FrancophonIA/ELRC3.0 huggingface dataset:
English: Crohn's disease is an inflammatory disease of the bowel.
Danish: Crohns sygdom er en betændelseslignende (inflammatorisk) sygdom i tarmen.
English: You and your doctor should decide if you should breast-feed or use Stelara - do not do both.
Danish: Sammen med din læge skal du beslutte, om du skal amme eller bruge Stelara - du må ikke gøre begge dele.
English: In ulcerative colitis, population PK model based simulations demonstrated that adjusting dosing from 90 mg every 12 weeks to every 8 weeks would be expected to result in a 3-fold increase in steady-state trough ustekinumab concentrations.
Danish: Ved colitis ulcerosa påviste simuleringer baseret på en farmakokinetisk populationsanalysemodel, at justering af dosis fra 90 mg hver 12. uge til hver 8. uge måtte forventes at resultere i en stigning på 3 gange i steady-state dalkoncentrationer af ustekinumab.
English: You must look out for certain signs of illness while you are taking Stelara.
Danish: Vær opmærksom på visse tegn på sygdom, mens du får Stelara.
English: • During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor through a drip in a vein in your arm (intravenous infusion).
Danish: • Under behandlingen gives den første dosis på ca. 6 mg/kg Stelara af din læge gennem et drop i en blodåre i armen (intravenøs infusion).
English: In developmental and reproductive toxicity studies in cynomolgus monkeys, neither adverse effects on male fertility indices nor birth defects or developmental toxicity were observed.
Danish: I udviklings- og reproduktionstoksicitetsstudier hos cynomolgusaber var der ingen uønskede virkninger på indikatorer for hanners fertilitet, og der sås ingen fødselsdefekter eller udviklingstoksicitet.
English: Table 5: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Danish: Tabel 5: Oversigt over de væsenligste effektresultater i UNIFI-I (uge 8) Placebo
English: Your doctor will check how well you are before treatment.
Danish: Lægen vil tjekke dit helbred før behandling.
English: • Used syringes and needles should be placed in a puncture-resistant container, like a sharps container.
Danish: • Brugte sprøjter og nåle skal anbringes i en punktérfri beholder beregnet til skarpe ting.
English: • Push the needle through the rubber stopper
Danish: • Tryk nålen gennem gummiproppen.
English: The proportion of patients achieving a modified PsA response criteria (PsARC) response was also significantly greater in the ustekinumab groups compared to placebo at week 24.
Danish: Andelen af patienter, der opnåede et modificeret PsA-responskriterium (PsARC) var også signifikant større i ustekinumab-grupperne sammenlignet med placebo i uge 24.
English: Improvement in HAQ-DI score from baseline was maintained through Weeks 52 and 100.
Danish: Forbedring af HAQ-DI-score fra baseline blev opretholdt til og med uge 52 og uge 100.
English: Recommended dose of ustekinumab N = 322
Danish: Anbefalet dosis af ustekinumab N = 322
English: Common: Back pain, myalgia, arthralgia
Danish: Almindelig: Rygsmerter, myalgi, artralgi
English: Table 7 Summary of primary and secondary endpoints at week 12 and week 52 Paediatric psoriasis study (CADMUS) (Age 12-17) Week 12
Danish: Tabel 7: Oversigt over primære og sekundære effektmål i uge 12 og i uge 52 Pædiatrisk psoriasis-studie (CADMUS) (12-17 år) Uge 12
English: Combined Symptomatic Remission and Mucosal Healing
Danish: Kombineret symptomatisk remission og slimhindeheling
English: Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
Danish: Når der træffes beslutning om, hvorvidt amningen skal stoppes under behandlingen og op til 15 uger efter behandlingen, eller om behandlingen med STELARA skal seponeres, skal der derfor tages hensyn til barnets fordel ved amning og kvindens fordel ved behandling med STELARA.
English: In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Danish: I studier af psoriasis er sikkerheden af og effekten ved STELARA i kombination med immunsuppressiva, herunder biologiske lægemidler, eller lysbehandling ikke vurderet.
English: Improvements in enthesitis score and dactylitis score were maintained through weeks 52 and 100.
