FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of an overdose or toxicity, colestyramine or charcoal is recommended to accelerate elimination.
Danish: I tilfælde af overdosering eller toksicitet anbefales det at give kolestyramin eller aktivt kul for at fremme udskillelsen.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Leflunomide ratiopharm rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Danish: Hvis testen bekræfter, at du er gravid, kan din læge forslå en behandling med bestemte lægemidler for at udvaske Leflunomide ratiopharm fra din krop hurtigt og tilstrækkeligt, da dette kan reducere risici for dit barn.
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal
Danish: interstitial lungesygdom (inklusive interstitial pneumonitis) som kan være fatal.
English: Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells).
Danish: Andre symptomer der påvirker hele kroppen er apptetitløshed, feber, mangel på energi og anæmi (mangel på røde blodlegemer).
English: 40 ml HDPE-wide-necked bottle, with polypropylene screw cap with integrated desiccant container (white silica gel), containing either 30 or 100 film-coated tablets.
Danish: 40 ml HDPE-bredhalset flaske, med polypropylen skruelåg med integreret beholder til tørremiddel (hvid siliciumdioxid gel) indeholdende enten 30 eller 100 filmovertrukne tabletter.
English: Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Danish: Symptomer fra lungerne, såsom hoste og dyspnø, kan være grund til at stoppe behandlingen og foretage yderligere passende undersøgelser efter behov.
English: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide ratiopharm.
Danish: Denne metabolit er ansvarlig for praktisk talt hele Leflunomide ratiopharms in-vivo effekt.
English: Certain vaccinations should not be given while taking Leflunomide ratiopharm, and for a certain amount of time after stopping treatment.
Danish: Visse vacciner bør ikke gives under behandling med Leflunomide ratiopharm og i et vist stykke tid efter endt behandling.
English: Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Danish: Både kolestyramin og aktivt kul kan have indflydelse på absorptionen af østrogener og progesteroner, hvorfor sikker kontraception med perorale kontraceptiva ikke kan garanteres under udvaskningsproceduren med kolestyramin og aktivt kul.
English: - a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the body.
Danish: • et lægemiddel, der hedder colestyramin (bruges til at reducere højt kolesteroltal) eller aktivt kul, da disse lægemidler kan nedsætte den mængde Leflunomide ratiopharm, der optages i kroppen.
English: • Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Danish: • Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe
English: Leflunomide ratiopharm is contraindicated in pregnancy (see section
Danish: Leflunomide ratiopharm er kontraindiceret under graviditet (se pkt.
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Danish: I forsøg MN302 havde leflunomid signifikant mindre effekt end methotrexate.
English: Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide ratiopharm, to monitor your blood cells and liver.
Danish: Din læge vil tage regelmæssige blodprøver, før og under behandling med Leflunomide ratiopharm, for at overvåge dine blodceller og din lever.
English: It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Danish: Det har immunomodulerende/ immunosuppressive karakteristika, virker som et antiproliferativt stof og har antiinflammatoriske egenskaber.
English: In either case it should be confirmed by a blood test that Leflunomide ratiopharm has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Danish: I alle tilfælde skal en blodprøve bekræfte, at Leflunomide ratiopharm er udskilt i tilstrækkelig grad fra kroppen og derefter skal du vente mindst 1 måned, før du bliver gravid.
English: Take the tablet with plenty of water.
Danish: Tag tabletten med rigeligt vand.
English: severe infections, including sepsis which may be fatal
Danish: alvorlige infektioner inklusive sepsis, som kan være fatal.
English: Do not take Leflunomide ratiopharm if you are, or think you may be pregnant.
Danish: Tag ikke Leflunomide ratiopharm hvis du er gravid, eller har en formodning om at du er gravid.
English: Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of medicines called anti-rheumatic medicines.
Danish: Leflunomide ratiopharm indeholder det aktive stof leflunomid, som tilhører en gruppe medicin der kaldes antirheumatisk medicin.
English: As leflunomide has a long persistence in the body, a switching to another DMARD (e.g. methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i.e. kinetic interaction, organ toxicity).
