FrancophonIA/ELRC3.0 huggingface dataset:
English: • While holding the vial, push the white plunger rod all the way down.
Danish: • Mens du holder fast i hætteglasset, skubbes den hvide stempelstang hele vejen ned.
English: Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Danish: Adalimumab er vurderet hos mere end 3.000 patienter i de kliniske reumatoid artrit studier.
English: Placebo/MTXAdalimumab/MTX (95% Confidence Interval b)
Danish: Placebo/MTXadalimumab/MTX (95 % konfidensintervalb)
English: The active ingredient in Imraldi, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Imraldi, adalimumab, er et monoklonalt antistof.
English: Imraldi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Imraldi is indicated.
Danish: Behandling med Imraldi bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Imraldi er indiceret til.
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p <0.001) and adalimumab monotherapy (p <0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Adalimumab/methotrexatkombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p < 0,001) og adalimumab-monoterapi (p < 0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Danish: • sygdomme i immunsystemet, som kan påvirke lungerne, huden og lymfeknuderne (som oftest en tilstand kaldet sarkoidose);
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referencelægemidlet, som indeholder adalimumab, i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa, se pkt.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Imraldi should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Imraldi straks ophøre og egnet behandling påbegyndes.
English: Place greenbase, press down, and hold
Danish: Anbring den grønne basis, tryk ned og hold
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
Danish: • systemisk lupus erythematosus (indbefatter betændelse i huden, hjertet, lungerne, leddene og andre organsystemer);
English: Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥90 days at week 52.
Danish: Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroid-fri remission i > 90 dage ved uge 52.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Danish: Det primære endepunkt i RA-studie I, II og III og det sekundære endepunkt i RA-studie IV var den procentdel af patienter, som fik ACR 20-respons i uge 24 eller 26.
English: Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Danish: Forsøgspersoner (n = 215, 54,7 %), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non-respondere i de dobbeltblindede statistiske analyser.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Danish: • Fortæl lægen, hvis du er bærer af hepatitis B-virus (HBV), hvis du har aktiv HBV-infektion, eller hvis du tror, du kan have risiko for at få HBV.
English: In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
Danish: Der er ved post-marketing erfaring fra januar 2003 til december 2010, hovedsageligt hos patienter med reumatoid artrit, rapporteret en hyppighed af maligniteter på cirka 2,7 pr. 1.000 patientbehandlingsår.
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Danish: Hudkræft eksklusive melanom (inklusive basal celle-karcinom og spinocellulært karcinom), benigne neoplasmer
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and not known (cannot be estimated from the available data).
Danish: Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Imraldi contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Danish: Imraldi indeholder det aktive stof adalimumab, som er et lægemiddel, der virker på din krops immunforsvar.
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Imraldi.
Danish: Opbevar Patientkortet på dig under din behandling og i 4 måneder efter din (eller dit barns) sidste injektion med Imraldi.
English: System Organ Class Frequency
Danish: Systemorganklasser
English: DO NOT rub the injection site.
Danish: Gnid IKKE på injektionsstedet.
English: Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Imraldi kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Following 3 years of adalimumab therapy, 75 % (301/402) continued to be in clinical remission per partial Mayo score.
Danish: Efter 3 års behandling med adalimumab fortsatte 75 % (301/402) med at være i klinisk remission i forhold til partiel Mayo score.
English: Infections and infestations*
Danish: Infektioner og parasitære sygdomme *
English: • With the free hand, gently grasp the cleaned area of skin and hold firmly.
Danish: • Klem forsigtigt med den frie hånd om det rensede hudområde, og hold fast.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Danish: Forstyrrelser i koagulations- og blødningssystemet (inklusive forlænget aktiveret partiel tromboplastintid), positiv auto-antistoftest (inklusive dobbeltstrenget DNA-antistof), forhøjet blodlactatdehydrogenase
English: • Throw away all other used items into your regular household waste.
Danish: • Det øvrige affald smides ud med husholdningsaffaldet.
English: Place your pre-filled pen and alcohol pads on a clean, dry surface.
Danish: Anbring den fyldte pen og spritservietter på en ren, tør overflade.
English: The proportions of subjects with PaedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Danish: Forholdet mellem patienter med pædiatrisk ACR 50/70/90 ved uge 12 og uge 24 var henholdsvis 90,3 %/61,3 %/38,7 % og 83,3 %/73,3 %/36,7 %.
English: - If you have moderate or severe heart failure.
Danish: - Hvis du lider af moderat eller alvorligt hjertesvigt.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Imraldi should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med Imraldi overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where adalimumab was given for at least an additional 108 weeks.
