FrancophonIA/ELRC3.0 huggingface dataset:
English: By touching them, the syringe guard may be activated too early.
Danish: Rører du ved dem, kan de måske blive aktiveret for tidligt.
English: Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, der intet respons har vist efter 16 ugers behandling.
English: The preparation time from piercing the stopper until end of reconstitution takes 20 minutes on average and should not exceed 90 minutes.
Danish: Klargøringstiden fra gennembrydning af proppen til rekonstitution er afsluttet varer i gennemsnit 20 minutter og bør ikke overstige 90 minutter.
English: Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: Fortæl din læge, hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid.
English: After initial weekly dosing during the first month, time to reach the maximum concentration was between 31 and 34 days based on population pharmacokinetic analysis.
Danish: Efter indledende ugentlig dosering i den første måned var tidsintervallet til opnåelse af maksimal koncentration på mellem 31 og 34 dage baseret på farmakokinetisk populationsanalyse.
English: For both studies, the primary endpoint was at least a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) criteria at week 16.
Danish: For begge studier var det primære endepunkt mindst 20 % forbedring i Assessment of Spondyloarthritis International Society (ASAS 20)-kriterier ved uge 16.
English: Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not been studied in this age group.
Danish: Cosentyx bør ikke bruges til børn og unge (under 18 år), da der ikke er gennemført studier for denne aldersgruppe.
English: Animal studies have not been conducted to evaluate the carcinogenic potential of secukinumab.
Danish: Der er ikke gennemført studier på dyr for at vurdere det karcinogene potentiale for secukinumab.
English: Patients were blinded to the treatment regimen up to week 52, and the study continued to week 156.
Danish: Patienter blev blindede for behandlingsregimet op til uge 52 og studiet fortsatte indtil uge 156.
English: • if you have recently had or are due to have a vaccination.
Danish: • hvis du for nylig har fået eller skal have en vaccination.
English: The primary endpoint was ASAS 20 at week 16.
Danish: Det primære endepunkt var ASAS 20 ved uge 16.
English: Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Danish: Nogle patienter, der til at begynde med udviser partielt respons, kan efterfølgende bedres med fortsat behandling ud over de 16 uger.
English: Statistically significant difference in ACR 20 versus placebo was reached at week 3.
Danish: Statistisk signifikante forskelle i ACR20 versus placebo var opnået ved uge 3.
English: Percentage of responders
Danish: Procentvist antal respondere
English: No increased susceptibility to tuberculosis was reported from clinical studies.
Danish: Der er ikke rapporteret om øget modtagelighed for tuberkulose fra kliniske studier.
English: Possible serious infection - the signs may include:
Danish: Potentielt alvorlig infektion - tegnene kan være:
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Din læge vil holde øje med din tilstand for at kontrollere, at behandlingen virker, som den skal.
English: Week 24 data are presented in Table 6.
Danish: Data for uge 24 er vist i tabel 6.
English: • severe allergic reaction with shock (anaphylactic reaction)
Danish: • alvorlige allergiske reaktioner med shock (anafylaktisk reaktion)
English: Caregivers and healthcare professionals only:
Danish: Kun for omsorgspersoner og sundhedspersonale:
English: Clearance was dose- and time-independent.
Danish: Clearance var dosis- og tidsuafhængig.
English: ASAS partial remission, %
Danish: ASAS partiel remission, %
English: • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Danish: • hvis du modtager nogen anden form for behandling for psoriasis, eksempelvis en anden immunosuppressiv eller lysbehandling med ultraviolet lys (UV-lys).
English: However, secukinumab should not be given to patients with active tuberculosis.
Danish: Secukinumab må dog ikke gives til patienter med aktiv tuberkulose.
English: Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity.
Danish: Doser på op til 30 mg/kg (ca. 2.000 til 3.000 mg) er administreret intravenøst i kliniske studier uden dosisbegrænsende toksicitet.
English: If a patient develops a serious infection, the patient should be closely monitored and secukinumab should not be administered until the infection resolves.
Danish: Hvis patienten udvikler en alvorlig infektion, skal patienten monitoreres tæt, og secukinumab må ikke administreres, før infektionen er ophørt.
