FrancophonIA/ELRC3.0 huggingface dataset:
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret {MM/YYYY}
English: RA Study III a**
Danish: RA-studie IIIa**
English: Humira was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Danish: Humiras sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt (< 40 kg eller ≥ 40 kg) er undersøgt i et multicenter, randomiseret, dobbeltblindet klinisk studie med 192 pædiatriske patienter i alderen 6 til 17 (inklusive) år med moderat til svær Crohns sygdom (CD), defineret som Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
English: • liquid is cloudy, discoloured, or has flakes or particles in it
Danish: • væsken er uklar, misfarvet eller indeholder flager eller partikler
English: • 3 pre-filled pens for patient use with 4 alcohol pads (1 spare)
Danish: • 3 fyldte penne til patientbrug med 4 alkoholservietter (1 overskydende).
English: Check the liquid in the pre-filled syringe.
Danish: Kontrollér væsken i den fyldte injektionssprøjte.
English: The other ingredients are mannitol, polysorbate 80 and water for injections.
Danish: Øvrige indholdsstoffer: mannitol, polysorbat 80 og vand til injektionsvæsker.
English: Humira may have a minor influence on the ability to drive and use machines.
Danish: Humira kan have en mindre påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: A single Humira pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt Humira fyldt injektionssprøjte kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: Among those, 64 patients (79.0%) had ACR 20 responses; 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Danish: Blandt disse havde 64 patienter (79,0%) ACR 20-respons, 56 patienter (69,1%) ACR 50-respons og 43 patienter (53,1%) ACR 70-respons.
English: Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate.
Danish: Humira er blevet undersøgt hos patienter med reumatoid artrit, polyartikulær juvenil idiopatisk artrit og psoriasisartrit, der udelukkende blev behandlet med Humira, og hos patienter, der også samtidigt tog methotrexat.
English: Significant improvements at Week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Danish: Der blev vist signifikante forbedringer i DLQI (Dermatology Life Quality Index) i forhold til baseline ved uge 16 sammenlignet med placebo (studie I og II) og MTX (studie II).
English: • multiple sclerosis
Danish: • dissemineret sklerose
English: Tel: +46 (0)8 684 44 600
Danish: AbbVie AB Tel: +46 (0)8 684 44 600
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score  0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Danish: Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Totale Sharp Score ≤ 0,5) signifikant højere med Humira/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p<0,001) og Humira monoterapi (henholdsvis 50,7%, p<0,002 og 44,5%, p<0,001).
English: Humira treated patients showed statistically significant improvements at Week 26 compared with placebo in the DLQI.
Danish: I DLQI viste patienter behandlet med Humira statistisk signifikant forbedring ved uge 26 sammenlignet med placebo.
English: • With the free hand, gently grasp the cleaned area of skin and hold firmly.
Danish: • Klem forsigtigt med den frie hånd om det rensede hudområde, og hold fast
English: Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly until the injection is complete.
Danish: Klem om huden på injektionsstedet med din anden hånd for at hæve området og hold fast, indtil injektionen er gennemført.
English: Corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Danish: kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Humira.
English: • Do not use the pre-filled pen if the liquid is cloudy or has particles
Danish: • Brug ikke den fyldte pen, hvis væsken er uklar eller indeholder partikler
English: At 10 years, 79 of 207 patients originally treated with 40 mg Humira every other week were evaluated radiographically.
Danish: Efter 10 år blev 79 af 207 patienter, som oprindeligt blev behandlet med 40 mg Humira hver anden uge, evalueret radiografisk.
English: • With one hand, gently grasp the cleaned areas of skin and hold firmly
Danish: • Klem forsigtigt med én hånd om det rensede hudområde, og hold fast
English: If you forget to use Humira
Danish: Hvis du har glemt at tage Humira
English: Humira is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Danish: Humira bruges til at behandle polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit.
English: Efficacy Outcomes Double Blind 32 weeks Humira / MTX (N = 38)
Danish: Resultater af effekt Dobbeltblindet 32 uger Humira/MTX (N = 38)
English: Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.
Danish: Psoriasisartrit er en en inflammatorisk sygdom i leddene, der som regel er forbundet med psoriasis.
English: • Your belly (abdomen) at least 5 cm from your belly button (navel)
Danish: • På din mave (abdomen) mindst 5 cm fra din navle
English: Among patients whose Humira treatment was withdrawn at Week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of Humira 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Danish: Blandt patienter, som fik afbrudt behandlingen med Humira ved uge 12 i HS-studie I og II, var HiSCR-raten 12 uger efter genoptagelse af behandling med Humira 40 mg ugentlig tilbage på samme niveau som før behandlingsafbrydelsen (56,0 %).
