FrancophonIA/ELRC3.0 huggingface dataset:
English: In the post-orthopedic surgery pain studies, anemia was reported more frequently, although the frequency was similar to placebo.
Danish: Der har i forsøgene vedrørende smerter efter ortopædiske operationer været hyppigere indberetninger af anæmi, selvom frekvensen svarede til placebos.
English: In patients who fail to respond, the dose may be increased to 200 mg daily in one or two divided doses.
Danish: Hos patienter med manglende respons, kan dosis øges til 200 mg daglig, fordelt på 1 eller 2 adskilte doser.
English: TARGET included patients taking low-dose ASA (75-100 mg daily) for primary or secondary prevention of coronary heart disease.
Danish: TARGET inkluderede patienter som fik lavdosis acetylsalicylsyre (75-100 mg) til primær eller sekundær forebyggelse af koronar hjertelidelse.
English: In clinical studies, few patients (<0.3%) treated with lumiracoxib developed perforations, obstruction or bleeds (POBs).
Danish: I kliniske forsøg har få patienter (<0,3%) behandlet med lumiracoxib udviklet perforationer, obstruktion eller blødninger (POB).
English: The use of lumiracoxib in pregnant women has not been studied in adequate and well controlled clinical trials and therefore it should not be used during the first two trimesters of pregnancy unless the potential benefit to the patients justifies the potential risk to the fetus.
Danish: Brug af lumiracoxib til gravide kvinder er ikke undersøgt i tilstrækkeligt og velkontrollerede kliniske forsøg, og derfor bør det ikke anvendes i de første 2 trimestre af graviditeten, med mindre fordelen for patienten opvejer den potentielle risiko for fostret.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take 100 mg and 200 mg film-coated tablets.
Danish: Patienter med sjældne, arvelige problemer med galaktoseintolerance, lappisk laktasemangel eller glucose-galactose malabsorption, bør ikke tage 100 mg og 200 mg filmovertrukne tabletter.
English: Three major metabolites were identified in plasma: 4'-hydroxy-lumiracoxib, 5-carboxy-lumiracoxib and 4'hydroxy-5-carboxy-lumiracoxib.
Danish: Der er identificeret 3 større metabolitter i plasma: 4'-hydroxy-lumiracoxib, 5carboxy-lumiracoxib og 4'-hydroxy-5-carboxy-lumiracoxib.
English: Following 400 mg once daily dosing, Cmax was about 9 µg/ml and AUC was about 31 µg h/ml.
Danish: Efter administration af 400 mg, én gang daglig, er Cmax ca. 9 µg/ml og AUC ca. 31 µg t/ml.
English: {Invented Name} filmcoated tablets can be administered without regard to timing of meals.
Danish: {Særnavn} filmovertrukne tabletter kan administreres uden hensyntagen til måltider.
English: As with other NSAIDs, lumiracoxib may mask fever and other signs of inflammation or infection.
Danish: Ligesom andre NSAID kan lumiracoxib maskere feber og andre tegn på inflammation eller infektion.
English: Lumiracoxib is highly bound to plasma proteins, (≥98%), and binding is independent of concentration over a range of 0.1 to 100 µg/mL.
Danish: Lumiracoxib bindes i udstrakt grad til plasmaproteiner (≥98%), og bindingen er koncentrationsuafhængig over spændet 0,1-100 µg/ml.
English: Ethnic differences: Dosing recommendations are the same for Asians, Blacks and Caucasians (see section 5.2).
Danish: Etniske forskelle: Dosis anbefalinger er ens for patienter af asiatisk, negroid og kaukasisk afstamning (se pkt.
English: Only about 5% of the administered dose was recovered in excreta as unchanged lumiracoxib.
Danish: Kun ca. 5% af den administrerede dosis kunne genfindes i ekskreterne som uomdannet lumiracoxib.
English: There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when lumiracoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Danish: Der er yderligere øget risiko for gastrointestinale bivirkninger (gastrointestinal ulceration eller andre gastrointestinale komplikationer), når lumiracoxib tages samtidig med acetylsalicylsyre (selv ved lave doser).
