FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare cerebrovascular accident, arteriosclerosis, Raynaud's phenomenon, livedo reticularis, telangiectasia
Danish: Sjælden cerebrovaskulær hændelse, arteriosklerose, Raynauds syndrom, livedo retikularis, telangiectasia
English: • Each new injection should be given on a site separate from the last injection site.
Danish: • Hver ny injektion skal gives på et andet sted end det senest anvendte injektionssted.
English: In a clinical study in 17 lactating women treated with Cimzia, minimal transfer of certolizumab pegol from plasma to breast milk was observed.
Danish: I et klinisk studie med 17 ammende kvinder, som blev behandlet med Cimzia, blev der observeret minimal overførsel af certolizumab pegol fra plasma til modermælk.
English: Cimzia should only be used during pregnancy if clearly needed.
Danish: Cimzia bør kun anvendes under graviditet, hvis det tydeligvis er nødvendigt.
English: Activated partial thromboplastin time (aPTT) assay Interference with certain coagulation assays has been detected in patients treated with Cimzia.
Danish: Analyse af aktiveret partiel tromboplastintid (APTT) Der er påvist interferens med visse koagulationsanalyser hos patienter i behandling med Cimzia.
English: Cimzia patients demonstrated significantly less radiographic progression than patients receiving placebo at Week 24 and Week 52 (see Table 5).
Danish: Cimzia-patienter viste signifikant mindre radiografisk progression end patienter, som fik placebo i uge 24 og uge 25 (se Tabel 5).
English: The CPK elevations in the axSpA study were mostly mild to moderate, transient in nature and of unknown clinical significance with no cases leading to withdrawal.
Danish: CPK-stigningerne i axSpA-studiet var for det meste mindre til moderate og forbigående, og den klinisk betydning er ukendt.
English: Table 9: ASDAS-MI and ASAS 40 responses in AS0006 (percent of patients)
Danish: Tabel 9: ASDAS-MI-respons og ASAS 40 respons i AS0006 (procentdel af patienter) Parametre
English: Manufacturer UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belgium
Danish: Fremstiller UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belgien
English: *These events have been related to this class of medicines but the incidence with Cimzia is not known.
Danish: *Disse bivirkninger er blevet forbundet med den type lægemidler, som Cimzia tilhører, men hyppigheden med Cimzia er ikke kendt.
English: • gastrointestinal obstructions (blockages of the digestive system).
Danish: • gastrointestinal obstruktion (blokering i mave-tarm-kanalen).
English: Paediatric malignancy
Danish: Pædiatrisk malignitet
English: C-EARLY (to 52 wee ks)
Danish: C-EARLY (til 52 uger)
English: If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose før eller under behandlingen, må behandling med Cimzia ikke påbegyndes, og igangværende behandling skal seponeres (se pkt.
English: It is important to tell your doctor if you have had or have a serious heart condition.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du har eller har haft en alvorlig hjertesygdom.
English: Pharmacokinetics observed in patients with rheumatoid arthritis and psoriasis were consistent with those seen in healthy subjects.
Danish: Farmakokinetik observeret hos patienter med reumatoid artritis og psoriasis var tilsvarende den, som blev set hos raske personer.
English: • stroke, blockage in blood vessels (arteriosclerosis), poor blood circulation which makes the toes and fingers numb and pale (Raynaud's phenomenon), mottled purplish skin discoloration, small veins near the surface of the skin may become visible
Danish: • slagtilfælde, blokering i blodårerne (arteriosklerose), dårligt blodomløb, hvilket gør tæer og fingre følelsesløse og blege (Raynauds fænomen), lillafarvet spættet misfarvning af huden, små blodårer nær hudens overflade kan blive synlige
English: A patient who requires surgery while on Cimzia should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som behøver kirurgi under behandling med Cimzia, bør observeres nøje for infektioner, og der bør tages passende forholdsregler.
English: Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Cimzia kan gives som monoterapi i tilfælde af intolerans over for methotrexat, eller når fortsat behandling med methotrexat er uhensigtsmæssig.
English: - Press the
Danish: - Tryk på
English: Marketing Authorisation Holder UCB Pharma S.A.
Danish: Indehaver af markedsføringstilladelsen UCB Pharma S.A.
English: Patients had a mean time since diagnosis at baseline of 2.9 months and were DMARD naïve (including MTX).
Danish: Ved baseline var det gennemsnitligt 2,9 måneder siden, patienterne var blevet diagnosticeret, og de havde ikke fået DMARD (inklusive MTX) tidligere.
