natgillin/translations-raw huggingface dataset:
En opdateret RMP 
An updated RMP should be submitted:
CD-Studie II: Infliximab erfarne patienter 
CD Study II: Infliximab Experienced Patients
Humira bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II). 
Humira should be used with caution in patients with mild heart failure (NYHA class I/II).
Eftersom immunogenicitetsanalyser er produktspecifikke, giver det ikke nogen mening at sammenligne antistofhyppigheden med andre produkter. 
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Ved uge 12 og uge 24 var pædiatrisk ACR 30-respons henholdsvis 93,5% og 90,0% ved anvendelse af observerede data. 
At Week 12 and Week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Patienterne i reumatoid artrit-studierne I, II og III blev testet på flere tidspunkter for anti-adalimumab antistoffer i løbet af 6 til 12 måneder. 
Patients in rheumatoid arthritis studies I, II and III were tested at multiple time points for anti-adalimumab antibodies during the 6 to 12 month period.
Din læge vil beslutte, om Humira skal anvendes sammen med methotrexat eller alene. 
Your doctor will decide if Humira should be used with methotrexate or alone.
• Kontrollér at væsken er klar og farveløs 
• Make sure the liquid is clear and colourless
• Slip huden med den første hånd 
• Release the skin with the first hand
Humira er ikke undersøgt hos disse patientpopulationer. 
Humira has not been studied in these patient populations.
Humira virker ved at reducere denne inflammation. 
Humira works by reducing this inflammation.
Uge 26 Placebokontrolleret 
Week 26 Placebo-Controlled
Tag en dosispakke, der indeholder en fyldt pen med Humira fra køleskabet. 
Take one dose tray containing a pre-filled pen of Humira from the refrigerator.
Behandling med Humira kan medføre dannelse af autoimmune antistoffer. 
Treatment with Humira may result in the formation of autoimmune antibodies.
Der er ingen tilgængelige data vedrørende den sekundære overførsel af infektion med levende vacciner hos patienter, der modtager Humira. 
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Hvis du har givet mindre Humira, end du skulle 
If you use less Humira than you should
Træk den grå hætte 1 lige af. 
Pull the Grey Cap 1 straight off.
PGA-F clear/minimal og ≥2-grade forbedring (%) 
≥ mNAPSI 75 (%) PGA-F clear/minimal and ≥2-grade improvement (%)
Humira i kombination med methotrexat er indiceret til: 
Humira in combination with methotrexate, is indicated for:
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 8.
I CD-studie III havde 58% (499/854) af patienterne klinisk respons i uge 4 og blev vurderet i den primære analyse. 
In CD Study III, at Week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Psoriasis formodes at være forårsaget af et problem med kroppens immunsystem, der fører til en øget produktion af hudceller. 
Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Foreliggende data tyder ikke på, at Humira forværrer eller forårsager forsnævringer. 
Available data suggest that Humira does not worsen or cause strictures.
Du skal indstille dosis til den foreskrevne volumen i trin 4, Forberedelse af dosis. 
You will set the volume to the prescribed dose in step 4, Dose Preparation.
Det hvide beskyttelseshylster til kanylen er der for at beskytte dig mod at røre ved kanylen. 
The white needle sleeve is there to protect you from touching the needle.
Hold trykket, og fortsæt med at holde den fyldte pen korrekt på huden med et stabilt tryk i omkring 10 sekunder for at sikre fuldstændig injektion. 
Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection.
• Pres stemplet ned for at injicere opløsningen - det tager fra 2 til 5 sekunder at tømme sprøjten 
• Push plunger to inject solution - it can take from 2 to 5 seconds to empty the syringe
Aldersgruppe 
Age Group
2D-stregkode 
2D code
Den potentielle risiko ved kombination af azathioprin eller 6mercaptopurin med Humira bør nøje overvejes. 
The potential risk with the combination of azathioprine or 6-mercaptopurine and Humira should be carefully considered.
• Lægen vil teste dit barn for HBV. 
• Your doctor should test your child for HBV.
Kanyle Inspektionsvindue 
Needle Inspection Window
Uge 16 Placebokontrolleret 
Week 16 Placebo-Controlled
Serumniveauer af matrixmetalloproteinaser (MMP-1 og MMP-3), som forårsager vævsomdannelse, der er ansvarlig for bruskdestruktionen, var også nedsatte efter Humira-administration. 
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.
Patienter i behandling med Humira havde signifikant lavere risiko for opblussen af sygdom i de første 12 ugers behandling. 
Patients treated with Humira had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
• Der var i følge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået Humira under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået Humira. 
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
• Kontroller at kanylens lille sorte beskyttelseshætte er fjernet sammen med hætten 
• Check that the small black needle cover of the syringe has been removed with the cap
Læs først vejledningen grundigt, og følg den herefter trin for trin. 
First read all the instructions carefully and then follow them step by step.
Bærere af HBV, som kræver behandling med Humira, 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 Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Træk med den anden hånd den grå hætte (1) lige af, kontroller at kanylens lille sorte beskyttelseshætte er fjernet sammen med hætten og kassér den herefter. 
