FrancophonIA/ELRC3.0 huggingface dataset:
English: In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).
Danish: I sådanne situationer er fornyet behandling med leflunomid kontraindiceret (se pkt.
English: If a patient taking Repso develops a peripheral neuropathy, consider discontinuing Repso therapy and performing the drug elimination procedure (see section 4.4).
Danish: Hvis en patient i behandling med Repso udvikler perifer neuropati, bør det overvejes at seponere behandlingen og iværksætte udvaskningsproceduren (se pkt.
English: Results of animal fertility studies have shown no effect on male and female fertility, but adverse effects on male reproductive organs were observed in repeated dose toxicity studies (see section 5.3).
Danish: Resultater fra dyrefertilitetsstudier har ikke vist nogen virkning på fertiliteten hos hanner og hunner, men der blev observeret bivirkninger i reproduktionsorganerne i toksicitetsstudier med gentagne doser (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Repso 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Repso 10 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 10 mg leflunomid.
English: Each film-coated tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose.
Danish: Hver filmovertrukne tablet indeholder 97,25 mg lactosemonohydrat og 3,125 mg vandfri lactose.
English: - Severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Danish: - alvorlige, nogle gange livstruende reaktioner (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse, erythema multiforme).
English: Do not use this medicine after the expiry date that is stated on the outer carton,blister or tablet container after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, som står på pakningen, blisteren eller tabletbeholderen.
English: Very rare side effects (may affect up to 1 in 10,000 people) - An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer) - en infektion, der er kendetegnet ved høj feber, ondt i halsen, hudlæsioner og et udtalt fald i antallet af hvid blodlegemer (agranulocytose).
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30 °C.
English: Since Repso can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Danish: Din læge vil også kontrollere dit blodtryk jævnligt, da Repso kan medføre en stigning i blodtrykket.
English: Each film-coated tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose.
Danish: Hver filmovertrukne tablet indeholder 194,5 mg lactosemonohydrat og 6,25 mg vandfri lactose.
English: Tell your doctor if you plan to become pregnant after stopping treatment with Repso, as you need to ensure that all traces of Repso have left your body before trying to become pregnant.
Danish: Hvis du planlægger at blive gravid efter du er stoppet i behandling med Repso, skal du fortælle det til din læge forinden, da du skal kunne sikre dig, at alle spor af Repso i kroppen er væk før du forsøger at blive gravid.
English: Other medicines and Repso
Danish: Brug af anden medicin sammen med Repso
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. Steven-Johnsons syndrom, toksisk epidermisk nekrolyse, erhytheme multiforme, lægemiddelreaktion med eosinofili og systemiske symptomer [DRESS]), se punkt
English: - Mild reduction in blood platelets, which increases the risk of bleeding or bruising.
Danish: (anæmi) - let fald i antallet af blodplader, hvilket øger risikoen for blødning eller blodudtrædninger.
English: Teva B.V.
Danish: Teva Nederland B.V.
English: • Physician Leaflet The Physician Leaflet should contain the following key messages:
Danish: Informationsfolderen til læger skal indeholde følgende nøgleinformation:
English: Uncommon side effects (may affect up to 1 in 100 people) - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer) - fald i antallet af røde blodlemeter, som kan gøre huden bleg og forårsage slaphed eller åndenød
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 sulfasalazinpatienterne, og henholdsvis 64,8% (forsøg MN302) og 43,9% (forsøg US301) hos methotrexat-patienterne.
English: Repso contains lactose.
Danish: Repso indeholder lactose.
English: The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5).
Danish: Samtidig anvendelse af leflunomid og antimalariamidler, som benyttes ved reumatiske sygdomme (f.eks chloroquin og hydroxychloroquin), intramuskulært eller oralt guld, penicillamin, azathioprin og andre immunsuppressive lægemidler, inklusive tumor nekrosis factor alfa-hæmmere er på nuværende tidspunkt ikke tilstrækkeligt undersøgt i randomiserede forsøg (dog undtaget methotrexat, se pkt.
English: Silica, colloidal anhydrous Lactose anhydrous Magnesium stearate
Danish: Kolloid vandfri silica Lactose, vandfri Magnesiumstearat
English: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous
Danish: Almindelig: Meget sjælden: svære anafylaktiske/anafylaktoide reaktioner, vasculitis inklusive kutan
English: Titanium dioxide (E171) Hypromellose (E464) Macrogol 400
Danish: Hypromellose (E464) Macrogol 400
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 A771726.
Danish: 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: NSAIDs/Corticosteroids
Danish: NSAID/Kortikosterider
English: In case you forget to take a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du indtage den manglende tablet, så snart du kommer i tanke om det. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Repso - If you already have low red or white blood cells (anaemia or leucopenia), low blood platelets, which may increase your bleeding or bruising (thrombocytopenia), low bone marrow function or if you are at risk of your bone marrow not working properly your doctor may advise you to take certain medicines to speed up the removal of Repso from your body.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apoteket eller sundhedspersonalet før du tager Repso - hvis du allerede har et lavt antal røde eller hvide blodlegemer (anæmi eller leukopeni), lavt antal blodplader, som kan øge blødninger eller blodudtrædninger (trombocytopeni), lav knoglemarvsfunktion, eller hvis du risikerer, at din knoglemarv ikke fungerer ordentligt, kan din læge råde dig til at tage visse lægemidler til at fremskynde udrensningen af Repso fra din krop.