English: Discontinuation of Cimzia therapy should be considered in patients with confirmed significant haematological abnormalities.
Danish: Det bør overvejes, om behandlingen med Cimzia bør seponeres hos patienter med bekræftede signifikante hæmatologiske abnormaliteter.
English: No mutagenic or clastogenic effects were demonstrated in preclinical studies.
Danish: Der blev ikke set mutagene eller klastogene vikninger i prækliniske studier.
English: Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Danish: Cimzia er indiceret til behandling af moderat til svær plaque psoriasis hos voksne, som er kandidater til systemisk behandling.
English: In rats and monkeys, at doses higher than those given to humans, histopathology revealed cellular vacuolation, present mainly in macrophages, in a number of organs (lymph nodes, injection sites, spleen, adrenal, uterine, cervix, choroid plexus of the brain, and in the epithelial cells of the choroid plexus).
Danish: I rotter og aber ved højere doser end der gives til mennesker, viste histopatologi cellulær vakuolation, som primært var til stede i makrofagerne, i nogle organer (lymfeknuder, injektionssted, milt, binyre, livmoder, cervix, plexus choroideus i hjernen og i epitelceller i plexus choroideus).
English: Then, talk to your doctor and inject the following doses as instructed.
Danish: Tal derefter med lægen og injicer følgende doser som anvist.
English: Inhibition of inflammation in Magnetic Resonance Imaging (MRI) In an imaging sub-study including 153 patients, signs of inflammation were assessed by MRI at week 12 and expressed as change from baseline in SPARCC (Spondyloarthritis Research Consortium of Canada) score for sacroiliac joints and ASspiMRI-a score in the Berlin modifications for the spine.
Danish: Hæmning af inflammation bedømt ved magnetisk resonans scanning (MRI) I et delstudie med scanning hos 153 patienter blev tegn på inflammation vurderet ved MRI ved uge 12 og udtrykt som ændring i forhold til baseline i SPARCC- (Spondyloarthritis Research Consortium of Canada) score for sacroiliacaleddene og i Berlin modifications of the ASspiMRI-a-score for rygsøjlen.
English: • Once ava is placed firmly against your skin “When ready press > once” is shown.
Danish: • Når ava er placere tæt ned mod huden, vises meddelelsen ”Når du er klar, tryk på > én gang.” • Tryk på (start/pause-knappen).
English: There is no evidence of an increased risk of infections with continued exposure over time (see section 4.4).
Danish: Der er ikke evidens for en forøget infektionsrisiko ved vedvarende eksponering over tid (se pkt.
English: Serious infections also included invasive opportunistic infections (e.g. pneumocystosis, fungal oesophagitis, nocardiosis and herpes zoster disseminated).
Danish: Alvorlige infektioner inkluderede også invasive opportunistiske infektioner (f.eks. pneumocytose, candida esophagitis, nocardia og dissemineret herpes zoster).
English: Effects on sperm motility measures and a trend of reduced sperm count in male rodents have been observed with no apparent effect on fertility (see section 5.3).
Danish: Der er observeret påvirkning af sædens motilitet samt en tendens til nedsat antal sædceller hos hangnavere uden åbenlys påvirkning af fertiliteten (se pkt.
English: MTX should be continued during treatment with Cimzia where appropriate.
Danish: Behandling med MTX bør fortsættes under behandlingen med Cimzia, hvis det er hensigtsmæssigt.
English: If you do not respond well enough to these medicines, you will be given Cimzia to:
Danish: Hvis du ikke reagerer tilfredsstillende på disse lægemidler, vil du få Cimzia for at:
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Danish: Efter markedsføring er der rapporteret maligniteter, hvoraf nogle har været letale, hos børn, unge og unge voksne (op til 22 år; ≤ 18 år ved terapistart) behandlet med TNF-antagonister.
English: In a placebo-controlled clinical trial in patients with rheumatoid arthritis, similar antibody response between Cimzia and placebo treatment were observed when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with Cimzia.
Danish: I et placebokontrolleret klinisk studie hos patienter med reumatoid artritis blev der observeret samme antistofreaktion ved Cimzia- og placebo-behandling, når polysaccharid-pneumokokvaccine og influenzavaccine blev administreret samtidig med Cimzia.
English: During controlled clinical trials through Week 16, the proportion of patients with serious adverse events was 3.5% for Cimzia and 3.7% for placebo.
Danish: I kontrollerede kliniske studier til og med uge 16 var andelen af patienter med alvorlige bivirkninger 3,5 % for Cimzia og 3,7 % for placebo.
