FrancophonIA/ELRC3.0 huggingface dataset:
English: Over the course of the entire study (up to 192 weeks), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 9.6% (4.8% had transient formation and an additional 4.8% had persistent formation of antibodies to Cimzia).
Danish: I løbet af hele studiet (op til 192 uger) var den samlede andel af patienter med antistoffer mod Cimzia, påvist mindst én gang, 9,6% (4,8% havde forbigående antistofdannelse mod Cimzia, og yderligere 4,8% havde vedvarende antistofdannelse mod Cimzia).
English: The most common adverse reactions reported through Week 16 belonged to the system organ classes Infections and infestations, reported in 6.1% of patients on Cimzia and 7% of patients on placebo, General disorders and administration site conditions, reported in 4.1% of patients on Cimzia and 2.3% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 3.5% of patients on Cimzia and 2.8% of patients on placebo.
Danish: De mest almindelige bivirkninger, der blev rapporteret til og med uge 16, hørte til systemorganklasserne ”Infektioner og parasitære sygdomme”, der blev rapporteret for 6,1 % af patienter på Cimzia, og 7 % af patienter på placebo, Almene symptomer og reaktioner på administrationsstedet, rapporteret for 4,1 % af patienter på Cimzia og 2,3 % af patienter på placebo, samt Hud og subkutane væv, rapporteret for 3,5 % af patienter på Cimzia og 2,8 % af patienter på placebo.
English: After proper training in the injection technique, patients may self-inject using the electromechanical injection device ava with the single-use dose-dispenser cartridge if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Hvis lægen vurderer, det er hensigtsmæssigt, kan patienten selv injicere Cimzia ved brug af den elektromekaniske injektionsanordning, ava, sammen med kassetten til dosisdispenser til engangsanvendelse efter passende oplæring i injektionsteknik og med lægelig opfølgning efter behov.
English: Pack of 2 pre-filled syringes and 2 alcohol wipes.
Danish: Pakning a 2 fyldte sprøjter og 2 alkoholservietter.
English: The efficacy and safety of Cimzia have been assessed in 2 randomised, placebo-controlled, doubleblind clinical trials in patients ≥ 18 years of age with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria, RA-I (RAPID 1) and RA-II (RAPID 2).
Danish: Cimzias virkning og sikkerhed er vurderet i 2 randomiserede, placebokontrollerede, dobbeltblinde, kliniske studier, RA-I (RAPID 1) og RA-II (RAPID 2), hos patienter ≥ 18 år med aktiv reumatoid artritis, som er diagnosticeret i henhold til American College of Rheumatology (ACR)-kriterier.
English: Patients were treated with placebo or a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 followed by 200 mg of Cimzia every 2 weeks.
Danish: Patienterne blev behandlet med placebo eller en støddosis på 400 mg Cimzia ved uge 0, 2 og 4 efterfulgt af 200 mg Cimzia hver 2. uge.
English: • skin sloughing, blistering, hair texture disorder
Danish: • afskalning af huden, dannelse af blærer, forandringer i hårstrukturen
English: If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject yourself as soon as you remember and contact your doctor for information.
Danish: Hvis lægen har ladet dig injicere dig selv, og du glemmer at tage en injektion, skal du injicere den næste dosis af Cimzia, så snart du kommer i tanke om det og kontakte lægen for information.
English: One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Danish: Én ml fyldt sprøjte (type I glas) med en stempelprop (brombutylgummi) indeholdende 200 mg certolizumab pegol.
English: Over the course of the entire study (up to 4 years of exposure), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 17.3% (8.7% had transient formation and an additional 8.7% had persistent formation of antibodies to Cimzia).
Danish: I løbet af hele studiet (op til 4 års eksponering) var den samlede andel af patienter med antistoffer mod Cimzia, påvist mindst én gang, 17,3% (8,7% havde forbigående antistofdannelse mod Cimzia, og yderligere 8,7% havde vedvarende antistofdannelse mod Cimzia).
