FrancophonIA/ELRC3.0 huggingface dataset:
English: It has not yet been possible to date to clarify whether the efficacy of methotrexate in the management of psoriasis, psoriatic arthritis and chronic polyarthritis is due either to an anti-inflammatory or immunosuppressive effect, or to what extent a methotrexate-induced increase in extracellular adenosine concentration at inflamed sites contributes to this effect.
Danish: Det har endnu ikke været muligt at klarlægge, om methotrexats virkning ved psoriasis, psoriasisartritis og kronisk polyartritis skyldes enten en antiinflammatorisk eller en immunsuppressiv virkning, eller i hvor høj grad en methotrexat-induceret stigning i den ekstracellulære adenosinkoncentration i inflammerede områder bidrager til denne virkning.
English: Insufficient data is available for methotrexate exposure during pregnancy higher than 30 mg (15 ml)/week, but higher rates of spontaneous abortions and congenital malformations are expected, in particular at doses commonly used in oncologic indications
Danish: Der foreligger utilstrækkelige data for methotrexateksponering under graviditet højere end 30 mg (15 ml)/uge, men der forventes højere antal spontane aborter og medfødte misdannelser, især ved doser, der almindeligvis anvendes i onkologiske indikationer
English: Your doctor may adjust the dose to suit you according to your response to treatment and side effects.
Danish: Lægen vil måske tilpasse din dosis alt efter, hvordan du reagerer på behandlingen, og hvilke bivirkninger du får.
English: In particular, elderly patients should be monitored at short intervals for early signs of toxicity (see section 4.2).
Danish: Navnlig ældre patienter bør monitoreres for tidlige tegn på toksicitet med korte mellemrum (se pkt.
English: Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Danish: Methotrexat bør kun ordineres af læger med ekspertise i brugen af methotrexat og med fuld forståelse for de risici, der er forbundet med methotrexat-behandling.
English: In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester (see section 5.3).
Danish: Methotrexat har udvist reproduktionstoksicitet i dyrestudier, navnlig i første trimester (se pkt.
English: Methotrexate affects spermatogenesis and oogenesis and may decrease fertility.
Danish: Methotrexat påvirker spermatogenese og oogenese og kan nedsætte fertiliteten.
English: Nocardiosis, Histoplasma and cryptococcus mycosis, Disseminated herpes simplex
Danish: Nocardiose Histoplasma og kryptokokmykose Dissemineret herpes simplex
English: 75 ml amber type III glass bottle with tamper evident child-resistant closure (polypropylene with expanded polyethylene liner) containing 60 ml of oral solution.
Danish: 75 ml flaske af ravfarvet type III-glas med anbrudssikker, børnesikker lukning (polypropylen med foring af ekspanderet polyethylen) indeholdende 60 ml oral opløsning.
English: During concomitant therapy with methotrexate, therefore, serum theophylline levels should be monitored.
Danish: Ved samtidig behandling med methotrexat skal serum-theophyllin derfor monitoreres.
English: If the drug is used during pregnancy or if the patient becomes pregnant while taking methotrexate the patient should be informed of the potential risk to the foetus.
Danish: Hvis lægemidlet anvendes under graviditet, eller hvis der opstår graviditet under behandlingen med methotrexat, skal patienten informeres om den mulige risiko for fostret.
English: • Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.
Danish: • Polyartritiske former af svær juvenil idiopatisk artritis (JIA) hos unge og børn på 3 år og derover ved utilstrækkelig respons på non‐steroide antiinflammatoriske lægemidler (NSAID).
English: The dose normalized AUC of the metabolite 7-hydroxymethotrexate was not dependent on age.
Danish: Det dosisnormaliserede AUC af metabolitten 7‐hydroxymethotrexat var ikke aldersafhængigt.
English: Cases of overdose have been reported, sometimes fatal, due to erroneous daily intake instead of weekly intake of oral methotrexate.
Danish: Der er beskrevet tilfælde af overdosering, undertiden med dødelig udgang, ved fejlagtig daglig indtagelse (i stedet for ugentlig) af methotrexat oralt.
English: Push the tip of the dosing syringe into the hole in the adaptor.
Danish: Spidsen af doseringssprøjten trykkes ind i hullet i adaptoren.
English: Opportunistic infections can occur during treatment with methotrexate, including Pneumocystis jiroveci pneumonia, which can also have a fatal outcome.
Danish: Under behandling med methotrexat kan der forekomme opportunistiske infektioner, herunder Pneumocystis jiroveci-pneumoni, som også kan have dødeligt udfald.
