FrancophonIA/ELRC3.0 huggingface dataset:
English: As methotrexate is predominantly excreted via the renal route, increased concentrations can be expected in cases of renal impairment, which may result in severe adverse reactions.
Danish: Da methotrexat fortrinsvist udskilles via nyrerne, kan der forventes forhøjede koncentrationer i tilfælde af nedsat nyrefunktion.
English: The recommended initial dose is 7.5 mg methotrexate once weekly.
Danish: Den anbefalede initialdosis er 7,5 mg methotrexat én gang om ugen.
English: Rare: Mood alterations.
Danish: Sjælden: Humørsvingninger.
English: The safety shield on the pen is now locked to prevent any needlestick injuries.
Danish: Kanylebeskyttelsen på pennen er nu låst for at undgå uheld med kanylestik.
English: Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Danish: De hyppigst observerede (meget almindelige) bivirkninger af methotrexat inkluderer gastrointestinale gener (fx stomatitis, dyspepsi, abdominalsmerter, nausea, appetitløshed) samt unormale leverfunktionstest (fx forhøjet alaninaminotransferase [ALAT], aspartataminotransferase [ASAT], bilirubin, alkalisk fosfatase).
English: Depending on the effects of treatment and results of blood and urine tests, the therapy is then continued or stopped.
Danish: Derefter fortsættes eller stoppes behandlingen, afhængigt af virkningerne af behandlingen og resultaterne af blod- og urinprøverne.
English: Women of childbearing potential / contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least 6 months thereafter (see section 4.4).
Danish: Kvinder i den fertile alder/kontraception til kvinder Kvinder må ikke blive gravide, mens de er i behandling med methotrexat, og der skal bruges sikker kontraception under behandling med methotrexat og i mindst 6 måneder efter behandlingen (se pkt.
English: The solution is to be visually inspected prior to use.
Danish: Injektionsvæsken skal kontrolleres visuelt inden brug.
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske midler.
English: Not known: Asthenia, injection site necrosis.
Danish: Ikke kendt: Asteni, nekrose på injektionsstedet.
English: In patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis or psoriasis vulgaris, administration of folic or folinic acid may reduce methotrexate toxicity (gastrointestinal symptoms, inflammation of oral mucosa, hair loss and increase of liver enzymes) (see section 4.5).
Danish: Hos patienter med reumatoid artrit, polyartikulær juvenil idiopatisk artrit, psoriasisartrit eller psoriasis vulgaris kan administration af folsyre eller folininsyre reducere methotrexats toksicitet (gastrointestinale symptomer, inflammation af oral mucosa, hårtab og forhøjede leverenzymer) (se pkt.
English: If you feel tired or dizzy, you should not drive or use machines.
Danish: Lad være med at føre motorkøretøj eller betjene maskiner, hvis du føler dig træt eller svimmel.
English: Methotrexate can cause miscarriage and severe birth defects.
Danish: Methotrexat kan forårsage abort og alvorlige fødselsdefekter.
English: An overactive immune system has been linked to inflammatory diseases.
Danish: Der er fundet en sammenhæng mellem et overaktivt immunsystem og inflammatoriske sygdomme (sygdomme med betændelseslignende reaktioner).
English: In humans, methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea.
Danish: Det er rapporteret, at methotrexat kan forårsage oligospermi, menstruel dysfunktion og amenoré hos mennesker.
English: Rare: Pulmonary fibrosis, Pneumocystis jiroveci pneumonia, shortness of breath and bronchial asthma, pleural effusion.
Danish: Sjælden: Lungefibrose, Pneumocystis jiroveci-pneumoni, stakåndethed og astma, pleuraeffusion.
English: Do not use this medicine after the expiry date which is stated on the label of the pre-filled pen and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten på den fyldte pen og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: reactivation of inactive chronic infection), sepsis, conjunctivitis.
Danish: Sjælden: Infektion (herunder reaktivering af latent kronisk infektion), sepsis, konjunktivitis.
English: - Severe renal impairment (creatinine clearance less than 30 ml/min) (see sections 4.2 and 4.4).
Danish: - Alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min) (se pkt.
English: Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Danish: Når det ønskede behandlingsresultat er opnået, bør dosis reduceres gradvist til den laveste effektive vedligeholdelsesdosis.
English: Other frequently (common) occurring adverse reactions are leukopenia, anaemia, thrombopenia, headache, tiredness, drowsiness, pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia, oral ulcers, diarrhoea, exanthema, erythema and pruritus.