English: Cosentyx is for long-term treatment.
Danish: Cosentyx er til langtidsbehandling.
English: There are no adequate data from the use of secukinumab in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af secukinumab hos gravide kvinder.
English: • if you have recently had a vaccination or if you are due to have a vaccination during treatment with Cosentyx.
Danish: • hvis du er blevet vaccineret for nylig, eller hvis du skal have en vaccination under behandling med Cosentyx.
English: Similar responses were seen in PsA study 1.
Danish: Lignende respons blev set i PsA-studie 1.
English: Do not use this medicine:
Danish: Brug ikke lægemidlet
English: You may see a small air bubble, which is normal.
Danish: Du vil evt. kunne se en lille luftboble, hvilket er helt normalt.
English: The effect of secukinumab on human fertility has not been evaluated.
Danish: Virkningen af secukinumab på human fertilitet er ikke undersøgt.
English: The preparation of the solution for subcutaneous injection must be done without interruption and ensuring that aseptic technique is used.
Danish: Klargøring af opløsningen til subkutan injektion skal udføres uden afbrydelse, og det skal sikres, at der anvendes aseptisk teknik.
English: The following information is intended for medical or healthcare professionals only.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale.
English: Neutropenia <1.0-0.5x10
Danish: Neutropeni<1,0-0,5x10
English: Elderly patients (aged 65 years and over) No dose adjustment is required (see section 5.2).
Danish: Ældre patienter (65 år og derover) Dosisjustering er ikke påkrævet (se pkt.
English: If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember.
Danish: Hvis du har glemt at indsprøjte en dosis Cosentyx, skal du indsprøjte den næste dosis, så snart du kommer i tanke om det.
English: Over 61% and 42% of the PsA patients had enthesitis and dactylitis at baseline, respectively.
Danish: Over 61 % og 42 % af PsA-patienterne havde henholdsvis enthesitis eller dactylitis ved baseline.
English: Patients should be instructed to inject the full amount of Cosentyx according to the instructions provided in the package leaflet.
Danish: Patienterne skal instrueres i at injicere den fulde mængde Cosentyx i henhold til de anvisninger, der er angivet i indlægssedlen.
English: Serious allergic reaction - the signs may include:
Danish: Alvorlig allergisk reaktion - tegnene kan være:
English: If you have received more Cosentyx than you should or the dose has been administered sooner than according to your doctor's prescription, inform your doctor.
Danish: Hvis du har fået mere Cosentyx, end du burde, eller hvis dosis er blevet givet tidligere end i henhold til din læges anvisning, skal du informere din læge.
English: The majority of IgG elimination occurs via intracellular catabolism, following fluid-phase or receptor mediated endocytosis.
Danish: Hovedparten af IgG-elimination finder sted via intracellulær katabolisme efter væskefase eller receptormedieret endocytose.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Danish: Dyrestudier tyder ikke på direkte eller indirekte skadelige virkninger med hensyn til fertilitet.
English: Secukinumab has been shown to lower (within 1 to 2 weeks of treatment) levels of C-reactive protein, which is a marker of inflammation.
Danish: Det er blevet påvist, at secukinumab sænker (inden for 1 til 2 ugers behandling) koncentrationen af C-reaktivt protein, som er en markør for inflammation.
English: After using Cosentyx you should not breast-feed for at least 20 weeks after the last dose.
Danish: Efter brug af Cosentyx bør du ikke amme i mindst 20 uger efter sidste dosis.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Danish: Det er vigtigt, at du ikke forsøger at klare indsprøjtningen selv, før du er blevet undervist i at gøre det af din læge, sundhedspersonalet eller apotekspersonalet.
English: ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Body Surface Area
Danish: ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Legemsoverfladeareal (Body Surface Area)
English: Clinically relevant levels of secukinumab reach the skin and reduce local inflammatory markers.
Danish: Klinisk relevante niveauer af secukinumab når huden og reducerer lokale inflammatoriske markører.
