FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose should be adjusted as follows for patients with rheumatoid arthritis, juvenile arthritis, psoriasis and psoriatic arthritis.
Danish: Dosis bør justeres på følgende måde hos patienter med reumatoid artritis, juvenil artritis, psoriasis og psoriasisartritis.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic products.
Danish: Ikke anvendt lægemiddel og affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
English: Neither haemodialysis nor peritoneal dialysis has been shown to improve the elimination of methotrexate.
Danish: Hverken hæmodialyse eller peritonealdialyse er påvist at fremme udskillelsen af methotrexat.
English: There are reports of deaths from sepsis, septic shock, renal failure and aplastic anaemia.
Danish: Der er indberetninger om dødsfald som følge af sepsis, septisk chok, nyresvigt og aplastisk anæmi.
English: It is presented in a brown glass bottle containing 60 ml of solution and capped with a child-resistant closure.
Danish: Det leveres i en brun glasflaske, der indeholder 60 ml opløsning og har børnesikkert låg.
English: EU/1/17/1172/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/1/17/1172/001
English: In the antineoplastic treatment, myelosuppression and mucositis are the predominant dose-limiting toxic effects of methotrexate.
Danish: Ved antineoplastisk behandling er myelosuppression og mucositis de fremherskende dosisbegrænsende toksiske virkninger af methotrexat.
English: Do not use Jylamvo during pregnancy except if your doctor has prescribed it for oncology treatment.
Danish: Du må ikke tage Jylamvo under graviditet, medmindre lægen har ordineret det til behandling af kræft.
English: Malignant lymphomas
Danish: Malignt lymfom
English: BATCH NUMBER
Danish: BATCHNUMMER Lot:
English: Take the medicine pack with you when you visit your doctor or the hospital.
Danish: Tag lægemiddelpakningen med til lægen eller hospitalet.
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg (15 ml)/week.
Danish: Tilgængelige data indikerer ikke øget risiko for misdannelser eller abort hvis faderen tager mindre end 30 mg (15 ml) methotrexat pr. uge.
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Danish: Dette lægemiddel skal opbevares utilgængeligt for børn, helst i aflåst skab.
English: Decide with your doctor the most suitable day of the week to take the medicine.
Danish: Aftal med lægen, hvilken ugedag det er bedst, at du tager lægemidlet.
English: In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications.
Danish: Derudover er der indberettet tilfælde af pulmonal alveolær blødning ved anvendelse af methotrexat i reumatologiske og relaterede indikationer.
English: Common accepted single doses lie in the range of 20-40 mg (10-20 ml)/m² body surface area.
Danish: Almindeligt anerkendte enkeltdoser ligger i området 20‐40 mg (10‐20 ml)/m² legemsoverflade.
English: Ensure that you drink a lot of fluids during treatment with Jylamvo because dehydration (the reduction of body water) can increase the side effects of methotrexate.
Danish: Sørg for at drikke rigeligt under behandlingen med Jylamvo, da væskemangel (dehydrering) kan forstærke methotrexats bivirkninger.
English: Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics may reduce intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting intestinal flora or suppressing bacterial metabolism.
Danish: Orale antibiotika såsom tetracykliner, chloramphenicol og ikke‐absorberbare bredspektrede antibiotika kan nedsætte den intestinale absorption af methotrexat eller interferere med det enterohepatiske kredsløb ved at hæmme den intestinale flora eller undertrykke den bakterielle metabolisme.
English: • Immunodeficiency
Danish: • Immundefekt
English: Cholestyramine can increase the non-renal elimination of methotrexate by interfering with the enterohepatic circulation.
Danish: Colestyramin kan øge den ikke-renale udskillelse af methotrexat ved at interferere med det enterohepatiske kredsløb.
English: The consumption of alcohol should be avoided during treatment with methotrexate (see section 4.4).
Danish: Alkoholindtagelse bør undgås under behandling med methotrexat (se pkt.
English: EXP: Discard 3 months after first opening.
Danish: EXP: Kasseres 3 måneder efter anbrud.
English: Doses are usually based on the patient's BSA and maintenance treatment represents a long-term treatment.
Danish: Dosis baseres sædvanligvis på patientens legemsoverfladeareal, og vedligeholdelsesbehandlingen er langvarig.
English: Highly proliferating tissue such as malignant cells, bone marrow, foetal cells, skin epithelium and mucosa is generally more sensitive to this effect of methotrexate.
