natgillin/translations-raw huggingface dataset:
Systemiske infektioner (inklusive sepsis, candidiasis og influenza), 
Systemic infections (including sepsis, candidiasis and influenza),
A. Tag det antal AMGEVITA fyldte injektionssprøjter, du skal bruge, ud af pakningen. 
A. Remove the number of AMGEVITA pre-filled syringes you need from the package.
Der var tre grupper i dettestudie. 
There were three groups in this study.
- I sjældne tilfælde kan behandling med AMGEVITA resultere i lupus-lignende syndrom. 
- On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome.
≥30 % reduktion af hudsmerterb 
≥30% Reduction in Skin Painb
Behandling med AMGEVITA skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens. 
Treatment with AMGEVITA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
• Hvis du har fået AMGEVITA, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion. 
• If you receive AMGEVITA during your pregnancy, your baby may have a higher risk for getting an infection.
- Rådfør dig med lægen, hvis du har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner. 
Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Ps-studie II (CHAMPION) - effektresultater ved uge 16 Placebo N = 53 n (%) 
Ps study II (CHAMPION) efficacy results at 16 weeks Placebo N = 53 n (%)
Plaque-psoriasis kan også ramme neglene, så de smuldrer, fortykkes og løfter sig fra neglelejet, hvilket kan være smertefuldt. 
Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Effektresultater ved uge 12, HS-Studie I og II 
Efficacy results at 12 weeks, HS studies I and II
Gul rude (injektion færdig) 
Yellow window (injection complete)
73 % af patienterne i Psoriasis-studie I og II havde tidligere fået systemisk behandling eller lysbehandling. 
73% of patients enrolled in psoriasis studies I and II had received prior systemic therapy or phototherapy.
Bærere af HBV, som kræver behandling med AMGEVITA, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen. 
Carriers of HBV who require treatment with AMGEVITA should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan AMGEVITA anvendes alene. 
If your doctor determines that methotrexate is inappropriate, AMGEVITA can be given alone.
• højt blodtryk, 
• high blood pressure;
PGA: clear/minimalc a MTX = methotrexat b P = 0,027, adalimumab 0,8 mg/kg versus MTX c P = 0,083, adalimumab 0,8 mg/kg versus MTX 
PGA: Clear/minimalc a MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX c P = 0.083, adalimumab 0.8 mg/kg versus MTX
Behandling med AMGEVITA kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler. 
Treatment with AMGEVITA can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Uge 26 Klinisk remission Klinisk respons Uge 52 Klinisk remission Klinisk respons * p-værdi for sammenligning af standard-dosis versus lav-dosis 
Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for standard dose versus low dose comparison
Statistisk signifikant øgning (forbedring) fra baseline til uge 26 og 52 i Body Mass Index og højdevækst blev set i begge behandlingsgrupper. 
Statistically significant increases (improvement) from baseline to week 26 and 52 in body mass index and height velocity were observed for both treatment groups.
Hos patienter, der udvikler reaktivering af HBV, bør AMGEVITA seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres. 
In patients who develop HBV reactivation, AMGEVITA should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Patienter, der udvikler en ny infektion under behandling med AMGEVITA, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering. 
Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation.
Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrolleredestudie, som var et allerede specificeret primært endepunkt ved uge 52 i RA-studie III. 
Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in RA study III.
Sjældne (kan påvirke op til 1 ud af 1.000 personer) • nedsat antal hvide blodlegemer, røde blodlegemer og blodplader. 
Rare (may affect up to 1 in 1,000 people) • low blood measurements for white blood cells, red blood cells and platelet count.
Din læge kan anbefale midlertidig afbrydelse af behandling med AMGEVITA. 
Your doctor may recommend temporary discontinuation of AMGEVITA.
• Merkelcelle karcinom (en type hudkræft), 
• Merkel cell carcinoma (a type of skin cancer);
• en bule eller åbent sår, som ikke vil hele, 
• a bump or open sore that doesn't heal;
Tid til behandlingssvigt i studie UV I og UV II Analyse 
Time to treatment failure in studies UV I and UV II
I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se Tabel 17 og 18). 
In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 17 and 18).
Opbevar AMGEVITA i den ydre karton for at beskytte mod lys. 
Keep AMGEVITA in the outer carton in order to protect from light.
