FrancophonIA/ELRC3.0 huggingface dataset:
English: Cimzia was studied in 4,049 patients with rheumatoid arthritis in controlled and open label trials for up to 92 months.
Danish: Cimzia blev undersøgt i op til 92 måneder hos 4.049 patienter med reumatoid artritis i kontrollerede og åbne studier.
English: Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis
Danish: Reumatoid artritis, psoriasis artritis, aksial spondylartritis og plaque psoriasis
English: Clinical response at Week 16 and 48 The key results of CIMPASI-1 and CIMPASI-2 studies are presented in Table 11.
Danish: Klinisk respons i uge 16 og 48 Hovedresultaterne af CIMPASI-1 og CIMPASI-2 studierne er vist i tabel 11.
English: In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo.
Danish: Endvidere blev patienter, som ikke responderede på behandlingen i uge 16 i studie RA-I og RA-II, obligatorisk trukket ud af studierne, og af disse patienter havde størstedelen fået placebo.
English: The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 11.7% in the Phase III placebo-controlled trial in patients with psoriatic arthritis.
Danish: Den samlede andel af patienter med antistoffer mod Cimzia, påvist ved mindst én lejlighed frem til uge 24, var 11,7% i det placebokontrollerede fase III-studie hos patienter med psoriasisartritis.
English: If new skin lesions appear during or after therapy with Cimzia or existing skin lesions change appearance, tell your doctor.
Danish: Du skal fortælle det til lægen, hvis der opstår nye hudlæsioner under eller efter behandlingen med Cimzia, eller hvis eksisterende hudlæsioner forandrer udseende.
English: Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled pen are given in the package leaflet.
Danish: Detaljeret vejledning til tilberedning og administrering af Cimzia i en fyldt pen er givet i indlægssedlen.
English: The incidence rate of new cases of infections in placebo-controlled clinical trials in psoriasis was 1,37 per patient-year for all Cimzia-treated patients and 1.59 per patient-year for placebo-treated patients.
Danish: Incidensraten af nye tilfælde med infektioner i placebokontrollerede kliniske studier med psoriasis var 1,37 pr. patient-år for alle Cimzia-behandlede patienter og 1,59 pr. patient-år for alle placebobehandlede patienter.
English: The axial spondyloarthritis overall population included subpopulations with and without (non-radiographic axial spondyloarthritis [nraxSpA]) radiographic evidence for ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis).
Danish: Den samlede population med aksial spondyloartritis omfattede subpopulationer med og uden [non-radiografisk aksial spondyloartritis (nr-axSpA]) radiografiske tegn på ankyloserende spondylitis (AS) (også kaldet radiografisk aksial spondyloartritis).
English: Table 6 Radiographic change at Week 52 in trial C-EARLY Placebo +MTX N= 163 Mean (SD)
Danish: Tabel 6 Radiografisk ændring ved uge 52 i C-EARLY-studiet Placebo + MTX N= 163 Gennemsnit (SD)
English: The total content (1 ml) of the pre-filled syringe should be administered as a subcutaneous injection only.
Danish: Hele indholdet (1 ml) i den fyldte sprøjte bør udelukkende administreres som subkutan injektion.
English: • immune disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of the fat tissue, angioneurotic oedema (swelling of the lips, face, throat)
Danish: • immunsygdomme, såsom sarkoidose (udslæt, ledsmerter, feber), serumsygdom, betændelse i fedtvævet, angioneurotisk ødem (hævelse af læberne, ansigtet, svælget)
English: Antibody positivity was associated with lowered drug plasma concentration and in some patients with reduced efficacy.
Danish: Antistof-positivitet var associeret med nedsat lægemiddel-plasmakoncentration og hos nogle patienter med reduceret effekt.
English: • injection site reactions
Danish: • reaktioner på injektionsstedet
English: Cimzia is used to treat severe active ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis (sometimes referred to as non-radiographic axial spondyloarthritis).
Danish: Cimzia anvendes til behandling af alvorlig aktiv ankyloserende spondylitis og aksial spondyloartritis uden tegn på ankyloserende spondylitis ved røntgen (undertiden benævnt som ikke-radiografisk aksial spondyloartritis).
English: It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: De ordinerende læger bør være opmærksomme på risikoen for falske negative resultater af tuberkulintesten, særligt hos patienter der er alvorligt syge eller immunforsvarskompromitterede.
English: Cimzia-treated patients reported significant improvements in axial spondyloarthritis-related productivity at work and within household, as reported by the Work Productivity Survey as compared to placebo.
