FrancophonIA/ELRC3.0 huggingface dataset:
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition
Danish: • sygdomme i immunsystemet som kan påvirke lungerne, huden og lymfeknuderne (oftest som en
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: Usually, Cyltezo is used with methotrexate.
Danish: Normalt gives Cyltezo sammen med methotrexat.
English: • Only use each pre-filled syringe for one injection.
Danish: • Brug kun hver fyldte injektionssprøjte til én injektion.
English: For the 2, 4 and 6 pre-filled pen packs, each pre-filled pen comes with 1 alcohol pad.
Danish: For pakningerne med 2, 4 og 6 fyldte penne leveres hver fyldte pen med 1 alkoholserviet.
English: ACR Responses in RA Study V (percent of patients)
Danish: ACR-respons i RA-studie V (Procentdel af patienter)
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studiet med adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit, som var fra 2 til < 4 år.
English: The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period.
Danish: De pivotale kontrollerede studier omfattede 6.089 patienter, der fik adalimumab, og 3.801 patienter, der fik enten placebo eller aktiv kontrol i den
English: During treatment with Cyltezo, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory
Danish: Under behandling med Cyltezo, bør andre samtidige behandlinger (f.eks., kortikosteroider og/eller
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 koagulationssystemet og af blødning (inklusive forlænget aktiveret partiel tromboplastintid), positiv auto-antistoftest (inklusive dobbeltstrenget DNA-antistof), forhøjet blodlactatdehydrogenase
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Danish: Forbedring i antallet af led med aktiv artrit blev opretholdt i den åbne del af studiet til og med uge 156 for 26 ud af 31 (84 %) patienter i adalimumabgruppen, som blev i studiet.
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 21) ved uge 12.
English: If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other
Danish: Hvis der opnås tilstrækkeligt respons med 40 mg hver uge eller 80 mg hver anden uge, kan dosis efterfølgende reduceres til 40 mg
English: Your doctor may recommend temporary discontinuation of Cyltezo.
Danish: Din læge kan anbefale midlertidig afbrydelse af behandling med Cyltezo.
English: • Relevant information on the safety concerns of serious infections, sepsis, tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; malignancies to be addressed by the additional risk minimisation measures (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable).
Danish: • Relevante oplysninger om sikkerhedsovervejelserne for alvorlige infektioner, sepsis, tuberkulose og opportunistiske infektioner, kongestivt hjertesvigt, demyeliniserende sygdomme, maligniteter, der skal behandles under yderligere risikominimeringsforanstaltninger (f.eks. alvorlighedsgrad, sværhedsgrad, hyppighed, tid til start, reversibilitet af den uønskede hændelse hvis relevant).
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Danish: Når kontrollerede dele af disse studier og igangværende og afsluttede åbne opfølgningsstudier med en gennemsnitlig varighed på omkring 3,3 år inkluderende 6.427 patienter og med over 26.439 patientårs behandling kombineres, er den observerede hyppighed af maligniteter, fraset lymfomer og ikkemelanom hudkræft, cirka 8,5 pr. 1.000 patientår.
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Danish: Hudkræft eksklusive melanom (inklusive basal cellekarcinom og spinocellulært karcinom), benigne neoplasmer
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Danish: Patienter i behandling med adalimumab havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema
English: Cyltezo is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Danish: Cyltezo bruges til at behandle hidrosadenitis suppurativa hos voksne og unge i alderen fra 12 år.
English: In patients who develop HBV reactivation, Cyltezo should be stopped and effective anti-viral therapy with appropriate supportive treatment should be
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Cyltezo seponeres og effektiv anti-viral behandling med passende
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see Table 29).
Danish: Resultaterne i begge studier viste en statistisk signifikant reduktion i risikoen for behandlingssvigt hos patienter behandlet med adalimumab versus patienter, som fik placebo (se tabel 29).
English: Treatment with Cyltezo must be discontinued in patients who develop new or worsening symptoms of
Danish: Behandling med Cyltezo skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: Full instructions for use are provided in the package A paediatric presentation is not available for patients who need to administer less than the full 40 mg dose.