Vurderinger af neglepsoriasis omfattede Modified Nail Psoriasis Severity Index (mNAPSI), Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og Nail Psoriasis Severity Index (NAPSI) (se tabel 19). 
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 19).
• blod i urinen, 
• blood in urine;
Kongestiv hjertesvigt 
Congestive heart failure
AMGEVITA bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år. 
AMGEVITA is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Meget almindelig Abdominalsmerter, Kvalme og opkastning 
Very common Abdominal pain, Nausea and vomiting
Klinisk remission (defineret som Mayo-score < 2 med ingen subscore > 1) blev vurderet i uge 8. 
Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week
Det primære endepunkt i RA-studie V var procentdelen af patienter, som opnåede et ACR50-respons i uge 52. 
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n=102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling. 
In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n = 102), 84% continued to show no radiographic progression through 144 weeks of treatment.
I RA-studie III opretholdt de fleste af de patienter, der opnåede forbedringer i fysisk funktion og fortsatte behandlingen forbedring gennem 520 uger (120 måneder) med åben behandling. 
In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
RA-studierne III og V havde yderligere primære endepunkter i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater). 
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by x-ray results).
Blandt de patienter, der afbrød studiet inden uge 78, blev 11 % afbrudt på grund af bivirkninger og 5 % på grund af utilstrækkelig respons på adalimumab behandling. 
Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
• følelse af svaghed eller træthed, 
• feeling weak or tired;
CD-StudieI I: Infliximab naive patienter 
CD study I: infliximab naïve patients
• alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion, 
• severe rash, hives or other signs of allergic reaction;
Uge 36 a Patienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling b Patienter, som opfylder protokol-specifikke kriterier for tab af respons eller ingen forbedring, var forpligtet til at udgå af studierne og blev optalt som non-respondere 
Week 36 a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Når du tager AMGEVITA, kan din risiko for at få et lymfom, leukæmi eller andre former for kræft øges. 
If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers may increase.
Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling før ≤ 18-års alderen), inklusive adalimumab post marketing. 
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post-marketing setting.
Fortæl din læge, hvis du får azathioprin eller 6-mercaptopurin sammen med AMGEVITA. 
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with AMGEVITA.
• kræft, 
• cancer;
- Rådfør dig med din læge, hvis du har fast bopæl eller rejser i områder, hvor svampeinfektioner som histoplasmose, kokcidioidomyse eller blastomykose er endemisk. 
Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.
Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR50-respons og pædiatrisk ACR70-respons. 
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), paediatric ACR 50 response, and paediatric ACR 70 response.
• lupus-lignende syndrom, 
• lupus-like syndrome;
Raten for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 27. 
Rates of discontinuation of corticosteroids or immunomodulators are presented in table 27.
Adalimumab udviste en behandlingsfordel hos patienter med neglepsoriasis med forskellige grader af involvering af hud (BSA ≥ 10% [60% af patienterne] og BSA < 10% og ≥ 5% [40% af patienterne]). 
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Adalimumab forsinkede tiden til behandlingssvigt signifikant sammenlignet med placebo (se figur 3, P < 0,0001 fra log rank test). 
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (see figure 3, P < 0.0001 from log rank test).
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET 
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Efter doser på 0,5 mg/kg (~40 mg) var clearance 11-15 ml/time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger. 
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Den tilsyneladende plasmakoncentation af adalimumab som giver 50 % sandsynlighed for PedACR 50-respons (EC50) var 3 μg/ml (95 % CI: 1-6 μg/ml). 
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Tag ikke AMGEVITA: 
Do not use AMGEVITA:
Den fyldte pen med 40 mg kan ikke bruges til dosen på 20 mg. 
The 40 mg pre-filled pen cannot be used for the 20 mg dose.
Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroid-fri remission i ≥ 90 dage ved uge 52. 
Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Vigtigt: Hold huden udstrakt eller klemt sammen, mens du injicerer. 
Important: Keep the skin stretched or pinched while injecting.
Du skal først behandles med anden sygdomsdæmpende medicin såsom methotrexat. 
You may first be given other disease-modifying medicines, such as methotrexate.
Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95 % KI 0,45-2,73) for RA og CD kombineret. 
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD
Inden start af behandling med AMGEVITA skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negative test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig. 
