FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10.
Danish: Effekt-resultater Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10.
English: In people who carry HBV, Humira can cause the virus to become active again.
Danish: Hos bærere af HBV, kan Humira forårsage at virus bliver aktiv igen.
English: 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.
Danish: 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.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Humira should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Humira straks ophøre og egnet behandling påbegyndes.
English: Do not use the product after the month and year shown.
Danish: Må ikke anvendes efter den angivne måned og år.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af studier af toksicitet efter enkeltdosering, gentagen dosistoksicitet og genotoksicitet.
English: A total of 233 PASI 75 responders at Week 16 and Week 33 received continuous Humira therapy for 52 weeks in Psoriasis Study I, and continued Humira in the open-label extension trial.
Danish: I alt 233 PASI 75-respondenter ved uge 16 og 33 fik kontinuerlig Humira-behandling i 52 uger i Psoriasis-studie I og fortsatte med Humira i det åbne forlængelsesstudie.
English: Physicians should exercise caution when considering the use of Humira in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af Humira til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: Do not remove the pre-filled pen while the injection is being given.
Danish: Fjern ikke den fyldte pen, imens injektionen gives.
English: The proportions of subjects with PedACR50/70/90 at Week 12 and Week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Danish: Forholdet mellem patienter med pædiatrisk ACR-50/70/90 ved uge 12 og uge 24 var henholdsvis 90,3%/61,3%/38,7% og 83,3%/73,3%/36,7%.
English: In a study of 64 patients with rheumatoid arthritis that were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.
Danish: I et studie, hvor 64 patienter med reumatoid artrit blev behandlet med Humira, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T-, B, - NK-celler, monocytter/makrofager og neutrofiler.
English: When the injection is completed, slowly pull the pre-filled pen from the skin.
Danish: Når injektionen er færdig, løftes pennen langsomt ud fra huden.
English: The pivotal controlled studies involved 6,089 patients receiving Humira and 3,801 patients receiving placebo or active comparator during the controlled period.
Danish: De pivotale kontrollerede studier, som omfattede 6.089 patienter, der fik Humira, og 3.801 patienter, der fik enten placebo eller aktiv kontrol i den kontrollerede behandlingsperiode.
English: Ankylosing Spondylitis Disease Activity Score Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Danish: c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen af sygdom er defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg.
English: • If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white plunger rod into the syringe until fluid begins to enter the syringe tip.
Danish: • Hvis der er en stor luftboble eller luftlomme nær sprøjtens spids, skubbes det hvide stempel LANGSOMT ind i sprøjten indtil der kommer væske ud af sprøjtens spids.
English: The decision to stop using Humira should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Humira skal diskuteres med din læge.
English: The safety and efficacy of Humira was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Danish: Humiras sikkerhed og virkning blev vurderet i to studier (pJIA I og II) hos børn med aktiv polyartikulær eller polyartikulært forløb af juvenil idiopatisk artrit, som havde en række forskellige JIA-typer (hyppigst reumatoid-faktor-negativ eller -positiv polyartrit og udvidet oligoartrit).
English: TNF-antagonists including Humira have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including GuillainBarré syndrome.
Danish: TNF-antagonister, herunder Humira, er i sjældne tilfælde blevet forbundet med nyt udbrud eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniserende sygdom i centralnervesystemet herunder dissemineret sklerose og optisk neurit og perifer demyeliniserende sygdom, inklusive Guillain-Barré syndrom.
English: Autoimmune disease
Danish: Autoimmune sygdomme
English: Study nr-axSpA I evaluated patients with active nr-axSpA.
Danish: Studie nr-axSpA I evaluerede patienter med aktiv nr-axSpA.
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with Humira.
Danish: Studie nr-axSpA II var et behandlingsseponerings-studie hos patienter med aktiv nr-axSpA, som opnåede remission i den åbne periode af behandlingen med Humira.
English: The decision to stop using Humira should be discussed with your child's doctor.
Danish: Beslutningen om at stoppe med at bruge Humira skal diskuteres med barnets læge.
English: • There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.
Danish: • Der er set meget sjældne tilfælde af visse kræfttyper hos børn og voksne patienter, som tager Humira eller andre TNF-hæmmere.
English: A patient who requires surgery while on Humira should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med Humira, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte tilLægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Danish: I RA-studie IV var ACR 20-respons for patienter behandlet med Humira plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p < 0,001).
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Danish: • Hold fast på sprøjtens pakning og træk LANGSOMT stemplet ud til 0,1 ml mere end den ordinerede dosis (fx hvis den ordinerede dosis er 0,5 ml skal du trække stemplet ud til 0,6 ml).
English: This study evaluated the efficacy of Humira 40 mg every other week/methotrexate combination therapy, Humira 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Danish: Dette studie vurderede virkningen af Humira 40 mg hver anden uge/methotrexat-kombinationsterapi, Humira monoterapi 40 mg hver anden uge og methotrexat-monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira.
