FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients must have been intolerant to or had an inadequate response to at least one NSAID.
Danish: Patienterne skulle have været intolerante overfor eller ikke have responderet tilstrækkeligt på mindst et NSAID.
English: Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment.
Danish: Tilgængelige data hos voksne med plaque psoriasis indikerer, at der sædvanligvis opnås klinisk respons inden for 16 ugers behandling.
English: Patients had ≥ 3 swollen and tender joints and increased acute phase reactants.
Danish: Patienterne havde ≥ 3 hævede og ømme led samt forhøjede akutfasereaktanter.
English: • suicide attempt, mental impairment, delirium
Danish: • selvmordsforsøg, mental svækkelse, delirium
English: Studies in rats indicated that > 90% of the administered PEG was eliminated in 3 months following a single dose, with the urine being the main route of excretion.
Danish: Studier i rotter indikerede, at > 90% af den indgivne PEG blev udskilt inden for 3 måneder efter en enkeltdosis, og at urinen var den vigtigste udskillelsesvej.
English: Table 3 ACR response in clinical trials RA-I and RA-II Study RA-I Methotrexate combination (24 and 52 weeks)
Danish: Tabel 3 ACR-respons i kliniske studier RA-I og RA-II Studie RA-I Methotrexat kombination (24 og 52 uger)
English: When assessed using the previous ELISA method, the presence of antibodies to certolizumab pegol resulted in an approximately three-fold increase in clearance.
Danish: Ved undersøgelse med brug af den tidligere ELISA-metode resulterede tilstedeværelsen af antistoffer mod certolizumab pegol i en tilnærmelsesvis tre gange forøgelse af clearance.
English: • Do not re-use the pen.
Danish: • Genbrug ikke pennen.
English: Check the medicine through the viewing window.
Danish: Kontroller medicinen ved at kigge gennem kontrolvinduet.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Danish: Der er en øget baggrundsrisiko for lymfomer og leukæmi hos patienter med reumatoid artritis med længerevarende, højaktiv, inflammatorisk sygdom, hvilket komplicerer risikovurderingen.
English: Do not try to touch the needle.
Danish: Forsøg ikke at røre nålen.
English: • the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Danish: • Behandling af svær, aktiv og progressiv RA hos voksne, som ikke tidligere er blevet behandlet med MTX eller andre DMARDs.
English: This will include a thorough medical history, a chest X-ray and a tuberculin test.
Danish: Dette vil omfatte en grundig undersøgelse af dine tidligere sygdomme, et røntgenbillede af brystkassen og en tuberkulintest.
English: Cimzia contains sodium acetate and sodium chloride This medicinal product contains less than 1 mmol sodium (23 mg) per 400 mg, i.e. essentially ‘sodium-free'.
Danish: Cimzia indeholder natriumacetat og natriumchlorid Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. 400 mg, dvs. den er stort set ”natriumfri”.
English: To complete your injection: o Repeat Step 2 (Choosing and preparing an injection site), using a different injection site o Press ava firmly against the skin to begin the injection again, then o Press the (Start/Pause button).
Danish: For at fuldføre injektionen: o Gentag trin 2 (Valg of forberedelse af injektionssted), anvend et andet injektionssted o Hold ava tæt ned mod huden for at genoptage injektionen, herefter o Tryk på (start/pause-knappen).
English: The pre-filled syringe with needle guard should only be used by healthcare professionals.
Danish: Den fyldte sprøjte med kanylebeskyttelse bør kun anvendes af sundhedspersonalet.
English: PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.
Danish: Pegylering, den kovalente binding af PEGpolymerer til peptider, forsinker elimineringen af disse enheder fra cirkulationen på en række forskellige måder inklusive nedsat renal clearance, nedsat proteolyse og nedsat immunogenicitet.
English: • tuberculosis infection
Danish: • tuberkuloseinfektion
English: Moderate to severe heart failure (NYHA classes III/IV) (see section 4.4).
Danish: Moderat til alvorligt hjertesvigt (NYHA funktionsklasse III/IV) (se pkt 4.4).
English: The conduct of these tests should be recorded on your Patient Reminder Card.
Danish: Udførelsen af disse undersøgelser bør noteres på dit patient-påmindelseskort.
English: • When the injection is complete, a message is shown on ava's screen saying "Injection complete.
Danish: • Nå injektionen er afsluttet, vises følgende meddelelse på avas skærm ”Injektion afsluttet.
