FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Danish: I Studie nr-axSpA I blev adalimumab 40 mg hver anden uge vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med adalimumab og 6,5 for patienter i placebo-armen), som havde haft utilstrækkeligt respons på eller var intolerante over for ≥ 1 NSAID eller havde en kontraindikation mod NSAID.
English: Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Danish: Fremstiller Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
English: Adverse Reaction unspecified (including cysts and polyps)*
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)*
English: Expiration date
Danish: UDLØBSDATO
English: The pen is a single use, disposable, handheld, mechanical injection device.
Danish: Pennen er en håndholdt injektionsanordning til engangsbrug.
English: Hyperhidrosis,
Danish: Hyperhidrosie
English: Steroid-free remission for ≥ 90 daysa
Danish: Klinisk remission Slimhindeheling Steroid-fri remission i ≥ 90 dagea
English: ● Do not recycle the pre-filled pen or sharps disposal container or throw them into the household waste.
Danish: ● Den fyldte pen og kanylebøtten må ikke smides til genbrug eller kasseres sammen med husholdningsaffaldet.
English: Very common Rash (including exfoliative rash) Common
Danish: Meget almindelig Udslæt (inklusive eksfoliativt udslæt) Almindelig
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Danish: Blandt disse havde 154 patienter (90,6 %) ACR 20-respons, 127 patienter (74,7 %) ACR 50-respons og 102 patienter (60,0 %) ACR 70-respons.
English: Using your AMGEVITA pre-filled pen
Danish: Anvendelse af AMGEVITA fyldte penne
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week (eow).
Danish: Efter afslutningen af begge studier blev 383 patienter inkluderet i et åbent forlængelsesstudie, hvor 40 mg adalimumab blev administreret hver anden uge.
English: AMGEVITA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Danish: AMGEVITA er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 18,9, og baseline-PGA-score varierede fra “moderat” (53 % af de inkluderede patienter) til “alvorlig” (41 %) og “meget alvorlig”
English: D. Prepare and clean your injection site.
Danish: D. Forbered og afrens injektionsstedet.
English: AMGEVITA Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Danish: AMGEVITA-dosis til pædiatriske patienter med plaque psoriasis Patientens vægt
English: • facial oedema associated with allergic reactions;
Danish: • ødem i ansigtet forbundet med allergiske reaktioner,
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Danish: Polyartikulær juvenil idiopatisk artrit og entesopati-relateret artrit er sygdomme med betændelseslignende (inflammatoriske) reaktioner.
English: 0.8 mL of solution.
Danish: 0,8 ml
English: AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years and enthesitis-related arthritis in patients from 6 years.
Danish: AMGEVITA bruges til at behandle polyartikulær juvenil idiopatisk artrit hos patienter fra 2-års-alderen og entesopati-relateret artrit hos patienter fra 6 års-alderen.
English: Clear and colourless to slightly yellow solution.
Danish: Klar og farveløs til lysegul opløsning.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the
Danish: Ved uge 12 blev der påvist større forbedringer fra baseline sammenlignet med placebo i hud-specifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), den globale patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
English: • vasculitis (inflammation of blood vessels);
Danish: • vaskulitis (betændelse i blodkar),
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 40 mg injection adalimumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) AMGEVITA 40 mg injektion adalimumab s.c.
English: The pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Danish: Den fyldte pen skal være beskyttet mod lys, og kasseres, hvis den ikke er brugt inden for de 14 dage.
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa Week 56
Danish: Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea
English: D. Prepare and clean your injection site(s).
Danish: D. Forbered og afrens injektionsstedet (-stederne).
English: Cerebrovascular accident1), Tremor,
Danish: Nerverodskompression Ikke almindelig Cerebrovaskulært attak1), Tremor,
English: Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Danish: I psoriasis-studie IV blev adalimumabs virkning og sikkerhed sammenlignet med placebo hos 217 voksne patienter med moderat til svær neglepsoriasis.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 20 mg injection adalimumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) AMGEVITA 20 mg injektion adalimumab s.c.
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient-years during an adalimumab trial in paediatric patients with chronic plaque psoriasis.
Danish: Der blev ikke observeret nogen maligniteter hos 77 pædiatriske patienter med en samlet eksponering på 80,0 patientår i adalimumab-studier hos pædiatriske patienter med kronisk plaque-psoriasis.
English: AMGEVITA is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: AMGEVITA kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: ACR responses in placebo-controlled trials (percent of patients)
Danish: ACR-respons i placebokontrollerede studie (procent af patienter)
English: If you do not respond well enough to these medicines, you will be given AMGEVITA 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 AMGEVITA til reduktion af sygdomstegn og symptomer på din Crohns sygdom.
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 dal-koncentration af adalimumab steady state 5 µg/ml ved monoterapibehandling med 40 mg adalimumab hver anden uge.
English: Regarding combination with disease-modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Danish: 4.4 og 5.1 vedrørende kombination med andre sygdomsmodificerende antireumatiske lægemidler end methotrexat.
English: ● Do not remove the finger flange.
Danish: ● Fjern ikke fingergrebet.
English: The usual dose of AMGEVITA is 40 mg every other week with methotrexate.
Danish: Den normale dosis af AMGEVITA er 40 mg hver anden uge med methotrexat.
English: Pack sizes of one, two, four or multipack of six (3x2) pre-filled syringes.
Danish: Pakningsstørrelser med én, to, fire eller multipakning med seks (3x2) fyldte injektionssprøjter.
English: The usual dose of AMGEVITA is 20 mg every other week with methotrexate.
Danish: Den normale dosis af AMGEVITA er 20 mg hver anden uge med methotrexat.
English: Should treatment be interrupted, AMGEVITA 40 mg every week or 80 mg every other week may be re-introduced (see section 5.1).
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med AMGEVITA 40 mg hver uge eller 80 mg hver anden uge (se pkt.
English: Eye infections,
Danish: Øjeninfektioner,
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Danish: Voksne med reumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis
English: A single AMGEVITA pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt AMGEVITA fyldt pen kan opbevares ved temperaturer op til 25 °C i en periode på højst 14 dage.
English: ● Do not recycle the syringe or sharps disposal container or throw them into the household waste.
Danish: ● Injektionssprøjten og kanylebøtten må ikke smides til genbrug eller kasseres sammen med husholdningsaffaldet.
English: • Rheumatoid arthritis
Danish: • Rheumatoid artrit
English: • nausea and vomiting;
Danish: • kvalme og opkastning,
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 g/ml.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge til voksne patienter med nonradiografisk aksial spondyloartritis var den gennemsnitlige (±SD) dal-koncentration ved steady state i uge 68 8,0 ± 4,6 g/ml.
English: Among those, 86 patients (75.4%) had ACR 20 responses; 72 patients (63.2%) had ACR 50 responses; and 41 patients (36%) had ACR 70 responses.
Danish: Blandt disse havde 86 patienter (75,4 %) ACR 20-respons, 72 patienter (63,2 %) ACR 50-respons og 41 patienter (36 %) ACR 70-respons.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Danish: Adalimumabs 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: 2 pre-filled syringes.
Danish: 2 fyldte injektionssprøjter.
English: 4 pre-filled syringes.
Danish: 4 fyldte injektionssprøjter.
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 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Danish: Patienterne fik en initialdosis på 80 mg adalimumab efterfulgt af 40 mg hver anden uge (første gang 1 uge efter initialdosis) eller placebo i 26 uger efterfulgt af åben behandling med adalimumab i yderligere 26 uger.
English: AMGEVITA is administered every other week via subcutaneous injection.
Danish: AMGEVITA administreres hver anden uge som subkutan injektion.
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Danish: En signifikant højere andel af patienterne, som fik behandling med adalimumab sammenlignet med placebo, opnåede HiSCR ved uge 12.
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 x 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 x ULN hos 0,3 % af patienterne i adalimumabbehandling og hos 0,6 % af patienterne i kontrol-behandling.
English: • fever;
Danish: • feber,
English: H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
Danish: Sæt ikke din finger på stempelstangen, mens du fører kanylen ind. H. Skub stempelstangen hele vejen ind med et langsomt og konstant tryk, indtil den ikke bevæger sig længere.
English: • double vision;
Danish: • dobbeltsyn,
English: AMGEVITA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: AMGEVITA er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive glukokortikoider og 6mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: AMGEVITA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Danish: Aksial spondyloartritis uden radiografiske tegn på AS AMGEVITA er indiceret til behandling af voksne med alvorlig aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation ved forhøjet CRP og/eller MRI, som ikke har responderet tilstrækkeligt på eller er intolerante overfor NSAID.
English: Among those, 64 patients (79.0%) had ACR 20 responses; 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Danish: Blandt disse havde 64 patienter (79,0 %) ACR 20-respons, 56 patienter (69,1 %) ACR 50respons og 43 patienter (53,1 %) ACR 70-respons.
English: Alternatively, if a patient has stopped AMGEVITA and signs and symptoms of disease recur, AMGEVITA may be re-administered.
Danish: Alternativt, kan AMGEVITA gen-administreres, hvis patienten er stoppet behandling med AMGEVITA, og tegn og symptomer på sygdommen kommer igen.
English: AMGEVITA is used to treat moderate to severe plaque psoriasis in adults.
Danish: AMGEVITA bruges til at behandle moderat til alvorlig plaque-psoriasis hos voksne.
English: • low blood measurements for phosphate;
Danish: • lave blodmålinger af fosfat,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED PEN
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FYLDT PEN
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 2 til <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) uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2 % CV) med samtidig methotrexat.
English: • abnormal blood measurements for sodium;
Danish: • unormale blodmålinger af natrium,
English: For patients who dose escalated from every other week 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: AMGEVITA Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Danish: AMGEVITA-dosis til patienter med polyartikulær juvenil idiopatisk artrit Patientens vægt
English: • inflammation of the eye lid and eye swelling;
Danish: • betændelse i øjenlåget og hævede øjne,
English: Important: Throw the needle cap into the sharps disposal container provided.
Danish: Vigtigt: Smid kanylehætten i kanylebøtten.
English: In CD study I, 299 TNF-antagonist naïve patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Danish: I CD-studie I blev 299 TNF-antagonist-naive patienter randomiseret til en af fire behandlingsgrupper: placebo i uge 0 og 2, 160 mg adalimumab i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
English: AMGEVITA 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: AMGEVITA 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: Bacterial infections,
Danish: • bakterieinfektioner,
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid AMGEVITA nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: The pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: Den fyldte injektionssprøjte eller fyldte pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: • lung diseases causing shortness of breath (including inflammation);
Danish: • lungesygdom som forårsager kortåndethed (inklusive inflammation/vævsirritation),
English: Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumabtreated patients.
Danish: Endoskopiske undersøgelser af tarmslimhinden har vist tegn på heling af slimhinden hos patienter, som blevet behandlet med adalimumab.
English: The recommended adolescent HS dosing schedule is 40 mg every other week.
Danish: Det anbefalede HS-doseringsregime til unge er 40 mg adalimumab hver anden uge.
English: AMGEVITA 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: AMGEVITA 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: Each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod).
Danish: Hver pakning indeholder 1 20 mg fyldt injektionssprøjte til engangsbrug (med gul stempelstang).
English: The recommended dose of AMGEVITA 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 AMGEVITA til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af ikkemelanom hudkræft var 8,8 (6,0-13,0) pr. 1.000 patientår blandt adalimumab-behandlede patienter og 3,2 (1,3-7,6) pr. 1.000 patientår blandt kontrolpatienterne.
English: INFORMATION IN BRAILLE AMGEVITA 20 mg syringe
Danish: INFORMATION I BRAILLESKRIFT AMGEVITA 20 mg injektionssprøjte
English: The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex) (see section 4.4).
Danish: Den fyldte pens kanylehætte er fremstillet af tørt naturgummi (et derivat af latex) (se pkt.
English: Before you use an AMGEVITA pre-filled pen, read this important information:
Danish: Læs disse vigtige oplysninger, inden du bruger en AMGEVITA fyldt pen:
English: Mean steady-state trough levels of approximately 8 μg/mL were observed in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week.
Danish: Der blev observeret gennemsnitlige steady state dal-koncentrationer på omkring 8 µg/ml hos colitis ulcerosa patienter, som fik en vedligeholdelsesdosis på 40 mg adalimumab hver anden uge.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om adalimumab findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Dermatitis (including eczema), Onychoclasis,
Danish: Tendens til blå mærker (inklusive purpura), Dermatitis (inklusive eksem), Onychoclasis,
English: ● Do not put the yellow cap back onto the pre-filled pen.
Danish: ● Sæt ikke den gule hætte på pennen igen.
English: p-value
Danish: P-værdib
English: Children and adolescents from 2 years of age weighing 30 kg or more
Danish: Børn og unge fra 2 år der vejer 30 kg eller mere
English: AMGEVITA is used to treat ulcerative colitis in adults.
Danish: AMGEVITA bruges til at behandle colitis ulcerosa hos voksne.
English: Chest pain, Oedema, Pyrexia1)
Danish: Brystsmerter, Ødem, Pyreksi1)
English: Table 25.
Danish: Tabel 25.
English: - The needle cap is missing or not securely attached.
Danish: - Kanylehætten mangler eller sidder ikke ordentligt på.
English: Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose
Danish: Initialdosis på 20 mg efterfulgt af 20 mg givet hver anden uge med start 1 uge efter initialdosen
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/mL (79% CV).
Danish: Efter subkutan administration af 0,8 mg/kg (op til maksimalt 40 mg) hver anden uge til pædiatriske patienter med kronisk plaque-psoriasis var den gennemsnitlige dal-koncentration af adalimumab ved steady state 7,4 ± 5,8 µg/ml (± SD) (79 % CV).
English: • Enthesitis-related arthritis
Danish: • Entesopati-relateret artrit
English: • hepatitis;
Danish: • hepatit,
English: Cholecystitis and cholelithiasis, Hepatic steatosis, Bilirubin increased
Danish: Meget almindelig Forhøjede leverenzymer Ikke almindelig Kolecystit og cholelithiasis, Hepatisk steatose, Forhøjet bilirubin