Danish: På trods af profylaktisk behandling mod tuberkulose er der forekommet tilfælde af reaktivering af tuberkulose hos patienter i behandling med Humira.
English: • blood in urine
Danish: • blod i urinen
English: Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Danish: d Patienter, som opfyldte protokol-specifikke kriterier for tab af respons eller ingen forbedring, udgik af studierne og blev talt som nonrespondere.
English: REMINDER STICKERS TEXT (included in pack)
Danish: PÅMINDELSESMÆRKATER (inkluderet i pakningen)
English: Turn the pre-filled pen so that the white arrow points toward the injection site.
Danish: Anbring den fyldte pen, så den hvide pil peger direkte mod injektionsstedet.
English: Some of these hepatosplenic T-cell lymphomas with Humira have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Danish: Nogle af disse hepatosplenisk T-celle lymfomer med Humira er forekommet hos unge voksne patienter i samtidig behandling med azathioprin eller 6-mercaptopurin for inflammatorisk tarmsygdom.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4).
Danish: Oftamologer rådes til at konsultere en passende specialist inden initering af behandling med Humira (se pkt.
English: Each new injection should be given at least 3 cm from the last injection site.
Danish: Hver ny injektion bør gives mindst 3 cm fra det senest anvendte injektionssted.
English: The recommended Humira dose is up to a maximum of 40 mg per dose.
Danish: Den anbefalede Humira-dosis er op til maksimalt 40 mg pr dosis.
English: In RA studies I-IV, Humira-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Danish: I RA-studie I-IV opnåede Humira-behandlede patienter statistisk signifikant ACR 20- og 50-respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
English: If you have active tuberculosis, do not use Humira.
Danish: Hvis du har aktiv tuberkulose, må du ikke tage Humira.
English: The white needle sleeve will move down over the needle and lock into place over the needle tip.
Danish: Det hvide beskyttelseshylster til kanylen vil flytte sig ned over kanylen og låses på plads lige over kanylespidsen.
English: • Do not remove the Grey or Plum-coloured Caps while allowing Humira to reach room temperature
Danish: • Fjern ikke den grå eller blommefarvede hætte, imens Humira opnår stuetemperatur
English: Humira showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to Week 12 compared to placebo.
Danish: Humira viste en statistisk signifikant større forbedring i HAQ-S total score og i SF-36 Physical Component Score (PCS) fra baseline til uge 12 sammenlignet med placebo.
English: 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 Humira and 5.4% for control treated patients.
Danish: 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 Humira, og 5,4 % for kontrolbehandlede patienter.
English: Improved physical function continued during the open label extension up to Week 136.
Danish: Den forbedrede fysiske funktion fortsatte i den åbne forlængelse frem til uge 136.
English: Tél: +33 (0) 1 45 60 13 00
Danish: AbbVie Tél: +33 (0) 1 45 60 13 00
English: • haematoma (collection of blood outside of blood vessels)
Danish: • blodansamling (ansamling af blod udenfor blodkarrerne)
English: Immunosuppressant therapy could only be discontinued at or after Week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Danish: 2 immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske respons-kriterium 3 defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: • Do not touch the needle with your fingers or let the needle touch anything
Danish: • Berør ikke kanylen med fingrene, og lad ikke kanylen røre nogen flade
English: D - 65205 Wiesbaden Germany and
Danish: D - 65205 Wiesbaden Tyskland og
English: DO NOT set the syringe down at any time.
Danish: NB: Læg IKKE sprøjten fra dig på noget tidspunkt.
English: Taking these results into consideration, Humira 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).
Danish: I betragtning af disse resultater anbefales Humira til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se pkt.
English: All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by Week 15.
Danish: Ved studiestart fik alle patienter standarddosis af prednison 60 mg/dag i 2 uger efterfulgt af en obligatorisk nedtrapningsplan med komplet seponering af kortikosteroid ved uge 15.
English: Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Danish: Administration af Humira uden methotrexat øgede antistofdannelsen og clearance og reducerede effekten af adalimumab (se pkt.
English: • It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Danish: • Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Humira under graviditeten, før dit barn får nogen vaccinationer (for mere information om vacciner, se afsnittet vedrørende ”Advarsler og forsigtighedsregler”).
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through Week 156.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev opretholdt i den åbne forlængelsesfase op til uge 156.
English: In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
Danish: I det største AS-studie I med 315 patienter, viste resultaterne statistisk signifikant forbedring af tegn og symptomer på ankyloserende spondylitis hos patienter behandlet med Humira sammenlignet med placebo.
English: With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Danish: Tryk på den blommefarvede knap i toppen med din pegefinger eller tommelfinger, når du er klar til at begynde injektionen (se nedenfor).
English: • new onset or worsening of psoriasis
Danish: • nye udbrud eller forværring af psoriasis
English: Your doctor may prescribe another strength of Humira if you need a different dose.
Danish: Din læge kan ordinere en anden styrke af Humira, hvis du har brug for en anden dosis.
