FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have questions, please ask your doctor.
Danish: Hvis du har spørgsmål, så kontakt lægen.
English: It is important that you tell your baby's doctors and other health care professionals about your Cimzia use before the baby receives any vaccine (for more information see section on vaccinations).
Danish: Det er vigtigt, at du fortæller det til dit barns læge og andet sundhedspersonale, at du har brugt Cimzia, inden dit barn bliver vaccineret (se afsnittet om vaccinationer for yderligere oplysninger).
English: One Cimzia pack contains:
Danish: En Cimzia-pakning indeholder:
English: Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia.
Danish: På trods af tidligere eller samtidig profylaktisk behandling for tuberkulose er de forekommet tilfælde af aktiv tuberkulose hos patienter, som fik TNF-antagonister herunder Cimzia.
English: Improvements in all afore-mentioned outcomes were maintained through Week 216.
Danish: Forbedringer af alle de ovennævnte resultater blev opretholdt til og med uge 216.
English: The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established.
Danish: Cimzias sikkerhed og virkning hos børn og unge under 18 år er endnu ikke fastlagt.
English: Data from a human closed-circuit placental transfer model ex vivo suggest low or negligible transfer to the foetal compartment.
Danish: Data fra en human model af placentaoverførsel i et lukket kredsløb ex-vivo tyder på lav eller ubetydelig overførsel til det føtale rum.
English: Certolizumab pegol does not bind to the human neonatal Fc receptor (FcRn).
Danish: Certolizumab pegol binder ikke til den humane neonatale Fcreceptor (FcRn).
English: • the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate.
Danish: • Behandling af moderat til svær, aktiv reumatoid artritis (RA) hos voksne, hvor responsen på sygdomsmodificerende antireumatiske lægemidler (DMARDs) inklusive MTX har været utilstrækkelig.
English: Cimzia was administered subcutaneously in combination with oral MTX for a minimum of 6 months with stable doses of at least 10 mg weekly for 2 months in both trials.
Danish: Cimzia blev administreret subkutant i kombination med MTX i minimum 6 måneder med stabile doser på mindst 10 mg ugentlig i 2 måneder i begge studier.
English: • Remove the Cimzia pack from the refrigerator.
Danish: • Tag Cimzia-pakningen ud af køleskabet.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Danish: Psoriasisartritis er en sygdom med inflammation i leddene, som regel ledsaget af psoriasis.
English: Improvements in all afore mentioned outcomes were maintained through Week 48.
Danish: Forbedringer af alle førnævnte udfald blev opretholdt til og med uge 48.
English: Rare nephropathy (including nephritis)
Danish: Sjælden nefropati (inklusive nefritis)
English: Carcinogenicity studies have not been performed with certolizumab pegol.
Danish: Der er ikke udført karcinogenicitetsstudier med certolizumab pegol.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Danish: • forværring af en tilstand kaldet dermatomyositis (ses som hududslæt med muskelsvaghed)
English: Assessments on remission (DAS28(ESR) <2.6), Low Disease Activity (DAS28(ESR) ≤3.2) status, ACR50 and ACR 70 by visit demonstrated that Cimzia+MTX treatment led to faster and greater responses than PBO+MTX treatment.
Danish: Vurdering af remission (DAS28(ESR) < 2,6), lav sygdomsaktivitet (DAS28(ESR) ≤ 3,2) samt ACR50 og ACR70 ved besøg viste, at Cimzia+MTX-behandlingen førte til hurtigere og bedre respons end placebo+MTX-behandling.
English: Cimzia should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Cimzia bør anvendes med forsigtighed hos patienter med let hjertesvigt (NYHA funktionsklasse I/II).
English: • You will be instructed by your doctor or healthcare giver how to inject the medicine.
Danish: • Lægen eller en sundhedsperson vil vise dig, hvordan du injicerer medicinen.
English: • Do not shake the medication.
Danish: • Ryst ikke medicinen.
English: • after 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis, or
Danish: • efter 12 uger, hvis du har reumatoid artritis, aksial spondyloartritis eller psoriasis artritis, eller
English: • feeling weak and generally unwell
Danish: • svaghedsfølelse og generel utilpashed
English: Missing data were imputed using multiple imputation based on the MCMC method.
Danish: Manglende data blev imputeret ved hjælp af multipel imputation på basis af MCMC-metoden.
English: The empty syringe and needle will automatically move back into the barrel and lock in place.
Danish: Den tomme sprøjte og nålen vil automatisk trække sig op i cylinderen og låse sig fast.
English: Common pyrexia, pain (any site), asthaenia, pruritus (any site), injection site reactions
Danish: Almindelig pyreksi, smerter (hvilket som helst sted), asteni, pruritus (hvilket som helst sted), reaktioner på injektionsstedet
English: Previous treatment with one TNF-antagonist was allowed and 20% of patients had prior TNF-antagonist exposure.
Danish: Tidligere behandling med en TNF-antagonist var tilladt, og 20% af patienterne var tidligere blev eksponeret for en TNF-antagonist.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus (i.e., surface antigen positive).
Danish: Reaktivering af hepatitis B er forekommet hos patienter, der fik en TNF-antagonist herunder certolizumab pegol, og som var kroniske bærere af dette virus (dvs. overfladeantigen-positive).
English: A risk for development of hepatosplenic T-cell lymphoma in patients treated with Cimzia cannot be excluded.
Danish: En risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der bliver behandlet med Cimzia, kan ikke udelukkes.
English: Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for:
Danish: Reumatoid artritis Cimzia i kombination med methotrexat (MTX) er indiceret til:
English: In a clinical trial with another TNF-antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Danish: I et klinisk studie med en anden TNF-antagonist, blev der observeret forværring af kronisk hjerteinsufficiens og forøget mortalitet som følge af kronisk hjerteinsufficiens.
English: Clear to opalescent, colourless to yellow solution.
Danish: Klar til opaliserende, farveløs til gul opløsning.
English: Cimzia may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.
Danish: Cimzia kan forårsage fejlagtigt forhøjede APTT-analyseresultater hos patienter uden koagulationsabnormaliteter.
English: Table 4: C-EARLY trial: percent of patients in sustained remission and sustained low disease activity at Week 52
Danish: C-EARLY-studiet: Procentdel af patienter i vedvarende remission og med vedvarende lav sygdomsaktivitet ved uge 52
English: Thereby this TNFα is blocked by Cimzia and this decreases inflammation diseases such as in rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and psoriasis.
Danish: Derved blokeres denne TNFα af Cimzia, og det sænker inflammationssygdomme som f.eks. i reumatoid artritis, aksial spondylartritis, psoriasis artritis og psoriasis.
English: Primary endpoint: proportion of subjects in sustained remission* at Week 52
Danish: Primært effektmål: andel af personer i vedvarende remission* i uge 52
English: The incidence of serious infections was 0.02 per patient-year in Cimzia treated patients.
Danish: Forekomst af alvorlige infektioner var 0,02 pr. patientår for Cimzia-behandlede patienter.
English: • blood and lymphatic system cancers like lymphoma and leukaemia
Danish: • kræft i blod- og lymfesystemet såsom lymfekræft og leukæmi
English: Children and adolescents Cimzia is not recommended for use in children and adolescents under the age of 18 years.
Danish: Børn og unge Cimzia anbefales ikke til børn og unge under 18 år.
English: If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to treat your rheumatoid arthritis.
Danish: Hvis du ikke reagerer tilfredsstillende på disse lægemidler, vil du få Cimzia i kombination med methotrexat til behandling af din reumatoid artritis.
English: Use of anti-tuberculosis therapy should also be considered before the initiation of Cimzia in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis.
Danish: Anti-tuberkulose-behandling bør også tages i betragtning før opstart af behandling med Cimzia hos patienter med latent eller aktiv tuberkulose i anamnesen, hvor det ikke kunne bekræftes, at behandlingen var tilstrækkelig, samt hos patienter, som har signifikante risikofaktorer for tuberkulose til trods for en negativ test for latent tuberkulose.
English: p value was estimated from an ANCOVA model on the ranks with treatment, region, time since RA diagnosis at Baseline (≤4 months vs >4 months) as factors and Baseline rank as a covariate.
Danish: P-værdi blev estimeret ud fra en rangordnet ANCOVA-model med behandling, region, tiden siden diagnosticering af RA ved baseline (≤ 4 måneder vs.> 4 måneder) som faktorer og baseline-rangorden som kovariat.
English: The dose-dispenser cartridge is also referred to as “medication”.