English: Dose reduction should be considered in elderly patients (65 years and over) due to reduced liver and kidney function as well as low folic acid reserves which occur with increased age.
Danish: Dosisreduktion bør overvejes hos ældre (65 år og derover) på grund af nedsat lever- og nyrefunktion samt lave folsyrereserver, som optræder med stigende alder.
English: Animal studies showed that the administration of NSAIDs including salicylic acid resulted in reduced tubular methotrexate secretion and accordingly potentiated its toxic effects.
Danish: I dyrestudier medførte administration af NSAID, herunder af salicylsyre, nedsat tubulær sekretion af methotrexat og potenserede derved dets toksiske virkninger.
English: Each pack contains one bottle, an LDPE bottle adaptor and a 10 ml white polypropylene dosing syringe (with major graduations at every 1 ml and minor graduations at every 0.25 ml).
Danish: Hver pakning indeholder en flaske, en LDPE-flaskeadaptor (overgangsstykke) og en 10 ml doseringssprøjte af hvid polypropylen (med hovedopdelinger for hver 1 ml og underopdelinger for hver 0,25 ml).
English: Women who are pregnant, planning to be or breast-feeding should not handle methotrexate.
Danish: Kvinder, som er gravide, planlægger graviditet eller ammer, bør ikke håndtere methotrexat.
English: Combination therapy with methotrexate and leflunomide may increase the risk for pancytopenia.
Danish: Kombinationsbehandling med methotrexat og leflunomid kan øge risikoen for pancytopeni.
English: If methotrexate-induced lung disease is suspected, treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.
Danish: Ved mistanke om methotrexat‐induceret lungesygdom bør kortikosteroider initieres, og behandlingen med methotrexat bør ikke genoptages.
English: Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans during and for a short period after the discontinuation of treatment, 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 hos mennesker forårsager nedsat fertilitet, oligospermi, menstruationsforstyrrelser og amenoré under behandlingen og i en kort periode efter seponering, hvilket påvirker spermatogenese og oogenese i administrationsperioden - virkninger, som synes at være reversible ved seponering af behandlingen.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues, ATC code: L01BA01
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antimetabolitter, folsyreanaloger, ATC-kode: L01BA01
English: It is important to determine any increase in active substance levels within 48 hours of therapy, otherwise irreversible methotrexate toxicity may occur.
Danish: Det er vigtigt at klarlægge en eventuel stigning i koncentrationen af det aktive stof inden for 48 timer, da methotrexat ellers kan forårsage irreversibel toksicitet.
English: This difference in cell proliferation rate is the starting point for the use of methotrexate in particularly severe, generalised, treatment-resistant psoriasis and psoriatic arthritis.
Danish: Denne forskel i hastigheden i celleproliferation er udgangspunktet for anvendelse af methotrexat ved særligt svær generaliseret behandlingsrefraktær psoriasis og psoriasisartritis.
English: Methotrexate is a powerful human teratogen, with an increased risk of spontaneous abortions, intrauterine growth restriction and congenital malformations in case of exposure during pregnancy.
Danish: Methotrexat er et stærkt humant teratogen med en øget risiko for spontane aborter, intrauterin vækstrestriktion og medfødte misdannelser i tilfælde af eksponering under graviditet.
English: Dosage in children and adolescents with polyarthritic forms of juvenile idiopathic arthritis
Danish: Dosering til børn og unge med polyartritiske former af juvenil idiopatisk artritis
English: Methotrexate can reduce the number of white blood cells and therefore weaken your immune defences.
Danish: Methotrexat kan nedsætte antallet af hvide blodlegemer og derved svække immunforsvaret.
English: If clinically indicated, tuberculosis and hepatitis B and C should be excluded.
Danish: Tuberkulose og hepatitis B og C skal udelukkes, hvis det er klinisk indiceret.
English: In view of its possible effects on the immune system, methotrexate can falsify vaccinal and test results (immunological procedures to assess the immune reaction).
Danish: På grund af methotrexats mulige virkninger på immunsystemet kan det være årsag til falske vaccinations- og prøveresultater (immunologiske procedurer til vurdering af immunreaktionen).
English: Conditions that cause dehydration such as vomiting, diarrhoea or stomatitis Conditions that cause dehydration such as vomiting, diarrhoea or stomatitis can increase toxicity as a result of raised active substance levels.
Danish: Tilstande, der medfører dehydrering, såsom opkastning, diarré eller stomatitis Tilstande, der medfører dehydrering, såsom opkastning, diarré eller stomatitis, kan øge toksiciteten pga. øget koncentration af det aktive stof.
