FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study, after meningococcal and inactivated influenza vaccinations, a similar proportion of healthy volunteers treated with 150 mg of secukinumab and those treated with placebo were able to mount an adequate immune response of at least a 4-fold increase in antibody titres to meningococcal and influenza vaccines.
Danish: Et studie har vist, at efter meningokok- og inaktiverede influenzavaccinationer var en lignende andel raske frivillige, der blev behandlet med 150 mg secukinumab, og de, der blev behandlet med placebo, i stand til at udvise et tilstrækkeligt immonrespons på mindst en firedoblet forøgelse af antistoftitre over for meningokok- og influenzavacciner.
English: Of the 2,403 patients who were included in the placebo-controlled studies, 79% were biologic-naive, 45% were non-biologic failures and 8% were biologic failures (6% were anti-TNF failures, and 2% were anti-p40 failures).
Danish: Ud af de 2.403 patienter, der deltog i de placebokontrollerede studier, var 79 % biologisk behandlingsnaive, 45 % var ikke-biologiske behandlingssvigt og 8 % var biologiske behandlingssvigt (6 % var anti-TNF behandlingssvigt og 2 % var anti-p40-behandlingssvigt).
English: For storage conditions after reconstitution of the medicinal product, see section 6.3
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: The solution should be administered within one hour after removal from 2°C to 8°C storage.
Danish: Opløsningen skal anvendes inden for en time, efter den er blevet fjernet fra opbevaring ved mellem 2 °C - 8 °C.
English: This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Danish: Dette lægemiddel fungerer ved at neutralisere aktiviteten af et protein kaldet IL-17A, der findes i øgede mængder ved lidelser som fx psoriasis, psoriasisgigt og gigt i rygsøjlen (ankyloserende spondylitis).
English: As a direct consequence treatment with secukinumab reduces erythema, induration and desquamation present in plaque psoriasis lesions.
Danish: Som direkte konsekvens reducerer behandling med secukinumab erytem, induration og deskvamation i plaque psoriasis-læsioner.
English: Similar responses were seen in PsA study 1 and efficacy was maintained up to week 52.
Danish: Lignende respons blev set i PsA-studie 1, og effekten blev opretholdt til uge 52.
English: Table 5 Clinical response in PsA study 2 and PsA study 3 at week 16 and week 24
Danish: Tabel 5 Klinisk respons i PsA-studie 2 og PsA-studie 3 ved uge 16 og uge 24
English: For Psoriatic Arthritis study 3 (PsA study 3), the primary endpoint was at week 16 with the key secondary endpoint, the change from baseline in modified Total Sharp Score (mTSS), at week 24.
Danish: I psoriasisartrit-studie 3 (PsA-studie 3) var det primære endepunkt ved uge 16 med det vigtigste sekundære endepunkt; ændring fra baseline i modificeret total Sharp Score (mTSS) ved uge 24.
English: Mean systemic clearance (CL) following a single intravenous administration to patients with plaque psoriasis ranged from 0.13 to 0.36 l/day.
Danish: Gennemsnitlig systemisk clearance (CL) efter en enkelt intravenøs administration til patienter med plaque psoriasis varierede fra 0,13 til 0,36 l/dag.
English: • Talk to your doctor if you are breast-feeding or are planning to breast-feed.
Danish: • Fortæl din læge, hvis du ammer eller planlægger at amme.
English: Over the entire treatment period (a total of 3,430 patients treated with secukinumab for up to 52 weeks for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab (0.9 per patient-year of follow-up).
Danish: Over hele behandlingsperioden (i alt blev 3.430 patienter behandlet med secukinumab i op til 52 uger for hovedparten af patienternes vedkommende) blev der rapporteret infektioner hos 47,5 % af de patienter, der blev behandlet med secukinumab (0,9 pr. patientår med opfølgning).
English: System Organ Class Frequency Adverse reaction Infections and infestations
Danish: Systemorganklasse Hyppighed Bivirkning Infektioner og parasitære sygdomme
English: • athlete's foot (tinea pedis)
Danish: • fodsvamp (tinea pedis)
English: The mean volume of distribution during the terminal phase (Vz) following single intravenous administration ranged from 7.10 to 8.60 litres in plaque psoriasis patients, suggesting that secukinumab undergoes limited distribution to peripheral compartments.
Danish: Det gennemsnitlige fordelingsvolumen under den terminale fase (Vz) efter enkel intravenøs administration varierede mellem 7,10 og 8,60 liter hos patienter med plaque psoriasis, hvilket antyder, at secukinumab i begrænset omfang fordeler sig til perifere dele.
English: The 300 mg dose provided improved skin clearance particularly for “clear” or “almost clear” skin across the efficacy endpoints of PASI 90, PASI 100, and IGA mod 2011 0 or 1 response across all studies with peak effects seen at week 16, therefore this dose is recommended.
Danish: Dosis på 300 mg gav forbedret hudrenhed, specielt for ”clear” og ”almost clear” hud på tværs af effektparameterne PASI 90, PASI 100 og IGA mod 2011 0- eller 1-respons på tværs af alle studier med maksimale virkninger i uge 16; og derfor anbefales denne dosis.
English: Over 17,900 patients have been treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions), representing 29,978 patient years of exposure.
Danish: Mere end 17.900 patienter er blevet behandlet med secukinumab i blindede og åbne kliniske studier inden for forskellige indikationer (plaque psoriasis, psoriasisartrit, ankyloserende spondylitis og andre autoimmunsygdomme), svarende til eksponering i 29.978 patientår.
English: After the medicine has been injected the syringe guard will be activated to cover the needle.
Danish: Når lægemidlet er indsprøjtet, aktiveres beskyttelsesnettet, så kanylen dækkes.
English: • fever, flu-like symptoms, night sweats
Danish: • feber, influenzalignende symptomer, nattesved
English: Statistically significant improvements at week 4 from baseline in patients treated with secukinumab compared to patients treated with ustekinumab (CLEAR) were demonstrated in the DLQI and these improvements were maintained for up to 52 weeks.
Danish: Ved uge 4 blev der påvist statistisk signifikante forbedringer fra baseline hos patienter behandlet med secukinumab sammenlignet med patienter behandlet med ustekinumab (CLEAR) i DLQI, og disse forbedringer blev opretholdt op til uge 52.
English: Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation.
Danish: De fleste af disse var lette eller moderate infektioner i de øvre luftveje, såsom nasopharyngitis, og krævede ikke ophør af behandlingen.
English: 2 pre-filled pens.
Danish: 2 fyldte penne.
English: Secukinumab-treated patients reported significant improvements in health-related quality of life as measured by the Short Form-36 Health Survey Physical Component Summary (SF-36 PCS) score (p<0.001).
Danish: Patienter behandlet med secukinumab rapporterede signifikante forbedringer i helbredsrelateret livskvalitet, målt ved Short Form-36 Health Survey Physical Component Summary (SF-36 PCS)-score (p<0,001).
English: Improvements in PASI 75 in patients with concurrent psoriatic arthritis at baseline were similar to those in the overall plaque psoriasis population.
Danish: Forbedring i PASI 75 hos patienter med samtidig psoriatisk artrit ved baseline svarede til den i den overordnede plaque psoriasis-population.
English: In a population pharmacokinetic analysis, the mean systemic clearance (CL) was 0.19 l/day in plaque psoriasis patients.
Danish: I en farmakokinetisk populationsanalyse var gennemsnitlig systemisk clearance (CL) 0,19 l/dag hos patienter med plaque psoriasis.
English: Included in the carton:
Danish: Medfølger i pakningen:
English: In PsA study 1 and PsA study 2, efficacy was maintained up to week 104.
Danish: I PsA-studie 1 og PsA-studie 2 blev effekten bevaret til uge 104.
English: • abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
Danish: • mavekramper og mavesmerter, diarré, vægttab eller blod i afføringen (tegn på tarmproblemer)
English: For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did not respond well to medicines called tumour necrosis factor (TNF) blockers:
Danish: Patienter med psoriasisgigt, som også har moderat til svær plaque psoriasis, og patienter, hvor lægemidler, der hedder tumornekrosefaktor (TNF)-blokkere, ikke har haft en god virkning:
English: Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 1 minute.
Danish: Vip hætteglasset til en vinkel på ca. 45°, og roter det forsigtigt mellem fingerspidserne i ca. 1 minut.
English: Cosentyx is used for the treatment of the following inflammatory diseases:
Danish: Cosentyx bruges til behandling af følgende betændelseslignende (inflammatoriske) sygdomme:
English: Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable syringe and adjust to 1.0 ml.
Danish: Udtag lidt mere end 1,0 ml sterilt vand til injektionsvæsker til en 1 ml gradueret engangssprøjte, og juster til 1,0 ml.
English: Statistically significant improvements at week 12 (studies 1-4) from baseline compared to placebo were demonstrated in the DLQI (Dermatology Life Quality Index).