Danish: Forbedringerne af enthesitis- og dactylitis-score blev opretholdt til og med uge 52 og uge 100.
English: • Tooth infections
Danish: • Infektion i tænderne
English: Tell your doctor straight away if you notice any of these signs of infection.
Danish: Fortæl det straks til lægen, hvis du bemærker et af disse tegn på infektion.
English: Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy and compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab and etanercept.
Danish: I psoriasisstudie 3 (ACCEPT) blev 903 patienter med moderat til alvorlig psoriasis, og som havde utilstrækkelig effekt af, var intolerant over for eller havde kontraindikationer mod anden systemisk behandling, vurderet, og effekten af ustekinumab og etanercept blev sammenlignet.
English: 80, sucrose and water for injections.
Danish: saccharose og vand til injektionsvæsker.
English: In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA.
Danish: I studier af psoriasisartrit syntes samtidig behandling med MTX ikke at påvirke sikkerheden eller virkningen af STELARA.
English: The solution in the STELARA vial should not be shaken.
Danish: Opløsningen i hætteglasset med STELARA må ikke rystes.
English: Common: Dizziness, headache Uncommon: Facial palsy
Danish: Almindelig: Svimmelhed, hovedpine Ikke almindelig: Facialisparese
English: All patients were followed for up to 52 weeks following first administration of study treatment.
Danish: Alle patienter blev fulgt i op til 52 uger efter første administration af forsøgsbehandlingen.
English: The formation of anti-ustekinumab antibodies is associated with increased clearance of ustekinumab in patients with Crohn's disease or ulcerative colitis.
Danish: Dannelsen af antistoffer mod ustekinumab er forbundet med øget clearance af usteukimab hos patienter med Crohns sygdom eller colitis ulcerosa.
English: • Do not remove the stopper
Danish: • Fjern ikke proppen.
English: Do not use if visibly opaque particles, discoloration or foreign particles are observed.
Danish: Infusionsvæsken må ikke anvendes, hvis der observeres uigennemsigtige partikler, misfarvning eller fremmedlegemer.
English: Histologic healing (defined as neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue) was assessed at week 8 of UNIFI-I and Week 44 of UNIFI-M. At week 8, after a single intravenous induction dose, significantly greater proportions of patients in the recommended dose group achieved histologic healing (36%) compared with patients in the placebo group (22%).
Danish: Histologisk heling (defineret som neutrofil infiltration i < 5% af krypterne, fravær af kryptdestruktion og ingen erosioner, ulcerationer eller granulationsvæv) blev vurderet i uge 8 i UNIFI-I og uge 44 i UNIFI-M. I uge 8 opnåede en signifikant større andel af patienterne i gruppen, der fik den anbefalede dosis, histologisk heling (36%) efter en enkelt intravenøs induktionsdosis, sammenlignet med patienterne i placebogruppen (22%).
English: Fistula Response
Danish: Fistelrespons
English: This includes exposure to STELARA in the controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,577 and 3,253 patients respectively with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis) and exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).
Danish: Disse omfatter eksponering for STELARA i de kontrollerede og ikke-kontrollerede perioder af de kliniske studier i mindst 6 måneder eller 1 år (henholdsvis 4.577 og 3.253 patienter med psoriasis, psoriasisartrit, Crohns sygdom eller colitis ulcerosa) og eksponering i mindst 4 eller 5 år (henholdsvis 1.482 og 838 patienter med psoriasis).
English: Table 1 Recommended dose of STELARA for paediatric psoriasis Body weight at the time of dosing
Danish: Tabel 1: Anbefalet dosis af STELARA ved pædiatrisk psoriasis Kropsvægt på doseringstidspunktet
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 questionnaires.
Danish: Helbredsrelateret livskvalitet blev vurderet med spørgeskemaerne IBDQ (Inflammatory Bowel Disease Questionnaire, spørgeskema om inflammatorisk tarmsygdom) og SF-36.
English: 61% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
Danish: 61% af disse patienter udviste enten manglende respons, var intolerante over for eller havde en kontraindikation mod anden systemisk behandling.
English: Administer the diluted solution over a period of at least one hour.
Danish: Administrer infusionsvæsken over en periode på mindst en time.
English: Table 1 Initial intravenous dosing of STELARA Body weight of patient at the time of dosing
Danish: Tabel 1 Initial intravenøs dosering af STELARA Kropsvægt på doseringstidspunktet
English: You must look out for signs of infection while you are using Stelara.
Danish: Vær opmærksom på tegn på infektion, når du bruger Stelara.
English: Patients randomised PGA
Danish: Randomiserede patienter PGA
English: For further instructions on preparation and special precautions for handling, see section 6.6.
Danish: 6.6 gives der yderligere anvisninger om præparering og særlige forholdsregler for håndtering.
English: Let the pre-filled syringe stand outside the box for about half an hour.
Danish: Lad den fyldte injektionssprøjte stå uden for kartonen i ca. en halv time.
English: • Then press the plunger until all of the air (but none of the liquid) has been removed • Do not lay the syringe down or allow the needle to touch anything.
Danish: • Tryk så stemplet ind, indtil al luften (men ikke noget af væsken) er fjernet.
English: In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA.
Danish: I studier af Crohns sygdom og colitis ulcerosa syntes samtidig brug af immunsuppressiva eller kortikosteroider ikke at påvirke sikkerheden eller virkningen af STELARA.
English: • Inflammation of tissue under the skin (‘cellulitis') is uncommon (may affect up to 1 in
Danish: • Betændelse i vævet under huden (cellulitis) er ikke almindelig (kan forekomme hos op til
English: Secondary endpoints included PASI 75, PASI 90, and change from baseline in Children's Dermatology Life Quality Index (CDLQI) at week 12.
Danish: Sekundære effektmål omfattede PASI 75, PASI 90 og ændring fra baseline i CDLQI (Children's Dermatology Life Quality Index) i uge 12.
English: When using the single-dose vial, a 1 mL syringe with a 27 gauge, ½ inch (13 mm) needle is recommended.
Danish: Ved anvendelse af enkeltdosishætteglasset anbefales en sprøjte på 1 ml med en 27 gauge, 0,5 tommer (13 mm) kanyle.
English: Approximately 43% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Danish: Ca. 43% af patienterne havde tidligere fået konventionel systemisk behandling eller lysbehandling.
English: The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Danish: Lægemidlet må ikke bruges, hvis opløsningen er misfarvet eller uklar, eller hvis der er partikelholdigt materiale i form af fremmedlegemer.
English: Inject the dose:
Danish: Injicer dosis:
English: 53% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
Danish: 53% af disse patienter udviste enten manglende respons, var intolerante over for eller havde en kontraindikation mod anden systemisk behandling.
English: The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache.
Danish: De hyppigste bivirkninger (> 5%) i de kontrollerede perioder i kliniske studier af ustekinumab hos voksne med psoriasis, psoriasisartrit, Crohns sygdom og colitis ulcerosa var nasopharyngitis og hovedpine.
English: Approximately 60% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Danish: Ca. 60% af patienterne havde tidligere fået konventionel systemisk behandling eller lysbehandling.
English: 90 mg ustekinumab every 8 weeks
Danish: 90 mg ustekinumab hver 8. uge
English: The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section 4.5).
Danish: Studiet viste, at IL-12 og/eller IL-23 i koncentrationer på 10 ng/ml ikke ændrede CYP450-aktiviteten (CYP1A2, 2B6, 2C9, 2C19, 2D6 eller 3A4) hos mennesker (se pkt.
English: • the solution in the pre-filled syringe is not frozen.
Danish: • at opløsningen i den fyldte injektionssprøjte ikke er frosset.
English: Do not remove the syringe's needle cover while allowing it to reach room temperature
Danish: Fjern ikke sprøjtens nålebeskyttelseshætte, mens væsken får lov til at få stuetemperatur.
