FrancophonIA/ELRC3.0 huggingface dataset:
English: • Press an antiseptic wipe over the injection site for a few seconds after the injection.
Danish: • Tryk en desinficerende serviet på injektionsstedet i et par sekunder efter injektionen.
English: In a population pharmacokinetic analysis using data from patients with psoriasis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
Danish: I en farmakokinetisk populationsanalyse, der anvendte data fra patienter med psoriasis, fandtes vægt at være den mest signifikante kovariant, der påvirkede clearance af ustekinumab.
English: Make sure you tell your doctor about any illness you have before each treatment.
Danish: Sørg for at fortælle lægen om enhver sygdom, du måtte have, før hver behandling.
English: Common: Oropharyngeal pain Uncommon: Nasal congestion Rare: Allergic alveolitis, eosinophilic pneumonia Very rare: Organising pneumonia*
Danish: Almindelig: Orofaryngeale smerter Ikke almindelig: Tilstoppet næse Sjælden: Allergisk alveolitis, eosinofil pneumoni Meget sjælden: Organiserende pneumoni*
English: • After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.
Danish: • Efter startdosen skal du have den næste dosis 4 uger senere og derefter hver 12. uge.
English: No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving STELARA.
Danish: Der er ikke udført studier af deltagelse af patienter, der har eller har haft maligniteter, eller studier, hvor der fortsat gives behandling til patienter, der udvikler en malignitet under behandlingen med STELARA.
English: • When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6)
Danish: • Når stemplet er trykket så langt ind, som det kan, fortsæt da med at holde trykket på stempelhovedet, tag nålen ud og slip huden (se figur 6).
English: A combined endpoint of histo-endoscopic mucosal healing defined as subjects having both mucosal healing and histologic healing was evaluated at week 8 of UNIFI-I and week 44 of UNIFI-M.
Danish: Et kombineret endepunkt med histo-endoskopisk slimhindeheling defineret som forsøgspersoner, der både har slimhindeheling og histologisk heling, blev evalueret i uge 8 i UNIFI-I og uge 44 i UNIFI-M.
English: Patients who were in 100 point clinical response to ustekinumab at start of maintenance therapy Patients who failed conventional therapy but not anti-TNFα therapy Patients who are anti-TNFα refractory/intolerant p < 0.01 p < 0.05 nominally significant (p < 0.05)
Danish: Patienter med et 100 point klinisk respons på ustekinumab i starten af vedligeholdelsesbehandlingen Patienter, som ikke responderede på konventionel behandling, men responderede på anti-TNF-alfa-behandling Patienter, som er anti-TNF-alfa refraktære/intolerante p < 0,01 p < 0,05 nominelt signifikant (p < 0,05)
English: Among patients who entered the study extension, clinical remission and response were generally maintained through week 92 for both patients who failed TNF-therapies and those who failed conventional therapies.
Danish: Hos de patienter, som deltog i forlængelsen af studiet, blev klinisk remission og respons generelt opretholdt til og med uge 92 både for patienter, som ikke havde responderet på TNF-behandling, og patienter, som ikke havde responderet på konventionelle behandlinger.
English: In patients with Crohn's disease and ulcerative colitis, treatment with ustekinumab resulted in a decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during the induction phase, which were then maintained throughout the maintenance phase.
Danish: Hos patienter med Crohns sygdom og colitis ulcerosa resulterede behandling med ustekinumab i et fald i inflammatoriske markører, herunder C-reaktivt protein (CRP) og fækal calprotectin, i løbet af induktionsfasen, som derefter vedblev i hele vedligeholdelsesfasen.
English: The median tmax values of ustekinumab following a single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to those observed in healthy subjects.
Danish: De mediane tmax -værdier for ustekinumab efter en enkelt subkutan administration af enten 45 mg eller 90 mg hos patienter med psoriasis var sammenlignelige med dem, der blev observeret hos raske forsøgspersoner.
English: Enrolled patients had to have failed conventional therapy (corticosteroids or immunomodulators) or at least one biologic (a TNFα antagonist and/or vedolizumab).
Danish: De deltagende patienter skulle have haft manglende respons på konventionel behandling (kortikosteroider eller immunmodulatorer) eller mindst ét biologisk middel (en TNF-alfa-antagonist og/eller vedolizumab).
