FrancophonIA/ELRC3.0 huggingface dataset:
English: Since the active metabolite of leflunomide, A771726, is highly protein bound and cleared via hepatic metabolism and biliary secretion, plasma levels of A771726 are expected to be increased in patients with hypoproteinaemia.
Danish: Da den aktive leflunomid-metabolit, A771726, er udtalt proteinbundet og udskilles via hepatisk metabolisme og biliær sekretion, kan det forventes, at plasmakoncentrationen af A771726 vil være øget hos patienter med hypoproteinæmi.
English: Leflunomide Zentiva 100 mg film-coated tablets are white to almost white and round.
Danish: Leflunomid Zentiva 100 mg filmovertrukne tabletter er hvide til næsten hvide og runde.
English: Leflunomide Zentiva 10 mg film-coated tablets are white to almost white and round.
Danish: Leflunomid Zentiva 10 mg filmovertrukne tabletter er hvide til næsten hvide og runde.
English: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30, 50 or 100 film-coated tablets.
Danish: 100 ml HDPE-bredhalset tabletbeholder, med skruelåg og integreret fugtbeholder Indeholdende enten 30, 50 eller 100 filmovertrukne tabletter.
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Danish: Den aktive metabolit, A771726, er i høj grad proteinbundet og elimineres via hepatisk metabolisering og biliær sekretion.
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Danish: svær leverskade som f.eks. leversvigt og akut hepatisk nekrose, som kan være letal
English: Cases of peripheral neuropathy have been reported in patients receiving leflunomide.
Danish: Perifer neuropati er rapporteret hos patienter i behandling med Leflunomid Zentiva.
English: In either case the A771726 plasma concentration is then measured for the first time.
Danish: I begge tilfælde måles plasmakoncentrationen af A771726 herefter for første gang.
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726.
Danish: Der var en stigning i den gennemsnitlige rosuvastatin Cmax og AUC (henholdsvis 2,65 og 2,51 gange), efter gentagne doser af A771726.
English: Pack sizes: 30 and 100 film-coated tablets.
Danish: Pakningsstørrelse: 30 og 100 filmovertrukne tabletter.
English: Other medicines and Leflunomide Zentiva
Danish: Brug af anden medicin sammen med Leflunomid Zentiva
English: Packs of 30 and 100 tablets are available.
Danish: Der findes pakninger med 30 og 100 tabletter
English: Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain.
Danish: Symptomerne på rheumatoid artrit er blandt andet en betændelseslignende tilstand i leddene, hævelse, besvær med at bevæge sig og smerter.
English: Leflunomide Zentiva contains lactose.
Danish: Leflunomid Zentiva indeholder lactose.
English: Contents of the pack and other information What Leflunomide Zentiva contains
Danish: Pakningsstørrelser og yderligere oplysninger Leflunomid Zentiva indeholder:
English: After a 2-year waiting period, the A771726 plasma concentration is measured for the first time.
Danish: Efter en pause på 2 år måles plasmakoncentrationen af A771726 for første gang.
English: All elevations resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Danish: Alle forhøjelser blev normaliseret, 2 efter fortsat behandling med begge lægemidler og 3 efter seponering af leflunomid.
English: A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of medicinal product in the dialysate.
Danish: En hurtigere elimination af A771726, som ikke skyldtes ekstraktion af lægemidlet i dialysatet, blev observeret hos hæmodialyse-patienter.
English: Haematological reactions
Danish: Hæmatologiske reaktioner
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Danish: Meget sjælden: toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme Ikke kendt:
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, mandlig infertilitet (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: 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: Imprint on one side: ZBN.
Danish: Præget med ZBN på den ene side.
English: Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Danish: Symptomerne på aktiv arthritis psoriatica er blandt andet en betændelseslignende i leddene, hævelse, besvær med at bevæge sig, smerter og røde, afskallende pletter på huden (hudlæsioner).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30 or 100 film-coated tablets.
Danish: 100 ml HDPE-bredhalset tabletbeholder, med skruelåg og integreret fugtbeholder indeholdende enten 30 eller 100 filmovertrukne tabletter.
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: Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo.
Danish: Efter gentagne doser af A771726 faldt den gennemsnitlige koffein Cmax og AUC (CYP1A2 substrat) med henholdsvis 18% og 55%, hvilket tyder på, at A771726 kan være en svag inducer af CYP1A2 in vivo.
English: Methotrexate
Danish: Methotrexat
English: Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L) Rare:
Danish: Ikke almindelig: anæmi, let trombocytopeni (trombocytter < 100 G/L) Sjælden:
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: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria
Danish: øget hårtab, eksem, udslæt (inklusive makulopapuløst udslæt), kløe, tør hud Ikke almindelig: urticaria
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1).
Danish: Den anbefalede vedligeholdelsesdosis er 20 mg en gang daglig (se pkt.
