FrancophonIA/ELRC3.0 huggingface dataset:
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 dalkoncentration ved steady state 5 µg/ml ved monoterapibehandling med 40 mg adalimumab hver anden uge.
English: Table 10 ACR Responses in RA Study V (percent of patients)
Danish: Tabel 10 ACR-respons i RA-studie V (Procentdel af patienter)
English: Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Danish: Tabel 13: Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week two weeks later.
Danish: Startdosis for Crohns sygdom er sædvanligvis 80 mg (som to 40 mg injektioner på en dag) efterfulgt af 40 mg hver anden uge 2 uger senere.
English: • oral infections (including tooth infections and cold sores);
Danish: • infektioner i munden (inklusive tandinfektioner og forkølelsessår);
English: • Check with your doctor before you receive any vaccines.
Danish: • Tal med lægen, før du får nogen form for vaccine.
English: Week 12 Week 24
Danish: Uge 26 Uge 52
English: • skin cancer
Danish: • hudkræft
English: The safety and efficacy of Humira were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI)  220 and  450) in randomised, double-blind, placebo-controlled studies.
Danish: Humiras sikkerhed og virkning er undersøgt i randomiserede, dobbelt-blinde, placebokontrollerede studier med over 1.500 patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdoms aktivitetsindeks (CDAI) ≥ 220 og ≤ 450).
English: It is important that you tell her baby's doctors and other health care professionals about your child's Humira use during her pregnancy so they can decide when her baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller spædbarnets læge og andre sundhedspersoner, at dit barn fik Humira under graviditeten, så de kan beslutte, hvornår spædbarnet bør vaccineres.
English: What you need to know before your child uses Humira
Danish: Det skal du vide, før dit barn begynder at tage Humira Tag ikke Humira
English: Table 21: Efficacy Results at 12 Weeks, HS Studies I and II HS Study I
Danish: Tabel 21: Effektresultater ved uge 12, HS-Studie I og II HS-studie I
English: • If your child is about to have surgery or dental procedures please inform your doctor that your child is taking Humira.
Danish: • Hvis dit barn skal opereres eller have tandbehandling, bør du informere din læge om, at dit barn tager Humira.
English: Humira 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: Humira 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: • severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Danish: • alvorlig kronisk 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.
English: • a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel
Danish: • sæklignende udposning på væggen af en større pulsåre (aneurisme), betændelse og blodprop i en blodåre, tilstopning af et blodkar
English: Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly.
Danish: Klem om huden på injektionsstedet med den anden hånd for at hæve området og hold fast.
English: • nerve root compression (including low back pain and leg pain)
Danish: • nerverodskompression (inklusive smerter i den nederste del af ryggen og bensmerter)
English: The recommended dose of Humira for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 1).
Danish: Den anbefalede Humira-dosis til patienter med aktiv Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 1).
English: When needed (for example, when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan en enkelt Humira fyldt injektionssprøjte opbevares ved stuetemperatur (op til 25 °C) i en periode på højst 14 dage - vær sikker på at beskytte den mod lys.
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at Week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Danish: I tilfælde, hvor der er brug for et hurtigere respons af behandlingen, kan regimet 160 mg i uge 0 (givet som fire 40 mg injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage), 80 mg i uge 2 (givet som to injektioner af 40 mg på en dag), anvendes med erkendelse af, at risikoen for bivirkninger er højere under induktionen.
English: Injectable Areas
Danish: Injektionssteder
English: • Gently flip the pink needle cover up, over the needle and snap into place and set the syringe with needle on the work surface.
Danish: • Tryk forsigtigt det lyserøde kanylehus tilbage over kanylen og læg sprøjten fra dig på dit arbejdssted
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during a Humira trial in paediatric patients with uveitis.
Danish: I Humira-studier med pædiatriske patienter med uveitis blev der ikke observeret nogen maligniteter hos 60 pædiatriske patienter med en samlet eksposition på 58,4 patientår.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score  0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and
Danish: Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Total Sharp Score ≤ 0,5) signifikant højere med Humira/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p<0,001) og Humira monoterapi (henholdsvis 50,7%, p<0,002 og 44,5%, p<0,001).
English: • oral infections (including tooth infections and cold sores)
Danish: • infektioner i munden (inklusive tandinfektioner og forkølelsessår)
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Danish: Polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit er sygdomme med betændelseslignende (inflammatoriske) reaktioner i leddene.