English: • In some patients, after the first injection under the skin, 90 mg Stelara may be given every 8 weeks.
Danish: • Efter den første injektion under huden vil visse patienter muligvis få 90 mg Stelara hver 8. uge.
English: If you do not respond well enough to these medicines, you may be given Stelara to:
Danish: Hvis du ikke opnår tilstrækkelig virkning af disse lægemidler, kan du få Stelara:
English: The primary endpoint was the percentage of patients who achieved American College of Rheumatology (ACR) 20 response at week 24.
Danish: Det primære endepunkt var den procentdel af patienterne, der opnåede ACR 20 respons i uge 24 ifølge kriterierne fastsat af American College of Rheumatology (ACR).
English: Improvements in PGA, PASI, CDLQI and PedsQL were maintained through week 52 (Table 7).
Danish: Forbedringer i PGA, PASI, CDLQI og PedsQL blev bibeholdt indtil uge 52 (tabel 7).
English: If necessary, the diluted infusion solution may be stored at room temperature.
Danish: Den fortyndede infusionsvæske kan om nødvendigt opbevares ved stuetemperatur.
English: Shedding of skin - increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions.
Danish: Hudafskalning - øget rødme og afskalning af huden på et større område af kroppen kan være symptomer på sygdommene erytroderm psoriasis eller eksfoliativ dermatitis, som er alvorlige hudsygdomme.
English: The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Danish: De mediane laveste serumkoncentrationer af ustekinumab hos patienter med højere vægt (> 100 kg) i 90 mg-gruppen var sammenlignelig med koncentrationerne hos patienter med lavere vægt (≤ 100 kg) i 45 mg-gruppen.
English: Concomitant doses of oral corticosteroids, immunomodulators, and aminosalicylates were permitted and 90% of patients continued to receive at least one of these medications.
Danish: Samtidig behandling med orale kortikosteroider, immunmodulatorer og aminosalicylater var tilladt, 90% af patienterne fortsatte med at få mindst ét af disse lægemidler.
English: • Gently pinch the cleaned skin between your thumb and index finger.
Danish: • Klem forsigtigt den rengjorte hud mellem tommel- og pegefinger.
English: How much Stelara is given Your doctor will decide how much Stelara you need to receive and for how long.
Danish: Hvor meget Stelara skal du have Lægen beslutter, hvor meget Stelara du skal have og i hvor lang tid.
English: Children and adolescents aged 6 years or older
Danish: Børn og unge på 6 år og derover
English: • Plaque psoriasis - in adults and children aged 6 years and older
Danish: • Plaque-psoriasis hos voksne og børn på 6 år og derover
English: Additionally in Crohn's disease, clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus non-Asian).
Danish: Hertil kommer, at clearance blev påvirket af C-reaktivt protein, status for fejlslagen behandling med TNF-antagonist og race (asiatisk og ikkeasiatisk) ved Crohns sygdom.
English: Efficacy (defined as PGA 0 or 1) was observed as early as the first post-baseline visit at week 4 and the proportion of subjects who achieved a PGA score of 0 or 1 increased through week 16 and then remained relatively stable through week 52.
Danish: Virkningen (defineret som PGA 0 eller 1) blev observeret så tidligt som ved det første besøg efter baseline i uge 4, og andelen af forsøgspersoner, der opnåede en PGA-score på 0 eller 1, steg til og med uge 16, hvorefter den forblev relativt stabil til og med uge 52.
English: • the solution is not frozen.
Danish: • at opløsningen ikke er frossen.
English: Table 2 Injection volumes of STELARA for paediatric psoriasis patients < 60 kg Body weight at time of dosing (kg)
Danish: Tabel 2: Injektionsvoluminer for STELARA til patienter med pædiatrisk psoriasis, som vejer < 60 kg Kropsvægt på doseringstidspunktet (kg)
English: • If you have recently had or are going to have a vaccination.
Danish: • Hvis du er blevet vaccineret for nylig eller skal have en vaccination.
English: As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis.
Danish: Som led i monitoreringen af patientens psoriasis skal lægen være opmærksom på symptomer på erytroderm psoriasis eller eksfoliativ dermatitis.
