FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of patients at Baseline n (%)
Danish: Antal patienter ved baseline n (%)
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements
Danish: Patientkortet (voksne og børn) indeholder følgende hovedelementer
English: Monoclonal antibodies are proteins that attach to a specific target.
Danish: Monoklonale antistoffer er proteiner, som binder til et bestemt mål.
English: TNF-antagonists, such as Humira affect the immune system and their use may affect the body's defence against infection and cancer.
Danish: TNF-antagonister, så som Humira påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstilerne af det biologisk aktive stof
English: Yellow Indicator Visible
Danish: Vindue Synlig gul indikator
English: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Danish: - infektioner, inklusive tuberkulose - cancer - problemer med nervesystemet - vaccinationer
English: Humira can be taken together with:
Danish: Humira kan anvendes sammen med:
English: Hold the pre-filled pen so that you can see the inspection window.
Danish: Hold den fyldt pen så du kan se inspektionsvinduet.
English: You will see a yellow indicator move into the window during the injection.
Danish: Du kan se en gul indikator bevæge sig i vinduet under injektionen.
English: Mean exposure in all adalimumab population was 762 days.
Danish: Den gennemsnitlige eksponering hos alle adalimumabpatienter var 762 dage.
English: • The Humira syringe should NEVER be reused.
Danish: • Humira-sprøjter må ALDRIG genbruges.
English: Most patients continued on Humira after the infection resolved.
Danish: De fleste patienter fortsatte med Humira, efter infektionen var overstået.
English: Place the following on a clean, flat surface
Danish: Læg følgende ting på en ren, flad overflade
English: The presence of one or more bubbles in the window is normal.
Danish: Det er normalt, at der findes en eller flere bobler i vinduet.
English: • If you see remaining air bubbles or air gaps in the liquid medication in the syringe, you may repeat this process up to 3 times.
Danish: • Hvis der stadig er luftbobler eller luftlommer i den flydende medicin kan du gentage processen op til 3 gange.
English: You may notice a spot of blood at the injection site.
Danish: Du kan måske se en plet af blod på injektionsstedet.
English: The yellow indicator is part of the plunger of the pre-filled pen.
Danish: Den gule indikator er en del af af stemplet i den fyldte pen.
English: Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window.
Danish: Hold den hvide ende af den fyldte pen i en ret vinkel (90 grader) mod huden, så du kan se vinduet.
English: Check the appearance of the Humira solution through the window on the sides of the pre-filled pen.
Danish: Kontrollér Humiraopløsningens udseende gennem vinduerne på siderne af den fyldte pen.
English: • Speak to your doctor, pharmacist or nurse if you think you have not given a full dose
Danish: • Tal med din læge, sygeplejerske eller apotekspersonalet, hvis du tror, at du ikke har fået fuld dosis
English: Humira is used to treat
Danish: Humira bruges til at behandle
English: • The needle is clean.
Danish: • Kanylen er ren
English: In rare cases, these infections can be life-threatening.
Danish: I sjældne tilfælde kan disse infektioner være livstruende.
English: How do I give my injection?
Danish: Hvordan skal jeg tage min injektion?
English: DO NOT use the same site that was used for the last injection.
Danish: Brug IKKE den samme injektionssted, der blev brugt ved forrige injektion.
English: Where should I give my injection?
Danish: Hvor skal jeg give injektionen?
English: The long halflife of adalimumab should be taken into consideration if a surgical procedure is planned.
Danish: Den lange halveringstid for adalimumab bør tages med i overvejelserne, når der planlægges kirurgisk indgreb.
English: • severe infection in the blood (sepsis)
Danish: • alvorlig infektion i blodet (sepsis)
English: Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Danish: Blandt de patienter, der afbrød studiet, blev samlet set 18% afbrudt på grund af bivirkninger og 8% på grund af utilstrækkelig respons på adalimumab behandling.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 0,8 ml dosis, dvs. i det væsentlige ”natriumfri”.
English: • expiry (EXP) date has passed
Danish: • udløbsdatoen (EXP) er passeret
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Danish: Klinisk remission er Mayo-score < 2 uden subscore >1;
English: If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med Humira er indiceret, bør ovenstående vejledning for dosering og behandligsvarighed følges.
