FrancophonIA/ELRC3.0 huggingface dataset:
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning skal produktet anvendes omgående, medmindre rekonstitutionsmetoden udelukker mikrobiologisk kontaminering.
English: The stream of sterile water for injections should be directed onto the powder.
Danish: Strømmen af sterilt vand til injektionsvæsker skal rettes direkte mod pulveret.
English: ASAS 20 response, %
Danish: ASAS 20-respons, %
English: A new and unused Cosentyx SensoReady pen (2 pens are needed for a 300 mg dose).
Danish: En ny og ubrugt Cosentyx SensoReady-pen (du skal bruge 2 penne til en dosis på 300 mg).
English: The renal elimination of intact secukinumab, an IgG monoclonal antibody, is expected to be low and of minor importance.
Danish: Renal udskillelse af intakt secukinumab, et IgG monoklonalt antistof forventes at være lav og af minimal betydning.
English: An effect of inhibition of structural damage was observed in anti-TNFα-naïve and anti-TNFα-IR patients and in patients treated with and without concomitant MTX.
Danish: Der blev observeret en effekt af hæmning af strukturel skade hos anti-TNFα-naïve og anti-TNFα-IR-patienter og hos patienter, der blev behandlet med og uden samtidig MTX.
English: If you forget to use Cosentyx If you have missed a Cosentyx injection, talk to your doctor.
Danish: Hvis du har glemt at bruge Cosentyx Hvis du har glemt at få en Cosentyx-indsprøjtning, skal du kontakte din læge.
English: Table 4 Summary of clinical response on CLEAR study
Danish: Tabel 4 Resume af klinisk virkning på CLEAR studie
English: 9/l (CTCAE grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose dependence and no temporal relationship to infections in 15 out of 18 cases.
Danish: 9/l (CTCAE klasse 3) blev rapporteret i 18 ud af 3.430 (0,5 %) patienter på secukinumab, med ingen dosisafhængighed og ingen tidsmæssig tilknytning til infektioner i 15 ud af 18 tilfælde.
English: Inhibition of progression of structural damage was also assessed in PsA study 1 at weeks 24 and 52, compared to baseline.
Danish: Hæmning af progression af strukturel ødelæggelse blev også vurderet i PsA-studie 1 ved uge 24 og 52 i forhold til baseline.
English: A caregiver may also give you your Cosentyx injection after proper training.
Danish: En omsorgsperson kan også give dig indsprøjtningen med Cosentyx efter at have modtaget korrekt undervisning.
English: • burning sensation when passing urine.
Danish: • brændende fornemmelse når du tisser
English: • runny nose (rhinorrhoea)
Danish: • løbende næse (rhinorrhoea)
English: ** p values versus placebo and adjusted for multiplicity: p<0.0001.
Danish: ** p-værdier kontra placebo og justeret for multiplicitet: p < 0,0001.
English: After storage at 2°C to 8°C, the solution should be allowed to come to room temperature for approximately 20 minutes before administration.
Danish: Efter opbevaring ved mellem 2 °C - 8 °C skal opløsningen bringes til stuetemperatur i ca. 20 minutter før administration.
English: Choose a different site each time an injection is administered.
Danish: Vælg forskellige steder, hver gang der gives en injektion.
English: Figure 2 ACR20 response in PsA study 2 over time up to week 52
Danish: Figur 2 ACR20-respons i PsA-studie 2 over tid op til uge 52
English: In an additional psoriasis study (CLEAR) 676 patients were evaluated.
Danish: I et supplerende psoriasisstudie (CLEAR) blev 676 patienter evalueret.
English: IgGs are mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance of secukinumab.
Danish: IgG'er elimineres hovedsagelig via katabolisme, og leverinsufficiens forventes ikke at påvirke clearance af secukinumab.
English: Prior to use, a visual inspection of the pre-filled pen is recommended.
Danish: Før anvendelse anbefales det at foretage en visuel kontrol af den fyldte pen.
English: ADRs from clinical studies and post-marketing reports (Table 1) are listed by MedDRA system organ class.
Danish: Bivirkningerne fra kliniske studier og rapporteringer efter markedsføring (Tabel 1) er ordnet efter MedDRA-systemorganklasse.
English: Do not use this medicine if either the seal on the outer box or the seal of the blister is broken, as it may not be safe for you to use.