Danish: Ved uge 12 blev der påvist statistisk signifikante forbedringer (studie 1-4) fra udgangsværdien sammenlignet med placebo i DLQI (Dermatology Life Quality Index; dermatologisk livskvalitetsindeks).
English: Not known (frequency cannot be estimated from the available data): • fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) • svampeinfektioner i hud og slimhinder (inkl.
English: On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively.
Danish: På baggrund af simuleret data var maksimale koncentrationer ved steady-state (Cmax,ss) efter subkutan administration af 150 mg eller 300 mg henholdsvis 27,6 µg/ml og 55,2 µg/ml.
English: Secukinumab 300 mg met the primary and secondary endpoints by showing superiority to ustekinumab based on PASI 90 response at week 16 (primary endpoint), speed of onset of PASI 75 response at week 4, and long-term PASI 90 response at week 52.
Danish: Secukinumab 300 mg opfyldte de primære og sekundære endepunkter ved at være superior i forhold til ustekinumab baseret på PASI 90-respons ved uge 16 (primære endepunkt), hurtigheden af indtræden af PASI 75-respons ved uge 4 samt langsigtet PASI 90 respons ved uge 52.
English: Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar.
Danish: De fleste farmakokinetiske egenskaber, der blev observeret hos patienter med plaque psoriasis, psoriasisartrit og ankyloserende spondylitis, var sammenlignelige.
English: Non-responder imputation used for missing binary endpoint
Danish: Imputation af non-respondere anvendt for manglende binært endepunkt
English: In a study with secukinumab, infiltrating epidermal neutrophils and various neutrophil-associated markers that are increased in lesional skin of plaque psoriasis patients were significantly reduced after one to two weeks of treatment.
Danish: I et studie med secukinumab blev infiltrerende epidermale neutrofiler og forskellige neutrofil-associerede markører, der øges i hud med læsioner hos patienter med plaque psoriasis, reduceret efter en til to ugers behandling.
English: Non-responder imputation used for missing binary endpoint.
Danish: Imputation af non-respondere anvendt for manglende binært endepunkt.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose and reproductive toxicity, or tissue cross-reactivity.
Danish: Prækliniske data viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, gentagne doser, reproduktionstoksicitet eller vævskrydsreaktivitet.
English: Following a single subcutaneous dose of 300 mg as a liquid formulation in healthy volunteers, secukinumab reached peak serum concentrations of 43.2±10.4 μg/ml between 2 and 14 days post dose.
Danish: Efter en enkelt subkutan dosis på 300 mg som flydende formulering hos raske frivillige, nåede secukinumab maksimale serumkoncentrationer på 43,2±10,4 μg/ml mellem 2 og 14 dage efter dosis.
English: methionine, polysorbate 80 and water for injections.
Danish: polysorbat 80 og vand til injektionsvæsker.
English: No pharmacokinetic data are available in patients with renal or hepatic impairment.
Danish: Der er ingen tilgængelige farmakokinetiske data for patienter med nyre- eller leverinsufficiens.
English: All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all endpoints at week 16.
Danish: Alle p-værdier er justeret for testmultiplicitet ud fra prædefineret hierarki ved uge 24 for PsA-studie 2, bortset fra ACR70, dactylitis og enthesitis, som var eksplorative endepunkter og alle endepunkter ved uge 16.
English: For Psoriatic Arthritis study 1 (PsA study 1) and Psoriatic Arthritis study 2 (PsA study 2), the primary endpoint was at week 24.
Danish: I psoriasisartrit-studie 1 (PsA-studie 1) og psoriasisartrit-studie 2 (PsA-studie 2) var det primære endepunkt ved uge 24.
English: The onset of action of secukinumab 150 mg occurred as early as week 1 for ASAS 20 and week 2 for ASAS 40 (superior to placebo) in AS study 2.
Danish: Virkningen af secukinumab 150 mg indtraf allerede ved uge 1 for ASAS 20 og uge 2 for ASAS 40 (superior i forhold til placebo) i AS-studie 2.
English: There were also statistically significant improvements demonstrated in exploratory endpoints assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores for 150 mg and 300 mg compared to placebo (7.97, 5.97 versus 1.63, respectively) and these improvements were maintained up to week 104 in PsA study 2.
Danish: Der blev også demonstreret statistisk signifikante forbedringer i eksplorative endepunkter ved Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)-scorer for 150 mg og 300 mg sammenlignet med placebo (henholdsvis 7,97 og 5,97 sammenlignet med 1,63) og disse forbedringer blev opretholdt til uge 104 i PsA-studie 2.
