natgillin/translations-raw huggingface dataset:
[Tekst på bakke i æske:] Hulio 
[Text displayed on the tray inside the box:] Hulio
Det samlede respons var generelt bedre, og færre patienter udviklede antistoffer, når de blev behandlet med kombinationen adalimumab og MTX sammenlignet med adalimumab alene. 
Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Administration af levende vacciner (f.eks. BCG vaccine) til spædbørn, som har været eksponeret for adalimumab in utero, anbefales ikke i 5 måneder efter moderens sidste adalimumab-injektion under graviditeten. 
Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Et hundrede 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.
Aftør huden på det valgte injektionssted med en ny alkoholserviet. 
Wipe the skin at the chosen injection site with a new alcohol swab.
I betragtning af disse resultater anbefales adalimumab til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se pkt. 
Taking these results into consideration, adalimumab is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95% CI 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 combined.
Målet for adalimumab er et protein kaldet tumornekrosefaktor (TNFα) som er til stede i øgede mængder i de inflammatoriske sygdomme nævnt ovenfor. 
The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
• smerter i knogler og muskler. 
• pain in bone and muscles.
Eksisterende data tyder ikke på, at adalimumab forværrer eller forårsager forsnævringer. 
Available data suggest that adalimumab does not worsen or cause strictures.
Behandling med Hulio kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler. 
Treatment with Hulio can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Før behandling med Hulio påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose. 
Before initiation of therapy with Hulio, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
• Der er set meget sjældne tilfælde af visse kræfttyper hos børn og voksne patienter, som tager adalimumab eller andre TNFα-hæmmere. 
• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Der er ved post-marketing erfaring fra januar 2003 til december 2010, hovedsageligt hos patienter med reumatoid artrit rapporteret en hyppighed af maligniteter på cirka 2,7 pr. 1.000 patientbehandlingsår. 
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
• Hvis stemplet ikke trykkes helt ned, vil kanylehuset ikke blive aktiveret bagefter og dække kanylen. 
• If the plunger is not pressed all the way the safety feature will not activate afterwards to cover the needle.
• kræft i lymfesystemet (lymfom); 
• cancer of the lymph system (lymphoma);
Raterne for klinisk remission forblev forholdsvis konstante uanset tidligere TNFantagonisteksposition. 
Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
JSNd score a methotrexat b 95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab. 
JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
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 ACR 70-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), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Injektionssprøjten eller pen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden. 
The pre-filled syringe or pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Der er en øget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, hvilket komplicerer 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.
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 studie UC-II resulterede behandling med adalimumab i forbedringer i score i det tarmsygdomsspecifikke-spørgeskema (IBDQ). 
In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Hos patienter, der udvikler reaktivering af HBV, bør Hulio seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres. 
In patients who develop HBV reactivation, Hulio should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
• BRUG IKKE pennen, hvis den er blevet tabt på et hårdt underlag. 
• DO NOT use the pen if it has been dropped onto a hard surface.
Trin 7 Injicér Hulio 
Step 7 - Inject Hulio
Læs indlægssedlen for at få yderligere information. 
See the package leaflet for further information.
Patienter, der udvikler en ny infektion under behandling med Hulio, bør monitoreres nøje og gennemgå en fuldstændig diagnostisk evaluering. 
Patients who develop a new infection while undergoing treatment with Hulio, should be monitored closely and undergo a complete diagnostic evaluation.
Du må ikke blande Hulio opløsningen med anden medicin. 
Do not mix the Hulio solution with any other medicine.
• Yderligere risikominimeringsforanstaltninger Før Hulio markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet. 
Prior to launch of Hulio in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Patienter med klinisk respons (nedgang i CDAI ≥ 70) ved 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.
Dato for første markedsføringstilladelse: 17 september 2018 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2018
SPARCC MRI rygsøjlend,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo og n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo og adalimumab j n=82 placebo og n=85 adalimumab 
SPARCC MRI Spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
I vinduet kan du kan se den orange indikator, der viser hvor langt injektionen er nået. 
In the Viewing Window, the Orange Indicator will advance to show the progress of the injection.
CD-studie I: Infliximab-naive patienter 
CD Study I: Infliximab Naive Patients
Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (kræft som påvirker lymfesystemet) og leukæmi (kræft som påvirker blodceller og knoglemarv). 
People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Patienter bør testes for HBV-infektion inden behandling med Hulio. 
Patients should be tested for HBV infection before initiating treatment with Hulio.
Tuberkulose kan udvikles under behandlingen, også selvom dit barn har fået forebyggende behandling mod tuberkulose. 
Tuberculosis can develop during therapy even if your child have had preventative treatment for tuberculosis.
Normalt gives Hulio sammen med methotrexat. 
Usually, Hulio is used with methotrexate.
For information vedrørende opbevaring, se indlægssedlen. 
For storage information, see the package leaflet.
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.
Behandling med Hulio skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens. 
Treatment with Hulio must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Det anbefales, at børn, om muligt, får alle planlagte vaccinationer for deres alder, inden de begynder behandling med Hulio. 
It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hulio.
Andelen af patienter, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af de pivotale studier, udgjorde 5,9% for patienter, der fik adalimumab, og 5,4% for kontrolbehandlede patienter. 
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control treated patients.
RA-studie III og V havde yderligere primære endepunkter ved 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).
Oftamologer rådes til at konsultere en passende specialist inden initiering af behandling med Hulio (se pkt. 
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hulio (see section 4.4).
Meget almindelig Reaktioner på injektionsstedet (inklusive erytem på injektionsstedet) 
Injection site reaction (including injection site erythema)
Efter passende oplæring i injektionsteknik kan patienter selv injicere Hulio, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning. 
