FrancophonIA/ELRC3.0 huggingface dataset:
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Danish: I tilfælde, hvor der er brug for et hurtigere respons af behandlingen, kan regimet 160 mg i uge 0 (givet som fire injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage), 80 mg i uge 2 (givet som to injektioner af 40 mg på en dag), anvendes med erkendelse af, at risikoen for bivirkninger er højere under induktionen.
English: Myocardial infarction1), arrhythmia, congestive heart failure
Danish: Myokardieinfarkt1), arytmi, kongestiv hjertesvigt
English: Step 7 Throw away your Syringe
Danish: Trin 7 Kassér din sprøjte
English: • Store the pre-filled pen in a refrigerator between 2°C to 8°C.
Danish: • Opbevar den fyldte pen i køleskab ved 2-8 °C.
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Danish: Patienterne blev randomiseret til at få enten adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg eller placebo hver anden uge i 12 uger.
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af lymfomer var 0,7 (0,2-2,7) pr. 1.000 patientår blandt de adalimumab-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: • You might get infections more easily while you are receiving Kromeya treatment.
Danish: • Du kan lettere få infektioner under behandling med Kromeya.
English: Kromeya dose for patients with polyarticular juvenile idiopathic arthrtis
Danish: Kromeya-dosis til patienter med polyartikulær juvenil idiopatisk artrit
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 10).
Danish: I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med adalimumab og methotrexat til hurtigere og signifikant større ACR-respons end methotrexat-monoterapi og adalimumab-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 10).
English: Kromeya is available as a vial, a pre-filled syringe and as a pre-filled pen.
Danish: Kromeya er tilgængelig som et hætteglas, en fyldt injektionssprøjte og som en fyldt pen.
English: • non-infectious uveitis
Danish: • Ikke-infektiøs uveitis.
English: • Store the Kromeya Vial Kit in a refrigerator between 2°C to 8°C.
Danish: • Opbevar Kromeya hætteglassæt i køleskab ved 2-8 °C.
English: Non-infectious uveitis Age or body weight
Danish: Ikke-infektiøs uveitis Alder eller vægt
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 8).
Danish: I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med adalimumab og methotrexat til hurtigere og signifikant større ACR-respons end methotrexat-monoterapi og adalimumab-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 8).
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/mL (without concomitant methotrexate) and 8 to 9 µg/mL (with concomitant methotrexate), respectively.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge hos voksne patienter med rheumatoid artrit (RA) var de gennemsnitlige dal-steady state-koncentrationer på henholdsvis cirka 5 g/ml (uden kombination med methotrexat) og 8-9 g/ml (i kombination med methotrexat).
English: Steroid-free remission for ≥ 90 days a
Danish: Steroid-fri remission i > 90 dagea
English: 7.1 Throw away your used pre-filled pen in a sharps disposal container right away after use (Figure S).
Danish: 7.1 Kassér den brugte pen i en affaldsbeholder til skarpe genstande straks efter injektionen (figur S).
English: Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Kromeya er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive glukokortikoider og 6mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Danish: Patienter fik testet serumprøver for autoantistoffer på forskellige tidspunkter i reumatoid artrit-studie IV. I disse havde 11,9% af de adalimumab-behandlede patienter og 8,1% af de placebo- og aktiv kontrolbehandlede patienter med negative antinukleære antistoftitere ved baseline positive titere efter 24 uger.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use in single-use vial 0.8 mL solution in vial (type I glass) with a rubber stopper (synthetic rubber) and aluminium crimp seal.
Danish: Kromeya 40 mg/0,8 ml injektionsvæske, opløsning til pædiatrisk brug i engangshætteglas 0,8 ml opløsning i hættelgas (type I glas) med en gummiprop (syntetisk gummiprop) og krympeforsegling af aluminium.
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (< 1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede sig fra “let” (<1%) til “moderat” (48%), “alvorlig” (46%) og “meget alvorlig” (6%).