Danish: Da leflunomid er i kroppen i lang tid, kan det at skifte til et andet DMARD (f.eks. methotrexate) uden at foretage udvaskningsproceduren (se nedenfor) eventuelt føre til additiv risiko selv lang tid efter præparatskiftet (dvs. kinetiske interaktioner, organtoksicitet).
English: • Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L (see section 4.6).
Danish: • Gravide kvinder eller kvinder i den fertile alder, som ikke anvender sikker kontraception under behandling med leflunomid og efterfølgende så længe plasmakoncentrationerne af den aktive metabolit er mere end 0,02 mg/l (se pkt.
English: Do not take Leflunomide ratiopharm when you are breast-feeding, as leflunomide passes into the breast milk.
Danish: Tag ikke Leflunomide ratiopharm, hvis du ammer, da leflunomid kan overføres til brystmælk.
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
Danish: I tilfælde af ALAT værdier mellem 2 og 3 gange det øvre normalområde, kan dosisreduktion fra 20 mg til 10 mg overvejes, og der bør foretages ugentlige kontroller.
English: Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Danish: Leflunomid indgivet peroralt og intraperitonealt er undersøgt i akutte toksicitetsforsøg på mus og rotter.
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10% to 50%.
Danish: A771725 forskyder ibuprofen, diclofenac og tolbutamid, men den ubundne fraktion af disse lægemidler øges kun med 10-50%.
English: If you suspect that you are pregnant while taking Leflunomide ratiopharm or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Danish: Hvis har en formodning om, at du er gravid mens du tager Leflunomide ratiopharm eller i 2 år efter afbrydelse af behandlingen skal du omgående kontakte lægen for at få foretaget en graviditetstest.
English: Colestyramine 8 g is administered 3 times daily.
Danish: Kolestyramin 8 g administreres 3 gange daglig.
English: Leflunomide ratiopharm is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Danish: Leflunomide ratiopharm anbefales ikke til behandling af patienter under 18 år, da sikkerhed og virkning ved juvenil reumatoid artrit (JRA) ikke er blevet fastslået (se pkt.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, som står på pakningen og tabletglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59% in the leflunomide group and 29.7% in the placebo group by 6 months (p<0.0001).
Danish: Leflunomid 20 mg/dag var signifikant bedre end placebo til at reducere arthritis symptomerne hos patienter med arthritis psoriatica: PsARC respons (Psoriatic Arthritis treatment Response Criteria) var 59% i leflunomidgruppen og 29,7% i placebogruppen ved 6 måneder (p< 0,0001).
English: Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Danish: Leflunomide ratiopharm bruges til at behandle voksne med aktiv rheumatoid artrit eller med aktiv arthritis psoriatica.
English: If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Danish: Hvis ALAT (SGPT) forbliver forhøjet med mere end 2 gange det øvre normalområde, eller hvis ALAT stiger til mere end 3 gange det øvre normalområde, skal leflunomidbehandlingen seponeres og en udvaskningsprocedure skal initieres.
English: Since such therapy can lead to additive or even synergistic toxicity (e.g. hepato- or haematotoxicity), combination with another DMARD (e.g. methotrexate) is not advisable.
Danish: Da en sådan behandling kan føre til additiv og endda synergistisk toksicitet (f.eks. hepato- eller hæmatotoksicitet), er kombination med andre DMARD's (f.eks. methotrexate) ikke tilrådelig.
English: Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients treated with leflunomide.
Danish: Meget sjældne tilfælde af Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse og lægemiddelreaktion med eosinofili og systemiske reaktioner (DRESS) er blevet rapporteret hos patienter i behandling med leflunomid.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen (ifølge aftalen i RMPmodul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/L), eosinophilia
Danish: pancytopeni (formentlig via en antiproliferativ mekanisme) leukopeni (leukocytter < 2 G/l), eosinofili
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst medicinal the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen er på plads og fungerer før og under markedsføringen af lægemidlet.
English: severe increase in blood pressure Respiratory, thoracic and mediastinal disorders Rare:
Danish: alvorlig blodtryksforhøjelse Luftveje ,thorax og mediastinum Sjælden:
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Danish: Resultaterne af en befolkningsfarmakokinetik analyse af disse forsøg har vist at pædiatriske patienter med en legemesvægt ≤ 40 kg har en reduceret systemisk eksponering (målt ved Css) af A771726 i forhold til voksne patienter med rheumatoid artrit (se pkt.
