FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary nonresponders were excluded from the studies and therefore these patients were not further evaluated.
Danish: De primære nonresponders blev ekskluderet fra studierne, og derfor blev disse patienter ikke yderligere undersøgt.
English: DO NOT use the same site that was used for the last injection.
Danish: Brug IKKE det samme injektionssted, der blev brugt ved den seneste injektion.
English: Monoclonal antibodies are proteins that attach to a specific target.
Danish: Monoklonale antistoffer er proteiner, der binder til et specifikt mål.
English: • Do not use a damaged pen.
Danish: • Anvend ikke en beskadiget pen.
English: There is no reason to remove it.  Do not remove the cap just yet!
Danish: Der er ingen grund til at fjerne den.  Hætten må ikke tages af endnu!
English: Table 19 Maintenance regimen
Danish: Tabel 19 Vedligeholdelsesregime
English: Prior to launch of Imraldi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før lancering af Imraldi i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen lave aftale om indholdet og formatet af uddannelsesprogrammet, herunder distributionsmetoder og eventuelle andre aspekter af programmet, med den nationale kompetente myndighed.
English: Never reuse a pen.
Danish: Genbrug aldrig en pen.
English: Imraldi can also be given alone.
Danish: Imraldi kan også anvendes alene.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Danish: • Der var i følge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået adalimumab under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået adalimumab.
English: The educational program consists of a Patient Reminder Card.
Danish: Uddannelsesprogrammet består af et Patientkort.
English: Primary analysis (ITT) Placebo
Danish: Primær analyse (ITT) Placebo
English: Table 25 Maintenance regimen
Danish: Tabel 25 Vedligeholdelsesregime
English: Hold the pen against your skin until the yellow indicator fills the medication window and stops moving.
Danish: Hold pennen mod huden, indtil den gule indikator fylder lægemiddelvinduet og stopper med at bevæge sig.
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Danish: 19,3 % af patienterne fortsatte med baseline oral antibiotikabehandling under studiet.
English: Be careful not to squirt the liquid medication into your eye.
Danish: Vær forsigtig så du ikke får den flydende medicin i øjet.
English: • severe allergic reaction with shock;
Danish: • alvorlig allergisk reaktion med shock;
English: • The new injection site should be given at least 3 cm from the last injection site.
Danish: • Det nye injektionsted skal være mindst 3 cm fra det senest anvendte injektionssted.
English: • new onset or worsening of psoriasis;
Danish: • nye udbrud eller forværring af psoriasis;
English: Inspect medicine & expiration date
Danish: Kontrollér medicinen & udløbsdatoen
English: After injecting Imraldi, confirm that the entire medication window is yellow.
Danish: Efter injektion af Imraldi skal du kontrollere, at hele lægemiddelvinduet er gult.
English: Choose an injection site on your body.
Danish: Vælg et injektionssted på kroppen.
English: 3) Choosing and preparing an injection site
Danish: 3) Valg og forberedelse af et injektionssted
English: It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Imraldi.
Danish: Det anbefales, at børn om muligt får alle de planlagte vaccinationer for deres alder, før de påbegynder behandling med Imraldi.
English: If there is a second box in the carton for a future injection, place it back in the refrigerator immediately.
Danish: Hvis der er en anden æske tilbage i kartonen til en fremtidig injektion, å læg den tilbage i køleskabet med det samme.
English: Your doctor may prescribe another strength of Imraldi if your child needs a different dose.
Danish: Lægen kan ordinere en anden styrke af Imraldi, hvis dit barn har brug for en anden dosis.
English: You might accidentally stick yourself or waste medication.
Danish: Du kan ved et uheld stikke dig selv eller tabe medicin.
English: There is limited experience in the initiation of treatment with Imraldi alone.
Danish: Der er begrænset erfaring med initiering af behandling med Imraldi alene.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrede produkts navn og batchnummer tydeligt registreres.
English: • On rare occasions, treatment with Imraldi could result in lupus-like syndrome.
Danish: • I sjældne tilfælde kan behandling med Imraldi resultere i lupus-lignende syndrom.