Danish: Du må ikke bruge lægemidlet, hvis enten forseglingen på yderpakningen eller forseglingen på blisterpakningen er brudt, da det så måske ikke er sikkert for dig at bruge.
English: Cosentyx has no or negligible influence on the ability to drive and use machines.
Danish: Cosentyx påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The onset of action of secukinumab occurred as early as week 2.
Danish: Starttidspunktet for secukinumabs virkning indtraf allerede ved uge 2.
English: Psoriasis study 2 (FIXTURE) evaluated 1,306 patients.
Danish: Psoriasisstudie 2 (FIXTURE) evaluerede 1.306 patienter.
English: Patients with each subtype of PsA were enrolled in these studies, including polyarticular arthritis with no evidence of rheumatoid nodules, spondylitis with peripheral arthritis, asymmetric peripheral arthritis, distal interphalangeal involvement and arthritis mutilans.
Danish: Patienter med alle undertyper af PsA blev inkluderet i disse studier, herunder polyartikulær artritis uden evidens for noduli rheumatici, spondylitis med perifer artritis, asymmetrisk perifer artritis, involvering af distale interfalangealled og arthritis mutilans.
English: After reconstitution: The solution can be used immediately or can be stored at 2°C to 8°C for up to 24 hours.
Danish: Efter opløsning: Opløsningen kan anvendes med det samme eller opbevares ved mellem 2 °C til 8 °C i op til 24 timer.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose.
Danish: Hvis du er en kvinde i den fødedygtige alder, bør du undgå at blive gravid, og du skal bruge passende prævention, mens du bruger Cosentyx og i mindst 20 uger efter sidste Cosentyx-dosis.
English: The most frequently reported adverse drug reactions (ADRs) are upper respiratory tract infections (most frequently nasopharyngitis, rhinitis).
Danish: De hyppigst indberettede bivirkninger er infektioner i de øvre luftveje (som oftest nasopharyngitis, rhinitis).
English: No natural rubber latex has to date been detected in the removable cap.
Danish: Intet naturgummilatex er hidtil blevet påvist i den aftagelige kanylehætte.
English: The frequency of IL-17-producing cells was also significantly higher in the subchondral bone marrow of facet joints from patients with ankylosing spondylitis.
Danish: IL-17-producerende celler var også signifikant højere i den subkondrale knoglemarv i facetled fra patienter med ankyloserende spondylitis.
English: You and your doctor should decide if you should inject Cosentyx yourself.
Danish: Du og din læge bør i fællesskab beslutte, om du selv skal indsprøjte Cosentyx eller ej.
English: Cases of new or exacerbations of Crohn's disease and ulcerative colitis have been reported.
Danish: Der er rapporteret om nye udbrud eller forværring af Crohn's sygdom og ulcerativ colitis.
English: Population pharmacokinetic analysis showed that secukinumab was absorbed with an average absolute bioavailability of 73% in patients with plaque psoriasis.
Danish: Farmakokinetisk populationsanalyser viste, at secukinumab blev absorberet med en gennemsnitlig absolut biotilgængelighed på 73 % hos patienter med plaque psoriasis.
English: Larger differences in response rates, favouring 300 mg over 150 mg, were observed in anti-TNFα-IR patients (n=36) compared to anti-TNFα-naïve patients (n=114).
Danish: Der blev observeret større forskelle i responsrater, der favoriserer 300 mg over 150 mg, hos anti-TNFα-IR-patienter (n=36) sammenlignet med anti-TNFαnaïve patienter (n=114).
English: Tell your doctor or pharmacist:
Danish: Fortæl altid lægen eller apotekspersonalet,
English: Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate.
Danish: Cosentyx bruges til voksne med aktiv psoriasisgigt og kan bruges alene eller sammen med et andet lægemiddel, der hedder methotrexat.
English: Radiographs of hands, wrists, and feet were obtained at baseline, week 16 and/or week 24 and scored independently by at least two readers who were blinded to treatment group and visit number.
Danish: Der blev taget røntgenbilleder af hænder, håndled og fødder ved baseline, uge 16 og/eller uge 24 og blev uafhængigt vurderet af mindst to personer, der var blindede ift.
English: Make sure you discuss with your doctor when you will have your injections and your follow-up appointments.
Danish: Sørg for at tale med din læge om, hvornår du skal have dine indsprøjtninger, og hvornår du skal have opfølgningssamtaler.
English: • It is preferable to avoid the use of Cosentyx in pregnancy.