English: In CD Study III, 854 patients received open-label 80 mg at Week 0 and 40 mg at Week 2.
Danish: I CD-studie III fik 854 patienter open-label 80 mg i uge 0 og 40 mg i uge 2.
English: The conduct and results of these tests should be recorded on your child's Patient Reminder Card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit barns patientkort.
English: Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Humira kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Humira is recommended for use in combination with methotrexate.
Danish: Humira anbefales anvendt sammen med methotrexat.
English: • cancer that affects the lymph system;
Danish: • kræft, der rammer lymfesystemet;
English: • Choose a site on your thigh or stomach.
Danish: • Vælg et sted på lår eller mave.
English: Press the plum activator button and count slowly for 15 seconds.
Danish: Tryk på den blommefarvede aktiveringsknap og tæl langsomt i 15 sekunder.
English: Should treatment be interrupted, Humira may be re-introduced as appropriate.
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Humira efter behov.
English: You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.
Danish: Du skal registrere den dato, hvor injektionssprøjten først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres.
English: After 12 weeks of therapy, patients who had received Humira in Period A were re-randomised in Period B to 1 of 3 treatment groups (Humira 40 mg every week, Humira 40 mg every other week, or placebo from Week 12 to Week 35).
Danish: Efter 12 ugers behandling blev patienterne, som havde fået Humira i periode A, randomiseret på ny i periode B til 1 af 3 behandlingsgrupper (Humira 40 mg hver uge, Humira 40 mg hver anden uge eller placebo fra uge 12 til uge 35).
English: The Humira pre-filled pen is a single-use grey and plum-coloured pen which contains a glass syringe with Humira.
Danish: Humira fyldt pen er en grå- og blommefarvet engangspen, som indeholder en glassprøjte med Humira.
English: Demyelinating disease
Danish: Demyeliserende sygdom
English: The safety and efficacy of Humira in children aged 4-17 years have been established for plaque psoriasis.
Danish: Humiras sikkerhed og virkning hos børn i alderen 4-17 år er fastlagt plaque-psoriasis.
English: • high blood sugar
Danish: • højt blodsukker
English: At Week 16, a statistically significantly greater proportion of patients who received Humira 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]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik Humira, 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]).
English: Mark your calendar with the stickers provided to remind you of the date for your next dose.
Danish: Humira Sæt de vedlagte mærkater ind i din kalender som en påmindelse om tidspunktet for næste dosis.
English: The safety profile for patients with uveitis treated with Humira every other week was consistent with the known safety profile of Humira.
Danish: Sikkerhedsprofilen hos patienter med uveitis, som behandles med Humira hver anden uge, var den samme som den kendte sikkerhedsprofil for Humira.
English: N/A N/A *** p < 0.001 for all comparisons between Humira and placebo * p < 0.05 for all comparisons between Humira and placebo N/A not applicable
Danish: N/A N/A *** p<0,001 for alle sammenligninger mellem Humira og placebo * p<0,05 for alle sammenligninger mellem Humira og placebo N/A ikke relevant
English: Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil.
Danish: Hold den fyldte injektionssprøjte med den ene hånd mellem tommel- og pegefingrene, som du holder en blyant.
English: Surgery or dental procedure
Danish: Kirurgi eller tandbehandling
English: a Partial Remission ASDAS
Danish: ASASa Delvis Remission
English: The syringe must be protected from light, and discarded if not used within the 14-day period.
Danish: Injektionssprøjten skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden.
English: At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy.
Danish: I uge 52 opnåede 42,9% af patienterne, som fik Humira/methotrexat-kombinationsterapi, klinisk remission (DAS28 < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexat-monoterapi og 23,4% af patienterne, som fik Humira-monoterapi.
English: Humira/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Humira monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Humira/methotrexat-kombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p<0,001) og Humira-monoterapi (p<0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: Humira has not been studied in patients aged less than 2 years.
Danish: Humira er ikke undersøgt hos patienter under 2 år.
English: NA NA 4.5% 23.2% RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks 40 mg Humira administered every other week MTX = methotrexate **p < 0.01, Humira versus placebo
Danish: NA NA 4,5% 23,2% a RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg Humira givet hver anden uge c MTX = methotrexat **p < 0,01, Humira over for placebo
English: The incidence of serious infections was 0.04 per patient year in Humira treated patients and 0.03 per patient year in placebo and active control − treated patients.
Danish: Incidensen af alvorlige infektioner var 0,04 pr. patientår hos Humira-behandlede patienter og 0,03 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: Cases of worsening congestive heart failure have also been reported in patients receiving Humira.
Danish: Tilfælde af forværret hjerteinsufficiens er også rapporteret for patienter i behandling med Humira.
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with Humira 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Danish: Patienter, som opnåede vedvarende remission i mindst 12 uger (N=305) (ASDAS < 1,3 ved uge 16, 20, 24, og 28) i den åbne periode, blev herefter randomiseret til at modtage enten fortsat behandling med Humira 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studie varighed 68 uger).