English: • Recommendation to always show the card to and alert new HCPs about the once weekly dosing of the patient's methotrexate (e.g. on hospital admission, change of carer, etc.)
Danish: • anbefaling om altid at vise kortet til og oplyse nye sundhedspersoner om doseringen én gang ugentligt af patientens methotrexat (f.eks. ved indlæggelse på hospitalet, ændring af pleje osv.)
English: The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
Danish: Den ordinerende læge skal sikre sig, at patienten eller dennes omsorgsperson vil være i stand til at overholde doseringsregimet med én ugentlig dosis.
English: Excessive consumption of caffeine- or theophylline-containing beverages (coffee, caffeinated beverages, black tea) should be avoided during methotrexate therapy as the effect of methotrexate may be reduced by the possible interaction between methotrexate and methylxanthines at the adenosine receptors.
Danish: Indtagelse af store mængder caffein- eller theophyllinholdige drikkevarer (kaffe, drikkevarer tilsat caffein, sort te) bør undgås under behandling med methotrexat, da methotrexats virkning kan nedsættes på grund af en mulig interaktion mellem methotrexat og methylxanthiner på adenosinreceptorerne.
English: Your doctor should perform blood tests before the beginning of treatment to check how well your kidneys and liver are working.
Danish: Før behandlingen påbegyndes, vil lægen tage nogle blodprøver for at kontrollere, hvor godt dine nyrer og din lever virker.
English: THIS PATIENT CARD IS ONLY INTENDED FOR PATIENTS WHO USE A METHOTREXATE-CONTAINING MEDICINE FOR ARTHRITIS AND PSORIASIS.
Danish: DETTE PATIENTKORT ER KUN TIL PATIENTER, DER BRUGER ET LÆGEMIDDEL INDEHOLDENDE METHOTREXAT MOD GIGT OG PSORIASIS.
English: Long-term studies in rats, mice and hamsters revealed no evidence of a tumorigenic potential of methotrexate.
Danish: Langtidsforsøg hos rotter, mus og hamstere viste ikke tegn på, at methotrexat har tumorigent potentiale.
English: Overdose could lead to serious adverse effects and may be fatal.
Danish: Overdosering kan medføre alvorlige bivirkninger og kan have dødeligt udfald.
English: In the event of accidental overdose, a dose of calcium folinate equal to or higher than the offending dose of methotrexate should be administered intravenously or intramuscularly within 1 hour, and dosing continued until serum level of methotrexate are below 10-7 mol/L.
Danish: I tilfælde af accidentel overdosering gives inden for 1 time mindst samme dosis calciumfolinat intravenøst eller intramuskulært som den administrerede dosis methotrexat, og dosering fortsættes, indtil serumkoncentrationen af methotrexat er under 10-7 mol/l.
English: Lung-related symptoms (particularly a dry, non-productive cough) or non-specific pneumonitis that occurs during treatment with methotrexate can be a sign of potentially dangerous damage and require the discontinuation of treatment and careful monitoring.
Danish: Lungerelaterede symptomer (navnlig tør, uproduktiv hoste) eller udvikling af uspecifik pneumonitis under methotrexat-behandling kan være tegn på potentielt farlig beskadigelse og kan nødvendiggøre behandlingsafbrydelse og nøje overvågning.
English: Do not miss your blood test appointments.
Danish: Udebliv ikke, når du har fået en tid til at få taget blodprøver.
English: The prescriber should specify the day of intake on the prescription.
Danish: Den ordinerende læge skal angive administrationsdagen på recepten.
English: If there is the possibility of renal impairment (e.g. in elderly subjects), monitoring should take place at shorter intervals.
Danish: Hvis der er risiko for nyrefunktionsnedsættelse (f.eks. hos ældre), skal der monitoreres hyppigere.
English: Probenecid and weak organic acids can also reduce the tubular secretion of methotrexate and thus likewise cause an indirect increase in dose.
Danish: Probenecid og svage organiske syrer kan desuden nedsætte den tubulære sekretion af methotrexat og derved forårsage en indirekte dosisstigning.
English: This evaluation should differentiate between patients with no risk factors and patients with risk factors, such as excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of a hereditary liver disease, diabetes mellitus, obesity and history of significant exposure to hepatotoxic medicinal product or chemicals, as well as prolonged methotrexate treatment or a cumulative total dose of 1.5 g or more.
