FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
Danish: I forsøg US301 sås ingen signifikante forskelle mellem leflunomid og methotrexat, hvad angår de primære effektparametre.
English: The leflunomide treatment effect was evident by 1 month, stabilised by 3 to 6 months and continued throughout the course of treatment.
Danish: Effekten af leflunomidbehandlingen sås efter 1 måned, og den stabiliserede sig efter 3-6 måneder og forsatte gennem hele behandlingsforløbet.
English: mild allergic reactions
Danish: lette allergiske reaktioner
English: Film-coated tablet.
Danish: Filmovertrukket tablet.
English: Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
Danish: Såfremt sådanne bivirkninger optræder eller hvis A771726 af eller anden årsag behøves clearet fra kroppen hurtigt, skal udvaskningsproceduren følges.
English: If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Danish: Hvis du glemmer at tage en dosis, skal du indtage den manglende tablet, så snart du kommer i tanke om det; dog ikke hvis tidspunktet for næste planlagte dosis er nært forestående.
English: While this interaction is not expected to adversely impact the efficacy of oral contraceptives, consideration should be given to the type of oral contraceptive treatment.
Danish: Selvom denne interaktion ikke forventes at påvirke effekten af p-piller negativt, bør typen af oral antikonception overvejes.
English: Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.
Danish: Derfor bør lægemidler, der metaboliseres via CYP1A2 (såsom duloxetin, alosetron, theophyllin og tizanidin) anvendes med forsigtighed under behandling, da det kan føre til en reduktion af effekten af disse produkter.
English: In the case of side effects such as dizziness the patient's ability to concentrate and to react properly may be impaired.
Danish: I tilfælde af bivirkninger som svimmelhed kan patientens evne til at koncentrere sig og reagere på passende måde være nedsat.
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 colestyramin eller aktivt kul for at fremme udskillelsen.
English: • active psoriatic arthritis.
Danish: • aktiv arthritis psoriatica.
English: It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection.
Danish: Det kan også forårsage alvorlige allergiske reaktioner (herunder lægemiddelreaktion med eosinofili og systemiske symptomer [DRESS]) og øge risikoen for en alvorlig infektion.
English: This includes medicines obtained without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept.
English: In either case it should be confirmed by a blood test that Leflunomide Zentiva 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 Leflunomid Zentiva er udskilt i tilstrækkelig grad fra kroppen og derefter skal du vente mindst 1 måned, før du bliver gravid.
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 colestyramin og aktivt kul kan have indflydelse på absorptionen af østrogener og progesteroner, hvorfor sikker kontraception med orale kontraceptiva ikke kan garanteres under udvaskningsproceduren med colestyramin og aktivt kul.
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Danish: marginalt (reversibelt) fald i spermkoncentration, totalt spermtal og hurtig progressiv spermmotilitet
English: Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anaemia (lack of red blood cells).
Danish: Andre symptomer der påvirker hele kroppen er appetitløshed, feber, mangel på energi og anæmi (mangel på røde blodlegemer).
English: The unbound fraction of A771726 is about 0.62%.
Danish: Den ubundne fraktion af A771726 er ca. 0,62%.
English: The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Danish: Den terapeutiske effekt sætter sædvanligvis ind efter 4-6 uger og kan forbedres yderligere i op til 4-6 måneder.
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Danish: • Nødvendigheden af at rådgive patienterne om vigtige risici i forbindelse med behandling med leflunomid og om passende forholdsregler under behandlingen.
English: Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide.
Danish: Som følge af en potentiel risiko for additive hepatotoxiske virkninger anbefales det, at alkoholindtagelse undgås under behandling med leflunomid.
English: However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Danish: Den mindre metabolit TFMA (4-trifluoromethylamilin) har dog in vitro forårsaget klastogenicitet og punktmutationer, hvorimod der er utilstrækkelig information tilgængelig hvad angår dets potentielle mulighed for også at udøve denne effekt in vivo.
English: Very rare:
Danish: Meget sjælden:
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Leflunomide Zentiva are provided with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Leflunomid Zentiva forsynes med en undervisningspakke for læger indeholdende følgende:
English: Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.
Danish: Forsøg MN303 var en valgfri 6-måneders blindet fortsættelse af MN301 uden placeboarmen, hvilket gav en 12 måneders sammenligning af leflunomid og sulfasalazin.
English: Leflunomide Zentiva belongs to a group of medicines called anti-rheumatic medicines.
Danish: Leflunomid Zentiva tilhører en gruppe medicin der kaldes antireumatisk medicin.
English: The tablets should be swallowed whole with sufficient amounts of liquid.
Danish: Tabletterne skal synkes hele med tilstrækkelig væske.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
Danish: Ikke almindelig: hypokaliæmi, hyperlipidæmi, hypofosfatæmi Sjælden:
English: At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.
Danish: Ved steady-state akkumuleres plasmakoncentrationerne 33-35 gange sammenlignet med enkeltdosis.