English: •Keep the container out of the sight and reach of children.
Danish: • Opbevar beholderen utilgængeligt for børn.
English: Cimzia contains the active substance certolizumab pegol, a human antibody fragment.
Danish: Cimzia indeholder certolizumab pegol, som er et fragment af et humant antistof.
English: The 24-week double-blind, placebo-controlled treatment period of the study was followed by a 24-week dose-blind treatment period, and a 156-week open-label treatment period.
Danish: Den 24-ugers, dobbeltblinde, placebokontrollerede behandlingsperiode i studiet blev efterfulgt af en 24-ugers behandlingsperiode med blindede doser, og en 156-ugers åben (open label) behandlingsperiode.
English: One ml dose-dispenser cartridge containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber).
Danish: Én ml kasette til dosisdispenser indeholdende en fyldt sprøjte (type I glas) med en stempelprop (brombutylgummi).
English: You will be instructed by your doctor or healthcare giver on the technique of self-injection.
Danish: Læs venligst vejledningen grundigt og følg den trin for trin. Din læge eller sundhedspersonale vil instruere dig i selv-injektionsteknik.
English: Specific clinical trials have not been performed to assess the effect of hepatic impairment on the pharmacokinetics of certolizumab pegol.
Danish: Der er ikke udført specifikke kliniske studier til at vurdere virkningen på certolizumab pegols farmakokinetik ved nedsat leverfunktion.
English: Patients received loading doses of Cimzia 400 mg at weeks 0, 2, and 4 followed by Cimzia 200 mg every 2 weeks during the initial open label period.
Danish: Patienterne fik en støddosis på 400 mg Cimzia ved uge 0, 2 og 4 efterfulgt af 200 mg Cimzia hver 2. uge i den første åbne fase.
English: Cimzia solution for injection in a dose-dispenser cartridge is intended for single-use in conjunction with the electromechanical injection device named ava.
Danish: Cimzia injektionsvæske, opløsning i kassette til dosisdispenser er til engangsanvendelse sammen med den elektromekaniske injektionsanordning, kaldet ava.
English: After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks.
Danish: Efter startdosen er vedligeholdelsesdosen af Cimzia til voksne patienter med plaque psoriasis 200 mg hver 2. uge.
English: - Do not inject in an area where the skin is reddened, bruised, or hard.
Danish: - Injicer ikke i et område, hvor huden er rød, har blå mærker eller er hård.
English: How Cimzia is given
Danish: Sådan gives Cimzia
English: Cimzia 200 mg + MTXPlacebo + MTX Mean Difference mTSS
Danish: Cimzia 200 mg + MTXPlacebo + MTX Gennemsnitlig forskel mTSS
English: Administration of Cimzia should be discontinued if a patient develops a new serious infection until the infection is controlled.
Danish: Hvis en patient udvikler en ny alvorlig infektion, bør behandlingen med Cimzia afbrydes, indtil infektionen er under kontrol.
English: INSTRUCTIONS FOR USE FOR CIMZIA INJECTION BY MEANS OF A PRE-FILLED SYRINGE
Danish: BRUGERVEJLEDNING TIL CIMZIA INJEKTION MED FYLDT SPRØJTE MED KANYLEBESKYTTELSE
English: How to use Cimzia
Danish: Sådan skal du bruge Cimzia
English: • Push the plunger to inject solution.
Danish: • Pres stemplet ned for at injicere opløsningen.
English: The pre-filled syringe contains 200 mg of certolizumab pegol.
Danish: Den fyldte sprøjte indeholder 200 mg certolizumab pegol.
English: • Allow the pre-filled syringe to reach room temperature.
Danish: • Lad den fyldte sprøjte opnå stuetemperatur.