Danish: Ved denne vurdering bør der skelnes mellem patienter uden risikofaktorer og patienter med risikofaktorer såsom tidligere stort alkoholforbrug, persisterende forhøjede leverenzymer, leversygdom i anamnesen, familiær anamnese med arvelig leversygdom, diabetes mellitus, fedme eller anamnese med signifikant eksponering for hepatotoksiske lægemidler eller kemikalier samt langvarig behandling med methotrexat eller en kumulativ totaldosis på 1,5 g eller derover.
English: Contact with the skin or mucous membrane must be avoided.
Danish: Kontakt med hud og slimhinder skal undgås.
English: Diabetes mellitus
Danish: Diabetes ernæring mellitus
English: Methotrexate is a folic acid antagonist that, as an antimetabolite, belongs to the class of cytotoxic active substances.
Danish: Methotrexat er en folsyreantagonist, der som en antimetabolit tilhører klassen af cytotoksiske lægemiddelstoffer.
English: If you suspect you have a severe side effect, talk to your doctor immediately.
Danish: Har du mistanke om, at du har en svær bivirkning, skal du straks kontakte lægen.
English: In these cases, symptoms that have been commonly reported are hematological and gastrointestinal reactions.
Danish: I sådanne tilfælde er de oftest beskrevne symptomer hæmatologiske og gastrointestinale reaktioner.
English: In the event of a massive overdose, hydration and alkalinisation of the urine may be required to prevent precipitation of methotrexate and/or its metabolites in the renal tubules.
Danish: Ved en massiv overdosis kan hydrering og alkalinisering af urinen være nødvendig for at forhindre udfældning af methotrexat og/eller dets metabolitter i nyretubuli.
English: Especially strict monitoring of the patient is indicated following prior radiotherapy (especially of the pelvis), functional impairment of the haematopoietic system (e.g., following prior radio- or chemotherapy), impaired general condition as well as advanced age and in very young children.
Danish: Særlig tæt overvågning er indiceret efter forudgående stråleterapi (navnlig af pelvis), nedsat funktion af det hæmatopoietiske system (f.eks. efter forudgående stråle- eller kemoterapi), påvirket almentilstand og høj alder samt hos meget unge børn.
English: However, as severe adverse reactions may occur even at low doses, it is essential for the treating physician to monitor patients closely (see section 4.4).
Danish: Svære bivirkninger kan dog også forekomme ved lave doser, hvorfor det er absolut nødvendigt, at den behandlende læge overvåger patienten tæt (se pkt.
English: In one case in which methotrexate was combined with pantoprazole, renal elimination of the metabolite 7-hydroxymethotrexate was inhibited and myalgia and shivering occurred.
Danish: I ét tilfælde, hvor methotrexat blev administreret sammen med pantoprazol, hæmmedes den renale udskillelse af metabolitten 7‐hydroxymethotrexat, så der opstod myalgi og rysten.
English: It is therefore very important that methotrexate is not given to pregnant women or to women who are planning to become pregnant unless used for oncology treatment.
Danish: Det er derfor meget vigtigt, at methotrexat ikke anvendes hos kvinder, der er gravide eller planlægger at blive det, medmindre der anvendes mod kræft.
English: Pharmacokinetic interactions between methotrexate, anticonvulsants (reduced serum methotrexate levels) and 5-fluoruracil (increased half-life of 5-fluoruracil) must be borne in mind.
Danish: Opmærksomheden skal være rettet imod farmakokinetiske interaktioner mellem methotrexat og antikonvulsiva (nedsat serumkoncentration af methotrexat) og 5‐fluoruracil (forlænget halveringstid af 5‐fluoruracil).
English: Certain brain disorders (encephalopathy/leukoencephalopathy) have been reported in cancer patients receiving methotrexate.
Danish: Der er beskrevet visse hjernesygdomme (encefalopati/leukoencefalopati) hos kræftpatienter, der får methotrexat.
English: In humans, methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea.
Danish: Hos mennesker er methotrexat rapporteret at forårsage oligospermi, menstruationsdysfunktion og amenoré.
English: The solution is provided ready for use, and it must be swallowed with some water to remove any methotrexate residue from the oral cavity.
Danish: Opløsningen leveres klar til brug og skal synkes med noget vand for at fjerne rester af methotrexat fra mundhulen.
English: Dysarthria, Unusual cranial sensations, Tinnitus
Danish: Usædvanlige fornemmelser i kraniet Tinnitus
English: Excretion occurs predominantly in the unchanged form by glomerular filtration and active secretion in the proximal tubule via the kidneys.
Danish: Eliminationen sker overvejende uomdannet gennem nyrerne ved glomerulær filtration og aktiv sekretion i de proksimale tubuli.