Danish: Patienter behandlet med Cimzia rapporterede om signifikant forbedring af aksial spondyloartritis-relateret produktivitet ved arbejdet og indenfor husholdning, som rapporteret ved Work Productivity Survey, sammenlignet med placebo.
English: Figure 2 Figure 3
Danish: Figur 3
English: Patients had to fulfil ASAS criteria for nraxSpA (not including family history and good response to NSAIDs), and have had objective signs of inflammation indicated by C-reactive protein (CRP) levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI), indicative of inflammatory disease [positive CRP (> ULN) and/or positive MRI], but without definitive radiographic evidence of structural damage on sacroiliac joints.
Danish: Patienterne skulle opfylde ASASkriterier for nr-axSpA (ikke omfattende familiær anamnese og god respons på NSAID) og have haft objektive tegn på inflammation indikeret ved niveauer af C-reaktivt protein (CRP) over den øvre normalgrænse og/eller sacroiliitis ved magnetisk resonansscanning (MRI), indikativ for inflammatorisk sygdom [positiv CRP (>ULN) og/eller positiv magnetisk resonansscanning (MRI)], men uden definitiv radiografisk evidens for strukturel skade på sacroiliacaleddene.
English: Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.
Danish: En populationsfarmakokinetisk analyse viste, at samtidig behandling med methotrexat, kortikosteroider, non-steroide antiinflammatoriske lægemidler (NSAIDer) og analgetika ikke havde indvirkning på certolizumab pegols farmakokinetik.
English: Cimzia in combination with methotrexate can also be used to treat severe, active and progressive rheumatoid arthritis without previous use of methotrexate or other medicines.
Danish: Cimzia i kombination med methotrexat kan også anvendes til behandling af alvorlig, aktiv og fremskridende reumatoid artritis uden forudgående behandling med metrotrexat eller andre lægemidler.
English: • Methotrexate is continued while using Cimzia.
Danish: • Behandling med methotrexat fortsættes under behandling med Cimzia.
English: Week 12 Week 24 ASAS 5/6(c,d)
Danish: Uge 12 Uge 24 ASAS 5/6
English: Some cases have had a fatal outcome.
Danish: I nogle tilfælde var udfaldet letalt.
English: Cimzia, which you will take in combination with methotrexate, is used to:
Danish: Cimzia i kombination med methotrexat anvendes for at:
English: The observed ACR 20 response rate at this timepoint was 91%.The reduction (RA-I) from Baseline in DAS28 (ESR) also was significantly greater (p<0.001) at Week 52 (RA-I) and Week 24 (RA-II) compared to placebo and maintained through 2 years in the open-label extension trial to RA-I.
Danish: Reduktionen (RA-I) i DAS28 (ESR) fra baseline var også signifikant større (p< 0,001) i uge 52 (RA-I) og uge 24 (RA-II) sammenlignet med placebo og blev fastholdt i 2 år i det åbne forlængelsesstudie til RA-I.
English: •Do not remove the cap until you are ready to inject.
Danish: • Tag ikke kanylehætten af, før du er klar til at injicere.
English: Other medicines and Cimzia
Danish: Brug af anden medicin sammen med Cimzia
English: Rare pancytopaenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal
Danish: Sjælden pancytopeni, splenomegali, erytrocytose, morfologiske forandringer i de hvide blodlegemer
English: • changed numbers of blood cells, including low red cell count (anaemia), low platelet counts,
Danish: • ændringer i antallet af blodlegemer, herunder lavt indhold af røde blodlegemer (anæmi), lavt indhold af blodplader i blodet, højt indhold af blodplader
English: Responders (achieved ACR 20) at week 16 were randomised at week 18 to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks, or placebo in combination with MTX for an additional 16 weeks (total trial length: 34 weeks).
Danish: Respondenterne (opnået ACR20) ved uge 16 blev ved uge 18 randomiseret til 200 mg Cimzia hver 2. uge, 400 mg Cimzia hver 4. uge eller placebo i kombination med MTX i yderligere 16 uger (total studievarighed 34 uger).
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 6.8%.
Danish: Den samlede procentdel af patienter, som var antistof-positive med en vedvarende nedsat lægemiddelkoncentration i plasma, blev estimeret til at være 6,8%.
English: The proportion of patients who discontinued treatment due to adverse events in the controlled clinical studies was 1.5% for patients treated with Cimzia and 1.4% for patients treated with placebo.
Danish: Andelen af patienter, som afbrød behandlingen på grund af bivirkninger i de kontrollerede kliniske studier, var 1,5 % for patienter, der blev behandlet med Cimzia, og 1,4 % for patienter, der blev behandlet med placebo.
