FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure you can see the skin area you are going to inject.
Danish: Sørg for, at du kan se det område af huden, du vil injicere i.
English: A blood test will be taken to check for possible reduction of white blood cells (agranulocytosis).
Danish: Der vil blive taget en blodprøve for at tjekke for et eventuelt fald i antallet af de hvide blodlegemer (agranulocytose).
English: Nordimet contains sodium
Danish: Nordimet indeholder natrium
English: Whilst this effect can be reduced by administering calcium folinate, the concomitant use should be avoided.
Danish: Mens denne virkning kan reduceres ved at administrere calciumfolinat, skal samtidig anvendelse undgås.
English: 11) Remove the needle by pulling it out straight.
Danish: 11) Fjern kanylen ved at trække den lige ud.
English: Methotrexate should be administered with great caution, if at all, to patients with significant current or previous liver disease, especially when caused by alcohol.
Danish: Methotrexat skal administreres med yderste forsigtighed, hvis overhovedet, til patienter med signifikant aktuel eller tidligere leversygdom, især hvis sygdommen skyldes alkohol.
English: This is to make sure that the needle stays clean.
Danish: Det er for at sikre, at kanylen forbliver ren.
English: If the results of any of these tests are abnormal, treatment will only be resumed when all readings are back to normal.
Danish: Hvis resultaterne af en eller flere af disse prøver er unormale, vil behandlingen først blive genoptaget, når alle målinger er normale igen.
English: Nordimet must not be used
Danish: Nordimet må ikke anvendes
English: You should see a yellow fluid through the viewing window.
Danish: Du skal kunne se en gul væske gennem vinduet.
English: However, as severe undesirable effects can occur even at lower doses, it is indispensable that patients are monitored regularly by the doctor at short intervals.
Danish: Da der kan opstå alvorlige bivirkninger selv ved lavere doser, er det imidlertid absolut nødvendigt, at patienterne kontrolleres regelmæssigt og med korte intervaller af lægen.
English: Prior to using folic acid products, monitoring of vitamin B12 levels is recommended, since folic acid may mask an existing vitamin B12 deficiency, particularly in adults over 50 years of age.
Danish: Monitorering af vitamin B12-niveauet anbefales inden anvendelse af folsyrepræparater, da folsyre kan maskere en eksisterende vitamin B12-mangel, især hos voksne over 50 år.
English: In these cases use of methotrexate should be interrupted until the symptoms cease.
Danish: I disse tilfælde skal behandlingen med methotrexat afbrydes, indtil symptomerne svinder.
English: Such abnormalities should return to normal within two weeks; after which, treatment may be resumed at the discretion of the doctor.
Danish: Sådanne anomalier skal vende tilbage til normalområdet inden for 2 uger, og derefter kan behandlingen genoptages, alt efter lægens vurdering.
English: Children, adolescents and the elderly being treated with Nordimet should be kept under close medical surveillance to identify possible side effects as early as possible.
Danish: Børn, unge og ældre, der behandles med Nordimet, skal kontrolleres tæt hos en læge, så eventuelle bivirkninger kan opdages så tidligt som muligt.
English: QPharma AB Agneslundsvagen 27 P.O.
Danish: QPharma AB Agneslundsvagen 27 P.O. Box 590
English: Temporary increases in transaminases to two or three times the upper limit of normal have been reported in patients at a frequency of 13-20 %.
Danish: Der er indberettet midlertidige stigninger i aminotransferaser til to eller tre gange den øvre normalgrænse med en hyppighed på 13-20 %.
English: Nordimet may cause a reduction in the number of white blood cells and your resistance to infection may be decreased.
Danish: Nordimet kan forårsage et fald i antallet af hvide blodlegemer, og din modstandskraft over for infektioner kan være forringet.
English: Nordimet has minor influence on the ability to drive and use machines.
Danish: Nordimet påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Therefore, it is very important that methotrexate is not given to pregnant patients or patients planning to become pregnant.
Danish: Det er derfor meget vigtigt, at methotrexat ikke bruges af gravide patienter eller patienter, der planlægger at blive gravide.
English: Nordimet is a medicine used to treat a range of inflammatory diseases: - active rheumatoid arthritis in adults.
Danish: Nordimet er et lægemiddel, der bruges til behandling af en række inflammatoriske sygdomme: - aktiv reumatoid artrit hos voksne.
English: B-1420 Braine-l'Alleud Belgium
Danish: B-1420 Braine-l'Alleud Belgien
English: The major metabolite is 7-hydroxymethotrexate.