English: pulmonary hypertension Gastrointestinal disorders Common:
Danish: pulmonal hypertension Mave-tarm-kanalen Almindelig:
English: (pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Danish: (leukopeni); fald i antallet af alle blodceller (pancytopeni), - alvorlig forhøjelse af blodtrykket, - lungebetændelse (interstitiel lungesygdom), - blodprøver kan vise en forhøjelse af nogle leverresultater som kan føre til alvorlige tilstande såsom leverbetændelse og gulsot, alvorlige infektioner (blodforgiftning), som kan være livstruende, - alvorlige infektioner kaldet sepsis, der kan være dødeligt, - en stigning i bestemte enzymer i blodet (laktatdehydrogenase).
English: Therefore, when warfarin or another coumarin anticoagulant is co-administered, close international normalised ratio (INR) follow-up and monitoring is recommended.
Danish: Tæt international opfølgning og overvågning af normaliseret ratio (INR) anbefales derfor, når warfarin eller andre coumarin antikoagulantia administreres samtidigt.
English: White to almost white, round film-coated tablet, imprinted with ZBN on one side.
Danish: Hvid til næsten hvid, rund filmovertrukken tablet, præget med ZBN på den ene side.
English: • For rheumatoid arthritis: 10 or 20 mg Leflunomide Zentiva once daily, depending on the severity of the disease.
Danish: • 1 tablet på 10 eller 20 mg Leflunomid Zentiva daglig til behandling af aktiv leddegigt afhængig af sygdommens alvorlighed.
English: Male patients should be aware of the possible male-mediated foetal toxicity.
Danish: Mandlige patienter skal være opmærksomme på risikoen for føtal toksicitet overført fra mandlig partner.
English: Leflunomide Zentiva contains lactose
Danish: Leflunomid Zentiva indeholder lactose
English: No data are available regarding treatment of patients with hepatic impairment.
Danish: Data vedrørende behandling af patienter med leverinsufficiens er ikke tilgængelige.
English: Human pharmacology
Danish: Human farmakologi
English: Pack size: 3 film-coated tablets.
Danish: Pakningsstørrelse: 3 filmovertrukne tabletter.
English: Serious undesirable effects might occur (e.g. hepatotoxicity, haematotoxicity or allergic reactions, see below), even if the treatment with leflunomide has been stopped.
Danish: Alvorlige bivirkninger kan forekomme selv efter ophør med leflunomid behandlingen (f.eks. hepatotoksisitet, hæmatotoksisitet eller allergiske reaktioner, se nedenfor).
English: Do not take Leflunomide Zentiva if you are, or think you may be pregnant.
Danish: Tag ikke Leflunomid Zentiva hvis du er gravid, eller har en formodning om, at du er gravid.
English: Effect on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Danish: Effekt på organisk aniontransporter-3 (OAT3) substrater Der var en stigning i den gennemsnitlige cefaclor Cmax og AUC (henholdsvis 1,43 og 1,54 gange), efter gentagne doser af A771726, hvilket tyder på, at A771726 hæmmer OAT3 in vivo.
English: The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104).
Danish: I fase II forsøget, forsøg YU203, blev 402 forsøgspersoner med aktiv reumatoid artrit randomiseret til placebo (n = 102), leflunomid 5 mg (n = 95), 10 mg (n = 101) eller 25 mg daglig (n = 104).
English: • alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
Danish: • eller 50 g aktivt kul 4 gange dagligt i 11 dage.
English: - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide Zentiva which is absorbed by the body.
Danish: - rosuvastatin, simvastatin, atorvastatin, pravastatin mod hyperkolesterolæmi (højt kolesteroltal) - sulfasalazin mod inflammatorisk tarmsygdom eller reumatoid artrit - et lægemiddel, der hedder colestyramin (bruges til at reducere højt kolesteroltal) eller aktivt kul,
English: Therefore, when warfarin is co-administered, close INR follow-up and monitoring is recommended.
Danish: Derfor anbefales tæt INR opfølgning og overvågning, når warfarin administreres samtidigt.
English: Together with ALT, a complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment as well as every 2 weeks for the first 6 months of treatment and every 8 weeks thereafter.
Danish: leukocytdifferentialtælling samt trombocyttal skal kontrolleres før behandling med leflunomid påbegyndes, såvel som hver 2. uge i behandlingens første 6 måneder og herefter hver 8. uge.
