FrancophonIA/ELRC3.0 huggingface dataset:
English: Conditions leading to dehydration such as emesis, diarrhoea or stomatitis, can increase the toxicity of methotrexate due to elevated levels of the active substance.
Danish: Tilstande, der kan medføre dehydrering, for eksempel emesis, diaré og stomatitis, kan øge toksiciteten af methotrexat på grund af forhøjet niveau af det aktive stof.
English: Excretion takes place, mainly in unchanged form, primarily renal via glomerular filtration and active secretion in the proximal tubulus.
Danish: Udskillelse sker fortrinsvis uomdannet og primært gennem nyrerne via glomerulær filtrering og aktiv sekretion i de proksimale tubuli.
English: This will send the medication under the skin.
Danish: Dermed føres medicinen ind i huden.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunosuppressants.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunomodulerende midler, andre immunsupprimerende midler.
English: Do not use this medicine if you notice that the solution is not clear and contains particles.
Danish: Brug ikke lægemidlet, hvis du bemærker, at injektionsvæsken ikke er klar, eller hvis den indeholder partikler.
English: For psoriasis patients the need of a liver biopsy prior to and during therapy is controversial.
Danish: Nødvendigheden af at udtage leverbiopsier hos psoriasispatienter inden og under behandlingen er kontroversiel.
English: One should be aware of pharmacokinetic interactions between methotrexate, anticonvulsant medicinal products (reduced methotrexate blood levels), and 5-fluorouracil (increased t½ of 5--fluorouracil).
Danish: Man skal være opmærksom på farmakokinetiske interaktioner mellem methotrexat, antikonvulsiva (fald i methotrexat-niveauet i blodet) samt 5-fluoruracil (forlænget halveringstid for 5-fluoruracil).
English: Do not breast-feed during treatment because methotrexate passes into breast milk.
Danish: Du må ikke amme under behandlingen, da methotrexat passerer over i din mælk.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http//www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Increased monitoring frequency should also be considered when increasing the dose.
Danish: Hyppigere monitorering bør ligeledes overvejes, hvis dosis forhøjes.
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 må kun ordineres af læger med ekspertise i brugen af methotrexat ogmed fuld forståelse for de risici, der er forbundet med behandling med methotrexat.
English: If you wish to become pregnant you should consult your doctor, who may refer you for specialist advice before the planned start of treatment.
Danish: Hvis du ønsker at blive gravid, skal du henvende dig til din læge, som kan henvise dig til en specialist inden den planlagte start af behandlingen.
English: Psoriatic lesions can exacerbate during UV-irradiation and simultaneous administration of methotrexate.
Danish: Psoriasislæsioner kan forværres i forbindelse med UV-stråling og samtidig administration af methotrexat.
English: In the event of any significant drop in leukocytes or platelets, treatment must be discontinued immediately and appropriate supportive therapy instituted.
Danish: I tilfælde af signifikant fald i leukocytter eller trombocytter skal behandlingen straks seponeres og passende understøttende behandling iværksættes.
English: In the event of a massive overdose, hydration and urinary alkalisation may be required to prevent precipitation of methotrexate and/or its metabolites within the renal tubules.
Danish: I tilfælde af en massiv overdosis kan der være behov for hydrering og alkalisering af urinen for at hindre, at methotrexat og/eller dets metabolitter udfældes i nyretubuli.
English: This means that the medicine may cause genetic mutation.
Danish: Det betyder, at det kan forårsage mutationer i generne.
English: In women of child-bearing age any possibility of pregnancy must be excluded with appropriate measures, e.g. a pregnancy test before starting treatment.
Danish: Hos kvinder i den fertile alder skal enhver mulighed for, at kvinden er gravid, udelukkes ved hjælp af relevante foranstaltninger, for eksempel en graviditetstest, inden behandlingen starter.
English: Symptoms typically include dyspnoea, cough (especially a dry non-productive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Danish: Symptomerne omfatter typisk dyspnø, hoste (især tør, uproduktiv hoste), brystsmerter og feber, som patienterne skal spørges om ved hvert kontrolbesøg.
English: Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
Danish: Lymfom/lymfoproliferative lidelser: Der har været rapporter om enkelte tilfælde af lymfom og andre lymfoproliferative lidelser, der i nogle tilfælde svandt efter seponering af methotrexat.
English: Make sure you hold the skin fold throughout the injection.
