FrancophonIA/ELRC3.0 huggingface dataset:
English: Repso tablets are tablets for oral use.
Danish: Repso tabletter er tabletter til oral anvendelse.
English: Repso tablets can be taken with or without food.
Danish: Repso kan tages enten med eller uden mad.
English: In such cases patients should refrain from driving cars and using machines.
Danish: I sådanne tilfælde bør patienten ikke føre motorkøretøj og betjene maskiner.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighedsgrupperingen er defineret i henhold til følgende konvention: 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: - If you have liver problems.
Danish: - hvis du har leverproblemer.
English: Repso belongs to a group of medicines called anti-rheumatic medicines.
Danish: Repso tilhører en gruppe af lægemidler, der kaldes antireumatisk medicin.
English: No special requirements for disposal.
Danish: Ingen særlige forholdsregler ved destruktion.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Repso are provided with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Repso forsynes med en undervisningspakke for læger indeholdende følgende:
English: - If you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Danish: - hvis du nogensinde har haft tuberkulose eller, hvis du har været i kontakt med en, som har eller har haft tuberkolose.
English: Most patients improved after discontinuation of Repso.
Danish: De fleste patienter kom i bedring efter seponering af Repso.
English: Pharmacokinetic data in elderly people (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Danish: Farmakokinetiske data på ældre (> 65 år) er begrænsede, men svarer til farmakokinetikken hos yngre voksne.
English: • Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Danish: • Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: If you are pregnant or become pregnant while taking Repso, the risk of having a baby with serious birth defects is increased.
Danish: Hvis du er gravid eller bliver gravid, mens du tager Repso, er der en øget risiko for at få et barn med alvorlige medfødte misdannelser.
English: pulmonary hypertension
Danish: pulmonal hypertension
English: Leflunomide is indicated for the treatment of adult patients with
Danish: Leflunomid er indiceret ved behandling af voksne patienter med
English: If you forget to take Repso
Danish: Hvis du har glemt at tage Repso
English: CYP450 inhibitors and inducers
Danish: CYP450 hæmmere og induktorer
English: In responders, this response was maintained during 48 weeks.
Danish: Dette respons blev vedligeholdt gennem 48 uger (se pkt.
English: Repso can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs.
Danish: Repso kan lejlighedsvis forårsage problemer med dit blod, din lever og lunger eller nerverne i dine arme eller ben.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • Når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
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: - If you are woman of child-bearing age and not using effective contraception.
Danish: - hvis du er en kvinde i den fødedygtige alder og du ikke bruger sikker prævention.
English: Effect on organic anion transporter 3 (OAT3) substrates
Danish: Effekt på organisk aniontransporter-3 (OAT3) substrater
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel)
Danish: Effekt på oral antikonception (0,03 mg ethinylestradiol og 0,15 mg levonorgestrel)
English: No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
Danish: Der findes ikke klinisk data på sikkerhed og effekt af vaccinationer givet under leflunomidbehandling.
English: - If you have ever had interstitial lung disease (feeling a shortness of breath).
Danish: - hvis du nogensinde har haft interstitiel lungesygdom (følelse af stakåndethed).
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid
Danish: marginalt (reversibelt) fald i spermkoncentration, totalt spermtal og hurtig progressiv spermmotilitet
English: Crospovidone type A Pregelatinized starch (maize) Talc
Danish: Crospovidon type A Prægelatiniseret stivelse (majs) Talcum
English: What Repso contains
Danish: Repso indeholder
English: For washout procedures and other recommended actions in case of desired or unintended pregnancy see section 4.6.
Danish: Hvad angår udvaskningsprocedure og andre anbefalede forholdsregler i tilfælde af ønsket eller utilsigtet graviditet se pkt.
English: 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: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Repso 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 forslå en behandling med bestemte lægemidler for at udvaske Repso fra din krop hurtigt og tilstrækkeligt, da dette kan reducere risici for dit barn.
English: Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Danish: Endvidere kan det at skifte fra leflunomid til et andet DMARD uden at følge udvaskningsproceduren (se 4.4) også øge risikoen for alvorlige bivirkninger selv lang tid efter præparatskiftet.
English: Some vaccinations should not be given while taking Repso, and for a certain amount of time after stopping treatment.