Danish: Patienter, som deltog i alle fase 2 og 3 psoriasis-studier, var egnede til inklusion i et åbent forlængelsesstudie, hvor adalimumab blev givet i mindst 108 uger yderligere.
English: Your child's doctor should test your child for HBV. Imraldi can reactivate HBV infection in people who carry this virus.
Danish: Dit barns læge vil teste dit barn for HBV. Imraldi kan reaktivere HBV-infektion hos mennesker, der bærer denne virus.
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, - NK-cells, monocyte/macrophages, and neutrophils.
Danish: I et studie, hvor 64 patienter med reumatoid artrit blev behandlet med adalimumab, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T-, B-, NK-celler, monocytter/makrofager og neutrofiler.
English: It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Danish: Sygdommen påvirker oftest bestemte områder af huden, såsom under brystet, i armhulerne, på inderlårerne, i lyskeområdet og på balderne.
English: SPARCCh MRI Sacroiliac Jointsd,i
Danish: SPARCCh MRI sakroiliakaleddened,i
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Danish: Studie nr-axSpA II var et behandlings-seponeringsstudie hos patienter med aktiv nr-axSpA, som opnåede remission i den åbne periode af behandlingen med adalimumab.
English: • elevated bilirubin measurement (liver blood test).
Danish: • Forhøjede bilirubinmålinger (leverblodtest)
English: • lupus-like syndrome;
Danish: • lupus-lignende syndrom;
English: Age Group Number of patients at Baseline N (%) Minimum, median and maximum
Danish: Aldersgruppe Antal patienter ved baseline N (%)
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75 % relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Danish: Efter 16 ugers behandling gik de patienter, der mindst havde opnået et PASI 75-respons (forbedring i PASI-score på mindst 75 % i forhold til baseline), over i periode B og fik åben 40 mg adalimumab hver anden uge.
English: Physicians should exercise caution when considering the use of Imraldi in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af Imraldi til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Imraldi, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres latent tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med Imraldi startes.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Danish: Polyartikulær juvenil idiopatisk artrit og entesopati-relateret artrit er betændelsessygdomme i leddene, som sædvanligvis viser sig i barndommen.
English: Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Imraldi bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen fra 2 til 17 år og entesopati-relateret artrit hos børn og unge i alderen 6-17 år.
English: Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Danish: Imraldi kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtmæssig (for virkning ved monoterapi, se pkt 5.1).
English: • Prepare the syringe by partially peeling the package open from the end closest to white plunger rod.
Danish: • Forbered sprøjten ved at åbne pakningen delvist fra enden nærmest den hvide stempelstang.
English: • If you dropped your pen with the cap ON, it is okay to use the pen.
Danish: • Hvis du taber pennen med hætten PÅ, er det okay at anvende pennen.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Danish: • autoimmun hepatitis (leverbetændelse forårsaget af kroppens eget immunsystem);
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl lægen, hvis du har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: Contents of the pack and other information What Imraldi contains
Danish: Pakningsstørrelser og yderligere oplysninger Imraldi indeholder
English: arrhythmia, congestive heart failure
Danish: arytmi, kongestiv hjertesvigt
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: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Danish: • nerveforstyrrelser (såsom betændelse i synsnerven til øjet og Guillain-Barré syndrom, en tilstand, som kan forårsage muskelsvaghed, unormal følesans, prikken i arme og overkrop);
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p <0.001).
Danish: I RA-studie IV var ACR 20-respons for patienter behandlet med adalimumab plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p < 0,001).
English: Among patients who were not in response at week 4, 43 % of adalimumab maintenance patients responded by week 12 compared to 30 % of placebo maintenance patients.
Danish: Blandt de patienter, som ikke havde respons i uge 4, responderede 43 % af patienterne i adalimumab vedligeholdelsesbehandling ved uge 12 sammenlignet med 30 % af patienter i placebogruppen.
English: After injecting Imraldi, confirm that the needle has retracted and immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Danish: Efter injektion af Imraldi skal du kontrollere, at kanylen har trukket sig tilbage, hvorefter den brugte sprøjte straks smides væk i en specialbeholder som anvist af lægen, sygeplejersken eller apoteket.
English: - If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis dit barn er allergisk over for adalimumab eller et af de øvrige indholdsstoffer i Imraldi (angivet i punkt 6).
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) including spontaneous reporting data
Danish: 4.3, 4.4 og 4.8 ** inklusive åbne forlængelsesstudier 1) inklusive spontane rapporter
English: • If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white plunger rod into the syringe until fluid begins to enter the syringe tip.