English: A total of 264 subjects (64.5%) completed the study through Week 216.
Danish: I alt 264 patienter (64,5%) gennemførte studiets 216 uger.
English: Please follow these carefully.
Danish: Følg disse vejledninger nøje.
English: The ava injection device currently does not support administration of a maintenance dose of 400 mg every 2 weeks; for plaque psoriasis patients receiving this maintenance dose, the physician is adviced to use other presentations.
Danish: Ava-injektionsanordningen tillader på nuværende tidspunkt ikke administration af en vedligeholdelsesdosis på 400 mg hver 2. uge; for patienter med plaque psoriasis, som får denne vedligeholdelsesdosis, tilrådes lægen at anvende andre metoder.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath or swelling of your feet), you must contact your doctor immediately.
Danish: Hvis du udvikler nye eller forværrede symptomer på hjertesvigt (f.eks. åndenød eller opsvulmede fødder), skal du straks kontakte lægen.
English: For women planning pregnancy, contraception may be considered for 5 months after the last Cimzia dose.
Danish: Hos kvinder, som planlægger graviditet, kan prævention overvejes i 5 måneder efter den sidste dosis af Cimzia.
English: - Do not remove the needle cap from the medication yet.
Danish: - Tag ikke nålehætten af medicinen endnu.
English: The physician should discuss with the patient which injection presentation option is the most appropriate.
Danish: Lægen og patienten bør drøfte hvilken injektionsmetode, der er mest hensigtsmæssig.
English: This was also the case for the other parameters of peripheral activity (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis).
Danish: Dette var også tilfældet for andre parametre for perifer aktivitet (f. eks. antal hævede led, antal smertefulde/ømme led, dactylitis og enthesitis).
English: *These events have been related to the class of TNF-antagonists, but incidence with certolizumab pegol is not known.
Danish: *Disse hændelser er relateret til gruppen af TNF-antagonister, men tilfælde med certolizumab pegol er ikke kendt.
English: Other disorders - Patients with chronic obstructive pulmonary disease (COPD), or who are heavy smokers, may be at increased risk for cancer with Cimzia treatment.
Danish: Andre sygdomme - Patienter med kronisk obstruktiv lungesygdom (KOL) eller storrygere kan have en øget risiko for kræft ved behandling med Cimzia.
English: Start/Pause button
Danish: Start/pause-knap
English: Tell your surgeon or dentist performing the procedure that you are having treatment with Cimzia by showing them your Patient Reminder Card.
Danish: Fortæl det til kirurgen eller tandlægen, som skal udføre behandlingen, at du får behandling med Cimzia ved at vise dem dit patient-påmindelseskort.
English: Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn.
Danish: På grund af hæmningen af TNF-α, kan administrering af Cimzia under graviditet påvirke det normale immunrespons hos den nyfødte.
English: • improve your physical function and performance of daily tasks.
Danish: • forbedre din fysiske funktion og formåen i forhold til at varetage daglige gøremål.
English: Of the 850 patients randomized to receive placebo or Cimzia in these placebo-controlled studies, 29% of patients were naïve to prior systemic therapy for the treatment of psoriasis.
Danish: Af de 850 patienter, der blev randomiseret til at få placebo eller Cimzia i disse placebokontrollerede studier, var 29 % af patienterne behandlingsnaive over for forudgående systemisk terapi til behandling af deres psoriasis.
English: During the 14-week follow-up, no treatment effects of certolizumab pegol were seen on semen quality parameters compared to placebo.
Danish: I opfølgningsperioden på 14 uger blev der ikke set nogen effekt af certolizumab pegol på sædkvalitetsparametre sammenlignet med placebo.
English: PGA clear or almost clear b)
Danish: PGA klar eller næsten klar b)
English: This injection should not be mixed in the same syringe with any other medicine.
Danish: Denne injektion bør ikke blandes med anden medicin i samme sprøjte.
English: About 22% (54/248) of the patients who were anti-certolizumab pegol antibody positive at any time, had antibodies that were classified as neutralizing.
Danish: Omkring 22 % (54/248) af de patienter, som var anti-certolizumab pegol antistofpositive på et hvilket som helst tidspunkt, havde antistoffer, der blev klassificeret som neutraliserende.
English: The typical Cavg that produces half the maximum probability of ACR 20 response (EC50) was 17 µg/ml (95% CI: 10-23 µg/ml).
