FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use a damaged syringe.
Danish: • Anvend ikke en beskadiget sprøjte.
English: • mood swings (including depression);
Danish: • humørsvingninger (inklusive depression);
English: Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Danish: Hidrosadenitis suppurativa (kaldes somme tider svedkirtelbetændelse) er en kronisk, ofte smertefuld betændelseslignende (inflammatorisk) hudsygdom.
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Danish: Blandt de patienter, der afbrød studiet inden uge 78, blev 11 % afbrudt på grund af bivirkninger og 5 % på grund af utilstrækkelig respons på adalimumab behandling.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
Danish: Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 26.
English: If you take off the needle cap before you are ready to inject, do not put the needle cap back on.
Danish: Hvis du tager kanylehætten af, før du er klar til at injicere, må du ikke sætte kanylehætten på igen.
English: Uncommon Erectile dysfunction
Danish: Ikke almindelig Erektil dysfunktion
English: Usually, Imraldi is used with methotrexate.
Danish: Normalt gives Imraldi sammen med methotrexat.
English: Your doctor should test you for HBV. Imraldi can reactivate HBV infection in people who carry this virus.
Danish: Lægen vil teste dig for HBV. Imraldi kan reaktivere HBV-infektion hos mennesker, der bærer denne virus.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Imraldi.
Danish: I overensstemmelse med klinisk praksis kan samtidig steroidbehandling nedtrappes med start to uger efter initiering af Imraldi-behandling.
English: At week 52, 42.9 % of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 <2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4 % of patients receiving adalimumab monotherapy.
Danish: I uge 52 opnåede 42,9 % af patienterne, som fik adalimumab/methotrexat-kombinationsterapi, klinisk remission (DAS28 < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexat-monoterapi og 23,4 % af patienterne, som fik adalimumab-monoterapi.
English: Do not remove the needle cap before you are ready to inject.
Danish: Tag ikke kanylehætten af, før du er klar til at injicere.
English: • Place the syringe on your clean work surface.
Danish: • Læg sprøjten på dit rene arbejdssted.
English: • serious infections
Danish: • alvorlige infektioner
English: Thus additional caution should be exercised in considering adalimumab treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med adalimumab overvejes til sådanne patienter (se pkt.
English: When Imraldi therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Danish: Når Imraldi-behandlingen påbegyndes kan en induktionsdosis på 40 mg til patienter < 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesdosis.
English: Your doctor will decide if you should receive Imraldi.
Danish: Din læge vil tage stilling til, om du skal have Imraldi.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at Week 96 was 65.1%.
Danish: Blandt patienter, der som minimum var delvise respondere ved uge 12, og som fik fortsat ugentlig adalimumab-behandling, var HiSCR-raten 68,3 % ved uge 48 og 65,1 % ved uge 96.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Danish: Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt 10 mg/dag).
English: • Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.
Danish: • Anvend ikke 40 mg fyldt pen, hvis der anbefales andre doser end 40 mg.
English: a
Danish: I
English: • inflammation of the skin (such as eczema);
Danish: • inflammation i huden (såsom eksem);
English: Erosion Score JSNd Score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Danish: Erosion score JSNd score a methotrexat b 95 % konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab c Baseret på ranganalyse d Ledspalteforsnævring
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: After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Danish: Efter yderligere 2 uger fortsættes med en dosis på 40 mg hver uge eller 80 mg hver anden uge, som foreskrevet af din læge.
English: Histidine hydrochloride monohydrate Sorbitol
Danish: Histidinhydrochloridmonohydrat Sorbitol
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: Fistula remission3
Danish: Remission af fistler3
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3 % on placebo and 10 % on adalimumab.
Danish: Blandt de patienter, som tidligere havde haft mislykket anti-TNF-behandling, opnåede 3 % på placebo og 10 % på adalimumab remission i uge 52.
English: • