FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you tell your baby's doctors and other health care professionals about your Cimza use so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller det til dit barns læge og andet sundhedspersonale, at du har brugt Cimzia, så de kan afgøre, hvornår dit barn kan blive vaccineret.
English: Tell your doctor AS SOON AS POSSIBLE if you notice any of the following side effects:
Danish: Kontakt lægen SÅ HURTIGT SOM MULIGT, hvis du får en eller flere af følgende bivirkninger:
English: Cimzia will usually be given to you by a specialist doctor or healthcare professional.
Danish: Cimzia indgives sædvanligvis af en speciallæge eller sundhedspersonale.
English: Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.
Danish: Biologiske tests til tuberkulosescreening bør overvejes før opstart af behandling med Cimzia uden hensyn til BCG-vaccination, hvis der er potentiel latent tuberkuloseinfektion til stede.
English: For these reasons, comparison of the incidence of antibodies to Cimzia with the incidence of antibodies to other TNF-antagonists is not appropriate.
Danish: Det er derfor ikke hensigtsmæssigt at sammenligne incidensen af antistoffer mod Cimzia med incidensen af antistoffer mod andre TNF-antagonister.
English: Cimzia has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes.
Danish: Cimzia har høj affinitet til human TNF-α og binder med en dissociationskonstant (KD) på 90 pM. TNF-α er et vigtigt pro-inflammatorisk cytokin med en central rolle i inflammatoriske processer.
English: However, population pharmacokinetic analysis based on subjects with mild renal impairment showed no effect of creatinine clearance.
Danish: Dog viste farmakokinetiske populationsanalyser baseret på personer med let nedsat nyrefunktion ingen indvirkning på kreatininclearance.
English: The mTSS Score was modified for psoriatic arthritis by addition of hand distal interphalangeal joints.
Danish: mTSS blev modificeret for psoriasisartritis ved at tilføje de distale interfalangeale led.
English: Injection site pain was observed in 1.5% of patients treated with Cimzia with no cases leading to withdrawal.
Danish: Der blev observeret smerter på injektionsstedet hos 1,5% af patienterne, som blev behandlet med Cimzia, men ingen tilfælde medførte seponering.
English: In both studies, the safety profile for these patients was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Danish: I begge studier svarede sikkerhedsprofilen hos disse patienter til sikkerhedsprofilen hos patienter med reumatoid artritis samt tidligere erfaringer med Cimzia.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB05
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, tumornekrosefaktor-alfa (TNF-α)-hæmmere, ATC-kode: L04AB05
English: No adverse effects were seen on maternal well-being or female fertility, embryo-foetal and peri- and post-natal reproductive indices in rats using a rodent antirat TNFα PEGylated Fab' (cTN3 PF) following sustained TNFα suppression.
Danish: Der blev ikke set bivirkninger på mødres velbefindende eller kvindelig fertilitet, embryonale/føtale eller peri- og postnatale reproduktionsindekser hos rotter med et antirotteTNFαPEGyleret Fab' (cTN3 PF) efter vedvarende TNFαsuppression.
English: Table 2 Clinical trial description Study number
Danish: Tabel 2 Beskrivelse af klinisk studie Studienum -mer
English: If your doctor has allowed you to self-inject, you should follow up with your doctor before you continue to self-inject:
Danish: Hvis lægen har givet dig tilladelse til selvinjektion, bør du følge op med lægen, før du går videre til at selvinjicere:
English: In the CIMPACT study, the primary efficacy endpoint was the proportion of patients achieving PASI 75 at Week 12.
Danish: I CIMPACT-studiet var det primære effektmål den andel af patienter, der opnåede PASI 75 i uge 12.
English: • changes in blood levels of different salts
Danish: • ændringer i indholdet af forskellige salte i blodet
English: The key results from the study are presented in table 4.
Danish: De vigtigste resultater fra studiet er vist i tabel 4.
English: • solid organ cancers
Danish: • kræft i faste organer
English: One case of lymphoma was also observed in the Phase III psoriatic arthritis clinical trial.
Danish: Der blev også observeret et tilfælde af lymfom i det kliniske fase III-studie med psoriasisartritis.
English: • Let go of the needle cap so that ava can push out the used medication.
Danish: • Slip nålehætten, så ava kan skubbe den brugte medicin ud.
English: Since tumour necrosis factor (TNF) mediates inflammation and modulates cellular immune responses, the possibility exists for TNF-antagonists, including Cimzia, to cause immunosupression, affecting host defences against infections and malignancies.
