FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatise, bilirubin).
Danish: De hyppigst rapporterede bivirkninger ved behandling med leflunomid er: let blodtryksstigning, leukopeni, paræstesi, hovedpine, svimmelhed, diarré, kvalme, opkastning, gener fra mundslimhinden, (f.eks. aftøs stomatitis, mundsår), abdominalsmerter, øget hårtab, eksem, udslæt (inklusive makulopapuløst udslæt), pruritus, tør hud, seneskedehindebetændelse, øget kreatinkinase, anoreksi, vægttab (sædvanligvis ubetydeligt), asteni, milde allergiske reaktioner og stigning i leverparametre (aminotransferaser særligt ALAT), mindre hyppigt gamma-GT, basisk fosfatase og bilirubin).
English: • severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Danish: • nogle gange livstruende reaktioner (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse,
English: CPK increased
Danish: forhøjet LDH
English: Uncommon: anxiety
Danish: Ikke almindelig: angst
English: The usual starting dosage of Leflunomide medac is 100 mg once daily for the first three days.
Danish: Leflunomide medac-behandlingen påbegyndes sædvanligvis med 100 mg daglig i de første 3 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) oralt 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: Symptoms of psoriatic arthritis include inflammation of joints, swelling, difficulty in moving, pain, and patches of red, scaly skin (skin lesions).
Danish: Symptomerne på aktiv arthritis psoriatica er blandt andet en betændelseslignende tilstand i leddene, hævelse, besvær med at bevæge sig, smerter og røde, afskallende pletter på huden (hudlæsioner).
English: • anxiety,
Danish: • angst,
English: If you forget to take Leflunomide medac
Danish: Hvis du har glemt at tage Leflunomide medac
English: • The active substance is leflunomide.
Danish: • Aktivt stof: Leflunomid.
English: • severe increase in blood pressure,
Danish: • alvorlig forhøjelse af blodtrykket,
English: • a slight decrease in the number of white blood cells (leucopenia),
Danish: • et mindre fald i antallet af hvide blodlegemer (leukopeni),
English: Do not take Leflunomide medac
Danish: Tag ikke Leflunomide medac
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 én gang daglig i 3 dage.
English: • other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e.g. methotrexate) as these combinations are not advisable,
Danish: • anden medicin mod reumatoid artrit såsom malariamedicin (f.eks. chloroquin og hydroxychloroquin), intramuskulært eller oralt guld, Penicillamin, azathioprin og andre stoffer, der påvirker dit immunforsvar (som f.eks. methotrexat), eftersom disse kombinationer ikke er tilrådelige
English: • inflammation of the pancreas (pancreatitis),
Danish: • betændelse i bugspytkirtlen (pankreatitis),
English: What you need to know before you take Leflunomide medac
Danish: Det skal du vide, før du begynder at tage Leflunomide medac
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal Not known: pulmonary hypertension
Danish: interstitial lungesygdom (inklusive interstitial pneumonitis) som kan være letal
English: • nausea, vomiting,
Danish: • kvalme, opkastning,
English: The efficacy of leflunomide was confirmed in this study, but 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: • For rheumatoid arthritis: 10 to 20 mg Leflunomide medac once daily, depending on the severity of the disease.
Danish: • 10 - 20 mg Leflunomide medac daglig til behandling af aktiv leddegigt afhængig af sygdommens alvorlighed.
English: • eczema, dry skin, rash, itching,
Danish: • eksem, tør hud, udslæt, kløe,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 July 2010
Danish: Dato for første markedsføringstilladelse: 27 juli 2010 Dato for seneste fornyelse: 23 marts 2015
English: • an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
Danish: • stigning i antallet af såkaldte eosinofile blodceller, et svagt fald i antallet af hvide blodlegemer
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: White to almost white, round film-coated tablet with a diameter of about 6 mm.
Danish: Hvid til næsten hvid, rund filmovertrukken tablet med en diameter på ca. 6 mm.
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: • furosemide for heart disease (diuretic, water pill)
Danish: • furosemid mod hjertelidelse (vanddrivende)
English: • urticaria (nettle rash),
Danish: • urticaria (nældefeber),
English: INFORMATION IN BRAILLE Leflunomide medac 10 mg
Danish: INFORMATION I BRAILLESKRIFT Leflunomide medac 10 mg
English: Immune system disorders
Danish: Immunsystemet:
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: • abnormal skin sensations like tingling (paraesthesia),
Danish: • unormale hudfornemmelser såsom prikken (paræstesi),
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme Not known: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Danish: kutan lupus erythematosus, pustuløs psoriasis, forværring af psoriasis, lægemiddelreaktion med eosinofili og systemiske reaktioner (DRESS)
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje,thorax og mediastinum
English: Each film-coated tablet contains 114 mg of lactose (as monohydrate) and 0.09 mg of soya lecithin.