English: red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis).
Danish: ledsmerter, røde pletter på huden eller blærer, f.eks. Steven-Johnsons syndrom) eller et af de øvrige indholdsstoffer i Repso (angivet i punkt 6), eller du er allergisk over for teriflunomid (til behandling af multipel sclerose).
English: - Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice).
Danish: - gulsot (leverbetændelse) - gulning af huden eller af det hvide i øjnene som følge af lever- eller blodproblemer (gulsot).
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 (see above and section 2) 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 (se ovenfor og i punkt 2) kan også forekomme.
English: OUTER CARTON/BLISTER PACK
Danish: YDRE KARTON / BLISTERPAK
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin, planlægger at bruge det, eller har brugt det for nylig.
English: The doctor that starts you on Repso and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Den læge, som sætter dig i behandling med Repso, og som rådgiver dig undervejs, skal være erfaren i behandlingen af reumatoid artrit.
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
Danish: • Arthritis psoriatica: leflunomidbehandling indledes med en startdosis på 100 mg en gang daglig i 3 dage.
English: Therefore, when warfarin or another coumarin anticoagulant is co-administered, close international normalised ratio (INR) follow-up and monitoring is recommended.
Danish: Tæt opfølgning og overvågning af international normaliseret ratio (INR) anbefales derfor, når warfarin eller andre coumarin antikoagulantia administreres samtidigt.
English: How to take Repso
Danish: Sådan skal du tage Repso
English: - Hepatitis (inflammation of the liver).
Danish: - furosemid mod hjertelidelse (vanddrivende).
English: - The other ingredients are (see section 2 “Repso contains lactose”)
Danish: 2 “Repso indeholder lactose”)
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Danish: Sjælden: Meget sjælden: svær leverskade som f.eks. leversvigt og akut hepatisk nekrose, som kan være letal
English: Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Danish: Mørk beige, trekantsformede filmovertrukne tabletter, præget med “20” på den ene side og “L” på den anden.
English: hypokalaemia, hyperlipidemia, hypophosphataemia
Danish: Ikke almindelig: hypokaliæmi, hyperlipidæmi, hypofosfatæmi Sjælden:
English: 28 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter 100 filmovertrukne tabletter
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 (ALAT), mindre hyppigt gamma-GT, basisk fosfatase og bilirubin).
English: severe infections, including sepsis which may be fatal Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Danish: Som andre lægemidler med immunsuppresiv effekt kan leflunomid forøge modtageligheden for infektioner, inklusive opportunistiske infektioner (se også pkt.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje ,thorax og mediastinum
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 metotrexat 7,5 mg ugentlig stigende til 15 mg ugentlig (n = 498).
English: Marketing Authorisation Holder Teva B.V.
Danish: Indehaver af markedsføringstilladelsen Teva Pharma B.V.
English: Repso provided in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Danish: Repso fås som blisterpakninger fås i pakningsstørrelser på 28, 30 og 100 filmovertrukne tabletter.
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
Danish: leukopeni (leukocytter < 2 G/l), eosinofili
English: Swallow tablets whole.
Danish: Tabletterne synkes hele.
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 Ikke almindelig: smagsforstyrrelser Meget sjælden: pancreatitis
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Teva Pharma B.V
English: Iron Oxide Yellow (E172) Polysorbate (E433)
Danish: Polysorbat (E433)
English: - If you are male and wish to father a child. As it cannot be excluded that Repso passes into semen, reliable contraception should be used during treatment with Repso.
Danish: Da det ikke kan udelukkes, at Repso findes i sæden, skal der bruges pålidelig prævention under behandlingen med Repso.
English: The symptoms include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Danish: Symptomerne på aktiv psoriasis artrit er blandt andet en betændelseslignende tilstand i leddene, hævelse, besvær med at bevæge sig, smerter og røde, afskallende pletter på huden (hudlæsioner)
English: In case of severe haematological reactions, including pancytopenia, Repso and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Danish: pancytopeni skal Repso og anden samtidig behandling med myelosuppresive lægemidler seponeres og leflunomid udvaskningsproceduren påbegyndes.
English: 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: 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: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of leflunomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg 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: HDPE tablet containers: 2 years
Danish: Repso 10 mg filmovertrukne tabletter HDPE-tabletbeholdere: 2 år Blister: 2 år
English: Common: Uncommon:
Danish: Almindelig: Ikke almindelig: seneruptur
English: For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/l):
Danish: For at sikre, at fosteret ikke udsættes for toksiske koncentrationer af A771726 (fokuskoncentration under 0,02 mg/l) anbefales en af følgende procedurer til kvinder i leflunomidbehandling, som ønsker at blive gravide:
English: Repso provided in tablet containers are available in pack sizes of 30 and 100 film-coated tablets.
