FrancophonIA/ELRC3.0 huggingface dataset:
English: Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing etoricoxib in the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, recommended follow up measures to further investigate the safety of etoricoxib.
Danish: CHMP - er af den opfattelse, at benefit/risk-forholdet for lægemidler indeholdende etoricoxib til de godkendte indikationer fortsat er gunstigt, og at markedsføringstilladelserne bør opretholdes i overensstemmelse med de reviderede produktresuméer (vedlagt i bilag III til CHMP's udtalelse), - konkluderede, at den kardiovaskulære sikkerhed og de alvorlige hudreaktioner løbende skal overvåges nøje og vurderes, - anbefaler opfølgningsforanstaltninger til videre undersøgelse af sikkerheden af etoricoxib.
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: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antirheumatiske lægemidler, non-steriod, coxiber.
English: Etoricoxib may mask fever and other signs of inflammation.
Danish: Etoricoxib kan maskere feber og andre tegn på inflammation.
English: Etoricoxib at 60 and 90 mg had no effect on methotrexate plasma concentrations or renal clearance.
Danish: Etoricoxib 60 og 90 mg havde ingen effekt på plasmakoncentrationen af methotrexat eller den renale clearance.
English: Caution should be exercised when co-administering etoricoxib with warfarin or other oral anticoagulants (see section 4.5).
Danish: Der bør udvises forsigtighed når etoricoxib administreres samtidig med warfarin eller andre orale antikoagulantia (se afsnit 4.5).
English: Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Danish: Aktivt peptisk ulcus eller gastrointestinal (GI) blødning
English: The CHMP agreed that an Urgent Safety Restriction (USR) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the SPC.
Danish: Der var i CHMP enighed om, at det var nødvendigt at iværksætte en Urgent Safety Restriction vedrørende den kardiovaskulære sikkerhed, med indførelse af nye kontraindikationer og skærpede advarsler og oplysninger om bivirkninger i produktresuméet.
English: If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, etoricoxib should be discontinued.
Danish: Ved tegn på leverinsufficiens, eller hvis der er vedvarende unormal leverfunktionstest (3 gange over normalgrænsen), bør etoricoxib seponeres.
English: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
Danish: Etoricoxib kan anvendes samtidig med acetylsalicylsyre i doser anvendt til kardiovaskulær profylakse (lav-dosis acetylsalicylsyre).
English: The MAH commits to inform the CHMP of the outcome of the MEDAL and EDGE II studies on cardiovascular and GI safety upon completion and will provide necessary updates as applicable.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at underrette CHMP om resultatet af MEDAL- og EDGE II-undersøgelserne af kardiovaskulær og gastrointestinal sikkerhed, så snart disse er afsluttet, og foretage eventuelle nødvendige opdateringer.
English: In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can catalyse the main metabolic pathway, but their quantitative roles in vivo have not been studied.
Danish: In vitro undersøgelser indikerer at CYP2D6, CYP2C9, CYP1A2 og CYP2C19 også kan katalysere den primære metaboliseringsvej, men deres kvantitative roller in vivo er ikke undersøgt.
English: In clinical trials, etoricoxib was evaluated for safety in approximately 4800 individuals, including approximately 3400 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for one year or longer).
Danish: Etoricoxib er i kliniske undersøgelser vurderet med hensyn til sikkerhed hos ca. 4800 patienter, inklusiv ca. 3400 patienter med OA, RA eller kroniske lændesmerter (ca. 600 patienter med OA eller RA blev behandlet i 1 år eller mere).
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 sædvanlige forholdsregler, for eksempel fjernelse af ikke absorberet materiale fra gastrointestinalkanalen samt instituering af understøttende behandling, hvis dette er påkrævet.
English: Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.
Danish: Der bør opretholdes medicinsk relevant supervision, når etoricoxib anvendes til ældre patienter og til patienter med nyre-, lever- eller hjertedysfunktion.
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 plasmakoncentrationen af etoricoxib.
English: In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
Danish: I 53-ugers og 106-ugers toxicitetsundersøgelser sås også gastrointestinale ulcera ved eksponeringer sammenlignelige med doser til mennesker i terapeutiske doser.
English: Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
Danish: Etoricoxib er ikke dialyserbart ved hæmodialyse; det vides ikke om etoricoxib er dialyserbart ved peritoneal dialyse.
English: Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/83/EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) and valdecoxib (Bextra/Valdyn), which were started in November 2004.