English: Cosentyx is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label.
Danish: Cosentyx leveres i en fyldt injektionssprøjte til engangsbrug, samlet i en trekantet pen med transparent vindue og etiket.
English: PEN LABEL
Danish: ETIKET PÅ PEN
English: IGA mod 2011 “clear” or “almost clear” response n (%) * The IGA mod 2011 is a 5-category scale including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe”, indicating the physician's overall assessment of the psoriasis severity focusing on induration, erythema and scaling.
Danish: IGA mod 2011 ”clear” eller ”almost clear”- respons n (%) * IGA mod 2011 er en skala på fem kategorier, hvor ”0 = clear”, ”1 = almost clear”, ”2 = let”, ”3 = moderat” og ”4 = svær”, der angiver lægens overordnede vurdering af sværhedsgraden af psoriasisen, med fokus på induration, erytem og afskalning.
English: Effect of weight on pharmacokinetics Secukinumab clearance and volume of distribution increase as body weight increases.
Danish: Vægtens indflydelse på farmakokinetikken Ved vægtøgning øges clearance og fordelingsvolumen af secukinumab.
English: In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1,382 patients treated with secukinumab and 694 patients treated with placebo for up to 12 weeks), infections were reported in 28.7% of patients treated with secukinumab compared with 18.9% of patients treated with placebo.
Danish: I den placebokontrollerede periode i de kliniske studier med plaque psoriasis (i alt 1.382 patienter blev behandlet med secukinumab, og 694 patienter blev behandlet med placebo i op til 12 uger), blev der rapporteret infektioner hos 28,7 % af patienterne, der blev behandlet med secukinumab, sammenlignet med 18,9 % af patienterne, der blev behandlet med placebo.
English: For other psoriatic arthritis patients:
Danish: Andre patienter med psoriasisgigt:
English: Table 7 Clinical response in AS study 2 at week 16
Danish: Tabel 7 Klinisk respons i AS-studie 2 ved uge 16
English: Cosentyx can potentially cause serious side effects, including infections and allergic reactions.
Danish: Vær opmærksom på infektioner og allergiske reaktioner Cosentyx kan eventuelt forårsage alvorlige bivirkninger, herunder infektioner og allergiske reaktioner.
English: Driving and using machines Cosentyx is unlikely to influence your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Cosentyx vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: • oral thrush (oral candidiasis)
Danish: • trøske i munden (oral candidiasis)
English: What Cosentyx contains - The active substance is secukinumab.
Danish: Cosentyx indeholder: - Aktivt stof: secukinumab.
English: This needle will only be used for withdrawing Cosentyx into the disposable syringe.
Danish: Denne kanyle skal kun anvendes til udtagning af Cosentyx til engangssprøjten.
English: Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation affecting the skin.
Danish: Cosentyx anvendes til behandling af en hudlidelse, kaldet ”plaque psoriasis”, som forårsager betændelse, der påvirker huden.
English: Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
Danish: Husk at tage injektionssprøjten ud af køleskabet, og lad den opnå stuetemperatur, før den klargøres til indsprøjtning (15-30 minutter).
English: Insert the syringe needle into the vial containing the powder through the centre of the rubber stopper and reconstitute the powder by slowly injecting 1.0 ml of sterile water for injections into the vial.
Danish: Sæt sprøjten i hætteglasset, der indeholder pulveret, gennem midten af gummiproppen, og rekonstituer pulveret ved langsomt at injicere 1,0 ml sterilt vand til injektionsvæsker i hætteglasset.
English: Week 52 Placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg
Danish: Uge 52 Placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg
English: Treatment with secukinumab resulted in significant improvement in measures of disease activity compared to placebo at weeks 16 and 24 (see Table 5).
Danish: Behandling med secukinumab medførte signifikant forbedring i målene for sygdomsaktivitet sammenlignet med placebo ved uge 16 og 24 (se tabel 5).
English: Caution should be exercised when considering concomitant use of other immunosuppressants and secukinumab (see also section 4.5).
Danish: Der bør udvises forsigtighed når samtidig behandling med andre immunsuppressiva og secukinumab overvejes (se også pkt.
English: Cosentyx is supplied in a colourless glass vial with a grey coated rubber stopper and aluminium cap with a white flip-off component containing 150 mg of secukinumab.
Danish: Cosentyx leveres i et farveløst hætteglas med grå overtrukket gummiprop og aluminiumlåg med en hvid ”flip off”-komponent indeholdende 150 mg secukinumab.