Danish: Fuldstændig instruktion vedrørende brug findes i En pædiatrisk formulering er ikke tilgængelig til patienter, der skal administrere mindre end den fulde
English: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and
Danish: Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Danish: Sammenlignet med placebo blev der ved uge 12 påvist større forbedringer i forhold til baseline i hudspecifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), global patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
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 Cyltezo 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 Cyltezo overvejes, inden behandlingen iværksættes (se Andre opportunistiske
English: • oedema (a build up of fluid in the body which causes the affected tissue to swell); • reduction in blood platelets which increases risk of bleeding or bruising;
Danish: • ødem (en ophobning af væske i kroppen, som får det berørte væv til at hæve) • nedsat antal blodplader med forøget risiko for blødning eller blå mærker
English: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Danish: Fordele og risici ved fortsat ugentlig behandling med 40 mg eller 80 mg hver anden uge, skal overvejes nøje hos patienter med utilstrækkeligt respons efter øget dosis (se pkt.
English: Once removed from the refrigerator for room temperature storage, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator.
Danish: Når pennen er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal pennen bruges indenfor 14 dage eller kasseres, også selv om den lægges tilbage i køleskab.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3 % and at week 96 was 65.1 %.
Danish: Blandt patienter, der som minimum var delvise respondenter ved uge 12, og som fortsat fik ugentlig adalimumab-behandling, var HiSCR-raten 68,3 % ved uge 48 og 65,1 % ved uge 96.
English: After 5 years of adalimumab therapy, 74.0 % (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46/50) of patients continued to be in clinical response per PCDAI.
Danish: Efter 5 års adalimumab-behandling var 74,0 % (37/50) af de 50 patienter, som stadig var i studiet, fortsat i klinisk remission, og 92,0 % (46/50) af patienterne havde fortsat
English: Cotton ball or gauze (not included)
Danish: Bomuldsvat eller gazebind (medfølger ikke)
English: It is important that you tell your baby's doctors and other health care professionals about your Cyltezo use during your pregnancy so they can decide when your
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Cyltezo under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
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 Cyltezo 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 Cyltezo-behandling.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with 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 adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt.
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: At week 52, 42.9 % of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4 % of patients receiving adalimumab monotherapy.
Danish: I uge 52 opnåede 42,9 % af patienterne, som fik adalimumab/methotrexat-kombinationsterapi, klinisk remission (DAS28 (CRP) < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexatmonoterapi og 23,4 % af patienterne, som fik adalimumab-monoterapi.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Danish: Et statistisk signifikant fald i værdierne for træthed, målt ved funktionel vurdering af kronisk sygdomsbehandling (FACIT), blev set i alle tre studier, i hvilke det
English: Ped ACR 30 Responses in the JIA study
Danish: Pædiatrisk ACR 30-respons i JIA-studiet
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 entesopatirelateret artrit er sygdommemed betændelseslignende (inflammatoriske) reaktioner i leddene, der normalt først opstår i barndommen.
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 %, 26.4 % (92/349) and 37.8 % (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Danish: I et åbent forlængelsesstudie med patienter, hvis dosis blev trappet op fra 40 mg hver anden uge til 40 mg ugentlig på grund af PASI-respons under 50 % opnåede 26,4 % (92/349) og 37,8 % (132/349) af patienterne PASI 75-respons ved henholdvis uge 12 og 24.
English: • If needed, press cotton ball or gauze over injection site to stop any bleeding.
Danish: • Hvis det er nødvendigt, presses bomuldsvat eller gazebind ned på injektionsstedet for at stoppe
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Danish: Hos nogle patienter, som er behandlet tilfredsstillende for aktiv tuberkulose, er aktiv tuberkulose reaktiveret, mens de har været i behandling
English: Adalimumab in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Danish: Adalimumab er i kombination med methotrexat indiceret til behandling af aktiv polyartikulær juvenil idiopatisk artrit hos patienter fra 2 år, som har haft et utilstrækkeligt respons på en eller flere sygdomsmodificerende anti-reumatiske lægemidler (DMARDs).
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Danish: Der blev observeret en signifikant mindre radiografisk progression hos adalimumab-/methotrexat-patienter end hos patienter, som alene fik methotrexat efter 6 måneder og 12 måneder (se tabel 9).
English: When adalimumab therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Danish: Når adalimumab-behandlingen påbegyndes, kan en induktionsdosis på 40 mg til patienter < 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesdosis.
