FrancophonIA/ELRC3.0 huggingface dataset:
English: Cell proliferation is usually greater in malignant tumours than in normal tissue and methotrexate can therefore exert a sustained effect on malignant growth without causing irreversible damage to normal tissue.
Danish: Celleproliferation er sædvanligvis mere udtalt i maligne tumorer end i normalt væv, hvorfor methotrexat kan have vedholdende virkning på malign vækst uden at medføre irreversible skader på normalt væv.
English: For higher doses, there is insufficient data to estimate the risks of malformations or miscarriage following paternal exposure.
Danish: Ved højere doser er der utilstrækkelige data til at estimere risikoen for misdannelser eller abort efter fostereksponering.
English: Approximately 10% of the administered methotrexate dose is metabolised in the liver.
Danish: Ca. 10 % af den administrerede methotrexatdosis metaboliseres i leveren.
English: A blood test will be done to check for reduction in the white blood cells (agranulocytosis).
Danish: Du vil få taget en blodprøve for at kontrollere, om der er et fald i antallet af hvide blodlegemer (agranulocytose).
English: If you are a parent or caregiver giving the medicine, wash your hands before and after giving a dose.
Danish: Hvis du som forælder eller omsorgsperson giver lægemidlet, skal du vaske hænder før og efter, at du har givet en dosis.
English: Symptoms may return after treatment discontinuation.
Danish: Symptomerne kan vende tilbage efter seponering af behandlingen.
English: Name and address of the manufacturer responsible for batch release Quay Pharmaceuticals Limited
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Quay Pharmaceuticals Limited
English: Summary of the safety profile In general, the incidence and severity of side effects are considered to be dose-related.
Danish: Resumé af sikkerhedsprofilen Generelt anses bivirkningernes hyppighed og sværhedsgrad for at være dosisrelaterede.
English: The Guide for healthcare professionals shall contain the following key elements:
Danish: Vejledningen til sundhedspersoner skal indeholde følgende hovedelementer:
English: Remove the syringe from the patient's mouth.
Danish: Sprøjten fjernes fra patientens mund.
English: The dose and duration of treatment are determined individually on the basis of the patient's clinical picture and the tolerability of methotrexate.
Danish: Dosis og behandlingsvarighed fastlægges individuelt på grundlag af patientens kliniske tilstand og tolerance over for methotrexat.
English: Repeat the above instructions for each dose, as instructed by your doctor or pharmacist.
Danish: Gentag ovennævnte punkter for hver dosis som anvist af lægen eller apotekspersonalet.
English: It is important to tell your doctor about all the medicines you take.
Danish: Det er vigtigt, at du oplyser lægen om den medicin, du får.
English: Methotrexate has been shown to be genotoxic in animal studies, such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Danish: Methotrexat har vist sig at være genotoksisk i dyreforsøg, således at risikoen for genotoksiske virkninger på sædceller ikke helt kan udelukkes.
English: Whilst this effect can be reduced by administering calcium folinate, the concomitant use should be avoided.
Danish: Selvom denne virkning kan reduceres ved indgift af calciumfolinat, bør samtidig anvendelse undgås.
English: If you suspect that you (or someone else) have (has) taken too much Jylamvo, tell your doctor immediately or contact the nearest hospital casualty department.
Danish: Har du mistanke om, at du selv (eller en anden) har taget for meget Jylamvo, skal du straks sige det til lægen eller kontakte nærmeste akutmodtagelse.
English: Children, adolescents and the elderly treated with methotrexate should have particularly careful medical monitoring in order to detect important side effects quickly.
Danish: Børn, unge og ældre, der behandles med methotrexat, skal overvåges særlig omhyggeligt, for at vigtige bivirkninger kan opdages hurtigt.
English: The prescriber should make sure patients understand that Jylamvo (methotrexate) should only be taken once a week.
Danish: Den ordinerende læge skal sikre sig, at patienter forstår, at Jylamvo (methotrexat) kun skal tages én gang om ugen.
English: Jylamvo is for oral use only.
Danish: Jylamvo er udelukkende til oral brug.
English: Data from a randomised trial in patients with juvenile rheumatoid arthritis (aged 2.8 to 15.1 years) indicated greater oral bioavailability of methotrexate in the fasting state.
Danish: Data fra et randomiseret forsøg hos patienter med juvenil reumatoid artritis (i alderen 2,8 til 15,1 år) indikerede, at methotrexats oral biotilgængelighed er højere ved fastende tilstand.