English: These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Danish: Disse oplysninger førte til, at indehaveren af markedsføringstilladelsen den 30. september 2004 tilbagetrak Vioxx (rofecoxib) fra verdensmarkedet, og satte spørgsmålstegn ved den kardiovaskulære sikkerhed ved andre Cox-2hæmmere.
English: In vitro studies indicate that lumiracoxib is not a significant inhibitor of other cytochrome P450 isoforms, including CYP1A2, CYP2C8, CYP 2C19, CYP2D6, CYP2E1, and CYP3A4.
Danish: In vitro studier indicerer, at lumiracoxib ikke er en signifikant hæmmer af andre cytokrom P450-isoformer, inklusiv CYP1A2, CYP2C8, CYP2C19, CYP2D6, CYP2E1 og CYP3A4.
English: Hypertension and oedema
Danish: Hypertension og ødem
English: Efficacy
Danish: Virkningsgrad
English: These interactions should be given consideration in patients taking lumiracoxib concomitantly with ACE-inhibitors or angiotensin II antagonists.
Danish: Disse interaktioner bør overvejes hos patienter der tager lumiracoxib samtidig med ACE-hæmmere eller angiotensin II antagonister.
English: Ciclosporin or tacrolimus: Although this interaction has not been studied with lumiracoxib, coadministration of ciclosporin or tacrolimus and any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
Danish: Ciclosporin eller tacrolimus: Selvom denne interaktion ikke er undersøgt med lumiracoxib, kan samtidig administration af ciclosporin eller tacrolimus og ethvert NSAID øge den nefrotoksiske effekt af ciclosporin og tacrolimus.
English: Over the range of 25 to 800 mg, extent of exposure (AUC) increases in a dose-proportional manner and the peak plasma concentration (Cmax) was roughly dose-proportional.
Danish: Over dosisspændet 25-800 mg, øges omfanget af optagelsen (AUC) dosisproportionalt, og maksimal plasma-koncentration (Cmax) er omtrent dosisproportional.
English: Lumiracoxib does not accumulate in plasma under once or twice daily administration and steady state is achieved on the first day of administration with no increase in Cmax or AUC after extended dosing.
Danish: Lumiracoxib akkumuleres ikke i plasma ved administration 1 eller 2 gange daglig, og steady-state opnås på første administrationsdag uden stigning i Cmax eller AUC efter forlænget dosering.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
Danish: Patientens behov for symptomlindring samt behandlingsrespons bør genovervejes med jævne mellemrum, især hos patienter med osteoarthrosis.
English: Administration of 100 mg, 200 mg or 400 mg once daily leads to >90% peak inhibition of COX-2.
Danish: Administration af 100 mg, 200 mg eller 400 mg, én gang daglig medfører >90% maksimal hæmning af COX-2.
English: This indicates lumiracoxib and/or its metabolites are preferentially distributed and retained in inflamed tissue.
Danish: Dette indikerer, at lumiracoxib og/eller dets metabolitter fordeles og forbliver med forskellige præferencer i inflammeret væv.
English: Other NSAIDs: Lumiracoxib can be used with low-dose aspirin.
Danish: Andre NSAID: Lumiracoxib kan anvendes sammen med lav-dosis aspirin.
English: Food had no significant effect on either Cmax or AUC of lumiracoxib when either 200 mg or 400 mg film-coated tablets of {Invented Name} were taken with a high-fat meal.
Danish: Mad har ingen signifikant effekt på hverken Cmax eller AUC af lumiracoxib, når enten 200 mg eller 400 mg filmovertrukne tabletter af {SÆRNAVN} administreredes med et måltid med høj fedtprocent.
English: Patients with congestive heart failure (NYHA II-IV).
Danish: Patienter med inflammatorisk tarmsygdom Patienter med venstresidig hjerteinsufficiens (NYHA II-IV).
English: Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing lumiracoxib 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 lumiracoxib.
Danish: CHMP - er af den opfattelse, at benefit/risk-forholdet for lægemidler indeholdende lumiracoxib 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 lumiracoxib.
English: Reproductive system disorders Rare: erectile dysfunction
Danish: Lidelser i det reproduktive system Sjælden: Erektil dysfunktion
English: Patients who have experienced asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
Danish: Patienter som har oplevet astma, akut rhinitis, nasalpolypper, angioneurotisk ødem, urticaria, eller anden type allergisk reaktion efter indtag af acetylsalicylsyre eller NSAID.
