FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Statistically significant increases (improvement) from Baseline to Week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Danish: Statistisk signifikant øgning (forbedring) fra baseline til uge 26 og 52 i Body Mass Index og højdevækst blev set i begge behandlingsgrupper.
English: Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of Humira and MTX compared to Humira alone.
Danish: Det samlede respons var generelt bedre og færre patienter udviklede antistoffer, når de blev behandlet med kombinationen Humira og MTX sammenlignet med Humira alene.
English: • On the front of your child's thighs or
Danish: • På forsiden af dit barns lår eller
English: 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.
Danish: 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.
English: Of those in clinical response at Week 4, 48% had been previously exposed to other TNFantagonists.
Danish: Blandt patienter med klinisk respons i uge 4 havde 48% tidligere været eksponeret for anden TNF-antagonist.
English: Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Humira, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: You will then hear a loud ‘click' as the needle is released and you will feel a small prick as the needle advances.
Danish: Du vil høre et højt 'klik', når kanylen udløses, og du vil føle et lille prik, når kanylen trænger ind.
English: Treatment with Humira 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Danish: Behandling med 40 mg Humira hver uge reducerede risikoen for forværring af abscesser og suppurerende fistler signifikant.
English: 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
Danish: 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.
English: 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
Danish: Vask hænderne grundigt Læg følgende ting på et rent underlag o En fyldt Humira-injektionssprøjte o En alkoholserviet
English: 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%).
Danish: Hyppigheden af alvorlige infektioner var højere hos Humira-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %).
English: The second received 20 mg of Humira every week for 52 weeks.
Danish: Den anden fik 20 mg Humira hver uge i 52 uger.
English: There are no clinical trials with Humira in adolescent patients with HS.
Danish: Der er ikke udført kliniske studier med Humira hos unge patienter med HS.
English: Vertigo and visual impairment may occur following administration of Humira (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Humira (se pkt 4.8).
English: Sustained Remission
Danish: Vedligeholdt remission
English: Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.
Danish: Behandling med Humira bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Humira er indiceret til.
English: • Certain vaccines may cause infections and should not be given while receiving Humira.
Danish: • Visse vacciner kan forårsage infektioner og bør ikke gives under Humira-behandling.
English: Treatment with Humira must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Humira skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: 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).
Danish: 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).
English: and
Danish: og
English: Humira/MTX 40 mg every other week
Danish: Humira/MTX 40 mg hver anden uge
English: 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.
Danish: 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.
English: • If you are over 65 years you may be more susceptible to infections while taking Humira.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Humira.
English: You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.
Danish: Du skal registrere den dato, hvor pennen først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres.
English: DO NOT RECAP as you may damage the needle inside.
Danish: SÆT IKKE HÆTTEN PÅ, da du kan beskadige kanylen indeni.
English: Keep this Patient Reminder Card with you or your child.
Danish: Opbevar patientkortet på dig eller dit barn.
English: Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
Danish: Humira er tilgængelig i andre styrker og/eller lægemiddelformer afhængigt af individuelt behandlingsbehov.
English: • severe rash, hives or other signs of allergic reaction • swollen face, hands, feet
Danish: • alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion • hævelser i ansigt, hænder eller fødder
English: 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)).
Danish: 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)).
English: 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).
Danish: 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).
English: Clinical remission Clinical response (CR-100)
Danish: Klinisk respons (CR-100)
English: The combination of Humira and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Danish: Kombination af Humira og abatacept anbefales ikke (se pkt.t 4.4 “Samtidig administration af biologiske DMARDs eller TNF-antagonister”).
English: There is a window on each side of the pen through which you can see the Humira solution inside the syringe.
Danish: Der er et vindue på hver side af pennen, gennem hvilket du kan se Humira-injektionsvæsken inden i sprøjten.
English: • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: • steroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler(NSAIDs).
English: Reports of serious allergic reactions including anaphylaxis have been received following Humira administration.
Danish: Der er modtaget rapporter om alvorlige allergiske reaktioner, inklusive anafylaksi, efter administration af Humira.
English: During treatment with Humira, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med Humira, bør andre samtidige behandlinger (f.eks., kortikosteroider og/eller immunmodulerende midler) optimeres.
English: One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study.
Danish: Ethundrede patienter (n=100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.
English: Packs of:
Danish: Pakninger af:
English: • The automatic needle guard will not activate unless all the liquid is injected
Danish: • Beskyttelseshætten aktiveres ikke automatisk med mindre al væske er injiceret
English: 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.
Danish: 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.
English: Patients receiving MTX who achieved a PASI 50 response at Week 8 and/or 12 did not receive further dose increases.
Danish: Patienter, som fik methotrexat, og som opnåede et ≥ PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning.
English: 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.
Danish: 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.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira and is positive for antibodies against double-stranded DNA, further treatment with Humira should not be given (see section
Danish: Hvis en patient efter behandling med Humira udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med Humira (se pkt.
English: Humira 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.
Danish: Humira 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.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Humira 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.
Danish: Inden start af behandling med Humira 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.
English: Use a plaster if you want to.
Danish: De kan eventuelt bruge et plaster.
English: 2) Preparing the Humira dose for injection
Danish: 2) Forberedelse af Humira-dosis til injektion
English: The injection is complete when the yellow indicator has stopped moving.
Danish: Injektionen er færdig, når den gule indikator ikke bevæger sig mere.
English: The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Danish: Humiras sikkerhed hos pædiatriske patienter med plaque-psoriasis blev vurderet i gennemsnitligt 13 måneder.
English: The Humira pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
Danish: Humira fyldt pen findes i pakninger indeholdende 1, 2, 4 og 6 fyldte penne.
