FrancophonIA/ELRC3.0 huggingface dataset:
English: urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhydrosis, alopecia 1),
Danish: urticaria, tendens til blå mærker (inklusive purpura), dermatitis (inklusive eksem), onychoclasis, hyperhidrose, alopeci1),
English: Other medicines and Hulio
Danish: Brug af anden medicin sammen med Hulio
English: Should treatment be interrupted, Hulio 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Hulio 40 mg hver uge eller 80 mg hver anden uge (se pkt.
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Hulio and during treatment with Hulio.
Danish: - Lægen vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på, før dit barn begynder at tage Hulio og under dit barns behandling med Hulio.
English: Note: Treatment failure at or after week 6 (Study UV I), or at or after week 2 (Study UV II), was counted as event.
Danish: Note: Behandlingssvigt ved eller efter uge 6 (Studie UV I) eller ved eller efter uge 2 (Studie UV II) blev talt med som hændelser.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Hulio.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med Hulio udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: Note: P = Placebo (Number at Risk); H = adalimumab (Number at Risk).
Danish: Note: P = Placebo (Antal med risiko); H = adalimumab (Antal med risiko).
English: All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52.
Danish: Alle doser/skemaer for adalimumab i alle fire studier viste statistisk signifikant større forbedring ifølge HAQ's fysiske funktionsevneindeks fra baseline til 6. måned sammenlignet med placebo, og i RA-studie III blev det samme set ved uge 52.
English: Seek medical attention urgently if you develop any of the following signs of allergic reaction or heart failure:
Danish: Søg omgående lægehjælp, hvis du får et eller flere af følgende symptomer på en allergisk reaktion eller nedsat hjertefunktion:
English: confidence interval)
Danish: konfidensint erval)
English: Hulio is used to treat Crohn's disease in children aged 6 to 17 years.
Danish: Hulio er beregnet til behandling af Crohns sygdom hos børn i alderen 6-17 år.
English: • DO NOT rub the injection site.
Danish: • GNID IKKE på injektionsstedet.
English: Table 18: Ps Study II (CHAMPION) Efficacy Results at 16 weeks
Danish: Tabel 18: Ps-studie II (CHAMPION) Effektresultater ved uge 16
English: • Hulio can be used during breast-feeding.
Danish: • Hulio kan anvendes under amning.
English: • Do not give Hulio to children with polyarticular juvenile idiopathic arthritis and chronic non infectious uveitis below the age of 2 years.
Danish: • Giv ikke Hulio til børn under 2 år med polyartikulær juvenil idiopatisk artrit og kronisk ikke infektiøs uveitis.
English: - If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Danish: - Hvis du har en alvorlig infektion, herunder aktiv tuberkulose (se ”Advarsler og forsigtighedsregler”).
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Danish: Hyppigheden af graviditeter, som blev afsluttet med mindst et levende født spædbarn med en større misdannelse var 6/69 (8,7%) hos de adalimumabbehandlede kvinder med RA og 5/74 (6,8%) hos de ubehandlede kvinder med RA (ukorrigerede OR 1,31; 95% CI 0,38-4,52) og 16/152 (10,5%) hos de adalimumab-behandlede kvinder med CD og 3/32 (9,4%) hos ubehandlede kvinder med CD (ukorrigerede OR 1,14; 95% CI 0,31-4,16).
English: Your symptoms may return upon stopping treatment.
Danish: Dine symptomer kan komme igen, efter du er stoppet med behandlingen.
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Danish: Blandt patienter, som fik seponeret adalimumab-behandlingen ved uge 12 i studie HS-I og HS-II, var HiSCR-raten 12 uger efter genoptagelse af behandling med adalimumab 40 mg ugentlig tilbage på samme niveau som før behandlingsafbrydelsen (56,0%).
English: Hulio is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Hulio kontraindiceres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: Hulio Dose for Paediatric Patients with Crohn's disease
Danish: Hulio-dosis til pædiatriske patienter med Crohns sygdom
English: Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Hulio har vist sig at hæmme udviklingen af leddestruktion bedømt ved måling med røntgen og at forbedre den fysiske funktion, når det gives i kombination med methotrexat.