English: If you accidentally inject a larger amount of Kromeya liquid, or if you inject Kromeya more frequently than told to by your doctor, call your doctor and tell him/her that your child has taken more.
Danish: Hvis du ved en fejltagelse har injiceret en større mængde Kromeya eller hvis du har injiceret hyppigere end forskrevet af lægen, kontakt lægen og fortæl ham/hende, at dit barn har fået for meget.
English: 5.1 Wipe the skin of your injection site with an alcohol pad to clean it (Figure K).
Danish: 5.1 Rengør huden på injektionsstedet med en spritserviet (figur K).
English: 7.1 Throw away your used syringe in a sharps disposal container right away after use (Figure U).
Danish: 7.1 Kassér den brugte injektionssprøjte i en affaldsbeholder til skarpe genstande straks efter injektionen (figur U).
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Kromeya.
Danish: Dit barn kan få en fornemmelse af, at rummet drejer rundt og synsforstyrrelser, efter at have taget Kromeya.
English: Step 4 Choose the Injection Site
Danish: Trin 4 Vælg injektionsstedet
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer)
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/mL (79% CV).
Danish: Efter subkutan administration af 0,8 mg/kg (op til maksimalt 40 mg) hver anden uge til pædiatriske patienter med kronisk plaque-psoriasis var den gennemsnitlige dal-koncentration af adalimumab ved steady state 7,4 ± 5,8 µg/ml (± SD) (79% CV).
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Danish: Patienterne fik placebo, en startdosis på 7,5 mg methotrexat og derefter dosisøgning op til uge 12 til en maksimum-dosis på 25 mg eller en startdosis på 80 mg adalimumab efterfulgt af 40 mg hver anden uge (med start en uge efter den første dosis) i 16 uger.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Danish: På trods af profylaktisk behandling mod tuberkulose er der forekommet tilfælde af reaktivering af tuberkulose hos patienter i behandling med adalimumab.
English: When needed (for example when you are travelling), Kromeya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan Kromeya opbevares ved stuetemperatur (op til 25 °C) i en periode på højst 14 dage - vær sikker på at beskytte den mod lys.
English: Kromeya is used to treat ulcerative colitis in adults.
Danish: Kromeya bruges til at behandle colitis ulcerosa hos voksne.
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 µg/mL during adalimumab 40 mg every other week monotherapy treatment.
Danish: Hos voksne patienter med psoriasis var den gennemsnitlige dalkoncentration ved steady state 5 g/ml ved monoterapibehandling med 40 mg adalimumab hver anden uge.
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab- treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Danish: Hos disse hudkræfttilfælde forekom planocellulært karcinom med en hyppighed (95 % konfidensinterval) på 2,7 (1,4-5,4) pr. 1.000 patientår blandt de adalimumab-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: Initial dose of 40 mg, followed by 40 mg one week later.
Danish: Startdosis på 40 mg efterfulgt af 40 mg en uge senere.
English: The blinded period was followed by an open−label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Danish: Den blindede periode blev efterfulgt af en åben periode, hvor patienterne modtog adalimumab 40 mg hver anden uge subkutant i op til yderligere 28 uger.
English: ACR 50 Week 12 Week 24
Danish: ACR 50 Uge 12 Uge 24
English: The recommended dose of Kromeya for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Kromeya til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
English: Kromeya dose for patients with enthesitis-related arthritis
Danish: Kromeya-dosis til patienter med entesopati relateret artrit
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Danish: Patienterne fik en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis eller placebo i 26 uger efterfulgt af åben adalimumab behandling i yderligere 26 uger.
English: Read carefully these entire instructions before using your Kromeya pre-filled pen.
Danish: Læs hele brugsanvisningen grundigt, inden du begynder at bruge din Kromeya fyldte pen.
English: 20 mg every other week
Danish: 20 mg hver anden uge
English: 6.4 If there is blood or liquid on the skin, treat the injection site by gently pressing a cotton ball or gauze on the site (Figure R).
Danish: 6.4 Hvis der er blod eller væske ved injektionsstedet, skal du forsigtigt duppe huden med et stykke vat eller gaze (figur R).
