FrancophonIA/ELRC3.0 huggingface dataset:
English: − The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections.
Danish: - Øvrige indholdsstoffer: adipinsyre, citronsyremonohydrat, natriumchlorid, mannitol, polysorbat 80, saltsyre, natriumhydroxid og vand til injektionsvæsker.
English: Of 207 patients who were randomised to adalimumab 40 mg every other week, 114 patients continued on adalimumab 40 mg every other week for
Danish: Ud af 207 patienter, som blev randomiseret til adalimumab 40 mg hver anden uge, fortsatte 114 patienter på adalimumab 40 mg hver anden uge i 5 år.
English: Incorrect
Danish: Forkert
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95 % confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Danish: Ud af disse hudkræfttilfælde forekom planocellulært karcinom med en hyppighed (95 % konfidensinterval) på 2,7 (1,4-5,4) pr. 1.000 patientår blandt de adalimumab-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: Hefiya is used to treat ulcerative colitis in adults.
Danish: Hefiya bruges til at behandle colitis ulcerosa hos voksne.
English: Preparing the syringe
Danish: Forberedelse af sprøjten
English: CD study I and CD study II induction of remission and response rates are presented in table 23.
Danish: Tabel 23 viser rater for induktion af remission og respons i CD-studie I og CD-studie II.
English: The recommended dose of Hefiya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Danish: Den anbefalede Hefiya-dosis til patienter med Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 4).
English: Chest pain, oedema, pyrexia1)
Danish: Brystsmerter, ødem, pyreksi1)
English: 10 kg to < 30 kg ≥ 30 kg
Danish: 10 kg til < 30 kg ≥ 30 kg
English: The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode, hvor patienterne fik adalimumab 40 mg subkutant hver anden uge i op til yderligere 144 uger.
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Danish: Patienterne fik en startdosis på 80 mg adalimumab efterfulgt af 40 mg hver anden uge (med start en uge efter initialdosis) eller placebo i 16 uger.
English: Thus, it is not possible to use Hefiya for children who require less than a full 40 mg dose.
Danish: Derfor er det ikke muligt at bruge Hefiya til børn, som skal have mindre end en hel 40 mg dosis.
English: Hefiya 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: Hefiya 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: 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.
Danish: 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.
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled pens (SensoReady)
Danish: Injektionsvæske, opløsning Multipakning: 6 (3 pakninger a 2) fyldte penne (SensoReady)
English: • do not open the outer box until you are ready to use the syringe.
Danish: • ikke åbner den ydre emballage, før du er klar til at bruge sprøjten.
English: • nausea and vomiting;
Danish: • kvalme og opkastning
English: SC
Danish: NEc
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: The recommended dose of Hefiya for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Hefiya til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
English: BASDAIb 50 week 2 week 12 week 24 ***,** statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Danish: uge 2 uge 12 uge 24 ***,** statistisk signifikant på p<0,001, <0,01 for alle sammenligninger mellem adalimumab og placebo ved uge 2, 12 og 24 a assessment in ankylosing spondylitis b Bath ankylosing spondylitis disease activity index
English: You should record the date when your prefilled pen is first removed from the refrigerator, and the date after which it should be discarded.
Danish: Du skal registrere den dato, hvor din fyldte pen først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres.
English: Crohn's disease
Danish: Crohns sygdom
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)
Danish: Hidrosadenitis suppurativa hos unge (fra 12 år, som vejer 30 kg eller mere)
English: Your Hefiya single-use pre-filled syringe with needle guard and add-on finger flange
Danish: Din Hefiya fyldte engangssprøjte med kanylebeskyttelse og fingerstøtte som tilføjelse
English: Children and adolescents from 2 years of age weighing less than 30 kg
Danish: Børn og unge fra 2 år, der vejer mindre end 30 kg
English: Hefiya 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: Hefiya 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: 15 kg to < 30 kg ≥ 30 kg
Danish: 15 kg til < 30 kg ≥ 30 kg
English: Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Danish: Når sprøjten er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal pennen bruges indenfor 14 dage eller kasseres, også selv om den senere lægges tilbage i køleskabet.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Danish: I studie UC-I blev 390 TNF-antagonist-naive patienter randomiseret til at få enten placebo i uge 0 og 2, 160 mg adalimumab i uge 0 efterfulgt af 80 mg i uge 2, eller 80 mg adalimumab i uge 0 efterfulgt af 40 mg i uge 2.
English: Table 3.
Danish: Tabel 3.
