natgillin/translations-raw huggingface dataset:
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.
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.
Psoriasisstudie 1 (ERASURE) evaluerede 738 patienter.
Psoriasis study 1 (ERASURE) evaluated 738 patients.
I yderligere to placebo-kontrollerede studier blev forbedringer observeret, ved neglepsoriasis (TRANSFIGURE, 198 patienter) og palmoplantar plaque psoriasis (GESTURE, 205 patienter).
In two additional placebo-controlled studies, improvement was seen in both nail psoriasis (TRANSFIGURE, 198 patients) and palmoplantar plaque psoriasis (GESTURE, 205 patients).
Cosentyx kan, hvis nødvendigt, opbevares uden for køleskab i op til 4 dage ved stuetemperatur (ikke over 30°C).
If necessary, Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C.
• forkølelsessår (oral herpes)
• cold sores (oral herpes)
hvis den grønne indikator ikke er synlig.
Contact your doctor if the green indicator is not visible.
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.
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.
Secukinumab er et rekombinant fuldt humant monoklonalt antistof, der produceres i CHO-celler (ovarieceller fra kinesisk hamster).
Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Secukinumab er et fuldt ud humant IgG1/κ monoklonalt antistof, der selektivt bindes til og neutraliserer proinflammatorisk cytokin-interleukin-17A (IL-17A).
Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A).
Der blev rapporteret alvorlige infektioner hos 1,2 % af de patienter, der blev behandlet med secukinumab (0,015 pr. patientår med opfølgning).
Serious infections were reported in 1.2% of patients treated with secukinumab (0.015 per patient-year of follow-up).
Hovedparten af patienterne havde også aktive psoriatriske hudlæsioner eller dokumenteret psoriasis i anamnesen.
The majority of patients also had active psoriasis skin lesions or a documented history of psoriasis.
Du og din læge bør beslutte, om du skal amme eller bruge Cosentyx.
You and your doctor should decide if you will breast-feed or use Cosentyx.
Hvis du ønsker yderligere oplysninger om Cosentyx, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Formålet med disse anvisninger er at hjælpe dig med at foretage korrekt indsprøjtning ved hjælp af Cosentyx SensoReady-pennen.
These instructions are to help you to inject correctly using the Cosentyx SensoReady pen.
Eventuel ubrugt opløsning i hætteglasset må ikke anvendes og skal bortskaffes i henhold til de lokale retningslinjer.
Any remaining solution in the vial must not be used and should be discarded in accordance with local requirements.
Patienter, der får secukinumab, må samtidig behandles med inaktiverede eller ikke-levende vaccinationer.
Patients receiving secukinumab may receive concurrent inactivated or non-live vaccinations.
Secukinumab virker målrettet mod IL-17A og hæmmer dens interaktion med IL-17-receptoren, som er udtrykt på forskellige celletyper, herunder keratinocytter.
Secukinumab works by targeting IL-17A and inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including keratinocytes.
Psoriasisstudie 5 (SCULPTURE) evaluerede 966 patienter.
Psoriasis study 5 (SCULPTURE) evaluated 966 patients.
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).
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).
Du må ikke åbne den forseglede yderpakning, førend du er klar til at bruge lægemidlet.
Do not open the sealed outer box until you are ready to use this medicine.
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.
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.
Injicer Cosentyx-opløsningen subkutant på forsiden af låret, det nederste af maven (men ikke i området 5 cm omkring navlen) eller udvendigt på overarmen.
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.
Levende vacciner bør ikke gives sideløbende med secukinumab.
Live vaccines should not be given concurrently with secukinumab.
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").
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″).
Patienter skal instrueres i at kontakte lægen, hvis der opstår tegn eller symptomer på en infektion.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Men hvis du holder op, kan dine symptomer på psoriasis, psoriasisgigt eller gigt i rygsøjlen vende tilbage.
However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back.
Cosentyx skal administreres ved subkutan injektion.
Cosentyx is to be administered by subcutaneous injection.
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)
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)
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
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.
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.
Secukinumab blev forbundet med hurtig indsættende effekt, med en 50 % reduktion i gennemsnitlig PASI i uge 3 med 300 mg dosis.
Secukinumab was associated with a fast onset of efficacy with a 50% reduction in mean PASI by week 3 for the 300 mg dose.
• tegn på lavt niveau af hvide blodceller, fx feber, ondt i halsen eller sår i munden på grund af infektioner (neutropeni)
• signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
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.
Serious infections occurred in 0.14% of patients treated with secukinumab and in 0.3% of patients treated with placebo (see section 4.4).
Farven kan variere fra farveløs til let gul.
Its colour may vary from colourless to slightly yellow.
Pulveret til injektionsvæske, opløsning, skal rekonstitueres før anvendelse.
The powder for solution for injection must be reconstituted before use.
Den resulterende opløsning skal være klar og farveløs til let gul.
The resulting solution should be clear and colourless to slightly yellow.
Der bør udvises forsigtighed, når det overvejes at anvende secukinumab til patienter med en kronisk infektion eller en anamnese med gentagne infektioner.
Caution should be exercised when considering the use of secukinumab in patients with a chronic infection or a history of recurrent infection.
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.
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.
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.
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).