English: The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Danish: Det anbefales ikke at kombinere adalimumab såvel som andre TNF-antagonister og anakira eller abatacept, fordi der er øget risiko for infektion herunder alvorlige infektioner og andre mulige farmakologiske interaktioner.
English: Kromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Danish: Kromeya er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos pædiatriske patienter (fra 6 år), som har haft utilstrækkeligt respons på konventionel behandling inklusive primær ernæringsbehandling og kortikosteroidbehandling og/eller immunmodulerende behandling, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: 6.5 If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin (Figure T).
Danish: 6.5 Hvis der er blod eller væske ved injektionsstedet, skal du forsigtigt duppe huden med et stykke vat eller gaze (figur T).
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Danish: I en analyse af non-respondenter, defineret som patienter, som udgik af studiet på grund af bivirkninger eller manglende effekt, eller hvor dosis blev trappet op,var PASI 75- og PGA clear/minimal responserater henholdvis 69,6 % og 55,7 % efter yderligere 108 ugers åben behandling (i alt 160 uger).
English: Get Familiar with your Kromeya Pre-Filled Syringe Before Use
Danish: Bliv fortrolig med din Kromeya fyldt injektionssprøjte Før brug
English: Warning: Do not remove the clear needle cap.
Danish: Advarsel: Du må ikke fjerne den gennemsigtige kanylehætte.
English: Table 17 Ps Study I (REVEAL) efficacy results at 16 weeks
Danish: Tabel 17 Ps-studie I (REVEAL) Effektresultater ved uge 16
English: Table 14 Ps study I (REVEAL) efficacy results at 16 weeks
Danish: Tabel 14 Ps-studie I (REVEAL) Effektresultater ved uge 16
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Danish: I kontrollerede studier med adalimumab hos voksne patienter med uveitis (startdosis på 80 mg i uge 0 efterfulgt af 40 mg hver anden uge med start i uge 1) i op til 80 uger med en gennemsnitligt behandlingtid på 166,5 dage for patienter behandlet med adalimumab og 105,0 dage for patienter i kontrol-armen, forekom ALAT-stigning ≥ 3 x ULN hos 2,4% af patienterne i adalimumab-armen og hos 2,4 % af patienterne i kontrol-armen.
English: Warning: Call your healthcare professional or pharmacist if:
Danish: Figur S Advarsel: Kontakt lægen eller apotekspersonalet:
English: Notes
Danish: Bemærkninger
English: 5.1 Wipe the skin of your injection site with an alcohol pad to clean it. (Figure M)
Danish: 5.1 Rengør huden på injektionsstedet med en spritserviet (figur M).
English: Kromeya is used in adults to treat these conditions.
Danish: Kromeya bruges til at behandle disse sygdomme.
English: Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Danish: Fortæl din læge hvis du får symptomer såsom vedvarende uforklarligt udslæt, feber, ledsmerter eller træthed.
English: • polyarticular juvenile idiopathic arthritis,
Danish: • Polyartikulær juvenil idiopatisk artrit,
English: Yellow syringe connector
Danish: Gul sprøjtekonnektor
English: There is no relevant use of Kromeya in children aged less than 2 years in this indication.
Danish: Det er ikke relevant at bruge Kromeya til patienter under 2 år til denne indikation.
English: ACR 20 Week 52 62.6% 54.4% 72.8% Week 104 56.0% 49.3% 69.4% ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Danish: Total Sharp Score Erosion score 3,7 (2,7-4,7) 1,7 (1,0-2,4) 0,8 (0,4-1,2) < 0,001 0,0082 < 0,001 JSN score 2,0 (1,2-2,8) 1,3 (0,5-2,1) 0,5 (0-1,0) < 0,001 0,0037 0,151 ap-værdien for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexat-kombinationsbehandling ved anvendelse af Mann-Whitney U test. bp-værdien for den parvise sammenligning af adalimumab monoterapi og adalimumab/methotrexat-kombinationsbehandling ved anvendelse af Mann-Whitney U test cp-værdien for den parvise sammenligning af adalimumab monoterapi og methotrexat- monoterapi ved anvendelse af Mann-Whitney U test
English: Warning: Do not warm the syringe any other way, such as in a microwave, hot water, or direct sunlight.