After proper training in injection technique, patients may self-inject with Hulio if their physician determines that it is appropriate and with medical follow-up as necessary.
Tuberkulose kan udvikles under behandlingen, også selvom du har fået forebyggende behandling mod tuberkulose. 
Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.
• UNDGÅ at overspænde. 
• DO NOT over-tighten.
Dette vil omfatte en omhyggelig gennemgang af din sygdomshistorie og relevante screeningstest (f.eks. røntgenundersøgelse af lunger og en tuberkulintest). 
This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
• Alle de andre anvendte genstande kan smides ud med dit husholdningsaffald. 
• Throw away all other used items and empty packaging into your regular household waste.
• Hulio bør kun anvendes under graviditet, hvis det er tydeligvis nødvendigt. 
• Hulio should only be used during a pregnancy if needed.
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%).
• nye udbrud eller forværring af psoriasis (rød, afskallende hud); 
• new or worsening psoriasis (red, flaky skin);
• 2 alkoholservietter (4) 
• 2 alcohol pads (4)
Inden for hver hyppighedsgruppering er bivirkningerne anført efter alvorlighedsgrad. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
• Du må IKKE sætte hætten på kanylen igen, røre kanylen med fingrene eller lade kanylen røre noget. 
• DO NOT re-cap or touch the needle with your fingers, or let the needle touch anything.
14 uger aPædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebobehandlede patienter b p = 0,015 c p = 0,031 
14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
- Hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i afsnit 6). 
- If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Vedligeholdelse af klinisk remission blev undersøgt i CD-studie III (CHARM). 
Maintenance of clinical remission was evaluated in CD Study III (CHARM).
Beslutningen om at stoppe med at tage Hulio skal diskuteres med din læge. 
The decision to stop using Hulio should be discussed with your doctor.
Forsøg ikke at injicere dig selv, før du er sikker på, hvordan du skal klargøre og give injektionen. 
Do not attempt to self-inject until you are sure that you understand how to prepare and administer the injection.
En enkelt Hulio fyldt injektionssprøjte eller pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage. 
A single Hulio 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.
Hvis der diagnosticeres aktiv tuberkulose, må Hulio-terapi ikke påbegyndes (se pkt. 
If active tuberculosis is diagnosed, Hulio therapy must not be initiated (see section 4.3).
Erosionsscore 3,7 (2,7-4,7) 1,7 (1,0-2,4) 
Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4)
Tid (UGER) 
TIME (MONTHS)
Beslutningen om at stoppe med at tage Hulio skal diskuteres med dit barns læge. 
The decision to stop using Hulio should be discussed with your child's doctor.
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]).
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.
Hvis dit barn lider af moderat eller alvorlig hjerteinsufficiens. 
If your child has moderate or severe heart failure.
Tabel 6: Bivirkninger 
Table 6: Undesirable Effects
Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponeringsrespons-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 med 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.
Mononatriumglutamat 
Monosodium glutamate
Inden start af behandling med Hulio skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negativ 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 Hulio 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.
Brug ikke Hulio 
Do not use Hulio
Diagnosticering og administration af empirisk antimykotisk behandling til disse patienter bør foretages i samråd med en læge med ekspertise i behandling af invasive svampeinfektioner. 
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Disse terapier omfatter methotrexat, leflunomid, hydroxychloroquin, sulfasalazin og/eller guldsalte. 
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Adalimumab havde numerisk en fordel ved de fleste af underscorerne med statistisk signifikante gennemsnitlige forskelle i generelt syn, okulær smerte, nærsyn, mental sundhed og totalscore i studie UV I og for generelt syn og mental sundhed i studie UV II. 
Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II.
Multipakning indeholdende 2 (2 pakninger med 1) hætteglas. 
Multipack containing 2 (2 packs of 1) vials.
Din læge kan have udskrevet Hulio i en anden styrke, hvis dit barn har behov for en anden dosis. 
Your doctor may prescribe another strength of Hulio if your child needs a different dose.
c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen afs sygdom defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg. 
c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Patienter i behandling med adalimumab havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og livskvalitetsspørgeskema ved ankyloserende spondylitis (ASQoL). 
Adalimumab 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).
Dit barn kan først blive behandlet med andre lægemidler. 
Your child may first be given other medicines.
For patienter, som udvikler tegn og symptomer såsom feber, utilpashed, vægttab, svedeture, hoste, dyspnø, og/eller pulmonale infiltrater eller anden alvorlig systemisk sygdom med eller uden samtidig shock, bør en invasiv svampeinfektion mistænkes, og administration af Hulio skal omgående afbrydes. 
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Hulio should be promptly discontinued.
Adalimumab nedsætter signifikant risikoen for behandlingssvigt med 75%, som vist med hazard ratio sammenlignet med placebo (HR = 0,25 [95% CI: 0,12; 0,49]). 
Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Hvis en patient efter behandling med Hulio udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbeltstrenget DNA, bør der ikke gives yderligere behandling med Hulio (se pkt. 
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Hulio and is positive for antibodies against double-stranded DNA, further treatment with Hulio should not be given (see section 4.8).
Forsøgspersoner (n=215, 54,7%), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non-respondenter i de dobbeltblindede statistiske analyser. 
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Dit barn bør ikke tage Hulio sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept. 
Your child should not take Hulio with medicines containing the active substances anakinra or abatacept.
Under behandling med Hulio bør andre samtidige behandlinger (f.eks. kortikosteroider og/eller immunmodulerende midler) optimeres. 
During treatment with Hulio, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
• Herudover er 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.
• Fortæl lægen, hvis du er bærer af hepatitis B-virus (HBV), hvis du har aktiv HBV, eller hvis du tror, du kan have risiko for at få HBV. 
• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
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.