FrancophonIA/ELRC3.0 huggingface dataset:
English: In RA study III, where adalimumab treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
Danish: I RA-studie III, hvor de adalimumab-behandlede patienter havde haft reumatoid artrit gennemsnitlig i 11 år, blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (TSS) og dennes delkomponenter, erosionsscore og ledspalteforsnævring (JSN).
English: ASAS partial remission BASDAI
Danish: ASAS delvis remission BASDAIb 50
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
Danish: I RA-studie I-IV forbedredes alle individuelle komponenter af ACR-responskriterierne (antal af ømme og hævede led, læge- og patientvurderinger af sygdomsaktivitet og smerter, fysisk funktionsevneindeksværdier (HAQ) og CRP (mg/dl)-værdier) efter 24 eller 26 uger sammenlignet med placebo.
English: Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Danish: Lægen vil teste dig for HBV. Adalimumab kan reaktivere af HBV-infektion hos mennesker, der bærer denne virus.
English: Kromeya is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: Kromeya bruges til at behandle børn fra 2 år med kronisk ikke-infektiøs uveitis med inflammation, som påvirker forreste del af øjet.
English: ▪ the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Danish: • behandling af moderat til alvorlig aktiv reumatoid artrit hos voksne patienter, hvor responsen på sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været utilstrækkelig.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Kromeya.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil din læge undersøge dig for tegn og symptomer på tuberkulose, før behandling med Kromeya påbegyndes.
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Danish: Baseret på anvendelse af observerede data var 222 (80,4%) inaktive (ingen aktive inflammatoriske læsioner, AC cell grade ≤ 0,5+, VH grad ≤ 0,5+) med en samtidig steroiddosis ≤ 7,5 mg pr. dag og 184 (66,7% ) var både steroidfri og inaktive.
English: If your child takes Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når dit barn tager Kromeya, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Danish: • tegn og symptomer på infektion, såsom feber, kvalme, sår, tandproblemer, smerter ved vandladning, følelse af svaghed eller træthed eller hoste.
English: 4.1 Choose an injection site (Figure L) on:
Danish: 4.1 Vælg et injektionssted (figur L):
English: • ankylosing spondylitis,
Danish: • Ankyloserende spondylitis,
English: Get Familiar with your Kromeya Pre-filled pen Before Use
Danish: Bliv fortrolig med din Kromeya fyldte pen Før brug
English: Lupus-like syndrome
Danish: • lupus-lignende syndrom
English: • The clear needle guard does not activate after injecting.
Danish: • hvis den gennemsigtige kanylebeskyttelse ikke aktiveres efter injektionen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referencelægemidlet indeholdende adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa , se pkt.
English: In rheumatoid arthritis, methotrexate is continued while using Kromeya.
Danish: Ved rheumatoid artrit kan du fortsætte med methotrexat, imens du bruger Kromeya.
English: • the injection site
Danish: • injektionssted
English: Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Danish: Patienter, der opretholdt  PASI 75-respons ved uge 33, og som oprindeligt var randomiseret til aktiv behandling i periode A, blev randomiseret igen i periode C til at få enten 40 mg adalimumab hver anden uge eller placebo i yderligere 19 uger.
English: • Hold the syringe firmly without moving it, at the same angle (Figure R).
Danish: • Fasthold injektionssprøjten i den samme vinkel uden at bevæge den (figur R).
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studiet med adalimumab hos patienter med polyartikulær juvenile idiopatisk artrit, som var fra 2 til <4 år.
English: HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Danish: HR af adalimumab vs placebo ved regressionsanalyse med behandling som baggrundsvariabel.
English: - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3% on placebo and 10% on adalimumab.
Danish: Blandt de patienter, som tidligere havde haft mislykket anti-TNF-behandling, opnåede 3 % på placebo og 10 % på adalimumab remission i uge 52.
English: Step 8 Record your Injection
Danish: Trin 8 Registrer din injektion
English: The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Danish: Dalserumkoncentration af adalimumab ved steady state blev forøget omtrent proportionalt med dosis ved subkutan dosering af doser på 20, 40 og 80 mg hver anden uge og hver uge.
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled studies.
Danish: Adalimumabs virkning og bivirkningsprofil blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede studier.
English: If you take Kromeya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager Kromeya, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Danish: Sjældne post-marketing tilfælde af hepatosplenisk T-celle lymfom er blevet identificeret hos patienter, der blev behandlet med adalimumab.
English: Disease flares at the end of 32 weeks a
Danish: Opblussen af sygdom i slutningen af de 32 ugera (n/N)
English: • The liquid is clear, colorless, and free of particles (Figure J).
Danish: • at den er klar, farveløs og fri for partikler (figur J).
English: Usually, Kromeya is used with methotrexate.
Danish: Normalt gives Kromeya sammen med methotrexat.
English: • children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: • Børn fra 2 år med kronisk ikke-infektiøs uveitis med inflammation, som påvirker forreste del af øjet.
