FrancophonIA/ELRC3.0 huggingface dataset:
English: Health-related quality of life
Danish: Helbredsrelateret livskvalitet
English: 10 people)
Danish: 10 brugere)
English: Approximately one third (Psoriasis Study 1) and one quarter (Psoriasis Study 2) of subjects had Psoriatic Arthritis (PsA).
Danish: Omtrent en tredjedel (psoriasisstudie 1) og en fjerdedel (psoriasisstudie 2) af forsøgspersonerne havde psoriasisartritis (PsA).
English: • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle.
Danish: • Du vil måske bemærke en luftboble i den fyldte injektionssprøjte eller en dråbe væske ved spidsen af nålen.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Stelara and for at least 15 weeks after the last Stelara treatment.
Danish: Hvis du er en kvinde i den fødedygtige alder, rådes du til at undgå at blive gravid, og du skal bruge sikker prævention, mens du bruger Stelara og i mindst 15 uger efter den sidste behandling med Stelara.
English: 51% of patients had failed or were intolerant to a biologic.
Danish: 51% af patienterne havde ikke responderet på eller var intolerante over for et biologisk middel.
English: Ustekinumab has been shown to improve signs and symptoms, physical function and health-related quality of life, and reduce the rate of progression of peripheral joint damage in adult patients with active PsA.
Danish: Det er påvist, at ustekinumab forbedrer symptomerne, fysisk funktion og helbredsrelateret livskvalitet og reducerer progressionsraten for perifere ledskader hos voksne patienter med aktiv PsA.
English: Prolonged vigorous shaking may damage the medicine.
Danish: Langvarig, voldsom rysten kan ødelægge lægemidlet.
English: • Take the pre-filled syringe(s) out of the refrigerator.
Danish: • Tag de(n) fyldte injektionssprøjte(r) ud af køleskabet.
English: • Put the vial on a flat surface.
Danish: • Sæt hætteglasset på en plan overflade.
English: • If you have or have had a recent infection.
Danish: • Hvis du har eller for nylig har haft en infektion.
English: Of those patients, 9% of patients who were initially randomized to the recommended induction dose achieved clinical remission and 58% achieved clinical response at Week 16.
Danish: Af disse opnåede 9% af de patienter, der oprindeligt blev randomiseret til den anbefalede induktionsdosis, klinisk remission, og 58% opnåede klinisk respons i uge 16.
English: The syringe, needle and vial must never be re-used.
Danish: Sprøjten, kanylen og hætteglasset må aldrig genbruges.
English: In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab.
Danish: I sjældne tilfælde er der blevet indberettet allergiske lungereaktioner og lungebetændelse hos patienter, der fik ustekinumab.
English: 70 point response is defined as reduction in CDAI score by at least 70 points * Anti-TNFα failures ** Conventional therapy failures p < 0.001
Danish: 70-point-respons defineres som reduktion i CDAI-score på mindst 70 point * Fejlslagen behandling med anti-TNF-alfa ** Fejlslagen behandling med konventionel terapi p < 0,001
English: Change from baseline Mean (SD)
Danish: Ændring fra baseline Median (SD)
English: There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.
Danish: Der var tilsyneladende ingen akkumulation i serumkoncentrationen af ustekinumab over tid, når det blev indgivet subkutant hver 12. uge.
English: Caution should be exercised when considering concomitant use of other immunosuppressants and STELARA or when transitioning from other immunosuppressive biologics (see section 4.5).
Danish: Der skal udvises forsigtighed, når der overvejes samtidig brug af andre immunsuppressiva og STELARA eller ved overgang fra andre immunsuppressive biologiske midler (se pkt.
English: No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients.
Danish: Samlet er der ikke observeret forskelle med hensyn til effekt og sikkerhed hos patienter på 65 år eller ældre, som fik Stelara, sammenlignet med yngre patienter i kliniske studier ved godkendte indikationer, men antallet af patienter i alderen 65 år og derover er dog ikke tilstrækkeligt til at fastslå, om de reagerer anderledes end yngre patienter.
English: After proper training in subcutaneous injection technique, patients or their caregivers may inject STELARA if a physician determines that it is appropriate.
Danish: Patienterne eller deres omsorgspersoner kan efter at have fået behørig undervisning i injektionsteknikken for subkutan injektion injicere STELARA, hvis lægen beslutter, at det er hensigtsmæssigt.