Danish: Stærkt prolifererende væv såsom maligne celler, knoglemarv, føtale celler, hudens epitel og slimhinder er generelt mere følsomme for denne virkning af methotrexat.
English: Persistent abnormalities of liver enzymes and/or a decrease in serum albumin can indicate severe hepatotoxicity.
Danish: Persisterende abnorme leverenzymer og/eller fald i serumalbumin kan være tegn på svær hepatotoksicitet.
English: - Examination of the mouth and throat for mucosal changes.
Danish: Undersøgelse af mund og svælg for slimhindeforandringer.
English: Pneumocystis jiroveci pneumonia and other lung infections, Chronic obstructive pulmonary disease, Pleural effusion
Danish: Pneumocystis jirovecipneumoni og andre lungeinfektioner Kronisk obstruktiv lungesygdom Pleuraeffusion
English: Following the occurrence of haematemesis, black-coloured stools or blood in the stools, treatment must be discontinued.
Danish: Hvis der optræder hæmatemese, melæna eller blod i afføringen skal behandlingen afbrydes.
English: Due to its potentially toxic effects on the liver, additional hepatotoxic medicinal products should not be taken during treatment with methotrexate unless urgently necessary and the consumption of alcohol should be avoided or reduced (see section 4.5).
Danish: På grund af methotrexats potentielt toksiske virkninger på leveren bør behandling med andre hepatotoksiske lægemidler undgås, hvis den ikke er tvingende nødvendig, og alkohol bør undgås eller indtagelse heraf nedsættes (se pkt.
English: Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic products - check with your pharmacist.
Danish: Ikke anvendt lægemiddel og affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler - spørg på apoteket.
English: The severity of these reactions depends on the dose, mode and duration of application of methotrexate.
Danish: Sværhedsgraden af disse reaktioner afhænger af dosis, administrationsmåde og behandlingsvarighed.
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: Behandling bør ikke initieres og bør seponeres ved ethvert unormalt fund i leverfunktionsprøver eller leverbiopsier, eller hvis det opstår under behandlingen.
English: Methotrexate therapy should only be resumed with particular caution, after careful consideration of the need for treatment and with increased vigilance for the possible recurrence of toxicity.
Danish: Eventuel genoptagelse af behandlingen bør kun ske med særlig forsigtighed, efter nøje overvejelse af behandlingsbehovet og med skærpet overvågning for, om bivirkningen vender tilbage.
English: When you have taken your dose, drink some water and swallow it to ensure you have taken your full dose and there is no methotrexate left in your mouth.
Danish: Når du har taget din dosis, skal du drikke noget vand og synke det for at sikre, at du har fået hele dosen, og at der ikke er noget methotrexat tilbage i munden.
English: Methotrexate has been shown to be teratogenic to humans; it has been reported to cause foetal death, miscarriages and/or congenital abnormalities (e.g. craniofacial, cardiovascular, central nervous system and extremity-related).
Danish: Methotrexat er påvist at være teratogent hos mennesker og er beskrevet at have medført fosterdød, spontanaborter og/eller kongenitte misdannelser (fx kraniofacale, kardiovaskulære, centralnervesystem og ekstremitetsrelaterede).
English: - Respiratory tract examination - patients must be monitored for symptoms of a lung function disorder and lung function tests performed if necessary.
Danish: Undersøgelse af luftveje - patienten skal overvåges for symptomer på lungefunktionsforstyrrelser, og om nødvendigt skal der udføres en lungefunktionsprøve.
English: Frequency, type and severity of adverse reactions in children and adolescents are expected to be the same as in adults.
Danish: Hos børn og unge forventes bivirkningerne at være af samme hyppighed, art og sværhedsgrad som hos voksne.
English: In chronic toxicity studies in mice, rats and dogs, toxic effects were seen in the form of gastrointestinal lesions, myelosuppression and hepatotoxicity.
Danish: I studier hos i mus, rotter og hunde for kronisk toksicitet sås toksiske virkninger i form af gastrointestinale læsioner, myelosuppression og hepatotoksicitet.
English: If such adverse reactions occur, the dose should either be reduced or treatment discontinued and appropriate countermeasures taken (see section 4.9).
Danish: Ved sådanne bivirkninger bør dosis nedsættes eller behandlingen afbrydes, og der bør træffes passende modforanstaltninger (se pkt.
English: • Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.