English: A patient who requires surgery while on Cyltezo 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 Cyltezo, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Administration of live vaccines (e.g. BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Danish: Administration af levende vacciner (f.eks. BCG-vaccine) til spædbørn, som har været eksponeret for adalimumab in utero, anbefales ikke i 5 måneder efter moderens sidste adalimumab-injektion under
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Cyltezo and is positive for antibodies against double-stranded DNA, further treatment with Cyltezo should not be given (see section
Danish: Hvis en patient efter behandling med Cyltezo udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med
English: After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Danish: Efter yderligere 2 uger fortsættes med 40 mg hver uge eller 80 mg hver anden uge, som foreskrevet af din læge.
English: The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control-treated patients.
Danish: Incidensen af alvorlige infektioner var 0,04 pr. patientår hos adalimumab-behandlede patienter og 0,03 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Cyltezo, 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 Cyltezo startes.
English: Try not to cover the window with your • Press tip firmly against squeezed injection site.
Danish: Undgå at dække vinduet • Tryk spidsen fast mod det sammenklemte injektionssted.
English: Patients who experience insufficient response may benefit from an increase in dosage: • < 40 kg:
Danish: Patienter, som oplever utilstrækkeligt respons, kan have fordel af at øge dosis til:
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Danish: I RA-studie I-IV opnåede adalimumab-behandlede patienter statistisk signifikant ACR 20- og 50-respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Danish: Der sås sammenlignelige remissions-rater ved uge 8 for 160/80 mg og 80/40 mg induktionsdosisregimerne, men bivirkninger var hyppigere i gruppen med 160/80 mg.
English: • Do not give Cyltezo to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
Danish: • Giv ikke Cyltezo til børn under 2 år med polyartikulær juvenil idiopatisk artrit.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those
Danish: Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artritpatienter målt i serum var 31-96 %.
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in
Danish: Benefit/risk-forholdet ved fortsat langtidsbehandling skal løbende evalueres (se data for voksne
English: The Cyltezo pre-filled pen is a single-use white- and green-coloured pen with a grey-coloured cap which contains a glass syringe with Cyltezo.
Danish: Cyltezo fyldt pen er en engangspen i hvid og grøn med en grå hætte, der indeholder en glassprøjte med Cyltezo.
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,
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Danish: Der er forekommet reaktivering af hepatitis B hos kroniske bærere af denne virus, som fik en TNF-antagonist herunder adalimumab (dvs. overflade-antigen-positive-patienter).
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Cyltezo.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Cyltezo.
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo
Danish: Alle p-værdier er parvise sammenligninger af andelene for adalimumab vs. placebo
English: Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Danish: Virkningsrespons i placebokontrolleret AS-studie I Reduktion af tegn og symptomer
English: Cyltezo reduces the rate of progression of joint damage as measured by X-ray and improves physical function, when given in combination with methotrexate.
Danish: Cyltezo hæmmer udviklingen af leddestruktion bedømt ved måling med røntgen og forbedrer den fysiske funktion, når det gives i kombination med methotrexat.
English: • Vaccinations: if possible children should be up to date with all vaccinations before using Cyltezo.
Danish: • Vaccinationer: hvis det er muligt, skal dit barn føres ajour med alle vaccinationer, før
English: Cyltezo can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease.
Danish: Cyltezo kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: Adalimumab should only be used during pregnancy if clearly needed.
Danish: Adalimumab må kun anvendes under graviditet på tvingende indikation.
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner
English: Placebo Adalimumab 40 mg Weekly
Danish: Placebo Adalimumab 40 mg ugentlig
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Danish: Hvis der er brug for et hurtigere behandlingsrespons, kan nedenstående dosis anvendes med opmærksomheden rettet mod, at risikoen for bivirkninger kan være øget med den højere
English: Alcohol wipe
Danish: Alkoholserviet
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of non-melanoma skin cancer prior to and during treatment with Cyltezo.
Danish: Alle patienter og specielt patienter, som tidligere har fået omfattende immunsuppressiv behandling, og psoriasis-patienter, der tidligere har været behandlet med PUVA, skal undersøges for ikke-melanom hudkræft inden og under behandling med Cyltezo.