FrancophonIA/ELRC3.0 huggingface dataset:
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 8 and 9).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se tabel 8 og 9).
English: In patients not given concomitant methotrexate, the incidence was 25.6% (22/86) compared to 5.9% (5/85) when adalimumab was used as add-on to methotrexate.
Danish: Hos patienter, der ikke fik samtidig methotrexat, var forekomsten 25,6 % (22/86) sammenlignet med 5,9 % (5/85) når adalimumab blev anvendt som tillæg til methotrexat.
English: In adult patients with psoriasis, anti-adalimumab antibodies were identified in 77/920 subjects (8.4%) treated with adalimumab monotherapy.
Danish: Hos voksne patienter med psoriasis, blev der identificeret anti-adalimumab-antistoffer hos 77/920 forsøgspersoner (8,4%), som blev behandlet med adalimumab som monoterapi.
English: In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Humira-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of Humira-treated patients and 2.4% of control-treated patients.
Danish: I kontrollerede studier med Humira hos voksne patienter med uveitis (startdosis på 80 mg i uge 0 efterfulgt af 40 mg hver anden uge med start i uge 1) i op til 80 uger med en gennemsnitligt behandlingtid på 166,5 dage for patienter behandlet med Humira og 105,0 dage for patienter i kontrolarmen, forekom ALAT-stigning ≥ 3 x ULN hos 2,4% af patienterne i Humira-armen og hos 2,4 % af patienterne i kontrol-armen.
English: In patients not given concomitant methotrexate, the incidence was 13.6% (3/22), compared to 8.3% (2/24) when adalimumab was used as add-on to methotrexate.
Danish: Hos patienter, der ikke fik samtidig methotrexat, var forekomsten 13,6 % (3/22) sammenlignet med 8,3 % (2/24), når adalimumab blev anvendt som tillæg til methotrexat.
English: • Polyarticular juvenile idiopathic arthritis,
Danish: • Polyartikulær juvenil idiopatisk artrit,
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Danish: Vurdering af neglepsoriasis inkluderede the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGAF) og the Nail Psoriasis Severity Index (NAPSI) (se tabel 16).
English: Table 11: Efficacy Results at 12 Weeks, HS Studies I and II
Danish: Tabel 11: Effektresultater ved uge 12, HS-Studie I og II HS-studie I
English: • If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Danish: • Hvis der kommer nye hudlæsioner under eller efter behandlingen, skal du fortælle det til din læge.
English: • After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Danish: • Efter injektion af Humira bortskaffes den brugte kanyle straks i en særlig beholder som angivet af din læge, sygeplejerske eller apotek.
English: • leukaemia (cancer affecting the blood and bone marrow)
Danish: • leukæmi (kræft som påvirker blod og knoglemarv)
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 14 and 15).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se Tabel 14 og 15).
English: Table 9 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Danish: Tabel 9 Ps-studie II (CHAMPION) Effektresultater ved uge 16
English: Humira 40 mg Weekly
Danish: Humira 40 mg ugentlig
English: • Keep the special container out of the sight and reach of children at all times.
Danish: • Opbevar altid den særlige beholderen utilgængeligt for børn.
English: Table 15 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Danish: Tabel 15 Ps-studie II (CHAMPION) Effektresultater ved uge 16
English: • vision disturbances
Danish: • synsforstyrrelser
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 10).
Danish: Vurdering af neglepsoriasis inkluderede the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGAF) og the Nail Psoriasis Severity Index (NAPSI) (se tabel 10).
English: Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Danish: Humira bruges til at behandle alvorlig ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne.
English: • Crohn's disease
Danish: • Crohns sygdom
English: Tel.:+36 1 455 8600
Danish: AbbVie Kft. Tel.:+36 1 455 8600
English: In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate.
Danish: Hos patienter, der ikke samtidig fik methotrexat, var forekomsten 16/185 (8,6 %), sammnelignet med 1/19 (5,3 %), når adalimumab blev anvendt som tillæg til methotrexat.