English: Lift the pre-filled pen straight up from the injection site.
Danish: Løft pennen lige ud fra injektionsstedet.
English: Instructions for preparing and giving an injection of Humira
Danish: Vejledning til forberedelse og injektion af Humira:
English: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Danish: Fordele og risici ved fortsat behandling med 40 mg ugentlig eller 80 mg hver anden uge, skal overvejes nøje hos patienter med utilstrækkeligt respons efter øget doseringshyppighed (se pkt.
English: 3) Injecting Humira
Danish: 3) Injektion af Humira
English: If your doctor decides that methotrexate is inappropriate, Humira can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Humira anvendes alene
English: You may first be given other disease-modifying medicines, such as methotrexate.
Danish: Du vil evt. først få andre sygdomsmodificerende antireumatiske lægemidler, såsom methotrexat.
English: Mean steady-state trough levels of approximately 8 g/ml were observed in ulcerative colitis patients who received a maintenance dose of 40 mg Humira every other week.
Danish: Der blev observeret gennemsnitlige steady state dal-koncentrationer på omkring 8 µg/ml hos colitis ulcerosa patienter, som fik en vedligeholdelsesdosis på 40 mg Humira hver anden uge.
English: • Do not recycle or throw the pre-filled syringe in the household waste
Danish: • Genbrug ikke og smid ikke den fyldte injektionssprøjte ud med husholdningsaffald
English: Patients received an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Danish: Patienterne fik en startdosis på 80 mg Humira efterfulgt af 40 mg hver anden uge (med start en uge efter initialdosis) eller placebo i 16 uger.
English: • If your child has moderate or severe heart failure.
Danish: • Hvis dit barn lider af moderat eller alvorlig hjerteinsufficiens.
English: Non-serious allergic reactions associated with Humira were uncommon during clinical trials.
Danish: Ikkealvorlige allergiske reaktioner relateret til Humira var ikke almindelige i de kliniske studier.
English: Rheumatoid arthritis Age or body weight
Danish: Reumatoid artrit Alder eller vægt
English: • If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section
Danish: • Hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i punkt
English: • If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis dit barn er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: b 50 Week 2 Week 12 Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Humira and placebo at Weeks 2, 12 and 24 Assessments in Ankylosing Spondylitis Bath Ankylosing Spondylitis Disease Activity Index
Danish: ***,** Statistisk signifikant på<0,001, <0,01 for alle sammenligning mellem Humira og placebo ved uge 2, 12 og a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: Fever, bruising, bleeding or looking pale
Danish: Feber, blå mærker, bløder eller bleghed
English: • Keep pushing the pre-filled pen down firmly against the injection site until the injection is complete.
Danish: • Hold et fast tryk på den fyldte pen ned mod injektionsstedet, indtil injektionen er gennemført.
English: Point the white arrow toward the injection site (thigh or abdomen).
Danish: Hold den hvide pil mod injektionsstedet (lår eller mave).
English: Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Humira er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive glukokortikoider og 6mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: For the 2, 4 and 6 pre-filled pen packs, each pre-filled pen comes with 1 alcohol pad.
Danish: For pakningerne med 2, 4 og 6 fyldte penne, indeholder hver fyldt pen 1 alkohol-serviet.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at Week 52.
Danish: Det primære endepunkt i RA-studie V var procentdelen af patienter, som opnåede et ACR 50-respons i uge 52.
English: Patients demonstrating a Pediatric ACR 30 response at Week 16 were eligible to be randomised into the double blind (DB) phase and received either Humira 24 mg/m up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Danish: Patienter, der udviste et pædiatrisk ACR 30-respons ved uge 16, var egnede til randomisering i den dobbeltblindede fase og fik enten Humira 24 mg/m2 op til maksimalt 40 mg eller placebo hver anden uge i yderligere 32 uger eller indtil opblussen af sygdommen.
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of Humira up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode (OL), hvor patienterne fik Humira 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg hver anden uge subkutant i op til yderligere 192 uger.
