FrancophonIA/ELRC3.0 huggingface dataset:
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 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59% in the leflunomide group and 29.7% in the placebo group by 6 months (p<0.0001).
Danish: Leflunomid 20 mg/dag var signifikant bedre end placebo til at reducere arthritis symptomerne hos patienter med arthritis psoriatica: PsARC respons (Psoriatic Arthritis treatment Response Criteria) var 59% i leflunomidgruppen og 29,7 % i placebogruppen ved 6 måneder (p< 0,0001).
English: Leflunomide Zentiva 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 Zentiva 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: • Patients with serious infections (see section 4.4).
Danish: • Patienter med alvorlige infektioner (se pkt.
English: hypouricemia Psychiatric disorders Uncommon: anxiety Nervous system disorders Common:
Danish: hypourikæmi Psykiske forstyrrelser Ikke almindelig: angst Nervesystemet Almindelig:
English: Neoplasms benign, malignant and unspecified (incl.
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: If you are pregnant or become pregnant while taking Leflunomide Zentiva, the risk of having a baby with serious birth defects is increased.
Danish: Hvis du er gravid, eller bliver gravid, mens du tager Leflunomid Zentiva, er der en øget risiko for at få et barn med alvorlige medfødte misdannelser.
English: If such effects occur, a washout (see below) to reduce plasma levels of A771726 should be considered.
Danish: Hvis sådanne reaktioner opstår, bør udvaskning (se nedenfor) overvejes for at reducere plasmakoncentrationen af A771726.
English: If a waiting period of up to approximately 2 years under reliable contraception is considered unpractical, prophylactic institution of a washout procedure may be advisable.
Danish: Hvis denne periode på ca. 2 år med samtidig anvendelse af en sikker kontraceptionsmetode ikke skønnes praktisk gennemførlig, kan det anbefales profylaktisk at gennemføre udvaskningsproceduren.
English: In a carcinogenicity study in mice an increased incidence of malignant lymphoma occurred in males of the highest dose group, considered to be due to the immunosuppressive activity of leflunomide.
Danish: I et carcinogenicitetsforsøg på mus sås øget forekomst af malignt lymfom hos hanner i den gruppe, der fik højeste dosis, hvilket anses at skyldes leflunomids immunsupprimerende aktivitet.
English: Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Danish: Kvinder i den fertile alder skal informeres om, at en pause på 2 år efter behandlingsophør er påkrævet, inden de må blive gravide.
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'er (f.eks. methotrexat) ikke tilrådelig.
English: Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
Danish: Leflunomid var ved døgndoser på mindst 10 mg (10-25 mg i forsøg YU203, 20 mg i forsøg MN301 og US301) statistisk signifikant bedre end placebo til at reducere tegn og symptomer på reumatoid artrit i alle 3 placebokontrollerede forsøg.
English: cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Danish: cyster og polypper) Risikoen for malignitet, særligt lymfoproliferative lidelser, øges ved samtidig behandling med visse immunsuppressive stoffer.
English: Leflunomide Zentiva can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs.
Danish: Leflunomid Zentiva kan lejlighedsvis forårsage problemer med dit blod, din lever og lunger eller nerverne i dine arme eller ben.
English: Leflunomide exhibits the best protective effects on animal models of autoimmune diseases when administered in the early phase of the disease progression.
Danish: Leflunomid har i dyremodeller af autoimmune sygdomme udvist de mest beskyttende virkninger, hvis det blev givet i sygdomsforløbets tidlige fase.
English: Most patients improved after discontinuation of leflunomide.
Danish: De fleste patienter kom i bedring efter seponering af Leflunomid Zentiva.
English: If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3-fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Danish: Hvis ALAT (SGPT) forbliver forhøjet med mere end 2 gange det øvre normalområde, eller hvis ALAT stiger til mere end 3 gange det øvre normalområde, skal leflunomidbehandlingen seponeres og en udvaskningsprocedure skal initieres.