Danish: Eftersom tumornekrosefaktor (TNF) medierer betændelse og modulerer cellulært immunrespons, er der mulighed for, at TNF-antagonister, inklusive Cimzia, kan medføre immunsuppression, som kan påvirke værtens modstandsdygtighed over for infektioner og maligniteter.
English: Do not try to repeat the injection process without speaking to your doctor or your pharmacist.
Danish: Forsøg ikke at gentage injektionsproceduren uden at tale med din læge eller apotekspersonalet først.
English: • anxiety and mood disorders such as depression, appetite disorders, weight change
Danish: • angst og humørforstyrrelser såsom depression, appetitforstyrrelser, vægtændring
English: Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28 modulator) and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone.
Danish: Der er rapportet tilfælde af alvorlige infektioner og neutropeni i kliniske studier ved samtidig anvendelse af anakinra (en interleukin-1-antagonist) eller abatacept (en CD28 modulator) og en anden TNF-antagonist, etanercept, uden nogen øget fordel sammenlignet med TNF-antagonist-behandling alene.
English: For patients remaining in the study, improvements in all afore-mentioned outcomes were largely maintained through Week 204.
Danish: Hos de patienter, som forblev i studiet, blev stort set alle de ovennævnte resultater opretholdt til og med uge 204.
English: PGA clear or almost clearb)
Danish: PGA klar eller næsten klarb)
English: Certolizumab pegol plasma concentrations were broadly dose-proportional.
Danish: Plasmakoncentrationer af certolizumab pegol var stort set propotionale med dosis.
English: After patients receive Cimzia, careful attention should be given to interpretation of abnormal coagulation results.
Danish: Når patienterne har fået Cimzia, skal abnorme koagulationsresultater fortolkes meget omhyggeligt.
English: - Use a clean dry cloth to wipe off any condensation on the outside of the cartridge.
Danish: - Brug en ren klud til at aftørre eventuel kondensering på ydersiden af kassetten.
English: • fistula (tract from one organ to another) (any site)
Danish: • fistel (en forbindelse mellem to organer) (kan opstå hvor som helst)
English: Key efficacy outcomes
Danish: Vigtige effektresultater
English: Interference with thrombin time (TT) and prothrombin time (PT) assays have not been observed.
Danish: Der er ikke observeret interferens med analyser af trombintid (TT) eller protrombintid (PT).
English: Similarly, on the basis of Phase III clinical trial data in patients with psoriasis, a population exposure-response relationship was established between plasma concentration of certolizumab pegol and PASI with an EC90 of 11.1 µg/ml.
Danish: På samme måde blev der, på basis af data fra kliniske Fase III studier hos patienter med psoriasis, etableret et populationseksponering-responsforhold mellem plasmakoncentration af certolizumab pegol og PASI med en EC90 på 11,1 µg/ml.
English: There is no evidence that Cimzia therapy has an effect on coagulation in vivo.
Danish: Der er ingen evidens for, at behandling med Cimzia kan påvirke koagulation in vivo.
English: Therefore, reproductive toxicology studies have been performed with a homologous reagent recognising rat TNF.
Danish: Der er derfor udført reproduktionstoksikologiske studier med et homologt reagens, som genkender rotteTNF.
English: Adverse reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class.
Danish: Bivirkninger primært på basis af erfaringer fra placebokontrollerede kliniske studier og tilfælde efter markedsføring, og som i det mindste muligvis er relateret til Cimzia, er opført efter frekvens og systemorganklasser i tabel 1 nedenfor.
English: mTSS: modified Total Sharp Score *Sustained remission at Week 52 is defined as DAS28[ESR] <2.6 at both Week 40 and Week 52.
Danish: mTSS: modified Total Sharp Score *Vedvarende remission ved uge 52 er defineret som DAS28[ESR] <2,6 både ved uge 40 og ved uge 52.
English: Primary endpoint: ACR 20 at Week 24.
Danish: Primære effektmål: ACR 20 i uge 24.
English: This evaluation should include a detailed medical history for patients with a personal history of tuberculosis, with possible previous exposure to others with active tuberculosis, and with previous and/or current use of immunosuppressive therapy.
Danish: Denne undersøgelse bør omfatte en detaljeret anamnese for personer, som tidligere har haft tuberkulose eller mulig, tidligere kontakt med andre personer med aktiv tuberkulose og/eller nuværende immunsuppressiv behandling.