With your other hand, pull the grey cap (1) straight off, check that the small black needle cover of the syringe has been removed with the cap, then discard cap.
Efterfølgende fulgte patienterne en obligatorisk nedtrapningsplan med komplet seponering af kortikosteroid i uge 19. 
Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19.
• Lægen vil teste dig for HBV. 
• Your doctor should test you for HBV.
Samtidige faste doser af aminosalicylater, kortikosteroider,og/eller immunmodulerende midler var tilladt, og 80 % af patienterne fortsatte med at få mindst et af disse lægemidler. 
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
10 sekunder 
10 Seconds
Vælg et injektionssted på låret eller maven (undtagen rundt om navlen). 
Choose a site on the top of your thigh or stomach (except the area around the navel).
Patienter i Humira-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner. 
Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Patienter med klinisk respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde klinisk respons ved uge 4. 
Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at Week 4.
Behandling med Humira kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler. 
Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Resultater fra den samlede UC-II studiespopulation er vist i tabel 18. 
Results from the overall UC-II study population are shown in Table 18.
Det vides ikke, hvilken virkning langtidsbehandling med Humira har på udviklingen af autoimmune sygdomme. 
The impact of long-term treatment with Humira on the development of autoimmune diseases is unknown.
Den procent af Humira-behandlede patienter, der fik ACR 20-, 50- og 70-respons, var konsistent mellem RA-studie I, II og III. 
The percent of Humira-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
• Der lyder et højt “klik”, når injektionen starter 
• A loud “click” will signal the start of the injection
Dannelse af adalimumab-antistoffer er forbundet med øget clearence og reduceret effekt af adalimumab. 
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Humira indeholder natrium 
Humira contains sodium
Ved at binde sig til TNFα reducerer Humira den inflammatoriske proces i disse sygdomme. 
By attaching to TNFα, Humira decreases the process of inflammation in these diseases.
Før behandling med Humira påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose. 
Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Der er begrænset erfaring med initiering af behandling med Humira alene. 
There is limited experience in the initiation of treatment with Humira alone.
Disse infektioner er ikke konsekvent blevet erkendt hos patienter, som tager TNFantagonister, hvorved iværksættelse af passende behandling er blevet forsinket, hvilket sommetider har resulteret i letale udfald. 
These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Delvis opblussen af sygdomd a Assessment of SpondyloArthritis international Society b Baseline er defineret som åben periode baseline, når patienterne har aktiv sygdom. 
c Inactive Disease Partial Flare Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Patienter bør testes for HBV-infektion inden behandling med Humira. 
Patients should be tested for HBV infection before initiating treatment with Humira.
Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrollerede studier, 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.
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.
• For at reducere risikoen for infektion skal du tørre injektionsstedet af med den anden alkoholserviet. 
• To reduce the chance of infection, wipe the injection site with the other alcohol pad.
Af de forsøgspersoner, som blev behandlet med Humira 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 Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Behandling med Humira bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol. 
Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
b 2-sidet p-værdi fra log rank test. c NE = ikke estimerbar. 
2-sided P value from log rank test. NE = not estimable.
Humiras sikkerhed og virkning hos børn i alderen 4-17 år er endnu ikke fastlagt. 
The safety and efficacy of Humira in children aged 4-17 years have not yet been established.
Opbevares i køleskab (2 - 8°C). 
Store in a refrigerator (2C - 8C).
Af de 424 patienter, der indgik i den ukontrollerede langtidsforlængelse af studierne UV I og UV II, blev 60 patienter anset for ikke egnede (f.eks. på grund af afvigelser eller på grund af komplikationer sekundært til diabetisk retinopati på grund af kataraktkirurgi eller vitrektomi) og blev udelukket fra den primære effektanalyse. 
Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Længere tids behanding med Humira 40 mg ugentlig viste ingen nye sikkerhedsfund. 
Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings.
Humira blev undersøgt hos 9.506 patienter i pivotale kontrollerede og åbne studier i op til 60 måneder eller mere. 
Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Kanylen vil herefter automatisk blive dækket af beskyttelseshætten. 
The needle will then be covered by the automatic needle guard.
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.
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.
Det samlede respons var generelt bedre og færre patienter udviklede antistoffer, når de blev behandlet med kombinationen Humira og MTX sammenlignet med Humira alene. 
Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of Humira and MTX compared to Humira alone.
• På forsiden af dit barns lår eller 
• On the front of your child's thighs or
Resultater fra Short Form Health Survey (SF 36) for alle doser/skemaer for Humira i alle fire studier understøtter disse resultater med statistisk signifikant værdi for physical component summary (PCS) såvel som med statistisk signifikant værdi for smerte- og vitalitetsområde for 40 mg dosering hver anden uge. 
Results from the Short Form Health Survey (SF 36) for all doses/schedules of Humira in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Blandt patienter med klinisk respons i uge 4 havde 48% tidligere været eksponeret for anden TNF-antagonist. 
Of those in clinical response at Week 4, 48% had been previously exposed to other TNFantagonists.