English: Any patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Danish: Enhver patient med symptomer og/eller tegn tydende på leverdysfunktion, eller med abnorm leverfunktionstest, skal monitoreres.
English: In rats the incidence of pre-implantation loss was increased at a dose of 100 mg/kg/day, (10.4 times the human therapeutic exposure following a dose of 200 mg), which caused maternal toxicity.
Danish: Hos rotter var forekomsten af præ-implantationstab øget ved en dosis på 100 mg/kg/dag (10,4 gange den humane terapeutiske optagelse efter en dosis på 200 mg), som forårsagede maternal toksicitet.
English: The undesirable effects profile was generally similar to that reported in the OA and RA studies.
Danish: Bivirkningsprofilen svarede generelt til den, der er rapporteret i OA- og RA-forsøg.
English: Compared to placebo treatment, recovery of the S-7-OH warfarin metabolite in urine was about 25% lower in subjects treated with lumiracoxib.
Danish: Sammenlignet med placebobehandling, var genfindelse af warfarinmetabolitten S-7-OH i urinen ca. 25% lavere hos patienter behandlet med lumiracoxib.
English: In repeat dose toxicity studies in rats and monkeys, target organs were the gastrointestinal tract and kidney.
Danish: I toksicitetsforsøg med gentagne doser til rotter og aber var målorganerne gastrointestinalkanal og nyrer.
English: By about 5 hour post dose, concentrations of lumiracoxib in human synovial fluid of rheumatoid arthritis patients were higher than plasma and remained substantially higher for the remainder of the dose interval (AUC12-24 in synovial fluid was 2.6 times higher than that for plasma).
Danish: Ca. 5 timer efter dosering er koncentrationen af lumiracoxib i human synovialvæske hos patienter med rheumatoid arthritis højere end i plasma og vedbliver at være betragteligt højere i resten af dosisintervallet (AUC12-24 i synovialvæske er 2,6 gange højere end i plasma).
English: The absolute bioavailability of lumiracoxib is approximately 74%.
Danish: Lumiracoxibs absolutte biotilgængelighed er ca. 74%.
English: Therefore, under conditions of compromised renal perfusion, administration of lumiracoxib 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 administrationen af lumiracoxib derfor forårsage en reduktion i prostaglandindannelsen og sekundært i den renale blodgennemstrømning, og dermed forårsage nedsat nyrefunktion.
English: After administration of a single dose of lumiracoxib 400 mg to healthy subjects, 54% of drug-related material was excreted in urine and 43% in feces.
Danish: Efter administration af enkeltdosis lumiracoxib 400 mg til raske frivillige, udskiltes 54% af det lægemiddelrelaterede materiale i urinen og 43% i fæces.
English: At 15 minutes post 400 mg dose, the plasma concentration reached 0.6 µg/ml, which is sufficiently high to achieve over 90% inhibition of COX-2.
Danish: 15 minutter efter administration af 400 mg, når plasmakoncentrationen 0,6 µg/ml, hvilket er tilstrækkeligt til at opnå mere end 90% hæmning af COX-2.
English: In single dose post-operative dental pain trials, the onset of analgesia occurred within 45 minutes and persisted for as long as 24 hours after dosing.
Danish: I enkeltdosisforsøg med postoperative tandsmerter indtrådte den analgetiske effekt inden for 45 minutter og varede op til 24 timer efter dosering.
English: However, patients who experience dizziness, vertigo or somnolence while taking lumiracoxib should refrain from driving or operating machinery.
Danish: Patienter der oplever svimmelhed, vertigo eller søvnighed under behandlingen med lumiracoxib, bør dog afstå fra at føre motorkøretøj og betjene maskiner.
English: As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used.
Danish: Da den kardiovaskulære risiko ved brug af lumiracoxib kan øges med dosis og varighed af behandlingen, bør den kortest mulige behandlingstid og den laveste effektive daglige dosis anvendes.
English: To support multiple venues for healthcare professionals including prescribers and pharmacists.
Danish: Indehaveren af markedsføringstilladelsen yder støtte til en række faglige arrangementer for sagkyndige inden for sundhedssektoren, herunder ordinerende læger og farmaceuter.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of lumiracoxib should be taken.