English: Paediatric plaque psoriasis (6 years and older)
Danish: Pædiatrisk plaque-psoriasis (6 år og derover)
English: Median systemic clearance (CL) following a single intravenous administration to patients with psoriasis ranged from 1.99 to 2.34 mL/day/kg.
Danish: Median systemisk clearance (CL) efter en enkelt intravenøs administration til patienter med psoriasis lå fra 1,99 til 2,34 ml/dag/kg.
English: • Moderate to severe ulcerative colitis - in adults
Danish: • Moderat til svær colitis ulcerosa hos voksne
English: • However, you and your doctor may decide that you may inject Stelara yourself.
Danish: • Du og din læge kan beslutte, at du selv injicerer Stelara.
English: Table 2 List of adverse reactions System Organ Class
Danish: Tabel 2 Oversigt over bivirkninger Systemorganklasse
English: Table 3 List of adverse reactions System Organ Class
Danish: Tabel 3 Oversigt over bivirkninger Systemorganklasse
English: If infection has been excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see section 4.8).
Danish: Hvis infektion er udelukket, og diagnosen bekræftet, skal ustekinumab seponeres og passende behandling iværksættes (se pkt.
English: STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Danish: STELARA, alene eller i kombination med MTX, er indiceret til behandling af aktiv psoriasisartrit hos voksne patienter, når deres respons på tidligere behandling med ikke-biologiske sygdomsmodificerende antireumatika (DMARD) har være utilstrækkelig (se pkt.
English: Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.
Danish: Hvert hætteglas er kun til engangsbrug, og ikke anvendt lægemiddel skal bortskaffes i henhold til lokale retningslinjer.
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36 and EuroQoL-5D (EQ-5D) questionnaires.
Danish: Helbredsrelateret livskvalitet blev vurderet med spørgeskemaerne IBDQ (Inflammatory Bowel Disease Questionnaire, SF-36 og EuroQoL-5-D (EQ-5D).
English: Using these therapies together with Stelara has not been studied.
Danish: Samtidig brug af disse behandlinger og Stelara er ikke undersøgt.
English: Recommended Dose
Danish: Anbefalet dosis
English: The ratio of patients with basal versus squamous cell skin cancers (3:1) is comparable with the ratio expected in the general population (see section 4.4).
Danish: Forholdet mellem patienter med basalcellekarcinom versus planocellulært karcinom (3:1) er sammenligneligt med forholdet i befolkningen generelt (se pkt.
English: Following the recommended intravenous induction dose, median peak serum ustekinumab concentration, observed 1 hour after the infusion, was 126.1 μg/mL in patients with Crohn's disease and 127.0 µg/mL in patients with ulcerative colitis.
Danish: Efter den anbefalede intravenøse induktionsdosis var den gennemsnitlige højeste serumkoncentration af ustekinumab, som blev observeret en time efter infusion, 126,1 µg/ml hos patienter med Crohns sygdom og 127,0 µg/ml hos patienter med colitis ulcerosa.
English: Common: Diarrhoea, nausea, vomiting
Danish: Almindelig: Diaré, kvalme, opkastning
English: • Push the plunger with your thumb as far as it will go to inject all of the liquid.
Danish: • Tryk stemplet så langt ind som muligt med tommelfingeren for at injicere al væsken.
English: The needle cover on the syringe in the STELARA pre-filled syringe is manufactured from dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Danish: Kanylehylsteret på den fyldte injektionssprøjte med STELARA er fremstillet af tørt naturgummi (et derivat af latex), som kan forårsage allergiske reaktioner hos personer, der er overfølsomme over for latex.
English: There was significant improvement in DLQI scores in the ustekinumab groups as compared with placebo at week 24, which was maintained through weeks 52 and 100.
Danish: Der sås en signifikant forbedring af DLQI-scorer i ustekinumab-grupperne sammenlignet med placebo i uge 24, og den blev opretholdt til og med uge 52 og uge 100.
English: Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
Danish: Ustekinumab er et fuldt humant monoklonalt IgG1κ antistof mod interleukin (IL) 12/23 fremstillet i en murin myelom cellelinje ved hjælp af rekombinant DNA-teknologi.
