FrancophonIA/ELRC3.0 huggingface dataset:
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Danish: Adalimumab-eksponering hos pædiatriske uveitis-patienter blev estimeret ved anvendelse af populationsfarmakokinetisk modellering og simulering, baseret på farmakokinetik på tværs af indikationerne hos andre pædiatriske patienter (pædiatrisk psoriasis, juvenil idiopatisk artrit, pediatrisk Crohns sygdom og entesopatirelateret artrit).
English: 5.3 Remove the clear needle cap by pulling it straight off and throw it away.
Danish: Fjern den gennemsigtige kanylehætte ved at trække den lige af, og smid den ud.
English: It is recommended that the conduct and results of these tests are recorded in the patient reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, særligt hos patienter, der er alvorligt syge eller immunkompromitterede.
English: Thereafter, the usual dose is 20 mg every other week.
Danish: Derefter den sædvanlige dosis på 20 mg hver anden uge.
English: Table 7 Distribution of patients by age and adalimumab dose received during the OL LI phase
Danish: Tabel 7 Fordelingen af patienter i henhold til alder og modtaget adalimumab-dosis i den åbne indkøringsfase
English: - if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Danish: • hvis du har en alvorlig infektion, herunder tuberkulose, sepsis (blodforgiftning) eller andre usædvanlige infektioner, der er forbundet med et svækket immunforsvar.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in one randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Danish: I Studie nr-axSpA I blev adalimumab 40 mg hver anden uge vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med adalimumab og 6,5 for patienter i placeboarmen), som havde haft utilstrækkeligt respons på eller var intolerante over for  1 NSAID eller havde en kontraindikation mod NSAID.
English: Amongst those who responded at week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Danish: Blandt de patienter, som responderede ved uge 16 (n=144), blev Pædiatrisk ACR 30/50/70/90responser opretholdt i op til seks år i den åbne forlængelsesfase hos dem, der fik adalimumab gennem hele studiet.
English: It is important that you tell your baby's doctors and other health care professionals about your Kromeya use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Kromeya under graviditeten, før dit barn får nogen vaccinationer (for mere information, se afsnittet om vaccinationer).
English: 1.6 Place the remaining syringe(s) in its (their) original box back in the refrigerator (Figure D).
Danish: 1.6 De(n) tilbageværende injektionssprøjte(r) lægges tilbage i køleskabet i den originale æske (figur D).
English: bleeding, paleness.
Danish: blødning, bleghed.
English: Polyarticular juvenile idiopathic arthritis Age or body weight
Danish: Polyartikulær juvenil idiopatisk artrit Alder eller vægt
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et multicenter-, randomiseret, dobbeltblindet, parallelgruppestudier hos 171 børn (4-17 år) med polyartikulær JIA.
English: Kromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Danish: Kromeya er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
English: The safety and efficacy of adalimumab were assessed in a multicenter, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et randomiseret, dobbeltblindet multicenterstudie hos 46 pædiatriske patienter (6-17 år) med moderat entesopatirelateret artrit.
English: Table 11 Distribution of patients by age and adalimumab dose received during the OL LI phase
Danish: Tabel 11 Fordelingen af patienter i henhold til alder og modtaget adalimumab-dosis i den åbne indkøringsfase
English: Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Danish: c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen af sygdom er defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg.
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Kromeya.
Danish: Patienter, som har behov for en mindre dosis end 40 mg, bør bruge Idacaio 40 mg i hætteglas.
English: • pull the pre-filled pen straight up and out of the packaging (Figure D).
Danish: • løft pennen lige op og ud af æsken (figur D).
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Danish: Disse studier omfattede patienter med reumatoid artrit af kortere og længere sygdomsvarighed, juvenil idiopatisk artrit (polyartikulær juvenil idiopatiske artrit og entesopatirelateret artrit) og patienter med aksial spondyloartritis (ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis (AS)), psoriasisartrit, Crohns sygdom, colitis ulcerosa, psoriasis, hidrosadenitis suppurativa og uveitis.
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Danish: ***, ** Statistisk signifikant ved p < 0,001 og < 0,01, henholdvis, ved alle sammenligninger af adalimumab og placebo.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Danish: Post-marketing er der rapporteret om sjældne tilfælde af hepatosplenisk T-celle lymfom hos patienter i behandling med adalimumab (se punk 4.4).
English: The safety and efficacy of adalimumab was assessed in an open-label, multicenter study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et åben-label, multicenter studie med 32 børn (2<4 år gamle eller 4 år og derover med en vægt < 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus4,3 % [P=0,014]).
English: • Top of the thighs or
Danish: • fortil på låret eller
English: 4.2 Insert the syringe tip into the yellow syringe connector and screw to connect.
Danish: 4.2 Før sprøjtespidsen ind i den gule sprøjtekonnektor, og skru delene sammen.