English: • enlarged spleen
Danish: • forstørret milt
English: Do NOT touch the needle guard activation clips (labelled as 3 in Figure 1) during removal (as shown in Figure 3) in order to prevent prematurely covering the needle with the needle guard.
Danish: Rør IKKE ved aktiveringsclipsen til kanylebeskyttelsen (se punkt 3 på Figur 1), når sprøjten tages ud (som vist på Figur 3).Hvis du rører ved aktiveringsclipsen, risikerer du, at nålen dækkes af kanylebeskyttelsen for tidligt.
English: If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.
Danish: Hvis latent tuberkulose diagnosticeres, skal egnet anti-tuberkulosebehandling i henhold til lokale vejledninger påbegyndes, før behandling med Cimzia initieres.
English: The efficacy and safety of 2 dose regimens (200 mg every 2 weeks and 400 mg every 4 weeks) of Cimzia versus placebo were assessed in an 18-week, open-label, run-in, and 16-week randomised, double-blind, placebo-controlled clinical trial in adult patients with active rheumatoid arthritis diagnosed according to the ACR criteria who had inadequate response to MTX.
Danish: Sikkerheden og virkningen af 2 doseringsregimer af Cimzia (200 mg hver 2. uge og 400 mg hver 4. uge) vs. placebo blev undersøgt i et 18-ugers åbent indkøringsstudie og et 16-ugers randomiseret, dobbeltblindt, placebokontrolleret klinisk studie hos voksne patienter med aktiv reumatoid artritis, diagnostiseret i henhold til ACR-kriterierne, som ikke har responderet tilstrækkeligt på MTX.
English: Do not use this medicine if the solution is discoloured, cloudy or if you can see particles in it.
Danish: Brug ikke lægemidlet, hvis opløsningen er misfarvet, uklar eller hvis du kan se partikler i den.
English: Treatment success of “clear” (0) or “almost clear”(1) consisted of no signs of psoriasis or normal to pink coloration of lesions, no thickening of the plaque, and none to minimal focal scaling.
Danish: PGA 5 kategoriskala.Behandlingssucces af ”klar” (0) eller ”næsten klar” (1) bestod i fravær af tegn på psoriasis eller normal til lyserød farvning af læsioner, ingen hævelse af plaquen og ingen til minimal lokal afskalning.
English: Among patients remaining in the study, improvements in all afore-mentioned key efficacy outcomes were maintained through Week 204 in the overall population as well as in the subpopulations.
Danish: Der blev opretholdt forbedringer af alle effektresultater anført ovenfor til og med uge 204 blandt de tilbageværende patienter i studiet, både i den samlede population samt i subpopulationerne.
English: Evaluation for treatment of signs and symptoms and inhibition of structural damage in DMARD naïve patients.
Danish: Evaluering af behandling på objektive fund og symptomer samt hæmning af strukturelle skader hos patienter, der ikke har fået DMARD tidligere.
English: The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and lower respiratory tract infections and herpes viral infections (see sections 4.3 and 4.4).
Danish: Infektionerne bestod primært af infektioner i de øvre luftveje, urinvejsinfektioner, infektioner i de nedre luftveje og virale herpesinfektioner (se pkt.
English: Pack size of 2 pre-filled syringes with needle guard and 2 alcohol wipes (for use by healthcare professionals only).
Danish: Pakning a 2 fyldte sprøjter med kanylebeskyttelse og 2 alkoholservietter (bør kun anvendes af sundhedspersonalet).
English: Compared with a 70 kg person, clearance is 29% lower and 38% higher, respectively, in individual RA patients weighing 40 kg and 120 kg.
Danish: Sammenlignet med en person som vejer 70 kg er clearance henholdsvis 29% lavere og 38% højere hos RApersoner som vejer 40 kg og 120 kg. Clearance efter subkutan dosering hos patienter med psoriasis var 14 ml/t med en variabilitet mellem forsøgspersoner på 22,2 % (CV).
English: Cimzia 200 mg + MTXPlacebo +MTX Difference*
Danish: Cimzia 200 mg + MTXPlacebo +MTX Forskel*
English: Cimzia has not been studied specifically in a lupus population (see section 4.8).
Danish: Cimzia er ikke blevet særligt undersøgt hos patienter med lupus (se pkt.
English: Cimzia-treated patients reported significant improvements in health-related quality of life as measured by the psoriatic arthritis QoL (PsAQoL) and the SF-36 Physical and Mental Components and in psoriatic arthritis-related productivity at work and within household, as reported by the Work Productivity Survey compared to placebo.