English: In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at Week 4 in patients randomised to Humira 80/40 mg and 160/80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Danish: I CD-studie I og CD-studie II blev der i uge 4 opnået statistisk signifikante forbedringer i total score i det sygdoms-specifikke inflammatorisk tarmsygdoms-spørgeskema (IBDQ)hos patienter randomiseret til Humira 80/40 mg og 160/80 mg sammenlignet med placebo, og i CD-studie III blev det også set ved uge 26 og 56 hos de adalimumab-behandlede-grupper sammenlignet med placebo-gruppen.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Danish: • hepatosplenisk T-celle lymfom (en sjælden form for blodkræft, som ofte er dødelig)
English: o Wipe the injection site with the enclosed alcohol pad, using a circular motion.
Danish: o Tør injektionsstedet af med den medfølgende alkoholserviet ved hjælp af cirklende bevægelser.
English: • Non-infectious uveitis
Danish: • Ikke-infektiøs uveitis
English: • cancer;
Danish: • kræft;
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 g/ml.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge til voksne non-radiografisk aksial spondylartritis patienter var den gennemsnitlige (±SD) dal-steady state-koncentration ved uge 68 8,0 ± 4,6 µg/ml.
English: Table 12 Ped ACR 30 Responses in the JIA study
Danish: Tabel 12 Pædiatrisk ACR 30-respons i JIA-studiet
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS PAKKE TEKST
English: In the OL LI phase all patients received 24 mg/m up to a maximum of 40 mg Humira every other week for 16 weeks.
Danish: 10 mg/dag) I den åbne indkøringsfase fik alle patienter 24 mg/m2 op til maksimalt 40 mg Humira hver anden uge i 16 uger.
English: • low blood measurements for calcium
Danish: • lave blodmålinger af calcium
English: MTX N=37
Danish: MTXa N=37
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving Humira.
Danish: Alvorlige infektioner, inklusive sepsis, forårsaget af bakterier, mykobakterier, invasive svampe, parasittereller virus eller andre opportunistiske infektioner såsom listeriose, legionellose og pneumocystis er blevet rapporteret hos patienter, som fik Humira.
English: • 1 pre-filled pen for patient use with 2 alcohol pads (1 spare)
Danish: • 1 fyldt pen til patientbrug med 2 alkoholservietter (1 overskydende).
English: • increased lipids in the blood
Danish: • forhøjede lipider i blodet
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Humira.
English: • When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted
Danish: • Når sprøjten er tom, trækkes kanylen ud af huden og holdes i den samme vinkel, som da den blev ført ind
English: N Failure N (%)
Danish: N Behandlingssvigt N (%)
English: • If you have moderate or severe heart failure.
Danish: • hvis du lider af moderat eller alvorlig hjerteinsufficiens.
English: Tell your doctor as soon as possible if you notice any of the following
Danish: Kontakt lægen så hurtigt som muligt, hvis du får følgende symptomer
English: The safety and efficacy of Humira were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Danish: Humiras sikkerhed og virkning blev vurderet i et randomiseret, dobbeltblindet multicenterstudie hos 46 pædiatriske patienter (6-17 år) med moderat entesopati relateret artrit.
English: • inflammation of the pancreas which causes severe pain in the abdomen and back
Danish: • inflammation i bugspytkirtlen, som kan give alvorlige smerter i maven og ryggen
English: • You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.
Danish: • Din læge, sygeplejerske eller apotekspersonalet vil instruere dig i teknik til selvinjektion.
English: • Peel the clear package just far enough to expose the white plunger rod, but do not take the syringe out of the package.
Danish: • Træk beklædningen så langt tilbage at det hvide stempel kommer fri, men tag ikke sprøjten ud af pakningen.
English: Hold the pre-filled syringe in one hand between the finger grip and the needle cover.
Danish: Hold den fyldte injektionssprøjte i en hånd mellem fingergrebet og beskyttelseshætten.
English: Patients with at least a partial response to Humira 40 mg weekly after 12 weeks of treatment.
Danish: Uge 24 Uge 36 a Patienter med minimum et delvist respons på Humira 40 mg ugentlig efter 12 ugers behandling.
English: STEP 9
Danish: TRIN 9
English: The double-blind period was followed by an open-label period during which patients receive Humira 40 mg every other week subcutaneously for up to an additional 144 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode, hvor patienterne fik Humira 40 mg subkutant hver anden uge i op til yderligere 144 uger.
English: • mood swings (including depression)
Danish: • humørsvingninger (inklusive depression)
English: • inflammation of the eye lid and eye swelling;
Danish: • betændelse i øjenlåget og hævede øjne;
English: The blinded period was followed by an open − label period during which patients received Humira 40 mg every other week subcutaneously for up to an additional 28 weeks.