Danish: Hvis der er kliniske tegn på forværring i disse patienters tilstand, skal der tages relevante forbehold inklusiv seponering af lumiracoxib.
English: Rare: pancytopenia, neutropenia, leucopenia
Danish: Sjældne: Pancytopeni, neutropeni, leukopeni
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 lumiracoxib containing medicinal products.
Danish: Bemærk: Dette er det SPC, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende lumiracoxib.
English: The use of lumiracoxib is contraindicated in the last trimester of pregnancy because, as with other drugs known to inhibit prostaglandin synthesis, it may cause uterine inertia and premature closure of the ductus arteriosus.
Danish: Brug af lumiracoxib er kontraindiceret i sidste trimester af graviditeten, da det, ligesom andre lægemidler der vides at hæmme prostaglandinsyntesen, kan forårsage uterus-atoni og præmatur lukning af ductus arteriosus.
English: Chronic use with 400 mg daily dose was associated with more frequent and more marked elevations in ALT/AST.
Danish: Kronisk anvendelse af 400 mg daglig var forbundet med hyppigere og mere betydelige stigninger i ALAT/ASAT.
English: Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and antihypertensive drugs.
Danish: Diuretika, ACE hæmmere og angiotensin II antagonister: NSAID kan nedsætte effekten af diuretika og antihypertensiva.
English: It is advisable to rehydrate patients prior to starting therapy with lumiracoxib.
Danish: Det anbefales at rehydrere patienterne, inden der påbegyndes behandling med lumiracoxib.
English: However care should be exercised when lumiracoxib is co-administered with substrates of CYP2C9 that have very narrow therapeutic index, such as phenytoin and warfarin.
Danish: Der bør dog udvises forsigtighed når lumiracoxib administreres samtidig med substrater af CYP2C9, der har meget smalle terapeutiske indeks, så som phenytoin og warfarin.
English: Other metabolites are not active as COX-1 or COX-2 inhibitors.
Danish: Andre metabolitter er ikke aktive som COX-1 eller COX-2 hæmmere.
English: Uncommon: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood urea increased, gamma-glutamyltransferase increased, weight increased.
Danish: Usædvanlig: Stigninger i alaninaminotransferase, stigninger i aspartataminotransferase, stigninger i blod-creatinin, stigninger i blod-urinstof, stigninger i gamma-glutamyltransferase, vægtstigninger.
English: Patients with established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: Patienter med konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Danish: Ved mistanke om overdosis skal der tages relevante, understøttende medicinske forholdsregler, så som eksempelvis ventrikeltømning, klinisk supervision og, hvis dette er nødvendigt, institueres symptomatisk behandling.
English: In a long-term controlled study with lumiracoxib 400 mg daily, rare cases of hepatitis have been reported (see section 4.8).
Danish: Der er i et længerevarende kontrolleret forsøg med lumiracoxib 400 mg daglig indberettet sjældne tilfælde af hepatitis (se pkt.
English: Effects of other drugs on the PK of lumiracoxib
Danish: Andre lægemidlers effekt på lumiracoxibs FK
English: The 4'-hydroxy metabolite has similar potency and COX-2 selectivity to lumiracoxib.
Danish: 4'-hydroxymetabolitten har samme potens og COX-2 selektivitet som lumiracoxib.
English: The recommended starting dose is 100 mg once daily.
Danish: Den anbefalede startdosis er 100 mg, én gang daglig.
English: Concomitant administration of lumiracoxib with high doses of aspirin, other NSAIDs or COX-2 inhibitors should be avoided.
Danish: Samtidig administration af lumiracoxib med høje doser aspirin, andre NSAID eller COX-2 hæmmere bør undgås.
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 og indlægssedlen.
English: Thus when lumiracoxib and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Danish: Ved samtidig administration af lumiracoxib og litium, skal patienterne derfor observeres omhyggeligt for tegn på litiumtoksicitet.
English: In patients with osteoarthritis, lumiracoxib doses up to 200 mg once daily provided significant improvements in pain, stiffness, function, and patient assessments of disease status.