Patienter, der udvikler en ny infektion under behandling med Humira, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering. 
Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
Du vil høre et højt 'klik', når kanylen udløses, og du vil føle et lille prik, når kanylen trænger ind. 
You will then hear a loud ‘click' as the needle is released and you will feel a small prick as the needle advances.
Behandling med 40 mg Humira hver uge reducerede risikoen for forværring af abscesser og suppurerende fistler signifikant. 
Treatment with Humira 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Sikkerheden af den anbefalede adalimumab-dosis i den unge HS-population er baseret på adalimumabs sikkerhedsprofil på tværs af indikationer hos både voksne og pædiatriske patienter ved samme eller hyppigere dosering (se pkt. 
Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section
Vask hænderne grundigt Læg følgende ting på et rent underlag o En fyldt Humira-injektionssprøjte o En alkoholserviet 
Wash your hands thoroughly Set up the following items on a clean surface o One pre-filled syringe of Humira for injection o One alcohol pad
Hyppigheden af alvorlige infektioner var højere hos Humira-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %). 
The frequency of serious infections among Humira treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Den anden fik 20 mg Humira hver uge i 52 uger. 
The second received 20 mg of Humira every week for 52 weeks.
Der er ikke udført kliniske studier med Humira hos unge patienter med HS. 
There are no clinical trials with Humira in adolescent patients with HS.
Vertigo og svækket syn kan forekomme efter administration af Humira (se pkt 4.8). 
Vertigo and visual impairment may occur following administration of Humira (see section 4.8).
Vedligeholdt remission 
Sustained Remission
Behandling med Humira bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Humira er indiceret til. 
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.
• Visse vacciner kan forårsage infektioner og bør ikke gives under Humira-behandling. 
• Certain vaccines may cause infections and should not be given while receiving Humira.
Behandling med Humira skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens. 
Treatment with Humira must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM1, VCAM-1 og ICAM-1 med en IC50 på 0,1-0,2 nM). 
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of0.1-0.2 nM).
Humira/MTX 40 mg hver anden uge 
Humira/MTX 40 mg every other week
Patienter, som fuldførte studie UV I og UV II var kvalificerede til at deltage i et ukontrolleret langtidsforlængelsesstudie med en oprindelig planlagt varighed på 78 uger. 
Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks.
• Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Humira. 
• If you are over 65 years you may be more susceptible to infections while taking Humira.
Du skal registrere den dato, hvor pennen først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres. 
You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.
SÆT IKKE HÆTTEN PÅ, da du kan beskadige kanylen indeni. 
DO NOT RECAP as you may damage the needle inside.
Opbevar patientkortet på dig eller dit barn. 
Keep this Patient Reminder Card with you or your child.
Humira er tilgængelig i andre styrker og/eller lægemiddelformer afhængigt af individuelt behandlingsbehov. 
Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
• alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion • hævelser i ansigt, hænder eller fødder 
• severe rash, hives or other signs of allergic reaction • swollen face, hands, feet
Humira viste en behandlingsfordel hos patienter med neglepsoriasis med forskellig omfang af hudinvolvering (BSA≥10% (60 % af patienterne) og BSA<10% og ≥5% (40 % af patienterne)). 
Humira 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)).
Patienter i behandling med Humira havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL). 
Humira treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Klinisk respons (CR-100) 
Clinical remission Clinical response (CR-100)
Kombination af Humira og abatacept anbefales ikke (se pkt.t 4.4 “Samtidig administration af biologiske DMARDs eller TNF-antagonister”). 
The combination of Humira and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Der er et vindue på hver side af pennen, gennem hvilket du kan se Humira-injektionsvæsken inden i sprøjten. 
There is a window on each side of the pen through which you can see the Humira solution inside the syringe.
• steroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler(NSAIDs). 
• steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Der er modtaget rapporter om alvorlige allergiske reaktioner, inklusive anafylaksi, efter administration af Humira. 
Reports of serious allergic reactions including anaphylaxis have been received following Humira administration.
Under behandling med Humira, bør andre samtidige behandlinger (f.eks., kortikosteroider og/eller immunmodulerende midler) optimeres. 
During treatment with Humira, 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.
Pakninger af: 
Packs of:
• Beskyttelseshætten aktiveres ikke automatisk med mindre al væske er injiceret 
• The automatic needle guard will not activate unless all the liquid is injected
Der blev taget røntgenbilleder af hænder, håndled og fødder ved baseline og uge 24 i den dobbeltblindede periode, hvor patienterne fik Humira eller placebo, og ved uge 48, hvor alle patienterne fik åben Humira. 
Radiographs of hands, wrists, and feet were obtained at baseline and Week 24 during the double-blind period when patients were on Humira or placebo and at Week 48 when all patients were on open-label Humira.
Patienter, som fik methotrexat, og som opnåede et ≥ PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning. 
Patients receiving MTX who achieved a PASI 50 response at Week 8 and/or 12 did not receive further dose increases.
Et embryoføtalt udviklingstoksicitet-/perinatalt udviklingsstudie 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 cynomologous 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.