FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥3 × ULN occurred in 0.3 % of adalimumab treated patients and 0.6 % of control-treated patients.
Danish: I kontrollerede studier med adalimumab (startdosis på 160 mg i uge 0 og 80 mg i uge 2, efterfulgt af 40 mg hver uge med start i uge 4) hos patienter med hidrosadenitis suppurativa med en kontrolperiode af 12 til 16 ugers varighed, forekom ALAT-stigning ≥ 3 × ULN hos 0,3 % af patienterne i adalimumab-behandling og hos 0,6 % af patienterne i kontrol-behandling.
English: Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Danish: Figur 3: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i det pædiatriske uveitis studie
English: The recommended dose of Imraldi 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 Imraldi 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: In controlled Phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥3 × ULN occurred in 1.8% of adalimumab-treated patients and 1.8 % of control-treated patients.
Danish: I kontrollerede fase 3-studier af adalimumab hos patienter med plaque-psoriasis med en kontrolperiode på 12 til 24 uger forekom ALAT-stigninger ≥ 3 × ULN hos 1,8 % af de adalimumabbehandlede patienter og hos 1,8 % af de kontrol-behandlede patienter.
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥40 kg, and 80 mg and 40 mg, respectively, for subjects <40 kg.
Danish: Alle patienter fik åben induktionsbehandling med doser baseret på deres baseline-legemsvægt: henholdsvis 160 mg i uge 0 og 80 mg i uge 2 til patienter ≥ 40 kg og 80 mg henholdsvis 40 mg til patienter < 40 kg.
English: • Use one of the alcohol pads to wipe the vial stopper.
Danish: • Brug den ene spritserviet til at rengøre hætteglassets prop.
English: Imraldi is administered via subcutaneous injection.
Danish: Imraldi administeres ved subkutan injektion.
English: • Keep the pen out of the sight and reach of children.
Danish: • Opbevar pennen utilgængeligt for børn.
English: • Let go of the skin in your hand.
Danish: • Slip huden.
English: The safety and efficacy of adalimumab 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: Adalimumabs 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: Adalimumab exposure in adolescent HS patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Danish: Adalimumab-eksponering hos unge HS-patienter er baseret på population-farmakokinetiske modeller og simulering af farmakokinetik hos andre pædiatriske patienter på tværs af indikationer (pædiatrisk psoriasis, juvenil idiopatisk artrit, pædiatrisk Crohns sygdom og entesopatirelateret artrit).
English: • 40 mg at week 0 and 20 mg at week 2
Danish: • 40 mg i uge 0 og 20 mg i uge 2
English: In Period A, patients received placebo or adalimumab 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 adalimumab 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: A little bleeding may occur.
Danish: Der kan forekomme en mindre blødning.
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor b 2-sided P value from log rank test c NE = not estimable.
Danish: a HR af adalimumab vs placebo ved regressionsanalyse med behandling som baggrundsvariabel.
English: Standard Dose 40/20 mg eow N=93
Danish: Standard-dosis 40/20 mg hver anden uge N = 93
English: The safety and efficacy of adalimumab were assessed in over 1,500 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: Adalimumabs 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: DO NOT try to reinsert the white plunger rod.
Danish: Prøv IKKE at sætte den hvide stempelstang tilbage i sprøjten.
English: The recommended Imraldi dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Danish: Den anbefalede Imraldi-dosis til patienter med plaque-psoriasis fra 4 til 17 år er baseret på legemsvægt (tabel 3).
English: The recommended dose of Imraldi is 40 mg every other week.
Danish: Den anbefalede dosis Imraldi er 40 mg hver anden uge.
English: • While holding the vial adapter firmly, insert the syringe tip into the vial adapter and twist the syringe clockwise with one hand until firm.
Danish: • Mens du holder godt fast på hætteglasadapteren, indsættes spidsen af sprøjten i hætteglasadapteren og sprøjten drejes med uret med én hånd til den sidder fast.