Danish: Hver filmovertrukken tablet indeholder 114 mg lactose (som monohydrat) og 0,09 mg sojalecithin.
English: Each film-coated tablet contains 76 mg of lactose (as monohydrate) and 0.06 mg of soya lecithin.
Danish: Hver filmovertrukken tablet indeholder 76 mg lactose (som monohydrat) og 0,06 mg sojalecithin.
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for
Danish: • Arthritis psoriatica: Leflunomidbehandling indledes med en startdosis på 100 mg en gang daglig i 3 dage.
English: Each film-coated tablet contains 152 mg of lactose (as monohydrate) and 0.12 mg of soya lecithin.
Danish: Hver filmovertrukken tablet indeholder 152 mg lactose (som monohydrat) og 0,12 mg sojalecithin.
English: Tablet core: lactose monohydrate low-substituted hydroxypropyl cellulose tartaric acid sodium laurylsulfate magnesium stearate
Danish: Lactosemonohydrat Lavsubstitueret hydroxypropylcellulose Vinsyre
English: • headache, dizziness,
Danish: • hovedpine, svimmelhed,
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 methotrexat7,5 mg ugentlig stigende til 15 mg ugentlig (n = 498).
English: severe increase in blood pressure
Danish: alvorlig blodtryksforhøjelse
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), methotrexat7,5 mg ugentlig stigende til 15 mg ugentlig (n = 182), eller placebo (n = 118).
English: Leflunomide medac 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
Danish: Leflunomide medac 10 mg filmovertrukne tabletter er hvide til næsten hvide og runde med en diameter på ca. 6 mm.
English: Leflunomide medac contains lactose.
Danish: Leflunomide medac indeholder lactose.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TABLETGLAS
English: • severe liver injury such as liver failure or necrosis which may be fatal,
Danish: • svær leverskade, såsom leversvigt eller nekrose der kan være livstruende,
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 medac contains lactose
Danish: Leflunomide medac indeholder lactose
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Leflunomide medac Fortæl altid lægen eller på apoteket, hvis du bruger, måske vil bruge anden medicin eller har gjort det for nylig.
English: Film-coating: lecithin (soybeans) poly(vinyl alcohol) talc titanium dioxide (E 171) xanthan gum
Danish: Titandioxid (E 171) Xanthangummi
English: In case of severe haematological reactions, including pancytopenia, Leflunomide medac and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Danish: pancytopeni skal Leflunomide medac og anden samtidig behandling med myelosuppresive lægemidler seponeres og leflunomid udvaskningsproceduren påbegyndes.
English: • if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Danish: • hvis du nogensinde har haft en allergisk reaktion over for leflonumid (specielt en alvorlig hudreaktion, ofte ledsaget af feber, ledsmerter, røde pletter på huden eller blærer, f.eks.
English: • tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands),
Danish: • seneskedebetændelse (smerte forårsaget af en inflammation i den hinde der omgiver senerne,
English: White to almost white, round film-coated tablet with a diameter of 8 mm and a break-mark on one side of the tablet.
Danish: Hvid til næsten hvid, rund filmovertrukken tablet med en diameter på 8 mm og en delekærv på den ene side af tabletten.
English: Leflunomide medac 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet.
Danish: Leflunomide medac 20 mg filmovertrukne tabletter er hvide til næsten hvide og runde med en diameter på ca. 8 mm og en delekærv på den ene side af tabletten.
English: with continuation of both drugs and 3 after discontinuation of leflunomide.
Danish: Alle disse normaliseredes også, 2 efter fortsat behandling med begge stoffer og 3 efter seponering af leflunomid.
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1) 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: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Danish: hepatitis, gulsot, kolestase Meget sjælden: svær leverskade som f.eks. leversvigt og akut hepatisk nekrose, som kan være letal
English: In multiple dose studies in patients with rheumatoid arthritis, the pharmacokinetic parameters of A771726 were linear over the dose range of 5 to 25 mg.
Danish: I forsøg med gentagen dosering til patienter med reumatoid artrit er de farmakokinetiske parametre for A771726 lineære i doseringsintervallet 5 - 25 mg. I disse forsøg hænger den kliniske effekt tæt sammen med plasmakoncentrationen af A771726 og den daglige dosis af leflunomid.
English: In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: < 20 kg, 20 - 40 kg, and > 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30 % (p = 0.02).