Danish: • Svær, behandlingsrefraktær invaliderende psoriasis, som ikke responderer tilstrækkeligt på andre behandlingsformer, såsom fototerapi, psoralen plus UV-A-bestråling (PUVA) og retinoider, samt svær psoriasisartritis hos voksne.
English: Inflammation and ulceration
Danish: Vaginal inflammation og ulceration
English: • Major birth defects occurred in 6.6% of live births in women exposed to low-dose methotrexate treatment (less than 30 mg [15 ml]/week) during pregnancy, compared to approximately 4% of live births in disease-matched patients treated with drugs other than methotrexate.
Danish: • Der forekom større fødselsdefekter hos 6,6 % af levende fødsler hos kvinder udsat for methotrexat med lav dosis (mindre end 30 mg [15 ml]/uge) under graviditeten sammenlignet med ca. 4 % af levende fødsler hos patienter med sygdomsrelateret behandling behandlet med andre lægemidler end methotrexat.
English: Keep the bottle tightly closed to protect the integrity of the product and minimise the risk of accidental spillage.
Danish: Flasken skal holdes tæt lukket for at beskytte lægemidlet mod forurening og minimere risikoen for accidentelt spild.
English: Methotrexate can have a genotoxic effect.
Danish: Methotrexat kan være genotoksisk.
English: They should then be rinsed thoroughly under COLD water and excess water shaken off before wiping dry with a clean paper towel.
Danish: De skylles derefter grundigt i KOLDT vand, og overskydende vand rystes af, hvorpå de tørres med et rent papirhåndklæde.
English: • Spontaneous abortions have been reported in 42.5% of pregnant women exposed to low-dose methotrexate treatment (less than 30 mg [15 ml]/week), compared to a reported rate of 22.5% in disease-matched patients treated with drugs other than methotrexate.
Danish: • Der er rapporteret spontane aborter hos 42, 5% af gravide kvinder udsat for methotrexatbehandling med lav dosis (mindre end 30 mg [15 ml]/uge) sammenlignet med en rapporteret andel på 22,5 % hos patienter med sygdomsrelateret behandling, der blev behandlet med andre lægemidler end methotrexat.
English: The risk of an interaction between NSAIDs and methotrexate should be considered in patients with a low methotrexate dose, particularly in the case of impaired kidney function.
Danish: Risikoen for interaktion mellem NSAID og methotrexat bør tages i betragtning ved behandling med methotrexat i lav dosering, navnlig hos patienter med nedsat nyrefunktion.
English: Methotrexate should be discontinued in patients with pulmonary symptoms and an immediate examination (including chest X-ray) should be performed to exclude infection and tumours.
Danish: Ved lungesymptomer bør methotrexat seponeres og en undersøgelse (herunder røntgen af thorax) straks iværksættes for at udelukke infektion og tumorer.
English: If methotrexate comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis methotrexat kommer i kontakt med hud eller slimhinder, skal området straks vaskes grundigt med sæbe og vand.
English: However, in clinical trials in which NSAIDs and salicylic acid were administered adjuvantly to patients with rheumatoid arthritis, no increase in adverse reactions was observed.
Danish: I kliniske forsøg, hvor NSAID og salicylsyre blev administreret som adjuverende terapi ved reumatoid artritis, sås derimod ingen stigning i bivirkninger.
English: 3 has been reported for methotrexate used in rheumatologic and related indications 4 see remarks on liver biopsy in section 4.4
Danish: 3 er indberettet ved anvendelse af methotrexat i reumatologiske og relaterede indikationer se bemærkningerne om leverbiopsi i pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Danish: Yderligere information om Jylamvo findes på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).
English: Methotrexate temporarily affects sperm and egg production.
Danish: Methotrexat påvirker produktionen af sædceller og æg midlertidigt.
English: There is a risk of excessive immunosuppression with risk of lymphoproliferation when the combination is used.
Danish: Kombination medfører risiko for excessiv immunsuppression med risiko for lymfoproliferation.
English: • The potential for fatal overdose due to medication errors (ME), including daily instead of once weekly use;
Danish: • risikoen for dødelig overdosis som følge af medicineringsfejl, herunder daglig indtagelse i stedet for ugentlig indtagelse
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Danish: Calciumfolinat er den specifikke antidot til neutralisering af methotrexats toksiske virkninger.
English: The plunger and barrel should then be separated and both washed thoroughly in the warm soapy water.