English: Hefiya is only available as 40 mg pre-filled syringe / pre-filled pen.
Danish: Hefiya er kun tilgængelig som 40 mg fyldt injektionssprøjte/fyldt pen.
English: • Do not give Hefiya to children with polyarticular juvenile idiopathic arthritis below the age of
Danish: • Giv ikke Hefiya til børn under 2 år med polyartikulær juvenil idiopatisk artrit.
English: Hefiya 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: Hefiya 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 egnet til konventionel behandling.
English: d score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab c based on rank analysis d
Danish: < 0,001c erosion score JSNd score a methotrexat b 95 % Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab.
English: Hefiya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Danish: Hefiya er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos pædiatriske patienter (fra 6 år), som har haft utilstrækkeligt respons på konventionel behandling inklusive primær ernæringsbehandling og kortikosteroidbehandling og/eller immunmodulerende behandling, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Danish: En stjerne (*) i systemorganklassekolonnen indikerer, at der findes yderligere information andre steder i pkt.
English: Hidradenitis suppurativa
Danish: Hidrosadenitis suppurativa
English: Multipack containing 6 (3 packs of 2) pre-filled syringes in a blister Packs of 1 and 2 pre-filled pens
Danish: Pakninger a 1 og 2 fyldte injektionssprøjter i en blisterpakning Multipakning indeholdende 6 (3 pakninger a 2) fyldte injektionssprøjter i en blisterpakning Pakninger a 1 og 2 fyldte penne
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Danish: Tilgængelige data tyder på, at klinisk respons sædvanligvis opnås inden for 12 ugers behandling.
English: Injection site reactions
Danish: Reaktioner ved injektionsstedet
English: If these medicines do not work well enough, you will be given Hefiya to reduce the signs and symptoms of your disease.
Danish: Hvis denne anden medicin ikke virker godt nok, kan du få Hefiya for at mindske symptomerne på din sygdom.
English: HS study I
Danish: HS-studie I
English: EU/1/18/1287/003 6 pre-filled syringes (3 packs of 2)
Danish: EU/1/18/1287/003 6 fyldte injektionssprøjter (3 pakninger a 2)
English: Method and route of administration
Danish: Metode og indgivelsesvej
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38 % (25 / 66) and 55 % (36 / 66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Danish: 38% (25/66) og 55% (36/66) af de patienter, som mistede tilstrækkeligt respons efter genrandomisering til placebo, og som derefter fortsatte i det åbne forlængelsesstudie, genvandt PASI 75-respons efter henholdsvis 12 og 24 ugers behandling.
English: Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Danish: Adalimumab har vist sig at reducere den udviklingshastighed, hvormed de perifere led destrueres, bedømt ved måling med røntgen hos patienter med polyartikulære, symmetriske undertyper af sygdommen (se pkt.
English: 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: 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 populationsfarmakokinetiske 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: Description of selected adverse reactions
Danish: Beskrivelse af udvalgte bivirkninger
English: Haematologic reactions
Danish: Hæmatologiske reaktioner
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Danish: Forbedring af tegn og symptomer blev opretholdt med adalimumab-behandling i den åbne forlængelsesfase op til uge 156.
English: Children and adolescents from 6 to 17 years of age weighing less than 40 kg
Danish: Børn og unge fra 6 til 17 år, som vejer mindre end 40 kg
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 x 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 x ULN hos 6,1 % af de adalimumab-behandlede patienter og hos 1,3 % af de kontrol-behandlede patienter.
English: Hefiya dose for patients with enthesitis-related arthritis Patient weight
Danish: Hefiya-dosis til patienter med entesopati relateret artrit
English: At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Danish: 81 af 207 patienter, der oprindeligt blev behandlet med 40 mg adalimumab hver anden uge, blev radiografisk evalueret efter 8 år.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Danish: Ved brug af adalimumab er der også rapporteret om letale og livstruende infektioner (inklusive sepsis, opportunistiske infektioner og tuberkulose), HBV-reaktivering og forskellige maligniteter (inklusive leukæmi, lymfomer og hepatosplenisk T-cellelymfom).
English: Musculoskeletal pain
Danish: Meget almindelig Muskuloskeletale smerter Almindelig
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Hefiya therapy and regularly during treatment to assess for preexisting or developing central demyelinating disorders.