Danish: • Du bør undgå at bruge Cosentyx under graviditet.
English: Never leave the syringe lying around where others might tamper with it. Do not shake the syringe.
Danish: Lad aldrig injektionssprøjten ligge tilgængeligt, så andre kan komme til at pille ved den. Du må ikke ryste injektionssprøjten.
English: Tell your doctor or pharmacist before using Cosentyx:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Cosentyx:
English: Serum levels of total IL-17A (free and secukinumab-bound IL-17A) are initially increased in patients receiving secukinumab.
Danish: Serumniveauer for total IL-17A (frit og secukinumab-bundet IL-17A) øges initialt hos patienter, der behandles med secukinumab.
English: Expel the air bubbles and advance the plunger to the 1.0 ml mark.
Danish: Pres luftboblerne ud, og flyt stemplet til 1,0 ml-mærket.
English: Cosentyx reduces the inflammation and other symptoms of the disease.
Danish: Cosentyx reducerer betændelsen og andre symptomer på lidelsen.
English: This is followed by a slow decrease due to reduced clearance of secukinumab-bound IL-17A, indicating that secukinumab selectively captures free IL-17A, which plays a key role in the pathogenesis of plaque psoriasis.
Danish: Dette følges af et langsomt fald på grund af reduceret clearance af secukinumab-bundet IL-17A, hvilket indicerer, at secukinumab selektivt opfanger frit IL-17A, som spiller en vigtig rolle i patogenesen af plaque psoriasis.
English: Clinically important, active infection, e.g. active tuberculosis (see section 4.4).
Danish: Klinisk vigtig, aktiv infektion, fx aktiv tuberkulose (se pkt.
English: The resulting solution should be clear.
Danish: Den færdige opløsning skal være klar.
English: Table 1 List of adverse reactions in clinical studies and post-marketing experience
Danish: Tabel 1 Liste med bivirkninger fra kliniske studier og efter markedsføring
English: The powder is a white solid lyophilisate.
Danish: Pulveret er et hvidt, fast lyofilisat.
English: How much Cosentyx is given and for how long Your doctor will decide how much Cosentyx you need and for how long.
Danish: Hvor meget Cosentyx gives der, og hvor længe Din læge vil afgøre, hvor meget Cosentyx, du har behov for, og i hvor lang tid.
English: Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction.
Danish: Hold op med at tage Cosentyx og kontakt din læge, eller søg omgående lægehjælp, hvis du bemærker tegn på en potentielt alvorlig infektion eller en allergisk reaktion.
English: Nevertheless, the use of Cosentyx pre-filled syringes in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions which cannot be completely ruled out.
Danish: Alligevel er anvendelsen af Cosentyx fyldte injektionssprøjter hos personer med overfølsomhed over for latex ikke blevet undersøgt, og der er derfor en potentiel risiko for overfølsomhedsreaktioner, som ikke helt kan udelukkes.
English: Compared with exposure after a single dose, the population pharmacokinetic analysis showed that patients exhibited a 2-fold increase in peak serum concentrations and area under the curve (AUC) following repeated monthly dosing during maintenance.
Danish: Sammenlignet med eksponering efter en enkelt dosis viste den farmakokinetiske populationsanalyse, at patienter udviste efter gentagen månedlig dosering ved vedligeholdelse 2-gange forøgelse af maksimale serumkoncentrationer og areal under kurven (AUC).
English: Improvement in both endpoints was sustained for secukinumab patients who continued treatment through to week 24.
Danish: Forbedring af begge endepunkter var bibeholdt for secukinumab-patienter som fortsatte behandling indtil uge 24.
English: The safety and efficacy of Cosentyx in children below the age of 18 years have not yet been established.
Danish: Pædiatrisk population Cosentyxs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: As a result, secukinumab inhibits the release of proinflammatory cytokines, chemokines and mediators of tissue damage and reduces IL-17A-mediated contributions to autoimmune and inflammatory diseases.
Danish: Resultatet er, at secukinumab hæmmer frigivelsen af proinflammatoriske cytokiner, kemokiner og mediatorer for vævskader samt reducerer IL-17A-medierede bidrag til autoimmune og inflammatoriske sygdomme.
English: Psoriasis study 1 (ERASURE) evaluated 738 patients.
Danish: Psoriasisstudie 1 (ERASURE) evaluerede 738 patienter.