Danish: Patienter behandlet med Cimzia rapporterede signifikante forbedringer i helbredsorienteret livskvalitet, vurderet ved psoriasisartritis QoL (PsAQoL) og SF-36 Physical and Mental Components, samt i psoriasisartritis-relateret produktivitet ved arbejde og indenfor husholdning, som rapporteret ved Work Productivity Survey, sammenlignet med placebo.
English: Uncommo blood and lymphatic system malignancies (including lymphoma and leukaemia), solid organ tumours, nonmelanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumours and cysts (including skin papilloma)
Danish: Ikke almindelig maligniteter i blod- og lymfesystemet (inklusive lymfomer og leukæmi), faste organtumorer, non-melanom hudcancer, præmaligne læsioner (inklusive oral leukoplaki, melanocytisk nævus), benigne tumorer og cyster (inklusive hudpapillom) Sjælden gastrointestinale tumorer, melanomer Ikke kendt
English: Common hepatitis (including hepatic enzyme increased) Uncommo hepatopathy (including cirrhosis), cholestasis, blood bilirubin increased
Danish: Almindelig hepatitis (inklusive forhøjet leverenzym) Ikke almindelig hepatopati (inklusive cirrhose), kolestase, øget indhold af bilirubin i blodet Sjælden cholelithiasis
English: • When ready, remove the needle cap by pulling it firmly downwards.
Danish: • Når du er klar, tages nålehætten af ved at trække den nedad med et fast tag.
English: • signs of infection such as fever, malaise, wounds, dental problems, burning on urination
Danish: • tegn på infektion, såsom feber, utilpashed, sår, tandproblemer, smerter ved vandladning
English: In RA-I, structural joint damage was assessed radiographically and expressed as change in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at Week 52, compared to baseline.
Danish: I RA-I blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer mTSS og dennes komponenter, erosionsscore og score for ledspalteforsnævring (JSN) i uge 52 sammenlignet med udgangsniveauet.
English: If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to:
Danish: Hvis du ikke reagerer tilfredsstillende på disse lægemidler, vil du få Cimzia samtidig med methotrexat for at:
English: What you need to know before you use Cimzia
Danish: Det skal du vide, før du begynder at bruge Cimzia
English: Cimzia was studied in 409 patients with psoriatic arthritis in the PsA001 clinical study for up to 4 years which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 168-week open-label treatment period.
Danish: Cimzia blev undersøgt i op til 4 år hos 409 patienter med psoriasisartritis i det kliniske studie PsA001, hvilket omfatter en 24-ugers placebokontrolleret fase efterfulgt af 24 uger med blindede doser, og en 168-ugers åben (open label) behandlingsperiode.
English: Uncommo renal impairment, blood in urine, bladder and urethral symptoms
Danish: Ikke almindelig nedsat nyrefunktion, blod i urinen, blære- og urinvejssymptomer
English: Axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis subpopulations)
Danish: Aksial spondyloartritis (non-radiografisk aksial spondyloartritis og ankyloserende spondylitis subpopulationer)
English: The proportion of patients who discontinued treatment due to adverse events during the controlled trials was 4.4% for patients treated with Cimzia and 2.7% for patients treated with placebo.
Danish: Andelen af patienter, som stoppede behandlingen under de kontrollerede studier på grund af bivirkninger, var 4,4% for patienter som fik Cimzia, og 2,7% for patienter som fik placebo.
English: If latent (inactive) tuberculosis is diagnosed, you might be required to receive appropriate anti tuberculosis medicines before starting Cimzia.
Danish: Hvis der diagnosticeres inaktiv (latent) tuberkulose, skal du måske have medicin mod tuberkulose, før du begynder på behandling med Cimzia.
English: • increased blood levels of uric acid
Danish: • forhøjet indhold af urinsyre i blodet
English: Axial spondyloarthritis without radiographic evidence of AS (also known as non-radiographic axial spondyloarthritis)
Danish: Aksial spondyloartritis uden radiografiske tegn på AS (også kaldet non-radiografisk aksial spondyloartritis)
English: Cimzia-treated patients reported greater improvements compared to placebo in the Hospital Anxiety and Depression Scale (HADS)-D.
Danish: Cimzia-behandlede patienter rapporterede større forbedringer sammenlignet med placebo på hospitalsangst- og depressionsskalaen (HADS)-D.
English: Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), have been reported in patients treated with TNF-antagonists.