Danish: Stemplet og cylinderen adskilles derefter fra hinanden, og begge vaskes grundigt i det varme sæbevand.
English: Increased caution is required in patients with insulin-dependent diabetes mellitus as hepatic cirrhosis has developed in individual cases without any elevation of transaminases during methotrexate treatment.
Danish: Hos patienter med insulinafhængig diabetes mellitus er ekstra forsigtighed påkrævet, da der i enkelte tilfælde er opstået levercirrose uden forhøjede aminotransferaser under methotrexatbehandling.
English: The syringe should be held under water and the plunger drawn in and out several times until all traces of medicine are removed from inside the syringe including the tip.
Danish: Sprøjten skal holdes nede i vandet, og stemplet trækkes ind og ud flere gange, indtil alle spor af lægemidlet er fjernet fra sprøjtens inderside, også spidsen.
English: Methotrexate should be used with caution in paediatric patients.
Danish: Der skal udvises forsigtighed ved anvendelse af methotrexat hos pædiatriske patienter.
English: Nephropathy Inflammation and ulceration of urinary bladder (possibly with haematuria), Dysuria
Danish: Nefropati Inflammation og ulceration i urinblæren (eventuelt med hæmaturi), dysuri
English: Effective clearance of methotrexate is reported to be achieved with acute intermittent haemodialysis using a high-flux dialyser.
Danish: Der er beskrevet effektiv clearance af methotrexat med akut intermitterende hæmodialyse med et highflux-dialyseapparat.
English: • Pre-existing blood disorders such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia
Danish: • Præeksisterende blodsygdom såsom knoglemarvshypoplasi, leukopeni, trombocytopeni eller signifikant anæmi
English: Your doctor will therefore do tests to check for any changes in your blood (such as a low white blood cell count, a low blood platelet count, lymphomas), kidneys or liver.
Danish: Lægen vil derfor tage blodprøver for at kontrollere, om der er ændringer (såsom lavt antal hvide blodlegemer, lavt antal blodplader, svulster i lymfeknuder (lymfomer) eller nyrernes eller leverens funktion).
English: If liver enzymes are constantly increased, a dose reduction or treatment discontinuation should be considered.
Danish: Ved persisterende forhøjede leverenzymer bør dosisreduktion eller behandlingsafbrydelse overvejes.
English: Acute or chronic interstitial pneumonia, often in association with blood eosinophilia, may occur and deaths have been reported.
Danish: Akut eller kronisk interstitiel pneumoni kan forekomme, ofte ledsaget af eosinofili, og dødelige tilfælde er beskrevet.
English: If use during the lactation period should become necessary, breast-feeding is to be stopped prior to treatment.
Danish: Hvis anvendelse i ammeperioden er nødvendig, skal amning ophøre før behandlingsstart.
English: Regular alcohol consumption and administration of additional hepatotoxic medicinal products increase the likelihood of hepatotoxic adverse reactions to methotrexate.
Danish: Regelmæssig alkoholindtagelse og administration af andre hepatotoksiske lægemidler øger risikoen for hepatotoksiske reaktioner på methotrexat.
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 [15 ml]/week).
Danish: Begrænset klinisk viden indikerer ikke en øget risiko for misdannelser eller abort efter fostereksponering for methotrexat med lav dosis (mindre end 30 mg [15 ml]/uge).
English: Methotrexate causes embryotoxicity, abortion and foetal malformations in humans.
Danish: Methotrexat medfører embryotoksicitet, abort og føtale misdannelser hos mennesker.
English: Confirm that the dose in the syringe is correct.
Danish: Det kontrolleres, at sprøjten indeholder den korrekte dosis.
English: Please read section 3 of this leaflet very carefully.
Danish: 3 i denne indlægsseddel meget nøje.
English: Oral solution 60 ml bottle Bottle adaptor 10 ml dosing syringe
Danish: 60 ml flaske Flaskeadaptor 10 ml doseringssprøjte
English: Before beginning treatment or resuming treatment after a recovery period Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest X-ray and renal function tests.
Danish: Før behandling initieres eller genoptages efter en restitutionsperiode Der skal udføres komplet blodtælling med differentialtælling og trombocyttælling, monitorering af leverenzymer, bilirubin, serumalbumin og nyrefunktion samt røntgen af thorax.
English: The antidote in the event of an overdose is calcium folinate.
Danish: I tilfælde af en overdosis er modgiften calciumfolinat.
English: Concurrent folic acid supplementation of 5 mg twice weekly (except on the day of administration) is indicated additionally.