English: Pen storage
Danish: Opbevaring af pen
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Danish: Figur 1: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i det pædiatriske uveitis studie
English: In rheumatoid arthritis, methotrexate is continued while using Imraldi.
Danish: Hvis du har reumatoid artrit, kan du fortsætte med methotrexat under behandling med Imraldi.
English: At Week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Danish: Ved uge 16 havde flere af patienterne, som var randomiseret til adalimumab 0,8 mg/kg, positivt respons for effekt (f.eks.
English: Table 10 Radiographic Mean Changes at Week 52 in RA Study V
Danish: Tabel 10 Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
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: Imraldi 40 mg injection adalimumab SC
Danish: Imraldi 40 mg injektion adalimumab s.c.
English: Adalimumab 40 mg Weekly
Danish: Adalimumab 40 mg ugentlig
English: • migraine;
Danish: • hovedpine;
English: 6 pre-filled pens 6 alcohol pads
Danish: 6 fyldte penne 6 spritservietter
English: • anxiety;
Danish: • angst;
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Imraldi therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Danish: Før initiering af Imraldi og regelmæssigt under behandlingen bør der foretages en neurologisk udredning for at vurdere allerede eksisterende eller udvikling af demyeliniserende sygdomme hos patienter med non-infektiøs intermediær uveitis.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3
Danish: Den tilsyneladende plasmakoncentation af adalimumab som giver 50 % sandsynlighed for PedACR 50 respons (EC50) var 3 μg/ml (95% CI: 1-6 μg/ml).
English: In controlled trials of adalimumab (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 adalimumab-treated and control-treated patients, respectively, ALT elevations ≥3 × ULN occurred in 2.4 % of adalimumab-treated patients and 2.4 % of control-treated patients.
Danish: I kontrollerede studier med adalimumab 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 adalimumab og 105,0 dage for patienter i kontrol-armen, forekom ALAT-stigning ≥ 3 × ULN hos 2,4 % af patienterne i adalimumab-armen og hos 2,4 % af patienterne i kontrol-armen.
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, and uveitis patients.
Danish: Disse studier omfattede patienter med reumatoid artrit af kortere og længere sygdomsvarighed, juvenil idiopatisk artrit (polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit) og patienter med aksial spondyloartritis (ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis (AS)), psoriasisartrit, Crohns sygdom, colitis ulcerosa, psoriasis, hidrosadenitis suppurativa og uveitis.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at week 2 and week 4.
Danish: Hos voksne patienter med hidrosadenitis suppurativa blev der med en dosis på 160 mg adalimumab i uge 0 efterfulgt af 80 mg ved uge 2 opnået dal-serumkoncentrationer af adalimumab på ca. 7 til 8 μg/ml ved uge 2 og uge 4.
English: Adalimumab 40 mg weekly N = 70
Danish: Adalimumab 40 mg ugentlig N = 70
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 den lyserøde kanylebeskyttelse tilbage over kanylen og læg sprøjten med kanylen fra dig på dit arbejdssted.
English: Enthesitis-related arthritis
Danish: Entesopati-relateret artrit
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET PÅ FYLDT PEN
English: Imraldi is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: Imraldi er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos voksne patienter, som på trods af et fuldt og adækvat behandlingsforløb med glukokortikoid og/eller immunsuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Danish: Farmakoterapeutisk klassifikation: Immunsupprimerende midler, TNF-hæmmende midler.
English: DO NOT wipe off the needle or the syringe.
Danish: Tør IKKE kanylen eller sprøjten af.
English: • You will need a special container for waste, such as a sharps container or as instructed by your nurse, doctor or pharmacist.
Danish: • Du har brug for en særlig affaldsbeholder, såsom en kanyleboks eller en anden beholder som anvist af lægen, sygeplejersken eller apotekspersonalet.