English: This may mean there is an infection.
Danish: Dette kan være tegn på en infektion.
English: PASI 75 PGA: Clear/minimal a
Danish: PGA: Clear/minimal
English: Due to its inhibition of TNF, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Danish: På grund af sin TNFα-hæmmende virkning kan adalimumab administreret under graviditet påvirke de normale immunresponser hos nyfødte.
English: Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Danish: Farmakokinetiske populationsanalyser med data fra flere end 1300 RA patienter viste en tendens til en tilsyneladende højere clearance af adalimumab med stigende legemsvægt.
English: HR a CI 95% for HR
Danish: CI 95% for HRa
English: If it is cloudy or discoloured or has flakes or particles in it, you must not use it. Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight.
Danish: Hvis den er uklar, misfarvet eller indeholder flager eller partikler, må De ikke anvende den. Anvend ikke en fyldt pen, som er frossen, eller som har ligget i direkte sollys.
English: After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere Humira, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Humira.
English: Choose an injection site:
Danish: Vælg et injektionssted:
English: You should continue to inject Humira for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Humira så længe, din læge har fortalt dig.
English: Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests.
Danish: Nogle bivirkninger, som er set med Humira har ikke symptomer og kan kun opdages ved blodprøver.
English: • Do not inject through clothes
Danish: • Injicer ikke gennem tøjet
English: • infections caused by viruses, fungi, parasites or bacteria
Danish: • infektioner forårsaget af virus, svampe, parasitter eller bakterier
English: Place hand on the middle of the pen so that neither the grey cap (1) nor the plum cap (2) is covered.
Danish: Sæt hånden på midten af pennen, så hverken den grå hætte (1) eller den blommefarvede hætte (2) er dækket.
English: Available data suggest that re-introduction of Humira after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Danish: Tilgængelige data tyder på, at genopstart af Humira efter doseringsindstilling i 70 dage eller længere resulterede i et klinisk respons i samme størrelsesorden og med samme sikkerhedsprofil som før behandlingsafbrydelsen.
English: Slowly take your thumb off the plunger.
Danish: Løft langsomt din tommelfinger fra stemplet.
English: 15 Seconds
Danish: 15 sekunder
English: The recommended doses for Humira in each of the approved uses are shown in the following table.
Danish: Den anbefalede Humira-dosis for hvert af de godkendte anvendelsesområder er vist nedenfor i tabellen.
English: Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Danish: Reduktion i HS-relateret hudsmerte blev evalueret ved hjælp af en numerisk vurderingsskala hos patienter, som gik ind i studiet med start-baseline score på 3 eller højere på en skala med 11 trin.
English: An updated RMP should be submitted:
Danish: En opdateret RMP
English: CD Study II: Infliximab Experienced Patients
Danish: CD-Studie II: Infliximab erfarne patienter
English: Humira should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Humira bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Danish: Eftersom immunogenicitetsanalyser er produktspecifikke, giver det ikke nogen mening at sammenligne antistofhyppigheden med andre produkter.
English: At Week 12 and Week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Danish: Ved uge 12 og uge 24 var pædiatrisk ACR 30-respons henholdsvis 93,5% og 90,0% ved anvendelse af observerede data.
English: Patients in rheumatoid arthritis studies I, II and III were tested at multiple time points for anti-adalimumab antibodies during the 6 to 12 month period.
Danish: Patienterne i reumatoid artrit-studierne I, II og III blev testet på flere tidspunkter for anti-adalimumab antistoffer i løbet af 6 til 12 måneder.
English: Your doctor will decide if Humira should be used with methotrexate or alone.
Danish: Din læge vil beslutte, om Humira skal anvendes sammen med methotrexat eller alene.
English: • Make sure the liquid is clear and colourless
Danish: • Kontrollér at væsken er klar og farveløs
English: • Release the skin with the first hand
Danish: • Slip huden med den første hånd
English: Humira has not been studied in these patient populations.
Danish: Humira er ikke undersøgt hos disse patientpopulationer.
English: Humira works by reducing this inflammation.
Danish: Humira virker ved at reducere denne inflammation.