English: Allergic reactions - If you experience ALLERGIC REACTIONS such as chest tightness, wheezing, dizziness,
Danish: Allergiske reaktioner - Hvis du oplever ALLERGISKE REAKTIONER, såsom trykken i brystet, hiven efter vejret,
English: In the placebo-controlled clinical trials, there were more new cases of serious infection in the Cimzia treatment groups (0.07 per patient-year; all doses), compared with placebo (0.02 per patient-year).
Danish: I de placebokontrollerede kliniske studier var der flere nye tilfælde af alvorlige infektioner i behandlingsgruppen som fik Cimzia (0,07 pr. patientår; alle doser) end med placebo (0,02 pr. patientår).
English: Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate
Danish: Cimzia kan gives som monoterapi i tilfælde af intolerans over for MTX, eller når fortsat behandling med MTX er uhensigtsmæssig.
English: Cimzia was also studied in 317 patients with nonradiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006).
Danish: Cimzia blev også undersøgt hos 317 patienter med non-radiografisk aksial spondyloartritis i et placebokontrolleret studie i 52 uger (AS0006).
English: • blood clots in the veins or lungs
Danish: • blodpropper i blodårerne eller lungerne
English: • Do not shake the pre-filled pen.
Danish: • Ryst ikke den fyldte pen.
English: Cimzia is used to treat rheumatoid arthritis.
Danish: Cimzia anvendes til behandling af reumatoid artritis.
English: Your doctor may decide to stop treatment with Cimzia.
Danish: Lægen kan beslutte, om behandlingen med Cimzia skal stoppe.
English: These diseases are inflammatory diseases of the spine.
Danish: Dette er sygdomme med inflammation i rygsøjlen.
English: Table 8 Key efficacy outcomes in AS001 clinical trial (percent of patients)
Danish: Tabel 8 Vigtige effektresultater i det kliniske studie AS001 (procentdel af patienter)
English: If you forget to use Cimzia If you forget or miss an appointment to receive Cimzia, make another appointment as soon as possible.
Danish: Hvis du glemmer eller springer en aftale over, hvor Cimzia gives, skal du lave en ny aftale så hurtigt som muligt.
English: • shortness of breath with exertion or upon lying down or swelling of the feet (heart failure)
Danish: • åndenød ved fysisk anstrengelse eller når du ligger ned, eller opsvulmede fødder (hjertesvigt)
English: Uncommo anxiety and mood disorders (including associated symptoms)
Danish: Ikke almindelig angst og humørsvingninger (inklusive associerede symptomer)
English: Excipients: sodium acetate, sodium chloride and water for injections.
Danish: Hjælpestoffer: natriumacetat, natriumchlorid og vand til injektionsvæsker.
English: If this occurs, you should stop using Cimzia.
Danish: Hvis dette gælder for dig, skal du stoppe med at anvende Cimzia.
English: N/A: Not Applicable *Wald p-values for Cimzia 200 mg vs. placebo and Cimzia 400 mg vs. placebo comparisons are estimated from a logistic regression model with factors for treatment
Danish: N/A: Ikke relevant *Wald p-værdier for sammenligning af Cimzia 200 mg vs. placebo og Cimzia 400 mg vs. placebo er estimeret ud fra en logistisk regressionsmodel med behandling som faktor.
English: The other ingredients are: sodium acetate, sodium chloride and water for injection (see “Cimzia contains sodium acetate and sodium chloride” in section 2).
Danish: - Øvrige indholdsstoffer: natriumacetat, natriumchlorid og vand til injektionsvæske (se ”Cimzia indeholder natriumacetat og natriumchlorid” i punkt 2).
English: • rheumatoid arthritis,
Danish: • reumatoid artritis,
English: • The medication is to be used with the electromechanical injection device called “ava” which is provided separately.
Danish: • Medicinen skal anvendes sammen med den elektromekaniske injektionsanordning kaldet ”ava”,
English: After suitable training, your doctor may allow you to inject Cimzia yourself.
Danish: Efter passende oplæring kan lægen lade dig injicere Cimzia selv.
English: In the placebo-controlled rheumatoid arthritis clinical trials, 5.8% of patients treated with Cimzia developed injection site reactions such as erythema, itching, haematoma, pain, swelling or bruising, compared to 4.8% of patients receiving placebo.
Danish: I de placebokontrollerede kliniske studier med reumatoid artritis udviklede 5.8% af patienterne, som blev behandlet med Cimzia, reaktioner på injektionsstedet, såsom erytem, kløe, hæmatomer, smerter, hævelse eller blåfarvning, sammenlignet med 4.8% af patienterne, som fik placebo.
