FrancophonIA/ELRC3.0 huggingface dataset:
English: This increase is not generally important for most patients.
Danish: Denne øgning er generelt ikke vigtig for de fleste patienter.
English: On 23 June 2005, the CHMP concluded that:
Danish: Den 23. juni 2005 konkluderede CHMP:
English: Children and adolescents under 16 years of age.
Danish: Børn og unge under 16 år
English: The potential for human risk in pregnancy is unknown.
Danish: Den potentielle humane risiko ved graviditet er ukendt.
English: The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Danish: Den absolutte risikoøgning for sådanne hændelser overstiger sandsynligvis ikke 1 % pr. år baseret på eksisterende data (Ikke almindelig).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Month Day, Year
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Måned dag, år
English: Therefore, this SPC may not necessarily represent the current text.
Danish: Denne tekst repræsenterer derfor ikke nødvendigvis de gældende tekster.
English: These data are not considered clinically significant.
Danish: Disse data anses ikke som værende klinisk signifikante.
English: [Very Common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare (<1/10,000) including isolated cases]
Danish: [Meget almindelig (>1/10), Almindelig (> 1/100, < 1/10), Ikke-almindelig (> 1/1000, < 1/100), Sjælden (> 1/10.000, < 1/1000), Meget sjælden (< 1/10.000) inklusiv enkeltstående rapporter]
English: The absolute bioavailability is approximately 100%.
Danish: Den orale biotilgængelighed er ca. 100%.
English: Patients were treated for a median duration of 11 months.
Danish: Patienterne blev i gennemsnit behandlet i 11 måneder.
English: 11415 Tallinn Estonia
Danish: 11415 Tallinn Estland
English: Five metabolites have been identified in man.
Danish: Der er idenficeret 5 metabolitter hos mennesker.
English: Therefore, the dose for each indication is the maximum recommended dose:
Danish: Dosis for hver indikation er derfor den maksimalt anbefalede dosis.
English: If blood pressure rises significantly, alternative treatment should be considered.
Danish: Hvis blodtrykket stiger signifikant, bør alternativ behandling overvejes.
English: DATE OF REVISION OF THE TEXT Month Day, Year
Danish: DATO FOR ÆNDRING AF TEKSTEN Måned dag, år
English: Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Danish: Doser der er højere end de anbefalede for hver indikation har enten ikke vist yderligere effekt eller er ikke undersøgt.
English: However, current estimates are based on limited data and the extent of under-reporting is unquantifiable.
Danish: De nuværende skøn er imidlertid baseret på et begrænset antal oplysninger, og det er umuligt at sætte tal på omfanget af underrapportering.
English: The onset of drug effect may be faster when <INVENTED NAME> is administered without food.
Danish: Virkningen af lægemidlet kan indtræde hurtigere når <SÆRNAVN> administreres uden mad.
English: 4.2 Posology and method of administration <INVENTED NAME> is administered orally and may be taken with or without food.
Danish: 4.2 Dosering og indgivelsesmåde <SÆRNAVN> administreres oralt og kan tages med eller uden mad.
English: The relationship to treatment is not established.
Danish: Sammenhængen med behandlingen er ikke påvist.
English: Common: hypertension.
Danish: Almindelig: Hypertension.
English: Patients with hypertension whose blood pressure has not been adequately controlled.
Danish: Patienter med hypertension, hvor blodtrykket ikke er tilfredsstillende kontrolleret
English: It may also play a role in ulcer healing.
Danish: Det spiller muligvis også en rolle i ulcusheling.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Danish: Kombinationsbehandling med disse lægemidler bør derfor administreres med forsigtighed, især hos ældre.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE OG NORGE OG ISLAND
English: Use of gastroprotective agents and low dose aspirin were permitted in the study.
Danish: Brug af gastrobeskyttende midler og lavdosis aspirin var tilladt i undersøgelsen.
English: Monitoring of renal function in such patients should be considered.
Danish: Monitorering af nyrefunktionen hos disse patienter bør overvejes.
English: Pain relief was observed as early as four hours after initiation of treatment.
Danish: Smertelindring blev observeret så tidligt som 4 timer efter påbegyndelse af behandling.
English: The gastrointestinal and cardiovascular safety data are summarized below.
Danish: Gastrointestinale og kardiovaskulære sikkerhedsdata er opsummeret nedenfor.
English: Two isoforms, COX-1 and COX-2, have been identified.
Danish: Der er identificeret to isoformer, COX1 og COX-2.
English: Very rare: confusion, hallucinations.
Danish: Meget sjælden: Konfusion, hallucinationer.
