FrancophonIA/ELRC3.0 huggingface dataset:
English: Certain vaccinations should not be given while taking Arava, and for a certain amount of time after stopping treatment.
Danish: Visse vacciner bør ikke gives under behandling med Arava og i et vist stykke tid efter endt behandling.
English: Your doctor will carry out blood tests at regular intervals, before and during treatment with Arava, to monitor your blood cells and liver.
Danish: Din læge vil tage regelmæssige blodprøver, før og under behandling med Arava, for at overvåge dine blodceller og din lever.
English: This metabolite is responsible for essentially all the in vivo activity of Arava.
Danish: Denne metabolit er ansvarlig for praktisk talt hele Aravas in vivo effekt.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Arava 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 Arava fra din krop hurtigt og tilstrækkeligt, da dette kan nedsætte risikoen for dit barn.
English: In either case it should be confirmed by a blood test that Arava 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 Arava er udskilt i tilstrækkelig grad fra kroppen og derefter skal du vente mindst 1 måned, før du bliver gravid.
English: Cases of peripheral neuropathy have been reported in patients receiving Arava.
Danish: Perifer neuropati er rapporteret hos patienter i behandling med Arava.
English: Arava is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Danish: Arava bruges til at behandle voksne med aktiv rheumatoid artrit eller med aktiv arthritis psoriatica.
English: If you forget to take Arava
Danish: Hvis du har glemt at tage Arava
English: Talk to your doctor, pharmacist or nurse before taking Arava - if you have ever suffered from inflammation of the lung (interstitial lung disease).
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Arava - hvis du nogensinde har haft betændelse i lungen (interstitiel lungesygdom).
English: Arava 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: Arava 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: Do not take Arava when you are breast-feeding, as leflunomide passes into the breast milk.
Danish: Tag ikke Arava, hvis du ammer, da leflunomid kan udskilles i mælk.
English: This medicinal product contains lactose (see leaflet for further information).
Danish: LISTE OVER HJÆLPESTOFFER Dette lægemiddel indeholder lactose (se indlægssedlen for yderligere information).
English: Women of childbearing potential must not take Arava without using reliable contraceptive measures.
Danish: Kvinder i den fødedygtige alder må ikke tage Arava, medmindre de anvender sikker prævention.
English: If you are pregnant or become pregnant while taking Arava, the risk of having a baby with serious birth defects is increased.
Danish: Hvis du er gravid, eller bliver gravid, mens du tager Arava, er der en øget risiko for at få et barn med alvorlige medfødte misdannelser.
English: If a patient taking Arava develops a peripheral neuropathy, consider discontinuing Arava therapy and performing the drug elimination procedure (see section 4.4).
Danish: Hvis en patient i behandling med Arava udvikler perifer neuropati, bør det overvejes at seponere behandlingen og iværksætte udvaskningsproceduren (se pkt.
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.
English: Other medicines and Arava
Danish: Brug af anden medicin sammen med Arava
English: The efficacy of Arava was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Danish: Effekten af Arava blev vist i et kontrolleret randomiseret dobbeltblindt forsøg 3L01 med 188 patienter med arthritis psoriatica, behandlet med 20mg/dag.
English: Arava contains lactose
Danish: Arava indeholder lactose
English: Arava is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Danish: Arava er kontraindiceret til patienter med svær hypoproteinæmi eller nedsat leverfunktion (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: Fertilitetsstudier hos dyr har ikke vist indvirkning på fertiliteten hos hanner og hunner, men negative virkninger på hanlige kønsorganer blev observeret i toksicitetsstudier med gentagen dosering (se pkt.
English: If you suspect that you are pregnant while taking Arava 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, enten mens du tager Arava eller inden for 2 år efter, du har stoppet 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 Arava from your body.
Danish: Denne periode kan forkortes til få uger, hvis du tager visse lægemidler, som øger udskillelsen af Arava.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.. 4.2).
English: If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Arava.
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 Arava.
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Arava.
Danish: Den lange halveringstid af leflunomid skal tages i betragtning, når vaccination med levende svækket vaccine til patienter, som er stoppet med Arava, overvejes.
English: Arava is contraindicated in pregnancy(see section 4.3).
Danish: Arava er kontraindiceret under graviditet (se pkt.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Danish: toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme
English: Arava contains lactose.
Danish: Arava indeholder lactose.
English: Men wishing to father a child should contact their doctor who may advise them to stop taking Arava and take certain medicines to remove Arava rapidly and sufficiently from their body.
Danish: Mænd der ønsker at få børn, skal kontakte lægen, der kan tilråde at stoppe med at tage Arava og ordinere bestemte typer medicin, der kan udrense Arava fra kroppen hurtigt og tilstrækkeligt.
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Arava 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 Arava og alle øvrige behandlinger, som kan give sådanne reaktioner, seponeres, og leflunomid udvaskningsprocedure skal straks påbegyndes.