English: Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Danish: Gentagen peroral indgift af leflunomid til mus i op til 3 måneder, og til rotter og hunde i op til 6 måneder og aber i op til 1 måned viste, at de overvejende målorganer for toksicitet var rygmarv, blod, mave-tarmkanalen, hud, milt, thymus og lymfekirtler.
English: You will normally take Leflunomide ratiopharm over long periods of time.
Danish: Du skal almindeligvis fortsætte med at anvende Leflunomide ratiopharm i en længere periode.
English: Pregnancy must be excluded before start of treatment with leflunomide.
Danish: Graviditet skal udelukkes, inden behandling med leflunomid påbegyndes
English: Leflunomide was administered as a single oral 100 mg dose to 3 haemodialysis patients and 3 patients on continuous peritoneal dialysis (CAPD).
Danish: Leflunomid som peroral enkeltdosis på 100 mg er blevet givet til 3 hæmodialysepatienter og 3 patienter i kontinuerlig peritonealdialyse (CAPD).
English: If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide ratiopharm.
Danish: Hvis du allerede tager non-steroid antiinflammatorisk medicin (NSAID) og/eller kortikosteroider, kan du fortsætte med at tage dem, efter du er begyndt at tage Leflunomide ratiopharm.
English: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Danish: Samtidig administration af hepatotoksiske eller hæmatotoksiske DMARD's (f.eks. methotrexate) er ikke tilrådelig.
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide ratiopharm and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Danish: Så snart der ses hud- og/eller slimhindereaktioner, som giver mistanke om sådanne alvorlige reaktioner, skal Leflunomide ratiopharm og alle øvrige behandlinger, som kan give sådanne reaktioner, seponeres, og leflunomid udvaskningsprocedure skal straks påbegyndes.
English: The efficacy of leflunomide was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Danish: Effekten af leflunomid blev vist i et kontrolleret randomiseret dobbeltblindt forsøg 3L01 med 188 patienter med arthritis psoriatica, behandlet med 20 mg/dag.
English: Patients were 317 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
Danish: Patienterne var 3-17 år gamle med et aktivt polyartikulært forløb af børnegigt (JRA) uanset starttype og ikke forud testet overfor methotrexate eller leflunomide.
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide ratiopharm.
Danish: Den lange halveringstid af leflunomid skal tages i betragtning, når vaccination med levende svækket vaccine til patienter, som er stoppet med Leflunomide ratiopharm, overvejes.
English: Women of childbearing potential must not take Leflunomide ratiopharm without using reliable contraceptive measures.
Danish: Kvinder i den fødedygtige alder må ikke tage Leflunomide ratiopharm, medmindre de anvender sikker prævention.
English: A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n = 121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Danish: Et randomiseret studie undersøgte den kliniske responsrate hos DMARD-naïve patienter med tidlig reumatoid artrit (n = 121), som i to parallelle grupper enten fik 20 mg eller 100 mg leflunomid i den indledende tre dage lange dobbeltblinde periode.
English: In patients with rheumatoid arthritis, no pharmacokinetic interaction between the leflunomide (10 to 20 mg per day) and methotrexate (10 to 25 mg per week) was demonstrated.
Danish: Hos patienter med reumatoid artrit sås ingen farmakokinetiske interaktioner mellem leflunomid (1020 mg daglig) og methotrexate (10-25 mg ugentlig).
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide ratiopharm from your body.
Danish: Denne periode kan forkortes til få uger, hvis du tager visse lægemidler, som øger udskillelsen af Leflunomide ratiopharm.
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Danish: Farmakokinetikken af A771726 efter oral administration af leflunomid er blevet undersøgt i 73 pædiatri patienter med polyartikulært forløb af børnegigt (JRA), som var i alderen 3 til 17 år.
English: The tablets must be swallowed whole with sufficient amounts of liquid.
Danish: Tabletterne skal synkes hele med tilstrækkelig væskemængde.
