FrancophonIA/ELRC3.0 huggingface dataset:
English: The oral solution contains 2 mg of methotrexate in each ml of solution; the scaling of the dosing syringe is in ml and not mg; care should be taken that the correct dosing volume is prescribed.
Danish: Den orale opløsning indeholder 2 mg methotrexat pr. ml opløsning; doseringssprøjten er skaleret i ml, ikke i mg; der skal drages omsorg for at ordinere det korrekte doseringsvolumen.
English: Pull the syringe plunger back SLOWLY so that the medicine is drawn from the bottle into the syringe until the WIDEST part of the white syringe plunger is lined up to the black syringe marking of the dose required.
Danish: Sprøjtens stempel trækkes LANGSOMT tilbage, så lægemidlet trækkes fra flasken op i sprøjten, indtil den BREDESTE del af stemplet i den hvide sprøjte er rettet ind efter sprøjtens sorte mærke, der markerer den nødvendige dosis.
English: Jylamvo is for oral use and provided ready for use.
Danish: Jylamvo anvendes oralt (indtages gennem munden) og er klar til brug.
English: Radiation-induced dermatitis and sunburn can reappear during methotrexate therapy (recall reactions).
Danish: Stråleinduceret dermatitis og solforbrænding kan komme igen under behandling med methotrexat (recall reaction).
English: If you had skin problems after radiotherapy (radiation dermatitis) or sunburn, these reactions can recur after methotrexate therapy (recall reaction).
Danish: Hvis du har haft hudproblemer efter strålebehandling (stråledermatitis) eller solskoldning, kan disse reaktioner komme igen under behandling med methotrexat.
English: Dosage in adults with severe forms of psoriasis and adult patients with psoriatic arthritis
Danish: Dosering til voksne med svære former af psoriasis og voksne med psoriasisartritis
English: Methotrexate can affect the production of sperm, which is associated with the possibility of birth defects.
Danish: Methotrexat kan påvirke produktionen af sædceller, hvilket er forbundet med en risiko for medfødte misdannelser.
English: Shake the bottle.
Danish: Flasken omrystes.
English: If you stop taking Jylamvo
Danish: Hvis du holder op med at tage Jylamvo
English: 10 Gently place the tip of the syringe into the patient's mouth and direct it to the inside of the cheek.
Danish: 10. Spidsen af sprøjten føres forsigtigt ind i patientens mund, så den er rettet mod indersiden af kinden.
English: Symptoms of overdose The symptoms following oral overdose predominantly affect the haematopoietic and gastrointestinal systems.
Danish: Symptomerne efter oral overdosering berører overvejende det hæmatopoietiske og gastrointestinale system.
English: Patients with pathological fluid accumulations (pleural effusion, ascites) As the half-life of methotrexate can be prolonged four-fold in patients with pathological fluid accumulations, it may be necessary to reduce the dose and in some cases even to discontinue methotrexate (see sections 4.4 and 5.2).
Danish: Patienter med patologisk væskeansamling (pleuraeffusion, ascites) Da methotrexats halveringstid kan være fire gange forlænget hos patienter med patologisk væskeansamling, kan dosisreduktion og undertiden seponering af methotrexat være nødvendig (se pkt.
English: - Liver function tests - particular attention should be given to the appearance of liver toxicity.
Danish: Leverfunktionsprøver der skal udøves særlig opmærksomhed for udvikling af levertoksicitet.
English: Wash the syringe immediately after use with fresh warm, soapy water and rinse well.
Danish: Sprøjten vaskes straks efter brug med friskt, varmt sæbevand og skylles godt.
English: Patients should be instructed on the importance of adhering to the once-weekly intakes.
Danish: Patienterne skal instrueres i vigtigheden af at overholde doseringen én gang om ugen.
English: • Hepatic impairment (bilirubin levels are >5 mg/dl [85.5 µmol/l], see section 4.2)
Danish: • Nedsat leverfunktion (bilirubin >5 mg/dl [85,5 µmol/l], se pkt.
English: Antibiotics such as penicillins, glycopeptides, sulphonamides, ciprofloxacin and cefalotin can in individual cases reduce the renal clearance of methotrexate, so that increased serum methotrexate concentrations can occur, accompanied by haematological and gastrointestinal toxicity.
Danish: Antibiotika såsom penicilliner, glykopeptider, sulfonamider, ciprofloxacin og cefalotin kan i enkelte tilfælde nedsætte den renale clearance af methotrexat, hvilket kan øge serumkoncentrationen af methotrexat og forårsage hæmatologisk og gastrointestinal toksicitet.
English: Put on disposable gloves before handling.