English: Rare cases of neutropenia <0.5x10
Danish: Sjældne tilfælde af neutropeni <0,5x10
English: The data suggest that secukinumab does not suppress the humoral immune response to the meningococcal or influenza vaccines.
Danish: Dataene antyder, at secukinumab ikke undertrykker humoral immunrespons over for meningokok- og influenzavacciner.
English: • low blood pressure, which can cause dizziness or light-headedness
Danish: • lavt blodtryk, som kan forårsage svimmelhed eller omtågethed
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2ºC to 8ºC.
Danish: Der er dokumenteret kemisk og fysisk stabilitet efter rekonstitution i 24 timer ved 2 ºC - 8 ºC.
English: About half of the treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of efficacy or pharmacokinetic abnormalities.
Danish: Omkring halvdelen af de behandlingsfremkaldte antistoffer mod lægemidlet var neutraliserende, men dette blev ikke associeret med manglende virkning eller farmakokinetiske abnormaliteter.
English: Improvements in HAQ-DI scores were seen regardless of previous anti-TNFα exposure.
Danish: Forbedringer i HAQ-DIscore sås uanset tidligere eksponering for anti-TNFα.
English: The percentage of patients achieving ACR 20 response by visit is shown in Figure 2.
Danish: Procentdelen af patienter, der opnåede ACR20-respons som funktion af besøg, er vist i figur 2.
English: Viewing window, label & expiry date
Danish: Vindue, etiket og udløbsdato
English: Table 6 Change in modified Total Sharp Score in psoriatic arthritis
Danish: Tabel 6 Ændring i modificeret Total Sharp Score ved psoriasisartrit
English: If an anaphylactic or other serious allergic reactions occur, administration of secukinumab should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk eller andre alvorlige allergiske reaktioner, skal administration af secukinumab stoppes straks og relevant behandling påbegyndes.
English: Overall, the efficacy response rates for the 300 mg group were consistently greater compared to the 150 mg group for the secondary endpoints.
Danish: Overordnet var effektresponsraten for 300 mg-gruppen konsekvent større sammenlignet med 150 mg-gruppen for det sekundære endepunkt.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment.
Danish: Kvinder i den fertile alder bør anvende en effektiv kontraception under behandling og i mindst 20 uger efter behandling.
English: • infection of the external ear (otitis externa)
Danish: • infektion i øregangen (otitis externa)
English: In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for tegn eller symptomer på bivirkninger, og at passende symptomatisk behandling omgående iværksættes.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Danish: Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden
English: The needle cap of the syringe may contain dry rubber (latex), which should not be handled by persons sensitive to this substance.
Danish: Sprøjtens kanylehætte kan indeholde tørt gummi (latex), der ikke må håndteres af personer, der er overfølsomme for dette stof.
English: Correct Incorrect
Danish: Rigtigt Forkert
English: Do not use Cosentyx:
Danish: Tag ikke Cosentyx:
English: Population pharmacokinetic analysis suggests that steady-state is reached after 20 weeks with monthly dosing regimens.
Danish: Farmakokinetisk populationsanalyse indikerer, at steady-state nås efter 20 uger med månedlig doseringsregime.
English: It is not dangerous to stop using Cosentyx.
Danish: Det er ikke farligt at holde op med at bruge Cosentyx.
English: There was an increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases were mild or moderate in severity, non-serious, responsive to standard treatment and did not necessitate treatment discontinuation.
Danish: Der var en stigning i mukosal eller kutan candidiasis, i overensstemmelse med virkningsmekanismen, men tilfældene var lette eller moderate, ikke-alvorlige samt reagerede på standardbehandling og nødvendiggjorde ikke afbrydelse af behandlingen.
English: Treatment success of “clear” or “almost clear” consisted of no signs of psoriasis or normal to pink colouration of lesions, no thickening of the plaque and none to minimal focal scaling.
Danish: Behandlingens succes i forhold til ”clear” eller ”almost clear” bestod af ingen tegn på psoriasis eller normalt- til pinkfarvede læsioner, ingen fortykning af plaque og ingen til minimal fokal afskalning.
English: • if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for secukinumab eller et af de øvrige indholdsstoffer i Cosentyx (angivet i punkt 6).
English: If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Danish: Hudområder, hvor der er udbrud af psoriasis, skal om muligt undgås som injektionssteder.
English: Approximately 15 to 25% of patients in phase III studies had psoriatic arthritis (PsA) at baseline.
Danish: Omkring 15 til 25 % af patienterne i fase III-studierne havde psoriasis artritis (PsA) ved baseline.
English: IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
Danish: IL-17A er et naturligt forekommende cytokin, der er involveret i normale inflammatoriske reaktioner eller immunreaktioner.
English: The bioavailability of secukinumab in PsA patients was 85% on the basis of the population pharmacokinetic model.
Danish: Secukinumabs biotilgængelighed hos PsA-patienter var 85 % baseret på den farmakokinetiske populationsmodel.
English: If you think you may be allergic, ask your doctor for advice before using Cosentyx.
Danish: Hvis du mener, at du er allergisk, skal du spørge lægen til råds, før du bruger Cosentyx.
English: ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; ASDAS: Ankylosing Spondylitis Disease Activity Score; BSL: baseline
Danish: ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; hsCRP: højsensitivt C-reaktivt protein; ASDAS: Ankylosing Spondylitis Disease Activity Score; BSL: baseline
English: Specific locations/forms of plaque psoriasis
Danish: Specifikke lokationer/former for plaque psoriasis
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC10
Danish: Farmakoterapeutisk klassifikation: Immunosuppressiv, interleukin-hæmmere, ATC-kode: L04AC10
English: In PsA study 3, inhibition of progression of structural damage was assessed radiographically and expressed by the modified Total Sharp Score (mTSS) and its components, the Erosion Score (ES) and the Joint Space Narrowing Score (JSN).
Danish: I PsA-studie 3 blev hæmning af progression af strukturelle skader vurderet radiografisk og udtrykt som modificeret total Sharp Score (mTSS) og dets komponenter Erosion Score (ES) og Joint Space Narrowing (JSN) score.
English: Figure 1 Time course of percentage change from baseline of mean PASI score in study 1 (ERASURE)
Danish: Figur 1 Tidsforløb for procentvis ændring fra udgangsværdi for gennemsnitlig PASI-score i studie 1 (ERASURE)
English: Quality of life/patient-reported outcomes
Danish: Livskvalitet/patientrapporterede resultater
English: Forty percent of the participants in studies 1 and 2 completed the Psoriasis Symptom Diary©.
Danish: 40 % af deltagerne i studie 1 og 2 førte dagbogen Psoriasis Symptom Diary©.
English: Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.
Danish: Cosentyx er beregnet til anvendelse under vejledning og tilsyn af en læge, der har erfaring med diagnosering og behandling af tilstande, hvortil Cosentyx er indiceret.
English: Similar responses for primary and key secondary endpoints were seen in PsA patients regardless of whether they were on concomitant MTX treatment or not.
Danish: Der sås lignende respons for primære og vigtige sekundære endepunkter hos PsA-patienter, hvad enten de fik samtidig behandling med MTX eller ikke.
English: Table 3 Summary of clinical response on psoriasis study 2 (FIXTURE)
Danish: Tabel 3 Resume af klinisk virkning på psoriasisstudie 2 (FIXTURE)
English: Immunoglobulins are excreted in human milk and it is not known if secukinumab is absorbed systemically after ingestion.
Danish: Immunoglobuliner udskilles i human modermælk, og det er ukendt om secukinumab bliver absorberet systemisk efter indtagagelse.
English: Uncommon Oral candidiasis Tinea pedis
Danish: Oral candidiasis Tinea pedis
English: ** p values versus etanercept: p=0.0250
Danish: ** p-værdier kontra etanercept: p = 0,0250
English: Based on population pharmacokinetic analysis with a limited number of elderly patients (n=71 for age ≥65 years and n=7 for age ≥75 years), clearance in elderly patients and patients less than 65 years of age was similar.
Danish: Baseret på farmakokinetisk populationsanalyse med et begrænset antal ældre patienter (n=71 i alderen ≥65 år og n=7 i alderen ≥75 år) var clearance hos ældre patienter og patienter under 65 år ens.