Danish: Du skal holde på hudfolden under hele injektionen.
English: An overdose of methotrexate can lead to severe toxic reactions.
Danish: En overdosis af methotrexat kan medføre alvorlige forgiftningsreaktioner.
English: 5) Visually inspect the syringe.
Danish: 5) Kontroller sprøjten.
English: Methotrexate is injected once weekly.
Danish: Methotrexat injiceres én gang om ugen.
English: Effective methotrexate clearance has been reported with acute, intermittent haemodialysis using a high-flux dialyser.
Danish: Der er rapporteret effektiv clearance af methotrexat efter akut intermitterende hæmodialyse med anvendelse af high-flux-dialyse.
English: These effects appear to be reversible after discontinuation of therapy in most cases.
Danish: Disse virkninger forekommer i de fleste tilfælde at være reversible efter seponering af behandling.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS for
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: In cases of possible renal impairment (e.g. in elderly patients), closer monitoring is required.
Danish: Ved risiko for nedsat nyrefunktion (fx hos ældre patienter) er tættere monitorering påkrævet.
English: Metabolism and nutrition disorders Uncommon: Precipitation of diabetes mellitus.
Danish: Metabolisme og ernæring Ikke almindelig: Udvikling af diabetes mellitus.
English: Nordimet must only be used once a week.
Danish: Nordimet skal kun tages én gang om ugen.
English: Radiation induced dermatitis and sun-burn can reappear under methotrexate therapy (recall-reaction).
Danish: Strålingsinduceret dermatitis og solforbrændinger kan dukke op igen under behandling med methotrexat (recall-reaktion).
English: Patients receiving therapy should be appropriately monitored, so that signs of possible toxic effects or adverse reactions can be recognised and assessed without delay.
Danish: De patienter, der får behandlingen, skal kontrolleres i tilstrækkelig grad til, at eventuelle tegn på toksiske virkninger eller bivirkninger kan opdages og udredes med det samme.
English: Folic acid or folinic acid supplementation may be considered in accordance with current therapeutic guidelines.
Danish: Tilskud af folsyre eller folininsyre kan overvejes i henhold til aktuelle retningslinjer for behandling.
English: Important warning about the dosage of Nordimet
Danish: Vigtig advarsel vedrørende dosering af Nordimet
English: In rheumatological indications, there is no evidence to support use of liver biopsies in monitoring hepatotoxicity.
Danish: Ved reumatologiske indikationer er der ikke evidens for, at leverbiopsier kan anvendes til monitorering for hepatotoksicitet.
English: It has not yet been clarified, as to whether the efficacy of methotrexate, in the management of psoriasis, psoriatic arthritis and chronic polyarthritis, is due to an anti-inflammatory or immunosuppressive effect and to which extent a methotrexate-induced increase in extracellular adenosine concentration at inflamed sites contributes to these effects.
Danish: Det er endnu ikke klarlagt, om methotrexats virkning i behandlingen af psoriasis, psoriasisartrit og kronisk polyartrit skyldes en anti-inflammatorisk eller immunsupprimerende effekt, og i hvilken udstrækning en methotrexat-induceret stigning i den ekstracellulære adenosinkoncentration på inflammerede steder bidrager til disse virkninger.
English: Pleural effusions and ascites should be drained prior to initiation of methotrexate treatment.
Danish: Pleuraeffusioner og ascites skal dræneres, inden behandling med methotrexat initieres.
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Danish: Calciumfolinat er den specifikke antidot til neutralisering af de toksiske virkninger af methotrexat.
English: Uncommon: Inflammation and ulceration of the vagina.
Danish: Ikke almindelig: Inflammation og ulceration i vagina.
English: Methotrexate is a folic acid antagonist which belongs to the class of cytotoxic agents known as antimetabolites.
Danish: Methotrexat er en folsyreantagonist, der tilhører klassen af cytotoksiske midler, der kaldes antimetabolitter.
English: If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • Spontaneous abortions have been reported in 42.5% of pregnant women exposed to lowdose methotrexate treatment (less than 30 mg/week), compared to a reported rate of 22.5% in disease-matched patients treated with drugs other than methotrexate.
Danish: • Der er rapporteret om spontane aborter hos 42,5% af gravide kvinder, der var eksponeret for lavdosisbehandling med methotrexat (mindre end 30 mg/uge), i sammenligning med en rapporteret procentdel på 22,5% hos patienter med samme sygdom, der var behandlet med andre lægemidler end methotrexat.
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 methotrexatinduceret lungesygdom skal behandling med kortikosteroider iværksættes, og behandling med methotrexat bør ikke reinitieres.
English: Nordimet is for single use only and any unused solution must be discarded.
Danish: Nordimet er kun beregnet til engangsbrug, og eventuel ikke anvendt injektionsvæske skal kasseres.
English: Methotrexate affects spermatogenesis and oogenesis and may decrease fertility.
Danish: Methotrexat påvirker spermatogenesen og oogenesen og kan nedsætte fertiliteten.
English: Take your medicine package and this leaflet with you if you go to a doctor or hospital.
Danish: Tag pakningen med medicin og denne indlægsseddel med til lægen eller hospitalet.
English: The active substance is methotrexate.
Danish: Aktivt stof: methotrexat.
English: • Major birth defects occurred in 6.6% of live births in women exposed to low-dose methotrexate treatment (less than 30 mg/week) during pregnancy, compared to approximately 4% of live births in in disease-matched patients treated with drugs other than methotrexate.
Danish: • Der forekom større fødselsdefekter hos 6,6% af levende fødsler hos kvinder, der var eksponeret for lavdosisbehandling med methotrexat (mindre end 30 mg/uge) under graviditeten, i sammenligning med ca. 4% af levende fødsler hos patienter med samme sygdom, der var behandlet med andre lægemidler end methotrexat.
English: Any used pen should be discarded.
Danish: Brugte penne skal kasseres.
English: Nordimet is also available in multipacks containing 12 prefilled pens in 3 cartons (4 pens and alcohol swabs per carton).
Danish: Nordimet fås også i multipakninger med 12 fyldte penne i 3 kartoner (4 penne og spritservietter pr. karton).
English: Excessive consumption of beverages containing caffeine or theophylline (coffee, soft drinks containing caffeine, black tea) should be avoided during methotrexate therapy since the efficacy of methotrexate may be reduced due to possible interaction between methotrexate and methylxanthines at adenosine receptors.
Danish: Overdrevet indtagelse af drikkevarer, der indeholder koffein eller theophyllin (kaffe, læskedrikke med koffein, sort te) skal undgås under behandling med methotrexat, da methotrexats effekt kan blive reduceret som følge af mulig interaktion mellem methotrexat og methylxanthiner ved adenosinreceptorer.
English: Enzyme diagnostics does not allow any reliable prediction of the development of a morphologically detectable hepatotoxicity, i.e. even in case of normal transaminases, hepatic fibrosis only histologically identifiable or, more rarely, also hepatocirrhosis may be present.
Danish: Enzymdiagnostik giver ikke nogen pålidelig prognose for udvikling af morfologisk detekterbar hepatotoksicitet, dvs. selv i tilfælde af normale aminotransferaseværdier kan histologisk detekterbar leverfibrose, og i sjældnere tilfælde også levercirrose, forekomme.
English: - Methotrexate may, due to its effect on the immune system, impair the response to vaccinations and interfere with the result of immunological tests.
Danish: - På grund af methotrexats virkning på immunsystemet kan det nedsætte responsen på vaccinationer og indvirke på resultaterne af immunologiske test.
English: Therefore, the possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with female patients of childbearing potential (see section 4.6).
Danish: Den mulige risiko for påvirkning af reproduktionen, abort og kongenitale misdannelser skal drøftes med kvindelige patienter i den fertile alder (se pkt.
English: You may also have a chest X-ray.
Danish: Du vil eventuelt også få taget et røntgenbillede af brystkassen.
English: Use in patient with a third distribution space (pleural effusions, ascitis) As the half-life of methotrexate can be prolonged to 4 times the normal length in patients who possess a third distribution space, dose reduction or, in some cases, discontinuation of methotrexate administration may be required (see sections 5.2 and 4.4).
Danish: Anvendelse til patienter med et tredje fordelingsrum (pleuraeffusion, ascites) Da methotrexats halveringstid kan være forlænget til 4 gange den normale halveringstid hos patienter med et tredje fordelingsrum, kan det være nødvendigt at reducere dosis eller i nogle tilfælde afbryde administrationen af methotrexat (se pkt.