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of AMGEVITA in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Respons, remission og slimhindeheling i studie UC-II (Procent patienter) 
Response, remission and mucosal healing in study UC-II (percent of patients)
Hvis du ikke reagerer tilstrækkeligt godt på disse lægemidler, vil du få AMGEVITA til behandling af din polyartikulære juvenile idiopatiske artrit eller entesopati-relaterede artrit. 
If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
● Maven - bortset fra et område på 5 cm omkring navlen 
● Belly, except for a 2 inch (5 centimetres) area around your belly button
Hyppigheden af alvorlige infektioner var højere hos adalimumab-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %). 
The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Mediantiden til behandlingssvigt var 24,1 uge for patienter behandlet med placebo mens mediantiden til behandlingssvigt hos patienter behandlet med adalimumab ikke var målbar, da mindre end halvdelen af disse patienter oplevede behandlingssvigt. 
The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Derudover er der set tilfælde af ikke-melanom hudkræft hos patienter, der tager adalimumab. 
In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
Det aktive stof i AMGEVITA, adalimumab, er et humant monoklonalt antistof. 
The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody.
Under behandling med AMGEVITA, bør andre samtidige behandlinger (f.eks. kortikosteroider og/eller immunmodulerende midler) optimeres. 
During treatment with AMGEVITA, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Ethundrede patienter (n=100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie. 
One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Patientens vægt 
Patient Weight
• genopblussen af hepatitis B, 
• reactivation of hepatitis B;
A. Tag én AMGEVITA fyldt pen ud af pakningen. 
A. Remove one AMGEVITA pre-filled pen from the package.
Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [P=0,014]). 
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
Forværring eller nye udbrud af psoriasis (herunder palmoplantar pustuløs psoriasis)1), Urticaria, 
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
-56,2a a p < 0,001, adalimumab vs. placebo 
-56.2a a p < 0.001, adalimumab versus placebo
Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponeringrespons-forhold hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau. 
Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende spondylitis. 
Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
● Forsøg ikke at opvarme sprøjten ved hjælp af en varmekilde, for eksempel varmt vand eller mikrobølgeovn. 
● Do not try to warm the syringe by using a heat source such as hot water or microwave.
• nedsat antal blodplader med forøget risiko for blødning eller blå mærker, 
• reduction in blood platelets which increases risk of bleeding or bruising;
Der er en forøget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, hvilketkomplicerer risikoestimeringen. 
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing highly active, inflammatory disease, which complicates the risk estimation.
Uge 2 Uge 12 Uge 24 ***,** Statistisk signifikant p<0,001, <0,01 for alle sammenligning mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index 
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 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Samtidig administration af AMGEVITA og andre biologiske DMARDs (f.eks, anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner (se pkt. 
Concomitant administration of AMGEVITA with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Hepatosplenisk T-celle-lymfom1), Merkelcelle karcinom (neuroendokrint karcinom)1) 
Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artrit-patienter målt i serum var 31-96%. 
Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum.
Et embryoføtalt udviklingstoksicitet-/perinatalt udviklingsstudier foretaget på cynomolgusaber med 0, 30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab. 
An embryo-foetal developmental toxicity/perinatal developmental study has been performed in Cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
AMGEVITA kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig. 
AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med AMGEVITA straks ophøre og egnet behandling påbegyndes. 
If an anaphylactic reaction or other serious allergic reaction occurs, administration of AMGEVITA should be discontinued immediately and appropriate therapy initiated.
JSNd score a methotrexat b 95 % Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab c Baseret på ranganalyse d Ledspalteforsnævring 
JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d Joint Space Narrowing
Behandling med AMGEVITA bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som AMGEVITA er indiceret til. 
AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated.
Reduktion af inflammatoriske læsioner og forebyggelse af forværring af abscesser og suppurerende fistler blev evalueret ved hjælp af ”Hidradenitis Suppurativa Clinical Response” (HiSCR; mindst 50% reduktion i det totale antal abscesser og inflammatoriske noduli og uden stigning i antallet af abscesser og antallet af suppurerende fistler i forhold til baseline). 
Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa clinical response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III 
Radiographic mean changes over 12 months in RA study III
Hepatit, 
Hepatitis,
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referencelægemidlet, som indeholder adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).