English: Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Danish: Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado Portugal
English: 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 indeholdende 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 eller 100 tabletter.
English: Elderly: No dosage adjustment is necessary for elderly patients.
Danish: Ældre Justering af dosis er ikke nødvendig til ældre patienter.
English: Hertfordshire EN11 9BU United Kingdom
Danish: Hertfordshire EN11 9BU Storbritannien
English: These beneficial effects were maintained over the 12week treatment periods.
Danish: Den gavnlige effekt blev opretholdt over behandlingsperioden på 12 uger.
English: This should be considered when rapid symptomatic relief is needed.
Danish: Dette bør overvejes når hurtig smertelindring er nødvendig.
English: Congestive heart failure (NYHA II-IV).
Danish: Venstresidig hjerteinsufficiens (NYHA II-IV)
English: Very rare: bronchospasm.
Danish: Meget sjælden: Bronchospasmus.
English: None of these metabolites inhibit COX-1.
Danish: Ingen af disse metabolitter hæmmer COX-1.
English: Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for etoricoxib on 18 January and 15 February 2005.
Danish: Mellem november 2004 og juni 2005 afgav indehaveren af markedsføringstilladelsen mundtlige redegørelser til CHMP vedrørende de kardiovaskulære og hudrelaterede sikkerhedsaspekter for etoricoxib den 18. januar og 15. februar 2005.
English: Blisters: Store in the original package.
Danish: Blisterpakning: Opbevares i den originale emballage.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Farmakodynamiske interaktioner
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreundersøgelser har vist reproduktionstoksicitet (se afsnit 5.3).
English: This USR was initiated on 16 February 2005 and finalised on 17 February 2005.
Danish: Urgent Safety Restriction-proceduren blev påbegyndt den 16. februar 2005 og afsluttet den 17. februar 2005.
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
Danish: CHMP bekræftede ændringen af produktinformationen i henhold til den allerede indsendte ansøgning om en type II variation, som blev godkendt i maj 2005 i forlængelse af Urgent Safety Restrictionproceduren vedrørende sikkerheden i februar, og anmodede om yderligere ændringer.
English: To undertaking its risk management plan as communicated to the CHMP during May 2005 CHMP meeting and outlined in the assessment report response on 10 May 2005.
Danish: Indehaveren af markedsføringstilladelsen gennemfører sin risikostyringsplan som meddelt CHMP på CHMP's møde i maj 2005 og angivet i svaret på vurderingsrapporten den 10. maj 2005.
English: In rabbits, no treatment-related external or skeletal foetal malformations were seen.
Danish: Hos kaniner sås ingen behandlingsrelaterede eksterne eller skeletale føtale misdannelser.
English: There were no statistically significant differences between etoricoxib and placebo.
Danish: Der var ingen statistisk signifikante forskelle mellem etoricoxib og placebo.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienterne bør hydreres tilfredsstillende og det bør overvejes at monitorere nyrefunktionen efter initiering af kombinationsbehandling samt regelmæssigt herefter.
English: Via G. Fabbroni, 6 I-00191 Roma Italy
Danish: Via G. Fabbroni, 6 I-00191 Roma Italien
English: Puławska 303 02-785 Warszawa Poland
Danish: Puławska 303 02-785 Warszawa Polen
English: On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing.
Danish: Den 20. april 2005 fremlagde Pfizer under en høring oplysninger om alvorlige hudreaktioner i forbindelse med valdecoxib.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet/tablet contains 60, 90 or 120 mg of etoricoxib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 60, 90 eller 120 mg etoricoxib.
English: White, round, HDPE bottles with a white, polypropylene closure containing 30 or 90 tablets.
Danish: Hvid, rund, HDPE-beholder med hvid polypropylenlukning, indeholdende 30 eller 90 tabletter.
English: Aluminum/aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Danish: Aluminum/aluminiumblister (enkeltdoser) i pakninger med 50 eller 100 tabletter.
English: No studies on the effect of etoricoxib on the ability to drive or use machines have been performed.
Danish: Der er ikke udført undersøgelser af effekten af etoricoxib på evnen til at køre eller betjene maskiner.
English: Etoricoxib 120 mg should be used only for the acute symptomatic period.
Danish: Etoricoxib 120 mg bør kun anvendes i den akutte symptomatiske fase.
English: Etoricoxib crosses the placenta in rats and rabbits, and the blood-brain barrier in rats.
Danish: Etoricoxib passerer placentabarrieren hos rotter og kaniner, og blod-hjernebarrieren hos rotter.
English: Orally administered etoricoxib is well absorbed.
Danish: Oralt administreret etoricoxib absorberes godt.