English: In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Danish: I Psoriasis-studie I oplevede 28% af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo ved uge 33, “tab af tilstrækkeligt respons” (PASI-score efter uge 33 og ved eller før uge 52, som resulterede i et <PASI 50-respons i forhold til baseline med en stigning på minimum 6 point i PASI-score i forhold til uge 33), sammenlignet med 5%, som fortsatte på adalimumab (p< 0,001).
English: Step 3 - Partially open syringe and needle packaging Partially peel open the syringe package from the end closest to the white plunger rod.
Danish: Trin 3 - Åbn pakningen med sprøjte og kanyle halvt Åbn emballagen med sprøjten halvt fra enden tættest på den hvide stempelstang.
English: The conduct and results of these tests should be recorded on child's Patient Reminder Card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit barns patientkort.
English: Step 6 - Place pen
Danish: Trin 6 Placér pennen
English: • vertigo (sensation of the room spinning);
Danish: • vertigo (fornemmelse af svimmelhed og af at snurre rundt);
English: INFORMATION IN BRAILLE Hulio 40 mg/0.8 ml
Danish: INFORMATION I BRAILLE-SKRIFT Hulio 40 mg/0,8 ml
English: Injecting Hulio
Danish: Injektion af Hulio
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Danish: Det primære endepunkt var den procentvise ændring i antallet af led med aktiv artrit (hævelse, som ikke skyldes deformitet, eller led med tab af bevægelse plus smerte og/eller ømhed) fra baseline til uge 12, som blev opnået med et mediant fald på -62,6% (median procentvise ændring -88,9%) hos patienter i adalimumab-gruppen sammenlignet med et fald på -11,6% (median procentvise ændring -50,0%) hos patienter i placebogruppen.
English: • lung diseases causing shortness of breath (including inflammation);
Danish: • lungesygdom som forårsager staktåndethed (inklusive inflammation);
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating adalimumab therapy.
Danish: Før behandling med adalimumab påbegyndes, anbefales det, hvis det er muligt, at bringe pædiatriske patienter ajour med alle immuniseringer i overensstemmelse med gældende immuniseringsvejledninger.
English: Follow the steps below carefully each time you inject Hulio:
Danish: Du skal nøje følge nedenstående trin, hver gang du injicerer Hulio:
English: It is important to tell your doctor if your child has had or have a serious heart condition (see “Warnings and precautions”).
Danish: Det er vigtigt at informere lægen, hvis dit barn har eller har haft en alvorlig hjertesygdom (se ”Advarsler og forsigtighedsregler”).
English: Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Danish: Patienterne blev herefter genbehandlet med adalimumab 0,8 mg/kg hver anden uge i yderligere 16 uger, og responsraterne, som blev observeret under genbehandlingen, var sammenlignelige med responsraterne i den tidligere dobbeltblindede periode: PASI 75-respons på 78,9% (15 ud af 19 forsøgspersoner) og PGA clear eller minimal på 52,6% (10 ud af 19 forsøgspersoner).
English: Table 26: Paediatric CD Study PCDAI Clinical Remission and Response
Danish: Tabel 26: Pædiatrisk Cd-studie PCDAI klinisk remission og respons
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2 - <4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Danish: Adalimumabs sikkerhed og virkning blev vurderet i et åben-label, multicenter studie med 32 børn (2<4 år gamle eller 4 år og derover med en vægt < 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
English: • DO NOT remove the needle cap until you are ready to inject.
Danish: • FJERN IKKE kanylehætten, før du er klar til at injicere.
English: Peel the clear plastic just far enough to expose the white plunger rod, but DO NOT take the syringe out of the package.
Danish: Åbn det klare plast lige akkurat nok til, at den hvide stempelstang kommer til syne, men TAG IKKE sprøjten ud af pakningen.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISKE AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hulio injection.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste injektion med Hulio.
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 adalimumab /methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab 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 Total Sharp Score ≤ 0,5) signifikant højere med adalimumab/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p < 0,001) og adalimumab-monoterapi (henholdsvis 50,7%, p < 0,002 og 44,5%, p < 0,001).