Danish: Den typiske Cavg, som producerer halvdelen af den maksimale sandsynlighed for ACR-respons (EC50), var 17 μg/ml (95 % CI: 10-23 μg/ml).
English: • Remove the Cimzia carton from the refrigerator.
Danish: • Tag Cimzia-kartonen ud af køleskabet.
English: - Do not twist the dose-dispenser cartridge - it is a special shape so that it fits correctly.
Danish: - Drej ikke kassetten til dosisdispenser - den er specielt udformet, så den passer korrekt.
English: In CIMPASI-1 and CIMPASI-2, sixty patients were antibody positive, 27 of these patients were evaluable for neutralizing antibodies and tested positive.
Danish: I CIMPASI-1 og CIMPASI-2 var 60 patienter antistof-positive, 27 af disse patienter kunne evalueres for neutraliserende antistoffer og blev testet positive.
English: Certolizumab pegol has a bioavailability (F) of approximately 80% (range 76% to 88%) following subcutaneous administration compared to intravenous administration.
Danish: Certolizumab pegol har en biotilgængelighed (F) på tilnærmelsesvis 80% (varierende mellem 76% til 88%) efter subkutan administration, sammenlignet med intravenøs administration.
English: Table 1 Adverse reactions in clinical trials and postmarketing System Organ Class
Danish: Tabel 1 Bivirkninger i kliniske studier og efter markedsføring Systemorganklasser
English: For details on therapeutic effects, see section 5.1.
Danish: For detaljer vedrørende terapeutisk virkning, se pkt.
English: Heart failure - If you have mild HEART FAILURE and you are being treated with Cimzia, your heart failure status must be closely monitored by your doctor.
Danish: Hjertesvigt - Hvis du har let HJERTESVIGT og du er i behandling med Cimzia, skal status for dit hjertesvigt følges nøje af lægen.
English: Study objectives
Danish: Studiets formål
English: The pharmacokinetics of the PEG fraction of certolizumab pegol are expected to be dependent on renal function but have not been assessed in patients with renal impairment.
Danish: Farmakokinetikken af PEGfraktionen af certolizumab pegol forventes at afhænge af nyrefunktionen, men er ikke blevet vurderet hos patienter med nedsat nyrefunktion.
English: Improvements in ASAS5/6, Partial Remission and BASDAI-50 were statistically signficant at Week 12 and Week 24 and were sustained up to Week 48 in the overall popualtion as well as in the subpopulations.
Danish: Forbedringer i ASAS 5/6 Partiel remission og BASDAI-50 var statistisk signifikante ved uge 12 og uge 24 og blev opretholdt frem til uge 48 i den samlede population samt i subpopulationerne.
English: Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Danish: Farmakokinetiske populationsanalyser viste ingen effekt af alder (se pkt.
English: Quality of life / Patient reported outcomes
Danish: Livskvalitet/patientrapporterede resultater
English: The clinical significance of low levels certolizumab pegol for infants is unknown.
Danish: Den kliniske signifikans af lave niveauer af certolizumab pegol hos spædbørn er ukendt.
English: B-1070 Bruxelles Belgium
Danish: B-1070 Bruxelles
English: Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.
Danish: Wald p-værdier er angivet for sammenligning af behandlingerne under anvendelse af logistisk regression med behandling og region som faktorer.
English: Both Cimzia regimens showed sustained clinical response and were statistically significant compared to placebo at week 34.
Danish: Begge Cimzia-regimer viste vedvarende klinisk respons og var statistisk signifikante sammenlignet med placebo ved uge 34.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor immediately.
Danish: Hvis du får feber, som ikke forsvinder, blå mærker, bløder meget let eller er meget bleg, skal du straks kontakte lægen.
English: The potential role of TNF-antagonist therapy in the development of malignancies is not known.
Danish: TNF-antagonisters potentielle rolle ved udviklingen af maligniteter er ikke kendt.
English: • feeling faint, including loss of consciousness
Danish: • nær-besvimelse, herunder bevidsthedstab
English: - If you have an infection or if you develop symptoms such as fever, wounds, tiredness or dental problems.
Danish: - Hvis du har en infektion, eller hvis du udvikler symptomer, såsom feber, sår, træthed eller tandproblemer.
English: The frequency of creatine phosphokinase (CPK) elevations was generally higher in patients with axSpA as compared to the RA population.
Danish: Frekvensen af forhøjet indhold af kreatininfosfokinase (CPK) var generelt højere hos patienter med axSpA sammenlignet med patienter med RA.