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among Humira-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 Humira-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: Table 17: Efficacy Results at 12 Weeks, HS Studies I and II
Danish: Tabel 17: Effektresultater ved uge 12, HS-Studie I og II HS-studie I
English: Humira 40 mg every other week N = 70
Danish: Humira 40 mg hver anden uge N = 70
English: Humira 40 mg solution for injection in pre-filled syringe and/or pre-filled pen is available for the maintenance dose.
Danish: Til vedligeholdelsesbehandling er Humira 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte og/eller fyldt pen tilgængelig.
English: There is no relevant use of Humira in children aged less than 12 years in this indication.
Danish: Det er ikke relevant at bruge Humira hos børn under 12 år til denne indikation.
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection),
Danish: Ikke almindelig Neurologiske infektioner (inklusive viral meningitis), opportunistiske infektioner og tuberkulose (inklusive kokcidioidomykose, histoplasmose og mycobakterium avium complex-infektion) bakterielle infektioner, øjeninfektioner, diverticulitis1)
English: In Period A, patients received placebo or Humira at an initial dose of 160 mg at Week 0 and 80 mg at Week 2 and 40 mg every week starting at Week 4 to Week 11.
Danish: I periode A fik patienterne placebo eller Humira med en startdosis på 160 mg i uge 0, 80 mg i uge 2 og 40 mg hver uge fra uge 4 til uge 11.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Danish: Vurdering af neglepsoriasis inkluderede the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGAF) og the Nail Psoriasis Severity Index (NAPSI) (se tabel 19).
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 7).
Danish: I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 7).
English: If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your Crohn's disease.
Danish: Hvis du ikke har tilstrækkelig effekt af den medicin, vil du blive tilbudt Humira til reduktion af sygdomstegn og symptomer på din Crohns sygdom.
English: • moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.
Danish: • moderat til alvorlig Crohns sygdom hos børn og unge fra 6 til 17 år.
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomized to methotrexate monotherapy,
Danish: I den åbne forlængelse af RA-studie V hos patienter oprindeligt randomiseret til henholdsvis methotrexat monoterapi, Humira monoterapi eller kombinationsbehandling med Humira og methotrexat, var den gennemsnitlige ændring fra baseline ved år 10 i modificeret Total Sharp Score 10,8; 9,2 og 3,9.
English: Humira is used to treat moderate to severe rheumatoid arthritis in adults.
Danish: Humira bruges til at behandle moderat til alvorlig reumatoid artrit hos voksne.
English: One pre-filled pen of Humira One alcohol pad
Danish: En fyldt pen med Humira
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 21) ved uge 12.
English: 6 pre-filled pens 6 alcohol pads
Danish: 6 fyldte penne 6 alkoholservietter
English: • Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
Danish: • Dit barn bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Humira.
English: If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Danish: Hvis han/hun udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f. eks. stakåndethed eller hævede fødder), skal du kontakte lægen øjeblikkeligt.
English: • elevated bilirubin measurement (liver blood test).
Danish: • forhøjede bilirubinmålinger (leverblodtest).
English: Humira 40 mg eow N=814 n (%)
Danish: Humira 40 mg hver anden uge N=814 n (%)
English: • low blood measurements for white blood cells, red blood cells and platelet count
Danish: • nedsat antal hvide blodlegemer, røde blodlegemer og blodplader
English: DO NOT put these items into regular household waste.
Danish: IKKE lægges i husholdningsaffaldet.
English: Only use each pre-filled pen for one injection.
Danish: Brug kun hver fyldt injektionssprøjte til én injektion.
English: • injection site reactions (including pain, swelling, redness or itching)
Danish: • reaktioner ved injektionsstedet (herunder smerter, hævelse, rødme eller kløe)
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 17) ved uge 12.