English: Response rates and p-values for PASI and PGA were estimated based on a logistic regression model where missing data were imputed using multiple imputation based on the MCMC method.
Danish: Responsrater og p-værdier for PASI og PGA blev skønnet på basis af en logistisk regressionsmodel, hvor manglende data blev imputeret ved hjælp af multipel imputation på basis af MCMC-metoden.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 16 weeks of treatment.
Danish: Fortsat behandling bør overvejes nøje hos patienter, som ikke viser tegn på terapeutisk effekt inden for de første 16 behandlingsuger.
English: In studies CIMPASI-1 and CIMPASI-2 the co-primary efficacy endpoints were the proportion of patients achieving PASI 75 and PGA “clear” or “almost clear” (with at least a 2-point reduction from baseline) at Week 16.
Danish: I studierne CIMPASI-1 og CIMPASI-2 var de co-primære effektmål den andel af patienter, der opnåede PASI 75 og PGA ”klar” eller ”næsten klar” (med en reduktion på mindst 2 point fra baseline) i uge 16.
English: Below is a diagram of the AutoClicks pre-filled pen.
Danish: Nedenfor ses en figur, som viser den fyldte AutoClicks pen.
English: Distribution studies have demonstrated that placental and milk transfer of cTN3 PF to the foetal and neonatal circulation is negligible.
Danish: Fordelingsstudier har påvist, at udskillelsen af cTN3 PF via placenta og mælk til henholdsvis fostrets og den nyfødtes kredsløb er ubetydelig.
English: For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate (see section 5.2), but the need for treatment of the woman should also be taken into account (see below).
Danish: 5.2), kan kontraception fortsat overvejes i 5 måneder efter den sidste dosis af Cimzia hos kvinder, der planlægger graviditet, men behovet for behandling af kvinden skal også tages med i overvejelserne (se nedenstående).
English: Rare skin exfoliation and desquamation, bullous conditions, hair texture disorder, Stevens-Johnson syndrome**, erythema multiforme**, lichenoid reactions
Danish: Sjælden hudeksfoliation og afskalning, bulløse tilstande, forandringer i hårstrukturen, Stevens-Johnsons syndrom**, erythema multiforme**, lichenoide reaktioner
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy with Cimzia tell your doctor immediately.
Danish: Hvis der opstår symptomer på tuberkulose (vedvarende hoste, vægttab, ligegyldighed, mild feber) eller en hvilken som helst anden infektion under eller efter behandlingen med Cimzia, skal du straks fortælle det til lægen.
English: The primary efficacy endpoint was the ASAS20 response rate at Week 12.
Danish: Det primære effektendepunkt var ASAS20-responsrate ved uge 12.
English: The infections consisted primarily of upper respiratory tract infections and viral infections (including herpes infections).
Danish: Infektionerne bestod primært af infektioner i de øvre luftveje og virusinfektioner (herunder herpes-infektioner).
English: At Week 4 and Week 8, all infant concentrations were BLQ.
Danish: Ved uge 4 og 8 var den målte koncentration under kvantificeringsgrænsen hos alle spædbørnene.
English: In both clinical trials, Cimzia-treated patients reported significantly greater improvements in the SF-36 Physical and Mental Component Summaries and all domain scores.
Danish: I begge kliniske studier, rapporterede patienter behandlet med Cimzia signifikant større forbedring i SF-36 Physical and Mental Component Summaries og scores for alle områder.
English: Cartridge/Injection port
Danish: Medicin-/injektionsport
English: Cimzia selectively neutralises TNFα (IC90 of 4 ng/ml for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralise lymphotoxin α (TNFβ).
Danish: Cimzia neutraliserer selektivt TNF-α (IC90 på 4 ng/ml til inhibering af human TNF-α i in vitro L929 murine fibrosarcom-cytotoksisitetsanalyse) men neutraliserer ikke lymfotoksin-α (TNF-).
English: Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Danish: Der bør derfor udvises forsigtighed, når TNF-antagonister anvendes hos KOL-patienter samt hos patienter med en forøget risiko for maligniteter på grund af massiv rygning.
English: * p<0.001 All percents reflect the proportion of patients who responded in the full analysis set.
Danish: Alle procenter afspejler andelen af patienter, som responderede i hele analysesættet.
English: You should not receive certain (live) vaccines while using Cimzia.