Danish: Brug engangshandsker ved håndtering.
English: Follow your doctor's dose recommendations.
Danish: Følg lægens anvisninger nøje.
English: Incorrect use of methotrexate can result in severe and even fatal adverse reactions.
Danish: Ukorrekt anvendelse af methotrexat kan medføre svære og endog dødelige bivirkninger.
English: Oligospermia, Menstrual dysfunction
Danish: Oligospermi, menstruationsfor styrrelser
English: Dosage in acute lymphoblastic leukaemia
Danish: Dosering ved akut lymfoblastær leukæmi
English: Hepatitis and liver failure4
Danish: Hepatitis og leversvigt4
English: Co-administration of proton pump inhibitors such as omeprazole or pantoprazole can result in interactions: co-administration of methotrexate and omeprazole has resulted in delayed renal elimination of methotrexate.
Danish: Samtidig administration af protonpumpehæmmere såsom omeprazol eller pantoprazol kan medføre interaktioner: Samtidig administration af methotrexat og omeprazol har medført forsinket renal udskillelse af methotrexat.
English: The plunger should be pushed back gently to the seated position until it clicks into place.
Danish: Stemplet trykkes forsigtigt tilbage, indtil det går på plads med et klik.
English: Other medicines and Jylamvo
Danish: Brug af anden medicin sammen med Jylamvo
English: Treatment of active rheumatoid arthritis, severe JIA, severe psoriasis and severe psoriatic arthritis represents a long-term treatment.
Danish: Behandling af aktiv reumatoid artritis, svær JIA, svær psoriasis og svær psoriasisartritis er langvarig.
English: If you forget to take Jylamvo
Danish: Hvis du har glemt at tage Jylamvo
English: In patients with rheumatoid arthritis or psoriasis, folic acid or folinic acid supplementation may reduce methotrexate toxicity, such as gastrointestinal symptoms, stomatitis, alopecia and elevated liver enzymes.
Danish: Hos patienter med reumatoid artritis eller psoriasis kan tilskud af folsyre eller folinsyre nedsætte methotrexats toksicitet såsom gastrointestinale symptomer, stomatitis, alopeci og forhøjede leverenzymer.
English: Additionally for non-oncological indications • Pregnancy (see section 4.6)
Danish: For ikke-onkologiske indikationer endvidere • Graviditet (se pkt.
English: • Causes of ME, severity and outcomes.
Danish: • årsager til medicineringsfejl, deres omfang og udfald
English: The plunger and barrel should be stored in a clean dry container with the medicine and reassembled before next use.
Danish: Stemplet og cylinderen opbevares i en ren, tør beholder sammen med lægemidlet og samles før næste anvendelse.
English: Women of childbearing potential/Contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least 6 months thereafter (see section 4.4).
Danish: Kvinder i den fertile alder/Antikonception til kvinder Kvinder må ikke blive gravide under behandling med methotrexat; effektiv antikonception skal anvendes under behandling med methotrexat og i mindst 6 måneder, efter behandlingen er afsluttet (se pkt.
English: Severe visual disturbances
Danish: Svære synsforstyrrelser
English: For arthritis and psoriasis take only once a week.
Danish: Ved gigt og psoriasis tages dette lægemiddel kun én gang om ugen.
English: One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium salt), and 0.2 mg ethyl hydroxybenzoate.
Danish: 1 ml opløsning indeholder 2 mg methylhydroxybenzoat (som natriumsalt) og 0,2 mg ethylhydroxybenzoat.
English: In patients with unimpaired elimination mechanisms, myelosuppression and mucositis are generally reversible within 14 to 28 days.
Danish: Myelosuppression og mucositis er sædvanligvis reversible inden for 14-28 dage hos patienter med normale eliminationsmekanismer.
English: This applies in particular when medicinal products that affect the elimination of methotrexate, or that cause kidney damage (e.g. NSAIDs) or that can potentially lead to impairment of haematopoiesis, are administered concomitantly.
Danish: Dette gælder navnlig ved samtidig administration af lægemidler, som har indvirkning på udskillelsen af methotrexat eller forårsager nyreskade (f.eks. NSAID), eller som potentielt kan hæmme hæmatopoiesen.
English: Pruritus vasculitis, herpetiform skin eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), Increased rheumatic nodules,
Danish: Vaskulitis, herpeslignende huderuptioner, StevensJohnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom) Øget antal reumatiske noduli
English: Increase in liver-related enzymes (ALAT [GPT], ASAT [GOT], alkaline phosphatase and bilirubin)
Danish: Forhøjede leverenzymer (ALAT, ASAT, alkalisk fosfatase og bilirubin)
English: Patients taking potentially hepatotoxic medicinal products during treatment with methotrexate (e.g. leflunomide, azathioprine, sulfasalazine and retinoids) should be monitored closely for increased hepatotoxicity.
