FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you experience: - Pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood.
Danish: Fortæl omgående lægen, hvis du oplever: - bleghed i huden, træthed eller blå mærker, da disse kan være tegn på blodsygdomme forårsaget af en ubalance i de forskellige typer blodceller, som blodet er sammensat af.
English: Folate supplementation was optional and only used in 10 % of patients.
Danish: Supplement med folininsyre var valgfri, og anvendtes kun til 10% af patienterne.Behandlingsvarighed var 12 måneder.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske sikkerhedsopdateringsrapport (PSUR).
English: - If you are pregnant, think you may be pregnant, or are breast-feeding.
Danish: - hvis du er gravid, tror du er gravid eller ammer
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Danish: - usædvanlig prikken, svaghed eller smerte i dine hænder eller fødder, da dette kan være tegn på problemer med dine nerver (perifer neuropati).
English: Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.
Danish: Nylig, samtidig eller umiddelbart efterfølgende anvendelse af potentielt myelotoksiske stoffer kan være forbundet med øget risiko for hæmatologiske bivirkninger.
English: Magyarország Teva Magyarország Zrt Tel.: +36 1 288 64 00
Danish: Teva Magyarország Zrt Tel.: +36 1 288 64 00
English: Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, som står på pakningen.
English: Blood and lymphatic system disorders Common:
Danish: Blod- og lymfesystem Almindelig:
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs 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: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
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: The PSUR cycle of Leflunomide Teva will correspond to the one attributed to the reference medicinal product, Arava, until otherwise specified.
Danish: PSUR-cyklussen for Leflunomide Teva vil svare til den, der er gældende for referenceproduktet Leflunomide Teva, indtil andet er angivet.
English: If you are still able to have a child, you must not take Leflunomide Teva without using reliable contraception for at least 2 years after treatment.
Danish: Hvis du stadig kan blive gravid, må du ikke tage Leflunomide Teva uden at bruge sikker prævention i mindst 2 år efter endt behandling.
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 mere end 0,02 mg/l (se pkt.
English: - Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of LeflunomideTeva absorbed by your body.
Danish: - colestyramin (bruges til at reducere kolesteroltallet og til at behandle kløe forbundet med gulsot) eller aktivt kul, da disse lægemidler kan nedsætte den mængde Leflunomide Teva, der optages i kroppen.
English: - If you have ever had tuberculosis or interstitial lung disease (lung disease).
Danish: - hvis du nogensinde har haft tuberkulose eller interstitiel lungesygdom (en lungesygdom).
English: Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis have been reported in patients treated with leflunomide.
Danish: Meget sjældne tilfælde af Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse er blevet rapporteret hos patienter i behandling med leflunomid.
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: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Danish: forhøjede leverparametre (transaminaser (specielt ALAT), mindre hyppigt gammaglutamyltransferase, basisk fosfatase, bilirubin).
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, mave-tarmkanalen, hud, milt, thymus og lymfekirtler.
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric 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: Marketing Authorisation Holder: Teva Pharma B.V.
Danish: Indehaveren af markedsføringstilladelsen Teva Pharma B.V
English: - Inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis).
Danish: - betændelse i de små blodkar (vaskulitis, herunder kutan nekrotisk vasculitis).
English: You will normally take Leflunomide Teva over long periods of time.
Danish: Du skal almindeligvis fortsætte med at anvende Leflunomide Teva i en længere periode.
English: Since such therapy can lead to additive or even synergistic toxicity (e.g. hepato- or haematotoxicity), combination with another DMARD (e.g. methotrexate) is not advisable.
Danish: Da en sådan behandling kan føre til additiv og endda synergistisk toksicitet (f.eks. hepato- eller hæmatotoksicitet), er kombination med andre DMARD's (f.eks. methotrexat) ikke tilrådelig.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Danish: • Patienter med svær immundefekt, f.eks. AIDS.
English: It is recommended that monitoring of liver enzymes be maintained after discontinuation of leflunomide treatment, until liver enzyme levels have normalised.
Danish: Det anbefales at fortsætte kontrollen af leverenzymer efter seponering af leflunomidbehandlingen, indtil leverenzymniveauet er normaliseret.
English: The doctor that starts you on Leflunomide Teva and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis.
Danish: Den læge, som sætter dig i behandling med Leflunomide Teva, og som rådgiver dig undervejs, skal være erfaren i behandlingen af reumatoid artrit.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet i rækkefølge efter hvor alvorlige, de er.
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: If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue to use these after starting Leflunomide Teva.
Danish: Hvis du allerede tager non-steroid antiinflammatorisk medicin (NSAID) og/eller kortikosteroider, kan du fortsætte med at tage dem, efter du er begyndt at tage Leflunomide Teva.
English: • Patients with impairment of liver function.
Danish: • Patienter med nedsat leverfunktion.
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤ 40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Danish: Resultaterne af en befolkningsfarmakokinetik-analyse af disse forsøg har vist at pædiatriske patienter med en legemesvægt ≤40 kg har en reduceret systemisk eksponering (målt ved Css) af A771726 i forhold til voksne patienter med rheumatoid artrit (se pkt.
