FrancophonIA/ELRC3.0 huggingface dataset:
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Danish: Forbedring i antallet af led med aktiv artrit blev opretholdt i den åbne del i 156 uger for 26 ud af 31 (84%) patienter i adalimumab-gruppen, som forblev i studiet.
English: • Vaccinations: if possible children should be up to date with all vaccinations before using Kromeya.
Danish: • Vaccinationer: hvis det er muligt, skal dit barn føres ajour med alle vaccinationer, før behandling med Kromeya startes.
English: Step 1
Danish: Trin 1
English: • Place your thumb above (not touching) the yellow injection button (Figure M).
Danish: • Placér tommelfingeren (uden at røre) over den gule injektionsknap (figur M).
English: If active tuberculosis is diagnosed, Kromeya therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Kromeya-terapi ikke påbegyndes (se pkt.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising,
Danish: • tegn og symptomer, som kan tyde på blodsygdomme så som vedvarende feber, blå mærker,
English: Do not try to recap needle as it could lead to needle stick injury.
Danish: Du må ikke prøve at sætte kanylehætten på igen, da det kan føre til stikskader.
English: In study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Danish: I studie UV I blev en statistisk signifikant forskel til fordel for adalimumab versus placebo observeret for alle komponenter for behandlingssvigt.
English: Symptoms of infections
Danish: Symptomer på infektioner
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Danish: Et embryoføtalt udviklingstoksicitet-/perinatalt udviklingsstudie foretaget på cynomolgusaber med 0,30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Danish: Der blev observeret et lignede antistof respons på den 23-valente standard pneumokok-vaccine og den trivalente influenza virus vaccine i et studie med 226 voksne individer med reumatoid artrit, som blev behandlet med adalimumab eller placebo.
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Danish: En stjerne (*) i systemorganklassekolonen (SOC) indikerer, at der findes yderligere information andre steder i pkt.
English: • Push the injection button (Figure P).
Danish: • Tryk på injektionsknappen (figur P).
English: Study UV II
Danish: Studie UV II
English: Treatment with Kromeya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Kromeya skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Danish: Kolecystit og cholelithiasis, hepatisk steatose,forhøjet bilirubin
English: Check with your doctor before you receive any vaccines.
Danish: Tal med din læge, før du får nogen form for vaccine.
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Danish: Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroid-fri remission i > 90 dage ved uge 52.
English: p-value a p-value b p-value c
Danish: p-værdia p-værdib p-værdic
English: - if you have moderate or severe heart failure.
Danish: • hvis du lider af moderat eller alvorlig hjerteinsufficiens.
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Danish: En større del af patienterne på adalimumab havde ingen opblussen af sygdommen i den dobbeltblinde periode ved sammenligning med dem på placebo (70,4% versus 47,1%, p<0,001) (Figur 1).
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Danish: Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artritpatienter målt i serum var 31-96%.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Kromeya should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Kromeya straks ophøre og egnet behandling påbegyndes.
English: • ulcerative colitis and
Danish: • Colitis ulcerosa og
English: During treatment with Kromeya, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med Kromeya, bør andre samtidige behandlinger (f.eks., kortikosteroider og/eller immunmodulerende midler) optimeres.
English: The combination of Kromeya and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Danish: Kombination af Kromeya og abatacept anbefales ikke (se pkt.t 4.4 “Samtidig administration af biologiske DMARDs eller TNF-antagonister”).
English: • With your other hand gently pinch skin (without squeezing) to avoid injecting into a muscle
Danish: • Klem forsigtigt huden sammen med den anden hånd (uden at nive) for at undgå at injicere i en muskel (figur O).
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Danish: Blandt de 68 patienter, som havde opblussen af sygdom i gruppen, som var allokeret til seponering af behandling, fuldførte 65 patienter 12 ugers rescue-behandling med adalimumab, ud af hvilke 37 (56,9%) genvandt remission (ASDAS < 1,3) 12 uger efter genstart af behandling i den åbne periode.
English: Taking these results into consideration, Kromeya is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Danish: I betragtning af disse resultater anbefales adalimumab til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se afsnit 4.2).
English: What Kromeya contains
Danish: Kromeya indeholder
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double−blind, placebo−controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende spondylitis.
English: Check with your doctor before your child receives any vaccines.
Danish: Tal med din læge, før dit barn får nogen form for vaccine.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Danish: • sygdomme i immunsystemet som kan påvirke lungerne, huden og lymfeknuderne (viser sig oftest som en sygdom, der kaldes sarkoidose)
English: Warning: If you have psoriasis, do not inject into any lesions or red, thick, raised or scaly patches.
Danish: Advarsel: Hvis du har psoriasis, må du ikke injicere i dine læsioner eller i røde, tykke, hævede eller skællede pletter.