English: Uncommon: Cellulitis, dental infections, herpes zoster, lower respiratory tract infection, viral upper respiratory tract infection, vulvovaginal mycotic infection
Danish: Almindelig: Øvre luftvejsinfektion, nasopharyngitis, sinusitis Ikke almindelig: Cellulitis, tandinfektioner, herpes zoster, infektion i de nedre luftveje, virusinfektion i de øvre luftveje, vulvovaginal mykotisk infektion
English: OUTER CARTON (130 mg)
Danish: YDRE PAKNING (130 mg)
English: • Feeling weak
Danish: • Følelse af svaghed
English: • Infections of the nose or throat and common cold are common (may affect up to 1 in
Danish: • Næse- og halsinfektioner og forkølelser er almindelige (kan forekomme hos op til 1 ud af
English: Secondary endpoints included PASI 75, PASI 90, change from baseline in Children's Dermatology Life Quality Index (CDLQI), change from baseline in the total scale score of PedsQL (Paediatric Quality of Life Inventory) at week 12.
Danish: Sekundære effektmål omfattede PASI 75, PASI 90, ændring fra baseline i CDLQI (Children's Dermatology Life Quality Index) samt ændring fra baseline af PedsQL (Paediatric Quality of Life Inventory) i uge 12.
English: At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
Danish: Efter 18 måneder (i uge 76) havde 84% af de patienter, der var genrandomiseret til vedligeholdelsesbehandling, et PASI 75 respons sammenholdt med 19% af de patienter, der var genrandomiseret til placebo (behandlingsophør).
English: • Do not touch the needle or let the needle touch anything
Danish: • Rør ikke ved nålen, og lad ikke nålen røre ved noget.
English: • A 45 mg vial is available if you need to receive less than the full 45 mg dose.
Danish: • Der findes et 45 mg hætteglas, hvis du har behov for mindre end den fulde dosis på 45 mg.
English: (see section 5.1, Table 4)
Danish: 5.1, tabel 4).
English: At week 12, subjects treated with ustekinumab showed significantly greater improvement in their psoriasis and health related quality of life compared with placebo (Table 7).
Danish: I uge 12 viste de forsøgspersoner, der blev behandlet med ustekinumab, markant større forbedring i deres psoriasis og helbredsrelaterede livskvalitet i forhold til placebo (tabel 7).
English: Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.
Danish: Patienter med plaque-psoriasis kan som en del af sygdommens naturlige forløb udvikle erytroderm psoriasis med symptomer, der klinisk kan være umulige at skelne fra eksfoliativ dermatitis.
English: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).
Danish: STELARA er indiceret til behandling af moderat til svær plaque-psoriasis hos voksne, der ikke har responderet på, har en kontraindikation mod eller er intolerante over for andre systemiske behandlinger, herunder ciclosporin, methotrexat (MTX) eller PUVA (psoralen og ultraviolet A) (se pkt.
English: PGA of Cleared (0) PASI
Danish: PGA clear (0) PASI
English: In PsA Study 2 there was a significant improvement in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores in the ustekinumab groups when compared with placebo at week 24.
Danish: I PsA-studie 2 sås signifikant forbedring i FACIT-F-scorerne (Functional Assessment of Chronic Illness Therapy - Fatigue) i ustekinumab-grupperne sammenlignet med placebo i uge 24.
English: • If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
Danish: • Hvis du vejer mellem 60 kg og 100 kg, er den anbefalede dosis 45 mg Stelara.
English: • Pick up the pre-filled syringe, hold the body of the syringe with one hand
Danish: • Tag den fyldte injektionssprøjte op. Hold om sprøjtens kappe med én hånd.
English: The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation).
Danish: Infusionsvæsken skal fremstilles ud fra det antal hætteglas med STELARA 130 mg, som er angivet i tabel 1 (se pkt.
English: The proportion of patients achieving a clinically significant improvement in fatigue (4 points in FACIT-F) was also significantly greater in the ustekinumab groups compared with placebo.
Danish: Andelen af patienter, der opnåede en klinisk signifikant forbedring af træthed, (4 point på FACIT-F), var også signifikant større i ustekinumab-grupperne sammenlignet med placebo.
English: • Do not use the pre-filled syringe if it is dropped without the needle cover in place.
Danish: • Brug ikke den fyldte injektionssprøjte, hvis den tabes, uden at nålebeskyttelseshætten er på.
English: • Stelara is given as an injection under the skin (‘subcutaneously').
Danish: • Stelara gives som injektion under huden (subkutant).