English: The enzymes involved in the metabolism of leflunomide and its metabolites are not exactly known.
Danish: De enzymer, som indgår i udskillelsen af leflunomid og dets metabolitter, er ikke helt klarlagt.
English: If both plasma concentrations are below 0.02 mg/l no teratogenic risk is to be expected.
Danish: Hvis begge plasmakoncentrationer er under 0,02 mg/l, kan der ikke forventes risiko for teratogen effekt.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal foretage de undersøgelser og pharmacovigilanceaktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i RMP, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
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: At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately 35 μg/ml.
Danish: Ved dosisniveauet på 20 mg/døgn er den gennemsnitlige plasmakoncentration af A771726 ved steady-state ca. 35 μg/ml.
English: Leflunomide Teva is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Danish: Leflunomid ”Teva” anbefales ikke til behandling af patienter under 18 år, da sikkerhed og virkning ved juvenil reumatoid artrit (JRA) ikke er blevet fastslået (se pkt.
English: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment
Danish: Koncentrationen kan forventes at falde til under 0,02 mg/l ca. 2 år efter behandlingen med leflunomid er ophørt.
English: This metabolite is responsible for essentially all the in vivo activity of leflunomide.
Danish: Denne metabolit er ansvarlig for praktisk talt hele leflunomids in vivo effekt.
English: However, also following either of the washout procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.
Danish: Selv efter en af ovenstående udvaskningsprocedurer er det nødvendigt, inden befrugtning at måle plasmakoncentrationen ved 2 adskilte prøver med et interval på mindst 14 dage, og at der går en periode på mindst 1½ måned fra første registrering af en plasmakoncentration under 0,02 mg/l.
English: Leflunomide Teva tablets should be swallowed whole with plenty of water.
Danish: Leflunomide Teva-tabletter skal synkes hele med masser af vand.
English: If you are pregnant or become pregnant while taking Leflunomide Teva, the risk of having a baby with serious
Danish: Hvis du er gravid eller bliver gravid, mens du tager Leflunomide Teva, er der en øget risiko for at få et barn med alvorlige medfødte misdannelser.
English: In patients with rheumatoid arthritis, no pharmacokinetic interaction between the leflunomide (10 to 20 mg per day) and methotrexate (10 to 25 mg per week) was demonstrated.
Danish: Hos patienter med reumatoid artrit sås ingen farmakokinetiske interaktioner mellem leflunomid (10-20 mg daglig) og methotrexat (10-25 mg ugentlig).
English: Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40 %, whereas the AUC was not significantly changed.
Danish: Efter samtidig indgift af enkeltdoser af leflunomid til personer, som fik multiple doser af rifampicin (non-specifik cytochrom P450 inducer) steg peakværdierne af A771726 med ca. 40%, mens AUC ikke ændredes signifikant.
English: An in vivo interaction study with cimetidine (non-specific cytochrome P450 inhibitor) has demonstrated a lack of a significant interaction.
Danish: Et in vivo interaktionsforsøg med cimetidin (non-specifik cytochrom P450 hæmmer) viste ikke signifikant interaktion.
English: A771726 plasma levels can be expected to be above 0.02 mg/l for a prolonged period.
Danish: A771726 plasmakoncentrationer kan forventes at være mere end 0,02 mg/l i en lang periode.
English: All of these also resolved, 2 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 10 mg to 20 mg once daily depending on the severity (activity) of the disease.
Danish: Den anbefalede vedligeholdelsesdosis er 10-20 mg leflunomid en gang daglig afhængig af sygdommens sværhedsgrad (aktivitet).
English: If you think you may be pregnant while you are taking Leflunomide Teva, contact your doctor immediately for a pregnancy test.
Danish: Hvis du har en formodning om, at du er gravid, mens du tager Leflunomide Teva, skal du omgående kontakte din læge for at få foretaget en graviditetstest.
English: - If you switch to another medicine to treat your rheumatoid arthritis or if you have recently taken medicines that may be harmful to your liver or blood, your doctor may advise you to take certain medicines to speed up the removal of Leflunomide Teva from your body or may closely monitor you when you start taking Leflunomide Teva.
Danish: - hvis du skifter over til anden medicin til behandling af din reumatoid artrit, eller hvis du fornylig har taget lægemidler, som kan være skadelige for din lever eller dit blod, vil din læge måske råde dig til at tage bestemte typer medicin for at fremskynde udrensningen af Leflunomide Teva fra kroppen eller vil måske kontrollere dig hyppigt, når du begynder at tage
English: - If you have bone marrow problems, or if you have low numbers of red or white blood cells or a reduced number of blood platelets, due to causes other than rheumatoid or psoriatic arthritis.
Danish: - hvis du har problemer med din knoglemarv, eller hvis du har et lavt antal røde eller hvide blodlegememer, eller et reduceret antal blodplader som følge af andre sygdomme end reumatoid artrit.
English: Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a "disease modifying antirheumatic drug" (DMARD).
Danish: Leflunomid er indiceret ved behandling af voksne patienter med aktiv reumatoid artrit som et sygdomsmodificerende antireumatisk middel ("Disease-Modifying Antirheumatic Drug", DMARD).