Danish: Du må ikke få visse (levende) vacciner under behandling med Cimzia.
English: At baseline, 37 % and 41% of patients had high disease activity (ASDAS ≥2.1, ≤3.5) and 62% and 58% of patient had very high disease activity (ASDAS >3.5) in the CIMZIA group and placebo group respectively.
Danish: Ved baseline havde henholdsvis 37 % og 41 % af patienterne høj sygdomsaktivitet (ASDAS ≥ 2,1, ≤ 3,5) og henholdsvis 62 % og 58 % af patienterne havde meget høj sygdomsaktivitet (ASDAS > 3,5) i CIMZIA-gruppen og placebogruppen.
English: There is limited safety experience with surgical procedures in patients treated with Cimzia.
Danish: Der er begrænset erfaring med sikkerhed ved kirurgiske indgreb hos patienter i behandling med Cimzia.
English: • benign (non-cancerous) tumours and cysts (including those of the skin)
Danish: • benigne (ikke ondartede) tumorer og cyster (herunder dem i huden)
English: • menstrual cycle (monthly period) disorders including lack of bleeding, or heavy or irregular bleeding
Danish: • forstyrrelse i menstruationscyklus, herunder udebleven blødning eller kraftig eller uregelmæssig blødning
English: On the basis of Phase II and Phase III clinical trial data in patients with rheumatoid arthritis, a population exposure-response relationship was established between average plasma concentration of certolizumab pegol during a dosing interval (Cavg) and efficacy (ACR 20 responder definition).
Danish: På basis af de kliniske Fase II og Fase III data hos patienter med reumatoid artritis blev der etableret et populationseksponerings-responsforhold mellem gennemsnitlig plasmakoncentration af certolizumab pegol i løbet af et doseringsinterval Cavg) og effekt (ACR 20 respondentdefinition).
English: If you have active psoriatic arthritis you will first be given other medicines, usually methotrexate.
Danish: Hvis du har aktiv psoriasisartritis vil du først få andre lægemidler, sædvanligvis methotrexat.
English: Some of these reactions could occur after the first administration of Cimzia.
Danish: Nogle af disse reaktioner kan opstå efter første indgift af Cimzia.
English: In patients who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Cimzia bør seponeres hos patienter, hvor HBV reaktiveres, og effektiv antiviral behandling med passende understøttende behandling bør igangsættes.
English: Patients receiving Cimzia and concomitant methotrexate had a lower humoral response compared with patients receiving Cimzia alone.
Danish: Patienter, der fik Cimzia og samtidig methotrexat, havde et lavere humoralt respons, sammenlignet med patienter, der kun fik Cimzia.
English: • changes in cholesterol and fat levels in the blood
Danish: • ændringer i kolesterol- og fedtindholdet i blodet
English: Tell your doctor IMMEDIATELY if you notice any of the following side effects:
Danish: Kontakt STRAKS lægen, hvis du får en eller flere af følgende bivirkninger:
English: Physicians should exercise caution when considering the use of Cimzia in patients with a history of recurring or opportunistic infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Lægen bør udvise forsigtighed, når brug af Cimzia overvejes til patienter med recidiverende eller opportunistiske infektioner eller med underliggende tilstande i anamnesen, som kan prædisponere patienten for infektioner, inklusive samtidig brug af immunsuppressive lægemidler.
English: In women, ASAS20 responses were not statistically significantly different from placebo until after the Week 12 time point.
Danish: ASAS20-respons var statistisk signifikant forskelligt fra placebo efter uge 12 hos kvinder.
English: If you are a woman of childbearing potential, discuss with your doctor regarding use of adequate contraception while using Cimzia.
Danish: Hvis du er en kvinde i den fødedygtige alder, tal da med din læge om brug af passende prævention under behandlingen med Cimzia.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks.
Danish: • Dette efterfølges af en vedligeholdelsesdosis på 200 mg hver 2. uge.
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines usually methotrexate.
Danish: Hvis du har moderat til alvorlig aktiv reumatoid artritis, er det muligt, at du først får andre lægemidler, sædvanligvis methotrexat.
English: • When “Remove and discard used medication” is shown, pull out the medication using the needle cap.
Danish: • Når meddelelsen ”Fjern den brugte medicin, og kasser den.” vises, trækkes medicinen ud ved hjælp af nålehætten.