English: paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders
Danish: paræstesi, hovedpine, svimmelhed, perifer neuropati
English: The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
Danish: Leflunomids aktive metabolit, A771726, har en lang halveringstid på sædvanligvis 1-4 uger.
English: Omission of the loading dose may decrease the risk of adverse events (see section 5.1).
Danish: Udeladelse af startdosis kan nedsætte risikoen for bivirkninger (se pkt.
English: You will normally take Leflunomide Zentiva over long periods of time.
Danish: Du skal almindeligvis fortsætte med at anvende Leflunomid Zentiva i en længere periode.
English: Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients treated with leflunomide.
Danish: Meget sjældne tilfælde af Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og lægemiddelreaktion med eosinofili og systemiske reaktioner (DRESS) er blevet rapporteret hos patienter i behandling med leflunomid.
English: Do not take Leflunomide Zentiva when you are breast-feeding, as leflunomide passes into the breast milk.
Danish: Tag ikke Leflunomid Zentiva, hvis du ammer, da leflunomid kan udskilles i mælk.
English: The principal faecal component was A771726.
Danish: Den væsentligste komponent i fæces var A771726.
English: Rare:
Danish: Sjælden:
English: The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser).
Danish: Interferens med fastsættelse af ioniserede calciumniveauer Målingen af ioniserede caliumniveauer kan vise fejlagtige reducerede værdier under behandling med leflunomid og/eller teriflunomid (leflunomids aktive metabolit), afhængigt af typen af apparat, der anvendes til analyse af ioniseret calcium (f.eks. blodgasanalyseapparat).
English: The Physician Leaflet should contain the following key messages:
Danish: Informationsfolderen til læger skal indeholde følgende nøgleinformation:
English: Binding of A771726 appeared slightly reduced and more variable in plasma from patients with rheumatoid arthritis or chronic renal insufficiency.
Danish: Bindingen af A771726 synes let nedsat og mere variabel i plasma fra patienter med reumatoid artrit eller kronisk nyreinsufficiens.
English: Sanofi Winthrop Industrie 56 route de Choisy au bac F-60205 Compiegne Cedex France
Danish: Sanofi Winthrop Industrie 56 route de Choisy au bac F-60205 Compiegne Cedex Frankrig
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that paediatric 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: 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: 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: 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: Treatment withdrawal may be considered taking into account patient's disease and past history.
Danish: Seponering kan overvejes afhængigt af patientens sygdom og anamnese.
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex France
Danish: Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex Frankrig
English: The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Danish: Farmakokinetikken af A771726 hos CAPD-patienter syntes at svare til den hos raske frivillige forsøgspersoner.
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Danish: • At der er risiko for alvorlig leverskade, og at det derfor er vigtigt regelmæssigt at måle ALAT for at overvåge leverfunktionen.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Blood pressure
Danish: Blodtryk
English: The relevance of the findings in mice relative to the clinical use of leflunomide is uncertain.
Danish: Betydningen af disse fund på mus for den kliniske anvendelse af leflunomid er endnu ikke klarlagt.
English: severe increase in blood pressure Respiratory, thoracic and mediastinal disorders Rare:
Danish: alvorlig blodtryksforhøjelse Luftveje, thorax og mediastinum Sjælden:
English: Leflunomide Zentiva is contraindicated in pregnancy (see section
Danish: Leflunomid Zentiva er kontraindiceret under graviditet (se pkt.
English: The metabolic biotransformation of leflunomide to A771726 and subsequent metabolism of A771726 is not controlled by a single enzyme and has been shown to occur in microsomal and cytosolic cellular fractions.
Danish: Den metaboliske biotransformation af leflunomid til A771726 og efterfølgende metabolisering af A771726 kontrolleres ikke af et enkelt enzym, og den har vist sig at finde sted i mikrosomale og cytosolisk cellulære fraktioner.
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, måske vil bruge anden medicin eller har gjort det for nylig.