English: • Recommendation to monitor patients for signs and symptoms of overdose (these predominantly affect the haematopoietic and gastrointestinal systems)
Danish: • anbefaling om at overvåge patienterne for symptomer på overdosering (disse påvirker overvejende det hæmatopoietiske og gastrointestinale system)
English: Treatment should follow currently published therapy protocols for children (see section 4.4).
Danish: Behandlingen bør følge de aktuelle publicerede behandlingsprotokoller for børn (se pkt.
English: Deeside Industrial Park, Flintshire, CH5 2NS United Kingdom
Danish: Deeside Industrial Park, Flintshire, CH5 2NS Storbritannien
English: Methotrexate-induced lung diseases such as pneumonitis can occur acutely and at any time during treatment, are not always completely reversible and have already been observed at all doses (including low doses of 7.5 mg (3.75 ml)/week).
Danish: Methotrexat‐inducerede lungesygdomme såsom pneumonitis kan optræde akut og på ethvert tidspunkt under behandlingen, er ikke altid fuldstændigt reversible og er iagttaget ved alle doser (herunder lave doser på 7,5 mg (3,75 ml) pr. uge).
English: Please read this section of the summary of product characteristics very carefully.
Danish: Læs dette punkt i produktresuméet meget omhyggeligt.
English: Recommended examinations and safety measures
Danish: Anbefalede undersøgelser og sikkerhedsforanstaltninger
English: Jylamvo is a clear yellow solution.
Danish: Jylamvo er en klar, gul opløsning.
English: All parts of the syringe should be completely dry before using it for the next dose.
Danish: Alle dele af sprøjten skal være helt tørre, før de anvendes til den næste dosis.
English: Therefore, the possible effects on reproduction, pregnancy loss and congenital malformations should be discussed with female patients of childbearing age (see section 4.6).
Danish: De mulige virkninger på reproduktion, graviditetstab og medfødte misdannelser skal derfor drøftes med kvindelige patienter i den fertile alder (se pkt.
English: With every prescription, healthcare professionals should advise the patient and/or caregiver on how to measure the prescribed dose.
Danish: Ved hver ordination skal sundhedspersoner orientere patienten og/eller omsorgspersonen om, hvordan den ordinerede dosis udmåles
English: Treatment with moderately high and high doses of methotrexate should not be initiated at urinary pH values of less than 7.0.
Danish: Behandling med moderat høje og høje doser methotrexat bør ikke initieres, hvis urinens pH er under 7,0.
English: If your doctor considers that continuing treatment with methotrexate is essential, you must stop breast-feeding.
Danish: Hvis din læge finder, at fortsat behandling med methotrexat er absolut nødvendig, skal du holde op med at amme.
English: You should not drink alcohol during treatment with Jylamvo and should avoid drinking excessive amounts of coffee, caffeinated drinks and black leaf tea.
Danish: Du bør ikke drikke alkohol, mens du er i behandling med Jylamvo, og du skal lade være med at indtage store mængder koffeinholdige drikke (kaffe, drikke med tilsætning af koffein, sort te).
English: A weekly dose of 25 mg (12.5 ml) should not be exceeded.
Danish: En ugentlig dosis på 25 mg (12,5 ml) bør ikke overskrides.
English: Always use the syringe provided to take your medicine.
Danish: Brug altid den medfølgende sprøjte til at tage lægemidlet.
English: This can be done with methotrexate as an intramuscular or subcutaneous administration and is recommended for patients who exhibit inadequate absorption of the oral form of methotrexate or who do not tolerate oral administration well.
Danish: Dette kan gøres med methotrexat til intramuskulær eller subkutan administration og anbefales til patienter, som ikke absorberer den orale form af methotrexat tilstrækkeligt, eller som ikke tolererer oral administration.
English: The usual caution should be exercised in handling cytostatics.
Danish: Den sædvanlige forsigtighed ved håndtering af cytostatika skal udvises.
English: The dose should be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.
Danish: Dosis bør øges gradvis, men bør normalt ikke overstige 25 mg methotrexat om ugen.
English: Methotrexate induces gene and chromosomal mutations in vitro and in vivo.
Danish: Methotrexat inducerer gen- og kromosommutationer in vitro og in vivo.
English: Any serious decrease in leucocyte or platelet counts indicates the immediate discontinuation of treatment and appropriate supportive therapy.
Danish: Ethvert alvorligt fald i leukocyt- eller trombocyttal er indikation for øjeblikkelig behandlingsafbrydelse og passende understøttende behandling.