Danish: Patienter, der under behandling med methotrexat får potentielt hepatotoksiske lægemidler (f.eks. leflunomid, azathioprin, sulfasalazin eller retinoider), skal overvåges tæt for øget hepatotoksicitet.
English: Thromboembolic reactions (including arterial and cerebral thrombosis, thrombophlebitis, deep leg vein thrombosis, retinal vein thrombosis, pulmonary embolism), Hypotension
Danish: Tromboemboliske reaktioner (herunder arteriel og cerebral trombose, tromboflebitis, dyb venetrombose i underekstremitet, retinal venetrombose, lungeemboli) Hypotension
English: You must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after the end of treatment.
Danish: Du skal undgå at blive gravid under behandlingen med methotrexat og i mindst seks måneder efter, du har afsluttet behandlingen.
English: Combined administration of mercaptopurine and methotrexate can increase the bioavailability of mercaptopurine, possibly as a result of inhibition of the metabolism of mercaptopurine.
Danish: Samtidig administration af mercaptopurin og methotrexat kan øge mercaptopurins biotilgængelighed, muligvis på grund af hæmmet metabolisering.
English: Jylamvo is used in patients with: - the following rheumatic and skin diseases: o active rheumatoid arthritis (RA) in adults o polyarthritic forms (when five or more joints are affected) 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 o severe, treatment-resistant, disabling psoriasis that does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, as well as in severe psoriasis that also affects the joints (psoriatic arthritis) in adult patients - acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over
Danish: Jylamvo anvendes hos patienter med: følgende gigt- og hudsygdomme: o aktiv leddegigt (reumatoid artritis, RA) hos voksne o svære former af aktiv gigt af ukendt oprindelse i mindst fem led hos unge og børn over 3 år (polyartritiske former af aktiv, svær juvenil idiopatisk artritis (JIA)), når non-steroide antiinflammatoriske lægemidler (NSAID) ikke har haft tilstrækkelig virkning o svær, behandlingsresistent, invaliderende psoriasis, hvor der ikke er tilstrækkelig virkning af andre behandlingsformer såsom lysbehandling (fototerapi), psoralen og UVAstrålebehandling (PUVA) og retinoider, og svær psoriasis, der også angriber leddene (psoriasisgigt), hos voksne patienter akut lymfoblastær leukæmi (ALL) hos voksne, unge og børn over 3 år
English: One ml of solution contains 2 mg methotrexate.
Danish: En ml opløsning indeholder 2 mg methotrexat.
English: Oncology
Danish: Onkologi
English: Particularly in the case of orthopaedic surgery where the risk of infection is high, combination therapy with methotrexate and immunomodulatory medicinal products must be used with caution.
Danish: Specielt i tilfælde af ortopædkirurgi skal der udvises forsigtighed ved kombinationsbehandling med methotrexat og immunmodulerende lægemidler på grund af den høje infektionsrisiko.
English: The other ingredients are: macrogol 400, glycerol, orange flavour, sucralose, ethyl parahydroxybenzoate (E214), sodium methyl parahydroxybenzoate (E219), citric acid, tri-sodium citrate, purified water.
Danish: Øvrige indholdsstoffer: macrogol 400, glycerol, orangearoma, sucralose, ethylparahydroxybenzoat (E214), natriummethylparahydroxybenzoat (E219), citronsyre, trinatriumcitrat, renset vand.
English: The symptoms of an overdose can include bleeding, an unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood with a coffee grounds appearance and a reduced urine.
Danish: Symptomerne på en overdosis kan være blødning, usædvanlig svaghedsfølelse, sår i munden, kvalme, opkastning, sort eller blodig afføring, ophostning af blod, opkastning af blod med kaffegrumslignende udseende samt nedsat vandladning.
English: Do not use the medicine after the expiry date which is stated on the carton and label after ‘Exp'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: DO NOT push down the plunger too hard or squirt the medicine to the back of the mouth or throat as this may cause choking.
Danish: Stemplet må IKKE trykkes for hårdt i, og medicinen må ikke sprøjtes mod det bageste af munden eller svælget, da dette kan medføre kvælningsanfald.
English: Symptoms include leucocytopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, myelosuppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration and bleeding.
Danish: Symptomerne omfatter leukocytopeni, trombocytopeni, anæmi, pancytopeni, neutropeni, myelosuppression, mucositis, stomatitis, oral ulceration, kvalme, opkastning, gastrointestinal ulceration og blødning.