English: • feeling tired or short of breath, cough which will not go away
Danish: • træthedsfornemmelse, åndenød og hoste, der ikke forsvinder
English: Secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month †In patients with dactylitis at baseline (n=27, 32, 46, respectively for PsA study 2 and n=124, 80, 82, respectively for PsA study 3) ‡In patients with enthesitis at baseline (n=65, 64, 56, respectively for PsA study 2 and n=192, 141, 140, respectively for PsA study 3)
Danish: Secukinumab 150 mg eller 300 mg s.c ved uge 0, 1, 2, 3 og 4, efterfulgt af den samme dosis hver måned †Hos patienter med dactylitis ved baseline (n=henholdsvis 27, 32, 46 for PsA-studie 2 og n=henholdsvis 124, 80, 82 for PsA-studie 3) ‡Hos patienter med enthesitis ved baseline (n=henholdsvis 65, 64, 56 for PsA-studie 2 og n=henholdsvis 192, 141, 140 for PsA-studie 3)
English: Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Danish: Cosentyx er indiceret til behandling af aktiv ankyloserende spondylitis hos voksne, når responset på konventionel terapi har været utilstrækkeligt.
English: Cosentyx is used in adults with moderate to severe plaque psoriasis.
Danish: Cosentyx anvendes til voksne med moderat til svær plaque psoriasis.
English: Clean the injection site with an alcohol swab.
Danish: Rens injektionsstedet med en spritserviet.
English: If you forget to use Cosentyx
Danish: Hvis du har glemt at bruge Cosentyx
English: If you stop using Cosentyx
Danish: Hvis du holder op med at bruge Cosentyx
English: In the anti-TNFα-IR patients subgroup, only the 300 mg dose showed significantly higher response rate for ACR 20 compared to placebo (p<0.05) and demonstrated clinical meaningful benefit over 150 mg on multiple secondary endpoints.
Danish: I anti-TNFα-IR-subgruppen var det kun 300 mg dosen, der viste en signifikant højere responsrate for ACR20 sammenlignet med placebo (p<0,05), og som viste en klinisk betydende fordel i forhold til 150 mg på flere af de sekundære endepunkter.
English: IGA mod 2011 “clear” or “almost clear” response n (%)
Danish: IGA mod 2011 “clear” eller “almost clear” respons n (%)
English: Replace the attached needle with a 27G x ½″ needle.
Danish: Skift den påsatte kanyle ud med en 27G x ½" kanyle.
English: Other medicines and Cosentyx
Danish: Brug af anden medicin sammen med Cosentyx
English: All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 16 for PsA study 3, except for ACR70 which was an exploratory endpoint and all endpoints at week 24.
Danish: Alle p-værdier er justeret for testmultiplicitet ud fra prædefineret hierarki ved uge 16 for PsA-studie 3, bortset fra ACR70, som var et eksplorativt endepunkt og alle endepunkter ved uge 24.
English: The box contains Cosentyx pre-filled syringe(s) individually sealed in a plastic blister.
Danish: Pakningen indeholder Cosentyx fyldt(e) injektionssprøjte(r), der er forseglet enkeltvis i en plastblister.
English: The single-use vial contains 150 mg secukinumab for reconstitution with sterile water for injections.
Danish: Engangshætteglasset indeholder 150 mg secukinumab til rekonstitution med sterilt vand til injektionsvæsker.
English: Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the following side effects:
Danish: Stop med at bruge Cosentyx, og kontakt din læge, eller søg omgående lægehjælp, hvis du oplever en eller flere af nedenstående bivirkninger.
English: In PsA study 1, inhibition of structural damage was maintained with secukinumab treatment up to week 52.
Danish: I PsA-studie 1 blev hæmningen af strukturelle skader opretholdt ved behandling med secukinumab til uge 52.
English: Comprehensive instructions for administration are given in the package leaflet.
Danish: Indlægssedlen indeholder omfattende anvisninger om administration.
English: Patients randomised to etanercept received 50 mg doses twice per week for 12 weeks followed by 50 mg every week.
Danish: Patienter, der var randomiseret til etanercept, fik doser på 50 mg to gange om ugen i 12 uger, fulgt af 50 mg hver uge.
English: Prepare the required number of syringes (2 syringes for the 300 mg dose).
Danish: Klargør det nødvendige antal sprøjter (2 sprøjter til dosis på 300 mg).
English: • lower respiratory tract infections
Danish: • infektioner i de nedre luftveje