English: • Do NOT shake the syringe.
Danish: • Ryst IKKE sprøjten.
English: Hold the pre-filled pen with the Grey Cap 1 pointing up.
Danish: Hold den fyldte pen med den grå hætte 1 pegende opad.
English: o One 1 ml syringe (1)
Danish: Lupuslignende syndrom1)
English: At 8 years, 81 of 207 patients originally treated with 40 mg Humira every other week were evaluated radiographically.
Danish: 81 af 207 patienter, der oprindeligt blev behandlet med 40 mg Humira hver anden uge, blev radiografisk evalueret efter 8 år.
English: Failure to perform the following steps as described may cause contamination which may lead to infection of your child.
Danish: Hvis nedenstående instruktioner ikke følges er der risiko for at dit barn kan få en betændelsesreaktion.
English: In patients with Crohn's disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 g/ml during the induction period.
Danish: Hos patienter med Crohns sygdom blev der med en induktionsdosis på 80 mg Humira i uge 0 efterfulgt af 40 mg Humira i uge 2 opnået dal-serumkoncentrationer af adalimumab på ca. 5,5 µg/ml i induktionsperioden.
English: Adolescents from 12 to 17 years of age weighing 30 kg or more
Danish: Unge fra 12 til 17 år, som vejer 30 kg eller mere
English: What you need to know before you use Humira
Danish: Det skal du vide, før du begynder at tage Humira Tag ikke Humira
English: • The following instructions explain how to give your child a subcutaneous injection of Humira using the pre-filled syringe.
Danish: • Følgende er en vejledning i, hvordan du injicerer dit barn med en subkutan injektion med Humira ved at bruge den fyldte injektionssprøjte.
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.By attaching to TNFα, Humira decreases the process of inflammation in these diseases.
Danish: Målet for adalimumab er et protein kaldet tumornekrosefaktor (TNFα) som er involveret i immun (forsvars) systemet og er til stede i øgede mængder i de inflammatoriske sygdomme nævnt ovenfor.Ved at binde sig til TNFα reducerer Humira den inflammatoriske proces i disse sygdomme.
English: Humira n=113
Danish: Humirab n=113
English: Humira/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 6).
Danish: Der blev observeret en significant mindre radiografisk progression hos Humira-/methotrexat- patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 6).
English: Patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
Danish: Patienterne fik placebo eller en startdosis af Humira på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: • If your child is about to undergo surgery or dental procedures please inform your doctor that he/she is taking Humira.
Danish: • Hvis dit barn skal opereres eller have tandbehandling, bør du informere lægen om, at han/hun tager Humira.
English: • gallbladder inflammation, gallbladder stones
Danish: • inflammation i galdeblæren, galdesten
English: P value
Danish: P Værdi b
English: Solution for injection
Danish: 1) Forberedelse til injektion
English: If you accidentally inject a smaller amount of Humira liquid, or if you inject Humira less frequently than told to by your child's doctor or pharmacist, you should call your child's doctor or pharmacist and tell him/her that your child has taken less.
Danish: Hvis du ved en fejltagelse har injiceret en mindre mængde Humira end ordineret, eller hvis du har injiceret mindre hyppigt end forskrevet af lægen eller apotekspersonalet, skal du kontakte lægen eller apotekspersonalet og fortælle ham/hende, at dit barn har fået for lidt.
English: Humira is used to treat psoriatic arthritis in adults.
Danish: Humira bruges til at behandle psoriasisartrit hos voksne.
English: If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Danish: Hvis du har utilstrækkeligt respons på Humira 40 mg hver anden uge, kan din læge øge dosis til 40 mg hver uge eller 80 mg hver anden uge.
English: • It is very important that you tell your doctor if your child has ever had tuberculosis, or if your child has been in close contact with someone who has had tuberculosis.
Danish: • Det er meget vigtigt at informere lægen, hvis dit barn nogensinde har haft tuberkulose, eller hvis dit barn har været i tæt kontakt med nogen, som havde tuberkulose.
English: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Danish: Humira er indiceret til behandling af aktiv moderat til svær hidrosadenitis suppurativa (svedkirtelbetændelse) hos voksne og unge fra 12 år, hvor responset på konventionel systemisk HSbehandling har været utilstrækkelig (se pkt.