English: There is insufficient evidence of the efficacy of Kromeya in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Danish: Der foreligger utilstrækkelig evidens for virkningen af Kromeya hos patienter med ankyloserende spondylitis-lignende psoriasis-artropati, da kun få patienter er blevet undersøgt.
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Danish: Adalimumab nedsætter signifikant risikoen for behandlingssvigt med 75 %, som vist med hazard ration sammenlignet med placebo (HR = 0,25 [95% CI: 0,12; 0,49]).
English: Warning: If the plunger rod is pulled completely out, throw away the syringe.
Danish: Advarsel: Hvis stemplet trækkes hele vejen ud, skal sprøjten kasseres.
English: Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Danish: Forsøgspersoner (n=215, 54,7%), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non-respondere i de dobbeltblindede statistiske analyser.
English: Sustained remission
Danish: Vedligeholdt remission
English: Median time to failure (months)
Danish: Gennemsnitlig tid til behandlingssvigt (måneder)
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Kromeya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Inden start af behandling med Kromeya skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negativ test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Danish: • ≥ 40 kg: 40 mg hver uge eller 80 mg hver anden uge Fortsat behandling skal overvejes nøje hos patienter, som ikke responderer inden for 12 uger.
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Adalimumab/methotrexatkombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p<0,001) og adalimumab-monoterapi (p<0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Danish: Der har imidlertid også været post-marketing rapporter om leversvigt samt mindre alvorlige leverlidelser, som kan optræde forud for leversvigt, såsom hepatit, inklusive autoimmun hepatit hos patienter, som får adalimumab.
English: • < 40 kg: 20 mg every week
Danish: • < 40 kg: 20 mg hver uge
English: The primary efficacy endpoint was the proportion of patients with no flare by week 68 of the study.
Danish: Studiets primære effektmål var andelen af patienter uden opblussen af sygdommen ved uge 68.
English: Before Injection
Danish: Før injektion
English: Following 3 years of adalimumab therapy, 75% (301/402) continued to be in clinical remission per partial Mayo score.
Danish: Efter 3 års behandling med adalimumab fortsatte 75% (301/402) med at være i klinisk remission i forhold til partiel Mayo score.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Danish: • Fortæl din læge, hvis du er bærer af hepatitis B-virus (HBV), hvis du har aktiv HBV-infektion, eller hvis du tror, du kan have risiko for at få HBV.
English: 3.5 Slowly push the plunger rod all the way in to push the medicine back into the vial.
Danish: 3.5 Tryk langsomt stemplet helt i bund, så medicinen kommer tilbage i hætteglasset.
English: The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Danish: Effekten af adalimumab var nedsat hos disse patienter sammelignet med anti-TNF-naïve patienter.
English: Do not use Kromeya
Danish: Tag ikke Kromeya
English: This will allow the needle to move up into the clear needle guard and cover the entire needle (Figure S).
Danish: Det vil få kanylen til at bevæge sig op i den gennemsigtige kanylebeskyttelse, hvor hele kanylen dækkes (figur S).
English: The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Danish: Forholdet mellem patienter med pædiatrisk ACR-50/70/90 ved uge 12 og uge 24 var henholdsvis 90,3%/61,3%/38,7% og 83,3%/73,3%/36,7%.
English: • vertigo (sensation of room spinning);
Danish: • vertigo (fornemmelse af at rummet snurrer rundt)
English: • It is important to tell your doctor if you have had or have a serious heart condition.
Danish: • Det er vigtigt at fortælle din læge hvis du har eller har haft en alvorlig hjertesygdom.
English: Warning: Do not take the needle out of its packaging.
Danish: Advarsel: Du må ikke tage kanylen ud af emballagen.
English: • In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
Danish: • Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som bekæmper infektioner eller stopper blødninger.
English: Kromeya can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Danish: Kromeya kan nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre den fysiske funktion.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity and genotoxicity.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af studier af toksicitet efter enkeltdosering, gentagen dosistoksicitet og genotoksicitet.
English: A 40 mg pre-filled syringe and a 40 mg prefilled pen are also available for use.
Danish: En 40 mg fyldt injektionssprøjte og en 40 mg fyldt pen er også tilgængelig til brug.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Kromeya.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Kromeya.
English: Do not shake the syringe.
Danish: Du må ikke ryste sprøjten.
English: The inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Danish: Inflammationen kan føre til nedsat syn og/eller fluer i øjet (sorte pletter eller sværm af uklarheder i øjet, som bevæger sig i synsfeltet).
English: A single pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt fyldt injektionssprøjte eller fyldt pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: Non-infectious uveitis in adults and children
Danish: Ikke-infektiøs uveitis hos voksne og børn.
English: The vial must be protected from light, and discarded if not used within the 14-day period.