English: Keep this patient reminder card with you during your treatment and for 4 months after your (or your child's) last injection of Kromeya.
Danish: Opbevar patientkortet på dig i løbet af din behandling og i 4 måneder efter din (eller dit barns) sidste injektion med Kromeya.
English: 4.1 Choose an injection site (Figure J) on:
Danish: 4.1 Vælg et injektionssted (figur J):
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Danish: 673 patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [BASDAI] var 7,0), som havde utilstrækkeligt respons på  2 NSAIDs, eller var intolerante over for eller havde en kontraindikation mod NSAIDs deltog i den åbne periode af studie nr-axSpA II, hvor de fik adalimumab 40 mg hver anden uge i 28 uger.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Kromeya cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle lymfom hos patienter, der bliver behandlet med Kromeya kan ikke udelukkes (se pkt.
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
Danish: I studier hos voksne med Crohns sygdom blev der set en højere forekomst af maligne og alvorlige infektionsrelaterede bivirkninger ved kombination af adalimumab og azathioprin/6-mercaptopurin end med adalimumab alene.
English: Clinical remission
Danish: Klinisk remission
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Kromeya should be promptly discontinued.
Danish: For patienter, som udvikler tegn og symptomer såsom feber, utilpashed, vægttab, svedeture, hoste, dyspnø, og/eller pulmonale infiltrater eller anden alvorlig systemisk sygdom med eller uden samtidig shock, bør en invasiv svampeinfektion mistænkes, og administration af Kromeya skal omgående afbrydes.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Kromeya.
Danish: I overensstemmelse med klinisk praksis kan samtidig steroidbehandling nedtrappes med start to uger efter initiering af Kromeya-behandling.
English: • The expiration date on the syringe has passed.
Danish: • hvis udløbsdatoen på injektionssprøjten er overskredet.
English: Your child may first be given other disease-modifying medicines, such as methotrexate.
Danish: Dit barn skal først behandles med anden sygdomsdæmpende medicin såsom methotrexat.
English: 4.4 Pull back the pink needle safety cover toward the syringe.
Danish: 4.4 Træk den lyserøde kanylebeskyttelse bagud mod sprøjten.
English: - if your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis dit barn er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Danish: Patienterne skulle have haft svigt af konventionel CD-behandling (inklusive et glukokortikoid og/eller et immunmodulerende lægemiddel).
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Danish: I et eksplorativt klinisk studie, hvor anvendelsen af et andet TNF-antagonist infliximab blev undersøgt hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om flere maligniteter, primært i lunger eller hoved og hals, hos infliximab-behandlede patienter end hos kontrol-patienter.
English: 4.2 Choose a different site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems.
Danish: 4.2 Vælg et nyt sted hver gang (mindst 2,5 cm fra det forrige injektionssted) for at reducere rødme, irritation og andre hudproblemer.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Danish: Multipel sklerose,demyeliniserende sygdomme (f.eks. opticus neuritis, Guillain-Barré syndrom)
English: Kromeya contains sodium
Danish: Kromeya indeholder natrium
English: Kromeya may have a minor influence on the ability to drive and use machines.
Danish: Kromeya kan have en mindre påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: In Psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Danish: I Psoriasis-studie I oplevede 28% af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo i uge 33, “tab af tilstrækkeligt respons” (PASI-score efter uge 33 og ved eller før uge 52, som resulterede i et <PASI 50-respons i forhold til baseline med en stigning på minimum 6 point i PASI-score i forhold til uge 33), sammenlignet med 5%, som fortsatte på adalimumab (p< 0,001).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: Table 13 Efficacy responses in placebo-controlled AS Study - Study I reduction of signs and symptoms
Danish: Tabel 13 Effekt respons i placebokontrolleret AS-studie I Reduktion af tegn og symptomer
English: Week 56
Danish: Uge 56
English: • Crohn's disease,
Danish: • Crohns sygdom,
English: 3.4 Keep the vial and syringe vertical and slowly pull the prescribed dose.
Danish: 3.4 Hold fortsat hætteglas og sprøjte lodret, og træk langsomt den ordinerede dosis ind i sprøjten.
English: If your child becomes pregnant, you should see your child's doctor.
Danish: Hvis dit barn bliver gravid, skal du kontakte dit barns læge.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 17.
Danish: Ved uge 4 blev patienterne på basis af deres legemsvægt på det tidspunkt randomiseret 1:1 til enten lav-dosis- eller standard-dosis-vedligeholdelsesregime som vist i tabel 17.
English: Kromeya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Kromeya bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Danish: RA-studie IV vurderede primært sikkerheden hos 636 patienter, der var  18 år, med moderat til alvorlig aktiv reumatoid artrit.
English: It is important that you tell your baby's doctors and other health care professionals about your Kromeya use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Kromeya under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Danish: Patienter, som fik methotrexat, og som opnåede et  PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning.
English: • Push and hold the pre-filled pen firmly against your skin until the safety guard is fully depressed.
Danish: • Tryk den fyldte pen ned mod huden og fasthold den dér, indtil sikkerhedsmekanismen er helt i bund.