English: Additionally on the basis of clinical trial data in patients with ulcerative colitis, a positive exposure-response relationship was established between trough concentrations, and clinical remission and mucosal healing.
Danish: Baseret på data fra kliniske forsøg hos patients med colitis ulcerosa blev der yderligere konstateret et positivt eksponerings-respons-forhold mellem dalkoncentrationer, klinisk remission og slimhindeheling.
English: Improvements in FACIT scores were maintained through week 52.
Danish: Forbedringerne af FACIT-scorer blev opretholdt til og med uge 52.
English: If this happens, please contact your doctor or pharmacist
Danish: Hvis det sker, så kontakt din læge eller apoteket.
English: The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis (see section 4.4).
Danish: Den mest alvorlige bivirkning indberettet om STELARA er alvorlige overfølsomhedsreaktioner, herunder anafylaksi (se pkt.
English: Of 131 patients who responded to ustekinumab induction, and were randomized to the placebo group at the start of the maintenance study, 51 subsequently lost response and received 90 mg ustekinumab subcutaneously every 8 weeks.
Danish: Af de 131 patienter, som responderede på induktionsbehandlingen med ustekinumab og blev randomiseret til placebo-gruppen i starten af vedligeholdelsesstudiet, ophørte respons efterfølgende hos 51 patienter, og disse fik derefter ustekinumab 90 mg subkutant hver 8. uge.
English: • Pull on the syringe plunger to fill the syringe with the amount of liquid prescribed by your doctor
Danish: • Træk i sprøjtestemplet for at fylde sprøjten med den mængde væske, som er foreskrevet af din læge.
English: No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in mice.
Danish: Der sås ingen uønskede virkninger på indikatorer for hunners fertilitet ved brug af et antistof analogt til IL-12/23 hos mus.
English: Always have the outer carton of the medicine with you, even if it is empty.
Danish: Tag æsken med, selv hvis den er tom.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Danish: Hvis du ikke er sikker på, om noget af ovenstående gælder for dig, så tal med din læge eller apotekspersonalet, før du begynder at bruge Stelara.
English: Treatment with ustekinumab resulted in significant improvements in the measures of disease activity compared to placebo at week 24.
Danish: Behandling med ustekinumab resulterede i signifikante forbedringer i målinger af sygdomsaktivitet sammenlignet med placebo i uge 24.
English: A TNFα antagonist and/or vedolizumab.
Danish: En TNF-alfa-antagonist og/eller vedolizumab.
English: Endoscopy
Danish: Endoskopi
English: Nominally significant (p < 0.05)
Danish: Nominelt signifikant (p < 0,05)
English: Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag.
Danish: Udtag 26 ml Stelara fra hvert hætteglas og føj det til 250 ml-infusionsposen.
English: PsARC responses were maintained through weeks 52 and 100.
Danish: PsARC-respons blev opretholdt til og med uge 52 og uge 100.
English: Choose two different sites for these injections (for example one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Danish: Vælg to forskellige steder for disse injektioner (f.eks. en injektion i det højre lår og den anden injektion i det venstre lår), og foretag injektionerne lige efter hinanden.
English: In Crohn's disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose.
Danish: I studier med intravenøs induktion i Crohns sygdom og colitis ulcerosa blev der ikke rapporteret om anafylaktiske hændelser eller andre alvorlige infusionsrelaterede bivirkninger efter en enkelt intravenøs dosis.
English: • When the plunger is pushed as far as it will go, take out the needle and let go of the skin
Danish: • Når stemplet er trykket så langt ind, som det kan komme, skal du tage nålen ud og slippe hudfolden.
English: Paediatric patients 6 years and older with plaque psoriasis The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate to severe plaque psoriasis.
Danish: Pædiatriske patienter på 6 år og derover med plaque-psoriasis Ustekinumabs sikkerhed er blevet undersøgt i to fase 3-studier hos pædiatriske patienter med moderat til svær plaque-psoriasis.
English: All patients were followed for up to 76 weeks following first administration of study treatment.
Danish: Alle patienter blev fulgt i op til 76 uger efter første administration af forsøgsbehandlingen.
English: Thus, ustekinumab is not likely to contribute to complement- or antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors.
Danish: Det er derfor ikke sandsynligt, at ustekinumab bidrager til komplement eller antistofmedieret cytotoksicitet i celler med IL-12- og IL-13-receptorer.