English: • Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.
Danish: • Patienter med alvorlig nedsat knoglemarvsfunktion eller markant anæmi, leukopeni, neutropeni eller trombocytopeni, som skyldes andre årsager end reumatoid artrit eller arthritis psoriatica,
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 af fertilitetsstudier hos dyr har ikke vist indvirkning på fertiliteten hos hanner og hunner, men negative virkninger på de hanlige kønsorganer sås i toksicitetsstudier efter gentagne doser (se pkt.
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed (specielt tidligere Stevens-Johnsons syndrom, toksisk epidermal nekrolyse, erythema multiforme) over for det aktive stof, den primære aktive metabolit teriflunomid eller over for et eller flere af hjælpestofferne anført i pkt.
English: The efficacy of Leflunomide Zentiva was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Danish: Effekten af Leflunomid Zentiva blev vist i et kontrolleret randomiseret dobbeltblindt forsøg 3L01 med 188 patienter med arthritis psoriatica, behandlet med 20mg/dag.
English: The extensive protein binding of A771726 could lead to displacement of other highly-bound drugs.
Danish: Den udtalte proteinbinding af A771726 kan føre til forskydning af andre lægemidler med høj binding.
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: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Danish: forhøjede leverparametre (aminotransferaser (specielt ALAT), mindre hyppigt gammaglutamyltransferase, basisk fosfatase, bilirubin).
English: Infections and infestations Rare:
Danish: Infektioner og parasitære sygdomme Sjælden:
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal.
Danish: interstitial lungesygdom (inklusive interstitial pneumonitis) som kan være letal.
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER UDLØBSDATO
English: Some patients may even still feel further improvements after 4 to 6 months of therapy.
Danish: Nogle patienter kan efter 4-6 måneders behandling stadig opleve bedring.
English: Similar studies showed that ibuprofen and diclofenac did not displace A771726, whereas the unbound fraction of A771726 is increased 2- to 3-fold in the presence of tolbutamide.
Danish: Tilsvarende forsøg viser, at ibuprofen og diclofenac ikke forskyder A771726, hvorimod den ubundne fraktion af A771726 stiger 2-3 gange ved tilstedeværelse af tolbutamid.
English: Pustular psoriasis and worsening of psoriasis have been reported after the use of leflunomide.
Danish: Pustuløs psoriasis samt forværring af psoriasis er blevet rapporteret efter behandling med leflunomid.
English: What you need to know before you take Leflunomide Zentiva Do not take Leflunomide Zentiva
Danish: Det skal du vide, før du begynder at tage Leflunomid Zentiva Tag ikke Leflunomid Zentiva
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 54.5% for 25 mg/day.
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: 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: The tablets are packed in blisters or bottles.
Danish: Tabletterne er pakket i blisterpakninger eller tabletglas.
English: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Danish: Samtidig administration af hepatotoksiske eller hæmatotoksiske DMARD'er (f.eks. methotrexat) er ikke tilrådelig.
English: ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 8 weeks thereafter.
Danish: ALAT skal kontrolleres inden behandling med leflunomid påbegyndes med samme hyppighed som det fulde blodbillede (hver anden uge) i de første 6 måneder og derefter hver 8. uge.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Leflunomide Zentiva rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Danish: Hvis testen bekræfter, at du er gravid, kan din læge foreslå en behandling med bestemte lægemidler for at udvaske Leflunomid Zentiva fra din krop hurtigt og tilstrækkeligt, da dette kan nedsætte risikoen for dit barn.
English: Yellow ferric oxide (E172)
Danish: Gul jernoxid (E172)
English: Effect of other medicinal products on leflunomide:
Danish: Andre lægemidlers effekt på leflunomid:
English: Leflunomide was studied in a single multicenter, randomized, double-blind, active-controlled trial in 94 patients (47 per arm) with polyarticular course juvenile rheumatoid arthritis.