English: The primary endpoint for the induction study was the proportion of subjects in clinical remission at week 8.
Danish: Det primære endepunkt i induktionsstudiet var andelen af forsøgspersoner med klinisk remission i uge 8.
English: • Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis).
Danish: • Rødme og afskalning af huden på et større område af kroppen, som kan klø eller gøre ondt (eksfoliativ dermatitis).
English: The first subcutaneous dose should be given at week 8 following the intravenous dose.
Danish: Den første subkutane dosis skal gives i uge 8 efter den intravenøse dosis.
English: The median time to reach the maximum serum concentration (tmax) was 8.5 days after a single 90 mg subcutaneous administration in healthy subjects.
Danish: Mediantiden til opnåelse af maksimal serumkoncentration (tmax) var 8,5 dage efter en enkelt subkutan administration af 90 mg hos raske forsøgspersoner.
English: Animal studies have shown excretion of ustekinumab at low levels in breast milk.
Danish: Dyrestudier har påvist udskillelse af ustekinumab i brystmælk, dog i lave koncentrationer.
English: In IM-UNITI, 29 of 129 patients did not maintain response to ustekinumab when treated every 12 weeks and were allowed to dose adjust to receive ustekinumab every 8 weeks.
Danish: I IM-UNITI havde 29 af de 129 patienter ikke vedvarende respons på ustekinumab ved behandling hver 12. uge og fik justeret dosis således, at de fik ustekinumab hver 8. uge.
English: • Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7:
Danish: • Fjern langsomt tommelfingeren fra stempelhovedet, og lad den tomme sprøjte bevæge sig op, indtil hele nålen er dækket af nålebeskyttelsesafskærmningen, som vist på figur 7.
English: • The needle cover should not be removed until you are ready to inject the dose
Danish: • Nålebeskyttelseshætten må ikke fjernes, før du er klar til at injicere dosis.
English: Population pharmacokinetic analysis showed that there was a trend towards a higher clearance of ustekinumab in patients who tested positive for antibodies to ustekinumab.
Danish: Populationsfarmakokinetisk analyser viste, at der var en tendens mod højere ustekinumab-clearance hos patienter, der var testet positive for antistoffer mod ustekinumab.
English: 2340 Beerse Belgium
Danish: 2340 Beerse Belgien
English: Patients with each subtype of PsA were enrolled, including polyarticular arthritis with no evidence of rheumatoid nodules (39%), spondylitis with peripheral arthritis (28%), asymmetric peripheral arthritis (21%), distal interphalangeal involvement (12%) and arthritis mutilans (0.5%).
Danish: I studiet indgik patienter med alle undertyper PsA, herunder polyartikulær artrit uden tegn på reumatoide nodi (39%), spondylitis med perifer arthritis (28%), asymmetrisk perifer arthritis (21%), påvirkning af de distale interfalangeale led (12%) og arthritis mutilans (0,5%).
English: • Do not touch this area again before giving the injection.
Danish: • Rør ikke dette område igen, før du har givet injektionen.
English: Psoriasis Study 2 (PHOENIX 2) evaluated 1,230 patients.
Danish: I psoriasisstudie 2 (PHOENIX 2) blev 1.230 patienter vurderet.
English: In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis.
Danish: I kliniske studier udviklede patienter med latent tuberkulose, der samtidig blev behandlet med isoniazid, ikke tuberkulose.
English: The primary endpoint was the proportion of patients who achieved a PGA score of cleared (0) or minimal (1) at week 12.
Danish: Det primære effektmål var den andel af patienterne, som opnåede en PGA-score på clear (0) eller minimal (1) i uge 12.
English: • Pull the needle cover straight off and throw it away.
Danish: • Træk nålebeskyttelseshætten lige af og smid den væk.
English: Ustekinumab-treated patients showed significant improvement in physical function as assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24.
Danish: Patienter behandlet med ustekinumab udviste signifikant forbedring af fysisk funktion vurderet ved hjælp af HAQ-DI-spørgeskemaet (Disability Index of the Health Assessment Questionnaire) i uge 24.
English: Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in monkeys that were more than 100-fold higher than observed in humans.
Danish: Dosisniveauerne i dyrestudier var op til ca. 45 gange højere end den højeste tilsvarende dosis beregnet til administration til psoriasispatienter og betød, at de højeste serumkoncentrationer hos aber var mere end 100 gange højere end dem, der blev observeret hos mennesker.