English: EU/1/09/604/010 3 tablets
Danish: EU/1/09/604/010 3 tabletter
English: Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Danish: Talcum (E 553b) Hypromellose (E 464) Titandioxid (E 171) Macrogol 8000
English: Animal pharmacology
Danish: Dyrefarmakologi
English: - a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Danish: - et udtalt fald i antallet af nogle hvide blodlegemer (agranulocytosis), - alvorlige og potentielt alvorlige allergiske reaktioner, - betændelse i de små blodkar (vasculitis inklusive kutan nekrotisk vasculitis), - forstyrrelser af nerverne i arme eller ben (perifer neuropati), - betændelse i bugspytkirtlen (pankreatitis), - svær leverskade, såsom leversvigt eller nekrose der kan være livstruende, - nogle gange livstruende reaktioner (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse,
English: This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill)
Danish: Dette er særligt vigtigt, hvis du tager: - anden medicin mod reumatoid artrit såsom malariamedicin (f.eks. chloroquin og hydroxychloroquin), intramuskulært eller oralt guld, Penicillamin, azathioprin og andre lægemidler, der påvirker dit immunforsvar (som f.eks. methotrexat), eftersom disse kombinationer ikke er tilrådelige - warfarin og andre orale blodfortyndende lægemidler, da overvågning er nødvendig for at mindske riskikoen for bivirkninger af dette lægemiddel - teriflunomid mod multipel sklerose - repaglinid, pioglitazon, nateglinid eller rosiglitazon mod sukkersyge (diabetes) - daunorubicin, doxorubicin, paclitaxel eller topotecan mod kræft (cancer) - duloxetin mod depression, urininkontinens eller nyresygdom hos diabetikere - alosetron til behandling af kraftig diarré - theophyllin mod astma - tizanidin, et muskelafslappende lægemiddel - orale præventionsmidler (indeholdende ethinylestradiol og levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin mod infektioner - indomethacin, ketoprofen mod smerter eller inflammation - furosemid mod hjertelidelse (vanddrivende) - zidovudin mod HIV infektion
English: White to almost white, round film-coated tablet, imprinted with ZBP on one side.
Danish: Hvid til næsten hvid rund filmovertrukken tablet præget med ZBP på den ene side.
English: Treatment duration was 12 months.
Danish: Behandlingsvarighed var 12 måneder.
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 Meget sjælden: agranulocytose
English: Excipients with known effect Each tablet contains 138.42 mg of lactose monohydrate
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 138,42 mg lactosemonohydrat.
English: Also contains lactose.
Danish: Dette lægemiddel indeholder lactose.
English: Leflunomide Zentiva 20 mg
Danish: Leflunomid Zentiva 20 mg
English: - a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
Danish: - fald i antallet af røde blodlegemer (anæmi) og fald i antallet af blodplader (trombocytopeni), - fald i blodets kaliumniveau, - angst, - smagsforstyrrelser, - urticaria (nældefeber), - seneruptur, - stigning i fedtniveauet i blodet (kolesterol og triglycerider), - fald i fosfatniveauet i blodet.
English: The usual starting dose of Leflunomide Zentiva is one 100 mg tablet once daily for the first three days.
Danish: Leflunomid Zentiva-behandlingen påbegyndes sædvanligvis med 1 tablet på 100 mg daglig i de første 3 dage.
English: Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n=498).
Danish: I forsøg MN302 blev 999 forsøgspersoner med aktiv reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 501) eller methotrexat 7,5 mg ugentlig stigende til 15 mg ugentlig (n = 498).
English: There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of CYP2C8 in vivo.
Danish: Der var en stigning i den gennemsnitlige repaglinid Cmax og AUC (henholdsvis 1,7 og 2,4 gange), efter gentagne doser af A771726, hvilket tyder på, at A771726 hæmmer CYP2C8 in vivo.
English: 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
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: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).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 sulfasalazin-patienterne, og henholdsvis 64,8% (forsøg MN302) og 43,9% (forsøg US301) hos methotrexat-patienterne.
English: Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
Danish: I forsøg US301 blev 482 forsøgspersoner med aktiv reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 182), methotrexat 7,5 mg ugentlig stigende til 15 mg ugentlig (n = 182), eller placebo (n = 118).
English: The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Danish: Patienten skal informeres om, at lægen ved uregelmæssigheder i menstruationscyklus eller andre tegn på graviditet omgående skal kontaktes, så graviditetstest kan udføres.
English: 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Danish: 30 filmovertrukne tabletter 50 filmovertrukne tabletter 100 filmovertrukne tabletter
English: A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose.
Danish: Et randomiseret dobbelt-blind, parallelgruppe non-inferior forsøg sammenlignede den relative effekt af to forskellige daglige vedligeholdelsesdoser på leflunomid, 10 mg og 20 mg.
English: Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92).
Danish: I forsøg MN301 blev 358 forsøgspersoner med reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 133), sulfasalazin 2 g daglig (n = 133) eller placebo (n = 92).
English: Leflunomide Zentiva 10 mg
Danish: Leflunomid Zentiva 10 mg
English: Leflunomide Zentiva 100 mg
Danish: Leflunomid Zentiva 100 mg
English: Treatment duration was 6 months.
Danish: Behandlingsvarighed var 6 måneder.
English: The tablets are packed in blisters.
Danish: Tabletterne er pakket i blisterpakninger Pakket i pakninger med 3 tabletter.
English: • In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
Danish: • Reumatoid artrit: Leflunomidbehandling indledes sædvanligvis med en startdosis på 100 mg en gang daglig i 3 dage.
English: If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.
Danish: Såfremt patienten i forvejen behandles med NSAID og/eller kortikosteroider, kan der fortsættes hermed efter påbegyndt behandling med leflunomid.