English: If you accidentally inject a larger amount of Humira liquid, or if you inject Humira more frequently than told to by your doctor, call your doctor and tell him/her that your child has taken more.
Danish: Hvis du ved en fejltagelse har injiceret en større mængde Humira end ordineret eller hvis du har injiceret hyppigere end forskrevet af lægen, kontakt lægen og fortæl ham/hende, at dit barn har fået for meget.
English: In patients with at least a partial response to Humira 40 mg weekly at Week 12, the HiSCR rate at Week 36 was higher in patients who continued weekly Humira than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 12).
Danish: Hos patienter med minimum et delvist respons på Humira 40 mg ugentlig ved uge 12 var HiSCR-raten ved uge 36 højere hos patienter, der fortsatte ugentlig Humira, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller behandlingen afbrudt (Se tabel 12).
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Danish: Den normale dosis for voksne med ikke-infektiøs uveitis er en startdosis på 80 mg (som to injektioner på en dag) efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: Humira 40 mg eow N=108 n (%)
Danish: Humira 40 mg hver anden uge N=108 n (%)
English: Humira/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Danish: Der blev observeret en significant mindre radiografisk progression hos Humira-/methotrexat- patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 11).
English: In patients with at least a partial response to Humira 40 mg weekly at Week 12, the HiSCR rate at Week 36 was higher in patients who continued weekly Humira 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 Humira 40 mg ugentlig ved uge 12 var HiSCR-raten ved uge 36 højere hos patienter, der fortsatte med ugentlig Humira, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller behandlingen afbrudt (Se tabel 18).
English: If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by 40 mg two weeks later.
Danish: Hvis et hurtigere respons er nødvendigt, kan lægen ordinere en startdosis på 80 mg, efterfulgt af 40 mg 2 uger senere.
English: Children and adolescents with chronic non-infectious uveitis from 2 years of age
Danish: Børn og unge fra 2 år med kronisk ikke-infektiøs uveitis Børn og unge fra 2 år der vejer mindre end 30 kg
English: For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at Week 52 were 15.3 ± 11.4 μg/ml (40/20 mg, weekly) and 6.7 ± 3.5 μg/ml (20/10 mg, weekly).
Danish: Hos patienter, hvis dosering øgedes fra hver anden uge til ugentlig, var den gennemsnitlige (±SD) serum-koncentration af adalimumab 15,3±11,4 μg/ml (40/20 mg ugentlig) og 6,7±3,5 μg/ml (20/10 mg ugentlig) ved uge 52.
English: In study UC-II, 248 patients received 160 mg of Humira at Week 0, 80 mg at Week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Danish: I studie UC-II fik 248 patienter 160 mg Humira i uge 0, 80 mg i uge 2 og derefter 40 mg hver anden uge.
English: In patients with at least a partial response to Humira 40 mg weekly at Week 12, the HiSCR rate at Week 36 was higher in patients who continued weekly Humira 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 Humira 40 mg ugentlig ved uge 12 var HiSCR-raten ved uge 36 højere hos patienter, der fortsatte ugentlig Humira, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller behandlingen afbrudt (Se tabel 22).
English: Humira 0.8 mg/kg eow N=38
Danish: Humira 0,8mg/kg hver anden uge N=38
English: It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Danish: Det anbefales, at børn føres a jour, hvad angår vaccinationer i overensstemmelse med gældende retningslinjer for vaccinationer, før behandlingen med Humira indledes.
English: • kidney problems
Danish: • nyreproblemer
English: Talk to your child's doctor or pharmacist before using Humira
Danish: Kontakt barnets læge, apotekspersonalet eller sundhedspersonalet, før barnet tager Humira.
English: • Rheumatoid arthritis
Danish: • Reumatoid artrit
English: Each 0.2 ml single dose pre-filled syringe contains 20 mg of adalimumab.
Danish: Hver fyldte 0,2 ml enkeltdosis injektionssprøjte indeholder 20 mg adalimumab.
English: For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at Week 52 were 15.3±11.4 μg/ml (40/20 mg, weekly) and 6.7±3.5 μg/ml (20/10 mg, weekly).
Danish: Hos patienter, hvis dosering øgedes fra hver anden uge til ugentlig, var den gennemsnitlige (±SD) serum-koncentration af adalimumab15,3 ± 11,4 μg/ml (40/20 mg ugentlig) og 6,7 ± 3,5 μg/ml (20/10 mg ugentlig) ved uge 52.