English: Remove the needle cover (see Figure 3):
Danish: Fjern nålebeskyttelseshætten (se figur 3):
English: This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Danish: Der skal tages højde for dette hos patienter, som er på en kontrolleret natriumdiæt (se pkt.
English: No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Danish: Der er ingen tilgængelige farmakokinetiske data for patienter med nedsat nyre- eller leverfunktion.
English: Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models for an antibody with no cross-reactivity to rodent IL-12/23 p40.
Danish: Der er ikke udført karcinogenicitetsstudier med ustekinumab på grund af manglen på egnede modeller for et antistof uden krydsreaktivitet over for IL-12/23 p40 hos gnavere.
English: Figure 1 shows what the pre-filled syringe looks like.
Danish: Figur 1 viser, hvordan den fyldte injektionssprøjte ser ud.
English: (see section 4.4).
Danish: (angivet i afsnit 6).
English: Corticosteroid-free clinical remission is defined as patients in clinical remission and not receiving corticosteroids at Week 44.
Danish: Kortikosteroidfri klinisk remission defineres som patienter med klinisk remission, og som ikke fik kortikosteroider i uge44.
English: If you don't know the amount or type of syringe needed, contact your healthcare provider for further instruction.
Danish: Hvis du ikke kender det nødvendige volumen eller ved, hvilken sprøjte der skal bruges, skal du kontakte lægen for at få yderligere anvisninger.
English: • For instructions on how to inject Stelara, see ‘Instructions for administration' at the end of this leaflet.
Danish: • Nærmere instruktioner i at give Stelara finder du under "Vejledning i injektion" sidst i denne indlægsseddel.
English: Ustekinumab 2 doses (week 0 and week 4) 45 mg
Danish: Ustekinumab 2 doser (uge 0 og uge 4) 45 mg
English: STELARA has not been evaluated in patients who have undergone allergy immunotherapy.
Danish: STELARA er ikke undersøgt hos patienter, som har fået allergenspecifik immunterapi.
English: However, before Stelara is given to you, it is mixed with a solution that contains sodium.
Danish: Inden du får Stelara, blandes det dog med en opløsning, som indeholder natrium.
English: In Crohn's disease, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
Danish: Hvis behandlingen i tilfælde af Crohns sygdom har været afbrudt midlertidigt, er det sikkert og effektivt at genoptage den med subkutan dosering hver 8. uge.
English: Clinical Remission Clinical Response Corticosteroid-Free Clinical Remission Clinical Remission in patients: in remission at the start of maintenance therapy who entered from study CRD3002 who are Anti-TNFα naïve who entered from study CRD3001
Danish: Kortikosteroidfri klinisk remission Klinisk remission hos patienter: i remission ved initiering af vedligeholdelsesbehandling som overgik fra studie CRD3002 som er anti-TNF-alfabehandlingsnaive som overgik fra studie CRD3001
English: In the placebo-controlled period of these clinical studies, the rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in placebo-treated patients.
Danish: I den placebokontrollerede periode i disse kliniske studier var forekomsten af infektioner i opfølgningsperioden 1,36 pr. patientår for patienter, der blev behandlet med ustekinumab, og 1,34 hos patienter, der blev behandlet med placebo.
English: Long term treatment with STELARA does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines (see section 5.1).
Danish: Langtidsbehandling med STELARA undertrykker ikke det humorale immunrespons på pneumokokpolysaccharidvaccine og tetanusvaccine (se pkt.
English: Systemic and respiratory hypersensitivity reactions
Danish: Systemiske og respiratoriske overfølsomhedsreaktioner Systemiske
English: • Inject the dose promptly after removing the needle cover.
Danish: • Foretag injektionen straks efter at have fjernet nålebeskyttelseshætten.
English: b 60 (28.7%) 116 (55.5%) Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)
Danish: b 60 (28,7%) 116 (55,5%) Klinisk respons (100 point), uge 8 50 (20,2%) 94 (37,8%)
English: Significant differences in partial Mayo score and symptomatic remission were observed between ustekinumab and placebo as early as Week 2.
Danish: Der blev observeret signifikante forskelle i partiel Mayoscore og symptomatisk remission mellem ustekinumab og placebo så tidligt som i uge 2.