English: Double-Blind Response at Week 68
Danish: Dobbelt-blind respons ved uge 68
English: In rare cases, these infections may be life-threatening.
Danish: Disse infektioner kan i sjældne tilfælde være livstruende.
English: When choosing an injection site, select an area that has not recently been used to avoid soreness and bruises.
Danish: Når der skal vælges et injektionssted, skal det være et område, der ikke har været anvendt for nyligt for at undgå ømhed og blåfarvning.
English: Follow this instruction guide carefully, and soon you will develop a routine for injecting confidently.
Danish: Følg omhyggeligt denne brugsanvisning, og du vil hurtigt udvikle en sikker injektionsrutine.
English: Pull the syringe away from your skin.
Danish: Træk sprøjten væk fra huden.
English: It may harm them, even if their signs of illness are the same as your child's.
Danish: Symptomerne kan være ømme knuder i huden (noduli) og abscesser (bylder), som kan udtømme pus.
English: • pain in the muscles.
Danish: • smerter i musklerne.
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: Mean exposure in all adalimumab population was 762 days.
Danish: Gennemsnitlig eksponering i hele adalimumab-populationen var 762 dage.
English: Imraldi contains sodium and sorbitol
Danish: Imraldi indeholder natrium og sorbitol
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Danish: Længere tids behandling med adalimumab 40 mg ugentligt i 96 uger identificerede ingen nye sikkerhedsrelaterede fund.
English: Patient Weight
Danish: Patient vægt
English: After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Danish: Efter grundig oplæring kan barnet selv tage injektionen, eller den kan gives af en anden person, f.eks. et familiemedlem eller en ven.
English: • In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi.
Danish: • Derudover er der set tilfælde af ikke-melanom hudkræft hos patienter, der tager Imraldi.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defense against infection and cancer.
Danish: TNF-antagonister, såsom adalimumab, påvirker immunsystemet, og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: • Remove the clear needle cap by pulling it straight up with your other hand.
Danish: • Fjern den klare kanylehætte ved at løfte den lige op med din anden hånd.
English: The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤10.
Danish: Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10.
English: Additional risk minimisation measures
Danish: • Yderligere risikominimeringsforanstaltninger
English: Not sure if you received your dose?
Danish:  Er du ikke sikker på, du har fået din dosis?
English: • Choose a fatty area for injection:
Danish: • Vælg et fedtholdigt område til injektion:
English: This is important to get the proper dose.
Danish: Dette er vigtigt for at kunne udtage den korrekte dosis.
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64 %.
Danish: Den gennemsnitlige absolutte biotilgængelighed af adalimumab, estimeret ud fra tre studier efter en enkelt 40 mg subkutan dosis, var 64 %.
English: 1 Pack of 2 boxes each containing:
Danish: 1 pakning med 2 æsker, der hver indeholder:
English: • You will set the volume to the prescribed dose in a later step.
Danish: • Du skal indstille volumen til den ordinerede dosis på et senere trin.
English: If you have Crohn's disease you will first be given other medicines.
Danish: Hvis du har Crohns sygdom, vil du først få andre lægemidler.
English: Double-Blind Response at Week 12
Danish: Dobbelt-blind respons ved uge 12
English: You and your doctor should pay special attention to signs of infection while you are being treated with Imraldi.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion, mens du er i behandling med Imraldi.
English: Concurrent administration of biologic DMARDS or TNF-antagonists
Danish: Samtidig administration af biologiske DMARDs eller TNF-antagonister
English: A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an open-label extension study.
Danish: I alt 347 stabile respondenter deltog i en evaluering af behandlingsafbrydelse og genbehandling i et åbent forlængelsesstudie.
English: It is normal to see a few drops of liquid come out of the needle.
Danish: Det er normalt, at nogle få dråber væske kommer ud af kanylen.
English: Dose + 0.1 ml
Danish: Dosis + 0,1 ml
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 % respectively.
Danish: Den tilsvarende andel af patienter uden radiografisk progression var henholdvis 31,3 %, 23,7 % og 36,7 %.
English: The response for the two monotherapy arms was similar (p = 0.447).
Danish: Responset i de to monoterapi-arme var ens (p = 0,447).