English: Week 26 Placebo-Controlled
Danish: Uge 26 Placebokontrolleret
English: Take one dose tray containing a pre-filled pen of Humira from the refrigerator.
Danish: Tag en dosispakke, der indeholder en fyldt pen med Humira fra køleskabet.
English: Treatment with Humira may result in the formation of autoimmune antibodies.
Danish: Behandling med Humira kan medføre dannelse af autoimmune antistoffer.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Danish: Der er ingen tilgængelige data vedrørende den sekundære overførsel af infektion med levende vacciner hos patienter, der modtager Humira.
English: If you use less Humira than you should
Danish: Hvis du har givet mindre Humira, end du skulle
English: Pull the Grey Cap 1 straight off.
Danish: Træk den grå hætte 1 lige af.
English: ≥ mNAPSI 75 (%) PGA-F clear/minimal and ≥2-grade improvement (%)
Danish: PGA-F clear/minimal og ≥2-grade forbedring (%)
English: Humira in combination with methotrexate, is indicated for:
Danish: Humira i kombination med methotrexat er indiceret til:
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at Week 8.
Danish: Klinisk remission (defineret som Mayo-score < 2 med ingen subscore > 1) blev vurderet i uge 8.
English: In CD Study III, at Week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Danish: I CD-studie III havde 58% (499/854) af patienterne klinisk respons i uge 4 og blev vurderet i den primære analyse.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Danish: Psoriasis formodes at være forårsaget af et problem med kroppens immunsystem, der fører til en øget produktion af hudceller.
English: Available data suggest that Humira does not worsen or cause strictures.
Danish: Foreliggende data tyder ikke på, at Humira forværrer eller forårsager forsnævringer.
English: You will set the volume to the prescribed dose in step 4, Dose Preparation.
Danish: Du skal indstille dosis til den foreskrevne volumen i trin 4, Forberedelse af dosis.
English: The white needle sleeve is there to protect you from touching the needle.
Danish: Det hvide beskyttelseshylster til kanylen er der for at beskytte dig mod at røre ved kanylen.
English: Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection.
Danish: Hold trykket, og fortsæt med at holde den fyldte pen korrekt på huden med et stabilt tryk i omkring 10 sekunder for at sikre fuldstændig injektion.
English: • Push plunger to inject solution - it can take from 2 to 5 seconds to empty the syringe
Danish: • Pres stemplet ned for at injicere opløsningen - det tager fra 2 til 5 sekunder at tømme sprøjten
English: Age Group
Danish: Aldersgruppe
English: 2D code
Danish: 2D-stregkode
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and Humira should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6mercaptopurin med Humira bør nøje overvejes.
English: • Your doctor should test your child for HBV.
Danish: • Lægen vil teste dit barn for HBV.
English: Needle Inspection Window
Danish: Kanyle Inspektionsvindue
English: Week 16 Placebo-Controlled
Danish: Uge 16 Placebokontrolleret
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.
Danish: Serumniveauer af matrixmetalloproteinaser (MMP-1 og MMP-3), som forårsager vævsomdannelse, der er ansvarlig for bruskdestruktionen, var også nedsatte efter Humira-administration.
English: Patients treated with Humira had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Danish: Patienter i behandling med Humira havde signifikant lavere risiko for opblussen af sygdom i de første 12 ugers behandling.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
Danish: • Der var i følge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået Humira under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået Humira.
English: • Check that the small black needle cover of the syringe has been removed with the cap
Danish: • Kontroller at kanylens lille sorte beskyttelseshætte er fjernet sammen med hætten
English: First read all the instructions carefully and then follow them step by step.
Danish: Læs først vejledningen grundigt, og følg den herefter trin for trin.
English: Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Humira, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: With your other hand, pull the grey cap (1) straight off, check that the small black needle cover of the syringe has been removed with the cap, then discard cap.
Danish: Træk med den anden hånd den grå hætte (1) lige af, kontroller at kanylens lille sorte beskyttelseshætte er fjernet sammen med hætten og kassér den herefter.
English: Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19.
Danish: Efterfølgende fulgte patienterne en obligatorisk nedtrapningsplan med komplet seponering af kortikosteroid i uge 19.