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept.
Danish: p < 0,001 for ustekinumab 45 mg eller 90 mg, sammenlignet med etanercept.
English: 90 mg ustekinumab every 12 weeks
Danish: 90 mg ustekinumab hver 12. uge
English: Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in the placebo group (5.7%, 10/175).
Danish: Op til uge 44 i UNIFI-M observeredes der et signifikant lavere antal UC-relaterede hospitalsindlæggelser hos forsøgspersoner i den kombinerede ustekinumab-gruppe (2,0%, 7/348) sammenlignet med placebogruppen (5,7%, 10/175).
English: Histologic & Histo-Endoscopic Mucosal Healing
Danish: Histologisk og histo-endoskopisk slimhindeheling
English: Serum ustekinumab concentrations in paediatric psoriasis patients 6 to 17 years of age, treated with the recommended weight-based dose were generally comparable to those in the adult psoriasis population treated with the adult dose.
Danish: Serumkoncentrationen af ustekinumab hos pædiatriske psoriasispatienter i alderen 6 til 17 år, som blev behandlet med den anbefalede vægtbaserede dosis, var generelt sammenlignelig med serumkoncentrationen hos den voksne psoriasispopulation, som blev behandlet med voksendosis.
English: At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 responders.
Danish: Efter 3 år (i uge 148) opnåede 82% af de patienter, der var genrandomiseret til vedligeholdelsesbehandling, et PASI 75 respons.
English: • If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
Danish: • Hvis du vejer over 100 kg, er den anbefalede dosis 90 mg Stelara.
English: Patients receiving ustekinumab at the recommended dose showed significant improvements on the histo endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to theplacebo group (9%).
Danish: Patienter i ustekinumab-gruppen, der fik ustekinumab ved den anbefalede dosis, udviste signifikante forbedringer for så vidt angår endepunktet histo-endoskopisk slimhindeheling i uge 8 (18%) sammenlignet med placebogruppen (9%).
English: Approximately 48% of the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies.
Danish: Ca. 48% af patienterne havde ikke responderet på én tidligere anti-TNF-alfa-terapi og 52% havde ikke responderet på to eller tre tidligere anti-TNF-alfa-terapier.
English: The infusion should be completed within 8 hours of the dilution in the infusion bag.
Danish: Infusionen skal være gennemført senest 8 timer efter fortynding i infusionsposen.
English: Marketing Authorisation Holder Janssen-Cilag International NV
Danish: Indehaver af markedsføringstilladelsen Janssen-Cilag International NV
English: • Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger.
Danish: • Hold den fyldte sprøjte mellem langfingeren og pegefingeren på den ene hånd, og placér tommelfingeren på toppen af stempelhovedet.
English: • Antiseptic wipes and other supplies can be disposed of in your garbage.
Danish: • Desinficerende servietter og andre artikler kan bortskaffes gennem dagrenovationen.
English: STELARA 45 mg and 90 mg vials or pre-filled syringes are for subcutaneous injection only.
Danish: STELARA 45 mg og 90 mg i hætteglas eller fyldte injektionssprøjter er kun til subkutan injektion.
English: Week 12 2 doses (week 0 and week 4)
Danish: Uge 12 - 2 doser (uge 0 og uge 4) Uge 28 - 3 doser (uge 0, uge 4 og uge 16)
English: PGA of cleared (0) or minimal
Danish: PGA clear (0) eller minimal
English: Your doctor will check how well you are before each treatment.
Danish: Lægen vil tjekke dit helbred før hver behandling.
English: The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg.
Danish: Den systemiske eksponering af ustekinumab hos patienter med psoriasis (Cmax og AUC) steg på tilnærmelsesvis dosisproportional måde efter en enkelt intravenøs administration ved doser fra 0,09 mg/kg til 4,5 mg/kg.
English: The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis.
Danish: Den systemiske eksponering af ustekinumab hos patienter med psoriasis (Cmax og AUC) steg på tilnærmelsesvis dosisproportional måde efter en enkelt intravenøs administration ved doser fra 0,09 mg/kg til 4,5 mg/kg eller efter en enkelt subkutan administration ved doser fra ca. 24 mg til 240 mg.