Danish: Andre hyppigt forekommende (almindelige) bivirkninger er leukopeni, anæmi, trombopeni, hovedpine, træthed, døsighed, pneumoni, interstitiel alveolitis/pneumonitis ofte forbundet med eosinofili, mundsår, diaré, eksantem, erytem og pruritus.
English: Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris and psoriatic arthritis with Nordimet is a long-term treatment.
Danish: Behandling af reumatoid artrit, juvenil idiopatisk artrit, psoriasis vulgaris og psoriasisartrit med Nordimet er langtidsbehandling.
English: Active rheumatoid arthritis is an inflammatory condition that affects the joints; - severe, active juvenile idiopathic arthritis in five or more joints (the condition is therefore called polyarthritic), in patients who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs); - a severe form of treatment resistant psoriasis (also called severe recalcitrant disabling psoriasis), in adult patients who have had an inadequate response to other treatments including phototherapy (light therapy), PUVA (ultraviolet light therapy), and retinoids (group of medicines derived from vitamin A).
Danish: Aktiv reumatoid artrit er en betændelseslignende tilstand, der rammer leddene; - alvorlig aktiv juvenil idiopatisk artrit i mindst fem led (derfor kaldes tilstanden for polyartritisk) hos patienter, der ikke har reageret tilstrækkeligt på behandling med nonsteroide antiinflammatoriske lægemidler (NSAID'er); - en alvorlig form af behandlingsresistent psoriasis (også kaldet for alvorlig, genstridig, invaliderende psoriasis) hos voksne patienter, der ikke har reageret tilstrækkeligt på andre behandlinger, herunder fototerapi (lysterapi), PUVA (behandling med ultraviolet lys) og retinoider (en gruppe lægemidler, som er afledt af vitamin A).
English: Any used syringe should be discarded.
Danish: Brugte injektionssprøjter skal kasseres.
English: Methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy, and to cause impaired fertility, affecting spermatogenesis and oogenesis during the period of its administration - effects that appear to be reversible on discontinuing therapy.
Danish: Det er rapporteret, at methotrexat kan forårsage oligospermi, menstruel dysfunktion og amenoré under behandlingen og i en kort periode efter seponering samt nedsat fertilitet pga. indvirkning på spermatogenesen og oogenesen i behandlingsperioden.
English: Any contact of methotrexate with skin and mucosa is to be avoided.
Danish: Enhver kontakt mellem methotrexat og hud og slimhinder skal undgås.
English: Contraception in males
Danish: Kontraception til mænd
English: 1 mL type I glass syringe with attached stainless steel needle, a chlorobutyl rubber plunger stopper and a needle guard to prevent needlestick injury and re-use.
Danish: 1 ml injektionssprøjte (type I-glas) med påsat kanyle af rustfrit stål, en stempelprop af chlorbutylgummi og kanylebeskyttelse, der forhindrer stikskader og genbrug.
English: Not known: Eosinophilia
Danish: Ikke kendt: Eosinofili.
English: 3) The syringe is pre-filled and ready to use.
Danish: 3) Injektionssprøjten er fyldt og klar til brug.
English: Co-administration of medicinal products which cause folate deficiency (e.g. sulphonamides, trimethoprim-sulphamethoxazole) can lead to increased methotrexate toxicity.
Danish: Samtidig administration af lægemidler, der medfører folatmangel (fx sulfonamider, trimethoprim-sulfamethoxazol), kan øge methotrexats toksicitet.
English: Pre-filled pen with a 1 mL type I glass syringe with attached stainless steel needle and a chlorobutyl rubber plunger stopper.
Danish: Fyldt pen med en 1 ml injektionssprøjte (type I-glas) med påsat kanyle af rustfrit stål og en stempelprop af chlorbutylgummi.
English: The absence of pregnancy must be confirmed before Nordimet is used.
Danish: Inden administration af Nordimet skal det bekræftes, at patienten ikke er gravid.
English: Pronounced enterohepatic blood flow exists.
Danish: Der findes et udtalt enterohepatisk kredsløb.
English: Symptoms include leukocytopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, bone marrow depression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration and gastrointestinal bleeding.
Danish: Symptomerne omfatter leukocytopeni, trombocytopeni, anæmi, pancytopeni, neutropeni, knoglemarvssuppression, mucositis, stomatitis, mundsår, nausea, opkastning, gastrointestinal ulceration og gastrointestinal blødning.