Danish: I fortsættelse af drøftelserne på CHMP's plenarmøde i oktober 2004 henstillede EuropaKommissionen til, at dette folkesundhedsspørgsmål, der vedrører alle aspekter af den kardiovaskulære sikkerhed, herunder thrombotiske hændelser og kardiorenale hændelser, indbringes for CHMP for at få det behandlet efter artikel 31 (”Referrals”) i direktiv 2001/83/EF, med senere ændringer, når det gælder decentralt godkendte produkter indeholdende celecoxib, etoricoxib og lumiracoxib, og underkastes en gennemgang af CHMP i henhold til artikel 18 i Rådets forordning (EF) nr. 2309/93, med senere ændringer, når det gælder de centralt godkendte produkter indeholdende celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) og valdecoxib (Bextra/Valdyn), hvilket blev påbegyndt i november 2004.
English: In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity.
Danish: I kliniske undersøgelser resulterede administration af enkeltdoser etoricoxib på op til 500 mg og gentagne doser på op til 150 mg/dag i 21 dage ikke i signifikant toksicitet.
English: Uncommon: flushing, cerebrovascular accident Very rare: hypertensive crisis.
Danish: Ikke-almindelig: Rødmen, cerebrovaskulære tilfælde Meget sjælden: Hypertensiv krise.
English: In rats and rabbits, no embryo/foetal effects were seen at systemic exposures equal to or less than those at the daily human dose [90 mg].
Danish: Hos rotter og kaniner sås ingen embryo/føtal påvirkning ved systemisk optagelse der svarer til, eller er lavere, end den daglige humandosis [90 mg].
English: Hepatocellular and thyroid follicular cell adenomas observed in rats are considered to be a consequence of rat-specific mechanism related to hepatic CYP enzyme induction.
Danish: Hepatocellulære og thyroide follikulære celleadenomer set hos rotter anses for at være en artsspecifik konsekvens af hepatisk CYP-enzyminduktion hos rotter.
English: Tatoiou Street 18 Km Athens-Lamia National Road
Danish: 18th Km Athens-Lamia National Road
English: Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.
Danish: Hvis der er kompromitteret renal perfusion, kan administration af etoricoxib derfor forårsage reduktion i prostaglandindannelsen og sekundært i den renale blodgennemstrømning, og dermed forårsage nedsat nyrefunktion.
English: Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Danish: Efter intravenøs administration af enkeltdosis på 25 mg radioaktivmærket etoricoxib til raske frivillige, blev 70% af radioaktiviteten genfundet i urinen og 20% i fæces, hovedsageligt i form af metabolitter.
English: A non-dose-related low incidence of cardiovascular malformations was observed in etoricoxib-treated rabbits.
Danish: En non-dosis relateret lav incidens af kardiovaskulære misdannelser observeredes hos kaniner behandlet med etoricoxib.
English: The clinical significance of these increases is unknown, and higher doses of PREMARIN <or local TRADEMARK> were not studied in combination with etoricoxib.
Danish: Den kliniske signifikans af disse stigninger er ukendt og højere doser af Premarin, givet i kombination med etoricoxib, er ikke undersøgt.
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: NSAIDs kan reducere effekten af diuretika og andre antihypertensiva.
English: Strength
Danish: Styrker
English: Laboratorios Abelló S.A. Josefa Valcárcel 38 Madrid 28027
Danish: Laboratorios Abello c/ Josefa Valcarcel 38 28027 Madrid Spanien
English: In one study, etoricoxib 120 mg had no effect, but in the other study, etoricoxib 120 mg increased methotrexate plasma concentrations by 28% and reduced renal clearance of methotrexate by 13%.
Danish: I én undersøgelse havde etoricoxib 120 mg ingen effekt, men i den anden undersøgelse øgede etoricoxib 120 mg plasmakoncentrationen af methotrexat med 28% og reducerede den renale clearance af methotrexat med 13%.
English: All active comparators showed an increase relative to placebo with respect to systolic blood pressures; however, etoricoxib was associated with a statistically significant increase at Day 14 when compared to celecoxib and naproxen (mean change from baseline for systolic blood pressure: etoricoxib 7.7 mmHg, celecoxib 2.4 mmHg, naproxen 3.6 mmHg).
Danish: Alle tre lægemidler viste en øgning i forhold til placebo med hensyn til det systoliske blodtryk; etoricoxib var imidlertid forbundet med en statistisk signifikant øgning ved dag 14 i sammenligning med celecoxib og naproxen (gennemsnitlig ændring fra baseline for det systoliske blodtryk var for etoricoxib 7,7 mmHg; celecoxib 2,4 mmHg; naproxen 3,6 mmHg).