English: • sensory abnormalities such as numbness, tingling, burning sensation
Danish: • sanseforstyrrelser, såsom følelsesløshed, snurren, brændende fornemmelse
English: Ankylosing spondylitis Non-radiographic axial spondyloarthritits
Danish: Non-radiografisk aksial spondyloartritis
English: • increase of red cell mass
Danish: • forhøjet indhold af røde blodlegemer i blodet
English: Rare blood uric acid increased
Danish: Sjælden forhøjet indhold af urinsyre i blodet
English: 879 400 mg (0,2,4 weeks) with MTX 200 mg every 2 weeks with MTX
Danish: 879 400 mg (uge 0,2,4) med MTX 200 mg hver 2. uge med MTX
English: • prolonged coagulation (clotting) test times
Danish: • forlænget koagulationstid (størkning af blodet)
English: When Cimzia has been used to treat other diseases the following uncommon side effects have occurred:
Danish: Følgende ikke almindelige bivirkninger er forekommet, når Cimzia er blevet brugt til behandling af andre sygdomme:
English: Rare interstitial lung disease, pneumonitis Common nausea Uncommo ascites, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis, dyspepsia, abdominal distension, oropharyngeal dryness
Danish: Almindelig Kvalme Ikke almindelig ascites, gastrointestinal ulceration og perforering, inflammation i mave-tarm-kanalen (hvilket som helst sted), stomatitis, dyspepsi, abdominal distension, orofaryngeal tørhed Sjælden odynofagi, hypermotilitet
English: The efficacy and safety of Cimzia was assessed in DMARD-naïve adult patients with active RA in a randomized, placebo-controlled, double-blind clinical trial (C-EARLY).
Danish: Cimzias virkning og sikkerhed blev vurderet i et randomiseret, placebokontrolleret, dobbeltblindt klinisk studie (C-EARLY) hos voksne patienter med aktiv RA, der ikke havde fået DMARD tidligere.
English: • two pre-filled syringes with needle guard of solution, and
Danish: • To fyldte sprøjter med kanylebeskyttelse med opløsning og
English: Cases of lymphoma occurred at an incidence rate of 0.05 per 100 patient-years and melanoma at an incidence rate of 0.08 per 100 patient-years with Cimzia in rheumatoid arthritis clinical trials (see section 4.4).
Danish: I kliniske studier med Cimzia ved reumatoid artritis forekom tilfælde af lymfomer med en incidensrate på 0,05 pr. 100 patientår og melanomer med en incidensrate på 0,08 pr. 100 patientår (se pkt.
English: Not known Merkel cell carcinoma* Common eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia)
Danish: Blod og lymfesystem Almindelig eosinofile sygdomme, leukopeni (inklusive neutropeni, lymfopeni)
English: • seizure
Danish: • Produktresumé
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of TNF-antagonist treatment should be carefully considered before initiation of Cimzia therapy.
Danish: En omhyggelig vurdering af fordele/ulemper ved behandling med TNF-antagonister bør overvejes nøje, før behandling med Cimzia initieres hos patienter med forudeksisterende eller nyligt indtrufne demyelinisationssygdomme.
English: Among PASI75 responders at Week 16 who received Cimzia 200 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 4 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (88.6%, 79.5%, and 45.5%, respectively).
Danish: Blandt PASI 75 respondenterne i uge 16, som fik Cimzia 200 mg hver 2. uge og blev gen-randomiseret til enten Cimzia 400 mg hver 4. uge, Cimzia 200 mg hver 2. uge eller placebo, var der også en højere procentdel af PASI 75 respondenter i uge 48 i Cimzia-grupperne, sammenlignet med placebo (henholdsvis 88,6 %, 79,5 % og 45,5 %).
English: 982 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Danish: 982 400 mg (uge 0,2,4) med MTX 200 mg eller 400 mg hver 2. uge med MTX
English: Clinically meaningful and statistically significant differences in Cimzia-treated patients compared with placebo-treated patients were demonstrated at each post-baseline visit.