Danish: Den vigtigste metabolit er 7-hydroxymethotrexat.
English: Nordimet contains the active substance methotrexate which works by: - reducing inflammation or swelling, and - reducing the activity of the immune system (the body's own defense mechanism).
Danish: Nordimet indeholder det aktive stof methotrexat, der virker ved at: - reducere inflammation (betændelseslignende reaktion) eller hævelse og - reducere aktiviteten af immunsystemet (kroppens egen forsvarsmekanisme).
English: Patients with JIA should always be referred to a rheumatology unit specializing in the treatment of children/adolescents.
Danish: Patienter med JIA skal altid henvises til en reumatologisk afdeling, der er specialiseret i behandling af børn og unge.
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 dyrestudier, således at risikoen for genotoksiske indvirkninger på sædceller ikke kan udelukkes helt.
English: Alcohol consumption must be avoided during treatment with methotrexate.
Danish: Indtagelse af alkohol skal undgås under behandling med methotrexat.
English: Nordimet is given as injection under the skin (subcutaneously).
Danish: Nordimet gives som en injektion under huden (subkutant).
English: Also, make sure you drink plenty of liquids during treatment with Nordimet because dehydration (reduction in body water) can increase the toxicity of Nordimet.
Danish: Du skal desuden sørge for at drikke masser af væske under behandlingen med Nordimet, da dehydrering (for lidt væske i kroppen) kan øge giftigheden af Nordimet.
English: Upon being distributed into body tissues, high concentrations particularly in liver, kidneys and spleen in form of polyglutamates can be found, which can be retained for weeks or months.
Danish: Efter fordeling til kropsvæv findes høje koncentrationer specielt i lever, nyrer og milt i form af polyglutamater, som kan opretholdes i uger til måneder.
English: Open the blister pack by peeling back the top layer all the way off the blister pack as shown.
Danish: Åbn blisterpakningen ved at trække det øverste lag helt af blisterpakningen som vist.
English: 3) The pen is pre-filled and ready to use.
Danish: 3) Pennen er fyldt og klar til brug.
English: Skin changes caused by psoriasis can worsen during treatment with Nordimet if exposed to ultraviolet irradiation.
Danish: Hudforandringer, der skyldes psoriasis, kan forværres under behandling med Nordimet, hvis de udsættes for ultraviolet stråling.
English: Using too much of Nordimet may be fatal.
Danish: Brug af for meget Nordimet kan have dødeligt udfald.
English: Rare: Acute hepatitis.
Danish: Sjælden: Akut hepatitis.
English: Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Danish: Du må under ingen omstændigheder forsøge selv at injicere, medmindre du har fået undervisning i det.
English: The safety and efficacy of Nordimet in children < 3 years of age have not been established (see section 4.4).
Danish: Nordimets sikkerhed og virkning hos børn under 3 år er ikke klarlagt (se pkt.
English: Use in children under < 3 years is not recommended due to insufficient experience in this age group.
Danish: Anvendelse til børn under 3 år anbefales ikke, da der ikke er tilstrækkelig erfaring med denne aldersgruppe.
English: Symptoms may return if treatment with Nordimet is stopped.
Danish: Symptomerne kan vende tilbage, hvis behandling med Nordimet afbrydes.
English: Change the place where you inject each time.
Danish: Skift injektionssted hver gang.
English: 11) Visually inspect the pen through the viewing window.
Danish: 11) Kontrollér pennen gennem vinduet.
English: In therapy-refractory cases the weekly dose may be increased up to 20 mg/m² BSA per week.
Danish: I refraktære tilfælde kan den ugentlige dosis forhøjes til op til 20 mg/m² BSA om ugen.
English: Clear, yellow solution with a pH of 8.0-9.0 and an osmolality of approximately 300 mOsm/kg.
Danish: Klar gul opløsning med en pH på 8,0-9,0 og en osmolalitet på ca. 300 mOsm/kg.
English: Female patients of reproductive potential must be counselled regarding pregnancy prevention and planning.
Danish: Kvindelige patienter i den fertile alder skal rådgives med hensyn til forebyggelse mod og planlægning af graviditet.
English: For higher doses, there is insufficient data to estimate the risks of malformations or miscarriage following paternal exposure.
Danish: Med hensyn til højere doser foreligger der ikke tilstrækkelige data til at vurdere risiciene for misdannelser eller abort efter faderlig eksponering.
English: Patients must be instructed to report all signs and symptoms suggestive of infection.
Danish: Patienterne skal informeres om at indberette alle tegn og symptomer, der kan tyde på infektion.