English: Partial Flared a Assessment of SpondyloArthritis international Society b 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 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: The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Danish: Adalimumabs sikkerhed og virkning hos børn i alderen 4-17 år er endnu ikke klarlagt.
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 i sprøjten, kan du gentage processen op til 3 gange.
English: Analysis Treatment
Danish: Analyse Behandling
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: Please read the instructions carefully and follow them step by step.
Danish: Læs vejledningen grundigt, og følg den trin for trin.
English: The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Danish: Patienterne i HS-I- og HSII-studierne havde sygdommen i Hurley-stadie II eller III med mindst 3 abscesser eller inflammatoriske noduli.
English: • Using a piece of gauze, apply pressure over the injection site for 10 seconds.
Danish: • Pres et stykke gazebind over injektionsstedet i 10 sekunder.
English: Continue with injection site and dose preparation immediately.
Danish: Fortsæt straks med at forberede injektionssted og dosis.
English: confidence interval)
Danish: konfidensinterval)
English: • high blood sugar;
Danish: • højt blodsukker;
English: Very common Musculoskeletal pain Common
Danish: Meget almindelig Muskuloskeletale smerter Almindelig
English: Imraldi is a biosimilar medicinal product.
Danish: Imraldi er et biosimilært lægemiddel.
English: When you push the pre-filled pen firmly onto your skin, the injection will start automatically.
Danish: Når du trykker den fyldte pen fast mod huden, vil injektionen starte automatisk.
English: Side effects may occur up to 4 months or more after the last Imraldi injection.
Danish: Bivirkninger kan forekomme op til mindst 4 måneder eller mere efter den sidste Imraldi injektion.
English: Phase
Danish: Fase
English: Vertigo and visual impairment may occur following administration of Imraldi (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Imraldi (se pkt 4.8).
English: You will set the volume to the prescribed dose in step 4 (Dose Preparation).
Danish: Du skal indstille volumen til den foreskrevne dosis i trin 4 (Forberedelse af dosis).
English: Contact your doctor, nurse or pharmacist.
Danish: Kontakt lægen, sygeplejersken eller apoteket.
English: You should continue to inject Imraldi for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Imraldi så længe, din læge har fortalt dig.
English: Hidradenitis Suppurativa Clinical Response (HiSCR)a
Danish: Hidrosadenitis Suppurativa Clinical Respons (HiSCR)a
English: If retreatment with Imraldi is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med Imraldi er indiceret, bør ovenstående vejledning for dosering og behandligsvarighed følges.
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Danish: Behandling med adalimumab 40 mg hver uge reducerede risikoen for forværring af abscesser og suppurerende fistler signifikant.
English: If new areas of damaged skin appear during or after therapy or if existing marks or areas of damage change appearance, tell your doctor.
Danish: Hvis der kommer nye områder med beskadiget hud under eller efter behandlingen, eller hvis eksisterende mærker eller beskadigede områder ændrer udseende, skal du fortælle det til din læge.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev vurderet ved brug af HAQ-S og SF 36 spørgeskemaer.
English: • If you are over 65 years you may be more susceptible to infections while taking Imraldi.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Imraldi.
English: For paediatric use.
Danish: Til pædiatrisk anvendelse.
English: If you receive Imraldi while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du får Imraldi, mens du er gravid, kan dit barn have en højere risiko for at få en infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: Imraldi should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Imraldi bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM1 with an IC50 of 0.1-0.2 nM).
Danish: Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM-1, VCAM-1 og ICAM-1 med en IC50 på 0,1-0,2 nM).
English: • allergic reactions (including seasonal allergy);
Danish: • allergiske reaktioner (inklusive sæsonbestemt allergi);
English: 4) Dose Preparation
Danish: 4) Forberedelse af dosis
English: • Look at the expiry date on the box to be used.
Danish: • Kontrollér udløbsdatoen på æsken.
English: Your doctor or nurse should make sure you can use your pen correctly.
Danish: Lægen eller sygeplejersken skal sikre sig, at du kan bruge pennen korrekt.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Imraldi.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Imraldi.
English: Never reuse a vial and other components.
Danish: Genbrug aldrig et hætteglas og andre bestanddele.