Danish: Hos patienter med osteoarthrose gav lumiracoxib i doser på op til 200 mg, 1 gang daglig, signifikant forbedring af smerter, stivhed, funktion og patientvurdering af sygdomsstatus.
English: However, there is no lactose in {Invented Name} 400 mg film-coated tablets.
Danish: Der er dog ikke lactose i {Særnavn} 400 mg filmovertrukne tabletter.
English: Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), greater than three times the upper limit of normal (>3xULN) have been reported in placebo/active-controlled clinical studies in approximately 1.2% of patients in clinical trials up to one year with lumiracoxib 100 mg and 200 mg daily.
Danish: Der er rapporteret stigninger i alaninaminotransferase (ALAT) og/eller aspartataminotransferase (ASAT) på tre gange eller mere end den øvre normalgrænse (>3 x ULN), i placebo/aktiv-kontrol kliniske studier hos ca. 1,2% af patienterne i kliniske undersøgelser af op til ét års varighed med 100 mg og 200 mg lumiracoxib daglig.
English: Marked elevations (>8xULN) have been observed in 0.3% with 100 mg once or twice daily and 0.6% of patients at 200 mg once daily.
Danish: Betydelige stigninger (>8 x ULN) er observeret hos 0,3% behandlet med 100 mg én eller to gange daglig, og hos 0,6% af patienterne behandlet med 200 mg én gang daglig.
English: There was no indication of genotoxic potential in three in vivo rat studies (micronucleus tests in bone marrow and liver and liver comet assay).
Danish: Der var ingen indikation af genotoksisk potentiale i 3 in vivo rotteforsøg (mikronukleus-test i knoglemarv og lever samt lever comet-assay).
English: Medically appropriate supervision should be maintained when using lumiracoxib in the elderly and in patients with mild renal, hepatic, or cardiac dysfunction.
Danish: Der bør opretholdes medicinsk relevant supervision når lumiracoxib anvendes til ældre og til patienter med mild nyre-, lever- eller hjertedysfunktion.
English: 6.6 Instructions for use and handling and disposal Not applicable.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering samt bortskaffelse Ikke relevant.
English: No studies on the effect of lumiracoxib on the ability to drive or use machines have been performed.
Danish: Der er ikke udført studier af om lumiracoxib påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: No difference was observed in the extent of lumiracoxib protein binding in synovial fluid compared to plasma.
Danish: Der er ikke observeret forskelle i omfanget af lumiracoxib-proteinbinding i synovialvæske sammenlignet med plasma.
English: There were no significant differences between lumiracoxib and NSAIDs.
Danish: Der var ingen signifikante forskelle mellem lumiracoxib og NSAID.
English: COX-2 selective 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 thromboxani blodpladerne.
English: The mean plasma half-life of lumiracoxib is approximately 4 hours.
Danish: Den gennemsnitlige halveringstid for lumiracoxib er ca. 4 timer.
English: Renal function should be monitored when lumiracoxib and either of these drugs is used in combination.
Danish: Nyrefunktionen skal monitoreres når lumiracoxib anvendes i kombination med et af disse lægemidler.
English: Mean exposure to the active 4'-hydroxy-lumiracoxib metabolite was largely unaffected.
Danish: Gennemsnitlig eksponering for den aktive 4'-hydroxy-lumiracoxibmetabolit var stort set uændret.
English: Multiple doses of lumiracoxib 1,200 mg once daily have been administered to patients with rheumatoid arthritis for 4 weeks without clinically significant adverse effects.
Danish: Der er administreret gentagne doser af lumiracoxib 1.200 mg, én gang daglig i 4 uger, til patienter med rheumatoid arthritis uden klinisk signifikante bivirkninger.
English: Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with lumiracoxib after careful consideration (see section 5.1).
Danish: Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med lumiracoxib efter nøje overvejelse (se pkt.
English: Thus no alteration in oral contraceptive medication is necessary when lumiracoxib is co-administered.
Danish: Ændringer i oral antikonception er derfor ikke nødvendigt ved samtidig administration af lumiracoxib.
English: Race: The pharmacokinetics of lumiracoxib are similar in Asians, Blacks and Caucasians.
Danish: Race: Lumiracoxibs farmakokinetik er ens hos patienter af asiatisk, negroid og kaukasisk afstamning.