English: Pulmonary diseases induced by methotrexate, like pneumonitis, can occur acutely at any time of therapy, they were not always completely reversible and have been reported already at all doses (inclusive low doses of 7.5 mg/week).
Danish: De var ikke altid fuldt reversible og er indberettet ved alle dosisniveauer (herunder lave doser på 7,5 mg/uge).
English: Nordimet is indicated for the treatment of - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, - severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients.
Danish: Nordimet er indiceret til behandling af - aktiv reumatoid artrit hos voksne, - polyartritiske former af alvorlig aktiv juvenil idiopatisk artrit (JIA), når der ikke har været tilstrækkelig respons på nonsteroide antiinflammatoriske lægemidler (NSAID'er), - alvorlig, vanskeligt behandlelig, invaliderende psoriasis, der ikke reagerer tilstrækkeligt på andre former for behandling, såsom fototerapi, psoralen plus UVA-lys (PUVA) samt retinoider, og alvorlig psoriasisartrit hos voksne.
English: Uncommon: Photosensitisation, loss of hair, increase in rheumatic nodules, skin ulcer, herpes zoster, vasculitis, herpetiform eruptions of the skin, urticaria.
Danish: Ikke almindelig: Fotosensibilisering, hårtab, øget antal gigtknuder, hudsår, herpes zoster, vaskulitis, herpetiforme udbrud i huden, urticaria.
English: Respiratory, thoracic and mediastinal disorders Common: Pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia.
Danish: Almindelig: Pneumoni, interstitiel alveolitis/pneumonitis, ofte forbundet med eosinofili.
English: In combination with pantoprazole, inhibited renal elimination of the 7-hydroxymethotrexate metabolite, with myalgia and shivering, was reported in one case.
Danish: Der blev i et enkelt tilfælde rapporteret nedsat renal eliminering af 7-hydroxymethotrexat-metabolitten ved kombination med pantoprazol med deraf følgende myalgi og kulderystelser.
English: For contraception advice for men, see section 4.6.
Danish: 4.6 vedrørende anbefaling om prævention til mænd.
English: Common: Leukopenia, anaemia, thrombopenia.
Danish: Almindelig: Leukopeni, anæmi, trombopeni.
English: Response to treatment can generally be expected after approximately 2-6 weeks.
Danish: Der kan generelt forventes en respons på behandlingen efter cirka 2-6 uger.
English: Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), increased pigmentary changes of the nails, acute paronychia, furunculosis, telangiectasia.
Danish: Meget sjælden: Stevens-Johnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom), stigning i pigmentforandringer på neglene, akut paronykie, furunkulose, telangiektasi.
English: Do not use this medicine after the expiry date which is stated on the label of the pre-filled syringe and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten på den fyldte injektionssprøjte og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Methotrexate is known to cause bone disorders such as joint and muscle pain and osteoporosis.
Danish: Man ved, at methotrexat forårsager knoglelidelser såsom led- og muskelsmerter samt knogleskørhed.
English: Very rare: Loss of libido, impotence, gynaecomastia, oligospermia, impaired menstruation, vaginal discharge.
Danish: Meget sjælden: Manglende libido, impotens, gynækomasti, oligospermi, unormal menstruation, vaginalt udflåd.
English: The following pens are available:
Danish: Følgende penne fås:
English: Administration of additional haematotoxic medicinal products (e.g. metamizole) increases the probability of severe haematoxic effects of methotrexate.
Danish: Administration af andre hæmatotoksiske lægemidler (fx metamizol) øger sandsynligheden for alvorlige hæmatotoksiske virkninger af methotrexat.
English: Methotrexate treatment of severe psoriasis vulgaris and psoriatic arthritis represents long-term treatment.
Danish: Behandling af alvorlig psoriasis vulgaris og psoriasisartrit med methotrexat er langtidsbehandling.
English: The duration of treatment is determined by the treating physician.
Danish: Den behandlende læge fastsætter behandlingens varighed.
English: Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and Stevens-Johnson syndrome.
Danish: De alvorligste bivirkninger af methotrexat inkluderer knoglemarvssuppression, lungetoksicitet, levertoksicitet, nyretoksicitet, neurotoksicitet, tromboemboliske bivirkninger, anafylaktisk shock og Stevens-Johnsons syndrom.
English: If a patient presents with pulmonary symptoms, the possibility of pneumocystis jiroveci pneumonia should be taken into account.