English: Treatment should follow current therapy protocols.
Danish: Gældende behandlingsprotokoller bør følges.
English: If the results of any test are abnormal, the treatment will not be restarted until all the values have returned to normal.
Danish: Hvis resultaterne af en eller flere prøver er unormale, vil behandlingen ikke blive genoptaget, før alle prøver igen er normale.
English: The main metabolite is 7-hydroxymethotrexate.
Danish: Hovedmetabolitten er 7‐hydroxymethotrexat.
English: If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Danish: Hvis du har spørgsmål, så tal med lægen eller apotekspersonalet, før du tager dette lægemiddel.
English: Testing of serum liver enzymes Transient increases in transaminases to twice or three times normal occur in 13-20% of patients.
Danish: Test af leverenzymer i serum - forbigående stigning i aminotransferaser til det dobbelte eller tredobbelte af normalværdien forekommer hos 13‐20 % af patienterne.
English: 2 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: 2 lymfom/lymfoproliferative sygdomme: Der er rapporteret om individuelle tilfælde af lymfom og andre lymfoproliferative sygdomme, som fortog sig i en række tilfælde, når behandling med methotrexat var blevet afbrudt.
English: Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later.
Danish: Mucositis indtræder sædvanligvis 3-7 dage efter behandlingsstart, leukopeni og trombocytopeni følger få dage senere.
English: A 10 ml oral dosing syringe is provided for accurate measurement of the prescribed dose (see Package Leaflet).
Danish: Der medfølger en 10 ml oral doseringssprøjte til nøjagtig afmåling af den ordinerede dosis (se indlægssedlen).
English: Dehydration may also intensify the toxicity of methotrexate.
Danish: Dehydrering kan ligeledes forstærke toksiciteten af methotrexat.
English: It is recommended to check levels of vitamin B12 prior to initiating folic acid supplementation, particularly in adults aged over 50 years, as folic acid intake may mask a vitamin B12 deficiency.
Danish: Det anbefales at kontrollere patientens vitamin B12-niveau før initiering af tilskud af folsyre, navnlig hos patienter over 50 år, da indtagelse af folsyre kan maskere vitamin B12-mangel.
English: Low-dose methotrexate is used in the maintenance treatment of ALL in children aged 3 years and over, adolescents and adults within complex protocols in combination with other cytostatic medicinal products.
Danish: Methotrexat i lav dosering anvendes til vedligeholdelsesbehandling af ALL hos børn på 3 år og derover og hos unge og voksne i kombination med andre cytostatiske lægemidler som led i komplekse protokoller.
English: If a patient develops pulmonary symptoms, the possibility of Pneumocystis jiroveci pneumonia should be considered.
Danish: Hvis patienten udvikler lungesymptomer, skal muligheden for Pneumocystis jiroveci-pneumoni overvejes.
English: It is recommended that a test dose of 2.5-5 mg (1.25-2.5 ml) be administered one week prior to initiation of therapy, in order to detect early occurring adverse reactions.
Danish: Det anbefales at administrere en testdosis på 2,5‐5 mg (1,25‐2,5 ml) én uge før initiering af behandlingen for at opdage tidligt optrædende bivirkninger.
English: Discard 3 months after first opening.
Danish: Kasseres 3 måneder efter første åbning.
English: When administered in low doses (7.5 mg/m2 to 80 mg/m2 body surface area), the mean bioavailability of methotrexate is approximately 70%, but considerable inter- and intra-individual variations are possible (25-100%).
Danish: Ved administration af lave doser (7,5 mg/m til 80 mg/m legemsoverflade) er methotrexats biotilgængelighed i gennemsnit ca. 70 %, dog med betydelige inter- og intra-individuelle forskelle (25‐100 %).
English: If you think you have taken more than the prescribed dose, consult a physician immediately.
Danish: Hvis du mener, at du har taget mere end den ordinerede dosis, skal du straks kontakte en læge.
English: If the lymphomas fail to regress spontaneously, cytotoxic treatment must be initiated.
Danish: Hvis lymfomet ikke svinder spontant, skal cytotoksisk behandling initieres.
English: • The pharmacist should counsel the patient about the inadvertent daily instead of once-weekly dosing.
Danish: • apotekspersonalet skal rådgive patienten om utilsigtet daglig dosering i stedet for ugentlig dosering
English: Methotrexate crosses the placental barrier in rats and monkeys.