English: Adult Uveitis
Danish: Uveitis hos voksne
English: Kromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Danish: Kromeya er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Danish: RA-studie I evaluerede 271 patienter, der var  18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge.
English: Warning: Do not rub the injection site.
Danish: Advarsel: Du må ikke gnide på injektionsstedet.
English: Tell your doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Danish: Fortæl straks din læge, hvis dit barn får symptomer såsom ændringer i dit syn, svaghed i arme eller ben eller følsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Danish: Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Totale Sharp Score  0,5) signifikant højere med adalimumab/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p<0,001) og adalimumab monoterapi (henholdsvis 50,7%, p<0,002 og 44,5%, p<0,001).
English: • a cotton ball or gauze, and
Danish: • et stykke vat eller gaze og
English: Each box of Kromeya pre-filled pen comes with two or six pre-filled pens.
Danish: Hver æske af Kromeya fyldt pen indeholder to eller seks fyldte penne.
English: • unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
Danish: • udsædvanlige infektioner (som inkluderere tuberkulose og andre infektioner), som forekommer,
English: • Continue to HOLD the pre-filled pen firmly.
Danish: • FASTHOLD den fyldte pen i denne position.
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Danish: Blandt disse havde 154 patienter (90,6 %) ACR 20-respons, 127 patienter (74,7%) ACR 50-respons og 102 patienter (60%) ACR 70-respons.
English: a a a p < 0.001, adalimumab vs. placebo
Danish: -56,2a a p<0.001, adalimumab vs. placebo
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Kromeya.
Danish: Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/symptomer, der tyder på tuberkulose (f.eks. vedvarende hoste, tæring/vægttab, lav feber, apati) under eller efter behandling med Kromeya.
English: • Do not use the Kromeya pre-filled syringe if liquid appears cloudy or discolored, or has -particles or flakes in it.
Danish: • Du må ikke bruge Kromeya fyldt injektionssprøjte, hvis væsken er uklar eller misfarvet eller indeholder partikler eller flager.
English: Each pack contains 1 vial (0.8 mL sterile solution), 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Danish: Hver pakning indeholder 1 hætteglas (0,8 ml steril opløsning), 1 steril injektionssprøjte, 1 steril kanyle, 1 hætteglasadaptor og 2 spritservietter.
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leucopenia) have been reported with adalimumab.
Danish: Hæmatologiske bivirkninger herunder klinisk signifikant cytopeni (f.eks. trombocytopeni, leukopeni) er rapporteret efter behandling med adalimumab.
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table
Danish: Resultaterne i uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med adalimumab sammenlignet med placebo (Tabel 14).
English: Your child is advised to avoid becoming pregnant and must use adequate contraception while using Kromeya and for at least 5 months after the last Kromeya injection.
Danish: Dit barn rådes til at undgå at blive gravid og skal bruge passende prævention, imens dit barn bruger Kromeya og i mindst 5 måneder efter sidste Kromeya injektion.
English: If you stop using Kromeya
Danish: Hvis du holder op med at tage Kromeya
English: • any issue you had
Danish: • eventuelle problemer
English: Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Danish: Kromeya er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og panuveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for steroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider.
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev opretholdt i den åbne forlængelsesfase op til uge
English: Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Danish: I DLQI viste patienter behandlet med adalimumab statistisk signifikant forbedring ved uge 26 sammenlignet med placebo.
English: 6.3 Insert the needle
Danish: 6.3 Indfør kanylen
English: Kromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Danish: Kromeya er indiceret til behandling af voksne med alvorlig aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation ved forhøjet CRP og/eller MRI, som ikke har responderet tilstrækkeligt på eller er intolerante overfor NSAID.
English: Talk to your child's doctor or pharmacist before using Kromeya
Danish: Kontakt dit barns læge eller apotekspersonalet, før dit barn tager Kromeya.
English: MRI sacroiliac joints d,i
Danish: SPARCCh MRI sakroiliakaleddened,i
English: Warning: Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Danish: Advarsel: Du må ikke injicere i et område, der er ømt, rødt, hårdt, arret eller har blå mærker eller strækmærker.
English: Each pack contains 2 or 6 pre-filled syringes, and 2 or 6 alcohol pads.
Danish: Hver pakning indeholder 2 eller 6 fyldte injektionssprøjter og 2 eller 6 spritservietter.
English: Ulcerative colitis Age or body weight
Danish: Colitis ulcerosa Alder eller vægt
English: • The name on the pre-filled pen says Kromeya (Figure I).
Danish: • at der står Kromeya på pennen (figur I).
English: Respiratory, thoracic and mediastinal disorders*
Danish: Luftveje, thorax og mediastinum *
English: Warning: Do not try to put the needle cap back on the needle.
Danish: Advarsel: Du må ikke prøve at sætte kanylehætten tilbage på kanylen.
English: Musculoskeletal pain
Danish: Meget almindelig Muskuloskeletale smerter
English: Alternatively, if a patient has stopped Kromeya and signs and symptoms of disease recur, Kromeya may be re-administered.