English: In two additional placebo-controlled studies, improvement was seen in both nail psoriasis (TRANSFIGURE, 198 patients) and palmoplantar plaque psoriasis (GESTURE, 205 patients).
Danish: I yderligere to placebo-kontrollerede studier blev forbedringer observeret, ved neglepsoriasis (TRANSFIGURE, 198 patienter) og palmoplantar plaque psoriasis (GESTURE, 205 patienter).
English: If necessary, Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C.
Danish: Cosentyx kan, hvis nødvendigt, opbevares uden for køleskab i op til 4 dage ved stuetemperatur (ikke over 30°C).
English: • cold sores (oral herpes)
Danish: • forkølelsessår (oral herpes)
English: Contact your doctor if the green indicator is not visible.
Danish: hvis den grønne indikator ikke er synlig.
English: Because of the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Danish: På grund af de potentielle bivirkninger fra secukinumab hos det diende barn, skal det besluttes, om amning skal ophøre under behandling og op til 20 uger efter behandling eller behandling med Cosentyx skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til fordele ved behandling af moderen.
English: Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Danish: Secukinumab er et rekombinant fuldt humant monoklonalt antistof, der produceres i CHO-celler (ovarieceller fra kinesisk hamster).
English: Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A).
Danish: Secukinumab er et fuldt ud humant IgG1/κ monoklonalt antistof, der selektivt bindes til og neutraliserer proinflammatorisk cytokin-interleukin-17A (IL-17A).
English: Serious infections were reported in 1.2% of patients treated with secukinumab (0.015 per patient-year of follow-up).
Danish: Der blev rapporteret alvorlige infektioner hos 1,2 % af de patienter, der blev behandlet med secukinumab (0,015 pr. patientår med opfølgning).
English: The majority of patients also had active psoriasis skin lesions or a documented history of psoriasis.
Danish: Hovedparten af patienterne havde også aktive psoriatriske hudlæsioner eller dokumenteret psoriasis i anamnesen.
English: You and your doctor should decide if you will breast-feed or use Cosentyx.
Danish: Du og din læge bør beslutte, om du skal amme eller bruge Cosentyx.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Cosentyx, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: These instructions are to help you to inject correctly using the Cosentyx SensoReady pen.
Danish: Formålet med disse anvisninger er at hjælpe dig med at foretage korrekt indsprøjtning ved hjælp af Cosentyx SensoReady-pennen.
English: Any remaining solution in the vial must not be used and should be discarded in accordance with local requirements.
Danish: Eventuel ubrugt opløsning i hætteglasset må ikke anvendes og skal bortskaffes i henhold til de lokale retningslinjer.
English: Patients receiving secukinumab may receive concurrent inactivated or non-live vaccinations.
Danish: Patienter, der får secukinumab, må samtidig behandles med inaktiverede eller ikke-levende vaccinationer.
English: Secukinumab works by targeting IL-17A and inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including keratinocytes.
Danish: Secukinumab virker målrettet mod IL-17A og hæmmer dens interaktion med IL-17-receptoren, som er udtrykt på forskellige celletyper, herunder keratinocytter.
English: Psoriasis study 5 (SCULPTURE) evaluated 966 patients.
Danish: Psoriasisstudie 5 (SCULPTURE) evaluerede 966 patienter.
English: The co-primary endpoints in the placebo and active-controlled studies were the proportion of patients who achieved a PASI 75 response and IGA mod 2011 “clear” or “almost clear” response versus placebo at week 12 (see Tables 2 and 3).
Danish: De co-primære effektparametre i placebo og aktivt kontrollerede studier var andelen af patienter, der opnåede et PASI 75-respons og IGA mod 2011-respons på ”clear” eller ”almost clear”, kontra placebo, i uge 12 (se Tabel 2 og 3).
English: Do not open the sealed outer box until you are ready to use this medicine.
Danish: Du må ikke åbne den forseglede yderpakning, førend du er klar til at bruge lægemidlet.
English: Patients in Ankylosing Spondylitis study 1 (AS study 1) and Ankylosing Spondylitis study 2 (AS study 2) had a diagnosis of AS for a median of 2.7 to 5.8 years.
Danish: Patienter i ankyloserende spondylitis-studie 1 (AS-studie 1) og ankyloserende spondylitis-studie 2 (AS-studie 2) havde haft diagnosen AS i en mediantid på 2,7 til 5,8 år.
English: Inject the Cosentyx solution subcutaneously into the front of thighs, lower abdomen (but not the area 5 centimetres around the navel) or outer upper arms.