English: How to store Humira
Danish: Sådan skal du tage Humira
English: In controlled Phase 3 trials of Humira in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of Humira-treated patients and 1.3% of control-treated patients.
Danish: I kontrollerede fase 3-studier med Humira hos patienter med polyartikulær juvenil idiopatisk artrit i alderen fra 4 til 17 år og hos patienter med entesopatirelateret artrit i alderenfra 6 til 17 år forekom ALAT-stigninger ≥ 3 x ULN hos 6,1% af de Humira-behandlede patienter og hos 1,3 % af de kontrolbehandlede patienter.
English: Hidradenitis suppurativa Age or body weight
Danish: Hidrosadenitis suppurativa Alder eller vægt
English: • If your child received Humira while she was pregnant, her baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose she received during pregnancy.
Danish: • Hvis dit barn har fået Humira, mens hun var gravid, kan spædbarnet have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter den sidste Humiradosis under graviditeten.
English: The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Danish: Den anbefalede Humira-dosis til patienter med polyartikulær juvenil idiopatisk artrit fra 2 år er baseret på legemsvægt (tabel 1).
English: Tel: +44 (0)1628 561090
Danish: AbbVie Ltd Tel: +44 (0)1628 561090
English: Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion
Danish: Lungeemboli1), interstitiel lungesygdom kronisk obstruktiv lungesygdom, pneumonitis, pleuraeffusion1)
English: Placebo/ MTX n=200
Danish: Placebo/ MTXc n=200
English: The safety and efficacy of Humira were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, doublemasked, placebo-controlled studies (UV I and II).
Danish: Humiras sikkerhed og effekt blev undersøgt i to randomiserede, dobbeltblinde, placebokontrollerede studier (UV I og UV II) hos voksne patienter med non-infektiøs intermediær, posterior og pan-uveitis; patienter med isoleret anterior uveitis blev ekskluderet.
English: If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Humira, 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: • Let go of the skin in your hand.
Danish: • Slip huden med den første hånd.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON
English: ACR 20 Week
Danish: ACR 20 Uge 52
English: In patients with ulcerative colitis, a loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 12 g/ml during the induction period.
Danish: Hos patienter med colitis ulcerosa gav en startdosis på 160 mg Humira i uge 0 efterfulgt af 80 mg Humira i uge 2 dal-serumkoncentrationer af adalimumab på omkring 12 µg/ml i induktionsperioden.
English: Hold the white plunger rod in and turn the vial and syringe upside down.
Danish: Hold den hvide stempelstang og vend hætteglas og sprøjten på hovedet.
English: If you forget to give your child an injection, you should inject the next dose of Humira as soon as you remember.
Danish: Hvis du glemmer at give dit barn en injektion, bør du injicere den næste dosis af Humira, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindeligt fastlagte dag, som om du ikke havde glemt en dosis.
English: • After proper training, the injection can be given by your child or given by another person, for example, a family member or friend.
Danish: • Efter grundig oplæring kan injektionen gives af dit barn eller af en anden person, f.eks. et familiemedlem eller en ven.
English: The recommended Humira dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days), followed by 80 mg two weeks later at Day 15.
Danish: Det anbefalede Humira dosisregime til voksne patienter med hidrosadenitis suppurativa (HS) er 160 mg på dag 1 (givet som to injektioner af 80 mg på en dag eller som en injektion af 80 mg pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg to uger senere på dag 15.
English: • If your child has a severe infection, including active tuberculosis (see “Warnings and precautions”).
Danish: • Hvis dit barn har en alvorlig infektion, herunder aktiv tuberkulose (se ”Advarsler og forsigtighedsregler”).
English: • abnormal muscle breakdown;
Danish: • unormale muskelsvigt;
English: • Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Danish: • Fortæl lægen, hvis dit barn har fast bopæl eller rejser i områder, hvor svampeinfektioner (som f.eks. histoplasmose, kokcidioidomykose eller blastomykose) er meget almindelige.
English: • Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
Danish: • Tuberkulose kan udvikles under behandlingen, også selv om du har fået behandling for at forebygge tuberkulose.
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
Danish: Børn og unge fra 4 til 17 år, der vejer fra 15 kg til mindre end 30 kg