Danish: Kassetten til dosisdispenser kaldes også for ”medicin”.
English: The two primary endpoints were the percentage of patients achieving ACR 20 response at Week 12 and change from baseline in modified Total Sharp Score (mTSS) at Week 24.
Danish: De to primære endepunkter var den procentdel af patienterne, som opnåede ACR20-respons ved uge 12 og ændring fra baseline i modificeret Total Sharp Score (mTSS) ved uge 24.
English: In the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group.
Danish: I placebokontrollerede studier havde patienter, som fik Cimzia, ca. fire gange længere eksponeringsvarighed end placebogruppen.
English: If you respond to the medicine, your doctor may prescribe an alternative maintenance dosing of 400 mg every 4 weeks.
Danish: Hvis du reagerer på lægemidlet, kan din læge ordinere en alternativ vedligeholdelsesdosis på 400 mg hver 4. uge.
English: The de-conjugated PEG component is rapidly eliminated from plasma and is to an unknown extent excreted renally.
Danish: Den dekonjugerede PEGkomponent elimineres hurtigt fra plasma og udskilles i ukendt omfang af nyrerne.
English: The following instructions explain how to use the pre-filled pen (AutoClicks) to inject Cimzia.
Danish: Nedenstående vejledning forklarer, hvordan den fyldte pen (AutoClicks) anvendes til at injicere Cimzia.
English: It is likely that this finding was caused by cellular uptake of the PEG moiety.
Danish: Det er sandsynligt, at dette fund skyldes cellulært optag af PEG-andelen.
English: Patients were evaluated in a double-blind placebo-controlled manner through Week 48.
Danish: Patienterne blev evalueret på en dobbeltblindet, placebokontrolleret måde til og med uge 48.
English: Do not rub the injection site.
Danish: - Gnid ikke på injektionsstedet.
English: • Use a piece of gauze, apply pressure over the injection site for a few seconds: - Do not rub the injection site.
Danish: • Brug et stykke gaze og pres på injektionsstedet i nogle få sekunder: - Gnid ikke på injektionsstedet.
English: Patients had active disease as defined by the BASDAI ≥4, and spinal pain ≥4 on a 0 to 10 NRS.
Danish: Patienterne havde aktiv sygdom defineret som BASDAI ≥ 4 og spinalsmerter ≥ 4 på en NRS fra 0 til 10.
English: Patients must have been intolerant to or had an inadequate response to at least two NSAIDs.
Danish: Patienterne skulle have været intolerante overfor eller ikke have responderet tilstrækkeligt på mindst to NSAID.
English: In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant.
Danish: Da certolizumab pegol er et protein, som nedbrydes i mave-tarm-kanalen efter oral administration, forventes den absolutte biotilgængelighed derudover at være meget lav hos et ammet spædbarn.
English: At Week 52, the percentage of patients achieving ASDAS inactive disease (ASDAS < 1.3) was 36.4 % for the Cimzia group compared to 11.8 % for the placebo group.
Danish: Ved uge 52 var procentdelen af patienter, der opnåede ASDAS inaktiv sygdom (ASDAS < 1,3), 36,4 % for Cimzia-gruppen sammenlignet med 11,8 % for placebogruppen.
English: (pancytopaenia, anaemia, low platelet count, low white blood cell count)
Danish: (pancytopeni, anæmi, lavt antal af blodplader, lavt antal af hvide blodlegemer)
English: Certolizumab pegol plasma concentrations measured in 14 infants at birth were Below the Limit of Quantification (BLQ) in 13 samples; one was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0.09%.
Danish: Plasmakoncentrationerne af certolizumab pegol, som blev målt hos 14 spædbørn ved fødslen, var under kvantificeringsgrænsen i 13 prøver; én var på 0,042 µg/ml med en spædbarn/moder plasma-ratio på 0,09 % ved fødslen.
English: Overall, 16% of patients had prior TNF-antagonist exposure.
Danish: I alt var 16% af patienterne tidligere blevet eksponeret for TNF-antagonister.
English: Tell your doctor if you have had or have a serious heart condition.
Danish: Fortæl det til lægen, hvis du har eller har haft en alvorlig hjertesygdom.
English: Accordingly, certolizumab pegol is an antibody Fab' fragment conjugated with PEG in order to extend the terminal plasma elimination half-life of the Fab' to a value comparable with a whole antibody product.