Danish: Ved hvert besøg efter baseline blev der vist klinisk meningsfulde og statistisk signifikante forskelle hos patienter, som fik Cimzia, sammenlignet med patienter, som fik placebo.
English: Frequency Adverse reactions Common hypertension Uncommo haemorrhage or bleeding (any site), hypercoagulation (including thrombophlebitis, pulmonary embolism), syncope, oedema (including peripheral, facial), ecchymoses (including haematoma, petechiae)
Danish: Almindelig hypertension Ikke almindelig blødning (hvilket som helst sted), hyperkoagulation (inklusive tromboflebit, lungeemboli), synkope, ødem (inklusive perifert, facialt), ekkymoser (inklusive hæmatomer, petekkier)
English: 619 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Danish: 619 400 mg (uge 0,2,4) med MTX 200 mg eller 400 mg hver 2. uge med MTX
English: Do not bend the needle.
Danish: Buk ikke nålen.
English: • If you feel unsure about the injection process, contact your doctor or pharmacist.
Danish: • Hvis du føler dig usikker på injektionsproceduren, skal du kontakte lægen eller apotekspersonalet.
English: In 2 long-term (up to 5 years of exposure) open-label studies, the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 13% (8.4% of the overall patients had transient formation of antibodies and an additional 4.7% had persistent formation of antibodies to Cimzia).
Danish: I 2 åbne langtidsstudier (op til 5 års eksponering) var den samlede procentdel af patienter, som havde detekterbare antistoffer mod Cimzia ved mindst en lejlighed, 13 % (8,4 % af det samlede antal patienter havde forbigående antistofdannelse mod Cimzia, og yderligere 4,7 % havde vedvarende antistofdannelse mod Cimzia).
English: • bile problems
Danish: • galdeproblemer
English: - Do not heat the medication - let it warm up on its own.
Danish: - Opvarm ikke medicinen - lad den selv opnå stuetemperatur.
English: In an integrated analysis of CIMPASI-1 and CIMPASI-2, among patients who were PASI 75 responders at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every other week, the maintenance response rates at Week 48 were 98.0% and 87.5%, respectively.
Danish: I den integrerede analyse af CIMPASI-1 og CIMPASI-2 blandt patienter, som var PASI 75 respondenter i uge 16 og fik Cimzia 400 mg hver 2. uge eller Cimzia 200 mg hver anden uge, var opretholdelses-responsraterne i uge 48 henholdsvis 98,0 % og 87,5 %.
English: Patients on Cimzia 200 mg every 2 weeks were re-randomized to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks or placebo.
Danish: Patienter på Cimzia 200 mg hver 2. uge blev gen-randomiseret til Cimzia 200 mg hver 2. uge, Cimzia 400 mg hver 4. uge eller placebo.
English: Week 12 Week 24 BASDAI 50(c,d)
Danish: Uge 12 Uge 24 BASDAI-50
English: Common bacterial infections (including abscess), viral infections
Danish: Almindelig bakterielle infektioner (inklusive absces), virale infektioner (inklusive herpes zoster, papillomavirus, influenza)
English: • two dose-dispenser cartridges of solution, and
Danish: • To kassetter til dosisdispenser med opløsning og
English: The use of adequate contraception should be considered for women of childbearing potential.
Danish: Brug af passende kontraception bør overvejes til kvinder i den fertile alder. På grund af eliminationshastigheden (se pkt.
English: ACR70 Week 12 Week 24
Danish: ACR70 Uge 12 Uge 24
English: No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia dose-dispenser cartridge.
Danish: Der er til dato ikke blevet fundet antigent latexprotein i den aftagelige kanylehætte til kasetten til dosisdispenser med Cimzia.
English: • thyroid disorders (goitre, tiredness, weight loss)
Danish: • sygdomme i skjoldbruskkirtlen (struma, træthed, vægttab)
English: If you feel unsure about the injection process, please contact your doctor or pharmacist.