English: Tell your doctor if you plan to become pregnant after stopping treatment with Arava, as you need to ensure that all traces of Arava have left your body before trying to become pregnant.
Danish: Hvis du planlægger at blive gravid efter du er stoppet i behandling med Arava, skal du fortælle det til din læge forinden, da du skal kunne sikre dig, at alle spor af Arava i kroppen er væk før du forsøger at blive gravid.
English: colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain
Danish: Colitis, herunder mikroskopisk colitis, såsom lymfocytær colitis, kollagenøs colitis, diarré, kvalme, opkastning, påvirkning af mundslimhinden (f.eks. aftøs stomatit, mundsår), abdominalsmerter
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Indberetning af bivirkninger Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Danish: Symptomerne på aktiv arthritis psoriatica er blandt andet en betændelseslignende tilstand i leddene, hævelse, besvær med at bevæge sig, smerter og røde, afskallende pletter på huden (hudlæsioner).
English: Arava with food, drink and alcohol
Danish: Brug af Arava sammen med mad, drikke og alkohol Du kan tage Arava med eller uden mad.
English: Tell your doctor immediately and stop taking Arava: - if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, - 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
Danish: Fortæl omgående lægen, og stop med at tage Arava: - hvis du oplever svaghed, føler dig ør i hovedet eller svimmel, eller har åndedrætsbesvær, da disse symptomer kan være tegn på en alvorlig allergisk reaktion - hvis du får udslæt, eller mundsår, da disse kan være tegn på alvorlige, nogle gange livstruende reaktioner (f.eks. Stevens-Johnsons syndrom, toksisk epidermisk nekrolyse, erythema multiforme, lægemiddelreaktion med eosinofili og systemiske symptomer [DRESS]), se punkt
English: Arava 10 mg film-coated tablets are white to almost white and round.
Danish: Arava 10 mg filmovertrukne tabletter er hvide til næsten hvide og runde.
English: Packs of 30, 50 and 100 tablets are available.
Danish: Der findes pakninger med 30, 50 og 100 tabletter
English: Arava 100 mg film-coated tablets are white to almost white and round.
Danish: Arava 100 mg filmovertrukne tabletter er hvide til næsten hvide og runde.
English: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany
Danish: Indehaveren af markedsføringstilladelsen Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Tyskland
English: However, a 25% decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Danish: Normalised Ratio (INR) observeret, når A771726 blev administreret samtidigt med warfarin sammenlignet med warfarin alene.
English: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30, 50 or 100 film-coated tablets.
Danish: 100 ml HDPE-bredhalset tabletbeholder, med skruelåg og integreret fugtbeholder indeholdende enten 30, 50 eller 100 filmovertrukne tabletter.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: How to take Arava
Danish: Sådan skal du tage Arava
English: The usual starting dose of Arava is one 100 mg tablet once daily for the first three days.
Danish: Arava-behandlingen påbegyndes sædvanligvis med 1 tablet på 100 mg daglig i de første 3 dage.
English: Imprint on one side: ZBO.
Danish: Præget med ZBO på den ene side.
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal Skin and subcutaneous tissue disorders
Danish: svær leverskade som f.eks. leversvigt og akut hepatisk nekrose, som kan være letal
English: What you need to know before you take Arava Do not take Arava
Danish: Det skal du vide, før du begynder at tage Arava
English: • For rheumatoid arthritis: 10 or 20 mg Arava once daily, depending on the severity of the disease.
Danish: • 1 tablet på 10 eller 20 mg Arava daglig til behandling af aktiv leddegigt afhængig af sygdommens alvorlighed.
English: Serious undesirable effects might occur (e.g. hepatotoxicity, haematotoxicity or allergic reactions, see below),
Danish: Alvorlige bivirkninger kan forekomme selv efter ophør med leflunomid behandlingen (f.eks. hepatotoksisitet, hæmatotoksisitet eller allergiske reaktioner, se nedenfor).
English: - if you are male and wish to father a child. As it can not be excluded that Arava passes into semen, reliable contraception should be used during treatment with Arava.
Danish: Da det ikke kan udelukkes, at Arava findes i sæden, skal der bruges pålidelig prævention under behandlingen med Arava.
English: often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis), - if you have any liver problems, - if you have moderate to severe kidney problems, - if you have severely low numbers of proteins in your blood (hypoproteinaemia), - if you suffer from any problem which affects your immune system (e.g. AIDS), - if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you are pregnant, think you may be pregnant, or are breast-feeding.
Danish: Johnsons syndrom) eller et af de øvrige indholdsstoffer i Arava (angivet i punkt 6), eller hvis du er allergisk over for teriflunomid (til behandling af multipel sklerose), - hvis du har leverproblemer, - hvis du har har moderate til svære nyreproblemer, - hvis du har et alvorligt lavt antal proteiner i dit blod (hypoproteinæmi), - hvis du lider af en sygdom der påvirker dit immunforsvar (f.eks. aids) - hvis du har problemer med din knoglemarv, eller hvis du har et lavt antal røde eller hvide blodlegemer, eller et reduceret antal blodplader, - hvis du lider af en alvorlig infektion, - hvis du er gravid, tror du er gravid eller ammer.