English: In psoriasis phase 3 clinical studies, neutropenia was more frequently observed with secukinumab than with placebo, but most cases were mild, transient and reversible.
Danish: I de kliniske fase III-studier vedrørende psoriasis blev neutropeni set hyppigere med secukinumab end med placebo, men de fleste tilfælde var lette, forbigående og reversible.
English: in patients treated with secukinumab compared to patients treated with ustekinumab.
Danish: hos patienter behandlet med secukinumab sammenlignet med patienter behandlet med ustekinumab.
English: • If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.
Danish: • Hvis det er en omsorgsperson eller sundhedspersonalet, der giver dig din indsprøjtning, kan de også bruge ydersiden af din overarm.
English: How much Cosentyx is given and for how long
Danish: Hvor meget Cosentyx gives der, og hvor længe
English: After proper training in subcutaneous injection technique, patients may self-inject Cosentyx if a physician determines that this is appropriate.
Danish: Efter grundig undervisning i subkutan injektionsteknik kan patienter selv injicere Cosentyx, hvis det efter lægens afgørelse er passende.
English: It is not known whether secukinumab is excreted in human milk.
Danish: Det er ukendt, om secukinumab udskilles i human mælk.
English: • warm, red and painful skin, or a painful skin rash with blisters
Danish: • varm, rød og smertende hud, eller smertefuldt udslæt med blærer
English: Improvements in the PASI 75 response were seen in both subgroups and the 300 mg dose showed statistically significant benefit in the anti-TNFα-IR patients.
Danish: Forbedringer i PASI 75-respons blev set i begge subgrupper, og 300 mg dosen viste en statistisk signifikant fordel hos anti-TNFα-IR-patienter.
English: The efficacy and safety of secukinumab 150 mg and 300 mg were evaluated versus either placebo or etanercept.
Danish: Virkning og sikkerhed for secukinumab 150 mg og 300 mg blev evalueret i forhold til enten placebo eller etanercept.
English: Your doctor will decide how much Cosentyx you need and for how long.
Danish: Din læge vil afgøre, hvor meget Cosentyx, du har behov for, og i hvor lang tid.
English: You must look out for signs of these conditions while you are taking Cosentyx.
Danish: Du skal være opmærksom på tegn på disse sygdomme, mens du tager Cosentyx.
English: Greater response rates favouring 300 mg were also observed for ASAS partial remission (ASAS PR) response at week 16 and were maintained up to week 156.
Danish: Der blev også observeret større responsrater, der favoriserer 300 mg, for ASAS partiel remission (ASAS PR) respons ved uge 16 og blev vedligeholdt op til uge 156.
English: Be careful not to touch the syringe guard wings before use.
Danish: Vær omhyggelig med ikke at røre ved aktiveringsklipsene før brug.
English: This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines, and individuals who assist self-injecting patients from accidental needlestick injuries.
Danish: Dette er påtænkt som hjælp til at beskytte sundhedspersonale, patienter, som selv indsprøjter lægeordinerede lægemidler, samt personer, som hjælper patienter, der selv klarer indsprøjtningen mod at blive stukket af kanylen ved et uheld.
English: If you have active psoriatic arthritis you will first be given other medicines.
Danish: Hvis du har aktiv psoriasisgigt, vil du først få andre lægemidler.
English: Note that foaming of the solution may occur.
Danish: Bemærk, at der kan forekomme skumdannelse i opløsningen.
English: Renal impairment / hepatic impairment Cosentyx has not been studied in these patient populations.
Danish: Nedsat leverfunktion/nedsat nyrefunktion Cosentyx er ikke blevet undersøgt hos disse patientpopulationer.
English: Anti-tuberculosis therapy should be considered prior to initiation of secukinumab in patients with latent tuberculosis.
Danish: Behandling mod tuberkulose skal overvejes inden start af secukinumab hos patienter med latent tuberkulose.
English: In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Danish: I psoriasisstudier er sikkerhed og virkning af secukinumab i kombination med immunosuppressiver, herunder biologiske, eller lysbehandling ikke blevet evalueret.