English: As methotrexate passes into breast milk and may cause toxicity in breast-fed children, treatment is contraindicated during the lactation period (see section 4.3).
Danish: Da methotrexat går over i human mælk og kan være toksisk for det ammede barn, er det kontraindiceret i ammeperioden (se pkt.
English: Tell your doctor immediately if you suddenly get wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Danish: Sig det straks til lægen, hvis du pludseligt får hvæsende vejrtrækning, vejrtrækningsbesvær, hævede øjenlåg, ansigt eller læber, udslæt eller kløe (navnlig, hvis der er over hele kroppen).
English: In children with JIA, the dose normalized area under the plasma concentration versus time-curve (AUC) of methotrexate increased with the age of the children and was lower than that found in adults.
Danish: Det dosisnormaliserede areal under plasmakoncentration‐tid-kurven for børn med JIA steg med alderen og var mindre end hos voksne.
English: Your doctor will decide what dose of Jylamvo you should take according to the condition you are being treated for, how severe it is and your general health.
Danish: Lægen fastsætter din dosis af Jylamvo alt efter, hvilken sygdom du behandles for, sygdommens sværhedsgrad og din almene helbredstilstand.
English: A chest X-ray must be taken in order to be able to exclude an infection.
Danish: Der skal tages røntgen af thorax for at udelukke infektion.
English: Ask the patient to swallow the medicine and then to drink some water, making sure no medicine is left in the mouth.
Danish: Bed patienten om at synke medicinen og derefter drikke noget vand for at sikre, at der ikke er medicin tilbage i munden.
English: PATIENT CARD TEXT
Danish: TEKST PÅ PATIENTKORT
English: Diarrhoea and ulcerative stomatitis may be signs of toxic effects and require the discontinuation of treatment, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.
Danish: Diarré og ulcerativ stomatitis kan være tegn på toksiske virkninger og nødvendiggøre behandlingsafbrydelse, da der ellers kan opstå hæmoragisk enteritis og død som følge af intestinal perforation.
English: In rheumatological and dermatological diseases
Danish: Ved reumatologiske og dermatologiske sygdomme
English: In oncologic indications, women who are planning to become pregnant are advised to consult a genetic counselling centre, if possible, prior to therapy and men should seek advice about the possibility of sperm preservation before starting therapy as methotrexate can be genotoxic at higher doses (see section 4.4).
Danish: I onkologiske indikationer anbefales kvinder, der planlægger graviditet, om muligt at søge rådgivning på et genetisk rådgivningscenter før behandlingsstart; mænd bør søge rådgivning om muligheden for sæddeponering, før behandling initieres, da methotrexat kan være genotoksisk i højere doser (se pkt.
English: It is associated with malformations of the skull, face, heart and blood vessels, brain, and limbs.
Danish: Det er forbundet med misdannelser af kranie, ansigt, hjerte, blodkar, hjerne og lemmer.
English: Men should not donate semen during therapy or for 6 months following discontinuation of methotrexate.
Danish: Mænd bør ikke donere sæd under behandlingen eller i 6 måneder efter seponering af methotrexat.
English: Keep the bottle tightly closed (see section 6.6).
Danish: Hold flasken tæt lukket (se pkt.
English: If combined treatment is required, the blood count and renal function should be monitored.
Danish: Hvis samtidig behandling er nødvendig, skal blodtal og nyrefunktion monitoreres.
English: - Complete blood count with differential blood count and platelets.
Danish: Komplet blodtælling med differentialtælling og trombocyttælling.
English: • Remarks on the importance of reporting ADRs
Danish: • bemærkninger om vigtigheden af at indberette bivirkninger
English: Treatment of rheumatoid arthritis with such medicinal products can be continued during therapy with low-dose methotrexate, but only under close medical supervision.
Danish: Sådanne lægemidler kan fortsat anvendes under behandling af reumatoid artritis med methotrexat i lav dosering, men kun under tæt klinisk monitorering.
English: In therapy-refractory cases the weekly dosage may be increased to 20 mg (10 ml)/m² BSA/week.
Danish: I behandlingsrefraktære tilfælde kan den ugentlige dosis øges til 20 mg (10 ml)/m² legemsoverflade/uge.
English: Do not breast-feed during treatment as methotrexate passes into the breast milk.
Danish: Du må ikke amme under behandlingen, da methotrexat går over i mælken.
English: Methotrexate-induced haematopoietic suppression may occur abruptly and with apparently safe dosages.
Danish: Methotrexat‐induceret suppression af hæmatopoiesen kan opstå pludseligt og ved tilsyneladende sikre doser.