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: 6.4 Special precautions for storage
Danish: 6.4 Særlige opbevaringsforhold Blister:
English: Arava 20 mg film-coated tablets are yellowish to ochre and triangular.
Danish: Arava 20 mg filmovertrukne tabletter er gullige til okkerfarvede og trekantede.
English: What Arava is and what it is used for What you need to know before you take Arava How to take Arava
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Arava Sådan skal du tage Arava Bivirkninger
English: In case of severe haematological reactions, including pancytopenia, Arava and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Danish: pancytopeni skal Arava og anden samtidig behandling med myelosuppresive lægemidler seponeres og leflunomid udvaskningsproceduren påbegyndes.
English: 3 film-coated tablets
Danish: 50 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 særligt ALAT), mindre hyppigt gamma-GT, basisk fosfatase og bilirubin).
English: It is not recommended to drink alcohol during treatment with Arava.
Danish: Da eventuelle leverskader forvoldt af alkohol kan forværres af behandling med Arava, anbefales det ikke at drikke alkohol under behandling med Arava.
English: If you take more Arava than you should
Danish: Hvis du har taget for meget Arava
English: - a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe, sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer) - et udtalt fald i antallet af nogle hvide blodlegemer (agranulocytosis), - alvorlige og potentielt alvorlige allergiske reaktioner, - betændelse i de små blodkar (vasculitis inklusive kutan nekrotisk vasculitis), - betændelse i bugspytkirtlen (pankreatitis), - svær leverskade, såsom leversvigt eller nekrose der kan være livstruende, - nogle gange livstruende reaktioner (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse,
English: - The active substance is leflunomide.
Danish: Aktivt stof: Leflunomid.
English: - a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer) - fald i antallet af røde blodlegemer (anæmi) og fald i antallet af blodplader (trombocytopeni), - fald i blodets kaliumniveau, - angst, - smagsforstyrrelser, - urticaria (nældefeber), - seneruptur, - stigning i fedtniveauet i blodet (kolesterol og triglycerider), - fald i fosfatniveauet i blodet.
English: GENERAL CLASSIFICATION FOR SUPPLY
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel
English: This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill) - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
Danish: Dette er særligt vigtigt, hvis du tager: - anden medicin mod reumatoid artrit såsom malariamedicin (f.eks. chloroquin og hydroxychloroquin), intramuskulært eller oralt guld, Penicillamin, azathioprin og andre lægemidler, der påvirker dit immunforsvar (som f.eks. methotrexat), eftersom disse kombinationer ikke er tilrådelige - warfarin og andre orale blodfortyndende lægemidler, da overvågning er nødvendig for at mindske riskikoen for bivirkninger af dette lægemiddel - teriflunomid mod dissemineret sklerose - repaglinid, pioglitazon, nateglinid eller rosiglitazon mod sukkersyge (diabetes) - daunorubicin, doxorubicin, paclitaxel eller topotecan mod kræft (cancer) - duloxetin mod depression, urininkontinens eller nyresygdom hos diabetikere - alosetron til behandling af kraftig diarré - theophyllin mod astma - tizanidin, et muskelafslappende lægemiddel - orale præventionsmidler (indeholdende ethinylestradiol og levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin mod infektioner - indomethacin, ketoprofen mod smerter eller inflammation - furosemid mod hjertelidelse (vanddrivende) - zidovudin mod HIV infektion - rosuvastatin, simvastatin, atorvastatin, pravastatin mod hyperkolesterolæmi (højt kolesteroltal) - sulfasalazin mod inflammatorisk tarmsygdom eller reumatoid artrit - et lægemiddel, der hedder colestyramin (bruges til at reducere højt kolesteroltal) eller aktivt kul,
English: - an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer) - stigning i antallet af såkaldte eosinofile blodceller, et svagt fald i antallet af hvide blodlegemer
English: - a slight decrease in the number of white blood cells (leucopenia), - mild allergic reactions, - loss of appetite, weight loss (usually insignificant), - tiredness (asthenia), - headache, dizziness, - abnormal skin sensations like tingling (paraesthesia), - mild increase in blood pressure, - colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, - an increase in some liver test results,
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) - et mindre fald i antallet af hvide blodlegemer (leukopeni), - lette allergiske reaktioner, - appetitløshed, vægttab (sædvanligvis ubetydeligt), - slaphed (asteni), - hovedpine, svimmelhed, - unormale hudfornemmelser såsom prikken (paræstesi), - let forhøjelse af blodtrykket, - colitis - diarré, - kvalme, opkastning, - inflammation i munden eller mundsår - mavesmerter, - blodprøver, som viser en stigning i nogle resultater for leverfunktion, - øget hårtab, - eksem, tør hud, udslæt, kløe,