English: It must be explicitly pointed out to the patient that Nordimet is applied only once a week.
Danish: Det skal understreges udtrykkeligt over for patienten, at Nordimet kun skal anvendes én gang om ugen.
English: If not, use another pen.
Danish: Brug en anden pen, hvis det ikke er tilfældet.
English: Particularly in the case of orthopaedic surgery where susceptibility to infection is high, a combination of methotrexate with immune-modulating medicinal products must be used with caution.
Danish: Især i forbindelse med ortopædkirurgi, hvor følsomheden for infektioner er høj, skal kombination af methotrexat og immunmodulerende lægemidler anvendes med forsigtighed.
English: Psychiatric disorders Uncommon: Depression, confusion.
Danish: Psykiske forstyrrelser Ikke almindelig: Depression, konfusion.
English: This is to make sure that the pen is not accidentally activated and that the needle stays clean.
Danish: Det er for at sikre, at pennen ikke aktiveres ved et uheld, og at kanylen forbliver ren.
English: In rhesus monkeys, no malformations comparable to humans occurred.
Danish: Hos rhesusaber var der ingen misdannelser, som var sammenlignelige med misdannelser hos mennesker.
English: If you have experienced problems with your skin after radiation therapy (radiation induced dermatitis) or sun-burn, these conditions can reappear when taking Nordimet.
Danish: Hvis du har haft problemer med din hud efter strålebehandling (strålingsinduceret dermatitis) eller solforbrændinger, kan disse tilstande dukke op igen under behandling med Nordimet.
English: You can now let go of the skin fold.
Danish: Herefter kan du slippe huden.
English: Long-term studies in rats, mice and hamsters did not show any evidence of a tumorigenic potential of methotrexate.
Danish: Langtidsstudier på rotter, mus og hamstre viste ingen tegn på tumorigent potentiale ved methotrexat.
English: Visually inspect the pen.
Danish: Kontroller pennen.
English: 4) Precaution: DO NOT lift the product by the plunger or needle cover.
Danish: 4) Sikkerhedsforanstaltning: Løft IKKE produktet i stemplet eller kanylebeskyttelsen.
English: - Concurrent vaccination with live vaccines.
Danish: - Samtidig vaccination med levende vaccine.
English: Methotrexate induces gene and chromosome mutations both in vitro and in vivo.
Danish: Methotrexat inducerer gen- og kromosommutationer både in vitro og in vivo.
English: In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet af methotrexat, især i første trimester (se pkt.
English: Insufficient data is available for methotrexate exposure during pregnancy higher than 30 mg/week, but higher rates of spontaneous abortions and congenital malformations are expected.
Danish: Der foreligger ikke tilstrækkelige data for eksponering for methotrexat under graviditet over 30 mg/uge, men der forventes højere procentsatser af spontane aborter og kongenitale misdannelser.
English: If the test dose is well tolerated, treatment will be continued after a week with a dose of approximately 7.5 mg.
Danish: Hvis du kan tåle denne prøvedosis, vil behandlingen fortsætte efter en uge med en dosis på cirka 7,5 mg.
English: Use in children under 3 years of age is not recommended due to insufficient experience of using this medicine in this age group.
Danish: Anvendelse til børn under 3 år anbefales ikke, da man mangler erfaring med anvendelse af lægemidlet til denne aldersgruppe.
English: Cytotoxic: handle with caution.
Danish: Cytotoksisk: Skal håndteres med forsigtighed.
English: It is especially important to tell your doctor if you are taking: - other treatments for rheumatoid arthritis or psoriasis such as leflunomide, sulphasalazine
Danish: Det er især vigtigt, at du fortæller det til din læge, hvis du får: - andre behandlinger for reumatoid artrit eller psoriasis, for eksempel leflunomid, sulfasalazin
English: Handling and disposal must be consistent with that of other cytotoxic preparations in accordance with local requirements.
Danish: Håndtering og bortskaffelse skal være som for andre cytotoksiske præparater og i overensstemmelse med lokale krav.
English: It acts by the competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Danish: Det virker ved kompetitiv hæmning af enzymet dihydrofolatreduktase og hæmmer således DNA-syntesen.
English: A mutagenic effect is suspected in humans.
Danish: Der formodes at være en mutagen virkning hos mennesker.
English: Note: the safety system allowing release of the safety shield, can only be activated when the syringe has been emptied by pressing the plunger all the way down.