English: The symptoms include inflammation of joints, swelling, difficulty moving and pain.
Danish: Symptomerne er bl.a. en betændelseslignende tilstand i leddene, hævelse, besvær med at bevæge sig og smerter.
English: The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Danish: Farmakokinetikken af A771726 hos CAPD individer så ud til at svare til den hos raske frivillige forsøgspersoner.
English: In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 μg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
Danish: I et studie, hvor leflunomid blev givet samtidig med en trifasisk oral kontraceptionstablet indeholdende 30 μg ethinyløstradiol til raske frivillige kvinder, reduceredes præparatets kontraceptive effekt ikke, og farmakokinetikken af A771726 lå indenfor de forventede værdier.
English: If you take more Leflunomide Teva than you should If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Danish: Hvis du eller en anden sluger en masse tabletter på én gang, eller hvis du har en formodning om, at et barn har slugt nogle tabletter, skal du omgående kontakte dit nærmeste hospitals skadestue eller din læge.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR
English: - Other medicines that are broken down by an enzyme called CYP2C9 e.g. phenytoin (an epilepsy treatment), warfarin and phenprocoumon (blood thinners), and tolbutamide (a type 2 diabetes treatment).
Danish: - andre lægemidler, som nedbrydes af et enzym, der kaldes CYP2C9, f.eks. phenytoin (til behandling af epilepsi), warfarin og phenprocoumon (blodfortyndende) og tolbutamid (til behandling af type 2-diabetes).
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
English: In such cases re-exposure to leflunomide is contra-indicated (see
Danish: I sådanne situationer er fornyet behandling med leflunomid kontraindiceret (se pkt.
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide Teva and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Danish: Så snart der ses hud- og/eller slimhindereaktioner, som giver mistanke om sådanne alvorlige reaktioner, skal Leflunomid ”Teva” og alle øvrige behandlinger, som kan give sådanne reaktioner, seponeres, og leflunomid udvaskningsprocedure skal straks påbegyndes.
English: Reliable contraception during treatment with leflunomide should also be guaranteed.
Danish: Der skal anvendes sikker kontraception under behandling med leflunomid skal også garanteres.
English: If you are pregnant, your doctor will discuss with you the risks to the pregnancy.
Danish: Hvis testen bekræfter, at du er gravid, kan din læge drøfte risikoen ved graviditet med dig.
English: • before initiation of leflunomide,
Danish: • inden behandlingsstart med leflunomid
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; afsnit.
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Danish: Interstitiel lungesygdom er en potentiel letal sygdom, som kan opstå akut under behandling.
English: Quinoline Yellow Aluminium lake (E104)
Danish: Quinolingul Aluminium Lake (E104) Indigotin Aluminium Lake (E132)
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma
Danish: Læger og patienter skal gøres opmærksomme på, at at der findes en ad hoc-informationsservice, som rådgiver i forbindelse
English: This 2 years may be reduced to a few weeks if you take a treatment, recommended by your doctor, which speeds up removal of Leflunomide Teva
Danish: Denne periode kan forkortes til få uger, hvis du tager lægemidler, som efter din læges mening øger udskillelsen af Leflunomide Teva fra din krop.
English: - Cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light)
Danish: - kutan lupus (karakteriseret ved udslæt/rødmen på hudområder udsat for lys).
English: • When new information is received that may impact on the current Safety Specification,
Danish: • når der modtages ny information, der kan have indflydelse på den gældende sikkerhedsspecifikation, pharmacovigilance-plan eller på risikominimeringsaktiviteter
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: 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: alvorlige infektioner inklusive sepsis, som kan være letal Som andre lægemidler med immunsuppresiv effekt kan leflunomid forøge modtageligheden for infektioner, inklusive opportunistiske infektioner (se også pkt.
English: The ACR (American College of Rheumatology) response rates in study YU203 were 27.7 % for placebo, 31.9 % for 5 mg, 50.5 % for 10 mg and
Danish: ACR (American College of Rheumatology) responsraten i forsøg YU203 var 27,7% for placebo, 31,9% for 5 mg, 50,5% for 10 mg og 54,4% for 25 mg daglig.
English: All elevations resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Danish: Alle forhøjelser blev normaliseret, 2 efter fortsat behandling med begge stoffer og 3 efter seponering af leflunomid.
English: Luxembourg/Luxemburg Teva Pharma Belgium S.A. Tél/Tel: +32 3 820 73 73
Danish: Teva Pharma Belgium S.A. Tél/Tel: +32 3 820 73 73
English: - Abnormal decrease in the levels of blood uric acid.
Danish: - abnormt fald i blodets indhold af urinsyre.
English: Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial
Danish: På lignende måde kan nylig behandling med hepatotoksiske eller hæmatotoksiske lægemidler (f.eks. methotrexat) give flere bivirkninger, hvorfor iværksættelse af leflunomidbehandling skal nøje overvejes med hensyn til disse risiko/benefit aspekter og mere omhyggelig kontrol i den første periode efter præparatskiftet anbefales.