Danish: Muligheden for Pneumocystis jiroveci-pneumoni skal overvejes, hvis en patient har lungesymptomer.
English: Method and duration of administration
Danish: Anvendelsesmåde og behandlingsvarighed
English: 12) Discard the used syringe into the sharps bin provided.
Danish: 12) Kassér den brugte injektionssprøjte i en kanylebøtte.
English: phenylbutazone, or amidopyrine - alcohol (drinking alcohol should be avoided while you are taking Nordimet) - azathioprine (used to prevent rejection after an organ transplant) - retinoids (used to treat psoriasis and other skin disorders) - anticonvulsant medicines (used to prevent fits), such as phenytoin, valproate or carbamazepine - cancer treatments - barbiturates (sleeping injection) - tranquillisers - oral contraceptives - probenecid (used to treat gout) - antibiotics - pyrimethamine (which is used to prevent and treat malaria) - vitamin preparations containing folic acid - proton-pump inhibitors (medicines that reduce the production of gastric acid and that are used to treat severe heartburn or ulcers), such as omeprazole - theophylline (used to treat asthma) - any vaccination with a live vaccine (must be avoided), such as measles, mumps, influenza or yellow fever vaccines.
Danish: (et lægemiddel, som udover artrit og psoriasis bruges til behandling af blødende tyktarmsbetændelse), acetylsalicylsyre, phenylbutazon eller aminophenazon - alkohol (du skal undgå at drikke alkohol, mens du tager Nordimet) - azathioprin (bruges til at forebygge afstødning efter en organtransplantation) - retinoider (bruges til behandling af psoriasis og andre hudsygdomme) - krampestillende midler (til at forebygge krampeanfald), for eksempel phenytoin, valproat eller carbamazepin - kræftbehandlinger - barbiturater (sovemidler) - beroligende midler - oral prævention (p-piller) - probenecid (bruges til behandling af urinsyregigt) - antibiotika - pyrimethamin (bruges til forebyggelse og behandling af malaria) - vitaminpræparater, der indeholder folsyre - protonpumpehæmmere, for eksempel omeprazol (bruges til at nedsætte produktionen af mavesyre og til behandling af alvorlig halsbrand og mavesår) - theophyllin (bruges til behandling af astma) - alle levende vacciner skal undgås, for eksempel vacciner mod mæslinger, fåresyge, influenza og gul feber.
English: On the other hand, concomitant administration of folinic acid containing drugs or of vitamin preparations, which contain folic acid or derivatives, may impair methotrexate efficacy.
Danish: På den anden side kan samtidig administration af lægemidler eller vitaminpræparater, der indeholder folininsyre eller derivater deraf, nedsætte effekten af methotrexat.
English: Methotrexate can affect sperm production with the potential to cause birth defects.
Danish: Methotrexat kan påvirke sædproduktionen og muligvis forårsage medfødte misdannelser.
English: Discard the used pen into the sharps bin provided.
Danish: Kassér den brugte pen i en kanylebøtte.
English: Prior to initiating therapy, women of childbearing potential must be informed of the risk of malformations associated with methotrexate and any existing pregnancy must be excluded with certainty by taking appropriate measures, e.g. a pregnancy test. During treatment pregnancy tests should be repeated as clinically required (e.g. after any gap of contraception).
Danish: Inden behandlingen påbegyndes, skal kvinder i den fertile alder informeres om den risiko for misdannelser, der er forbundet med methotrexat, og eventuel eksisterende graviditet skal udelukkes med sikkerhed ved hjælp af relevante foranstaltninger, for eksempel en graviditetstest.
English: Central nervous system (CNS) symptoms, such as fatigue and confusion, can occur during treatment.
Danish: Under behandlingen kan der opstå symptomer relateret til centralnervesystemet (CNS), for eksempel træthed og konfusion.
English: How to give yourself an injection of Nordimet If you have difficulty handling the syringe, ask your doctor or pharmacist.
Danish: Sådan giver du dig selv en injektion af Nordimet Spørg din læge eller apotekspersonalet til råds, hvis du har svært ved at håndtere pennen.
English: Rare: Increased pigmentation, acne, petechiae, ecchymosis, allergic vasculitis.
Danish: Sjælden: Øget pigmentering, akne, petekkier, ekkymose, allergisk vaskulitis.
English: Bleeding from the lungs, bone damage in the jaw (secondary to excessive growth of white blood cells), tissue destruction at injection site.