Danish: Repso fås som tabletbeholdere i pakningsstørrelser på 30 og 100 filmovertrukne tabletter.
English: Before and during treatment with Repso, your doctor will carry out blood tests at regular times.
Danish: Din læge vil tage regelmæssige blodprøver, før og under behandling med Repso, for at overvåge dine blodceller og din lever.
English: Renal and urinary disorders
Danish: Nyre- og urinvejslidelser
English: If you take more Repso than you should
Danish: Hvis du har taget for meget Repso
English: In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Danish: In vitro hæmningsforsøg med humane levermikrosomer tyder på, at cytochrom P450 (CYP) 1A2, 2C19 og 3A4 er involverede i leflunomids metabolisering.Et in vivo interaktionsforsøg med leflunomid og cimetidin (non-specifik, svag cytochrom P450 (CYP) hæmmer) viste ikke signifikant indvirkning på A771726s eksponering.
English: - Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm.
Danish: - smagsforstyrrelser - nældefeber - seneruptur - lavt kaliumniveau i blodet, hvilket giver muskelsvaghed, kramper eller unormal puls.
English: - An increase in the number of blood cells called eosinophiles (eosinophilia).
Danish: - stigning i antallet af blodlegemer kaldet eosinofile blodceller - lungebetændelse (interstitial lungesygdom), som kan være livstruende.
English: Do not pass it on to others.
Danish: Lad derfor være med at give det til andre, selvom de har de samme symptomer, som du har.
English: Repso 20 mg film-coated tablets
Danish: Repso 20 mg filmovertrukne tabletter
English: Repso 10 mg film-coated tablets
Danish: Repso 10 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Repso 20 mg tablets leflunomide
Danish: LÆGEMIDLETS NAVN Repso 20 mg tabletter leflunomid
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: Repso 20 mg film-coated tablets leflunomide
Danish: Repso 20 mg filmovertrukne tabletter leflunomid
English: What Repso looks like and contents of the pack Repso 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Danish: Repso 10 mg filmovertrukne tabletter er hvide, runde filmovertrukne tabletter præget med “10” på den ene side og “L” på den anden.
English: Repso 10 mg film-coated tablets leflunomide
Danish: Repso 10 mg filmovertrukne tabletter leflunomid
English: You will then need a blood test to make sure that Repso has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Danish: Derefter skal du vente mindst 3 måneder yderligere, inden du forsøger at blive far.
English: Rare side effects (may affect up to 1 in 1,000 people) - Severe increase in blood pressure.
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer)
English: OUTER CARTON/BOTTLE PACK
Danish: YDRE KARTON/ÆSKE TIL MEDICINGLAS
English: LIST OF EXCIPIENTS Contains lactose (see leaflet for further information).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose (se indlægsseddel).
English: EU/1/11/674/008 28 film-coated tablets EU/1/11/674/009 30 film-coated tablets EU/1/11/674/010 100 film-coated tablets
Danish: EU/1/11/674/008 28 filmovertrukne tabletter EU/1/11/674/009 30 filmovertrukne tabletter EU/1/11/674/010 100 filmovertrukne tabletter
English: Common side effects (may affect up to 1 in 10 people) - Mild increase in blood pressure.
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) - svag stigning i blodtryk - et mindre fald i antallet af hvide blodlegemer, hvilket øger risikoen for infektioner (leukopeni).
English: • Each film-coated tablet contains 20 mg of leflunomide.
Danish: • Hver filmovertrukket tablet indeholder 20 mg leflunomid.
English: Each film-coated tablet contains 20 mg of leflunomide.
Danish: Hver filmovertrukne tablet indeholder 20 mg leflunomid.
English: 2031GA Haarlem
Danish: 2031 GA Haarlem Nederlandene
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/674/001-010
Danish: EU/1/11/674/001-010
English: EU/1/11/674/007 100 film-coated tablets
Danish: EU/1/11/674/003 28 filmovertrukne tabletter
English: • Each film-coated tablet contains 10 mg of leflunomide.
Danish: • Hver filmovertrukket tablet indeholder 10 mg leflunomid.
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets Repso 20 mg film-coated tablets
Danish: Repso 10 mg filmovertrukket tablet Repso 20 mg filmovertrukne tabletter
English: Each film-coated tablet contains 10 mg of leflunomide.
Danish: Hver filmovertrukket tablet indeholder 10 mg leflunomid.
English: NAME OF THE MEDICINAL PRODUCT Repso 20 mg film-coated tablets leflunomide
Danish: LÆGEMIDLETS NAVN Repso 20 mg filmovertrukne tabletter leflunomid
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets leflunomide
Danish: LÆGEMIDLETS NAVN Repso 10 mg filmovertrukne tabletter leflunomid