English: Certain vaccinations should not be given while taking Leflunomide Zentiva, and for a certain amount of time after stopping treatment.
Danish: Visse vacciner bør ikke gives under behandling med Leflunomid Zentiva og i et vist stykke tid efter endt behandling.
English: However, a 25% decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Danish: Imidlertid blev et fald på 25% i peak International Normalised Ratio (INR) observeret, når A771726 blev administreret samtidigt med warfarin sammenlignet med warfarin alene.
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 undersøgelser efter behov.
English: Symptoms
Danish: Symptomer
English: Falsely low levels of calcium can be detected.
Danish: Målingen kan vise fejlagtige lave calciumniveauer.
English: The concentration may be expected to decrease below 0.02 mg/L about 2 years after stopping the treatment with leflunomide.
Danish: Koncentrationen kan forventes at falde til under 0,02 mg/l ca. 2 år efter behandlingen med leflunomid er ophørt.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arveligt betingede problemer med galactoseintolerans, Lapp lactasemangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
English: Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Danish: Leflunomid indgivet oralt og intraperitonealt er undersøgt i akutte toksicitetsforsøg på mus og rotter.
English: Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide.
Danish: Derfor skal der stilles spørgsmålstegn ved sandsynligheden for observerede reducerede ioniserede calciumniveauer hos patienter under behandling med leflunomid eller teriflunomid.
English: Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/hr.
Danish: Elimination af A771726 er langsom og er kendetegnet ved en tilsyneladende clearance på ca. 31 ml/t.
English: There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Danish: Der er rapporteret tilfælde af øget prothrombintid, når leflunomid og warfarin blev administreret samtidigt.
English: Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide Zentiva, to monitor your blood cells and liver.
Danish: Din læge vil tage regelmæssige blodprøver, før og under behandling med Leflunomid Zentiva, for at overvåge dine blodceller og din lever.
English: The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Behandlingen bør initieres og overvåges af specialister med særligt kendskab til behandling af reumatoid artrit og arthritis psoriatica.
English: CYP450 inhibitors and inducers
Danish: CYP450 hæmmere og inducere
English: Colestyramine 8 g is administered 3 times daily.
Danish: Colestyramin 8 g administreres 3 gange daglig.
English: Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Danish: Blodtryk skal kontrolleres før behandling med leflunomid påbegyndes og derefter regelmæssigt.
English: If you suspect that you are pregnant while taking Leflunomide Zentiva or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Danish: Hvis du har en formodning om, at du er gravid, enten mens du tager Leflunomid Zentiva eller inden for 2 år efter, du har stoppet behandlingen, skal du omgående kontakte lægen for at få foretaget en graviditetstest.
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Danish: I forsøg MN302 havde leflunomid signifikant mindre effekt end methotrexat.
English: Do not use this medicine after the expiry date which is stated on the packaging.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, som står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of A771726.
Danish: Mekanismen antages at skyldes afbrydelse af det enterohepatiske kredsløb og/eller gastrointestinal dialyse af A771726.
English: In the event that severe, uncontrolled infections occur, it may be necessary to interrupt leflunomide treatment and administer a washout procedure as described below.
Danish: Såfremt der indtræder svære, ukontrollerbare infektioner, kan det blive nødvendigt at afbryde leflunomidbehandlingen, og foretage en udvaskningsprocedure som beskrevet nedenfor.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Danish: Kontakt venligst indehaveren af markedsføringstilladelsen eller dennes lokale repræsentant (se pkt.
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. methotrexat) uden at foretage udvaskningsproceduren (se nedenfor) eventuelt føre til additiv risiko selv lang tid efter præparatskiftet (dvs. kinetiske interaktioner, organtoksicitet).
English: No incremental overall benefit was observed in the studied population with the use of a loading dose regimen.
Danish: Ingen gradvis overordnet fordel blev observeret ved anvendelse af startdosisregime hos populationen i studiet.
English: Swallow the tablet whole and with plenty of water.
Danish: Synk tabletten hel med rigeligt vand.
English: mild increase in blood pressure
Danish: lettere blodtryksforhøjelse
English: In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Danish: I et carcinogenicitetsforsøg på rotter udviste leflunomid ingen carcinogene egenskaber.
English: Leflunomide was not mutagenic.
Danish: Leflunomid er ikke mutagent.
English: Binding of A771726 is linear in the therapeutic concentration range.
Danish: Bindingen af A771726 er lineær i det terapeutiske koncentrationsinterval.
English: In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.
Danish: In vivo metaboliseres det hurtigt og næsten fuldstændigt til A771726, der er aktivt in vitro, og som antages at være ansvarlig for den terapeutiske effekt.
English: Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva - if you have ever suffered from inflammation of the lung (interstitial lung disease).
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Leflunomid Zentiva - hvis du nogensinde har haft betændelse i lungen (interstitiel lungesygdom).