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% vs. 9% respectively, p=0.031) and study UC-II (17% vs. 9% respectively, p=0.019).
Danish: I forhold til placebo opnåede en statistisk signifikant større procentdel af de patienter, der blev induceret med 160/80 mg adalimumab, klinisk remission ved uge 8 (studie UC-I: henholdsvis 18% og 9%, p=0,031; studie UC-II: henholdsvis 17% og 9%, p=0,019).
English: You may first be given other medicines.
Danish: Du vil blive tilbudt anden medicin først.
English: Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive the injection.
Danish: Vælg et roligt område med et veloplyst, rent og plant underlag og læg de ting frem, som du skal bruge for at give dig selv injektionen.
English: Step 7 - Begin injection Step 8 - Hold down for 2nd “CLICK” & 10 seconds
Danish: Trin 7 - Begynd injektionen Trin 8 Tryk ned mod huden i 10 sekunder, og indtil du hører 2 klik
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Danish: Alle p-værdier er parvise sammenligninger af andelene for adalimumab vs. placebo * p < 0,001 ** p < 0,01
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Danish: * p < 0,001 for adalimumab versus placebo parvise sammenligninger af andelene ** p < 0,02 for adalimumab versus placebo parvise sammenligninger af andelene a Af dem, som fik kortikosteroider ved baseline
English: Hulio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Hulio er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: When needed (for example when you are travelling), a single Hulio pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan en enkelt Hulio fyldt injektionssprøjte opbevares ved stuetemperatur (op til 25°C) i en periode på højst 14 dage - vær sikker på at beskytte den mod lys.
English: Wash your hands thoroughly with soap and water.
Danish: Trin 2: Vask hænder Vask hænderne grundigt med vand og sæbe.
English: • If you are about to have surgery or dental procedures, tell your doctor that you are taking Hulio.
Danish: • Hvis du skal opereres eller have tandbehandling, bør du informere din læge om, at du tager Hulio.
English: Placebo/MTXAdalimumab /MTX (95% Confidence Intervalb)
Danish: Placebo/MTXAdalimumab /MTX (95% konfidensintervalb)
English: • DO NOT hold the syringe by the white plunger rod.
Danish: • HOLD IKKE på den hvide stempelstang.
English: Push the plunger rod gently in until the syringe contains the prescribed amount.
Danish: Skub stempelstangen forsigtigt ned, indtil sprøjten indeholder den ordinerede mængde.
English: • abnormal muscle breakdown;
Danish: • unormal nedbrydning af musklerne;
English: Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
Danish: Når injektionssprøjten er taget ud af køleskabet og opbevaret ved stuetemperatur, skal injektionssprøjten bruges inden for 14 dage eller kasseres, også selvom den lægges tilbage i køleskabet.
English: On rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab.
Danish: I sjældne tilfælde er der set en ikke almindelig og alvorlig type af lymfom hos patienter, som tog adalimumab.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Danish: Der er forekommet reaktivering af hepatitis B hos kroniske bærere af denne virus, som fik en TNFantagonist herunder adalimumab (dvs. overflade-antigen-positive patienter).
English: fungal infections, joint infections);
Danish: svampeinfektion, ledinfektioner);
English: Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day).
Danish: To uger senere (Dag 29) fortsættes med en dosis på 40 mg hver uge eller 80 mg hver anden uge (givet som to injektioner á 40 mg på en dag).
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Danish: aPatienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling.
English: • Do not give Hulio to children with hidradenitis suppurativa below the age of 12 years.
Danish: • Giv ikke Hulio til børn under 12 år med hidrosadenitis suppurativa.
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Danish: Adalimumabs sikkerhed og virkning blev vurderet i to randomiserede dobbeltblindede, placebokontrollerede studier hos patienter med non-radiografisk aksial spondyloartritis (nr-axSpA).
English: Clear or slightly opalescent, colourless to pale brownish-yellow solution.
Danish: Klar eller lettere opaliserende, farveløs til lys brungullig opløsning.
English: Peel the clear plastic just far enough to expose the yellow connector, but DO NOT take the needle out of the package.