English: Table 20 Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Danish: Tabel 20 Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more The recommended dose of Imraldi is an initial dose of 80 mg (as two 40-mg injections in one day), followed by 40 mg every other week starting one week later.
Danish: Unge med hidrosadenitis suppurativa fra 12 til 17 år, som vejer 30 kg eller mere Den anbefalede startdosis af Imraldi er 80 mg (som to 40 mg-injektioner på en dag), efterfulgt af 40 mg hver anden uge startende en uge efter den første dosis.
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 (givetsom fire 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: • difficulty sleeping;
Danish: • søvnbesvær;
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate.
Danish: Hos patienter med polyartikulær JIA, som var 2til < 4 år eller 4 år og derover med en vægt < 15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state 6,0 ± 6,1 µg/ml (101 % CV) for adalimumab uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2 % CV) med samtidig methotrexat.
English: Method of administration
Danish: ADMINISTRATIONSMETODE UDLØBSDATO
English: 4 pre-filled pens 4 alcohol pads
Danish: 4 fyldte penne 4 spritservietter
English: Imraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Danish: Imraldi er indiceret til behandling af pædiatrisk kronisk non-infektiøs anterior uveitis hos børn fra 2 år, som har haft utilstrækkeligt respons på konventionel behandling eller, som er intolerante eller, som ikke er egnede til konventionel behandling.
English: • Peel the cover off the vial adapter package but do not take out the vial adapter.
Danish: • Tag beklædningen af hætteglasadapteren, men tag ikke hætteglasadapteren ud.
English: DO NOT shake the syringe.
Danish: Ryst IKKE sprøjten.
English: Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication.
Danish: Dette er vigtigt for få den korrekte dosis og for at undgå luftbobler eller luftlommer i den flydende medicin.
English: years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Danish: RA-studie I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge.
English: • vision disturbances;
Danish: • synsforstyrrelser;
English: Table 18 Proportion of Patientsa Achieving HiSCRb at Weeks 24 and 36 After
Danish: Tabel 18 Andel af patientera, som opnåede HiSCRb ved uge 24 og 36 efter tildeling af behandling ved uge 12 fra ugentlig adalimumab
English: • Pop off the white plastic cap from the vial to see the top of the vial stopper.
Danish: • Pres den hvide plastikhætte på hætteglasset op, så hætteglassets prop kommer til syne.
English: Week 12 Week 24
Danish: Uge 12 Uge 24
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Danish: Børn og unge fra 6 til 17 år, som vejer 40 kg eller mere Den sædvanlige startdosis er 80 mg (som to 40 mg-injektioner på en dag) efterfulgt af 40 mg to uger senere.
English: Vial storage
Danish: Opbevaring
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Imraldi is an initial dose of 40 mg, followed by 40 mg one week later.
Danish: Børn og unge fra 4 til 17 år, der vejer 30 kg eller mere Den anbefalede startdosis af Imraldi er 40 mg, efterfulgt af 40 mg en uge senere.
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Imraldi is 40 mg every other week.
Danish: Børn, unge og voksne fra 6 år, der vejer 30 kg eller mere Den anbefalede dosis Imraldi er 40 mg hver anden uge.
English: Table 12 Radiographic Mean Changes at Week 52 in RA Study V
Danish: Tabel 12 Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
English: Table 9 Radiographic Mean Changes Over 12 Months in RA Study III
Danish: Tabel 9 Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: Package leaflet: Information for the patient Imraldi 40 mg solution for injection in pre-filled pen adalimumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Imraldi 40 mg injektionsvæske, opløsning i fyldt pen adalimumab Dette lægemiddel er underlagt supplerende overvågning.
English: • breaking of finger nails and toe nails;
Danish: • fingernegle og tånegle knækker;
English: Low Dose 20/10 mg eow N=95
Danish: Lav-dosis 20/10 mg hver anden uge N = 95
English: 0.8 ml solution for injection in single-use pre-filled syringe (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger (bromobutyl), a plunger rod, a safe-shield body and a finger flange for patient use.
