, før De tager ARCOXIA.
English: Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Danish: Lithium: NSAID nedsætter udskillelsen af lithium i nyrerne og kan derfor øge plasmakoncentrationen af lithium.
English: Cardiorenal Events:
Danish: Kardiorenale hændelser:
English: CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo.
Danish: CYP3A4 synes at bidrage til etorixocibs metabolisering in vivo.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration (see section 5.1).
Danish: Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus og rygning) bør kun behandles med etoricoxib efter nøje overvejelse (se pkt.
English: There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or non naproxen NSAIDs.
Danish: Der var ingen mærkbar forskel i incidensen af bekræftede alvorlige thrombotiske kardiovaskulære hændelser hos patienter, der fik etoricoxib ≥60 mg, placebo eller non-naproxen NSAID.
English: Etoricoxib is contraindicated in pregnancy (see section 4.3).
Danish: Etorixocib er kontraindiceret under graviditet (se pkt.
English: In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.
Danish: I kliniske undersøgelser var bivirkningsprofilen den samme hos patienter med OA eller RA, der havde fået behandling med etoricoxib i 1 år eller mere.
English: • You have a history of high blood pressure.
Danish: • De har tidligere haft forhøjet blodtryk.
English: In addition to class warnings and contraindications, introduced for all COX-2 selective inhibitors, a contraindication in patients with hypertension whose blood pressure is not adequately controlled was included specifically for etoricoxib because of evidence of higher rates of cardiorenal events than other COX-2 inhibitor products.
Danish: Ud over de lægemiddelgruppeadvarsler og kontraindikationer, der blev indført for alle selektive COX-2-hæmmere, blev der specifikt for etoricoxib også tilføjet en kontraindikation for patienter med hypertension, hvis blodtryk ikke er behandlet tilstrækkeligt, fordi der er tegn på, at etoricoxib hyppigere medfører kardiorenale hændelser end andre selektive COX-2-hæmmere.
English: If you forget to take <ARCOXIA>
Danish: Hvis De har glemt at tage ARCOXIA
English: Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Danish: Meget sjælden: Nyreinsufficiens, inklusive nyresvigt, som almindeligvis er reversibel ved seponering af behandling (se pkt.
English: The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Danish: Den anbefalede dosis er 120 mg én gang dagligt, som kun bør tages i den akutte smertefulde periode, og behandlingen skal begrænses til maksimalt at vare i 8 dage.