Danish: Alternativt, kan Kromeya gen-administreres, hvis patienten er stoppet behandling med Kromeya, og tegn og symptomer på sygdommen kommer igen.
English: 2.7 With the vial adapter still in its packaging, push the vial adapter onto the vial top until it snaps in place.
Danish: 2.7 Tryk hætteglasadapteren, der stadig er i sin emballage, fast på hætteglastoppen, til den klikker på plads.
English: The recommended Kromeya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 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) and 80 mg at week 2 (given as two 40 mg injections in one day).
Danish: Det anbefalede Kromeya dosis-induktionsregime til voksne patienter med moderat til svær colitis ulcerosa er 160 mg i uge 0 (givet som fire 40 mg injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage) og 80 mg i uge 2 (givet som to 40 mg injektioner på en dag).
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
Danish: I PsA-studie I blev 313 voksne patienter, som havde et utilstrækkeligt respons på nonsteroid anti-inflammatorisk behandling, behandlet i 24 uger.
English: Abdominal pain, nausea and vomiting
Danish: Meget almindelig Abdominalsmerter, kvalme og opkastning
English: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Danish: Tag altid Kromeya nøjagtigt som dit barns læge eller apotekspersonalet har anvist.
English: Table 14 Efficacy response in placebo-controlled study nr-axSpA I
Danish: Tabel 14 Respons på effektmål i placebokontrolleret Studie nr-axSpA I
English: • rheumatoid arthritis,
Danish: • Reumatoid artrit,
English: Week 12
Danish: Uge 12
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Danish: I de kontrollerede dele af de pivotale adalimumab-studier med voksne af mindst 12 ugers varighed hos patienter med moderat til svær aktiv reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS, psoriasisartrit, psoriasis, hidrosadenitis suppurativa, Crohns sygdom, colitis ulcerosa og uveitis blev der observeret maligniteter, fraset lymfomer eller ikkemelanom hudkræft, med en hyppighed (95 % konfidensinterval) på 6,8 (4,4-10,5) pr. 1.000 patientår blandt 5.291 adalimumabbehandlede patienter mod en hyppighed på 6,3 (3,4-11,8) pr. 1.000 patientår blandt 3.444 kontrolpatienter (gennemsnitlig varighed af behandlingen var 4,0 måneder for adalimumab og 3,8 måneder for de kontrol-behandlede patienter).
English: Warning: Do not touch the yellow connector.
Danish: Advarsel: Du må ikke røre ved den gule sprøjtekonnektor.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Danish: Hos pædiatriske patienter med moderat til svær CD var åben-label adalimumab-induktionsdosis henholdsvis 160/80 mg eller 80/40 mg i uge 0 og 2, afhængigt af legemsvægt med en skillelinje ved 40 kg. Ved uge 4 blev patienterne randomiseret 1:1 til vedligeholdelsesbehandlingsgrupper: enten standard-dosis (40/20 mg hver anden uge) eller lav-dosis (20/10 mg hver anden uge) baseret på deres legemsvægt.
English: Each box contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Danish: Hver æske indeholder 1 hætteglas, 1 steril injektionssprøjte, 1 steril kanyle, 1 hætteglasadaptor og 2 spritservietter.
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Kromeya.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), skal du kontakte din læge, før du begynder at bruge Kromeya.
English: Each pack contains 2 or 6 pre-filled pens with 2 or 6 alcohol pads.
Danish: Hver pakning indeholder 2 eller 6 fyldte penne og 2 eller 6 spritservietter.
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during a adalimumab trial in paediatric patients with chronic plaque psoriasis.
Danish: Der blev ikke observeret nogen maligniteter hos 77 pædiatriske patienter med en samlet eksponering på 80,0 patientår i adalimumab-studier hos pædiatriske patienter med kronisk plaque-psoriasis.
English: Figure 1: Kaplan-Meier curves summarizing time to flare in study nr-axSpA II
Danish: Figur 1: Kaplan-Meier-kurver opsummerende tid til opblussen af sygdom i Studie nr-axSpA II
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Danish: I alt 76,5 % (218/285) af de patienter, som fik genbehandling, havde et PGA-respons på “clear” eller “minimal” efter 16 ugers genbehandling, uanset om de fik tilbagefald i den behandlingsfri periode (69,1 % [123/178] for patienter, som fik tilbagefald, og 88,8 % [95/107] for patienter, som ikke fik tilbagefald).
English: Table 12 Ped ACR 30 responses in the JIA study
Danish: Tabel 12 Pædiatrisk ACR 30-respons i JIA-studiet
English: Refer to Storage Information for how to store your unused pre-filled pen(s).
Danish: Se under afsnittet Opbevaring, hvordan du skal opbevare ubrugte penne.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for den aktive substans eller over for ét eller flere af hjælpestofferne anført i pkt.