Danish: Imraldi 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte 0,8 ml injektionsvæske, opløsning i fyldt engangssprøjte (type 1-glas) med en kanyle af rustfrit stål, en stiv kanylebeskytter, et gummistempel (brombutyl), en stempelstang, en beskyttelsesskærm og en fingerkrave til patientbrug.
English: Imraldi 40 mg solution for injection in pre-filled pen Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Danish: Imraldi 40 mg injektionsvæske, opløsning i fyldt pen Hver fyldte 0,8 ml enkeltdosis pen indeholder 40 mg adalimumab.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Imraldi (see section 4.4).
Danish: Før initiering af behandling med Imraldi rådes øjenlæger til at rådføre sig med en passende specialist (se pkt.
English: urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1),
Danish: Forværring eller nye udbrud af psoriasis (inklusive palmoplantar pustuløs psoriasis) 1), urticaria, tendens til blå mærker (inklusive purpura), dermatitis (inklusive eksem), onychoclasis, hyperhidrose, alopeci1), pruritus
English: If you forget to give yourself an injection, you should inject the next dose of Imraldi as soon as you remember.
Danish: Hvis du glemmer at give dig selv en injektion, bør du injicere den næste dosis af Imraldi, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindelig fastlagte dag, som om du ikke havde glemt en dosis.
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: Der er fundet en sammenhæng mellem plasmakoncentration og PedACR 50 respons på basis af data fra kliniske studier i patienter med JIA (pJIA og ERA).
English: Imraldi Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Danish: Imraldi-dosis til patienter med entesopati relateret artrit Patient vægt
English: Table 7 ACR Responses in Placebo Controlled Trials (Percent of Patients)
Danish: Tabel 7 ACR-respons i placebokontrollerede studier (Procentdel af patienter)
English: Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a pre-filled syringe (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger for patient use and 2, 2, 4 or 6 alcohol pads are enclosed in packs respectively.
Danish: Imraldi findes i pakninger, der indeholder 1, 2, 4 eller 6 fyldt(e) pen(ne) indeholdende en fyldt injektionssprøjte (type 1-glas) med en kanyle af rustfrit stål, en stiv kanylebeskytter og et gummistempel til patientbrug.
English: Imraldi 40 mg solution for injection in pre-filled syringe Imraldi 40 mg solution for injection in pre-filled pen
Danish: Imraldi 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Imraldi 40 mg injektionsvæske, opløsning i fyldt pen
English: Table 13 Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Danish: Tabel 13 Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis
English: Anaphylaxis1)
Danish: Leukæmi1)
English: How to use Imraldi
Danish: Sådan skal du bruge Imraldi
English: If you dropped your syringe with the cap OFF, do not use it.
Danish: Hvis du taber sprøjten med hætte AF, må den ikke anvendes.
English: Table 11 Radiographic Mean Changes Over 12 Months in RA Study III
Danish: Tabel 11 Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: • Gently set the vial with vial adapter down on your clean work surface.
Danish: • Sæt forsigtigt hætteglasset med hætteglasadapteren på dit rene arbejdssted.
English: In controlled Phase 3 trials of adalimumab 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 × ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
Danish: I kontrollerede fase 3-studier med adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit i alderen fra 4 til 17 år og hos patienter med entesopatirelateret artrit i alderen fra 6 til 17 år forekom ALAT-stigninger ≥ 3 × ULN hos 6,1 % af de adalimumab-behandlede patienter og hos 1,3 % af de kontrol-behandlede 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: • gallbladder inflammation, gallbladder stones;
Danish: • inflammation i galdeblæren, galdesten;
English: If these medicines do not work well enough, you will be given Imraldi to reduce the signs and symptoms of your Crohn's disease.
Danish: Hvis disse lægemidler ikke har tilstrækkelig effekt, vil du få Imraldi til at mindske symptomerne på din Crohns sygdom.