natgillin/translations-raw huggingface dataset:
• Hvis dit barn skal opereres eller have tandbehandling, skal du fortælle lægen, at dit barn tager Imraldi. 
• If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Imraldi.
• Klargør kanylen ved at åbne emballagen delvist fra enden tættest på den gule vedhæftning til sprøjten, så den gule vedhæftning til sprøjten netop er tilgængelig. 
• Prepare the needle by partially peeling the package open from the end closest to the yellow syringe connector.
Den dobbeltblindede periode blev efterfulgt af en åben periode (OL), hvor patienterne fik adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg hver anden uge subkutant i op til yderligere 192 uger. 
The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
• lungesygdom som forårsager kortåndethed (inklusive inflammation/vævsirritation); 
• lung diseases causing shortness of breath (including inflammation);
• Hvis den ordinerede dosis fx er 0,5 ml, må du IKKE skubbe den hvide stempelstang længere end til 0,5 mærket 
• For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Steroid-fri remission i > 90 dagea 
Patients in steroid-free remission for >=90 daysa
Blandt de patienter, som responderede ved uge 16 (n = 144), blev pædiatriske ACR 30/50/70/90responser opretholdt i op til seks år i den åbne forlængelsesfase hos dem, der fik adalimumab gennem hele studiet. 
Amongst those who responded at week 16 (n=144), the Paediatric 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.
Blandt de børn, som responderede (pædiatrisk ACR-30) ved uge 24 (n = 27 ud af 30 patienter), blev pædiatrisk ACR 30respons opretholdt i op til 60 uger i åben-label-fasen hos de patienter, som fik adalimumab gennem hele denne periode. 
Amongst those who responded (Paediatric ACR 30) at week 24 (n=27 out of 30 patients), the Paediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Hepatosplenisk T-celle-lymfom1), Merkelcelle karcinom (neuroendokrint karcinom i huden)1) 
Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Efter subkutan administration af 40 mg adalimumab hver anden uge hos voksne patienter med rheumatoid artrit (RA) var de gennemsnitlige dal steady state-koncentrationer på henholdsvis cirka 5 µg/ml (uden kombination med methotrexat) og 8-9 µg/ml (i kombination med methotrexat). 
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively.
Imraldi kan i mindre grad påvirke din evne til at føre motorkøretøj, cykle eller betjene maskiner. 
Imraldi may have a minor influence on your ability to drive, cycle or use machines.
Efter subkutan administration af 40 mg adalimumab hver anden uge til voksne non-radiografisk aksial spondylartritis patienter var den gennemsnitlige (±SD) dal-steady state-koncentration ved uge 68 8,0 ± 4,6 µg/ml. 
Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 μg/ml.
Der blev observeret en significant mindre radiografisk progression hos adalimumab-/methotrexat- patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 11). 
Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Imraldi bruges til at behandle svær plaque-psoriasis hos børn og unge i alderen 4 til 17 år, hos hvem lokal behandling og lysbehandlinger enten ikke har virket godt nok eller ikke er egnede. 
Imraldi is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have either not worked very well or are not suitable.
6 pædiatriske ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier. 
and improvement of >30% in no more than 1 of the 6 criteria.
Imraldi 40 mg injektionsvæske, opløsning i engangshætteglas (type 1-glas) med gummiprop, aluminiumklemme og letaftagelig forsegling. 
Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Vær sikker på at du har fjernet hættegalsset med hætteglasadapteren fra sprøjten. 
Be sure to remove the vial adapter with the vial from the syringe.
Alternativt, kan Imraldi gen-administreres, hvis patienten er stoppet behandling med Imraldi, og tegn og symptomer på sygdommen kommer igen. 
Alternatively, if a patient has stopped Imraldi and signs and symptoms of disease recur, Imraldi may be re-administered.
Hyppigheden (95 % konfidensinterval) af ikkemelanom hudkræft var 8,8 (6,0-13,0) pr. 1.000 patientår blandt adalimumab-behandlede patienter og 3,2 (1,3-7,6) pr. 1.000 patientår blandt kontrolpatienterne. 
The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
36,8 % (14/38) 64,9 % (24/37)b 
36.8 % (14/38) 64.9 % (24/37)b 43.3 % (13/30) 71.4 % (20/28)c Median time to disease flare >32 weeks
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. 
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.
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). 
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).