Danish: Post-marketing er der rapporteret tilfælde af hepatosplenisk T-celle-lymfom hos patienter behandlet med TNF-antagonister.
English: Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists.
Danish: Der er rapporteret sjældne tilfælde af pancytopeni, inklusive aplastisk anæmi, ved behandling med TNF-antagonister.
English: • Press the pre-filled pen firmly against the skin.
Danish: • Hold den fyldte pen mod huden.
English: There was no effect of gender on the pharmacokinetics of certolizumab pegol.
Danish: Køn havde ingen effekt på certolizumab pegols farmakokinetik.
English: - There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death (see further down “Children and adolescents”).
Danish: - Hos børn og unge, som tager TNF-blokerende midler, har der været tilfælde af kræft, herunder usædvanlige typer, som undertiden har været dødelige (se nedenfor under ”Børn og unge”).
English: • inflammation of the nerves for hearing, seeing, or of the face, impaired coordination or balance
Danish: • betændelse i hørenerven, synsnerven eller nerverne i ansigtet, dårlig koordinationsevne eller balance
English: No trials have been conducted that include patients with a history of malignancy, or that continue treatment in patients who develop malignancy, while receiving Cimzia.
Danish: Der er ikke udført kliniske studier med patienter, som har maligne sygdomme i anamnesen, eller hos patienter, som fortsætter behandlingen efter at have udviklet maligne sygdomme under behandling med Cimzia.
English: Specific clinical trials have not been performed to assess the effect of renal impairment on the pharmacokinetics of certolizumab pegol or its PEG fraction.
Danish: Der er ikke udført specifikke kliniske studier for at bestemme virkningen af nedsat nyrefunktion på certolizumab pegols farmakokinetik eller dennes PEGfraktion.
English: Cimzia was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 18 months.
Danish: Cimzia blev undersøgt hos 1112 patienter med psoriasis i kontrollerede så vel som ikke-blindede studier i op til 18 måneder.
English: Inject within 5 minutes of removing the needle cap.
Danish: Injicér senest 5 minutter efter, kanylehætten er taget af.
English: Cimzia can be used during breastfeeding.
Danish: Cimzia kan anvendes under amning.
English: • If you need to have a second injection as prescribed by your doctor repeat the injection process starting at Step 2.
Danish: • Hvis den dosis, din læge har ordineret, kræver, at du indgiver endnu en injektion, skal du gentage injektionsproceduren startende fra trin 2.
English: See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.
Danish: 6.4 vedrørende opbevaringstid for opbevaring i rumtemperatur op til maksimalt 25 °C.
English: The ACR 20 endpoint was achieved for both Cimzia 200 mg every 2 weeks and 400 mg every 4 weeks.
Danish: ARC20-endepunktet blev nået for både 200 mg Cimzia hver 2. uge og 400 mg Cimzia hver 4. uge.
English: Partial remission(c,d)
Danish: (c,d)
English: Uncommo visual disorder (including decreased vision), eye and eyelid inflammation, lacrimation disorder
Danish: Ikke almindelig synsforstyrrelser (inklusive nedsat syn), inflammation i øje eller øjenlåg, lakrimationsforstyrrelser
English: The efficacy and safety of Cimzia were assessed in two placebo-controlled studies (CIMPASI-1 and CIMPASI-2) and one placebo- and active-controlled study (CIMPACT) in patients ≥18 years of age with moderate to severe chronic plaque psoriasis for at least 6 months.
Danish: Cimzias virkning og sikkerhed blev vurderet i to placebokontrollerede studier (CIMPASI-1 og CIMPASI-2) og et placebokontrolleret og aktivt-kontrolleret studie (CIMPACT) hos patienter, der var ≥18 år gamle, med moderat til svær kronisk plaque psoriasis i mindst 6 måneder.
English: Physical function response and health-related outcomes In RA-I and RA-II, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) from Week 1 through to the end of the studies compared to placebo.
Danish: Fysisk funktionsrespons og helbredsrelaterede resultater I RA-I og RA-II rapporterede patienter behandlet med Cimzia signifikante forbedringer i fysisk funktion, som vurderet ved Health Assessment Questionnaire - Disability Index (HAQ-DI) og ved træthed (fatigue), som rapporteret af Fatigue Assessment Scale (FAS), fra uge 1 frem til slutningen af studierne sammenlignet med placebo.
English: Uncommo muscle disorders, blood creatine phosphokinase increased
Danish: Ikke almindelig muskellidelser, forhøjet indhold af kreatininfosfokinase i blodet