English: Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Danish: Virkningsmekanisme adalimumab binder specifikt til TNF og neutraliserer dennes biologiske funktion ved at blokere dens interaktion med celleoverflade-TNF-receptorerne p55 og p75.
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl dit barns læge eller apotekspersonalet, hvis dit barn bruger anden medicin eller har gjort det for nylig.
English: 6 months 13.3% 65.1% 19.1% 12 months NA
Danish: 6 måneder 13,3% 65,1% 19,1% 46,0% 29,5% 63,3% 12 måneder NA
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Danish: Konsultation hos en læge med erfaring i behandling af hepatitis B anbefales til patienter, der testes positive for hepatitis B-infektion.
English: ASDAS inactive disease hs-CRP
Danish: ASDAS inaktiv sygdom hs-CRPd,f,g
English: By Week 68, patients receiving continuous Kromeya treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Danish: Ved uge 68, viste patienter, som fik forsat behandling med adalimumab statistisk signifikant større forbedring af tegn og symptomer på aktiv nr-axSpA sammenlignet med patienter, som blev allokeret til seponering af behandling i studiets dobbeltblindede periode (Tabel 15).
English: The conduct and results of these tests should be recorded on your patient reminder card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit patientkort.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Mannitol
Danish: Natriumdihydrogenphosphatdihydrat Dinatriumphosphatdihydrat Mannitol
English: - if your child has moderate or severe heart failure.
Danish: • hvis dit barn lider af moderat eller alvorlig hjerteinsufficiens.
English: The safety profile for patients with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab.
Danish: Sikkerhedsprofilen for patienter med HS, som fik ugentlig behandling med adalimumab var i overenstemmelse med adalimumabs kendte sikkerhedsprofil.
English: If your doctor decides that methotrexate is inappropriate, Kromeya can be given alone.
Danish: Hvis din læge beslutter, at behandling med methotrexat ikke er hensigtsmæssig, kan Kromeya anvendes alene.
English: The pre-filled syringe or the pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Danish: Injektionssprøjten eller pennen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden.
English: - Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before you are given Kromeya and during treatment with Kromeya.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Kromeya.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Kromeya treatment.
Danish: Kvinder i den fertile alder bør overveje at anvende passende prævention for at forebygge graviditet og fortsætte med at anvende prævention i mindst fem måneder efter den sidste Kromeya-behandling.
English: Methotrexate should be continued during treatment with Kromeya.
Danish: Der fortsættes med methotrexat under behandling med Kromeya.
English: 6.2 Pinch the skin
Danish: 6.2 Klem huden sammen
English: • A clean cotton ball or gauze, and
Danish: • et stykke rent vat eller gaze og
English: 5.2 Clean the injection site with an alcohol pad and throw the pad away.
Danish: 5.2 Rens injektionsstedet med en spritserviet, og smid servietten ud.
English: Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Danish: Patienter, der blev behandlet med adalimumab, viste en statistisk signifikant forbedring i den fysiske funktion, målt ved hjælp af HAQ og Short Form Health Survey (SF 36), sammenlignet med placebo ved uge 24.
English: • leukaemia (cancer affecting the blood and bone marrow);
Danish: • leukæmi (kræft som påvirker blod og knoglemarv)
English: • Do not insert your fingers into the opening of the clear needle guard.
Danish: • Du må ikke føre dine fingre ind i den gennemsigtige kanylebeskyttelses åbning.
English: Kromeya 40 mg solution for injection in pre-filled pen EU/1/19/1357/003
Danish: Kromeya 40 mg injektionsvæske, opløsning i fyldt pen EU/1/19/1357/003
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Kromeya.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med Kromeya, udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Danish: Der blev ikke observeret nogen maligniteter hos 249 pædiatriske patienter med en samlet eksposition på 655,6 patientår i adalimumab-studier hos patienter med juvenil idiopatisk artrit (polyartikulær juvenil idiopatiske artrit og entesopatirelateret artrit).
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Kromeya.
Danish: • Hvis du skal opereres eller have tandbehandling, skal du fortælle din læge, at du tager Kromeya.
English: • Always inject using the technique your healthcare professional taught you.
Danish: • Du skal altid bruge den injektionsteknik, som lægen eller andet sundhedspersonale har vist dig.
English: If you forget to use Kromeya
Danish: Hvis du har glemt at tage Kromeya
English: Warning: Do not touch where you aim to inject.
Danish: Advarsel: Du må ikke røre dér, hvor du vil injicere.
English: Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Danish: SPARCC MRI rygsøjlend,j a Assessments of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo og adalimumab j n=82 placebo og n=85 adalimumab ***, **, * Statistisk signifikant ved henholdvis p < 0,001, < 0,01 og < 0,05 for alle sammenligninger mellem adalimumab og placebo.
English: Warning: Do not reuse a syringe in case of partial injection.
Danish: Advarsel: Du må ikke genbruge en injektionssprøjte efter delvis injektion.