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with Humira is continued following development of malignancy.
Danish: Der er ikke gennemført nogen studier med patienter, der tidligere har haft maligniteter, eller hos hvem behandling med Humira er fortsat med efterfølgende udvikling af maligniteter.
English: In patients who develop HBV reactivation, Humira should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Humira seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposureresponse 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.
Danish: Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponeringrespons-forhold hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau.
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira.
Danish: Tuberkulose, herunder reaktivering og nye tilfælde af tuberkulose er rapporteret hos patienter, der fik Humira.
English: Two patients out of 3,441 treated with Humira in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Danish: To patienter ud af 3.441, som blev behandlet med Humira i alle reumatoid artrit og psoriasisartrit-studier, udviklede kliniske tegn, der tydede på et nyopstået lupuslignende syndrom.
English: The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Danish: Humira-dosis hos disse patienter er fastlagt ud fra farmakokinetiske modeller og simulering (se pkt.
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Humira.
Danish: Hos nogle patienter, som er behandlet tilfredsstillende for aktiv tuberkulose, er aktiv tuberkulose reaktiveret, mens de har været i behandling med Humira.
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Danish: Reduktion af inflammatoriske læsioner og forebyggelse af forværring af abscesser og suppurerende fistler blev evalueret ved hjælp af ”Hidradenitis Suppurativa Clinical Response” (HiSCR; mindst 50% reduktion i det totale antal abscesser og inflammatoriske noduli og uden stigning i antallet af abscesser og suppurerende fistler i forhold til baseline).
English: ≥30% Reduction in Skin Pain
Danish: ≥30% reduktion af hudsmerterb
English: The primary endpoint in RA studies VI and VII was injection site pain immediately after injection as measured by a 0-10 cm VAS.
Danish: Det primære endepunkt i RA-studie VI og VII var smerte ved injektionsstedet umiddelbart efter injektion målt på en 0-10 cm VAS (visual analog skala).
English: • A small amount of liquid on the injection site is normal
Danish: • En lille smule væske på injektionsstedet er normalt
English: If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Humira-terapi ikke påbegyndes (se pkt.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Danish: Disse infektioner kan være alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter eller bakterier eller andre opportunistiske infektioner og sepsis, som i sjældne tilfælde kan være livstruende.
English: 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 Humira should be promptly discontinued.
Danish: 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 Humira skal omgående afbrydes.
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Danish: Patienter, som opnåede PASI 75 og PGA clear eller minimal, blev taget ud af behandling i op til 36 uger og monitoreret for tab af sygdomskontrol (dvs. forværring af PGA med mindst 2 enheder).
English: • It is normal to see a few drops of liquid come out of the needle
Danish: • Det er normalt at se nogle få dråber væske komme ud af kanylen
English: 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.
Danish: 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-respondere i de dobbeltblindede statistiske analyser.
English: With your free hand, gently grasp a sizable area of the cleaned skin at the injection site and hold firmly (see below).
Danish: Klem forsigtigt med din frie hånd om et passende område af den rensede hud på injektionsstedet, og hold fast (se nedenfor).
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with Humira, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Danish: Blandt de 68 patienter, som havde opblussen af sygdom i gruppen, som var allokeret til seponering af behandling, fuldførte 65 patienter 12 ugers rescue-behandling med Humira, ud af hvilke 37 (56,9%) genvandt remission (ASDAS < 1,3) 12 uger efter genstart af behandling i den åbne periode.
English: There is insufficient evidence of the efficacy of Humira in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Danish: Der foreligger utilstrækkelig evidens for virkningen af Humira hos patienter med ankyloserende spondylitis-lignende psoriasis-artropati, da kun få patienter er blevet undersøgt.
English: UNIQUE INDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: A greater proportion of patients on Humira had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Danish: En større del af patienterne på Humira havde ingen opblussen af sygdommen i den dobbeltblinde periode ved sammenligning med dem på placebo (70,4% versus 47,1%, p<0,001) (Figur
English: D-65205 Wiesbaden Germany and
Danish: D-65205 Wiesbaden Tyskland og
English: Keep pushing down to prevent the pre-filled pen from moving away from the skin during the injection.
Danish: Bliv ved med at trykke nedad for at forhindre den fyldte pen i at bevæge sig væk fra huden under injektionen.
English: Administration of Humira should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af Humira bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: Serious adverse reactions have been reported for Humira.
Danish: Der er rapporteret alvorlige bivirkninger for Humira.
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the Humira treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Danish: I de pivotale kontrollerede studier med voksne og børn var infektionshyppigheden 1,51 pr. patientår hos Humira-behandlede patienter og 1,46 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where Humira was given for at least an additional 108 weeks.
Danish: Patienter, som deltog i alle fase 2 og 3 psoriasis-studier, var egnede til inklusion i et åbent forlængelsesstudie, hvor Humira blev givet i mindst 108 uger yderligere.
English: Do not put either of the caps back on the pre-filled pen.
Danish: Sæt ikke nogen af hætterne tilbage på den fyldte pen.
English: Patients were randomised to receive a single dose of Humira 40 mg/0.8 ml or Humira 40 mg/0.4 ml, followed by a single injection of the opposite treatment at their next dose.
Danish: Patienterne blev randomiseret til at få en enkelt dosis Humira 40 mg/0,8 ml eller Humira 40 mg/0,4 ml, efterfulgt af en enkelt injektion med den modsatte behandling ved deres næste dosis.
English: Active tuberculosis or other severe infections such as sepsis and opportunistic infections (see section 4.4).
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se pkt.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med Humira overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).