Danish: Hvis du føler dig usikker på injektionsprocessen, skal du kontakte din læge eller apotekspersonalet.
English: (a) Cimzia all dosing regimen = data from Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 plus Cimzia 400 mg administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Results are from the randomized set (c) Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.
Danish: Cimzia alle doseringsregimer = data fra Cimzia 200 mg administeret hver 2. uge forudgået af en støddosis på 400 mg ved uge 0, 2 og 4 og fra Cimzia 400 mg administreret hver 4. uge forudgået af en støddosis på 400 mg ved uge 0, 2 og 4 (b) Resultater fra det randomiserede sæt
English: The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
Danish: De hyppigste bivirkninger tilhørte systemorganklasserne ”Infektioner og parasitære sygdomme”, rapporteret hos 14,4% af patienterne, som fik Cimzia, og hos 8,0% af patienterne, som fik placebo, ”Almene symptomer og reaktioner på administrationsstedet”, rapporteret hos 8,8% af patienterne, som fik Cimzia, og 7,4% af patienterne, som fik placebo, samt ”Hud og subkutane væv”, rapporteret hos 7,0% af patienterne, som fik Cimzia, og 2,4% af patienterne, som fik placebo.
English: • Grasp the clear cap with the other hand and pull it straight off. Do not twist the cap while removing it, this could jam the internal mechanism.
Danish: Drej ikke hætten, når den fjernes, det kan stoppe den interne mekanisme.
English: Table 11: Clinical response in studies CIMPASI-1 and CIMPASI-2 at Week 16 and Week 48 Week 16
Danish: Tabel 11: Klinisk respons i CIMPASI-1 og CIMPASI-2 studierne i uge 16 og uge 48 Uge 16
English: Of the 783 patients initially randomised to active treatment in RA-I, 508 completed 52 weeks of placebo-controlled treatment and entered the open-label extension study.
Danish: Effekten blev opretholdt i 52 uger (RA-I) og 24 (RA-II) Af de 783 patienter, som i begyndelsen blev randominiseret til aktiv behandling i RA-I, gennemførte 508 de 52 ugers placebokontrolleret behandling og gik ind i det åbne (open label) forlængelsesstudie.
English: Patient on Cimzia 400 mg every 2 weeks were re-randomized to Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo.
Danish: Patienter på Cimzia 400 mg hver 2. uge blev gen-randomiseret til Cimzia 400 mg hver 2. uge, Cimzia 200 mg hver 2. uge eller placebo.
English: Among patients who were PGA clear or almost clear at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every 2 weeks, the maintenance response rate at Week 48 were 85.9% and 84.3% respectively.
Danish: Blandt patienter, som var PGA klar eller næsten klar i uge 16, og som fik Cimzia 400 mg hver 2. uge eller Cimzia 200 mg hver 2. uge, var opretholdelsesresponsraten i uge 48 på henholdsvis 85,9 % og 84,3 %.
English: No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia pre-filled pen.
Danish: Der er til dato ikke blevet fundet antigent latexprotein i den aftagelige kanylehætte til den fyldte pen med Cimzia.
English: The 24-week double-blind placebo controlled treatment period of the study was followed by a 24-week dose-blind treatment period and an 168-week open-label treatment period.
Danish: Den 24-ugers, dobbeltblinde, placebokontrollerede behandlingsperiode i studiet blev efterfulgt af en 24-ugers behandlingsperiode med blindede doser, og en 168-ugers åben (open label) behandlingsperiode.
English: • psoriatic arthritis,
Danish: • psoriasisartritis,
English: In both studies patients were randomized to receive placebo or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4) or Cimzia 400 mg every 2 weeks.
Danish: I begge studier blev patienterne randomiseret til at få placebo eller Cimzia 200 mg hver 2. uge (efter en støddosis af Cimzia 400 mg i uge 0, 2 og 4) eller Cimzia 400 mg hver 2. uge.