English: • Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye
Danish: • børn fra 2 år med kronisk ikke-infektiøs sygdom, som påvirker forreste del af øjet
English: • pre-filled syringe has been dropped or crushed
Danish: • den fyldte injektionssprøjte har været tabt eller knust
English: Patients treated with Humira usually experienced improvement in haematological signs of chronic inflammation.
Danish: Hæmatologiske tegn på kronisk inflammation forbedredes sædvanligvis hos patienter behandlet med Humira.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 11).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 11) ved uge 12.
English: Your child should not take Humira with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Danish: På grund af øget risiko for alvorlig infektion, bør dit barn ikke tage Humira sammen med medicin, der indeholder de aktive stoffer anakinra eller abatacept.
English: First dose of 20 mg, followed by 20 mg one week later.
Danish: Startdosis på 20 mg, efterfulgt af 20 mg en uge senere.
English: There is no relevant use of Humira in patients aged less than 2 years for this indication.
Danish: Det er ikke relevant at bruge Humira hos patienter under 2 år til denne indikation.
English: Table 8 ACR Responses in RA Study V (percent of patients)
Danish: Tabel 8 ACR-respons i RA-studie V (Procentdel af patienter)
English: Your child's doctor may increase the dose frequency to 20 mg every week.
Danish: Dit barns læge kan øge dosis til 20 mg hver uge.
English: Solution for injection 2 pre-filled syringes 2 alcohol pads
Danish: Injektionsvæske, opløsning 2 fyldte injektionssprøjter 2 alkoholservietter
English: When the injection is completed, slowly pull the needle out of the skin while keeping the pre-filled syringe at the same angle.
Danish: Når injektionen er færdig, trækkes kanylen ud af huden og holdes i den samme vinkel, som da den blev ført ind.
English: • lung diseases causing shortness of breath (including inflammation)
Danish: • lungesygdom som forårsager kortåndethed (inklusive inflammation/vævsirritation)
English: Your doctor may increase the dose frequency to 20 mg every week.
Danish: Din læge kan øge dosis til 20 mg hver uge
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Danish: Tabel 18 Ps-studie II (CHAMPION) Effektresultater ved uge 16
English: Exposure-response relationship in paediatric population On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Danish: Sammenhæng mellem eksponering og respons i den pædiatriske population Der er fundet en eksponering-respons sammenhæng mellem plasmakoncentration og PedACR 50 respons på basis af data fra kliniske studier i patienter med JIA (pJIA og ERA).
English: Do not remove the needle cover until just before injection.
Danish: Fjern først beskyttelseshætten umiddelbart før injektion.
English: In period A, 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: I periode A fik patienterne placebo eller Humira i en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: In patients with Crohn's disease, anti-adalimumab antibodies were identified in 7/269 subjects (2.6%).
Danish: Der blev identificeret anti-adalimumab-antistoffer hos 7/269 patienter (2,6%) med Crohns sygdom.
English: Maintenance of remission and response rates are presented in Table 23.
Danish: Rater for vedligeholdelse af remission- og respons er vist i Tabel 23.
English: Please check with your doctor before you receive any vaccines.
Danish: Tal venligst med lægen, før du får nogen form for vaccine.
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 4).
Danish: Den anbefalede Humira-dosis til patienter med Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 4).
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days), 80 mg at Week 2, 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 to injektioner af 80 mg på en dag eller som en injektion af 80 mg pr. dag i to på hinanden følgende dage), 80 mg i uge 2, anvendes med erkendelse af, at risikoen for bivirkninger er højere under induktionen.
English: If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok , vil dit barn få Humira til behandling af hans/hendes polyartikulære juvenile idiopatiske artrit.
English: The safety and efficacy of Humira 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: Humiras sikkerhed og virkning blev undersøgt hos voksne patienter med kronisk plaque-psoriasis (≥ 10% BSA-involverering og PASI ≥ 12 eller ≥ 10), som var kandidater til systemisk behandling eller lysbehandling i randomiserede, dobbelt-blinde studier.