English: ATC Code: MO1 AH05
Danish: ATC-kode: M01 AH05
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 den kardiovaskulære risiko ved brug af etoricoxib kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingstid og den laveste effektive daglige dosis anvendes.
English: Very rare: peptic ulcers including gastrointestinal perforation and bleeding (mainly in the elderly).
Danish: Meget sjælden: Peptisk ulcera inklusiv gastrointestinal perforation og blødning (hovedsagelig hos ældre).
English: Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion.
Danish: Elimination af etoricoxib foregår næsten udelukkende gennem metabolisme efterfulgt af renal udskillelse.
English: Etoricoxib is contraindicated in pregnancy (see section 4.3).
Danish: Etorixocib er kontraindiceret til gravide (se afsnit 4.3).
English: On 7 April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Danish: Den 7. april 2005 anmodede FDA (Food and Drug Administration) og EMEA Pfizer om frivilligt at trække Bextra (valdecoxib) tilbage fra markedet, og Pfizer indvilligede i at indstille salget og markedsføringen af Bextra på verdensplan, mens man afventede de videre drøftelser af det ugunstige risk/benefit-forhold på grundlag af oplysningerne om alvorlige hudreaktioner.
English: A higher rate of discontinuation due to hypertension was seen (2.3% versus 0.7%) and this was statistically significant.
Danish: Der sås en højere forekomst af behandlingsophør på grund af hypertension (2,3% versus 0,7%), og dette var statistisk signifikant.
English: The volume of distribution at steady state (Vdss) was approximately 120 l in humans.
Danish: Distributionsvolumen ved steady-state (Vdss) hos mennesker er ca. 120 liter.
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: CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo.
Danish: CYP3A4 synes at bidrage til etorixocib metabolisering in vivo.
English: After the Commission Decision, the Member State competent authorities will update the product information as required.
Danish: Efter Europa-Kommissionens beslutning vil denne text blive opdateret om nødvendigt af myndighederne i medlemsstaterne.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION
Danish: BILAG IV BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors.
Danish: Disse hovedmetabolitter viste enten ingen målelig aktivitet eller kun svag aktivitet som COX-2 hæmmere.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Danish: COX-2 er identificeret i væv omkring gastriske ulcera hos mennesker, men dets relevans ved heling af ulcera er ikke fastslået.
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 afsnit 4.3 og 4.4).
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 (se afsnit 4.2).
English: Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Danish: Meget sjælden: Nyreinsufficiens, inklusiv nyresvigt, som almindeligvis er reversibel ved seponering af behandling (se afsnit 4.4).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne, arvelige problemer med galaktoseintolerans, lappisk laktasemangel eller glucose-galaktose malabsorption bør ikke tage denne medicin.
English: The geometric mean area under the curve (AUC0-24hr) was 37.8 µg•hr/ml.
Danish: Det geometriske middelareal under kurven (AUC0-24 timer) er 37,8 µg t/ml.
English: Approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Danish: Ca. 3100 patienter blev behandlet med etoricoxib ≥ 60 mg daglig i 12 uger eller længere.
English: Therefore, special attention should be paid to blood pressure monitoring during treatment with etoricoxib.
Danish: Derfor bør der udvises særlig opmærksomhed på monitorering af blodtrykket under behandling med etoricoxib.
English: Etoricoxib is approximately 92% bound to human plasma protein over the range of concentrations of 0.05 to 5 µg/ml.
Danish: Etoricoxib bindes med ca. 92% til humant plasmaprotein ved koncentrationer på 0,05-5 µg/ml.
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Danish: Svær leverdysfunktion (serumalbumin <25 g/l eller Child Pugh score ≥ 10)
English: The majority of elevations in liver function tests on diclofenac that resulted in discontinuation were greater than 3 times the upper limit of normal.
Danish: Størstedelen af stigningerne i leverfunktionstestene for diclofenac, som resulterede i tilbagetrækning, var mere end tre gange den øvre grænse i normalområdet.
English: Etoricoxib is extensively metabolised with <1% of a dose recovered in urine as the parent drug.
Danish: Etoricoxib metaboliseres i udstrakt grad, < 1% af dosis genfindes i urinen som moderstoffet.
English: Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Danish: Meget sjælden: Urticaria, Steven-Johnsons syndrom, toksisk epidermisk nekrolyse..
English: Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses.
Danish: Etoricoxib er muligvis forbundet med en hyppigere forekomst af og mere alvorlig hypertension end visse andre NSAID og selektive COX-2 hæmmere, især ved høje doser.