Danish: Før initiering af Hefiya 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: Figure E: choose your injection site
Danish: Figur E: vælg dit injektionssted
English: Hefiya 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: Hefiya er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos voksne patienter, som på trods af et fuldt og adækvat behandlingsforløb med kortikosteroid og/eller immunsuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
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: The recommended Hefiya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Danish: Den anbefalede Hefiya-dosis til patienter med plaque-psoriasis fra 4 til 17 år er baseret på legemsvægt (tabel 3).
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, double-masked, placebo-controlled studies (UV I and II).
Danish: Adalimumabs sikkerhed og effekt blev undersøgt i to randomiserede, dobbeltblindede, 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: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Danish: Det får dem til at smuldre, blive fortykket og løfte fra neglelejet, hvilket kan være smertefuldt.
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 µg/ml.
Danish: Hos voksne patienter med uveitis resulterede en startdosis på 80 mg adalimumab i uge 0 efterfulgt af 40 mg adalimumab hver anden uge fra uge 1 i en gennemsnitskoncentration på ca. 8-10 µg/ml ved steady state.
English: Hefiya 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 5.1).
Danish: Hefiya er indiceret til behandling af aktiv entesopatirelateret artrit hos patienter fra 6 år, som har haft et utilstrækkeligt respons på, eller som er intolerante over for konventionel behandling (se pkt.
English: Hefiya 40 mg solution for injection in a single-use pre-filled syringe Hefiya is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Danish: Hefiya, 40 mg injektionsvæske, opløsning i fyldt engangssprøjte Hefiya leveres i fyldt type 1-glas engangssprøjte med gummiprop og en kanyle i rustfrit stål med en automatisk beskyttelseshætte med fingerstøtte, kanylehætte i gummi og plastikstempel med 0,8 ml injektionsvæske.
English: EU/1/18/1287/001 1 pre-filled syringe EU/1/18/1287/002 2 pre-filled syringes
Danish: EU/1/18/1287/001 1 fyldt injektionssprøjte EU/1/18/1287/002 2 fyldte injektionssprøjter
English: Cartons contain 1 and 2 pre-filled syringes of Hefiya.
Danish: Pakningerne indeholder 1 og 2 fyldte injektionssprøjter med Hefiya.
English: PROBABILITY OF NO FLARE
Danish: SANDSYNLIGHEDEN FOR INGEN OPBLUSSEN AF SYGDOM
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hefiya.
Danish: Multipakninger indeholder 6 (3 pakninger a 2) fyldte penne med Hefiya.
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 x ULN occurred in 1.8 % of adalimumabtreated 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 x ULN hos 1,8 % af de adalimumab-behandlede patienter og hos 1,8 % af de kontrol-behandlede patienter.
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Danish: • lichenoid hudreaktion (kløende rødligt-lilla hududslæt).
English: Enthesitis-related arthritis
Danish: Entesopatirelateret artrit
English: adalimumab / M TX n=268 (95% confidence interval) p-valuea p-valueb p-valuec total Sharp score erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Danish: p-værdia p-værdib p-værdic total sharp score erosion score 3,7 (2,7-4,7) 1,7 (1,0-2,4) JSN score a p-værdien for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexat- kombinationsbehandling ved anvendelse af Mann-Whitney U test. b p-værdien for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexat- kombinationsbehandling ved anvendelse af Mann-Whitney U test c p-værdien for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test
English: 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: • anxiety;
Danish: • angst
English: • vision disturbances;
Danish: • synsforstyrrelser
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I PRODUKTRESUME
English: Hefiya is administered by injection under the skin (by subcutaneous injection).
Danish: Hefiya indgives ved injektion under huden (subkutan injektion).
English: The patients received 24 mg / m2 body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Danish: Patienterne fik adalimumab 24 mg/m2 legemsoverfladeareal op til maksimalt 20 mg som subkutan injektion hver anden uge i mindst 24 uger.
English: Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Danish: Fortæl din læge hvis du får symptomer såsom vedvarende uforklarligt udslæt, feber, ledsmerter eller træthed.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Danish: Ved behandling med adalimumab kan der ske dannelse af adalimumab-antistoffer.
English: Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg / ml (102 % CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg / ml (47.7 % CV) with concomitant methotrexate.
Danish: Efter administration af 24 mg/m2 (op til et maksimum på 40 mg) subkutant hver anden uge til patienter med polyartikulær juvenil idiopatisk artrit (JIA), som var 4 til 17 år, var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state (værdier målt fra uge 20 til 48) 5,6 ± 5,6 µg/ml (102 % CV) uden samtidig methotrexat og 10,9 ± 5,2 µg/ml (47,7 % CV) med samtidig methotrexat.