Danish: Hætteglasset skal beskyttes mod lys og kasseres, hvis det ikke bliver anvendt inden for den 14-dages periode.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Kromeya and is positive for antibodies against double-stranded DNA, further treatment with Kromeya should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Kromeya udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med Kromeya (se pkt.
English: 1.1 Remove the Kromeya Vial Kit from the refrigerator.
Danish: Tag Kromeya hætteglassættet ud af køleskabet.
English: Open your sharps disposal container so it is ready to use.
Danish: Åbn affaldsbeholderen til skarpe genstande, så den er klar til brug.
English: If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Danish: Hvis der opnås tilstrækkeligt respons med 40 mg hver uge eller 80 mg hver anden uge kan dosis efterfølgende reduceres til 40 mg hver anden uge.
English: You may see drops of liquid at the needle tip.
Danish: Du kan muligvis se nogle dråber væske ved kanylespidsen.
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B,- NK-cells, monocyte/macrophages, and neutrophils.
Danish: I et studie, hvor 64 patienter med reumatoid artrit blev behandlet med adalimumab, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T-, B, - NK-celler, monocytter/makrofager og neutrofiler.
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Danish: TNF-antagonister, herunder adalimumab, er i sjældne tilfælde blevet forbundet med nyt udbrud eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniserende sygdom i centralnervesystemet herunder dissemineret sklerose og optisk neurit og perifer demyeliniserende sygdom, inklusive Guillain-Barré syndrom.
English: 1.4 Check the expiration date on the side of the box (Figure B).
Danish: 1.4 Tjek udløbsdatoen på siden af æsken (figur B).
English: • Do not try to activate the clear needle guard before injecting.
Danish: • Du må ikke prøve at aktivere den gennemsigtige kanylebeskyttelse inden injektionen.
English: Table 17 Maintenance regimen
Danish: Tabel 17 Vedligeholdelsesregime Patient vægt
English: Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day).
Danish: Studie UV I undersøgte 217 patienter med aktiv uveitis på trods af behandling med kortikosteroid (oral prednison i doser fra 10 til 60 mg/dag).
English: • Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
Danish: • Fortæl din læge, hvis dit barn er bærer af hepatitis B-virus (HBV), hvis han/hun har aktiv HBVinfektion, eller hvis du tror, han/hun kan have risiko for at få HBV.
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis study I, and continued adalimumab in the open-label extension trial.
Danish: I alt 233 PASI 75-respondenter ved uge 16 og 33 fik kontinuerlig adalimumab-behandling i 52 uger i Psoriasis-studie I og fortsatte med adalimumab i det åbne forlængelsesstudie.
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl din læge, hvis du har en sygdomshistorie med gentagne infektioner eller andre forhold, der forøger risikoen for infektioner.
English: Step 7
Danish: Trin 7
English: If you receive Kromeya while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Kromeya, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: 6.2 Position the pre-filled pen
Danish: 6.2 Positionering af pennen
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Kromeya therapy, your doctor may decide to give Kromeya 40 mg every week or 80 mg every other week.
Danish: Hvis du har rheumatoid artrit og ikke får methotrexat sammen med din Kromeya behandling, kan din læge beslutte at give Kromeya 40 mg hver uge eller 80 mg hver anden uge.
English: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Danish: Fordele og risici ved fortsat behandling med 40 mg ugentlig eller 80 mg hver anden uge, skal overvejes nøje hos patienter med utilstrækkeligt respons efter øgning af dosis(se pkt.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Kromeya should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med Kromeya overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Danish: I de pivotale kontrollerede studier med voksne og børn var infektionshyppigheden 1,51 pr. patientår hos adalimumab-behandlede patienter og 1,46 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Kromeya bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen fra 2 til 17 år og entesopatirelateret artrit hos børn og unge i alderen 6-17 år.
English: • Place the pre-filled pen against your skin at a 90° angle (Figure N).
Danish: • Anbring den fyldte pen mod huden i en vinkel på 90° (figur N).
English: • Properly labeled to warn of hazardous waste inside the container.
Danish: • som er mærket med en advarsel om farligt affald.
English: 20 mg every other week in combination with methotrexate
Danish: 20 mg hver anden uge i kombination med methotrexat
English: Warning: Do not use if damaged.
Danish: Sprøjte Advarsel: Må ikke bruges, hvis beskadiget.
English: TIME (MONTHS)
Danish: Tiden (UGER)
English: In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Danish: I sjældne tilfælde, specielt hvis dit barn tager anden medicin, der undertrykker immunsystemet, kan reaktivering af HBV-infektion blive livstruende.
English: 6.3 Gently push the white plunger rod all the way down until the syringe is empty.
Danish: 6.3 Tryk forsigtigt det hvide stempel helt i bund, indtil sprøjten er tom.