Danish: I overensstemmelse hermed er certolizumab pegol et antistof Fab' fragment konjugeret med PEG for at forlænge den terminale plasmaeliminationshalveringstid for Fab' til en værdi, som er sammenlignelig med det fuldstændige antistof.
English: Inhibition of radiographic progression was maintained with Cimzia treatment up to Week 48 in the subset of patients at higher risk of radiographic progression (patients with a Baseline mTSS score of > 6).
Danish: Hæmning af radiografisk progression ved behandling med Cimzia blev opretholdt frem til uge 48 i gruppen af patienter med en øget risiko for radiografisk progression (patienter med mTSS > 6 ved baseline).
English: A pharmacodynamic model based on the Phase III trial data predicts that around 15% of the patients develop antibodies in 6 months at the recommended dose regimen (200 mg every 2 weeks following a loading dose) without MTX co-treatment.
Danish: I henhold til en farmakodynamisk model baseret på fase III-studiedata vil ca. 15% af patienterne udvikle antistoffer i løbet af 6 måneder ved det anbefalede doseringsregime (200 mg hver 2. uge efter en startdosis) uden samtidig behandling med MTX.
English: Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more DMARDs.
Danish: Patienterne havde også aktive hudlæsioner forårsaget af psoriasis eller dokumenteret psoriasis i anamnesen og havde ikke responderet på behandling med 1 eller flere DMARDs.
English: With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Danish: Baseret på den nuværende viden kan en mulig risiko for udvikling af lymfomer, leukæmi eller andre maligniteter hos patienter behandlet med en TNF-antagonist ikke udelukkes.
English: In male rats, reduced sperm motility and a trend of reduced sperm count were observed.
Danish: Hos hanrotter blev der observeret nedsat sædmotilitet og en tendens til nedsat spermtal.
English: Cimzia binds to a specific protein called tumour necrosis factor α (TNFα).
Danish: Cimzia bindes til et specielt protein, som kaldes tumornekrosefaktor-alfa (TNF-α).
English: Treatment with Cimzia may result in the formation of antinuclear antibodies (ANA) and, uncommonly, in the development of a lupus-like syndrome (see section 4.8).
Danish: Behandling med Cimzia kan medføre dannelse af antinukleære antistoffer (ANA) og i sjældne tilfælde i udvikling af et lupus-lignende syndrom (se pkt.
English: Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia.
Danish: Sjældne tilfælde af neurologiske sygdomme, inklusive sygdom med krampeanfald, neuritis og perifer neuropati er blevet rapporteret hos patienter behandlet med Cimzia.
English: Cimzia treated patients also had significant improvements in ACR 50 and 70 response rates.
Danish: Patienter behandlet med Cimzia havde også signifikante forbedringer i ACR50- og ACR70-responsraterne.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Cimzia, treatment must be discontinued.
Danish: Hvis en patient udvikler symptomer, der tyder på et lupus-lignende syndrom efter behandling med Cimzia, skal behandlingen seponeres.
English: If your doctor says you can inject yourself, you need to be fully trained first.
Danish: Hvis lægen fortæller dig, at du kan injicere selv, skal du først gennemgå en grundig træning.
English: The primary endpoint of the study was the ACR 20 responder rate at week 34.
Danish: Det primære endepunkt i studiet var ACR20-responsraten ved uge 34.
English: • reduce the signs and symptoms of your disease,
Danish: • mindske dine sygdomstegn og -symptomer,
English: Co-administration of Cimzia with methotrexate had no significant effect on the pharmacokinetics of methotrexate.
Danish: Samtidig administrering af Cimzia og methotrexat havde ingen signifikant indvirkning på methotrexats farmakokinetik.
English: Because of the nature of the adverse events seen with the combination of another TNF-antagonist with either abatacept or anakinra therapy, similar toxicities may also result from the combination of anakinra or abatacept and other TNF-antagonists.
Danish: Grundet bivirkningernes egenskaber, som er set ved kombinationsbehandling med en anden TNF-antagonist med enten abatacept eller anakinra, kan lignende toksicitet muligvis forekomme ved kombination af anakinra eller abatacept og andre TNF-antagonister.
English: Axial spondyloarthritis Overall Population
Danish: Aksial spondyloartritis Total population
English: An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate.