Danish: Visse vacciner bør ikke gives under behandling med Repso og i et vist stykke tid efter endt behandling.
English: Psoriatic arthritis is the combination of psoriasis and arthritis.
Danish: Psoriasis artrit er en kombination af psoriasis og arthritis.
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: - For psoriatic arthritis: 20 mg once daily.
Danish: - for psoriasis artrit: 20 mg én gang dagligt.
English: In either case it should be confirmed by a blood test that Repso has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Danish: I alle tilfælde skal en blodprøve bekræfte, at Repso er udskilt i tilstrækkelig grad fra kroppen og derefter skal du vente mindst 1 måned, før du bliver gravid.
English: - The active substance is leflunomide.
Danish: - Det aktive stof er leflunomid.
English: Do not take Repso - If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain,
Danish: Tag ikke Repso - hvis du er allergisk over for leflunomid (specielt en alvorlig hudreaktion, ofte ledsaget af feber,
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
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: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment with leflunomide.
Danish: Koncentrationen kan forventes at falde til under 0,02 mg/l ca. 2 år efter behandlingen med leflunomid er ophørt.
English: Effect of leflunomide on other medicinal products
Danish: Leflunomids effekt på andre lægemidler
English: Repso is contraindicated in pregnancy (see section 4.3).
Danish: Repso er kontraindiceret under graviditet (se pkt.
English: paraesthesia, headache, dizziness, peripheral neuropathy
Danish: paræstesi, hovedpine, svimmelhed, perifer neuropati
English: Repso tablets should be swallowed whole with plenty of water.
Danish: Repso-tabletter skal synkes hele med masser af vand.
English: If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue to use these after starting Repso.
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 Repso.
English: What you need to know before you take Repso
Danish: Det skal du vide, før du begynder at tage Repso
English: If you suspect that you are pregnant while taking Repso or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Danish: Hvis har en formodning om, at du er gravid mens du tager Repso eller i 2 år efter afbrydelse af behandlingen skal du omgående kontakte lægen for at få foretaget en graviditetstest.
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Repso from your body.
Danish: Denne periode kan forkortes til få uger, hvis du tager visse lægemidler, som øger udskillelsen af Repso.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 30 tablets 100 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukket tablet 30 tabletter 100 tabletter ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Repso 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: Repso 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: - An increase in the levels of fat in the blood (cholesterol and triglycerides).
Danish: - en stigning i fedtniveauet i blodet (kolesterol og triglycerider).
English: After this the dose is: - For rheumatoid arthritis: 10 mg or 20 mg once daily depending on the severity of the disease.
Danish: Herefter er dosis: - for rheumatoid artrit: 10 mg eller 20 mg én gang dagligt afhængig af sygdommens sværhedsgrad.
English: Tell your doctor immediately and stop taking Repso - If you feel weak, light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction.
Danish: Fortæl omgående lægen og stop med at tage Repso - hvis du føler dig svag, føler dig ør i hovedet eller svimmel, eller har åndedrætsbesvær, da disse symptomer kan være tegn på en alvorlig allergisk reaktion.
English: Effect of other medicinal products on leflunomide
Danish: Andre lægemidlers effekt på leflunomid
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),
Danish: • aktiv reumatoid artrit som et sygdomsmodificerende antireumatisk middel ("DiseaseModifying Antirheumatic Drug", DMARD).
English: Patients were 3-17 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
Danish: Patienterne var 3-17 år gamle med et aktivt polyartikulært forløb af børnegigt (JRA) uanset starttype og ikke forud testet overfor methotrexat eller leflunomide.
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 Repso from your body or may closely monitor you when you start taking Repso.
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 Repso fra kroppen eller vil måske kontrollere dig hyppigt, når du begynder at tage Repso.
English: Cholestyramine or activated charcoal
Danish: Colestyamin og aktivt kul
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; afsnit.
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: Do not take Repso when you are breast-feeding, as leflunomide passes into the breast milk.
Danish: Tag ikke Repso, hvis du ammer, da leflunomid kan overføres til brystmælk.
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Repso.
Danish: Den lange halveringstid af leflunomid skal tages i betragtning, når vaccination med levende svækket vaccine til patienter, som er stoppet med Repso, overvejes.