English: Elimination in patients with impaired renal function is markedly delayed.
Danish: Hos patienter med nedsat nyrefunktion er eliminationen markant forlænget.
English: Administration of additional haematotoxic medicinal products (e.g. metamizole) increases the likelihood of severe haematotoxic adverse reactions to methotrexate.
Danish: Administration af andre hæmatotoksiske lægemidler (f.eks. metamizol) øger risikoen for svære hæmatotoksiske reaktioner på methotrexat.
English: Malignant lymphomas may occur in patients receiving low dose methotrexate, in which case therapy must be discontinued.
Danish: Malignt lymfom kan optræde hos patienter, der får methotrexat i lav dosis; i sådanne tilfælde skal behandlingen seponeres.
English: Therapeutic management of overdose
Danish: Behandling af overdosering
English: Respiratory paralysis, Bronchial asthma-like reactions such as cough, dyspnoea and pathological changes in lung function tests, Pharyngitis
Danish: Astmalignende bronkiale reaktioner såsom hoste, dyspnø og patologiske ændringer i lungefunktionsprøver
English: Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Danish: De hyppigste (meget almindelige) bivirkninger er gastrointestinale lidelser (f.eks. stomatitis, dyspepsi, abdominalsmerter, kvalme, appetitløshed) og unormale leverfunktionsprøver (f.eks. forhøjet alaninaminotransferase (ALAT), aspartat-aminotransferase (ASAT), bilirubin og alkalisk fosfatase).
English: The recommended initial dose is 7.5 mg (3.75 ml) methotrexate once weekly.
Danish: Den anbefalede initialdosis er 7,5 mg (3,75 ml) methotrexat én gang om ugen.
English: Immunosuppression, Allergic vasculitis (severe toxic symptom), Hypogammaglobulinaemia
Danish: Immunsuppression, allergisk vaskulitis (et symptom på svær toksicitet)
English: Your pack of Jylamvo contains a bottle of medicine with a cap, a bottle adaptor and a white dosing syringe.
Danish: Jylamvo-pakningen indeholder en flaske med lægemiddel med låg, et overgangsstykke (en adaptor) og en hvid doseringssprøjte.
English: Salicylates, phenylbutazone, diphenylhydantoin (= phenytoin), barbiturates, tranquillisers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulphonamides, thiazide diuretics, oral hypoglycaemics, doxorubicin and p-aminobenzoic acid displace methotrexate from serum albumin binding and thus increase bioavailability and hence toxicity (indirect dose increase).
Danish: Salicylater, phenylbutazon, phenytoin, barbiturater, beroligende midler, orale antikonceptiva, tetracykliner, aminophenazon-derivater, sulfonamider, thiaziddiuretika, orale antidiabetika, doxorubicin og para‐aminobenzoesyre fortrænger methotrexat fra serumalbumin og øger derved methotrexats biotilgængelighed og toksicitet (indirekte dosisstigning).
English: Concurrent vaccination using live vaccines should not be given.
Danish: Der bør ikke vaccineres med levende vaccine under behandlingen.
English: Pleural effusions and ascites should be drained prior to initiation of methotrexate treatment (see section 4.2).
Danish: Pleuraeffusion eller ascites Pleuraeffusion og ascites skal dræneres før initiering af behandling med methotrexat (se pkt.
English: For protection, you should wear disposable gloves when handling Jylamvo.
Danish: For at beskytte dig selv skal du bruge engangshandsker, når du håndterer Jylamvo.
English: After oral administration, methotrexate is absorbed from the gastrointestinal tract.
Danish: Efter oral administration absorberes methotrexat fra mave-tarm-kanalen.
English: After first opening 3 months.
Danish: Efter anbrud 3 måneder
English: Prior to initiating therapy, women of childbearing potential must be informed of the risk of malformations associated with methotrexate and any existing pregnancy must be excluded with certainty by taking appropriate measures, e.g. a pregnancy test. During treatment pregnancy tests should be repeated as clinically required (e.g. after any gap of contraception).
Danish: Inden behandlingen påbegyndes, skal fertile kvinder oplyses om risikoen for misdannelser forbundet med methotrexat, og enhver eksisterende graviditet skal udelukkes med sikkerhed ved at træffe passende foranstaltninger, f.eks. en graviditetstest.
English: Cytotoxic: Handle with caution
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk: Håndteres med forsigtighed
English: Dosage errors in the use of Jylamvo (methotrexate) can result in serious adverse reactions, including death.
