FrancophonIA/ELRC3.0 huggingface dataset:
English: Imraldi 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: Imraldi 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: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 29).
Danish: Resultaterne i begge studier viste en statistisk signifikant reduktion i risikoen for behandlingssvigt hos patienter behandlet med adalimumab versus patienter, som fik placebo (se tabel 29).
English: The usual dose regimen is 40 mg initially followed by 20 mg two weeks later.
Danish: Den sædvanlige startdosis er 40 mg efterfulgt af 20 mg to uger senere.
English: • enthesitis-related arthritis,
Danish: • entesopati-relateret artrit,
English: Pull off the clear needle cap
Danish: Træk den klare kanylehætte af
English: Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger, a plunger rod, a safe-shield body, a finger flange and 2, 2, 4 or 6 alcohol pads enclosed in packs respectively.
Danish: Imraldi findes i pakninger, der indeholder 1, 2, 4 eller 6 fyldt(e) injektionssprøjte(r) (type 1-glas) med en kanyle af rustfrit stål, en stiv kanylebeskytter, et gummistempel, en stempelstang, en beskyttelsesskærm, en fingerkrave og 2, 2, 4 eller 6 spritservietter indeholdt i pakningerne.
English: Imraldi is used to treat rheumatoid arthritis in adults.
Danish: Imraldi bruges til at behandle reumatoid artrit hos voksne.
English: DO NOT touch the vial adapter.
Danish: Rør IKKE ved hætteglasadapteren.
English: • Keep the special container out of the sight and reach of children at all times.
Danish: • Opbevar altid den særlige affaldsbeholder utilgængeligt for børn.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 μg/ml for the Standard Dose group and 3.5±2.2 μg/ml for the Low Dose group.
Danish: Hos patienter, som blev på deres randomiserede behandling, var den gennemsnitlige laveste (±SD) adalimumab-koncentration 9,5 ± 5,6 µg/ml for standard-dosis-gruppen og 3,5 ± 2,2 µg/ml for lavdois-gruppen ved uge 52.
English: Depending on your response, your doctor may increase the dose frequency to 20 mg every week.
Danish: Afhængigt af dit respons kan lægen øge dosis til 20 mg hver uge.
English: • low blood measurements for phosphate;
Danish: • lave blodmålinger af fosfat;
English: Mean steady-state trough levels of approximately 8 μg/ml were observed in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week.
Danish: Der blev observeret gennemsnitlige steady state dal-koncentrationer på omkring 8 µg/ml hos colitis ulcerosa patienter, som fik en vedligeholdelsesdosis på 40 mg adalimumab hver anden uge.
English: Excipients: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections.
Danish: Hjælpestoffer: Natriumcitrat, citronsyremonohydrat, histidin, histidinhydrochloridmonohydrat, sorbitol, polysorbat 20 og vand til injektionsvæsker.
English: Your doctor may recommend temporary discontinuation.
Danish: Din læge kan anbefale midlertidig afbrydelse af behandlingen.
English: Week 2 Week 12 Week 24
Danish: Uge 2 Uge 12 Uge 24
English: Uncommon Night sweats, scar
Danish: Ikke almindelig Nattesved, ar
English: • injection site reactions (including pain, swelling, redness or itching);
Danish: • reaktioner ved injektionsstedet (herunder smerter, hævelse, rødme eller kløe);
English: 104 Week 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: Uge 52 27,2 % 25,9 % Uge 104 28,4 % 28,1 % ap-værdi for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexatkombinationeterapi ved anvendelse af Mann-Whitney U test. bp-værdi for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexatkombinationsterapi ved anvendelse af Mann-Whitney U test cp-værdi for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test
English: What you need to know before your child uses Imraldi Do not use Imraldi
Danish: Det skal du vide, før dit barn begynder at bruge Imraldi Brug ikke Imraldi
English: Table 27 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Danish: Tabel 27 Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 24).
Danish: Resultaterne i begge studier viste en statistisk signifikant reduktion i risikoen for behandlingssvigt hos patienter behandlet med adalimumab versus patienter, som fik placebo (se tabel 24).
English: Hold the white plunger rod in and turn the vial and syringe upside down.
Danish: Hold den hvide stempelstang inde og vend hætteglasset og sprøjten på hovedet.