Danish: Leflunomid blev undersøgt i et single, multicenter, randomiseret dobbelt-blind, aktiv-kontrol forsøg i 94 patienter (47 i hver arm) med polyartikulært forløb af børnegigt.
English: A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
Danish: A771726, der er leflunomids aktive metabolit, hæmmer det humane enzym dihydroorotatdehydrogenase (DHODH) og udviser antiproliferativ aktivitet.
English: severe infections, including sepsis which may be fatal.
Danish: alvorlige infektioner inklusive sepsis, som kan være letal.
English: The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Danish: Den aktive metabolit af leflunomid, A771726 mistænkes for at forårsage alvorlige medfødte misdannelser ved indgivelse under graviditet.
English: Effect on warfarin (CYP2C9 substrate)
Danish: Effekt på warfarin (CYP2C9 substrat)
English: • before initiation of leflunomide
Danish: • inden behandlingsstart med leflunomid
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 (1020 mg daglig) og methotrexat (10-25 mg ugentlig).
English: In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Danish: I et forsøg med radioaktivt mærket 14C-leflunomid hos tre raske forsøgspersoner genfandt man ikke uomdannet leflunomid i plasma, urin og fæces.
English: Effect on caffeine (CYP1A2 substrate)
Danish: Effekt på koffein (CYP1A2 substrat)
English: It is possible that rapidly lowering the blood level of the active metabolite, by instituting the drug elimination procedure described below, at the first delay of menses may decrease the risk to the foetus from leflunomide.
Danish: Det er muligt, at en hurtig sænkning af plasmakoncentrationen af den aktive metabolit (ved gennemførelse af den nedenfor beskrevne procedure for lægemiddelelimination) ved første tegn på udebleven menstruation kan mindske leflunomids mulige skadevirkninger på fosteret.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n=121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Danish: Et randomiseret studie undersøgte den kliniske responsrate hos DMARD-naïve patienter med tidlig reumatoid artrit (n=121), som i to parallelle grupper enten fik 20 mg eller 100 mg leflunomid i den indledende tre dage lange dobbeltblinde periode.
English: If you forget to take Leflunomide Zentiva
Danish: Hvis du har glemt at tage Leflunomid Zentiva
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate).
Danish: • Information om den identificerede risiko for synergistisk hepato- eller hæmatotoksicitet forbundet med kombinationsbehandling med andre DMARDs (Disease-Modifying Antirheumatic Drugs) (f.eks. methotrexat).
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 virkninger.
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Danish: Interstitiel lungesygdom er en potentielt dødelig sygdom, som kan opstå akut under behandling.
English: Psoriatic arthritis
Danish: Arthritis psoriatica
English: If a patient taking Leflunomide Zentiva develops a peripheral neuropathy, consider discontinuing Leflunomide Zentiva therapy and performing the drug elimination procedure (see section 4.4).
Danish: Hvis en patient i behandling med Leflunomid Zentiva udvikler perifer neuropati, bør det overvejes at seponere behandlingen og iværksætte udvaskningsproceduren (se pkt.
English: 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: In other studies, unchanged leflunomide levels in plasma have rarely been detected, however, at ng/ml plasma levels.
Danish: I andre forsøg er plasmakoncentrationer af uomdannet leflunomid sjældent blevet genfundet, og da i plasmakoncentrationer i ng/ml.
English: Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Danish: Leflunomid er et sygdomsmodificerende antireumatisk lægemiddel med antiproliferative egenskaber.
English: Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.
Danish: Der er indrapporteret sjældne tilfælde af progressiv multifokal leukoencelopati (PML) hos patienter, der får leflunomid og andre immunsuppressiva.
English: DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Danish: DRESS viser sig først som influenzalignende symptomer og udslæt i ansigtet, herefter som et udbredt udslæt med høj temperatur, forhøjede niveauer af leverenzymer i blodprøver, en forøgelse af en type hvide blodlegemer (eosinofili) og forstørrede lymfeknuder.