English: Check the pre-filled syringe(s) to make sure
Danish: Kontrollér de(n) fyldte injektionssprøjte(r) for at sikre
English: In the treatment regimen, the first dose of STELARA is administered intravenously.
Danish: Den første dosis af STELARA i behandlingsregimet administreres intravenøst.
English: Maintenance of clinical remission through Week 44 is defined as patients in clinical remission through Week 44 among patients in clinical remission at maintenance baseline.
Danish: Opretholdelse af klinisk remission til uge 44 defineres som patienter med klinisk remission til uge 44 blandt patienter med klinisk remission ved baselinefor vedligeholdelse.
English: > 55 kg to ≤ 85 kg
Danish: > 55 kg til ≤ 85 kg
English: As early as Week 2, the earliest scheduled study visit, and at each visit thereafter, a higher proportion of ustekinumab patients had no rectal bleeding or achieved normal stool frequency as compared with placebo patients.
Danish: Så tidligt som i uge 2, det tidligste planlagte studiebesøg, og ved hvert af de efterfølgende besøg var andelen af patienter, som ikke havde rektalblødning, eller som havde normal afføringshyppighed, større hos dem, der havde fået ustekinumab, end hos dem, der fik placebo.
English: Median volume of distribution during the terminal phase (Vz) following a single intravenous administration to patients with psoriasis ranged from 57 to 83 mL/kg.
Danish: Den mediane fordelingsvolumen i løbet af den terminale fase (Vz) efter en enkelt intravenøs administration til patienter med psoriasis lå fra 57 til 83 ml/kg.
English: Concomitant immunosuppressive therapy
Danish: Samtidig immunsuppressiv behandling
English: Clinical response and remission were significant as early as week 3 in ustekinumab treated patients and continued to improve through week 8.
Danish: Der var signifikant klinisk respons og remission så tidligt som i uge 3 hos patienter behandlet med ustekinumab, og dette respons blev fortsat bedre til og med uge 8.
English: In these patients, clinical remission was achieved in 41.4% of patients 16 weeks after dose adjustment.
Danish: Blandt disse patienter opnåede 41,4% klinisk remission 16 uger efter justering af dosis.
English: • the vial is not damaged and the seal is not broken
Danish: • at hætteglasset ikke er beskadiget, og at forseglingen ikke er brudt
English: Concomitant doses of oral corticosteroids, immunomodulators, aminosalicylates and antibiotics were permitted and 75% of patients continued to receive at least one of these medications.
Danish: Samtidig behandling med orale kortikosteroider, immunmodulatorer, aminosalicylater og antibiotika var tilladt, og 75% af patienterne fortsatte med at få mindst ét af disse lægemidler.
English: Talk to your doctor if you have any questions about receiving Stelara.
Danish: Tal med din læge, hvis du har spørgsmål i forbindelse med at få Stelara.
English: The first subcutaneous administration of 90 mg STELARA should take place at week 8 after the intravenous dose.
Danish: Den første subkutane administration af 90 mg STELARA bør finde sted i uge 8 efter den intravenøse dosis.
English: In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
Danish: I de farmakokinetiske populationsanalyser af fase 3-studierne blev effekten af de hyppigst, samtidigt anvendte lægemidler til psoriasispatienter undersøgt (herunder paracetamol, ibuprofen, acetylsalicylsyre, metformin, atorvastatin, levothyroxin) på ustekinumabs farmakokinetik.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om Stelara findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: UNIFI-M, evaluated 523 patients who achieved clinical response with single IV administration of ustekinumab in UNIFI-I.
Danish: UNIFI-M evaluerede 523 patienter, der havde opnået klinisk respons med en enkelt i.v.
English: STELARA should not be administered concomitantly in the same intravenous line with other medicinal products.
Danish: STELARA må ikke administreres samtidig med andre lægemidler i den samme intravenøse slange.
English: Table 5 Summary of clinical response at week 12 in Psoriasis Study 3 (ACCEPT) Psoriasis Study 3
Danish: Tabel 5 Oversigt over klinisk respons i uge 12 i psoriasisstudie 3 (ACCEPT) Psoriasisstudie 3
English: (kg) may start on a dose of 90 mg instead of 45 mg.
Danish: kan starte med en dosis på 90 mg i stedet for 45 mg.