English: - Wipe the injection site with an alcohol wipe, using a circular motion moving from the inside out.
Danish: - Tør injektionsstedet med den medfølgende alkoholserviet med en cirkulær bevægelse indefra og ud.
English: • two AutoClicks pre-filled pens of solution, and
Danish: • To AutoClicks fyldte penne med opløsning og
English: Patients in the Cimzia+MTX group had a greater reduction from baseline in DAS 28 (ESR) compared with the placebo+MTX group observed as early as Week 2 and continued through Week 52 (p<0.001 at each visit).
Danish: Patienterne i Cimzia+MTX-gruppen havde større reduktion fra baseline i DAS28(ESR) sammenlignet med placebo+MTX-gruppen, hvilket blev observeret så tidligt som fra uge 2 og fortsatte til og med uge 52 (p< 0,001 ved hvert besøg).
English: In addition, experiments of FcRn-mediated transcytosis in cells transfected with human FcRn showed negligible transfer (see section 4.6).
Danish: Ydermere viste forsøg med FcRn-medieret transcytose i celler transficeret med human FcRn ubetydelig overførsel (se pkt.
English: Cimzia should only be used during pregnancy if clinically needed.
Danish: Cimzia bør kun anvendes under graviditet, hvis det er klinisk nødvendigt.
English: The apparent volume of distribution (V/F) was estimated at 8.01 l in a population pharmacokinetic analysis of patients with rheumatoid arthritis and at 4.71 l in a population pharmacokinetic analysis of patients with plaque psoriasis.
Danish: Det tilsyneladende distributionsvolumen (V/F) blev estimeret til 8,01 liter i en farmakokinetisk populationsanalyse hos patienter med reumatoid artritis og ved 4,71 l i en analyse af farmakokinetiske patienter med plaque psoriasis.
English: For subjects who were anti-dsDNA antibody negative at baseline, 2.2% of those treated with Cimzia developed positive anti-dsDNA antibody titers, compared with 1.0% of subjects in the placebo group.
Danish: For personer, som var negative i forhold til anti-dsDNA antistof ved baseline, udviklede 2,2% af dem, som blev behandlet med Cimzia positive anti-dsDNA antistof-titer sammenlignet med 1,0% af personerne i placebogruppen.
English: If your doctor has allowed you to self-inject and you accidentally inject Cimzia more frequently than prescribed, you should tell your doctor.
Danish: Hvis lægen har ladet dig injicere dig selv, og du ved en fejltagelse har injiceret Cimzia hyppigere end ordineret, skal du fortælle det til lægen.
English: Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, spinal pain ≥ 4 on a 0 to 10 Numerical Rating Scale (NRS) and increased CRP or current evidence of sacroiliitis on Magnetic Resonance Imaging (MRI).
Danish: Patienterne havde aktiv sygdom defineret som Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, spinalsmerter ≥ 4 på en numerisk rangskala (NRS) fra 0 til 10 og forhøjet CRP eller sacroiliitis påvist ved magnetisk resonans scanning (MRI).
English: In C-EARLY, Cimzia+ MTX inhibited the radiographic progression compared to placebo+MTX at Week 52 (see Table 6).
Danish: I C-EARLY hæmmede Cimzia+MTX radiografisk progression sammenlignet med placebo+MTX ved uge 52 (se tabel 6).
English: Instructions for self-injecting Cimzia
Danish: Vejledning til selvinjektion af Cimzia
English: Handle with care!” and “Please replace needle cap” are shown until the needle cap is put back on.
Danish: Forsigtig!” og ”Sæt nålehætten på igen.” vises, indtil hætten sættes på igen.
English: Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Danish: Ankyloserende spondylitis (AS) (også kaldet radiografisk aksial spondyloartritis) Voksne med svær, aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på eller er intolerante overfor antiinflammatoriske lægemidler (NSAID).
English: Cimzia is used to treat moderate to severe plaque psoriasis.
Danish: Cimzia bruges til at behandle moderat til svær plaque psoriasis.
English: In the Phase III placebo- and active-controlled studies, the percentages of patients who were positive for antibodies to Cimzia on at least one occasion during treatment up to Week 48 were 8.3 % (22/265) and 19.2% (54/281) for the Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks respectively.
Danish: I fase III placebo- og aktivt-kontrollerede studier var procentdelene af patienter, som var positive for antistoffer over for Cimzia ved mindst én lejlighed under behandlingen op til uge 48, på henholdsvis 8,3 % (22/265) og 19,2 % (54/281) for Cimzia 400 mg hver 2. uge og Cimzia 200 mg hver 2. uge.