Danish: • Hvis der er en stor luftboble eller luftlomme nær sprøjtens spids, skubbes den hvide stempelstang LANGSOMT ind i sprøjten indtil der kommer væske ud af sprøjtens spids.
English: Then lift your thumb to let the needle retract into the body of the syringe.
Danish: Løft herefter tommelfingeren, så kanylen kan trække sig tilbage ind i sprøjtelegemet.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Danish: Der kan udvikles adalimumab-antistoffer under behandling med adalimumab.
English: If your doctor considers that methotrexate is inappropriate, Imraldi can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Imraldi anvendes alene.
English: • Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl lægen, hvis dit barn har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: If these medicines do not work well enough, patients will be given Imraldi to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Danish: Hvis disse lægemidler ikke har tilstrækkelig effekt, vil patienterne få Imraldi til behandling af deres polyartikulære juvenile idiopatiske artrit eller entesopati-relaterede artrit.
English: - If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Danish: - Hvis du har en alvorlig infektion, herunder tuberkulose (se ”Advarsler og forsigtighedsregler”).
English: General handling: DO NOT dispose of any waste items until after the injection is completed.
Danish: Generelt: Smid FØRST affaldet ud, når injektionen er fuldført
English: Discontinuation of Immunomodulators2
Danish: Seponering af immunomodulerende-midler2
English: Improvement in health-related quality of life and physical function was maintained during the openlabel extension through week 156.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev opretholdt i den åbne forlængelsesfase op til uge 156.
English: Imraldi can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: Imraldi kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: A patient who requires surgery while on Imraldi should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med Imraldi, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Your child's symptoms may return upon stopping treatment.
Danish: Dit barns symptomer kan komme igen, hvis behandlingen stoppes.
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Danish: • Hold fast på sprøjtens pakning og træk LANGSOMT den hvide stempelstang ud til 0,1 ml mere end den ordinerede dosis (fhvis den ordinerede fx dosis er 0,5 ml skal du trække den hvide stempelstang ud til 0,6 ml).
English: p-valuea p-valueb p-valuec
Danish: pværdia pværdib p-værdic
English: Wait 15-30 minutes for your pre-filled pen to reach to room temperature, which helps reduce your pain during injection.
Danish: Vent 15-30 minutter, så din fyldte pen kan nå stuetemperatur, hvilket kan medvirke til at reducere smerterne ved injektionen.
English: Check with your doctor before your child receives any vaccines.
Danish: Tal med lægen, før dit barn får nogen form for vaccine.
English: • Before you inject, ask your doctor or nurse to show you how to use your pre-filled pen.
Danish: • Før du begynder med at injicere, skal du bede lægen eller sygeplejersken om at vise dig, hvordan du bruger din fyldte pen.
English: If you have COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Danish: Hvis du har KOL, eller du ryger meget, bør du diskutere med din læge, om behandling med en TNFα-hæmmer er passende for dig.
English: - If your child has moderate or severe heart failure.
Danish: - Hvis dit barn lider af moderat eller alvorligt hjertesvigt.
English: - If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer i Imraldi (angivet i punkt 6).
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Danish: Behandlingssvigt blev defineret som et multipelt sammensat endepunkt bestående af inflammatoriske korioretinale og/eller inflammatoriske retinale læsioner, antal celler i det anteriore kammer (AC), grad af glaslegemesløring (VH) og bedste korrigerede synsstyrke (BCVA).
English: Keep this Patient Reminder Card with you or your child during his/her treatment and for 4 months after your child's last injection of Imraldi.
Danish: Opbevar Patientkortet på dig eller på dit barn under dit barns behandling og i 4 måneder efter dit barns sidste injektion med Imraldi.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Imraldi treatment.
Danish: Kvinder i den fertile alder bør overveje at anvende passende prævention for at forebygge graviditet og fortsætte med at anvende prævention i mindst fem måneder efter den sidste Imraldi-behandling.
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Danish: Dosis af adalimumab hos disse patienter er fastlagt ud fra farmakokinetiske modeller og simulering (se pkt.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤18 years of age), including adalimumab in the post marketing setting.
Danish: Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling før 18-års alderen), inklusive adalimumab post marketing.
English: If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Imraldi provider for a replacement.
Danish: Hvis du trækker den hvide stempelstang helt ud af sprøjten, skal du kassere sprøjten og kontakte det sted, hvor du fik Imraldi, for at få en erstatningssprøjte.