Danish: Samtidigt tilskud af folsyre 5 mg to gange ugentligt er indiceret (dog ikke på administrationsdagen).
English: Therefore, methotrexate should only be administered by, or under the supervision of, doctors whose knowledge and experience includes treatment with antimetabolites.
Danish: Methotrexat bør derfor kun administreres under supervision af læger med kendskab til og erfaring i behandling med antimetabolitter.
English: If methotrexate is administered in combination with chemotherapy regimens, the dosage should take into consideration any overlapping toxicity of the other medicinal product components.
Danish: Hvis methotrexat anvendes i kombination med et kemoterapi-regime, skal der ved fastlæggelse af dosis tages hensyn til eventuelt overlappende toksicitet af de andre lægemidler.
English: Ciclosporin may potentiate methotrexate efficacy and toxicity.
Danish: Ciclosporin kan potensere methotrexats virkning og toksicitet.
English: Encephalopathy/leukoencephalopathy
Danish: Encefalopati/leukoencefalopati
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du får bivirkninger, bør du tale med din læge eller apoteket.
English: If risk factors such as renal function disorders, including mild renal impairment, are present, combined administration with NSAIDs is not recommended.
Danish: Hvis der foreligger risikofaktorer såsom nyrefunktionsforstyrrelser, herunder let nedsat nyrefunktion, frarådes samtidig anvendelse af NSAID.
English: Severe, occasionally fatal, dermatologic reactions, including toxic epidermal necrolysis (Lyell's syndrome) or Stevens-Johnson syndrome have been reported after single or multiple doses of methotrexate.
Danish: Der er beskrevet svære, undertiden dødelige dermatologiske reaktioner, herunder toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, efter enkeltdoser og gentagne doser af methotrexat.
English: Pulmonary symptoms require a rapid diagnosis and discontinuation of methotrexate therapy.
Danish: Lungesymptomer kræver hurtig diagnosticering og seponering af methotrexat.
English: Renal impairment and patients at risk of renal impairment As methotrexate is eliminated mainly via the kidneys, increased concentrations are to be expected in the presence of renal impairment, which may result in severe adverse reactions.
Danish: Nyrefunktionsnedsættelse og patienter med risiko for nyrefunktionsnedsættelse Da methotrexat hovedsagelig udskilles via nyrerne, kan der ved nyreinsufficiens forventes højere koncentrationer, som kan medføre svære bivirkninger.
English: • Severe renal impairment (creatinine clearance less than 30 ml/min, see section 4.2)
Danish: • Svært nedsat nyrefunktion (kreatininclearance under 30 ml/min, se pkt.
English: Muscular asthenia or paraesthesia of the extremities, Taste changes (metallic taste), Irritation,
Danish: Muskulær asteni eller paræstesi af ekstremiteter Smagsændringer (metalsmag) Irritation
English: Each pack contains one bottle, a bottle adaptor and a white dosing syringe.
Danish: Hver pakning indeholder en flaske, et overgangstykke (adaptor) og en hvid doseringssprøjte.
English: The use of nitrous oxide potentiates the effect of methotrexate on folate metabolism, yielding increased toxicity such as severe, unpredictable myelosuppression, stomatitis and neurotoxicity with intrathecal administration.
Danish: Anvendelsen af dinitrogenoksid forstærker virkningen af methotrexat på folatmetabolisme, hvilket giver øget toksicitet såsom alvorlig uforudsigelig myelosuppression, stomatitis og neurotoksicitet ved intratekal administration.
English: Hepatic steatosis, fibrosis and cirrhosis, Decrease in serum albumin
Danish: Hepatisk steatose, fibrose og cirrose Nedsat serumalbumin
English: Take Jylamvo only once a week for the treatment of rheumatic or skin diseases (RA, JIA and psoriasis or psoriatic arthritis).
Danish: Tag kun Jylamvo én gang om ugen til behandling af gigt- og hudsygdomme (leddegigt, JIA og psoriasis og psoriasisgigt).
English: Allergic reactions, Anaphylactic shock,
Danish: Allergiske reaktioner Anafylaktisk chok
English: Because of the reduced liver and kidney function and the lower folate reserves in elderly patients, a relatively low dosage should be chosen for them.
Danish: Da ældre patienter har nedsat lever- og nyrefunktion og mindre reserver af folinsyre, bør ældre patienter have en forholdsvis lav dosis.