English: • Your doctor should test you for HBV.
Danish: • Lægen vil teste dig for HBV.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Danish: Samtidige faste doser af aminosalicylater, kortikosteroider,og/eller immunmodulerende midler var tilladt, og 80 % af patienterne fortsatte med at få mindst et af disse lægemidler.
English: 10 Seconds
Danish: 10 sekunder
English: Choose a site on the top of your thigh or stomach (except the area around the navel).
Danish: Vælg et injektionssted på låret eller maven (undtagen rundt om navlen).
English: Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i Humira-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at Week 4.
Danish: Patienter med klinisk respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde klinisk respons ved uge 4.
English: Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Humira kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Results from the overall UC-II study population are shown in Table 18.
Danish: Resultater fra den samlede UC-II studiespopulation er vist i tabel 18.
English: The impact of long-term treatment with Humira on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med Humira har på udviklingen af autoimmune sygdomme.
English: The percent of Humira-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Danish: Den procent af Humira-behandlede patienter, der fik ACR 20-, 50- og 70-respons, var konsistent mellem RA-studie I, II og III.
English: • A loud “click” will signal the start of the injection
Danish: • Der lyder et højt “klik”, når injektionen starter
English: Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Danish: Dannelse af adalimumab-antistoffer er forbundet med øget clearence og reduceret effekt af adalimumab.
English: Humira contains sodium
Danish: Humira indeholder natrium
English: By attaching to TNFα, Humira decreases the process of inflammation in these diseases.
Danish: Ved at binde sig til TNFα reducerer Humira den inflammatoriske proces i disse sygdomme.
English: Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Humira påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: There is limited experience in the initiation of treatment with Humira alone.
Danish: Der er begrænset erfaring med initiering af behandling med Humira alene.
English: These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Danish: Disse infektioner er ikke konsekvent blevet erkendt hos patienter, som tager TNFantagonister, hvorved iværksættelse af passende behandling er blevet forsinket, hvilket sommetider har resulteret i letale udfald.
English: c Inactive Disease Partial Flare Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Danish: Delvis opblussen af sygdomd a Assessment of SpondyloArthritis international Society b Baseline er defineret som åben periode baseline, når patienterne har aktiv sygdom.
English: Patients should be tested for HBV infection before initiating treatment with Humira.
Danish: Patienter bør testes for HBV-infektion inden behandling med Humira.
English: Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at Week 52 in RA study III.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrollerede studier, som var et allerede specificeret primært endepunkt ved uge 52 i RA-studie III.
English: 73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
Danish: 73% af patienterne i Psoriasis-studie I og II havde tidligere fået systemisk behandling eller lysbehandling.
English: • To reduce the chance of infection, wipe the injection site with the other alcohol pad.
Danish: • For at reducere risikoen for infektion skal du tørre injektionsstedet af med den anden alkoholserviet.
English: In subjects treated with Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Danish: Af de forsøgspersoner, som blev behandlet med Humira uden at vise progression radiografisk fra baseline til uge 48 (n=102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
English: Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Humira bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: 2-sided P value from log rank test. NE = not estimable.
Danish: b 2-sidet p-værdi fra log rank test. c NE = ikke estimerbar.
English: The safety and efficacy of Humira in children aged 4-17 years have not yet been established.
Danish: Humiras sikkerhed og virkning hos børn i alderen 4-17 år er endnu ikke fastlagt.
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2 - 8°C).
English: Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Danish: Af de 424 patienter, der indgik i den ukontrollerede langtidsforlængelse af studierne UV I og UV II, blev 60 patienter anset for ikke egnede (f.eks. på grund af afvigelser eller på grund af komplikationer sekundært til diabetisk retinopati på grund af kataraktkirurgi eller vitrektomi) og blev udelukket fra den primære effektanalyse.
English: Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings.
Danish: Længere tids behanding med Humira 40 mg ugentlig viste ingen nye sikkerhedsfund.
English: Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Danish: Humira blev undersøgt hos 9.506 patienter i pivotale kontrollerede og åbne studier i op til 60 måneder eller mere.
English: The needle will then be covered by the automatic needle guard.
Danish: Kanylen vil herefter automatisk blive dækket af beskyttelseshætten.