English: The majority of reported TNF-antagonist cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis.
Danish: Hovedparten af de rapporterede tilfælde med TNF-antagonist forekom hos unge og unge voksne mænd med Crohns sygdom eller colitis ulcerosa.
English: Some of these reactions occurred after the first administration of Cimzia.
Danish: Nogle af disse reaktioner opstod efter den første administrering af Cimzia.
English: - You may cover the injection site with a small adhesive bandage, if necessary.
Danish: - Du kan om nødvendigt dække injektionsstedet med et lille plaster.
English: Additionally, the observed incidence of antibodies in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
Danish: Endvidere kan den observerede incidens af antistoffer i en analyse være påvirket af flere faktorer, herunder prøvehåndtering, tidspunkt for prøvetagning, andre samtidige lægemidler samt underliggende sygdom.
English: Your physician will also give you a Patient Reminder Card, which contains important safety information of which you need to be aware before you are given Cimzia and during treatment with Cimzia.
Danish: Lægen vil også give dig et patient-påmindelseskort, der indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på, før og under behandlingen med Cimzia.
English: Among patients remaining in the study, ACR 20, 50 and 70 response rates were maintained through Week 216.
Danish: Blandt de tilbageværende patienter i studiet blev ACR 20-, 50- og 70-responsraterne opretholdt til og med uge 216.
English: If you received Cimzia during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: Hvis du har fået Cimzia, mens du var gravid, kan dit barn have en højere risiko for at få en infektion.
English: This effect has been observed with the PTT-Lupus Anticoagulant (LA) test and Standard Target Activated Partial Thromboplastin time (STA-PTT) Automate tests from Diagnostica Stago, and the HemosIL APTT-SP liquid and HemosIL lyophilised silica tests from Instrumentation Laboratories.
Danish: Denne virkning er blevet observeret med PTT-Lupus Anticoagulant Test (LA) og Standard Target Activated Partial Thromboplastin Time Automate Test (STA-PTT) fra Diagnostica Stago samt HemosIL APTT-SP Liquid Test og HemosIL Lyophilised Silica Test fra Instrumentation Laboratories.
English: At both Week 12 and 52, ASAS 40 responses were significantly greater than placebo.
Danish: Ved både uge 12 og uge 52 var ASAS 40-respons signifikant højere end placebo.
English: • When the syringe is empty, carefully remove the needle from the skin at the same angle at which it was inserted.
Danish: • Når sprøjten er tom, trækkes nålen forsigtigt ud af huden i samme vinkel, som da den blev stukket ind.
English: Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their disease and concomitant medicinal products.
Danish: Patienter med reumatoid artritis vil ikke altid udvise typiske infektionssymptomer, inklusive feber, grundet deres sygdom og samtidig behandling med andre lægemidler.
English: • Do not use the syringe if it has been dropped without its packaging.
Danish: • Brug ikke sprøjten, hvis den har været tabt uden emballage.
English: Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia.
Danish: Patienterne bør undersøges nøje for tegn og symptomer på infektioner inklusive tuberkulose før, under og efter behandling med Cimzia.
English: • sepsis (serious infection which can result in organ failure, shock or death)
Danish: • blodforgiftning (alvorlig infektion, som kan resultere i organsvigt, shock eller død)
English: Some of these events have been fatal.
Danish: I nogle af disse tilfælde har udfaldet været letalt.
English: If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis you will first be given other medicines.
Danish: Hvis du har ankyloserende spondylitis eller ikke-radiografisk aksial spondyloartritis vil du først få andre lægemidler.
English: In all situations described below, the benefit/risk balance of Cimzia therapy should be very carefully considered.
Danish: I alle de situationer, som er beskrevet nedenfor, bør balancen mellem fordele og ulemper ved behandling med Cimzia tages meget nøje i betragtning.
English: In a clinical trial to assess the effect of certolizumab pegol on semen quality parameters, 20 healthy male subjects were randomized to receive a single subcutaneous dose of 400 mg of certolizumab pegol or placebo.
Danish: I et klinisk studie til bedømmelse af certolizumab pegols effekt på sædkvalitetsparametre blev 20 raske mandlige forsøgspersoner randomiseret til at få en enkelt subkutan dosis af 400 mg certolizumab pegol eller placebo.
English: People with more severe rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma.
Danish: Patienter med mere alvorlig reumatoid artritis, som har haft sygdommen i lang tid, kan i forhold til gennemsnittet have øget risiko for at få en kræfttype, som kaldes lymfomer, som påvirker lymfesystemet.