English: Table 15 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Danish: Tabel 15 Ps-studie II (CHAMPION) - Effektresultater ved uge 16
English: Table 21 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Danish: Tabel 21 Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Danish: Systemiske infektioner (inklusive sepsis, candidiasis og influenza), intestinale infektioner (inklusive viral gastroenteritis), hud- og bløddelsinfektioner (inklusive paronychia, cellulitis, impetigo, nekrotiserende fasciitis og herpes zoster), øreinfektioner, orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner), infektioner i reproduktionsvejene (inklusive vulvovaginal svampeinfektion), urinvejsinfektioner (inklusive pyelonephritis), svampeinfektioner, ledinfektioner
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections,
Danish: Systemiske infektioner (inklusive sepsis, candidiasis og influenza), intestinale infektioner (inklusive viral gastroenteritis), hud- og bløddelsinfektioner (inklusive paronychia, cellulitis, impetigo, nekrotiserende fasciitis og herpes zoster), øreinfektioner, orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner), infektioner i reproduktionsvejene (inklusive vulvovaginal svampeinfektion), urinvejsinfektioner (inklusive pylonephritis), svampeinfektioner ledinfektioner
English: You will be instructed by your child's doctor or his/her assistant on the technique of injection and the amount to give to your child. Do not attempt to give your child an injection until you are sure that you understand how to prepare and give the injection.
Danish: Dit barns læge eller dennes assistent vil instruere dig i, hvordan du skal injicere dit barn, og hvor meget du skal give.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 18).
Danish: Hos patienter med minimum et delvist respons på adalimumab 40 mg ugentligt ved uge 12 var HiSCR-raten ved uge 36 højere hos patienter, der fortsatte ugentlig adalimumab, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller behandlingen afbrudt (se tabel 18).
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: Imraldi may have a minor influence on the ability to drive, cycle or use machines.
Danish: Imraldi kan i mindre grad påvirke evnen til at føre motorkøretøj, cykle eller betjene maskiner.
English: • increased sweating;
Danish: • øget svedtendens;
English: What you need to know before you use Imraldi Do not use Imraldi
Danish: Det skal du vide, før du begynder at bruge Imraldi Brug ikke Imraldi
English: • nausea and vomiting;
Danish: • kvalme og opkastning;
English: The recommended dose of Imraldi 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 Imraldi til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 22).
Danish: Hos patienter med minimum et delvist respons på adalimumab 40 mg ugentlig ved uge 12 var HiSCRraten ved uge 36 højere hos patienter, der fortsatte ugentlig adalimumab, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller behandlingen afbrudt (se tabel 22).
English: Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Danish: Tabel 16 ACR-respons i placebokontrollerede psoriasisartrit-studier (Procentdel af patienter)
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
Danish: Børn og unge fra 6 til 17 år, som vejer 40 kg eller mere:
English: Imraldi Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Danish: Imraldi-dosis til patienter med polyartikulær juvenil idiopatisk artrit Patient vægt
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 steady state dal-koncentration af adalimumab 5 µg/ml under monoterapibehandling med 40 mg adalimumab hver anden uge.
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 responsrater henholdvis 69,6 % og 55,7 % efter yderligere 108 ugers åben-behandling (i alt 160 uger).
English: 1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
Danish: 1 steril injektionssprøjte 1 steril kanyle 1 steril hætteglasadapter 2 spritservietter
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥10% BSA involvement and PASI ≥12 or ≥10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Danish: Adalimumabs sikkerhed og virkning blev undersøgt hos voksne patienter med kronisk plaquepsoriasis (≥ 10 % BSA-involverering og PASI ≥ 12 eller ≥ 10), som var kandidater til systemisk behandling eller lysbehandling i randomiserede, dobbelt-blinde studier.
English: Imraldi is used to treat ulcerative colitis in adults.
Danish: Imraldi bruges til at behandle colitis ulcerosa hos voksne.
English: • While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand.
Danish: • Mens du stadig holder sprøjten på området med inddelinger og med spidsen opad, fjernes hætteglasadapteren med hætteglasset ved at dreje den af med den anden hånd.
English: • With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
Danish: • Mens hætteglasadapteren stadig er i den klare pakning placeres den ovenpå hætteglassets prop og skubbes ned til den klikker på plads.
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Danish: Voksne med reumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis.
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Danish: Tabel 18 Ps-studie II (CHAMPION) - Effektresultater ved uge 16
English: The recommended dose of Imraldi for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Danish: Den anbefalede Imraldi-dosis til patienter med Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 4).
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥20 or ≥10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Danish: Adalimumabs virkning er undersøgt i et randomiseret, dobbelt-blindet kontrolleret studie med 114 pædiatriske patienter fra 4 år med svær kronisk plaque-psoriasis (defineret ved PGA (physician global assessment) ≥ 4 eller > 20 % BSA (body surface area)-involvering eller > 10 % BSAinvolvering med meget tykke læsioner eller PASI (psoriasis area and severity index) ≥ 20 eller ≥ 10 med klinisk relevante manifestioner i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling.