Danish: Hyppigheden ikke kendt (kan ikke estimeres ud fra forhåndenværende data): blødning i lungerne, beskadigelse af kæbeknoglen (sekundær til for høj dannelse af hvide blodlegemer), vævsdød på injektionsstedet.
English: Overdose symptoms may include easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and decreased urinating.
Danish: Symptomerne på en overdosis kan være, at du nemmere får blå mærker eller bløder, oplever unormal svaghed, sår i munden, kvalme, opkastning, sort eller blodig afføring, hoste med blod, opkast, der ligner kaffegrums, samt nedsat urinmængde.
English: Rare: Renal failure, oliguria, anuria, electrolyte disturbances.
Danish: Sjælden: Nyresvigt, oliguri, anuri, elektrolytforstyrrelser.
English: If clinically indicated, exclude tuberculosis and hepatitis.
Danish: Tuberkulose og hepatitis skal udelukkes, hvis det er klinisk relevant.
English: Cardiac disorders Rare: Pericarditis, pericardial effusion, pericardial tamponade.
Danish: Hjerte Sjælden: Perikarditis, perikardie-effusion, perikardietamponade.
English: During therapy
Danish: Under behandlingen
English: Do not miss appointments for blood tests.
Danish: Det er vigtigt, at du møder op, når du skal have taget blodprøver.
English: Blister - PRE-FILLED SYRINGE
Danish: BLISTER - FYLDT INJEKTIONSSPRØJTE
English: Malignant lymphomas may occur in patients receiving low-dose methotrexate; in which case, methotrexate must be discontinued.
Danish: Der kan opstå maligne lymfomer hos patienter, som får lavdosis-methotrexat.
English: If you suspect that you have used too much Nordimet, tell your doctor or contact the nearest hospital immediately.
Danish: Fortæl det straks til lægen eller kontakt det nærmeste hospital, hvis du har mistanke om, at du har brugt for meget Nordimet.
English: When methotrexate was discontinued prior to conception, normal pregnancies have been reported.
Danish: Der er rapporteret normale graviditeter, når methotrexat blev seponeret inden konception.
English: Use Nordimet only once a week for the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis, psoriasis and psoriatic arthritis requiring dosing once a week.
Danish: Nordimet må kun bruges én gang om ugen til behandling af leddegigt (rheumatoid arthritis), aktiv børneleddegigt (juvenil idiopatisk arthritis), psoriasis og psoriasisgogt (psoriatisk arthritis), der kræver dosering én gang om ugen.
English: 7) Move the pen towards the skin fold (site of injection) with the needle shield pointing directly at the site of injection.
Danish: 7) Flyt pennen hen mod hudfolden (injektionsstedet), mens kanylebeskyttelsen peger direkte mod injektionsstedet.
English: Depending on the clinical picture and the changes of laboratory parameters, the therapy is then continued or discontinued.
Danish: Derefter fortsættes eller seponeres behandlingen, afhængigt af det kliniske billede og ændringer i laboratorieparametre.
English: Methotrexate should be used with caution in patients with impaired renal function (see sections 4.3 and 4.4).
Danish: Methotrexat skal anvendes med forsigtighed til patienter med nedsat nyrefunktion (se pkt.
English: Reduced blood cell formation with decrease in white and/or red blood cells and/or platelets (leukopenia, anaemia, thrombocytopenia), headache, tiredness, drowsiness, inflammation of the lungs (pneumonia) with dry, non-productive cough, shortness of breath and fever, diarrhoea, rash, reddening of the skin, itching.
Danish: Nedsat dannelse af blodlegemer med et fald i antallet af hvide og/eller røde blodlegemer og/eller blodplader (leukopeni, anæmi, trombocytopeni), hovedpine, træthed, døsighed, lungebetændelse (pneumoni) med tør, uproduktiv hoste, åndenød og feber, diaré, udslæt, hudrødme, kløe.
English: How to use Nordimet
Danish: Sådan skal du bruge Nordimet
English: Subcutaneous, intravenous and intramuscular administration demonstrated similar bioavailability.
Danish: Sammenlignelig biotilgængelighed er påvist efter subkutan, intravenøs og intramuskulær administration.
English: Common: Oral ulcers, diarrhoea.
Danish: Almindelig: Mundsår, diaré.
English: Keep the pre-filled pen and pre-filled syringe in the outer carton in order to protect from light.
Danish: Opbevar den fyldte pen og den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys.