FrancophonIA/ELRC3.0 huggingface dataset:
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week.
Danish: Den foreliggende evidens indikerer ikke en øget risiko for misdannelser eller abort, hvis faderen tager methotrexat i doser på under 30 mg/uge.
English: As methotrexate is transferred into human milk and may cause toxicity in breast-feeding children, treatment is contraindicated during breast-feeding (see section 4.3).
Danish: Da methotrexat udskilles i human mælk og kan forårsage toksicitet hos ammede spædbørn, er behandling kontraindiceret under amning (se pkt.
English: There are reports of death due to sepsis, septic shock, renal failure and aplastic anaemia.
Danish: Der er rapporter om dødsfald som følge af sepsis, septisk shock, nyresvigt og aplastisk anæmi.
English: Very common: Stomatitis, dyspepsia, nausea, loss of appetite, abdominal pain.
Danish: Meget almindelig: Stomatitis, dyspepsi, nausea, appetitløshed, abdominalsmerter.
English: - Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease.
Danish: - Stomatitis, sår i mundhulen og kendt aktivt gastrointestinalt ulcus.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially “sodium-free“.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. at det stort set er “natriumfrit“.
English: - Check the pen is not damaged and the medicine in it is a clear, yellow solution.
Danish: - Kontrollér, at pennen ikke er beskadiget, og at lægemidlet indeni er en klar, gul opløsning.
English: Haematopoietic suppression induced by methotrexate may occur abruptly and at apparently safe doses.
Danish: Methotrexatinduceret hæmatopoietisk suppression kan opstå pludseligt og ved ellers tilsyneladende sikre doser.
English: Methotrexate leads to increased plasma levels of mercaptopurines.
Danish: Methotrexat øger plasmaniveauet af mercaptopuriner.
English: Dosage in patients with psoriasis vulgaris and psoriatic arthritis It is recommended that a test dose of 5-10 mg be administered subcutaneously one week prior to initiation of therapy, in order to detect idiosyncratic adverse effects.
Danish: Dosering til patienter med psoriasis vulgaris og psoriasisartrit Det anbefales, at der administreres en prøvedosis på 5-10 mg subkutant en uge inden initiering af behandlingen for at opfange eventuelle idiosynkratiske bivirkninger.
English: Immune system disorders Rare: Allergic reactions, anaphylactic shock, hypogammaglobulinaemia.
Danish: Immunsystemet Sjælden: Allergiske reaktioner, anafylaktisk shock, hypogammaglobulinæmi.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, and so is essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis og er således stort set ‘natriumfrit'.
English: Very common: Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and bilirubin).
Danish: Meget almindelig: Unormale leverfunktionstest (forhøjet ALAT, ASAT, alkalisk fosfatase og bilirubin).
English: Do not try to inject yourself if you have not been trained on how to do so.
Danish: Du må ikke forsøge at give dig selv en injektion, hvis du ikke har fået undervisning i det.
English: Therefore, the combination of these may require dose adjustment.
Danish: Ved kombination kan dosisjustering derfor være nødvendig.
English: 6) Make a fold in the skin by gently pinching the skin of the injection place with your forefinger and thumb.
Danish: 6) Lav en fold i huden ved forsigtigt at klemme huden på injektionsstedet sammen med din pegefinger og tommelfinger.
English: Not known: Osteonecrosis of jaw (secondary to lymphoproliferative disorders)
Danish: Ikke kendt: Osteonekrose i kæben (sekundær til lymfoproliferative lidelser).
English: Probenecid and mild organic acids may also reduce tubular methotrexate secretion, and thus cause indirect dose elevations, too.
Danish: Probenecid og svage organiske syrer kan også nedsætte den tubulære udskillelse af methotrexat og således også medføre indirekte dosisstigning.
English: During treatment with Nordimet, you must not drink any alcohol and should avoid excessive consumption of coffee, soft drinks containing caffeine and black tea as this may enhance side effects or interfere with the efficacy of Nordimet.
Danish: Brug af Nordimet sammen med mad, drikke og alkohol Under behandlingen med Nordimet må du ikke drikke alkohol, og du skal undgå overdreven indtagelse af kaffe, læskedrikke med koffein og sort te, da disse kan forstærke bivirkningerne eller indvirke på effekten af Nordimet.
English: - Check your last injection site to see if the last injection caused any redness, change in skin colour, swelling, oozing or is still painful, if so talk to your doctor or nurse.
Danish: - Se på det sidste injektionssted, om den seneste injektion har medført hudrødme, ændret hudfarve, hævelse eller siveblødning, eller det stadig gør ondt.
English: What you need to know before you use Nordimet
Danish: Det skal du vide, før du begynder at bruge Nordimet
English: - Check the syringe is not damaged and the medicine in it is a clear, yellow solution.
Danish: - Kontrollér, at injektionssprøjten ikke er beskadiget, og at lægemidlet indeni er en klar, gul opløsning.
English: During methotrexate therapy, opportunistic infection can occur including pneumocystis jiroveci pneumonia, which may take a lethal course.
Danish: Der kan opstå opportunistisk infektion under behandling med methotrexat, herunder Pneumocystis jiroveci-pneumoni, som kan have et dødeligt forløb.
English: Closer monitoring of liver enzymes should be undertaken in patients concomitantly taking other hepatotoxic medicinal products (e.g. leflunomide).
Danish: Tættere monitorering af leverenzymer skal udføres hos patienter, der samtidig får andre hepatotoksiske lægemidler (fx leflunomid).
English: The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal disorders.
Danish: De mest relevante bivirkninger er suppression af det hæmatopoietiske system og gastrointestinale gener.
English: Remove the syringe from the box by the body as shown in the picture below.
Danish: Tag sprøjten ud af æsken ved at holde på hoveddelen som vist på billedet herunder.
English: Very rare: Agranulocytosis, severe courses of bone marrow depression, lymphoproliferative disorders (see “description below”).
Danish: Meget sjælden: Agranulocytose, alvorlige forløb med knoglemarvsdepression., lymfoproliferative lidelser (se beskrivelsen herunder).
English: This particularly applies to the co-administration of medicinal products which affect methotrexate excretion, cause kidney damage (e.g. NSAIDs) or can potentially lead to haematopoietic disorders.
Danish: Dette gælder især ved samtidig administration af lægemidler, der påvirker udskillelsen af methotrexat, forårsager nyreskader (fx NSAID'er), eller som potentielt kan medføre hæmatopoietiske forstyrrelser.
English: Generally, improvement of symptoms can be expected after 4-8 weeks of treatment.
Danish: Normalt kan man forvente en bedring af symptomerne efter 4-8 ugers behandling.
English: When switching from oral use to subcutaneous use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
Danish: På grund af methotrexats variable biotilgængelighed efter oral administration kan det være nødvendigt at reducere dosis i forbindelse med skift fra oral til subkutan administration.
English: A rise in the toxicity of methotrexate is generally not anticipated when methotrexate is used concomitantly with other antirheumatic agents (e.g. gold compounds, penicillamine, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporin).
Danish: Øget toksicitet af methotrexat forventes generelt ikke, når methotrexat bruges sammen med andre antireumatika (fx guldforbindelser, penicillamin, hydroxychloroquin, sulfasalazin, azathioprin, ciclosporin).
English: If women of a sexually mature age are treated, effective contraception must be performed during treatment and for at least six months after.
Danish: Hvis der behandles kønsmodne kvinder, skal der anvendes effektiv kontraception under behandlingen og i mindst 6 måneder efter behandlingen.
English: Place the yellow needle shield against the area of injection so that the entire rim of the needle shield is touching the skin.
Danish: Sæt den gule kanylebeskyttelse ned på injektionsområdet, så hele kanten af kanylebeskyttelsen berører huden.
English: However, an increased monitoring frequency is indicated if the dose is increased.
Danish: Hyppigere monitorering er dog nødvendigt, hvis dosen forhøjes.
English: Uncommon: Pancytopenia.
Danish: Ikke almindelig: Pancytopeni.
English: In animal experiments non-steroidal anti-inflammatory drugs (NSAIDs) including salicylic acid caused reduction of tubular methotrexate secretion and consequently increased its toxic effects.
Danish: Nonsteroide antiinflammatoriske lægemidler (NSAID'er), herunder salicylsyre, medførte i dyreforsøg et fald i den tubulære udskillelse af methotrexat og forstærkede således dets toksiske virkninger.
English: A droplet may appear at the tip of the needle.
Danish: Der kan komme en lille dråbe til syne på spidsen af kanylen.
English: Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Danish: Fortæl det straks til lægen, hvis du pludseligt får hvæsende vejrtrækning, vejrtrækningsbesvær, hævelse i øjenlåg, ansigt eller læber og udslæt eller kløe (især, hvis det er på hele kroppen).
English: Very rare: Impaired vision, Retinopathy.
Danish: Meget sjælden: Nedsat syn, retinopati.
English: You will feel and hear a second “click” once the injection is completed.
Danish: Når injektionen er færdig, hører og mærker du endnu et “klik”.
English: - Examination of the oral cavity and throat for mucosal changes.
Danish: - Undersøgelse af mundhule og hals for slimhindeforandringer.
English: If you stop taking Nordimet
Danish: Hvis du holder op med at bruge Nordimet
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Very rare: lymphoma (see “description” below)
Danish: cyster og polypper) Meget sjælden: Lymfom (se beskrivelsen herunder).
English: Pulmonary symptoms require a quick diagnosis and discontinuation of methotrexate therapy.
Danish: Lungesymptomer kræver en hurtig diagnose og seponering af methotrexat.
English: Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate.
Danish: Vitaminpræparater eller andre produkter, der indeholder folsyre, folininsyre eller derivater deraf, kan nedsætte methotrexats virkning.
English: Other medicines and Nordimet
Danish: Brug af anden medicin sammen med Nordimet
English: Before initiating therapy or upon resuming therapy after a rest period Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest X-ray and renal function tests must be conducted.
Danish: Før initiering af behandling eller ved genoptagelse af behandling efter en pause Komplet blodtælling med differentialtælling og trombocyttal, leverenzymer, bilirubin, serumalbumin, thoraxrøntgen og test for nyrefunktion skal udføres.
English: Methotrexate should not come into contact with the skin or mucosa.
Danish: Methotrexat må ikke komme i kontakt med hud eller slimhinder.
English: A weekly dose of 25 mg should in general not be exceeded.
Danish: Generelt bør en ugentlig dosis på 25 mg ikke overskrides.
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
Danish: I tilfælde af accidental overdosering skal calciumfolinat administreres intravenøst eller intramuskulært inden for 1 time i en dosis svarende til eller højere end den for høje dosis methotrexat.
English: Rare: Visual disturbances.
Danish: Sjælden: Synsforstyrrelser.
English: Antibiotics, like penicillin, glycopeptides, sulfonamides, ciprofloxacin and cefalotin can, in individual cases, reduce the renal clearance of methotrexate, so that increased serum concentrations of methotrexate with simultaneous haematological and gastro-intestinal toxicity may occur.
Danish: Antibiotika, fx penicilliner, glykopeptider, sulfonamider, ciprofloxacin og cefalotin, kan i enkelte tilfælde reducere den renale clearance af methotrexat, så der kan opstå forhøjet serumkoncentration af methotrexat med samtidig hæmatologisk og gastrointestinal toksicitet.
English: Uncommon: Gastrointestinal ulcers and bleeding, enteritis, vomiting, pancreatitis.
Danish: Ikke almindelig: Gastrointestinale ulcera og blødning, enteritis, opkastning, pankreatitis.
English: - Renal function should be monitored via renal function tests and urinanalysis (see sections 4.2 and 4.3).
Danish: - Nyrefunktionen skal monitoreres gennem nyrefunktionstest og urinalyser (se pkt.
English: Increased caution should generally be exercised in patients with insulin-dependent diabetes mellitus, as during methotrexate therapy hepatocirrhosis developed in isolated cases without intermittent increase in transaminases.
Danish: Der skal generelt udvises større forsigtighed hos patienter med insulinafhængig diabetes mellitus, da der i enkelte tilfælde er set levercirrose uden intermitterende stigning i aminotransferaser under behandling med methotrexat.
English: If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Danish: Er du i tvivl, så spørg lægen eller apotespersonalet, før du tager dette lægemiddel.
English: If use of methotrexate during the breast-feeding period should become necessary, breast-feeding is to be stopped prior to treatment.
Danish: Hvis anvendelse af methotrexat bliver nødvendig under amning, skal amningen ophøre inden behandling.
English: If lymphomas should fail to regress spontaneously, initiation of cytotoxic therapy is required.
Danish: Hvis et lymfom ikke svinder spontant, er behandling med cytostatika påkrævet.
English: In the case of contamination, the parts concerned should be rinsed with plenty of water.
Danish: I tilfælde af kontaminering skal de udsatte steder skylles med masser af vand.
English: Common: Headache, tiredness, drowsiness.
Danish: Almindelig: Hovedpine, træthed, døsighed.
English: Concomitant administration of folate antagonists such as trimethoprim /sulphamethoxazole has been reported to cause an acute megaloblastic pancytopenia in rare instances.
Danish: Det er rapporteret, at samtidig administration af folatantagonister såsom trimethoprim/sulfamethoxazol i sjældne tilfælde har medført akut megaloblastisk pancytopeni.
English: Only mild local skin reactions (such as burning sensations, erythema, swelling, discolouration, pruritus, severe itching, pain) were observed with subcutaneous use, decreasing during therapy.
Danish: Der blev kun observeret lette lokale hudreaktioner (såsom brændende fornemmelse, erytem, hævelse, misfarvning, pruritus, kraftig kløe, smerter) ved subkutan anvendelse, og hudreaktionerne formindskedes under fortsat behandling.
English: Very rare: Pain, muscular asthenia or paraesthesia in the extremities, changes in sense of taste (metallic taste), convulsions, meningism, acute aseptic meningitis, paralysis.
Danish: Meget sjælden: Smerter, muskulær asteni eller paræstesi i ekstremiteter, ændret smagssans (metallisk smag), krampeanfald, meningisme, akut septisk meningitis, paralyse.
English: Methotrexate is contraindicated if bilirubin values are > 5 mg/dl (85.5 µmol/L) (see section 4.3).
Danish: Methotrexat er kontraindiceret, hvis bilirubin er > 5 mg/dl (85,5 µmol/l) (se pkt.
English: In patients with impaired renal function, concomitant administration of NSAIDs is not recommended.
Danish: Samtidig administration af NSAID'er anbefales ikke til patienter med nedsat nyrefunktion.
English: The adverse toxic effects of methotrexate mainly affect the haematopoietic and gastrointestinal system.
Danish: De toksiske bivirkninger af methotrexat påvirker fortrinsvis det hæmatopoietiske system og gastrointestinalkanalen.
English: Salicylates, phenylbutazone, phenytoin, barbiturates, tranquillisers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulfonamides and p-aminobenzoic acid displace methotrexate from serum albumin binding and thus increase bioavailability (indirect dose increase).
Danish: Salicylater, phenylbutazon, phenytoin, barbiturater, beroligende midler, orale kontraceptiva, tetracykliner, aminophenazon-derivater, sulfonamider og p-aminobenzoesyre fortrænger methotrexat fra serumalbumin og øger således biotilgængeligheden (indirekte dosisstigning).
English: Uncommon: Cirrhosis, fibrosis and fatty degeneration of the liver, decrease in serum albumin.
Danish: Ikke almindelig: Cirrose, fibrose og fedtdegeneration i leveren, nedsat serumalbumin.
English: If serum creatinine is increased, the dose should be reduced.
Danish: Dosis skal reduceres, hvis serumkreatinin er forhøjet.
English: Particular caution should therefore also be exercised in the presence of existing folic acid deficiency.
Danish: Der skal derfor udvises særlig forsigtighed ved eksisterende folsyremangel.
English: Do not allow the syringe to touch anything else.
Danish: Lad ikke injektionssprøjten berøre noget andet.
English: Response to treatment can be expected after approximately 4-8 weeks.
Danish: Der kan forventes respons på behandlingen efter cirka 4-8 uger.
English: Dosage errors in the use of Nordimet can result in serious adverse reactions, including death.
Danish: Doseringsfejl under brug af Nordimet kan resultere i alvorlige bivirkninger, herunder dødsfald.
English: Methotrexate treatment of rheumatoid arthritis represents long-term treatment.
Danish: Behandling af reumatoid artrit med methotrexat er langtidsbehandling.
English: Insert the full length of the needle into the skin fold.
Danish: Før kanylen i sin fulde længde ind i hudfolden.
English: The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.
Danish: Dosis kan øges gradvist, men bør generelt ikke overstige 25 mg methotrexat om ugen.
English: Do not use Nordimet if: - you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6) - you have severe kidney disease (your doctor will be able to tell you if you have severe kidney disease) - you have severe liver disease (your doctor will be able to tell you if you have severe liver disease) - you have disorders of the blood-forming system - your alcohol consumption is high - you have an impaired immune system - you have a severe or existing infection, e.g. tuberculosis or HIV - you have gastrointestinal ulcers - you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”) - you receive vaccinations with live vaccines at the same time.
Danish: Brug ikke Nordimet, hvis - du er allergisk over for methotrexat eller et af de øvrige indholdsstoffer i Nordimet (angivet i afsnit 6) - du har en alvorlig nyresygdom (din læge vil kunne fortælle dig, om det er tilfældet) - du har en alvorlig leversygdom (din læge vil kunne fortælle dig, om det er tilfældet) - du har sygdomme i det bloddannende system - du har et højt forbrug af alkohol - du har et svækket immunsystem - du har en alvorlig eller kronisk infektion, for eksempel tuberkulose eller hiv - du har sår i mave-tarm-kanalen - du er gravid eller ammer (læs afsnittet “Graviditet, amning og frugtbarhed”)
English: Uncommon: Pharyngitis.
Danish: Ikke almindelig: Faryngitis.
English: Dose in patients with rheumatoid arthritis The recommended starting dose is 7.5 mg methotrexate once a week.
Danish: Dosis til patienter med reumatoid artrit Den anbefalede startdosis er 7,5 mg methotrexat én gang om ugen.
English: Methotrexate can cause birth defects, harm unborn babies or cause miscarriage.
Danish: Methotrexat kan forårsage medfødte misdannelser, skade det ufødte barn eller medføre abort.
English: The safety shield on the syringe will automatically cover the needle to prevent any needlestick injuries.
Danish: Kanylebeskyttelsen på injektionssprøjten vil automatisk dække kanylen for at undgå uheld med kanylestik.
English: Depending on the individual activity of the disease and patient tolerability, the initial dose may be increased.
Danish: Initialdosis kan forhøjes, afhængigt af sygdomsaktivitet og patientens tolerabilitet.
English: The pre-filled pens are designed to prevent needlestick injury and reuse.
Danish: De fyldte penne er udformet med henblik på at forebygge skader fra nålestik og forebygge genbrug.
English: Only mild local skin reactions were observed with Nordimet and these decreased during therapy.
Danish: Ved behandling med Nordimet blev der kun observeret lette lokale hudreaktioner, som aftog under behandlingen.
English: In case of contamination, the affected parts are to be rinsed immediately with plenty of water (see section 6.6).
Danish: I tilfælde af kontaminering skal de udsatte steder straks skylles med masser af vand (se pkt.
English: Particular attention should be paid to the onset of liver toxicity.
Danish: Man skal især være opmærksom på debut af hepatotoksicitet.
English: 4) Choose an injection site and clean it with the enclosed alcohol swab.
Danish: 4) Vælg et injektionssted, og rengør det med den vedlagte spritserviet.
English: Not known: Proteinuria.
Danish: Ikke kendt: Proteinuri.
English: Methotrexate for the therapy of rheumatic diseases or diseases of the skin must only be used once weekly.
Danish: Ved behandling af reumatiske sygdomme og hudsygdomme må methotrexat kun bruges én gang om ugen.
English: - Severe hepatic impairment, if serum if bilirubin is > 5 mg/dl (85.5 µmol/l) (see section 4.2).
Danish: - Alvorligt nedsat leverfunktion, hvis serumbilirubin er > 5 mg/dl (85,5 µmol/l) (se pkt.
English: Under (pre-)treatment with substances that may have adverse effects on the bone marrow (e.g. sulphonamides, trimethoprim-sulphamethoxazole, chloramphenicol, pyrimethamine), the possibility of marked haematopoietic disorders should be considered.
Danish: Under (for)behandling med stoffer, der kan have negative virkninger på knoglemarven (fx sulfonamider, trimethoprim-sulfamethoxazol, chloramphenicol, pyrimethamin), skal risikoen for udtalte hæmatopoietiske forstyrrelser overvejes.
English: Vascular disorders Rare: Hypotension, thromboembolic events
Danish: Vaskulære sygdomme Sjælden: Hypotension, tromboemboliske bivirkninger.
English: General disorders and administration site conditions Rare: Fever, wound-healing impairment.
Danish: Almene symptomer og reaktioner på administrationsstedet Sjælden: Feber, påvirket sårheling.
English: You must avoid becoming pregnant when using methotrexate and for at least six months after treatment has stopped.
Danish: Du skal undgå at blive gravid, mens du bruger methotrexat og i mindst 6 måneder, efter behandlingen er ophørt.
English: Patients taking potentially hepatotoxic and haematoxic medicinal products during methotrexate therapy (e.g. leflunomide, azathioprine, sulphasalazine, and retinoids) should be closely monitored for possibly increased hepatotoxicity.
Danish: Patienter, som tager potentielt hepatotoksiske og hæmatotoksiske lægemidler (fx leflunomid, azathioprin, sulfasalazin og retinoider) under behandling med methotrexat, skal monitoreres nøje for eventuelt øget hepatotoksicitet.
English: Close the container lid tightly and place the container out of reach of children.
Danish: Luk bøttens låg godt til og anbring bøtten, så den er utilgængelig for børn.
English: 6) Choose an injection site and clean it with the enclosed alcohol swab.
Danish: 6) Vælg et injektionssted, og rengør det med den vedlagte spritserviet.
English: In case of renal insufficiency, elimination is delayed significantly.
Danish: Eliminationen er betydeligt forsinket i tilfælde af nyreinsufficiens.