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these medicinal products 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: Therefore, monitoring patients with concomitant use of medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, is recommended as they may have higher exposure.
Danish: Derfor anbefales kontrol af patienter med samtidig brug af lægemidler, der metaboliseres af CYP2C8 såsom repaglinid, paclitaxel, pioglitazon eller rosiglitazon, da de kan have en højere eksponering.
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 is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase.
Danish: Leflunomid er effektivt i dyremodeller af artrit såvel som af andre autoimmune lidelser, allergi og transplantation, især hvis det gives i den sensibiliserende fase.
English: Without a loading dose, it is estimated that attainment of steady-state plasma concentrations would require nearly two months of dosing.
Danish: Uden en initialdosis regner man med, at steady-state plasmakoncentrationer først vil kunne opnås efter næsten 2 måneders behandling.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Leflunomide Zentiva is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Danish: Leflunomid Zentiva bruges til at behandle voksne med aktiv rheumatoid artrit eller med aktiv arthritis psoriatica.
English: The safety data obtained from both treatment groups were consistent with the known safety profile of leflunomide, however, the incidence of gastrointestinal adverse events and of elevated liver enzymes tended to be higher in the patients receiving the loading dose of 100 mg leflunomide.
Danish: Sikkerhedsdata fra de to behandlingsgrupper var i overensstemmelse med den kendte sikkerhedsprofil for leflunomid; imidlertid tenderede hyppigheden af gastrointestinale bivirkninger og forhøjede leverenzymer at være højere hos patienter, som fik startdosis på 100 mg leflunomid.
English: No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
Danish: Der findes ikke data på sikkerhed og effekt af vaccinationer givet under leflunomidbehandling.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Renal and urinary disorders Not known:
Danish: Nyrer og urinveje Ikke kendt:
English: Effect of leflunomide on other medicinal products:
Danish: Leflunomids effekt på andre lægemidler:
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 over 0,02 mg/l (se pkt.
English: This is thought to be achieved by a gastrointestinal dialysis mechanism and/or by interrupting enterohepatic recycling.
Danish: Dette skyldes formentlig en gastrointestinal dialysemekanisme og/eller en afbrydelse af det enterohepatiske kredsløb.
English: Film-coating:
Danish: Filmovertræk:
English: Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.
Danish: Derfor anbefales mere omhyggelig kontrol af leverenzymer og hæmatologiske parametre i den første periode efter præparatskiftet.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til < 1/10); ikke almindelig (≥1/1.000 til < 1/100); sjælden (≥1 /10.000 til < 1/1.000); meget sjælden (<1 /10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: After administration of a radiolabelled dose of leflunomide, radioactivity was equally excreted in faeces, probably by biliary elimination, and in urine.
Danish: Efter indgift af radioaktivt mærkede doser af leflunomid, udskiltes lige store mængder radioaktivitet i fæces, formentlig via biliær elimination, og i urin.
English: Reproductive system and breast disorders Not known:
Danish: Det reproduktive system og mammae Ikke kendt:
English: Patients were 3-17 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 leflunomid.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Danish: • Patienter med svær immundefekt, f.eks. aids,
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 paediatric 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: 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 oral 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, mavetarmkanalen, hud, milt, thymus og lymfekirtler.
English: Tell your doctor if you have unexplained chronic diarrhoea.
Danish: Sig det til lægen, hvis du har længerevarende diarré af ukendt årsag.
English: Metabolism and nutrition disorders Common:
Danish: Metabolisme og ernæring Almindelig:
English: It is known that medicinal products with immunosuppressive properties - like leflunomide - may cause patients to be more susceptible to infections, including opportunistic infections.
Danish: Det er kendt, at lægemidler med immunsupprimerende egenskaber som leflunomid kan gøre patienterne mere modtagelige over for infektioner inklusive opportunistiske infektioner.
English: Your doctor may perform additional tests for differential diagnosis.
Danish: Lægen vil muligvis foretage yderligere undersøgelser for at stille en mere præcis diagnose.
English: This metabolite is responsible for essentially all the in vivo activity of Leflunomide Zentiva.
Danish: Denne metabolit er ansvarlig for praktisk talt hele Leflunomid Zentivas in vivo effekt.
English: In patients with pre-existing anaemia, leucopenia, and/or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased.
Danish: Hos patienter med eksisterende anæmi, leukopeni, og/eller trombocytopeni og hos patienter med nedsat knoglemarvsfunktion eller patienter med risiko for knoglemarvssuppression er risikoen for hæmatologiske forstyrrelser øget.
English: All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
Danish: Alle leflunomid-patienter i fase III forsøgene fik en initialdosis på 100 mg i 3 dage.
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 oral enkeltdosis på 100 mg er blevet givet til 3 hæmodialysepatienter og 3 patienter i kontinuerlig peritonealdialyse (CAPD).
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse:
English: leucopenia (leucocytes >2 G/L)
Danish: leukopeni (leukocyter > 2 G/L)