English: Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Danish: Aksial spondyloartritis Cimzia er indiceret til behandling af svær aksial spondyloartritis (axSpA) hos voksne omfattende:
English: - One or two pre-filled syringe(s), depending on your prescribed dose - One or two alcohol wipe(s)
Danish: - En eller to fyldt(e) sprøjte(r), afhængigt af hvilken dosis du har fået ordineret - En eller to alkoholserviet(ter)
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Sandoz GmbH
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: Cimzia vs. placebo: *p≤0.01, ** p<0.001
Danish: Overordnet klinisk respons a. Cimzia vs. placebo: *p≤ 0,01, ** p< 0,0012
English: (difference between etanercept and Cimzia 200 mg every 2 weeks was 8.0%, 95% CI -2.9, 18.9, based on a pre-specified non-inferiority margin of 10%).
Danish: §Cimzia 200 mg hver 2. uge versus etanercept 50 mg to gange om ugen påviste non-inferioritet (forskel mellem etanercept og Cimzia 200 mg hver 2. uge var 8,0 %, 95 % KI -2,9; 18,9, baseret på en forud specificeret non-inferioritetsmargen på 10 %).
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Danish: Ankyloserende spondylitis og aksial spondyloartritis uden tegn på ankyloserende spondylitis ved røntgen
English: Table 12: Clinical response in CIMPACT study at Week 12 and Week 16 Week 12
Danish: Tabel 12: Klinisk respons i CIMPACT-studie i uge 12 og uge 16 Uge 12
English: Uncommo skin injuries, impaired healing
Danish: Ikke almindelig skader på huden, nedsat sårheling
English: Do not heat the pre-filled syringe - let it warm on its own.
Danish: - Opvarm ikke den fyldte sprøjte - lad den selv opnå stuetemperatur.
English: Keep this Patient Reminder Card with you.
Danish: Hav altid dette patient-påmindelseskort på dig.
English: After proper training in injection technique, patients may self-inject using the pre-filled pen if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Hvis lægen vurderer, det er hensigtsmæssigt, kan patienten selv injicere den fyldte pen efter passende oplæring i injektionsteknik og med lægelig opfølgning efter behov.
English: Uncommo cardiomyopathies (including heart failure), ischaemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations
Danish: Ikke almindelig kardiomyopatier (inklusive hjertesvigt), iskæmisk koronararteriesygdom, arytmier (inklusive atrieflimmer), palpitationer Sjælden pericarditis, atrioventrikulært blok
English: In the CIMPACT study, among PASI 75 responders at Week 16 who received Cimzia 400 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (98.0%, 80.0%, and 36.0%, respectively).
Danish: I CIMPACT-studiet var der, blandt PASI 75 respondenterne i uge 16, som fik Cimzia 400 mg hver 2. uge og blev gen-randomiseret til enten Cimzia 400 mg hver 2. uge, Cimzia 200 mg hver 2. uge eller placebo, en højere procentdel af PASI 75 respondenter i uge 48 i Cimzia-grupperne, sammenlignet med placebo (henholdsvis 98,0 %, 80,0 % og 36,0 %).
English: Cimzia 200 mg + MTX N=393 Mean (SD)
Danish: Cimzia 200 mg + MTX N=393 Gennemsnitlig (SD)
English: INFORMATION IN BRAILLE Cimzia 200 mg
Danish: Cimzia 200 mg
English: Cimzia 400 mg + MTX every 4 weeks N=69
Danish: Cimzia 400 mg + MTX hver 4. uge N=69
English: DoseFlex clinical trial
Danish: Det kliniske studie DoseFlex
English: Pack size of 2 dose-dispenser cartridges and 2 alcohol wipes.
Danish: Pakning a 2 kassetter til dosisdispenser og 2 alkoholservietter.
English: a Cimzia administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4
Danish: Cimzia administeret hver 2.uge forudgået af en støddosis på 400 mg ved uge 0, 2 og 4