English: Further to a request from the European Commission, the scope of the ongoing class was broadened review to include the assessment of serious skin reactions in addition to the cardiovascular safety aspects.
Danish: Efter anmodning fra Europa-Kommissionen blev den igangværende undersøgelse af denne lægemiddelklasse udvidet til ud over de kardiovaskulære sikkerhedsaspekter også at omfatte alvorlige hudreaktioner.
English: Further to the assessment of the data on serious skin reactions, etoricoxib is associated with a relatively low rate of serious skin reactions.
Danish: Efter vurdering af oplysningerne om alvorlige hudreaktioner forbindes etoricoxib med en relativ lav forekomst af alvorlige hudreaktioner.
English: NAME OF THE MEDICINAL PRODUCT <INVENTED NAME (see Annex 1)> 60 mg Film-coated Tablets/Tablets <INVENTED NAME (see Annex 1)> 90 mg Film-coated Tablets/Tablets <INVENTED NAME (see Annex 1)> 120 mg Film-coated Tablets/Tablets
Danish: LÆGEMIDLETS NAVN <SÆRNAVN> (se Bilag I) 60 mg filmovertrukne tabletter/tabletter <SÆRNAVN> (se Bilag I) 90 mg filmovertrukne tabletter/tabletter <SÆRNAVN> (se Bilag I) 120 mg filmovertrukne tabletter/tabletter
English: Clinical experience is limited particularly in patients with moderate hepatic dysfunction and caution is advised.
Danish: Der foreligger begrænset klinisk erfaring specielt hos patienter med moderat leverdysfunktion, og forsigtighed tilrådes derfor.
English: There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Danish: Der er en yderligere øget risiko for gastrointestinale bivirkninger (gastrointestinal ulceration eller andre gastrointestinale komplikationer), når etoricoxib tages samtidig med acetylsalicylsyre (selv ved lave doser).
English: Cyclosporin and tacrolimus: Although this interaction has not been studied with etoricoxib, coadministration of cyclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of cyclosporin or tacrolimus.
Danish: Ciclosporin og tacrolimus: Selvom denne interaktion ikke er undersøgt med etoricoxib kan samtidig administration af ciclosporin eller tacrolimus og et hvilket som helst NSAID øge den nefrotoksiske effekt af ciclosporin eller tacrolimus.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by proinflammatory 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 hovedsagelig har ansvaret for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
English: The effect of the recommended chronic doses of etoricoxib (60 and 90 mg) has not been studied.
Danish: Effekten af de anbefalede doser ved kronisk behandling med etoricoxib (60 mg og 90 mg), er ikke undersøgt.
English: The clinical relevance of these observations has not been established.
Danish: Den kliniske betydning af disse fund er endnu ikke klarlagt.
English: Etoricoxib was not carcinogenic in mice.
Danish: Etoricoxib var ikke carcinogent hos mus.
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 lithium koncentrationerne monitoreres tæt og lithium dosis justeres når kombinationen tages og når NSAID seponeres.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Danish: COX-2 er også involveret i ovulation, implantation og lukning af ductus arteriosus, regulering af nyrefunktionen og funktioner i centralnervesystemet (induktion af feber, smerteopfattelse og cognitive funktioner).
English: This increase in EE concentration should be considered when selecting an oral contraceptive for use with etoricoxib.
Danish: Denne øgning i EØ-koncentrationer bør overvejes, når der vælges oral antikonception til anvendelse sammen med etoricoxib.
English: MSD Hungary Ltd. Alkotás utca 48-50 H-1123 Budapest Hungary
Danish: MSD Hungary Ltd. Alkotás utca 50 H-1123 Budapest Ungarn
English: increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%), and 17-βestradiol (22%).
Danish: ), i 28 dage, øgede den gennemsnitlige steady-state AUC0-24t af ukonjugeret estron (41 %), equilin (76 %) og 17-ß-østradiol (22 %).
English: The rates for confirmed upper gastrointestinal perforations, ulcerations and bleeds were the same for etoricoxib and diclofenac (1.11 events per 100 patient years.)
Danish: Størrelsesordenen for bekræftede øvre gastrointestinale perforationer, ulcerationer og blødninger var den samme for etoricoxib og diclofenac (1,11 hændelse pr. 100 patientår).
English: There was no discernible difference in the rate of serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or non-naproxen NSAIDs.
Danish: Der var ingen mærkbar forskel i incidensen af alvorlige thrombotiske kardiovaskulære hændelser hos patienter der fik etoricoxib ≥ 60 mg, placebo eller non-naproxen NSAID.
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 afsnit 4.4).
English: An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g., venous thromboembolic 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: 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.