Danish: Bemærk: Sikkerhedssystemet, der udløser kanylebeskyttelsen, kan kun aktiveres, når injektionssprøjten er blevet tømt, ved at stemplet er trykket helt i bund.
English: The dose for elderly patients should be lowered due to age-related reduced liver and kidney function.
Danish: Dosis til ældre patienter skal nedsættes på grund af aldersrelateret nedsat lever- og nyrefunktion.
English: This activates the pen and the solution will inject automatically into the skin.
Danish: Dette aktiverer pennen, og injektionsvæsken injiceres automatisk ind i huden.
English: Before the start of treatment and recommended follow-up examinations and precautions Before treatment is started your doctor may carry out blood tests, and also check how well your kidneys and liver are working.
Danish: Undersøgelser inden behandlingsstart og anbefalede kontrolundersøgelser og forsigtighedsregler Inden behandlingen starter, vil din læge muligvis tage blodprøver og desuden undersøge, hvor godt dine nyrer og din lever fungerer.
English: They are to be informed about the necessity to immediately consult the physician if symptoms of intoxication occur, as well as about the subsequent necessary monitoring of symptoms of intoxication (including regular laboratory tests).
Danish: Patienterne skal informeres om nødvendigheden af straks at kontakte lægen, hvis der opstår forgiftningssymptomer, og om den efterfølgende nødvendige kontrol af forgiftningssymptomerne (herunder regelmæssige laboratorieanalyser).
English: Therefore, theophylline blood levels should be monitored under concomitant methotrexate administration.
Danish: Theophyllin-niveauet i blodet skal derfor monitoreres ved administration sammen med methotrexat.
English: When administered in small doses, methotrexate passes into the body fluids in minimal amounts; under high doses (300 mg/kg body weight), concentrations between 4 and 7 µg/ml have been measured in the body fluids.
Danish: Efter administration af små doser passerer methotrexat ind i kropsvæskerne i minimale mængder; ved høje doser (300 mg/kg legemsvægt) er der målt koncentrationer på mellem 4 og 7 µg/ml i kropsvæsker.
English: If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible.
Danish: Hvis du alligevel bliver gravid under behandlingen eller har mistanke om, at du kan være blevet gravid, skal du tale med din læge så hurtigt som muligt.
English: Persistent anomalies of liver-related enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity.
Danish: Vedvarende anomalier i leverrelaterede enzymer og/eller fald i serumalbumin kan være tegn på svær hepatotoksicitet.
English: It must be injected once weekly and it is recommended to always inject Nordimet on the same day of the week.
Danish: Det skal injiceres én gang om ugen, og det anbefales, at du altid gør det på den samme ugedag.
English: Delayed methotrexate clearance should be considered in combination with other cytostatic medicinal products.
Danish: Forsinket clearance af methotrexat skal tages i betragtning ved kombination med andre cytostatika.
English: Methotrexate is a powerful human teratogen, with an increased risk of spontaneous abortions, intrauterine growth restriction and congenital malformations in case of exposure during pregnancy.
Danish: Methotrexat er et kraftigt humant teratogen med en forøget risiko for spontane aborter, intrauterine vækstbegrænsninger og kongenitale misdannelser i tilfælde af eksponering under graviditeten.
English: Approximately 10% of the administered methotrexate is metabolised intrahepatically.
Danish: Cirka 10 % af det administrerede methotrexat metaboliseres i leveren.
English: Rare: Stress fracture.
Danish: Sjælden: Stressfraktur.
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 lægen konsulteres vedrørende risikoen for skadelige indvirkninger på barnet kombineret med behandling, og der skal foretages ultralydscanninger for at bekræfte normal fosterudvikling.
English: See also section “Pregnancy, breast-feeding and fertility”.
Danish: Se også afsnittet “Graviditet, amning og frugtbarhed”.
English: Please read section 3 of this leaflet very carefully.
Danish: Læs afsnit 3 i denne indlægsseddel meget omhyggeligt.
English: Mutagenic and carcinogenic potential
Danish: Mutagenicitet og karcinogenicitet
English: Colestyramine can increase the non-renal elimination of methotrexate by interrupting the enterohepatic circulation.
Danish: Colestyramin kan øge den ikke-renale elimination af methotrexat ved at bryde det enterohepatiske kredsløb.
English: Methotrexate should be discontinued in patients with pulmonary symptoms and a thorough investigation (including chest x-ray) should be made to exclude infection and tumours.
Danish: Methotrexat skal seponeres hos patienter med lungesymptomer, og der skal foretages en grundig undersøgelse (inklusive thoraxrøntgen) for at udelukke infektion og tumorer.