Den sædvanlige startdosis er 40 mg efterfulgt af 20 mg to uger senere. 
The usual dose regimen is 40 mg initially followed by 20 mg two weeks later.
• entesopati-relateret artrit, 
• enthesitis-related arthritis,
Træk den klare kanylehætte af 
Pull off the clear needle cap
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. 
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.
Imraldi bruges til at behandle reumatoid artrit hos voksne. 
Imraldi is used to treat rheumatoid arthritis in adults.
Rør IKKE ved hætteglasadapteren. 
DO NOT touch the vial adapter.
• Opbevar altid den særlige affaldsbeholder utilgængeligt for børn. 
• Keep the special container out of the sight and reach of children at all times.
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. 
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.
Afhængigt af dit respons kan lægen øge dosis til 20 mg hver uge. 
Depending on your response, your doctor may increase the dose frequency to 20 mg every week.
• lave blodmålinger af fosfat; 
• low blood measurements for phosphate;
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. 
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.
Hjælpestoffer: Natriumcitrat, citronsyremonohydrat, histidin, histidinhydrochloridmonohydrat, sorbitol, polysorbat 20 og vand til injektionsvæsker. 
Excipients: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections.
Din læge kan anbefale midlertidig afbrydelse af behandlingen. 
Your doctor may recommend temporary discontinuation.
Uge 2 Uge 12 Uge 24 
Week 2 Week 12 Week 24
Ikke almindelig Nattesved, ar 
Uncommon Night sweats, scar
• reaktioner ved injektionsstedet (herunder smerter, hævelse, rødme eller kløe); 
• injection site reactions (including pain, swelling, redness or itching);
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 
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
Det skal du vide, før dit barn begynder at bruge Imraldi Brug ikke Imraldi 
What you need to know before your child uses Imraldi Do not use Imraldi
Tabel 27 Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler 
Table 27 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
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). 
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).
Hold den hvide stempelstang inde og vend hætteglasset og sprøjten på hovedet. 
Hold the white plunger rod in and turn the vial and syringe upside down.
Tabel 15 Ps-studie II (CHAMPION) - Effektresultater ved uge 16 
Table 15 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Tabel 21 Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler 
Table 21 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
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 
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
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 
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,
Dit barns læge eller dennes assistent vil instruere dig i, hvordan du skal injicere dit barn, og hvor meget du skal give. 
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.
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). 
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).
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). 
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).
Imraldi kan i mindre grad påvirke evnen til at føre motorkøretøj, cykle eller betjene maskiner. 
Imraldi may have a minor influence on the ability to drive, cycle or use machines.
• øget svedtendens; 
• increased sweating;
Det skal du vide, før du begynder at bruge Imraldi Brug ikke Imraldi 
What you need to know before you use Imraldi Do not use Imraldi
• kvalme og opkastning; 
• nausea and vomiting;
Den anbefalede dosis af Imraldi til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge. 
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.
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). 
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).
Tabel 16 ACR-respons i placebokontrollerede psoriasisartrit-studier (Procentdel af patienter) 
Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Børn og unge fra 6 til 17 år, som vejer 40 kg eller mere: 
Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
Imraldi-dosis til patienter med polyartikulær juvenil idiopatisk artrit Patient vægt 
Imraldi Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
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. 
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment.
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). 
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).
1 steril injektionssprøjte 1 steril kanyle 1 steril hætteglasadapter 2 spritservietter 
1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
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. 
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.
Imraldi bruges til at behandle colitis ulcerosa hos voksne. 
Imraldi is used to treat ulcerative colitis in adults.
• 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. 
• 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.
• Mens hætteglasadapteren stadig er i den klare pakning placeres den ovenpå hætteglassets prop og skubbes ned til den klikker på plads. 
• 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.
Voksne med reumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis. 
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Tabel 18 Ps-studie II (CHAMPION) - Effektresultater ved uge 16 
Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Den anbefalede Imraldi-dosis til patienter med Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 4). 
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).
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. 
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.
Imraldi bruges til at behandle ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne. 
Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
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. 
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.
Brug altid Imraldi nøjagtigt efter dit barns læges eller apotekspersonalets anvisning. 
Always use this medicine exactly as your child's doctor or pharmacist has instructed.
≥ 30 % reduktion af hudsmerterb 
≥ 30% Reduction in
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. 
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.
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. 
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
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. 
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.