English: Lactose monohydrate Low-substituted hydroxypropyl cellulose Tartaric acid
Danish: Lactosemonohydrat Lavsubstitueret hydroxypropylcellulose Vinsyre
English: Leflunomide ratiopharm is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Danish: Leflunomide ratiopharm er kontraindiceret til patienter med svær hypoproteinæmi eller nedsat leverfunktion (se pkt.
English: This medicinal product contains lactose and soya lecithin.
Danish: Dette lægemiddel indeholder lactose og sojalecithin.
English: Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40% in 24 hours and by 49% to 65% in 48 hours.
Danish: Kolestyramin givet peroralt i doser på 8 g 3 gange daglig i 1 døgn til 3 raske frivillige forsøgspersoner reducerede plasmakoncentrationen af A771726 med ca. 40% i løbet af 24 timer og 49-65% i løbet af 48 timer.
English: If a patient taking leflunomide develops a peripheral neuropathy, consider discontinuing leflunomide therapy and performing the drug elimination procedure (see section 4.4).
Danish: Hvis en patient i behandling med leflunomid udvikler perifer neuropati, bør det overvejes at seponere behandlingen og iværksætte udvaskningsproceduren (se pkt.
English: Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial phase after switching.
Danish: På lignende måde kan nylig behandling med hepatotoksiske eller hæmatotoksiske lægemidler (f.eks. methotrexate) give flere bivirkninger, hvorfor iværksættelse af leflunomidbehandling skal nøje overvejes med hensyn til disse risiko/benefit aspekter og mere omhyggelig kontrol i den første periode efter præparatskiftet anbefales.
English: Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide.
Danish: Sjældne tilfælde af svær leverskade, heraf nogle fatalt forløbende, har været rapporteret i forbindelse med behandling med leflunomid.
English: In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 μg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
Danish: I et forsøg, hvor leflunomid blev givet samtidig med en trifasisk peroral kontraceptionstablet indeholdende 30 μg ethinyløstradiol til raske frivillige kvinder, reduceredes præparatets kontraceptive effekt ikke, og farmakokinetikken af A771726 lå indenfor de forventede værdier.
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel) There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of A771726.
Danish: Effekt på oral antikonception (0,03 mg ethinylestradiol og 0,15 mg levonorgestrel) Der var en stigning i den gennemsnitlige ethinylestradiol Cmax og AUC0-24 (henholdsvis 1,58 og 1,54 gange) og levonorgestrel Cmax og AUC0-24 (henholdsvis 1,33 og 1,41 gange) efter gentagne doser af A771726.
English: Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable
Danish: Forsøg med både hæmodialyse og CAPD (Chronic ambulatory peritoneal dialysis) tyder på at A771726, den primære metabolit af leflunomid ikke kan dialyseres.
English: Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.
Danish: Nylig eller samtidig behandling med hepatotoksiske eller hæmatotoksiske DMARD's (f.eks. methotrexate) kan være forbundet med en øget risiko for alvorlige bivirkninger, hvorfor iværksættelse af leflunomidbehandling nøje må overvejes med hensyn til disse risiko/benefit aspekter.
English: • colestyramine 8 g is administered 3 times daily for a period of 11 days,
Danish: • kolestyramin 8 g 3 gange dagligt i 11 dage,
English: Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37% in 24 hours and by 48% in 48 hours.
Danish: Indgift af aktivt kul (suspension ud fra pulver) peroralt eller via sonde (50 g hver 6. time i 24 timer) har vist sig at reducere plasmakoncentrationen af den aktive metabolit, A771726, med 37% i løbet af 24 timer og med 48% i løbet af 48 timer.
English: - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
Danish: • sulfasalazin mod inflammatorisk tarmsygdom eller reumatoid artrit
English: The tablets must be swallowed with sufficient amounts of liquid.
Danish: Tabletterne skal tages med tilstrækkelig væskemængde.
English: • Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.
Danish: • Patienter med alvorlig nedsat knoglemarvsfunktion eller markant anæmi, leukopeni, neutropeni eller trombocytopeni, som skyldes andre årsager end reumatoid artrit eller arthritis psoriatica
English: If you forget to take Leflunomide ratiopharm
Danish: Hvis du har glemt at tage Leflunomide ratiopharm