English: Patients receiving ustekinumab experienced significantly more improvements in work productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI-GH questionnaire than patients receiving placebo.
Danish: De patienter, der fik ustekinumab, oplevede signifikant flere forbedringer i arbejdsproduktivitet målt som en øget reduktion af den generelle, nedsatte arbejdsevne og i aktivitetsnedsættelse målt ved hjælp af spørgeskemaet WPAI-GH end de patienter, der fik placebo.
English: IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL-23 induces the T helper 17 (Th17) pathway.
Danish: IL-12 og IL-23 er heterodimere cytokiner, der udskilles af aktiverede antigenpræsenterende celler, f.eks. makrofager og dendritiske celler, og begge cytokiner deltager i immunsystemets funktioner: IL-12 stimulerer natural killer-celler (NK-celler) og driver differentieringen af CD4+ T-celler til fænotypen T-hjælper 1 (Th1), mens IL-23 inducerer aktivering af T-hjælper 17 (Th17).
English: If you stop using Stelara It is not dangerous to stop using Stelara.
Danish: Det er ikke farligt at holde op med at bruge Stelara.
English: Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple subcutaneous dose administrations.
Danish: Tidsforløbet af serumkoncentration for ustekinumab var generelt forudsigeligt efter subkutan administration af en enkelt dosis eller flere doser.
English: Of these 51 patients, 70.6% achieved clinical response and 39.2% percent achieved clinical remission 16 weeks after receiving the first subcutaneous dose of ustekinumab.
Danish: Af disse 51 patienter havde 70,6% opnået klinisk respons og 39,2% opnået klinisk remission 16 uger efter den første subkutane dosis med ustekinumab.
English: STELARA concentrate for solution for infusion should only be used for the intravenous induction dose.
Danish: STELARA koncentrat til infusionsvæske må kun anvendes som intravenøs induktionsdosis.
English: Patients in UNITI-2 had failed at least one conventional therapy, including corticosteroids or immunomodulators, and were either anti-TNF-α naïve (68.6%) or had previously received but not failed anti-TNFα therapy (31.4%).
Danish: Patienterne i UNITI-2 havde ikke responderet på mindst én konventionel behandling, herunder kortikosteroider eller immunmodulatorer, og var enten anti-TNF-alfa-naive (68,6%) eller havde tidligere fået, men ikke responderet på, anti-TNF-alfa-terapi (31,4%).
English: Durable Remission is defined as partial Mayo remission at ≥80% of all visits prior to Week 44 and in partial Mayo remission at last visit (Week 44).
Danish: Vedvarende remission defineres som partiel Mayo-remission på ≥ 80% ved alle besøg før uge 44 og med partiel Mayo-remission ved sidste besøg(uge44).
English: Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI of at least 100 points or being in clinical remission * The placebo group consisted of patients who were in response to ustekinumab and were randomized to receive placebo at the start of maintenance therapy.
Danish: Klinisk respons defineres som reduktion i CDAI score på mindst 100 point eller at være i klinisk remission * Placebo-gruppen bestod af patienter som responderede på ustekinumab og blev randomiseret til placebo i starten af vedligeholdelsesbehandlingen.
English: How much Stelara is given Your doctor will decide how much Stelara you need to use and for how long.
Danish: Hvor meget Stelara skal du have Lægen beslutter, hvor meget Stelara du har brug for og i hvor lang tid.
English: Make sure you tell your doctor about any illness you have before treatment.
Danish: Sørg for at fortælle lægen om enhver sygdom, du måtte have, før behandling.
English: The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein.
Danish: Injektionsvæsken er klar til let opaliserende, farveløs til lys gul og kan indeholde enkelte små gennemsigtige eller hvide proteinpartikler.
English: The primary endpoint was change from baseline in Simplified Endoscopic Disease Severity Score for Crohn's Disease (SES-CD), a composite score across 5 ileocolonic segments of presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions and presence/type of narrowing/strictures.
Danish: Det primære endepunkt var ændring fra baseline i Simplified Endoscopic Disease Severity Score for Crohns Disease (SES-CD), en sammensat score for 5 segmenter i ileum-colon for tilstedeværelse/størrelse af sår, andel af mucosa dækket af sår, andel af mucosa påvirket af eventuelle andre læsioner og tilstedeværelse/type af forsnævringer/strikturer.