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 inkluderende interstitiel nefritis og nefrotisk syndrom; hepatotoksicitet inkluderende leversvigt, icterus og pancreatitis.
English: Estimated renal creatinine clearance <30 mL/min.
Danish: Anslået creatininclearance < 30 ml/min
English: These interactions should be considered in patients taking etoricoxib concomitantly with ACE inhibitors or angiotensin II antagonists.
Danish: Disse interaktioner bør tages i betragtning hos patienter, som tager etoricoxib samtidig med ACE-hæmmere eller angiotensin-II-receptorantagonister.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS Note: This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for etoricoxib containing medicinal products.
Danish: Bemærk: Dette er det SPC, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende etoricoxib.
English: Etoricoxib has not been shown to cause hepatic CYP3A enzyme induction in humans.
Danish: Etoricoxib er ikke vist at forårsage hepatisk CYP3A-enzyminduktion hos mennesker.
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
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 afsnit 5.1).
English: A study of approximately 7100 osteoarthritis patients compared the gastrointestinal tolerability of etoricoxib 90 mg (1.5 times the recommended OA dose) with diclofenac 150 mg.
Danish: En undersøgelse med ca. 7100 osteoarthrosepatienter sammenlignede den gastrointestinale tolerabilitet af etoricoxib 90 mg (1,5 gange den anbefalede OA dosis) med diclofenac 150 mg.
English: To submit a descriptive study protocol to CHMP.
Danish: Indehaveren af markedsføringstilladelsen forelægger CHMP en deskriptiv undersøgelsesprotokol.
English: Acute gouty arthritis
Danish: Akut arthritis urica
English: No special requirements.
Danish: Ingen mærkning.
English: The 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Danish: 60 mg og 120 mg tabletten indeholder endvidere gul jernoxid (E172) og indigo carmine lake (E132).
English: Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib (see section 4.8).
Danish: Der er indberettet alvorlige hypersensitivitetsreaktioner (så som anafylakse og angioødem) hos patienter som fik etoricoxib (se afsnit 4.8).
English: 2003 PC Haarlem The Netherlands
Danish: 2003 PC Haarlem Holland
English: Prednisone/prednisolone: In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone.
Danish: Prednison/prednisolon: I lægemiddelinteraktionsundersøgelser påvirkede etoricoxib ikke farmakokinetikken af prednison/prednisolon i klinisk betydelig grad.
English: Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom
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 er bivirkningsprofilen den samme hos patienter med OA eller RA behandlet med etoricoxib i 1 år eller mere.
English: Etoricoxib had a higher incidence of ulceration as compared to placebo.
Danish: Etoricoxib havde en højere incidens af ulceration end placebo.
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 etoricoxibeffekt indtrådte denne så tidligt som 24 minutter efter dosering.
English: In clinical trials, etoricoxib was administered without regard to food intake.
Danish: I kliniske undersøgelser blev etoricoxib administreret uden hensyntagen til fødeindtag.
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Danish: Patienter, som tidligere har haft bronchospasmer, akut rhinitis, nasale polypper, angioneurotisk ødem, urticaria eller anden type allergisk reaktion efter at have taget acetylsalicylsyre eller NSAIDs herunder COX-2 (cyclooxygenase-2) hæmmere
English: For excipients, see section 6.1.
Danish: Hjælpestoffer er anført under afsnit 6.1.
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Danish: Graviditet og amning (se afsnit 4.6 og afsnit5.3)
English: The principal metabolite is the 6'-carboxylic acid derivative of etoricoxib formed by further oxidation of the 6'-hydroxymethyl derivative.
Danish: Hovedmetabolitten er 6'-carboxylsyrederivatet af etoricoxib, dannet ved yderligere oxydering af 6'-hydroxymethylderivatet.
English: Hepatic effects
Danish: Hepatisk effekt
English: 14671 Nea Erythrea Athens
Danish: 14671Nea Erythrea, Athens Grækenland
English: To continue to monitor patient exposure to etoricoxib in GPRD and evaluate potential contribution of observational study(-ies).
Danish: Indehaveren af markedsføringstilladelsen overvåger fortsat patienteksponeringen for etoricoxib i GPRD og evaluerer mulige resultater fra observationsundersøgelsen(-erne).