English: • gastrointestinal stenosis (narrowing of part of the digestive system).
Danish: • gastrointestinal stenose (forsnævring i en del af fordøjelsessystemet).
English: A total of 199 subjects (61.2% of randomized subjects) completed the study through Week 204.
Danish: I alt 199 patienter (61,2% af de randomiserede patienter) gennemførte studiets 204 uger.
English: • severe rash, hives or other signs of allergic reaction (urticaria)
Danish: • alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion (urticaria)
English: Live vaccines should not be administered concurrently with Cimzia.
Danish: Levende vacciner bør ikke administreres samtidig med Cimzia.
English: Use of TNF-antagonists has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, including multiple sclerosis.
Danish: Brug af TNF-antagonister har i sjældne tilfælde været forbundet med nye kliniske symptomer eller forværring af kliniske symptomer og/eller radiografiske tegn på demyelinisationssygdomme, inklusive multipel sklerose.
English: • slow down the damage to the cartilage and bone of the joints caused by the disease,
Danish: • bremse skader på brusk og knogler i leddene, som er forårsaget af sygdommen,
English: The symptoms described above can be due to some of the side effects listed below, which have been observed with Cimzia:
Danish: Ovennævnte symptomer kan være tegn på nogle af de nedenstående bivirkninger, som er observeret ved brug af Cimzia:
English: • Guillain Barré syndrome*
Danish: • Guillain-Barré syndrom*
English: If the indicator is not at the bottom, contact your pharmacist.
Danish: Hvis indikatoren ikke er i bunden, skal du kontakte apotekspersonalet.
English: No effect of age was observed in a population pharmacokinetic analysis in adult patients with plaque psoriasis.
Danish: Der blev ikke observeret nogen alderseffekt i en populations-farmakokinetisk analyse af voksne patienter med plaque psoriasis.
English: The additional following adverse reactions have been observed uncommonly with Cimzia in other indications: gastrointestinal stenosis and obstructions, general physical health deterioration, abortion spontaneous and azoospermia.
Danish: De supplerende, følgende ikke almindelige bivirkninger er blevet observeret med Cimzia ved andre indikationer: gastrointestinale stenoser og obstruktioner, generel forværring af det fysiske helbred, spontan abort og azoospermi.
English: All patients received Cimzia in both the dose-blind and openlabel follow-up periods.
Danish: Alle patienter fik Cimzia både i perioden med blindede doser og i den åbne (open label) opfølgningsperiode.
English: Patients who miss a dose should be advised to inject the next dose of Cimzia as soon as they remember and then continue injecting subsequent doses as instructed.
Danish: Patienter, som glemmer en dosis, bør rådgives i at injicere den næste Cimzia-dosis, så snart de husker det, og derefter fortsætte injektion af efterfølgende doser, som planlagt.
English: Allée de la Recherche 60 1070 Brussels Belgium
Danish: Allée de la Recherche 60 1070 Bruxelles Belgien
English: • With the other hand, hold the syringe at a 45-degree angle to the skin.
Danish: • Hold sprøjten med den anden hånd i en vinkel på 45 grader mod huden.
English: Key results are presented in Table 9.
Danish: De vigtigste resultater er vist i tabel 9.
English: Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered.
Danish: Når klinisk respons er bekræftet, kan en alternativ vedligeholdelsesdosis på 400 mg hver 4. uge overvejes.
English: • Patient Reminder Card
Danish: • Patient-påmindelseskort
English: Severe hypersensitivity reactions have been reported rarely following Cimzia administration.
Danish: Sjældne tilfælde af alvorlige overfølsomhedsreaktioner er blevet rapporteret efter administration af Cimzia.
English: Statistically significant improvements at Week 16 (CIMPASI-1 and CIMPASI-2) from baseline compared to placebo were demonstrated in the DLQI (Dermatology Life Quality Index).
Danish: Statistisk signifikante forbedringer i uge 16 (CIMPASI-1 og CIMPASI-2)i forhold til baseline sammenlignet med placebo blev påvist i dermatologisk livskvalitetsindeks (Dermatology Life Quality Index, DLQ1).
English: • Take your thumb off the plunger head.
Danish: • Fjern tommelfingeren fra stempelhovedet.
English: Treatment with Cimzia must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Cimzia skal seponeres hos patienter, som udvikler nye eller får forværrede symptomer på kronisk hjerteinsufficiens.