Danish: Doseringsfejl ved anvendelse af Jylamvo (methotrexat) kan medføre alvorlige, herunder dødelige bivirkninger.
English: Psoriatic lesions can worsen during UV radiation and co-administration of methotrexate.
Danish: Psoriasislæsioner kan forværres under UV-bestråling og samtidig behandling med methotrexat.
English: Skin and subcutaneous
Danish: Hud og subkutane væv
English: During methotrexate therapy, concurrent vaccination with live vaccines should be avoided (see sections 4.3 and 4.4).
Danish: Under behandling med methotrexat bør vaccination med levende vacciner undgås (se pkt.
English: The amount of dose reduction should be decided on a case by case basis.
Danish: Det skal fastlægges i hvert enkelt tilfælde, hvor meget dosis skal reduceres.
English: The application of procarbazine during high-dose methotrexate therapy increases the risk of impairment or renal function
Danish: Anvendelse af procarbazin under methotrexat-højdosisbehandling øger risikoen for nedsat nyrefunktion.
English: Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate (see sections 4.2 and 4.5).
Danish: Vitaminpræparater og andre produkter indeholdende folsyre, folinsyre eller derivater heraf kan nedsætte virkningen af methotrexat (se pkt.
English: Acute liver degeneration, Liver failure, Reactivation of chronic hepatitis,
Danish: Akut leverdegeneration, leversvigt Reaktivering af kronisk hepatitis
English: Dosage for psoriasis and psoriatic arthritis: The usual initial dose is 7.5 mg (3.75 ml), once a week.
Danish: Dosering ved psoriasis og psoriasisgigt: Den normale startdosis er 7,5 mg (3,75 ml) én gang om ugen.
English: Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and StevensJohnson syndrome.
Danish: Methotrexats alvorligste bivirkninger er knoglemarvssuppression, pulmonal toksicitet, hepatotoksicitet, renal toksicitet, neurotoksicitet, tromboemboliske hændelser, anafylaktisk chok og Stevens-Johnsons syndrom.
English: In the treatment of rheumatological or dermatological diseases, Jylamvo (methotrexate) must only be taken once a week.
Danish: Vigtig advarsel om doseringen af Jylamvo (methotrexat) Til behandling af reumatiske og dermatologiske sygdomme må Jylamvo (methotrexat) kun tages én gang om ugen.
English: An increased monitoring frequency should be considered when the dose is increased.
Danish: Ved dosisstigning bør hyppigere monitorering overvejes.
English: Posology Rheumatological and dermatological diseases
Danish: Reumatologiske og dermatologiske sygdomme
English: Concomitant therapy with medicinal products that can cause folic acid deficiency (e.g. sulphonamides, trimethoprim/sulphamethoxazole) can result in increased methotrexate toxicity.
Danish: Sideløbende behandling med lægemidler, der kan medføre folsyremangel (f.eks. sulfonamider og trimethoprim/sulfamethoxazol), kan medføre øget toksisk virkning af methotrexat.
English: In the event of (prior) treatment with medicinal products that can have adverse reactions on bone marrow (e.g. sulphonamides, trimethoprim/sulphamethoxazole, chloramphenicol, pyrimethamine), the possibility of haematopoietic disorders must be considered.
Danish: Hvis patienten (tidligere) er blevet behandlet med lægemidler med mulige uønskede virkninger på knoglemarven (f.eks. sulfonamider, trimethoprim/sulfamethoxazol, chloramphenicol, pyrimethamin) skal risikoen for hæmatopoietiske forstyrrelser tages i betragtning.
English: This medicinal product contains sodium methyl parahydroxybenzoate (E219) and ethyl parahydroxybenzoate (E214).
Danish: Dette lægemiddel indeholder natriummethylparahydroxybenzoat (E219) og ethylparahydroxybenzoat (E214).
English: When you use the medicine follow the instructions below:
Danish: Følg nedenstående anvisninger for anvendelse af lægemidlet:
English: Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
Danish: Flasken skal være tæt tillukket for at beskytte lægemidlet mod ødelæggelse og for at nedsætte risikoen for utilsigtet spild.
English: Leucocytopenia, Thrombocytopenia, Anaemia
Danish: Leukocytopeni Trombocytopeni Anæmi
English: Particular caution is required in patients with impaired pulmonary function.
Danish: Der skal udvises særlig forsigtighed ved nedsat lungefunktion.
English: See also section 4 “Possible side effects”.
Danish: 4 "Bivirkninger".
English: Cerebral oedema, Acute aseptic meningitis with meningism (paralysis, vomiting), Lethargy,
Danish: Cerebralt ødem Akut aseptisk meningitis med meningisme (parese, opkastning) Letargi