English: Symptoms indicating potentially severe lung injury (interstitial pneumonitis) are: dry, not productive cough, shortness of breath and fever.
Danish: Symptomer, der tyder på potentielt alvorlig lungeskade (interstitiel pneumonitis) er: tør, uproduktiv hoste, stakåndethed og feber.
English: 10) Press down on the plunger with your finger until the syringe is empty.
Danish: 10) Tryk stemplet ned med fingeren, indtil injektionssprøjten er tømt.
English: Due to the potentially toxic effect on the liver, additional hepatotoxic medicinal products should not be given during treatment with methotrexate unless clearly necessary and alcohol consumption should be avoided or greatly reduced (see section 4.5).
Danish: På grund af den potentielle toksiske virkning på leveren bør der ikke gives andre hepatotoksiske lægemidler under behandlingen med methotrexat, medmindre det er på tvingende indikation, og indtagelse af alkohol skal undgås eller reduceres markant (se pkt.
English: Once Nordimet starts working, the doctor may reduce the dose gradually to the lowest possible effective maintenance dose.
Danish: Når Nordimet begynder at virke, kan lægen reducere dosis gradvist til den lavest mulige effektive vedligeholdelsesdosis.
English: If you forget to use Nordimet
Danish: Hvis du har glemt at bruge Nordimet
English: You must avoid becoming pregnant whilst taking methotrexate and for at least 6 months after treatment is stopped by using reliable contraception throughout this time (see also section “Warnings and precautions”).
Danish: Du skal undgå at blive gravid, mens du bruger methotrexat og i mindst 6 måneder efter, at behandlingen er stoppet, ved at bruge sikker prævention i hele denne periode (se også afsnittet “Advarsler og forsigtighedsregler”).
English: Do not take a double dose to make up for a forgotten dose, but continue taking the prescribed dose as normal.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Special caution is required in patients with impaired pulmonary function.
Danish: Særlig forsigtighed er påkrævet hos patienter med nedsat lungefunktion.
English: The other ingredients are sodium chloride, sodium hydroxide and water for injections.
Danish: Øvrige indholdsstoffer: natriumchlorid, natriumhydroxid og vand til injektionsvæsker.
English: In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate as toxicity will markedly increase.
Danish: En dosis over 25 mg kan i undtagelsestilfælde være klinisk berettiget, men dosis bør ikke overstige 30 mg methotrexat om ugen, da toksiciteten vil stige betydeligt.
English: Nordimet is for subcutaneous use (see section 6.6.
Danish: Nordimet er beregnet til subkutan anvendelse (se pkt.
English: Hence, methotrexate should be only administered by, or under the supervision of, doctors whose knowledge and experience include the use of antimetabolite therapy.
Danish: Methotrexat bør således kun administreres af læger eller under supervision af læger, der har viden om og erfaring med behandling med antimetabolitter.
English: Treatment should not be initiated or should be discontinued if there are any abnormalities in liver function tests or liver biopsies, or if these develop during therapy.
Danish: Behandlingen må ikke initieres og skal seponeres, hvis der er nogen som helst anomalier i leverfunktionstest eller leverbiopsier, eller hvis sådanne anomalier opstår under behandlingen.
English: When administered in low doses (7.5 mg/m to 80 mg/m
Danish: Efter administration i lave doser (7,5 mg/m til 80 mg/m
English: 8) Hold the syringe in the hand you write with (like a pencil) and with your other hand, make a fold in the skin by gently pinching the skin of the injection place with your forefinger and thumb.
Danish: 8) Hold injektionssprøjten i den hånd, du normalt skriver med (som en blyant), og en fold i huden med den anden hånd ved forsigtigt at klemme huden på injektionsstedet sammen med din pegefinger og tommelfinger.
English: In the event of contamination, the affected area must be rinsed immediately with ample amount of water.
Danish: I tilfælde af kontaminering skylles det ramte område straks med rigelige mængder vand.
English: Limited clinical evidence does not indicate an increased risk of malformations or miscarriage following paternal exposure to low-dose methotrexate (less than 30 mg/week).
Danish: En begrænset klinisk evidens indikerer ikke en øget risiko for misdannelser eller abort efter faderlig eksponering for lave doser methotrexat (mindre end 30 mg/uge).
English: As precautionary measures, sexually active male patients or their female partners are recommended to use reliable contraception during treatment of the male patient and for at least 6 months after cessation of methotrexate.