English: • bump or open sore that doesn't heal
Danish: • bule eller åbent sår, som ikke vil hele
English: Clearance following subcutaneous dosing was estimated to be 21.0 ml/h in a rheumatoid arthritis population pharmacokinetic analysis, with an inter-subject variability of 30.8% (CV) and an interoccasion variability of 22.0%.
Danish: Clearance efter subkutan dosering blev anslået til at være 21,0 ml/time i en farmakokinetisk populationsanalyse med reumatoid artritis, med en interindividuel variation på 30,8% (CV) og en intraindividuel variation på 22,0%.
English: • Use a piece of gauze, apply pressure over the injection site for a few seconds:
Danish: • Brug et stykke gaze og pres på injektionsstedet i nogle få sekunder:
English: Cimzia-treated patients also had improvements compared to placebo in multiple components of axial spondyloarthritis disease activity, including CRP.
Danish: Cimzia-behandlede patienter havde også forbedringer sammenlignet med placebo for flere komponenter af aksial spondyloartritis sygdomsaktivitet, herunder CRP.
English: swelling or rash, stop using Cimzia and contact your doctor IMMEDIATELY.
Danish: svimmelhed, hævelser eller udslæt, skal du stoppe med at bruge Cimzia og STRAKS kontakte lægen.
English: Patients who develop a new infection while undergoing treatment with Cimzia should be monitored closely.
Danish: Patienter, der udvikler en ny infektion under behandlingen med Cimzia, bør følges tæt.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.
Danish: Fortsat behandling bør overvejes nøje hos patienter, som ikke viser tegn på terapeutisk effekt inden for de første 12 behandlingsuger.
English: At week 12 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Cimzia-treated patients (nominal p-value p<0.01).
Danish: Ved uge 12 og 24 sås der forbedringer i parametrene for perifer aktivitet, som er karakteristisk for psoriasisartritis (f. eks. antal hævede led, antal smertefulde/ømme led, dactylitis og enthesitis), hos patienter behandlet med Cimzia (nominel p-værdi p< 0,01).
English: These results were maintained over 52 weeks of treatment in DMARD-naïve subjects.
Danish: Disse resultater blev opretholdt over 52 behandlingsuger hos patienter, der ikke havde fået DMARDs tidligere.
English: In both placebo-controlled and open-label follow-up clinical trials for rheumatoid arthritis, cases of lupus-like syndrome were reported uncommonly.
Danish: I både placebokontrollerede og åbne kliniske opfølgningsstudier af reumatoid artritis blev lupuslignende syndrom kun sjældent observeret.
English: • heart problems including weakened heart muscle, heart failure, heart attack, chest discomfort or chest pressure, abnormal heart rhythm including irregular heart beats
Danish: • hjerteproblemer, herunder svækket hjertemuskel, hjertesvigt, hjertetilfælde, ubehag i brystet eller trykken i brystet, unormal hjerterytme, herunder uregelmæssige hjerteslag
English: Certolizumab pegol is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Danish: Certolizumab pegol er et rekombinant, humaniseret antistof Fab'-fragment mod tumornekrosefaktor-alfa (TNF), som er fremstillet ved ekspression i Escherichia coli og konjugeret til polyethylenglycol (PEG).
English: Similar to the placebo-controlled studies, antibody positivity was associated with reduced efficacy in some patients.
Danish: Ligesom i de placebokontrollerede studier blev antistof-positivitet hos nogle patienter forbundet med nedsat effekt.
English: You might get an infection more easily while you are being treated with Cimzia, including serious, or in rare cases, life-threatening infections.
Danish: Det er muligt, at du nemmere får en infektion, herunder alvorlige eller i sjældne tilfælde livstruende infektioner, mens du er i behandling med Cimzia.
English: In study-to-study comparison, the pharmacokinetics of certolizumab pegol appeared similar to those observed previously in healthy subjects.
Danish: Ved sammenligning af undersøgelser viste certolizumab pegols farmakokinetik sig at være lig dem, som tidligere var observeret hos raske individer.
English: However, no effect of age was observed in a population pharmacokinetic analysis in patients with rheumatoid arthritis in which 78 subjects (13.2% of the population) were aged 65 or greater and the oldest subject was aged 83 years.
Danish: Der blev dog ikke observeret nogen betydning af alder i en farmakokinetisk populationsanalyse hos ældre patienter med reumatoid artritis, hvor 78 personer (13,2% af populationen) var over 65 år eller ældre og den ældste person var 83 år.