Danish: Injicer Cosentyx-opløsningen subkutant på forsiden af låret, det nederste af maven (men ikke i området 5 cm omkring navlen) eller udvendigt på overarmen.
English: Live vaccines should not be given concurrently with secukinumab.
Danish: Levende vacciner bør ikke gives sideløbende med secukinumab.
English: Carefully withdraw slightly more than 1.0 ml of the solution for subcutaneous injection from the vial into a 1 ml graduated disposable syringe using a suitable needle (e.g. 21G x 2″).
Danish: Udtag forsigtigt en smule mere end 1,0 ml af opløsningen til subkutan injektion fra hætteglasset til en 1 ml gradueret engangssprøjte ved hjælp af en passende kanyle (fx 21G x 2").
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Danish: Patienter skal instrueres i at kontakte lægen, hvis der opstår tegn eller symptomer på en infektion.
English: However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back.
Danish: Men hvis du holder op, kan dine symptomer på psoriasis, psoriasisgigt eller gigt i rygsøjlen vende tilbage.
English: Cosentyx is to be administered by subcutaneous injection.
Danish: Cosentyx skal administreres ved subkutan injektion.
English: Table 2 Summary of PASI 50/75/90/100 & IGA mod 2011 “clear” or “almost clear” clinical response in psoriasis studies 1, 3 and 4 (ERASURE, FEATURE and JUNCTURE)
Danish: Tabel 2 Resumé af PASI 50/75/90/100 og IGA mod 2011 ”clear” eller ”almost clear” klinisk virkning i psoriasisstudie 1, 3 og 4 (ERASURE, FEATURE og JUNCTURE)
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
English: A placebo-controlled study evaluated 102 patients with moderate to severe scalp psoriasis, defined as having a Psoriasis Scalp Severity Index (PSSI) score of ≥12, an IGA mod 2011 scalp only score of 3 or greater and at least 30% of the scalp surface area affected.
Danish: Et placebo-kontrolleret studie evaluerede 102 patienter med moderat til svær psoriasis i hovedbunden, defineret som Psoriasis Scalp Severity Index (PSSI) score på ≥12, IGA mod 2011 (kun hovedbund) score på 3 eller højere og påvirkning af mindst 30% af hovedbunden.
English: Secukinumab was associated with a fast onset of efficacy with a 50% reduction in mean PASI by week 3 for the 300 mg dose.
Danish: Secukinumab blev forbundet med hurtig indsættende effekt, med en 50 % reduktion i gennemsnitlig PASI i uge 3 med 300 mg dosis.
English: • signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
Danish: • tegn på lavt niveau af hvide blodceller, fx feber, ondt i halsen eller sår i munden på grund af infektioner (neutropeni)
English: Serious infections occurred in 0.14% of patients treated with secukinumab and in 0.3% of patients treated with placebo (see section 4.4).
Danish: Der opstod alvorlige infektioner hos 0,14 % af de patienter, der blev behandlet med secukinumab, og hos 0,3 % af de patienter, der blev behandlet med placebo (se pkt.
English: Its colour may vary from colourless to slightly yellow.
Danish: Farven kan variere fra farveløs til let gul.
English: The powder for solution for injection must be reconstituted before use.
Danish: Pulveret til injektionsvæske, opløsning, skal rekonstitueres før anvendelse.
English: The resulting solution should be clear and colourless to slightly yellow.
Danish: Den resulterende opløsning skal være klar og farveløs til let gul.
English: Caution should be exercised when considering the use of secukinumab in patients with a chronic infection or a history of recurrent infection.
Danish: Der bør udvises forsigtighed, når det overvejes at anvende secukinumab til patienter med en kronisk infektion eller en anamnese med gentagne infektioner.
English: The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 27 days in plaque psoriasis patients, ranging from 18 to 46 days across psoriasis studies with intravenous administration.
Danish: Den gennemsnitlige halveringstid, estimeret ud fra farmakokinetisk populationsanalyse, var 27 dage hos patienter med plaque psoriasis, varierende fra 18 til 46 dage på tværs af psoriasisstudier med intravenøs administration.
English: Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Danish: Cosentyx er alene eller i kombination med methotrexat (MTX) indiceret til behandling af aktiv psoriasisartrit hos voksne patienter, når responset på tidligere behandling med sygdomsmodificerende antireumatika (DMARD) har været utilstrækkeligt (se pkt.