Danish: Som sikkerhedsforanstaltning skal seksuelt aktive mandlige patienter eller deres kvindelige partnere rådes til at anvende pålidelig prævention under behandlingen af den mandlige patient og i mindst 6 måneder efter ophør af behandling med methotrexat.
English: Your doctor will do tests to check for abnormalities developing in the blood (e.g. low white blood cells, low platelets, lymphoma) and changes in the kidney and the liver.
Danish: Din læge vil tage prøver for at kontrollere, om der er uregelmæssigheder i blodet (for eksempel lavt antal hvide blodlegemer, lavt antal blodplader, lymfom) eller ændringer i nyrer og lever.
English: Though the combination of methotrexate and sulfasalazine may enhance methotrexate efficacy by sulfasalazine related inhibition of folic acid synthesis, and thus may lead to an increased risk of adverse reactions, these were only observed in single patients within several trials.
Danish: Selvom kombination af methotrexat og sulfasalazin kan forstærke methotrexats virkning gennem en sulfasalazin-relateret hæmning af folsyre-syntesen og således medføre øget risiko for bivirkninger, blev sådanne bivirkninger kun observeret hos enkelte patienter inden for adskillige studier.
English: This assessment should differentiate between patients without any risk factors and patients with risk factors, e.g. excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of hereditary liver disorders, diabetes mellitus, obesity and previous contact with hepatotoxic medicinal products or chemicals and prolonged methotrexate treatment or cumulative doses of 1.5 g or more.
Danish: Denne evaluering skulle skelne mellem patienter uden risikofaktorer og patienter med risikofaktorer, fx tidligere overforbrug af alkohol, vedvarende forhøjelse af leverenzymer, leversygdom i anamnesen, arvelig leversygdom i familien, diabetes mellitus, adipositas og tidligere kontakt med hepatotoksiske lægemidler eller kemikalier samt langvarig behandling med methotrexat eller kumulative doser på 1,5 g eller derover.
English: Regular alcohol consumption and administration of additional hepatotoxic medicinal products increase the probability of hepatotoxic effects of methotrexate.
Danish: Regelmæssig indtagelse af alkohol og administration af andre hepatotoksiske lægemidler øger risikoen for hepatotoksiske virkninger af methotrexat.
English: Methotrexate causes embryotoxicity, abortion and foetal defects in humans.
Danish: Methotrexat forårsager embryotoksicitet, abort og føtale defekter hos mennesker.
English: If you accidently get methotrexate on the surface of the skin or soft tissues you must rinse with plenty of water.
Danish: Hvis du ved et uheld får methotrexat på huden eller andre steder, skal du skylle med masser af vand.
English: Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics may reduce intestinal methotrexate absorption or interfere with the enterohepatic circulation, due to inhibition of the intestinal flora or suppression of bacterial metabolism.
Danish: Orale antibiotika, såsom tetracykliner, chloramphenicol og ikke-absorberbare bredspektrede antibiotika, kan reducere den intestinale absorption af methotrexat eller interferere med det enterohepatiske kredsløb på grund af hæmning af tarmfloraen eller suppression af den bakterielle metabolisme.
English: Nordimet is for single use only.
Danish: Nordimet er kun beregnet til engangsbrug.
English: Follow the dose recommendations of your treating doctor.
Danish: Følg de anbefalinger til dosering, som din læge har givet dig.
English: - Complete blood count with differential blood count and platelets.
Danish: - Komplet blodtælling med differentialtælling og trombocyttal.
English: Neither haemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination.
Danish: Hverken hæmodialyse eller peritoneal dialyse er vist at øge udskillelsen af methotrexat.
English: The use of nitrous oxide potentiates the effect of methotrexate on folate metabolism, yielding increased toxicity such as severe unpredictable myelosuppression and stomatitis.
Danish: Anvendelse af dinitrogenoxid forstærker methotrexats virkning på folat-metabolismen og medfører forøget toksicitet som alvorlig og uforudsigelig myelosuppression og stomatitis.
English: Men should not donate semen during therapy or for 6 months following discontinuation of methotrexate.
Danish: Mænd må ikke donere sæd under behandlingen eller i 6 måneder efter ophør af behandling med methotrexat.
English: The medicinal product is for single use only.
Danish: Dette lægemiddel er kun beregnet til engangsbrug.