Danish: Methotrexat krydser placentabarrieren hos rotter og aber.
English: Patients must be appropriately monitored during treatment so that signs of possible toxic effects or adverse reactions can be detected and evaluated with minimal delay.
Danish: Under behandlingen skal patienterne monitoreres på passende vis, så tegn på mulige toksiske virkninger og bivirkninger opdages og vurderes så hurtigt som muligt.
English: See also section “Pregnancy, breast-feeding and fertility”.
Danish: Se også punktet "Graviditet, amning og frugtbarhed".
English: The MAH shall ensure that, in each Member State where Jylamvo is marketed, all healthcare professionals who are expected to prescribe or dispense Jylamvo have access to the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedspersoner, der forventes at ordinere eller administrere Jylamvo, i alle medlemsstater, hvor Jylamvo markedsføres, har adgang til følgende informationspakke:
English: Lymphoma1
Danish: Lymfom1
English: Patients should be informed of the risks of pneumonia and advised to contact their doctor immediately if they develop a persistent cough or persistent dyspnoea.
Danish: Patienterne skal informeres om risikoen for pneumoni og rådes til straks at kontakte lægen i tilfælde af vedholdende hoste eller vedholdende dyspnø.
English: Since cases of encephalopathy/leukoencephalopathy have occurred in cancer patients treated with methotrexate, this cannot be ruled out either for patients with non-cancer indications.
Danish: Da der er forekommet tilfælde af encefalopati/leukoencefalopati hos kræftpatienter, der er behandlet med methotrexat, kan dette ikke udelukkes for patienter med andre indikationer end cancer.
English: Patients should be encouraged to report all signs and symptoms suggestive of infection to their doctor.
Danish: Patienterne skal opfordres til at fortælle lægen om alle tegn og symptomer, der tyder på infektion.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
English: It acts by competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Danish: Det virker gennem kompetitiv hæmning af enzymet dihydrofolatreduktase og hæmmer derved DNA-syntesen.
English: The MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Danish: Indehaveren af markedsføringstilladelsen bør anvende de vedtagne målrettede opfølgningsspørgeskemaer for alle medicineringsfejl, der medfører overdosering.
English: Jylamvo is a medicine that: - suppresses the growth of certain cells in the body that multiply rapidly (an anticancer medicine) - reduces unwanted reactions by the body's own defense mechanisms (an immunosuppressive agent) - has an anti-inflammatory effect
Danish: Jylamvo er et lægemiddel, som: undertrykker væksten af visse celler i kroppen, der formerer sig hurtigt (et lægemiddel mod kræft) nedsætter uønskede reaktioner fra kroppens egne forsvarsmekanismer (et immundæmpende middel) modvirker betændelseslignende tilstande (virker antiinflammatorisk)
English: If there are air bubbles in the syringe, repeat until bubbles are eliminated.
Danish: Hvis der er luftbobler i sprøjten, gentages optrækningen, indtil boblerne er væk.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA Ikke relevant
English: Megaloblastic anaemia
Danish: Megaloblastisk anæmi
English: In rheumatological indications, there is no evidence to support use of liver biopsies in monitoring hepatotoxicity.
Danish: Ved reumatologiske indikationer foreligger der ikke evidens, der understøtter anvendelse af leverbiopsier til at overvåge hepatotoksicitet.
English: - Renal function should be monitored by renal function tests and urinalyses.
Danish: Nyrefunktionen bør monitoreres ved nyrefunktionsprøver og urinanalyser.
English: • Management of overdose (including the use of calcium folinate and dose interruption).
Danish: • håndtering af overdosering (herunder administration af calciumfolinat og behandlingsafbrydelse)
English: Stress fracture
Danish: Stressfraktur
English: Methotrexate can reduce the clearance of theophylline.
Danish: Methotrexat kan nedsætte clearance af theophyllin.
English: Always show this card to health care professionals not familiar with your methotrexate treatment to alert them about your once weekly use (e.g. on hospital admission, change of care).
Danish: Vis altid dette kort til sundhedspersoner, som ikke er bekendt med din methotrexatbehandling, for at advisere dem om din indtagelse én gang ugentligt (f.eks. ved hospitalsindlæggelse, ændring afpleje).
English: In oncology
Danish: I onkologien
English: Diarrhoea can be a possible side effect of Jylamvo and requires an interruption of therapy.
Danish: Diarré er en mulig bivirkning af Jylamvo og nødvendiggør afbrydelse af behandlingen.