English: Table 5 ACR Responses in RA Study V (percent of patients)
Danish: Tabel 5 ACR-respons i RA-studie V (Procentdel af patienter)
English: The mean steady-state trough concentration at Week 12 through Week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment.
Danish: Den gennemsnitlige dal-koncentration ved steady state var ca. 8 til 10 μg/ml under behandling med adalimumab 40 mg hver uge fra uge 12 frem til og med uge 36.
English: • If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Danish: • Hvis der viser sig symptomer på tuberkulose (f.eks hoste som ikke forsvinder vægttab, mangel på energi, let feber) eller anden form for infektion under eller efter behandlingen, bør lægen straks informeres.
English: Depending on your child's response, your child's doctor may increase the dose frequency to 20 mg every week.
Danish: Afhængigt af dit barns respons kan lægen øge dosis til 20 mg hver uge.
English: pleural effusion
Danish: • kløende udslæt
English: Non-infectious uveitis
Danish: Ikke-infektiøs uveitis
English: Table 17 Maintenance regimen Patient Weight
Danish: Tabel 17 Vedligeholdelsesregime Patient vægt
English: When needed (for example, when you are travelling), a single Humira pre-filled pen 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 pen opbevares ved stuetemperatur (op til 25°C) i en periode på højst 14 dage - vær sikker på at beskytte den mod lys.
English: • certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine,
Danish: • visse sygdomsmodificerende antireumatiske lægemidler (f.eks.sulfasalazin,
English: If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember.
Danish: Hvis du glemmer at give dig selv 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: • Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Danish: • Aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis
English: • Recheck the prescribed medication amount.
Danish: • Tjek den foreskrevne dosis igen.
English: If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Danish: Hvis der kommer nye hudlæsioner under eller efter behandlingen, skal du fortælle det til din læge.
English: • Enthesitis-related arthritis,
Danish: • Entesopatirelateret artrit,
English: Table 19 Maintenance regimen Patient Weight
Danish: Tabel 19 Vedligeholdelsesregime Patient vægt
English: Your child should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
Danish: På grund af øget risiko for alvorlig infektion, bør dit barn bør ikke tage Humira sammen med medicin, som indeholder følgende aktive stoffer:
English: • inflammation of the eye lid and eye swelling
Danish: • betændelse i øjenlåget og hævede øjne
English: • If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive Humira.
Danish: • Hvis du har eller udvikler demyeliniserende sygdom som dissemineret sklerose vil din læge afgøre om du skal have eller fortsætte med at få Humira.
English: The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Humira til patienter med ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS og til patienter med psoriasisartrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge.
English: Table 25 Maintenance regimen Patient Weight
Danish: Tabel 25 Vedligeholdelsesregime Patient vægt
English: Table 20: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Danish: Tabel 20: Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis
English: • If your child has mild heart failure and is being treated with Humira, his/her heart failure status must be closely monitored by your doctor.
Danish: • Hvis dit barn har lettere hjerteinsufficiens og bliver behandlet med Humira, skal status for han/huns hjerteinsufficiens følges nøje af din læge.
English: It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Humira under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Danish: Humira bruges til at behandle ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne.
English: Humira is used to treat moderate to severe ulcerative colitis in adults.
Danish: Humira bruges til at behandle moderat til alvorlig colitis ulcerosa hos voksne.
English: • Tuberculosis can develop during therapy even if your child has received treatment for the prevention of tuberculosis.
Danish: • Tuberkulose kan udvikles under behandlingen, også selv om dit barn har fået behandling for at forebygge tuberkulose.
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma),
Danish: Hudkræft eksklusive melanom (inklusive basal celle-karcinom og spinocellulært karcinom), benign neoplasmer
English: Placebo Humira 40 mg eow
Danish: Placebo Humira 40 mg hver anden uge
English: Humira/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
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 9).
English: Table 7 Radiographic Mean Changes at Week 52 in RA Study V
Danish: Tabel 7 Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V