Danish: Åbn det klare plast lige akkurat nok til, at den gule vedhæftning kommer til syne, men TAG IKKE kanylen ud af pakningen.
English: In paediatric uveitis, there is no experience in the treatment with Hulio without concomitant treatment with methotrexate.
Danish: Der er ingen erfaring ved behandling med Hulio uden samtidig behandling med methotrexat ved pædiatrisk uveitis.
English: Thereafter, the usual dose is 20 mg every other week.
Danish: Herefter er den sædvanlige dosis 20 mg hver anden uge.
English: If your child develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of feet), you must contact your child's doctor immediately.
Danish: Hvis dit barn udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f.eks. stakåndethed eller hævede fødder), skal du kontakte barnets læge øjeblikkeligt.
English: Each Hulio single vial box will contain:
Danish: En æske med et Hulio-hætteglas indeholder:
English: At week 52, 42.9% of patients who received adalimumab/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 adalimumab monotherapy.
Danish: Ved uge 52 opnåede 42,9% af patienterne, som fik adalimumab/methotrexat-kombinationsterapi, klinisk remission (DAS28(CRP) < 2,6) sammenlignet med 20,6% af patienterne, som fik methotrexatmonoterapi og 23,4% af patienterne, som fik adalimumab-monoterapi.
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
Danish: 506 (62,2)b a Procent af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p<0,001, adalimumab versus placebo
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Danish: I de kontrollerede dele af de pivotale adalimumab-studier med voksne af mindst 12 ugers varighed hos patienter med moderat til svær aktiv reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS, psoriasisartrit, psoriasis, hidrosadenitis suppurativa, Crohns sygdom, colitis ulcerosa og uveitis blev der observeret maligniteter, fraset lymfomer eller ikke-melanom hudkræft, med en hyppighed (95% konfidensinterval) på 6,8 (4,4; 10,5) pr. 1.000 patientår blandt 5.291 adalimumab-behandlede patienter mod en hyppighed på 6,3 (3,4; 11,8) pr. 1.000 patientår blandt 3.444 kontrolpatienter (gennemsnitlig varighed af behandlingen var 4,0 måneder for adalimumab og 3,8 måneder for de kontrol-behandlede patienter).
English: Erosion score
Danish: Erosionsscore
English: • nerve damage;
Danish: • beskadigelse af nerver;
English: • DO NOT throw the sharps container in your household bin.
Danish: • Du må IKKE smide kanyleboksen i dit husholdningsaffald.
English: • DO NOT use the pen if the needle cap is missing or not securely attached.
Danish: • BRUG IKKE pennen, hvis kanylehætten mangler eller ikke sidder ordentligt fast.
English: If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash, do not inject more Hulio and contact your doctor immediately since, in rare cases, these reactions can be life-threatening.
Danish: Hvis du får allergiske reaktioner med symptomer såsom trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Hulio, og kontakt straks lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Danish: Der er endvidere rapporteret melanom- og Merkelcelle karcinom hos patienter i behandling med TNF-antagonister inklusive adalimumab (se pkt.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Danish: Disse infektioner kan være alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter, bakterier eller andre usædvanlige infektioner og sepsis (blodforgiftning), som i sjældne tilfælde kan være livstruende.
English: Hulio 40 mg solution for injection in pre-filled pen EU/1/18/1319/004
Danish: Hulio 40 mg injektionsvæske, opløsning i fyldt pen EU/1/18/1319/004
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Danish: I studie UC-II var 21/41 (51%) af de adalimumab-behandlede patienter, der var i remission ved uge 8, også i remission ved uge 52.
English: Week 104 56.0% 49.3%
Danish: Uge 104 56,0% 49,3%
English: The recommended Hulio induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Danish: Det anbefalede Hulio induktions-dosis-regime til voksne patienter med moderat til svær aktiv Crohns sygdom er 80 mg ved uge 0 efterfulgt af 40 mg ved uge 2.
English: Table 19: Ps Study IV Efficacy Results at 16, 26 and 52 weeks
Danish: Tabel 19: Ps-studie IV Effektresultater ved uge 16, 26 og 52