English: Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Danish: Imraldi bruges til at behandle ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne.
English: Imraldi 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: Imraldi 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: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Danish: Brug altid Imraldi nøjagtigt efter dit barns læges eller apotekspersonalets anvisning.
English: ≥ 30% Reduction in
Danish: ≥ 30 % reduktion af hudsmerterb
English: If you accidentally inject a larger amount of Imraldi liquid, or if you inject Imraldi more frequently than you should, call your child's doctor or pharmacist and explain that your child has taken more.
Danish: Hvis du ved en fejltagelse injicerer en større mængde Imraldi-væske eller injicerer Imraldi hyppigere, end du skulle, skal du kontakte dit barns læge eller apoteket og forklare, at dit barn har fået mere Imraldi, end det skulle.
English: Imraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section
Danish: Imraldi er indiceret til behandling af aktiv entesopatirelateret artrit hos patienter fra 6 år, som har haft et utilstrækkeligt respons på, eller som er intolerante over for konventionel behandling (se pkt.
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: JSN Score 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: JSN score 2,0 (1,2-2,8) 1,3 (0,5-2,1) a p-værdien for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexatkombinationsbehandling ved anvendelse af Mann-Whitney U test b p-værdien for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexatkombinationsbehandling ved anvendelse af Mann-Whitney U test c p-værdien for den parvise sammenligning af adalimumab-monoterapi og methotrexat- monoterapi ved anvendelse af Mann-Whitney U test
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: • Put the syringe with needle, vial and vial adapter into a special sharps container.
Danish: • Læg sprøjten med kanyle, hætteglas og hætteglasadapten ned i den særlige affaldsbeholder.
English: Leukocytosis, thrombocytopenia Uncommon Idiopathic thrombocytopenic purpura Rare
Danish: Ikke almindelig Idiopatisk trombocytopenisk purpura Sjælden
English: • eye infections;
Danish: • øjeninfektioner;
English: Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Danish: Adalimumab har vist sig at reducere den udviklingshastighed, hvormed de perifere led destrueres, bedømt ved måling med røntgen hos patienter med polyartikulære, symmetriske undertyper af sygdommen (se pkt.
English: Package leaflet: Information for the patient Imraldi 40 mg/0.8 ml solution for injection adalimumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Imraldi 40 mg/0,8 ml injektionsvæske, opløsning adalimumab Dette lægemiddel er underlagt supplerende overvågning.
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38 % (25/66) and 55 % (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Danish: 38 % (25/66) og 55 % (36/66) af de patienter, som mistede tilstrækkeligt respons efter genrandomisering til placebo, og som derefter fortsatte i det åbne forlængelsesstudie, genvandt PASI 75-respons efter henholdsvis 12 og 24 ugers behandling.
English: • haematoma (a solid swelling with clotted blood);
Danish: • hæmatom (en fast hævelse med størknet blod);
English: • DO NOT try to put the clear needle cap back on the needle.
Danish: • Sæt IKKE den klare kanylehætte tilbage på kanylen.
English: Table 14 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Danish: Tabel 14 Ps-studie I (REVEAL) - Effektresultater ved uge 16
English: Table 17 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Danish: Tabel 17 Ps-studie I (REVEAL) - Effektresultater ved uge 16
English: • inflammation of the eyelid and eye swelling;
Danish: • betændelse i øjenlåget og hævede øjne;
English: Imraldi is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Danish: Imraldi er indiceret til behandling af svær kronisk plaque-psoriasis hos børn og unge fra 4 år, som har haft et utilstrækkeligt respons på, eller som ikke er egnede til topikal behandling eller lysbehandling.
English: Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Danish: Afhængigt af dit respons, kan din læge øge dosis til 40 mg hver uge eller 80 mg hver anden uge.
English: Table 22 Proportion of Patientsa Achieving HiSCRb at Weeks 24 and 36 After Treatment Reassignment from Weekly Adalimumab at Week 12 Placebo (treatment withdrawal) N = 73
Danish: Tabel 22 Andel af patientera, som opnåede HiSCRb ved uge 24 og 36 efter tildeling af behandling ved uge 12 fra ugentlig adalimumab
English: • You might get infections more easily while you are receiving Imraldi treatment.
Danish: • Infektioner kan opstå lettere under behandling med Imraldi.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Danish: Polyartikulær juvenil idiopatisk artrit og entesopati-relateret artrit