English: Imraldi works by reducing this inflammation.
Danish: Imraldi virker ved at reducere denne inflammation.
English: Place the greenbase straight (90 degrees) on your skin, and push the entire pre-filled pen down firmly to start the injection.
Danish: Anbring den grønne basis vinkelret (90 grader) på huden, og tryk hele den fyldte pen fast ned for at starte injektionen.
English: • There have been very rare cases of certain kinds of cancer in children and adults taking Imraldi or other TNFα blockers.
Danish: • Der er set meget sjældne tilfælde af visse kræfttyper hos børn og voksne, som tager Imraldi eller andre TNFα-hæmmere.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section
Danish: Behandling efter uge 12 resulterede ikke i signifikant flere respondere (se pkt.
English: • nervous system problems
Danish: • problemer med nervesystemet
English: After proper training in injection technique, patients may self-inject with Imraldi 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 Imraldi, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: Patients were permitted to be either disease-modifying, anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Danish: Det var tilladt for patienterne at være enten fri for sygdomsmodificerende antireumatisk lægemiddel eller at forblive i deres allerede eksisterende reumatologiske terapi, forudsat at terapien havde været stabil i mindst 28 dage.
English: At week 12 and week 24, PaedACR30 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: Median Time to Failure (months)
Danish: Gennemsnitlig tid til behandlingssvigt (måneder)
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: The syringe or pen must be protected from light, and discarded if not used within the 28-day period.
Danish: Injektionssprøjten eller pennen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 28-dages perioden.
English: Treatment with Imraldi may result in the formation of autoimmune antibodies.
Danish: Behandling med Imraldi kan medføre dannelse af autoimmune antistoffer.
English: Week 16 Placebo-Controlled
Danish: Uge 16 Placebo-kontrolleret
English: A large number (approximately 2,100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1,500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Danish: Prospektivt indsamlede data for et stort antal (cirka 2.100) graviditeter med eksponering for adalimumab, som resulterede i levende fødte med kendt graviditetsudfald, inklusive mere end 1.500 eksponeringer i det første trimester, indikerer ikke stigning i hyppighed af misdannelser hos nyfødte.
English: • neurological infections (including viral meningitis);
Danish: • neurologiske infektioner (inklusive viral meningitis);
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Danish: Målet for adalimumab er et protein kaldet tumornekrosefaktor (TNFα), som er til stede i øget mængde ved betændelsessygdommene, der er anført ovenfor.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Danish: • Hvis du er gravid, har mistanke, om at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • Use each pen only once.
Danish: • Hver pen må kun bruges én gang.
English: NOTE:
Danish: BEMÆRK:
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Imraldi injection.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste injektion med Imraldi.
English: DO NOT over-tighten.
Danish: UNDGÅ at overspænde.
English: Taking these results into consideration, adalimumab is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Danish: I betragtning af disse resultater anbefales adalimumab til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se afsnit 4.2).
English: Patients may first be given other disease-modifying medicines, such as methotrexate.
Danish: Patienterne vil muligvis først få anden sygdomsdæmpende medicin, såsom methotrexat.
English: Choose an injection site & clean skin
Danish: Vælg et injektionssted & rens huden
English: • swollen face, hands, feet;
Danish: • hævelser i ansigt, hænder eller fødder;
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Danish: • hepatosplenisk T-celle lymfom (en sjælden form for blodkræft, som ofte er dødelig);
English: Clinical response (CR-100)
Danish: Klinisk respons (CR-100)
English: • cancer, including cancer of the lymph system (lymphoma) and melanoma (a type of skin cancer);
Danish: • kræft, herunder kræft i lymfesystemet (lymfom) og melanom (en slags hudkræft);
English: You may first be given other medicines.
Danish: Du kan vil muligvis få andre lægemidler først.
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Danish: 117/276 patienter fra CD-studie I og 272/777 patienter fra CD-studierne II og III blev fulgt gennem mindst 3 års åben-label adalimumab-behandling.
English: Administration of Imraldi should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af Imraldi bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Danish: Adalimumab er et rekombinant humant monoklonalt antistof dannet i ovarieceller fra kinesiske hamstre.