English: Titanium dioxide (E171) Polydextrose (E1200) Hypromellose (E464) Triethyl citrate (E1505) Macrogol 8000
Danish: Titandioxid (E171) Polydextrose (E1200) Hypromellose (E464) Triethylcitrat (E1505) Macrogol 8000
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal
Danish: interstitial lungesygdom (inklusive interstitial pneumonitis) som kan være letal
English: Women of childbearing potential must not take Repso without using reliable contraceptive measures, and they must use reliable contraceptive measures up to 2 years after treatment.
Danish: Kvinder i den fødedygtige alder må ikke tage Repso, medmindre de anvender sikker prævention, og de skal anvende sikre præventionsmidler i op til 2 år efter behandlingen.
English: The tablets should be swallowed whole with sufficient amounts of liquid.
Danish: Tabletterne skal synkes hele med tilstrækkelig væskemængde.
English: - If you develop swollen spongy gums, ulcers, and loose teeth (an infectious mouth disease known as ulcerative stomatitis) then you should contact your doctor who may advise you to stop taking Repso.
Danish: - hvis du udvikler hævede og svampede gummer, sår, og løse tænder (en smitsom mundsygdom, der kaldes ulcerøs stomatitis), skal du kontakte din læge, som måske vil råde dig til at holde op med at tage Repso.
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 eller psoriasis artrit.
English: You will normally take Repso over long periods of time.
Danish: Du skal almindeligvis fortsætte med at anvende Repso i en længere periode.
English: - Cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension).
Danish: - hoste eller åndedrætsproblemer, da disse kan være tegn på lungeproblemer (interstitiel lungesygdom eller pumonal hypertension).
English: 6.4 Special precautions for storage
Danish: 6.4 Særlige opbevaringsbetingelser
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: 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: 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 4.2).
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: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Danish: Samtidig administration af hepatotoksiske eller hæmatotoksiske DMARD's (f.eks. methotrexat) er ikke tilrådelig.
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Repso 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 Repso og alle øvrige behandlinger, som kan give sådanne reaktioner, seponeres, og leflunomid udvaskningsprocedure skal straks påbegyndes.
English: Cases of peripheral neuropathy have been reported in patients receiving Repso.
Danish: Perifer neuropati er rapporteret hos patienter i behandling med Repso.
English: The efficacy of leflunomide 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 blev vist i et kontrolleret randomiseret dobbeltblindt forsøg 3L01 med 188 patienter med arthritis psoriatica, behandlet med 20mg/dag.
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: - Cimetidine, medicine for the treatment of heartburn and peptic ulcers
Danish: - cimetidin, medicin til behandling af halsbrand og mavesår.
English: - If you get any side effects , talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Danish: Risikoen for malignitet, særligt lymfoproliferative lidelser, øges ved samtidig behandling med visse immunsuppressive stoffer.
English: For tablets stored in tablet containers: Do not store above 30°C.
Danish: For tabletter opbevaret i tabletbeholdere: Må ikke opbevares over 30 °C.
English: Men wishing to father a child should contact their doctor who may advise them to stop taking Repso and take certain medicines to remove Repso rapidly and sufficiently from their body.
Danish: Mænd, der ønsker at få børn, skal kontakte lægen, der kan råde dig til at stoppe med at tage Repso og tage bestemte typer medicin, der kan udrense Repso fra kroppen hurtigt og tilstrækkeligt.
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 nogle af de øvrige indholdsstoffer i tabletterne anført i pkt.
English: If both plasma concentrations are below 0.02 mg/l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Danish: Hvis begge plasmakoncentrationsmålinger er under 0,02 mg/l og efter en pause på mindst 3 måneder er risikoen for føtal toksicitet meget lille.
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 forsøg, 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: Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40 % in 24 hours and by 49 % to 65 % in 48 hours.
Danish: Colestyramin givet oralt i doser på 8 g 3 gange daglig i 1 døgn til 3 raske frivillige forsøgspersoner reducerede plasmakoncentrationen af A771726 med ca. 40% i løbet af 24 timer og 49-65% i løbet af 48 timer.
English: Repso is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Danish: Repso er kontraindiceret til patienter med svær hypoproteinæmi eller nedsat leverfunktion (se pkt.
English: Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Danish: Repso bruges til at behandle voksne med aktiv reumatoid artrit eller med aktiv psoriasis artrit .