Danish: Efter 16 ugers behandling var forskellen i responsraterne statistisk signifikant til methotrexats fordel til børnegigt ”definition of improvement (DOI)” ≥ 30 % (p = 0,02 %).
English: <Leflunomide medac 10 mg:> 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Danish: <Leflunomide medac 10 mg> 30 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 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: often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome), peanut or soya or to any of the other ingredients of this medicine (listed in section 6),
Danish: • hvis du nogensinde har haft en allergisk reaktion over for leflonumid (specielt en alvorlig hudreaktion, ofte ledsaget af feber, ledsmerter, røde pletter på huden eller blærer, f.eks. Stevens-Johnsons syndrom), jordnødder eller soja eller et af de øvrige indholdsstoffer i Leflunomide medac (angivet i punkt 6),
English: Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets leflunomide
Danish: Leflunomide medac 10 mg filmovertrukne tabletter Leflunomide medac 15 mg filmovertrukne tabletter Leflunomide medac 20 mg filmovertrukne tabletter leflunomid
English: • mild increase in blood pressure,
Danish: • let forhøjelse af blodtrykket,
English: Suomi/Finland medac GmbH sivuliike suomessa Puh/Tel: +358 10 420 4000
Danish: Suomi/Finland medac GmbH sivuliike suomessa Puh/Tel: +358 10 420 4000 Leflunomide@medac.eu
English: • an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice,
Danish: • 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,
English: • a decrease in the levels of potassium in the blood,
Danish: • fald i blodets kaliumniveau,
English: Each film-coated tablet contains 20 mg of leflunomide.
Danish: Hver filmovertrukken tablet indeholder 20 mg leflunomid.
English: Each film-coated tablet contains 15 mg of leflunomide.
Danish: Hver filmovertrukken tablet indeholder 15 mg leflunomid.
English: What Leflunomide medac is and what it is used for What you need to know before you take Leflunomide medac How to take Leflunomide medac Possible side effects
Danish: Det skal du vide, før du begynder at tage Leflunomide medac Sådan skal du tage Leflunomide medac Bivirkninger
English: One tablet of Leflunomide medac 20 mg film-coated tablets contains 20 mg of leflunomide.
Danish: En filmovertrukken tablet med Leflunomide medac 20 mg filmovertrukne tabletter indeholder 20 mg leflunomid.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Danish: Colitis Ved behandling med leflunomid er beskrevet colitis, herunder mikroskopisk colitis.
English: One tablet of Leflunomide medac 15 mg film-coated tablets contains 15 mg of leflunomide.
Danish: En filmovertrukken tablet med Leflunomide medac 15 mg filmovertrukne tabletter indeholder 15 mg leflunomid.
English: Leflunomide medac 15 mg film-coated tablets: Pack sizes of 30, 60, 90 or 100 film-coated tablets per bottle are available.
Danish: Leflunomide medac 15 mg filmovertrukne tabletter: Der findes pakningsstørrelser på 30, 60, 90 og 100 filmovertrukne tabletter pr. tabletglas.
English: Leflunomide medac contains soya lecithin.
Danish: Leflunomide medac indeholder sojalecithin.
English: • if you are male and wish to father a child. As it cannot be excluded that Leflunomide medac passes into semen, reliable contraception should be used during treatment with Leflunomide medac.
Danish: Da det ikke kan udelukkes, at Leflunomide medac findes i sæden, skal der bruges pålidelig prævention under behandlingen med Leflunomide medac.
English: EU/1/10/637/010 (15 mg, 30 tablets) EU/1/10/637/011 (15 mg, 60 tablets) EU/1/10/637/012 (15 mg, 90 tablets) EU/1/10/637/013 (15 mg, 100 tablets)
Danish: EU/1/10/637/010 (15 mg, 30 tabletter) EU/1/10/637/011 (15 mg, 60 tabletter) EU/1/10/637/012 (15 mg, 90 tabletter) EU/1/10/637/013 (15 mg, 100 tabletter)
English: Hepatobiliary disorders
Danish: pulmonal hypertension
English: What Leflunomide medac contains
Danish: Leflunomide medac indeholder:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/637/001 (10 mg, 30 tablets) EU/1/10/637/002 (10 mg, 60 tablets) EU/1/10/637/004 (10 mg, 100 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/637/001 (10 mg, 30 tabletter) EU/1/10/637/002 (10 mg, 60 tabletter) EU/1/10/637/004 (10 mg, 100 tabletter)
English: One tablet of Leflunomide medac 10 mg film-coated tablets contains 10 mg of leflunomide.