English: Serum ustekinumab concentrations in paediatric psoriasis patients 12-17 years of age (CADMUS) treated with half of the recommended weight-based dose were generally lower than those in adults.
Danish: Serumkoncentrationen af ustekinumab hos pædiatriske patienter i alderen 12-17 år (CADMUS), som blev behandlet med halvdelen af den anbefalede vægtbaserede dosis, var generelt lavere end hos voksne.
English: • If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Stelara looks like and contents of the pack').
Danish: • hvis væsken er misfarvet, uklar, eller der flyder fremmedlegemer i den (se afsnit 6 "Udseende og pakningsstørrelser").
English: Patients who were re-randomised to placebo at week 40 reinitiated ustekinumab at their original dosing regimen when they experienced at least a 50% loss of their PASI improvement obtained at week 40.
Danish: De patienter, der blev genrandomiseret til placebo i uge 40, fik genoptaget behandlingen med ustekinumab med deres oprindelige dosisregime, når de oplevede et tab på mindst 50% af den forbedring af PASI-scoren, de havde opnået i uge 40.
English: p = 0.012 for ustekinumab 45 mg in comparison with etanercept.
Danish: p = 0,012 for ustekinumab 45 mg, sammenlignet med etanercept.
English: Approximately 11% of the patients had prior exposure to biologics.
Danish: Cirka 11% af patienterne havde tidligere fået biologiske lægemidler.
English: • Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5)
Danish: • Injicer al medicinen ved at trykke stemplet ind, indtil stempelhovedet er helt nede mellem nålebeskyttelsesafskærmningsvingerne (se figur 5).
English: However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Danish: Anormal regulering af IL 12 og IL 23 er imidlertid blevet associeret med immunmedierede sygdomme såsom psoriasis, psoriasisartrit, Crohns sygdom og colitis ulcerosa.
English: Improvements in PGA, PASI, and CDLQI were maintained through week 52 (Table 8).
Danish: Forbedringer i PGA, PASI og CDLQI blev bibeholdt til uge 52 (tabel 8).
English: • You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
Danish: • Du kan presse en vattot eller et stykke gaze på injektionsstedet og holde det der i 10 sekunder.
English: • Redness and pain where the injection is given
Danish: • Rødme og smerter på injektionsstedet
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
Danish: p < 0,001 for ustekinumab 45 mg eller 90 mg, sammenlignet med placebo (PBO).
English: Table 3: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Danish: Tabel 3: Induktion af klinisk respons og remission i UNITI-1 og UNITI 2 UNITI-1*
English: The clinical development program consisted of two 8-week intravenous induction studies (UNITI-1 and UNITI-2) followed by a 44 week subcutaneous randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy.
Danish: Det kliniske udviklingsprogram bestod af to 8-ugers studier med intravenøs induktion (UNITI-1 og UNITI-2) efterfulgt af et 44-ugers subkutant vedligeholdelsesstudie med randomiseret tilbagetrækning (IM-UNITI), hvilket sammenlagt udgjorde 52 ugers behandling.
English: In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4.8).
Danish: I kliniske studier er der observeret alvorlige bakterie-, svampe- og virusinfektioner hos patienter, der fik STELARA (se pkt.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Danish: Psoriasisartrit er en betændelseslignende tilstand i leddene, der sædvanligvis ledsages af psoriasis.
English: By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Danish: Ved at binde den p40-underenhed, som IL-12 og IL-23 deler, kan ustekinumab udøve sin kliniske virkning på psoriasis, psoriasisartrit, Crohns sygdom og colitis ulcerosa gennem afbrydelse af forløbene for Th1- og Th17-cytokiner, som spiller en central rolle i disse sygdommes patologi.
English: Clinical Remission** In patients who failed conventional therapy, but not a biologic d49% (50/102)
Danish: Klinisk remission** hos patienter uden respons på konventionel behandling, men kan have responderet på et biologisk middel d 49% (50/102)
English: Stelara contains sodium
Danish: Stelara indeholder natrium
English: Table 9: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Danish: Tabel 9: Induktion af klinisk respons og remission i UNITI-1 og UNITI 2 UNITI-1*