Danish: Advarsel: Du må ikke varme injektionssprøjten på andre måder som f.eks. i mikroovn, varmt vand eller i direkte sollys.
English: • Keep Kromeya pre-filled syringe and the sharps disposal container out of reach and sight of children.
Danish: • Opbevar Kromeya hætteglassæt og affaldsbeholderen til skarpe genstande utilgængeligt for børn.
English: 4.5 Place the syringe on a clean, flat surface.
Danish: 4.5 Læg sprøjten på en ren, plan flade.
English: The double-blind period is followed by an openlabel (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode (OL), hvor patienterne fik adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg hver anden uge subkutant i op til yderligere 192 uger.
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open- label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Danish: Efter at have gennemførst de første 52 uger blev 457 patienter optaget i et åbent forlængelsesstudie, hvor 40 mg adalimumab/MTX blev administreret hver anden uge i op til 10 år.
English: Initial dose of 40 mg, followed by 20 mg two weeks later.
Danish: Startdosis på 40 mg efterfulgt af 20 mg to uger senere.
English: • Store the pre-filled pen in its original box to protect it from light.
Danish: • Opbevar den fyldte pen i den originale æske for at beskytte mod lys.
English: Ear and labyrinth disorders Common
Danish: Øre og labyrint
English: Warning: Do not remove the needle cap while allowing syringe to reach room temperature.
Danish: Advarsel: Du må ikke fjerne kanylehætten, imens injektionssprøjten hviler ved stuetemperatur.
English: Enthesitis-related arthritis Age or body weight
Danish: Entesopatirelateret artrit Alder eller vægt
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Danish: Det får dem til at smuldre, blive fortykket og løftet fra neglelejet, hvilket kan være meget smertefuldt.
English: ACR 70 Week 12 Week 24
Danish: ACR 70 Uge 12 Uge 24
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 18,9, og baseline-PGA-score varierede fra “moderat” (53% af de inkluderede patienter) til “alvorlig” (41%) og “meget alvorlig”
English: You should record the date when the vial is first removed from refrigerator, and the date after which it should be discarded.
Danish: Du skal registrere den dato, hvor hætteglasset først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres.
English: Step 1 Prepare for your Injection
Danish: Trin 1 Forbered din injektion
English: • a sharps disposal container.
Danish: • en affaldsbeholder til skarpe genstande.
English: Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Danish: Samtidig administration af adalimumab og andre biologiske DMARDs (f.eks, anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner (se pkt.
English: Some patients who experience decrease in their response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg Kromeya every week or 80 mg every other week.
Danish: Nogle patienter, som oplever, at deres respons på Kromeya 40 mg hver anden uge bliver dårligere, kan have fordel af at øge dosis til 40 mg Kromeya hver uge eller 80 mg hver anden uge.
English: Kromeya is administered every other week via subcutaneous injection.
Danish: Kromeya administreres hver anden uge som subkutan injektion.
English: Kromeya is recommended for use in combination with methotrexate.
Danish: Det er anbefalet at tage Kromeya sammen med methotrexat.
English: What you need to know before you use Kromeya
Danish: Det skal du vide, før du begynder at tage Kromeya
English: Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Danish: Kromeya er indiceret til behandling af pædiatrisk kronisk non-infektiøs anterior uveitis hos børn fra 2 år, som har haft utilstrækkeligt respons på konventionel behandling eller, som er intolerante eller, som ikke er egnet til konventionel behandling.
English: Clinical remission Mucosal healing
Danish: Klinisk remission Slimhindeheling
English: autoantibody test positive (including double stranded DNA antibody),
Danish: Positiv auto-antistoftest (inklusive dobbeltstrenget DNA-antistof), forhøjet blodlactatdehydrogenase