natgillin/translations-raw huggingface dataset:
I de kontrollerede dele af de pivotale adalimumab-studier med voksne af mindst 12 ugers varighed hos patienter med moderat til svær aktiv reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS, psoriasisartrit, psoriasis, hidrosadenitis suppurativa, Crohns sygdom, colitis ulcerosa og uveitis blev der observeret maligniteter, fraset lymfomer eller ikke-melanom hudkræft, med en hyppighed (95 % konfidensinterval) på 6,8 (4,4-10,5) pr. 1.000 patientår bandt 5.291 adalimumab-behandlede patienter mod en hyppighed på 6,3 (3,4-11,8) pr. 1.000 patientår blandt 3.444 kontrolpatienter (gennemsnitlig varighed af behandlingen var 4,0 måneder for adalimumab og 3,8 måneder for de kontrol-behandlede patienter). 
During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
ACR-respons i placebokontrollerede psoriasisartrit-studier (procentdel af patienter) 
ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Ikke almindelig Lymfom**, Solide organ-neoplasmer (inklusive brystkræft, lungekræft og thyroideakræft), Melanom** 
Solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), Melanoma**
• øget svedtendens, 
• increased sweating;
Den fyldte pennens kanylehætte er fremstillet af tørt naturgummi (et derivat af latex), som kan medføre allergiske reaktioner. 
The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Adalimumabs sikkerhed og virkning undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til < 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære overfor mindst 12 ugers behandling med methotrexat. 
The safety and efficacy of adalimumab was assessed in a randomised, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
• følelsesforstyrrelser såsom snurren, prikken eller følelsesløshed, 
• sensation disorders such as tingling, prickling or numbness;
• tilstedeværelse af autoantistoffer i blodet, 
• autoantibodies present in the blood;
Der foreligger ingen kliniske data om brugen af en AMGEVITA-induktionsdosis til børn < 6 år (se pkt. 
No clinical data are available on the use of a AMGEVITA loading dose in children < 6 years of age (see section 5.2).
Medicin Kontrollér, at medicinen i ruden er klar og farveløs til lysegul. 
Medicine Make sure the medicine in the window is clear and colourless to slightly yellow.
Adalimumab 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt-blinde placebo-kontrollerede studier med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling. 
Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studier af adalimumab hos pædiatriske patienter med plaque-psoriasis. 
No ALT elevations ≥ 3 X ULN occurred in the phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Hver pakning indeholder 1, 2, 4 eller 6 40 mg fyldte injektionssprøjter til engangsbrug (med blå stempelstang). 
Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).
F. Klem sammen om injektionsstedet, så der dannes et fast underlag. 
F. Pinch your injection site to create a firm surface.
Der fortsættes med methotrexat under behandling med AMGEVITA. 
Methotrexate should be continued during treatment with AMGEVITA.
Efter yderligere 2 uger fortsættes med 40 mg hver uge eller 80 mg hver anden uge, alt efter lægens ordination. 
After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
● Brug ikke en fyldt injektionssprøjte, hvis den har været tabt på en hård flade. 
● Do not use an AMGEVITA pre-filled syringe if it has been dropped on a hard surface.
Tag fat i sprøjtehuset for at få sprøjten ud af bakken. 
Grab the syringe barrel to remove the syringe from the tray.
Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ± 1,9 i adalimumab-gruppen (ved uge 48) (p<0,001). 
Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p < 0.001) in the adalimumab group (at week 48).
AMGEVITA er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant. 
AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Adalimumab-behandlede patienter viste statistisk signifikante forbedringer i DLQI ved uge 26 sammenlignet med placebo. 
Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Multipakning: 6 (3 pakninger á 2) fyldte injektionssprøjter. 
Multipack: 6 (3 packs of 2) pre-filled syringes.
For at injektionen skal være mere behagelig, kan du tage pennen ud og opbevare den ved stuetemperatur 15 til 30 minutter inden injektionen. 
For a more comfortable injection, leave the pre-filled pen at room temperature for 15 to 30 minutes before injecting.
NA NA NA 4,5 % 23,2% a RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg adalimumab givet hver anden uge c MTX = methotrexat **p < 0,01, adalimumab versus placebo 
a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate ** p < 0.01, adalimumab versus placebo
• høje blodmålinger af lactatdehydrogenase, 
• high blood measurements for lactate dehydrogenase;
Ca. dobbelt så mange patienter i placebo-gruppen som i adalimumabgruppen oplevede forværring af abscesser (henholdvis 23,0% versus 11,4%) og suppurerende fistler (henholdvis 30,0% versus 13,9%) i de første 12 uger af HS-studie I og II. 
Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% versus 11.4%, respectively) and draining fistulas (30.0% versus 13.9%, respectively).
• luftvejsinfektioner (inklusive forkølelse, løbende næse, bihulebetændelse, lungebetændelse), 
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
De gennemsnitlige dal-serumkoncentrationer (±SD) af adalimumab, som blev opnået ved uge 4, var 15,7±6,6 µg/ml for patienter ≥ 40 kg (160/80 mg) og 10,6±6,1 µg/ml for patienter < 40 kg (80/40 mg). 
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7 ± 6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients < 40 kg (80/40 mg).
Efter 12 ugers behandling blev patienterne, som havde fået adalimumab i periode A, randomiseret igen i periode B til 1 af 3 behandlingsgrupper (adalimumab 40 mg hver uge, adalimumab 40 mg hver anden uge eller placebo fra uge 12 til uge 35). 
After 12 weeks of therapy, patients who had received adalimumab in Period A were rerandomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
I CD-studie II GAIN blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at få enten 160 mg adalimumab i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2. 
In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Hvis det er nødvendigt, kan behandling med antibiotika fortsættes under AMGEVITA-behandlingen. 
Antibiotics may be continued during treatment with AMGEVITA if necessary.
Tilgængelige data tyder på, at klinisk respons sædvanligvis opnås inden for 12 uger. 
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Efter enkeltvise intravenøse doser på mellem 0,25 og 10 mg/kg var koncentrationerne dosisrelaterede. 
After single intravenous doses ranging from 0.25 to 10 mg/kg,
Forhøjet blodlactatdehydrogenase 
Blood lactate dehydrogenase increased
40 mg Adalimumab hver uge 
40 mg adalimumab every week
Der foreligger ikke tilstrækkelige data fra anti-viral behandling i kombination med TNFantagonister for at forebygge HBV-reaktivering hos patienter, som er bærere af. 
Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Sæt en finger på kanten af bakken for at holde bakken fast, mens du tager sprøjten ud. 
Place your finger or thumb on edge of tray to secure it while you remove the syringe.
Brug i alle disse tilfælde en ny injektionssprøjte. 
In all cases, use a new syringe.
EU/1/16/1164/005 - multipakning med 6 (3x2) AMGEVITA 40 mg injektionsvæske, opløsning i fyldt pen EU/1/16/1164/006 - pakning med 1 
EU/1/16/1164/005 - 6 (3x2) multipack AMGEVITA 40 mg solution for injection in pre-filled pen EU/1/16/1164/006 - 1 pack
For synsrelaterede effekter havde adalimumab ikke numererisk en fordel ved farvesyn i Studie UV I og ved farvesyn, langsyn og nærsyn i studie UV II. 
vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Effekt-resultater 
Efficacy Outcomes
• tarminfektioner (inklusive gastroenteritis) 
• intestinal infections (including gastroenteritis);
AMGEVITA injiceres under huden (subkutan anvendelse). 
AMGEVITA is injected under the skin (subcutaneous use).
● Ryst ikke den fyldte pen. 
● Do not shake the pre-filled pen.
1 SureClick fyldt pen. 
1 SureClick pre-filled pen.
AMGEVITA er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og panuveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for kortikosteroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider. 
AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Pakningsstørrelser med én, to, fire eller multipakning med seks (3x2) fyldte penne. 
Pack sizes of one, two, four or multipack of six (3x2) pre-filled pens.
Vigtigt: Opbevar altid kanylebøtten utilgængeligt for børn. 
Important: Always keep the sharps disposal container out of the sight and reach of children.
AMGEVITA bruges til at behandle reumatoid artrit hos voksne. 
AMGEVITA is used to treat rheumatoid arthritis in adults.
I en analyse af non-respondenter, defineret som patienter, som udgik af studiet på grund af bivirkninger eller manglende effekt, eller hvor dosis blev trappet op var PASI 75- og PGA clear/minimal responserater henholdvis 69,6 % og 55,7 % efter yderligere 108 ugers åben-behandling (i alt 160 uger). 
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Resultaterne i uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med adalimumab sammenlignet med placebo (Tabel 14). 
Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14).
Kontrollér, at medicinen i sprøjten er klar og farveløs til lysegul. 
Make sure the medicine in the syringe is clear and colourless to slightly yellow.
Pleuraeffusion1) 
Pleural effusion1)
Efter uge 2 fik patienterne i begge adalimumab-arme 40 mg hver anden uge. 
After week 2, patients in both adalimumab arms received 40 mg every other week.
Patienter, der udviste pædiatrisk ACR 30-respons ved uge 16, var egnede til randomisering i den dobbeltblindede fase og fik enten adalimumab 24 mg/m2 op til maksimalt 40 mg eller placebo hver anden uge i yderligere 32 uger eller indtil opblussen af sygdommen. 
Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Før behandling med AMGEVITA påbegyndes, anbefales det, hvis det er muligt, at bringe pædiatriske patienter ajour med alle immuniseringer i overenstemmelse med gældende immuniseringsvejledninger. 
It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating AMGEVITA therapy.
Adalimumabs virkning er undersøgt i et randomiseret, dobbelt-blindet kontrolleret studie med 114 pædiatriske patienter fra 4 år med svær kronisk plaque-psoriasis (defineret ved PGA (physician global assessment) ≥ 4 eller > 20 % BSA (body surface area)-involvering eller > 10 % BSA-involvering med meget tykke læsioner eller PASI (psoriasis area and severity index) ≥ 20 eller ≥ 10 med klinisk relevante manifestioner i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling. 
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
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. 
RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 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.
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. 
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.
Fremstiller Amgen NV Telecomlaan 5-7 1831 Diegem Belgium 
Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)* 
Adverse Reaction unspecified (including cysts and polyps)*
UDLØBSDATO 
Expiration date
Pennen er en håndholdt injektionsanordning til engangsbrug. 
The pen is a single use, disposable, handheld, mechanical injection device.
Hyperhidrosie 
Hyperhidrosis,
Klinisk remission Slimhindeheling Steroid-fri remission i ≥ 90 dagea 
Steroid-free remission for ≥ 90 daysa
● Den fyldte pen og kanylebøtten må ikke smides til genbrug eller kasseres sammen med husholdningsaffaldet. 
● Do not recycle the pre-filled pen or sharps disposal container or throw them into the household waste.
Meget almindelig Udslæt (inklusive eksfoliativt udslæt) Almindelig 
Very common Rash (including exfoliative rash) Common
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. 
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.
Anvendelse af AMGEVITA fyldte penne 
Using your AMGEVITA pre-filled pen
Efter afslutningen af begge studier blev 383 patienter inkluderet i et åbent forlængelsesstudie, hvor 40 mg adalimumab blev administreret hver anden uge. 
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).
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. 
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.
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” 
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%).
D. Forbered og afrens injektionsstedet. 
D. Prepare and clean your injection site.
AMGEVITA-dosis til pædiatriske patienter med plaque psoriasis Patientens vægt 
AMGEVITA Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
• ødem i ansigtet forbundet med allergiske reaktioner, 
• facial oedema associated with allergic reactions;
Polyartikulær juvenil idiopatisk artrit og entesopati-relateret artrit er sygdomme med betændelseslignende (inflammatoriske) reaktioner. 
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
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. 
AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years and enthesitis-related arthritis in patients from 6 years.
Klar og farveløs til lysegul opløsning. 
Clear and colourless to slightly yellow solution.
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). 
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
• vaskulitis (betændelse i blodkar), 
• vasculitis (inflammation of blood vessels);
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) AMGEVITA 40 mg injektion adalimumab s.c. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 40 mg injection adalimumab
Den fyldte pen skal være beskyttet mod lys, og kasseres, hvis den ikke er brugt inden for de 14 dage. 
The pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea 
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa Week 56
D. Forbered og afrens injektionsstedet (-stederne). 
D. Prepare and clean your injection site(s).
Nerverodskompression Ikke almindelig Cerebrovaskulært attak1), Tremor, 
Cerebrovascular accident1), Tremor,
I psoriasis-studie IV blev adalimumabs virkning og sikkerhed sammenlignet med placebo hos 217 voksne patienter med moderat til svær neglepsoriasis. 
Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) AMGEVITA 20 mg injektion adalimumab s.c. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 20 mg injection adalimumab
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. 
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.
AMGEVITA kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt. 
AMGEVITA is contraindicated in moderate to severe heart failure (see section 4.3).
ACR-respons i placebokontrollerede studie (procent af patienter) 
ACR responses in placebo-controlled trials (percent of patients)
Hvis du ikke har tilstrækkelig effekt af den medicin, vil du blive tilbudt AMGEVITA til reduktion af sygdomstegn og symptomer på din Crohns sygdom. 
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.
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. 
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during adalimumab 40 mg every other week monotherapy treatment.
4.4 og 5.1 vedrørende kombination med andre sygdomsmodificerende antireumatiske lægemidler end methotrexat. 
Regarding combination with disease-modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.