Danish: En filmovertrukken tablet med Leflunomide medac 10 mg filmovertrukne tabletter indeholder 10 mg leflunomid.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of leflunomide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 20 mg leflunomid.
English: If you are allergic to peanut or soya, do not use this medicine.
Danish: Du må ikke bruge denne medicin, hvis du er overfølsom over for jordnødder eller soja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of leflunomide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 15 mg leflunomid.
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 26.3 % (study US301).
Danish: I fase III forsøgene var ACR responsraterne for leflunomid 20 mg daglig vs. placebo 54,6 % vs.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of leflunomide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 10 mg leflunomid.
English: Leflunomide medac 10 mg film-coated tablets: Pack sizes of 30, 60 or 100 film-coated tablets per bottle are available.
Danish: Leflunomide medac 10 mg filmovertrukne tabletter: Der findes pakningsstørrelser på 30, 60 og 100 filmovertrukne tabletter pr. tabletglas.
English: EU/1/10/637/005 (20 mg, 15 tablets) EU/1/10/637/006 (20 mg, 30 tablets) EU/1/10/637/007 (20 mg, 60 tablets) EU/1/10/637/009 (20 mg, 100 tablets)
Danish: EU/1/10/637/005 (20 mg, 15 tabletter) EU/1/10/637/006 (20 mg, 30 tabletter) EU/1/10/637/007 (20 mg, 60 tabletter) EU/1/10/637/009 (20 mg, 100 tabletter)
English: Leflunomide medac 20 mg film-coated tablets: Pack sizes of 15, 30, 60 or 100 film-coated tablets per bottle are available.
Danish: Leflunomide medac 20 mg filmovertrukne tabletter: Der findes pakningsstørrelser på 15, 30, 60 og 100 filmovertrukne tabletter pr. tabletglas
English: agranulocytosis
Danish: Sojalecithin
English: It is not recommended to drink alcohol during treatment with Leflunomide medac.
Danish: Da eventuelle leverskader forvoldt af alkohol kan forværres af behandling med Leflunomide medac, anbefales det ikke at drikke alkohol under behandling med Leflunomide medac.
English: Do not take Leflunomide medac if you are, or think you may be pregnant.
Danish: Tag ikke Leflunomide medac, hvis du er gravid eller har en formodning om, at du er gravid.
English: How to take Leflunomide medac
Danish: Sådan skal du tage Leflunomide medac
English: Leflunomide medac 20 mg film-coated tablets leflunomide
Danish: Leflunomide medac 20 mg filmovertrukne tabletter leflunomid
English: Leflunomide medac 15 mg film-coated tablets leflunomide
Danish: Leflunomide medac 15 mg filmovertrukne tabletter leflunomid
English: Leflunomide medac 10 mg film-coated tablets leflunomide
Danish: Leflunomide medac 10 mg filmovertrukne tabletter leflunomid
English: EU/1/10/637/001 (10 mg, 30 tablets) EU/1/10/637/002 (10 mg, 60 tablets) EU/1/10/637/004 (10 mg, 100 tablets)
Danish: EU/1/10/637/001 (10 mg, 30 tabletter) EU/1/10/637/002 (10 mg, 60 tabletter) EU/1/10/637/004 (10 mg, 100 tabletter)
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 30, 60, 90 or 100 film-coated tablets per container.
Danish: 40 ml HDPE-bredhalset tabletbeholder med skruelåg og integreret fugtbeholder (hvid silica gel) indeholdende enten 30, 60, 90 eller 100 filmovertrukne tabletter pr. beholder.
English: Soya lecithin
Danish: Natriumlaurylsulfat
English: • For psoriatic arthritis: 20 mg Leflunomide medac once daily.
Danish: • 20 mg Leflunomide medac daglig til behandling af gigt i forbindelse med psoriasis.
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 15, 30, 60 or 100 film-coated tablets per container.
Danish: 40 ml HDPE-bredhalset tabletbeholder med skruelåg og integreret fugtbeholder (hvid silica gel) indeholdende enten 15, 30, 60 eller 100 filmovertrukne tabletter pr. beholder.
English: White to almost white, round film-coated tablet, debossed with “15” on one side with a diameter of about 7 mm.
Danish: Hvid til næsten hvid, rund filmovertrukken tablet med en diameter på ca. 7 mm, hvor den ene side af tabletten er præget med tallet "15".
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 30, 60 or 100 film-coated tablets per container.
Danish: 40 ml HDPE-bredhalset tabletbeholder med skruelåg og integreret fugtbeholder (hvid silica gel) indeholdende enten 30, 60 eller 100 filmovertrukne tabletter pr. beholder.
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Leflunomide medac 20 mg filmovertrukken tablet