English: Methotrexate is contraindicated during pregnancy in non-oncological indications (see section 4.3).
Danish: Methotrexat er kontraindiceret under graviditet ved indikationer, der ikke er onkologiske (se pkt.
English: Half-life may be prolonged to 4 times the normal length in patients with third spaces (pleural effusion, ascites).
Danish: Halveringstiden kan være forlænget til 4 gange den normale halveringstid hos patienter med ”det tredje rum” (pleuraeffusion, ascites).
English: It is associated with malformations of the skull, face, heart and blood vessels, brain and limbs.
Danish: Det er forbundet med misdannelser af kranie, ansigt, hjerte og blodkar, hjerne og lemmer.
English: Not known: Encephalopathy/ Leukoencephalopathy.
Danish: Ikke kendt: Encefalopati/leukoencefalopati.
English: Further research is needed to establish whether serial liver chemistry tests or propeptide of type III collagen can detect hepatotoxicity sufficiently.
Danish: Yderligere forskning er nødvendig for at fastlægge, om løbende analyser for leverfunktion eller af propeptidet af type III-kollagen i tilstrækkelig grad kan påvise hepatotoksicitet.
English: Methotrexate may reduce theophylline clearance.
Danish: Methotrexat kan nedsætte clearance af theophyllin.
English: Encephalopathy / Leukoencephalopathy have been reported in oncologic patients receiving methotrexate therapy and cannot be excluded for methotrexate therapy in non-oncologic indications.
Danish: Encefalopati/leukoencefalopati er rapporteret hos onkologiske patienter, der fik behandling med methotrexat, og kan ikke udelukkes ved methotrexatbehandling ved ikke-onkologiske indikationer.
English: The skin on the front side abdominal wall and the skin at the front of the thigh are suitable as injection sites.
Danish: Huden på forsiden af mavevæggen og huden foran på lårene er velegnede injektionssteder.
English: On account of its possible effect on the immune system, methotrexate can falsify vaccinal and test results (immunological procedures to record the immune reaction).
Danish: På grund af methotrexats mulige virkning på immunsystemet kan det give falske vaccine- og testresultater (immunologiske procedurer til undersøgelse af immunreaktionen).
English: Treatment of rheumatoid arthritis with such drugs can be continued during low-dose methotrexate therapy but only under close medical supervision.
Danish: Behandling af reumatoid artrit med sådanne præparater kan fortsætte under behandling med lavdosis-methotrexat, men kun under nøje supervision af en læge.
English: The combined use of methotrexate and leflunomide may increase the risk for pancytopenia.
Danish: Kombination af methotrexat og leflunomid kan øge risikoen for pancytopeni.
English: Use in adults with severe forms of psoriasis vulgaris or psoriatic arthritis Your doctor will give you a single test dose of 5-10 mg, in order to assess possible side effects.
Danish: Anvendelse til voksne med alvorlige former af psoriasis vulgaris eller psoriasisartrit Din læge vil give dig en enkelt prøvedosis på 5-10 mg for at vurdere eventuelle bivirkninger.
English: Methotrexate passes the placental barrier in rats and monkeys.
Danish: Methotrexat passerer placenta hos rotter og aber.
English: Dehydration may also potentiate the toxicity of methotrexate.
Danish: Dehydrering kan også øge methotrexats toksicitet.
English: In the event of a constant increase in liver-related enzymes, consideration should be given to reducing the dose or discontinuing therapy.
Danish: I tilfælde af konstant forhøjede leverrelaterede enzymer bør det overvejes at reducere dosis eller seponere behandlingen.
English: The appearance and degree of severity of undesirable effects depends on the dosage level and the frequency of administration.
Danish: Bivirkningernes forekomst og sværhedsgrad afhænger af dosisniveau og administrationshyppighed.
English: Particular caution should be exercised in the presence of inactive, chronic infections (e.g. herpes zoster, tuberculosis, hepatitis B or C) due to possible activation.
Danish: Der skal udvises særlig forsigtighed ved forekomst af inaktive kroniske infektioner (fx herpes zoster, tuberkulose, hepatitis B eller C) på grund af muligheden for reaktivering.
English: Chronic toxicity studies in mice, rats and dogs showed toxic effects in the form of gastrointestinal lesions, myelosuppression and hepatotoxicity.
Danish: Studier af kronisk toksicitet hos mus, rotter og hunde viste toksiske virkninger i form af gastrointestinale læsioner, myelosuppression og hepatotoksicitet.