Danish: En ANCOVA blev tilpasset den rangordnede ændring fra baseline for hver parameter, med region og behandling som faktorer og udgangsværdi rangorden som kovariat.
English: In a clinical study 16 women were treated with certolizumab pegol (200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy.
Danish: I et klinisk studie blev 16 kvinder behandlet med certolizumab pegol (200 mg hver anden uge eller 400 mg hver fjerde uge) under graviditeten.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: • ava then shows: - Your current dose and how often you need to inject it, - This is then followed by the message, “Inspect and then insert medication”.
Danish: - Din aktuelle dosis og hvor ofte du skal tage den. - Dette efterfølges af meddelelsen ”Inspicer medicinen, og indsæt den derefter”.
English: Treatment with Cimzia must not be initiated in patients with a clinically important active infection, including chronic or localised infections, until the infection is controlled (see section 4.3).
Danish: Behandling med Cimzia må ikke initieres hos patienter med en aktiv infektion af klinisk betydning, inklusive kroniske eller lokale infektioner, før infektionen er under kontrol (se pkt.
English: However, if any of the following steps go wrong and/or if you feel unsure about the injection process, contact your doctor or pharmacist.
Danish: Hvis et af de følgende trin imidlertid mislykkes og/eller hvis du føles dig usikker med hensyn til injektionsprocessen, skal du kontakte din læge eller apotekspersonalet.
English: In addition, uncommon cases of non-melanoma skin cancer have been observed in patients taking Cimzia.
Danish: Desuden er der observeret ualmindelige tilfælde af non-melanom hudkræft hos patienter, som tog Cimzia.
English: Efficacy and safety of Cimzia in patients with PsA whose predominant symptoms were sacroiliitis or axial spondyloarthritis have not been separately analysed.
Danish: Cimzias sikkerhed og virkning hos patienter med PsA, hvis dominerende symptomer var sacroiliitis eller aksial spondyloartritis, er ikke blevet analyseret separat.
English: In the C-EARLY trial patients were ≥ 18 years of age and had ≥ 4 swollen and tender joints each and must have been diagnosed with moderate to severe active and progressive RA within 1 year (as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria).
Danish: I C-EARLY-studiet var patienterne ≥ 18 år, havde ≥ 4 hævede og ømme led og skulle være diagnosticeret med moderat til svær aktiv og progressiv RA inden for det seneste år (defineret i henhold til 2010 ACR/European League Against Rheumatism (EULAR) klassifikationskriterier).
English: These response rates were based on a logistic regression model where missing data were imputed using multiple imputation (MCMC method).
Danish: Disse responsrater blev skønnet på basis af en logistisk regressionsmodel, hvor manglende data blev imputeret ved hjælp af multipel imputation (MCMC-metoden).
English: Patients treated with concomitant immunosuppressants (MTX) had a lower rate of antibody development than patients not taking immunosuppressants at baseline.
Danish: Patienter, som samtidig blev behandlet med immunosuppressiva (MTX), havde en lavere antistofudviklingshastighed end patienter, som ikke tog immunosuppressiva ved udgangspunktet.
English: Latex-sensitivity
Danish: Overfølsomhed over for latex
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia.
Danish: Hos nogle patienter, som er behandlet tilfredsstillende for aktiv tuberkulose, er aktiv tuberkulose reaktiveret under behandling med Cimzia.
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Danish: Reumatoid artritis er en sygdom med inflammation i leddene.
English: Carriers of HBV who require treatment with Cimzia should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Patienter, som er bærere af HBV, og som har brug for behandling med Cimzia, skal overvåges nøje for sygdomstegn og symptomer på aktiv HBV-infektion under hele behandlingen og i adskillige måneder efter, behandlingen er afsluttet.
English: • lung inflammation (interstitial lung disease, pneumonitis)
Danish: • lungebetændelse (interstitiel lungesygdom, pneumonitis)
English: **Cimzia+MTX vs placebo+MTX: p<0.001 p value was estimated from a logistic regression model with factors for treatment, region, and time since RA diagnosis at Baseline (≤4 months vs >4 months)
Danish: **Cimzia+MTX vs. placebo+MTX: p< 0,001 p-værdi blev estimeret ud fra en logistisk regressionsmodel med behandling, region og tiden siden diagnosticering af RA ved baseline (≤ 4 måneder vs.> 4 måneder) som faktorer