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.
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.
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).
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).
Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
For storage conditions after reconstitution of the medicinal product, see section 6.3
Opløsningen skal anvendes inden for en time, efter den er blevet fjernet fra opbevaring ved mellem 2 °C - 8 °C.
The solution should be administered within one hour after removal from 2°C to 8°C storage.
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).
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.
Som direkte konsekvens reducerer behandling med secukinumab erytem, induration og deskvamation i plaque psoriasis-læsioner.
As a direct consequence treatment with secukinumab reduces erythema, induration and desquamation present in plaque psoriasis lesions.
Lignende respons blev set i PsA-studie 1, og effekten blev opretholdt til uge 52.
Similar responses were seen in PsA study 1 and efficacy was maintained up to week 52.
Tabel 5 Klinisk respons i PsA-studie 2 og PsA-studie 3 ved uge 16 og uge 24
Table 5 Clinical response in PsA study 2 and PsA study 3 at week 16 and week 24
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.
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.
Gennemsnitlig systemisk clearance (CL) efter en enkelt intravenøs administration til patienter med plaque psoriasis varierede fra 0,13 til 0,36 l/dag.
Mean systemic clearance (CL) following a single intravenous administration to patients with plaque psoriasis ranged from 0.13 to 0.36 l/day.
• Fortæl din læge, hvis du ammer eller planlægger at amme.
• Talk to your doctor if you are breast-feeding or are planning to breast-feed.
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).
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).
Systemorganklasse Hyppighed Bivirkning Infektioner og parasitære sygdomme
System Organ Class Frequency Adverse reaction Infections and infestations
• fodsvamp (tinea pedis)
• athlete's foot (tinea pedis)
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.
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.
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.
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.
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.
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.
Når lægemidlet er indsprøjtet, aktiveres beskyttelsesnettet, så kanylen dækkes.
After the medicine has been injected the syringe guard will be activated to cover the needle.
• feber, influenzalignende symptomer, nattesved
• fever, flu-like symptoms, night sweats
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.
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.
De fleste af disse var lette eller moderate infektioner i de øvre luftveje, såsom nasopharyngitis, og krævede ikke ophør af behandlingen.
Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation.
2 fyldte penne.
2 pre-filled pens.
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).
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).
Forbedring i PASI 75 hos patienter med samtidig psoriatisk artrit ved baseline svarede til den i den overordnede plaque psoriasis-population.
Improvements in PASI 75 in patients with concurrent psoriatic arthritis at baseline were similar to those in the overall plaque psoriasis population.
I en farmakokinetisk populationsanalyse var gennemsnitlig systemisk clearance (CL) 0,19 l/dag hos patienter med plaque psoriasis.
In a population pharmacokinetic analysis, the mean systemic clearance (CL) was 0.19 l/day in plaque psoriasis patients.
Medfølger i pakningen:
Included in the carton:
I PsA-studie 1 og PsA-studie 2 blev effekten bevaret til uge 104.
In PsA study 1 and PsA study 2, efficacy was maintained up to week 104.
• mavekramper og mavesmerter, diarré, vægttab eller blod i afføringen (tegn på tarmproblemer)
• abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
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:
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:
Vip hætteglasset til en vinkel på ca. 45°, og roter det forsigtigt mellem fingerspidserne i ca. 1 minut.
Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 1 minute.
Cosentyx bruges til behandling af følgende betændelseslignende (inflammatoriske) sygdomme:
Cosentyx is used for the treatment of the following inflammatory diseases:
Udtag lidt mere end 1,0 ml sterilt vand til injektionsvæsker til en 1 ml gradueret engangssprøjte, og juster til 1,0 ml.
Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable syringe and adjust to 1.0 ml.
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).
Statistically significant improvements at week 12 (studies 1-4) from baseline compared to placebo were demonstrated in the DLQI (Dermatology Life Quality Index).
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) • svampeinfektioner i hud og slimhinder (inkl.
Not known (frequency cannot be estimated from the available data): • fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
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.
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.
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.
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.
De fleste farmakokinetiske egenskaber, der blev observeret hos patienter med plaque psoriasis, psoriasisartrit og ankyloserende spondylitis, var sammenlignelige.
Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar.
Imputation af non-respondere anvendt for manglende binært endepunkt
Non-responder imputation used for missing binary endpoint
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.
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.
Imputation af non-respondere anvendt for manglende binært endepunkt.
Non-responder imputation used for missing binary endpoint.
Prækliniske data viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, gentagne doser, reproduktionstoksicitet eller vævskrydsreaktivitet.
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.
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.
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.
polysorbat 80 og vand til injektionsvæsker.
methionine, polysorbate 80 and water for injections.
Der er ingen tilgængelige farmakokinetiske data for patienter med nyre- eller leverinsufficiens.
No pharmacokinetic data are available in patients with renal or hepatic impairment.
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.
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.
I psoriasisartrit-studie 1 (PsA-studie 1) og psoriasisartrit-studie 2 (PsA-studie 2) var det primære endepunkt ved uge 24.
For Psoriatic Arthritis study 1 (PsA study 1) and Psoriatic Arthritis study 2 (PsA study 2), the primary endpoint was at week 24.
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.
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.
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.
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.