English: In the placebo-controlled trial in patients with non-radiographic axial spondyloarthritis, using a more sensitive and drug tolerant assay than in previous trials, the overall incidence of patients who were antibody positive to certolizumab pegol was 97% (248/255 patients) after up to 52 weeks of treatment.
Danish: I det placebokontrollerede studie hos patienter med non-radiografisk aksial spondyloartritis, som anvendte en mere følsom og lægemiddeltolerant analyse end i tidligere studier, var den samlede incidens af patienter, som var antistofpositive over for certolizumab pegol, 97 % (248/255 patienter) efter op til 52 ugers behandling.
English: At the end of this period the pre-filled pens must be used or discarded.
Danish: Ved afslutningen af denne periode skal de fyldte penne bruges eller kasseres.
English: • kidney and urinary problems including impairment of kidney function, blood in the urine and urinary disturbances
Danish: • problemer med nyrer og urinveje, herunder svækkelse af nyrefunktionen, blod i urinen og vandladningsforstyrrelser
English: Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Danish: Cimzia i kombination med methotrexat (MTX) er indiceret til behandling af aktiv psoriasisartritis hos voksne, hvor responsen på tidligere behandling med DMARDs har været utilstrækkelig.
English: In all 3 studies, the PASI 75 response rate was significantly greater for Cimzia compared to placebo starting at Week 4.
Danish: I alle tre studier var responsraten for PASI 75 væsentlig større for Cimzia sammenlignet med placebo med begyndelse i uge 4.
English: The following instructions explain how to inject Cimzia.
Danish: Nedenstående vejledning forklarer, hvordan Cimzia skal injiceres.
English: The combination of certolizumab pegol and anakinra or abatacept is not recommended (see section 4.4).
Danish: Kombination af certolizumab pegol og anakinra eller abatacept anbefales ikke (se pkt.
English: Co-primary endpoints: ACR 20 at Week 24 and change from baseline in mTSS at Week 52
Danish: Andre primære effektmål: ACR 20 i uge 24 og ændring fra udgangsniveau i mTSS i uge 52
English: Evaluation for treatment of signs and symptoms and inhibition of structural damage.
Danish: Evaluering af behandling på objektive fund og symptomer samt hæmning af strukturel skade.
English: If you are given too much Cimzia
Danish: Hvis du får for meget Cimzia
English: Patients had a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area (BSA) involvement of ≥ 10%, Physician Global Assessment (PGA) of ≥ 3, and were candidates for systemic therapy and/or phototherapy and/or chemophototherapy.
Danish: Patienterne havde en score for psoriasisareal og sværhedsindeks (Psoriasis Area and Severity Index, PASI) ≥ 12, legemsoverflade (body surface area, BSA) involvering på ≥ 10%, lægens generelle vurdering (Physician Global Assessment, PGA) på ≥ 3, og var kandidater til systemisk behandling og/eller lysterapi og/eller kemolysterapi.
English: • skin cancers, pre-cancerous skin lesions
Danish: • hudkræft, forstadier til hudkræft
English: Do not touch this area again before injection.
Danish: - Berør ikke området igen før injektionen.
English: It is usually injected into the thigh or tummy.
Danish: Der injiceres sædvanligvis i låret eller maven.
English: Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Danish: Der bør udvises forsigtighed, når behandling med TNF-antagonister overvejes til patienter med maligniteter i anamnesen, eller når fortsat behandling overvejes hos patienter, som udvikler maligniteter.
English: • The messages “Needle uncapped!
Danish: • Meddelelsen ”Nålehætten er ikke påsat!
English: Uncommo blood alkaline phosphatase increased, coagulation time prolonged
Danish: Ikke almindelig forhøjet indhold af alkalisk fosfatase, forlænget koagulationstid
English: The efficacy and safety of Cimzia were evaluated versus etanercept in the CIMPACT study.
Danish: Cimzias virkning og sikkerhed blev vurderet vs.etanercept i CIMPACT-studiet.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Cimzia if any of the following applies to you:
Danish: Fortæl det til lægen, apotekspersonalet eller sygeplejersken før behandlingen med Cimzia, hvis noget af nedenstående gælder for dig:
English: Of the 783 patients initially randomised to active treatment in RA-I, 508 completed 52 weeks of placebocontrolled treatment and entered the open-label extension study.
Danish: Af de 783 patienter, som i begyndelsen blev randominiseret til aktiv behandling i RA-I, gennemførte 508 52 ugers placebokontrolleret behandling og gik ind i det åbne forlængelsesstudie.