English: If you do become pregnant during treatment, you should be offered advice regarding the risk of harmful effects on the child through treatment.
Danish: Hvis du bliver gravid under behandlingen, vil du få tilbud om rådgivning om risikoen for skadelige virkninger på barnet under behandling.
English: If the oral route is ineffective, a change to a parenteral dosage form is indicated.
Danish: Hvis oral administration ikke er effektiv, er der indikation for at skifte til parenteral administration.
English: Parents, care givers and patients should be advised to keep methotrexate out of the reach of children, preferably in a locked cupboard.
Danish: Forældre, omsorgspersoner og patienter skal informeres om at opbevare methotrexat utilgængeligt for børn, helst i aflåst skab.
English: Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours, since in this case methotrexate plasma levels can rise and toxicity be increased as a result.
Danish: Der skal udvises forsigtighed, hvis NSAID og methotrexat administreres inden for 24 timer, da plasmaniveauet af methotrexat kan stige med øget toksicitet som resultat.
English: Important warning about the dose of Jylamvo (methotrexate):
Danish: Vigtig advarsel om doseringen af Jylamvo (methotrexat):
English: Jylamvo should be prescribed only by doctors who are familiar with the properties of the medicine and how it works.
Danish: Jylamvo bør kun ordineres af læger, der er fortrolige med lægemidlets egenskaber og virkemåde.
English: As treatment with methotrexate at higher doses commonly used in cancer treatment can cause infertility and genetic mutations, it may be advisable for male patients treated with methotrexate doses higher than 30 mg (15 ml)/week to consider sperm preservation before the beginning of treatment (see also section "Warnings and precautions").
Danish: Da behandling med methotrexat ved højere doser sædvanligvis anvendt ved kræftbehandling kan forårsage ufrugtbarhed og genetiske mutationer, tilrådes mandlige patienter, der tager mere end 30 mg (15 ml) methotrexat pr. uge, at overveje sæddeponering, før behandling påbegyndes (se også "Advarsler og forsigtighedsregler").
English: Patients should be informed that they must notify the doctor immediately if any symptoms of an overdose occur and that the symptoms of the overdose need to be monitored (including regular laboratory tests).
Danish: Patienterne skal informeres om straks at kontakte lægen, hvis de får symptomer på overdosering, og at overvågning (herunder jævnlige laboratorieprøver) er nødvendig ved symptomer på overdosering.
English: If pregnancy occurs during treatment with methotrexate and up to six months thereafter, medical advice should be given regarding the risk of harmful effects on the child associated with treatment and ultrasonography examinations should be performed to confirm normal foetal development.
Danish: Hvis der opstår graviditet under behandling med methotrexat og i op til seks måneder derefter, skal der gives lægelig rådgivning vedrørende risikoen for skadelige virkninger på barnet i forbindelse med behandling, og der skal foretages ultralydsundersøgelser for at bekræfte normal fosterudvikling.
English: • Patient Card
Danish: • patientkort
English: Alkalinisation of the urine must be tested by repeated pH monitoring (value greater than or equal to 6.8) for at least the first 24 hours after the administration of methotrexate is started.
Danish: Alkalinisering af urinen skal testes ved gentagen pH-måling (mindst 6,8) i mindst 24 timer efter initiering af methotrexat.
English: Taking too much of Jylamvo (methotrexate) may be fatal.
Danish: For stor indtagelse af Jylamvo (methotrexat) kan være dødelige.
English: Due to its effect on the immune system, methotrexate may impair the response to vaccinations and affect the results of immunological tests.
Danish: På grund af sin virkning på immunsystemet kan methotrexat nedsætte responsen på vaccinationer og påvirke resultaterne af immunologiske analyser.
English: Acute hepatitis and hepatotoxicity
Danish: Akut hepatitis og hepatotoksicitet
English: • Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcers
Danish: • Stomatitis, sår i mundhulen og kendte aktive gastrointestinale ulcera
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 forebyggende foranstaltning anbefales seksuelt aktive mandlige patienter eller deres kvindelige partnere at anvende pålidelig prævention under behandling af den mandlige patient og i mindst 6 måneder efter ophør af methotrexat.
English: Instructions for use of the syringe provided in the pack
Danish: Anvisninger for brug af sprøjten, som ligger i pakningen
English: When used in oncological indications, methotrexate should not be administered during pregnancy in particular during the first trimester of pregnancy.
Danish: Ved onkologiske indikationer bør methotrexat ikke administreres ved graviditet, specielt ikke i første trimester.