Danish: Den blindede periode blev efterfulgt af en åben periode, hvor patienterne modtog Humira 40 mg hver anden uge subkutant i op til yderligere 28 uger.
English: • At least 3 cm from your child's last injection site
Danish: • Mindst 3 cm fra barnets senest anvendte injektionssted
English: Humira is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: Humira bruges til at behandle børn fra 2 år med kronisk ikke-infektiøs uveitis, som påvirker forreste del af øjet.
English: • At least 3 cm from your last injection site
Danish: • Mindst 3 cm fra dit senest anvendte injektionssted
English: Subjects who flared during the double-blind period were allowed Humira 40 mg eow rescue therapy for at least 12 weeks.
Danish: Patienter, der fik opblussen af sygdommen i den dobbeltblindede periode, fik lov til at få rescue-behandling med Humira 40 mg hver anden uge i mindst 12 uger.
English: Both studies demonstrated an early and sustained effect of Humira on the treatment failure rate versus placebo (see Figure 1).
Danish: Begge studier viste en tidlig og vedvarende effekt af Humira på tid til behandlingssvigt versus placebo (se figur 1).
English: • nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
Danish: • nerveforstyrrelser (såsom inflammation (betændelse) i synsnerven og Guillain-Barré syndrom, som kan forårsage muskelsvaghed, unormal følesans, prikken i arme og overkrop)
English: • 1 single-use pre-filled syringe and • 1 alcohol pad
Danish: • 1 fyldt injektionssprøjte til engangsbrug og • 1 alkoholserviet
English: If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.
Danish: Hvis disse lægemidler ikke virker godt nok, vil dit barn få Humira for at mindske tegn og symptomer på hans/hendes sygdom.
English: Wipe the injection site in a circular motion with the alcohol pad.
Danish: Tør injektionsstedet af med cirklende bevægelser med den medfølgende alkoholserviet.
English: • nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Danish: • nerveforstyrrelser (såsom inflammation (betændelse) i synsnerven og Guillain-Barré syndrom, som kan forårsage muskelsvaghed, unormal følesans, prikken i arme og overkrop);
English: At Week 12, a significantly higher proportion of patients treated with Humira versus placebo achieved HiSCR.
Danish: En signifikant større andel af patienterne, som fik behandling med Humira sammenlignet med placebo, opnåede HiSCR ved uge 12.
English: Note: P = Placebo (Number at Risk); H = HUMIRA (Number at Risk).
Danish: Note: P = Placebo (Antal med risiko); H = HUMIRA (Antal med risiko).
English: In patients not given concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Danish: Hos patienter, som ikke fik methotrexat samtidig, var incidensen 12,4% sammenlignet med 0,6%, når adalimumab blev givet i kombination med methotrexat.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om Humira findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Other medicines and Humira
Danish: Brug af anden medicin sammen med Humira
English: The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among Humira-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af ikke-melanom hudkræft var 8,8 (6,0-13,0) pr. 1.000 patientår blandt Humira-behandlede patienter og 3,2 (1,3-7,6) pr. 1.000 patientår blandt kontrolpatienterne.
English: In patients with non-radiographic axial spondyloarthritis, anti-adalimumab antibodies were identified in 8/152 subjects (5.3%) who were treated continuously with adalimumab.
Danish: Hos patienter med non-radiografisk aksial spondylartritis, blev der påvist anti-adalimumab antistoffer hos 8/152 patienter (5,3%) behandlet kontinuertligt med adalimumab.
English: A single Humira pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt Humira fyldt injektionssprøjte eller fyldt pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: • Put the syringe with needle, vial and vial adapter into a special sharps container.
Danish: • Læg sprøjten med kanylen, hætteglas og hætteglasadapteren ned i en særlig kanyleboks.
English: Excipients: mannitol, polysorbate 80 and water for injections.
Danish: Hjælpestoffer: mannitol, polysorbat 80 og vand til injektionsvæsker.
English: • Only use each pre-filled syringe for one injection.
Danish: • Brug kun hver fyldt injektionssprøjte til én injektion.
English: • moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.
Danish: • moderat til alvorlig hidrosadenitis suppurativa hos unge fra 12 til 17 år.
English: Your symptoms may return upon discontinuation.
Danish: Dine symptomer kan komme igen efter ophør.
English: • high blood measurements for lactate dehydrogenase
Danish: • høje blodmålinger af lactatdehydrogenase