English: COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Danish: COX-2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel-deriveret) prostacyclin uden at påvirke thromboxan i blodpladerne.
English: Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Danish: Patienterne synes at have størst risiko for udvikling af disse reaktioner tidligt i behandlingsforløbet.
English: Steady state concentrations of etoricoxib are reached within seven days of once daily administration of 120 mg, with an accumulation ratio of approximately 2, corresponding to a half-life of approximately 22 hours.
Danish: Steady state-koncentrationer af etoricoxib nås inden for 7 dage efter administration af 120 mg, én gang daglig med en akkumuleringsratio på ca. 2, svarende til en halveringstid på ca. 22 timer.
English: These increases in estrogenic concentration should be taken into consideration when selecting post-menopausal hormone therapy for use with etoricoxib because the increase in oestrogen exposure might increase the risk of adverse events associated with HRT.
Danish: Stigningerne i østrogenkoncentrationen skal tages med i overvejelserne, når der vælges et hormon til post-menopausal substitutionsterapi til brug samtidig med etoricoxib, fordi brug af af en øget østrogenmængde kan øge risikoen for bivirkninger forbundet med hormonsubstitutionsbehandling.
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: There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥10); therefore, its use is contra-indicated in these patients (see sections 4.3, 4.4 and 5.2).
Danish: Der er ingen klinisk erfaring hos patienter med svær leverdysfunktion (Child-Pugh score ≥10), derfor er brug hos disse patienter kontraindiceret (se afsnit 4.3, 4.4, og 5.2).
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 litium.
English: The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
Danish: Bivirkningsprofilen for denne undersøgelse var generelt sammenlignelig med den, som sås i undersøgelserne for OA, RA og kronisk lændesmerter.
English: It is advisable to rehydrate patients prior to starting therapy with etoricoxib.
Danish: Det tilrådes at rehydrere patienterne inden etoricoxib behandling påbegyndes.
English: Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Danish: Patienter med symptomer og/eller tegn på leverinsufficiens eller med unormal leverfunktionstest bør monitoreres.
English: This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin.
Danish: Denne interaktion kan resultere i genopblussen af symptomerne ved samtidig administration af etoricoxib og rifampicin.
English: Rats developed hepatocellular and thyroid follicular cell adenomas at >2-times the daily human dose [90 mg] based on systemic exposure when dosed daily for approximately two years.
Danish: Rotter udviklede hepatocellulære og thyroide follikulære celleadenomer ved doser > 2 gange den daglige humandosis [90 mg] baseret på systemisk optagelse ved daglig dosering i ca. 2 år.
English: There was an increase in digoxin Cmax (approximately 33%).
Danish: Der sås øgning i digoxin Cmax (ca.
English: 2003 PC Haarlem
Danish: 2003 PC Haarlem Holand
English: Digoxin: Etoricoxib 120 mg administered once daily for 10 days to healthy volunteers did not alter the steady-state plasma AUC0-24hr or renal elimination of digoxin.
Danish: Digoxin: Etoricoxib 120 mg, administreret én gang daglig i 10 dage til raske frivillige ændrede ikke steady-state plasma AUC0-24t eller renal elimination af digoxin.
English: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA) and the pain and signs of inflammation associated with acute gouty arthritis.
Danish: Symptomlindring i behandling af osteoarthrose (OA), rheumatoid arthritis (RA) samt ved smerter og tegn på inflammation i forbindelse med akut arthritis urica.
English: SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Danish: FAGLIGE KONKLUSIONER VEDRØRENDE ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSEN
English: Gastrointestinal tolerability and safety results: Etoricoxib was associated with a statistically significantly lower incidence of patient withdrawals due to a predefined composite endpoint of clinical gastrointestinal adverse events and laboratory adverse events related to elevated liver function tests compared to diclofenac.
Danish: Gastrointestinal tolerabilitet og sikkerhedsresultater: Etoricoxib var forbundet med en statistisk signifikant lavere forekomst af patienttilbagetrækninger på grund af et prædefineret, sammensat effektmål for kliniske gastrointestinale hændelser og laboratoriemæssige hændelser relateret til leverfunktionstest sammenlignet med diclofenac.
English: The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/min.
Danish: Plasmaclearance estimeres til ca. 50 ml/min for en intravenøs dosis på 25 mg.
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 daglig, signifikant forbedring af smerter og patientens vurdering af sygdomsstatus.
English: Gastrointestinal disorders:
Danish: Gastrointestinale lidelser: