FrancophonIA/ELRC3.0 huggingface dataset:
English: Leflunomide medac 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 medac 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: In a study with radiolabelled
Danish: I et forsøg med radioaktivt mærket
English: • if you have any liver problems,
Danish: • hvis du har leverproblemer,
English: Leflunomide medac belongs to a group of medicines called anti-rheumatic medicines.
Danish: Leflunomide medac tilhører en gruppe medicin der kaldes antireumatisk medicin.
English: Alanine aminotransferase (ALT) (or serum glutamopyruvate transferase SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:
Danish: Alanin-aminotransferase (ALAT), (eller serum-glutamopyruvattransferase, SGPT) og det fulde blodbillede inklusive leukocytdifferentialtælling og trombocyttal skal kontrolleres samtidigt med og med samme hyppighed:
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: • tizanidine, a muscle relaxant
Danish: • tizanidin, et muskelafslappende lægemiddel
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 (Exp) er den sidste dag i den nævnte måned.
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Danish: Interstitiel lungesygdom er en potentielt letalsygdom, som kan opstå akut under behandlingen.
English: Men wishing to father a child should contact their doctor who may advise them to stop taking Leflunomide medac and take certain medicines to remove Leflunomide medac rapidly and sufficiently from their body.
Danish: Mænd, der ønsker at få børn, skal kontakte lægen, der kan tilråde at stoppe med at tage Leflunomide medac og ordinere bestemte typer medicin, der kan udrense Leflunomide medac fra kroppen hurtigt og tilstrækkeligt.
English: ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 8 weeks thereafter.
Danish: ALAT (SGPT) skal kontrolleres inden behandling med leflunomid påbegyndes med samme hyppighed som det fulde blodbillede (hver anden uge) i de første 6 måneder og derefter hver 8. uge.
English: Date of latest renewal: 23 March 2015
Danish: Dato for første markedsføringstilladelse: 25 juli 2013 Dato for seneste fornyelse: 23 marts 2015
English: Leflunomide medac is contraindicated in pregnancy (see section 4.3).
Danish: Leflunomide medac er kontraindiceret under graviditet (se pkt.
English: • any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening,
Danish: • nogen som helst symptomer på en infektion såsom feber, ømhed i halsen, eller hoste, da dette lægemiddel kan øge risikoen for at du får en alvorlig infektion, der kan være livstruende.
English: The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
Danish: Leflunomids aktive metabolit, A771726, har en lang halveringstid på sædvanligvis 1 - 4 uger.
English: • if you have ever suffered from interstitial lung disease,
Danish: • hvis du nogensinde har haft interstitiel lungesygdom,
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 (10 - 20 mg daglig) og methotrexat (10 - 25 mg ugentlig).
English: • daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
Danish: • daunorubicin, doxorubicin, paclitaxel eller topotecan mod kræft (cancer)
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that paediatric patients with body weights ≤ 40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section 4.2).
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: In a small prospective study in women (n = 64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p = 0.13) were observed in the overall rate of major structural defects (5.4 %) compared to either of the comparison groups (4.2 % in the disease matched group [n = 108] and 4.2 % in healthy pregnant women [n = 78]).
Danish: I en lille, prospektiv undersøgelse hos kvinder (n = 64), som uforvarende blev gravide, mens de tog leflunomid (højst 3 uger efter undfangelse efterfulgt af en udvaskningsprocedure), blev ingen signifikante forskelle (p = 0,13) observeret i den totale hyppighed af større misdannelser (5,4 %) sammenlignet med de to sammenligningsgrupper (4,2 % i sygdomsgruppen [n = 108]) og 4,2 % i gruppen med raske kvinder [n = 78]).
English: You will normally take Leflunomide medac over long periods of time.
Danish: Du skal almindeligvis fortsætte med at anvende Leflunomide medac i en længere periode.
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, toksisk epidermal nekrolyse og lægemiddelreaktion med eosinofili og systemiske reaktioner (DRESS) er blevet rapporteret hos patienter i behandling med leflunomid.
English: Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
Danish: Leflunomid var ved døgndoser på mindst 10 mg (10 - 25 mg i forsøg YU203, 20 mg i forsøg MN301 og US301) statistisk signifikant bedre end placebo til at reducere tegn og symptomer på reumatoid artrit i alle 3 placebokontrollerede forsøg.
English: The ACR (American College of Rheumatology) response rates in study YU203 were 27.7 % for placebo, 31.9 % for 5 mg, 50.5 % for 10 mg and 54.5 % for 25 mg/day.
Danish: ACR (American College of Rheumatology) responsraten i forsøg YU203 var 27,7 % for placebo, 31,9 % for 5 mg, 50,5 % for 10 mg og 54,4 % for 25 mg daglig.
English: • zidovudine for HIV infection
Danish: zidovudin mod HIV infektion
English: Similar studies showed that ibuprofen and diclofenac did not displace A771726, whereas the unbound fraction of A771726 is increased 2- to 3-fold in the presence of tolbutamide.
Danish: Tilsvarende forsøg viser, at ibuprofen og diclofenac ikke forskyder A771726, hvorimod den ubundne fraktion af A771726 stiger 2 - 3 gange ved tilstedeværelse af tolbutamid.
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 påvist i et kontrolleret randomiseret dobbeltblindt forsøg 3L01 med 188 patienter med arthritis psoriatica, behandlet med 20 mg/dag.
English: • cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension),
Danish: • hoste eller åndedrætsproblemer, da disse kan være tegn på lungeproblemer (interstitial lungesygdom eller pulmonal hypertension).
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: • an increase in the levels of fat in the blood (cholesterol and triglycerides),
Danish: • stigning i fedtniveauet i blodet (kolesterol og triglycerider),
English: The principal urinary metabolites were glucuronide products derived from leflunomide (mainly in 0 to 24 hour samples) and an oxanilic acid derivative of A771726.
Danish: De væsentligste metabolitter i urinen var glukoronidprodukter afledt af leflunomid (især opsamlet i tiden 0 - 24 timer) og et oxanilderivat af A771726.
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide medac 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 medac og alle øvrige behandlinger, som kan give sådanne reaktioner, seponeres, og leflunomid udvaskningsprocedure skal straks påbegyndes.
English: Do not take Leflunomide medac when you are breast-feeding, as leflunomide passes into the breast milk.
Danish: Tag ikke Leflunomide medac, hvis du ammer, da leflunomid kan overføres til brystmælk.
English: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Danish: forhøjede leverparametre (aminotransferaser (specielt ALAT), mindre hyppigt gammaglutamyltransferase, basisk fosfatase, bilirubin)
English: Human pharmacology Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Danish: Human farmakologi Leflunomid er et sygdomsmodificerende antireumatisk lægemiddel med antiproliferative egenskaber.
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 methotrexat eller leflunomide.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlig(e) for batchfrigivelse
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide medac from your body.
Danish: Denne periode kan forkortes til få uger, hvis du tager visse lægemidler, som øger udskillelsen af Leflunomide medac.
English: Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40 %, whereas the AUC was not significantly changed.
Danish: Efter samtidig indgift af enkeltdoser af leflunomid til personer, som fik multiple doser af rifampicin (non-specifik cytochrom P450 inducer) steg peakværdierne af A771726 med ca. 40 %, mens AUC ikke ændredes signifikant.
English: Women of childbearing potential must not take Leflunomide medac without using reliable contraceptive measures.
Danish: Kvinder i den fødedygtige alder må ikke tage Leflunomide medac, medmindre de anvender sikker prævention.
English: If a patient is hypersensitive to peanut or soya, Leflunomide medac must not be used.
Danish: Patienter, der er overfølsomme over for jordnødder eller soja, må ikke behandles med Leflunomide medac.
English: Cases of peripheral neuropathy have been reported in patients receiving Leflunomide medac.
Danish: Perifer neuropati er rapporteret hos patienter i behandling med Leflunomide medac.
English: • inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),
Danish: • betændelse i de små blodkar (vasculitis inklusive kutan nekrotisk vasculitis.
English: • teriflunomide for multiple sclerosis
Danish: • teriflunomid mod dissemineret sklerose
English: The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.
Danish: Den anbefalede vedligeholdelsesdosis er 10 - 20 mg leflunomid en gang afhængigt af sygdommens sværhedsgrad (aktiviteten).
English: C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Danish: C-leflunomid hos tre raske forsøgspersoner genfandt man ikke uomdannet leflunomid i plasma, urin og fæces.
English: An in vivo interaction study with leflunomide and cimetidine (non-specific weak cytochrome P450 (CYP) inhibitor) has demonstrated a lack of a significant impact on A771726 exposure.
Danish: Et in vivo interaktionsforsøg med leflunomid og cimetidin (non-specifik svag cytochrom P450 [CYP] hæmmer) viste ikke signifikant indvirkning på A771726 eksponering.
English: Leflunomide medac is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Danish: Leflunomide medac er kontraindiceret til patienter med svær hypoproteinæmi eller nedsat leverfunktion (se pkt.
English: For other substrates of BCRP (e.g. methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Danish: For andre substrater af BCRP (f.eks. methotrexat, topotecan, sulfasalazin, daunorubicin, doxorubicin) og OATP-familien, især HMG-CoA reduktasehæmmere (f.eks. simvastatin, atorvastatin, pravastatin, methotrexat, nateglinid, repaglinid, rifampicin), bør samtidig administration også ske med forsigtighed.
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide medac.
Danish: Den lange halveringstid af leflunomid skal tages i betragtning, når vaccination med levende svækket vaccine til patienter, som er stoppet med Leflunomide medac, overvejes.
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: Colestyramin givet oralt 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: • tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal,
Danish: • træthed, mavesmerter, eller gulsot (gul misfarvning af øjne og hud), da disse kan være tegn på alvorlige problemer, såsom leversvigt, der kan være dødeligt.
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with an unknown frequency.
Danish: Andre bivirkninger såsom nyresvigt, nedsat indhold af urinsyre i blodet, pulmonal hypertension, infertilitet hos mænd (der er reversibel, efter du er stoppet med at tage dette lægemiddel), kutan lupus (karakteriseret ved udslæt/rødme på hudområder udsat for lys), psoriasis (ny eller forværret) og DRESS kan også forekomme.
English: • The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E 171) and xanthan gum in the film-coating.
Danish: • Øvrige indholdsstoffer: Lactosemonohydrat, lavsubstitueret hydroxypropylcellulose, vinsyre, natriumlaurylsulfat og magnesiumsterat i tabletkernen, såvel som lecithin (sojabønner), polyvinylalkohol, talcum, titandioxid (E171) og xanthangummi i filmovertrækket.
English: Falsely low levels of calcium can be detected.
Danish: Målingen kan vise fejlagtige lavecalciumniveauer.
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. methotrexat) 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: • taste disturbances,
Danish: • smagsforstyrrelser,
English: • inflammation of the lung (interstitial lung disease),
Danish: • lungebetændelse (interstitial lungesygdom),
English: • if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
Danish: • hvis du får udslæt, eller mundsår, da disse kan være tegn på alvorlige, nogle gange livstruende reaktioner (f.eks. Stevens-Johnsons syndrom, toksisk epidermisk nekrolyse, erythema multiforme, lægemiddelreaktion med eosinofili og systemiske symptomer [DRESS]), se punkt 2.
English: • a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia),
Danish: • fald i antallet af røde blodlegemer (anæmi) og fald i antallet af blodplader (trombocytopeni),
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 with matching placebo 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: • an increase of certain enzymes in the blood (creatine phosphokinase),
Danish: • stigning af visse enzymer i blodet (kreatin fosfokinase),
English: Not known: renal failure
Danish: Ikke kendt: nyresvigt
English: • a marked decrease of some white blood cells (agranulocytosis),
Danish: • et udtalt fald i antallet af nogle hvide blodlegemer (agranulocytosis),
English: diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
Danish: diarré, kvalme, opkastning, påvirkning af mundslimhinden (f.eks. aftøs stomatit, mundsår), abdominalsmerter, colitis, herunder mikroskopisk colitis såsom lymfocytær colitis, kollagenøs colitis
English: • repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
Danish: • repaglinid, pioglitazon, nateglinid eller rosiglitazon mod sukkersyge (diabetes)
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, peanut or soya or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed (specielt tidligere Stevens-Johnsons syndrom, toksisk epidermal nekrolyse, erythema multiforme) over for det aktive stof, den primære aktive metabolit teriflunomid jordnødder eller soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: If a patient taking Leflunomide medac develops a peripheral neuropathy, consider discontinuing Leflunomide medac therapy and performing the drug elimination procedure (see section 4.4).
Danish: Hvis en patient i behandling med Leflunomide medac udvikler perifer neuropati, bør det overvejes at seponere behandlingen og iværksætte udvaskningsproceduren (se pkt.
English: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
Danish: Meget sjælden: svære anafylaktiske/anafylaktoide reaktioner, vasculitis inklusive kutan nekrotiserende vasculitis
English: Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide medac, as you need to ensure that all traces of Leflunomide medac have left your body before trying to become pregnant.
Danish: Hvis du planlægger at blive gravid efter du er stoppet i behandling med Leflunomide medac, skal du fortælle det til din læge forinden, da du skal kunne sikre dig, at alle spor af Leflunomide medac i kroppen er væk før du forsøger at blive gravid.
English: After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3 % (studies MN301/303), 50.5 % (study MN302) and 49.4 % (study US301), compared to 53.8 % (studies MN301/303) in sulphasalazine patients, 64.8 % (study MN302), and 43.9 % (study US301) in methotrexate patients.
Danish: Efter 12 måneder med aktiv behandling var ACR responsraterne hos leflunomidpatienterne 52,3 % (forsøg MN301/303), 50,5 % (forsøg MN302) og 49,4 % (forsøg US301) sammenlignet med 53,8 % (forsøg MN301/303) hos sulfasalazinpatienterne, og henholdsvis 64,8 % (forsøg MN302) og 43,9 % (forsøg US301) hos methotrexatpatienterne.
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD).
Danish: • aktiv reumatoid artrit som et sygdomsmodificerende antireumatisk middel ("Disease-Modifying
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen på apoteket eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: In a small (n = 30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients.
Danish: I et mindre forsøg (n = 30), hvor leflunomid (10 - 20 mg daglig) blev givet samtidig med methotrexat (10 - 25 mg ugentlig), sås en 2 - 3 gange forhøjelse af leverenzymer hos 5 ud af 30 patienter.
English: Skin reactions In case of ulcerative stomatitis, leflunomide administration should be discontinued.
Danish: Hudreaktioner I tilfælde af ulcerøs stomatit bør behandling med leflunomid seponeres.
English: Uncommon: anaemia, mild thrombocytopenia (platelets < 100 G/l) Rare:
Danish: Ikke almindelig: anæmi, let trombocytopeni (trombocytter < 100 G/l) Sjælden:
English: film-coated tablet
Danish: filmovertrukken tablet
English: • Colestyramine 8 g is administered 3 times daily for a period of 11 days.
Danish: • Colestyramin 8 g 3 gange dagligt i 11 dage.
English: • duloxetine for depression, urinary incontinence or in kidney disease in diabetics
Danish: • duloxetin mod depression, urininkontinens eller nyresygdom hos diabetikere
English: • sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
Danish: • sulfasalazin mod inflammatorisk tarmsygdom eller reumatoid artrit
English: • an increase of certain enzymes in the blood (lactate dehydrogenase).
Danish: • en stigning i bestemte enzymer i blodet (laktatdehydrogenase).
English: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide medac.
Danish: Denne metabolit er ansvarlig for praktisk talt hele Leflunomide medacs in vivo effekt.
English: • an increase in some liver test results,
Danish: • blodprøver som viser en stigning i nogle levertest resultater,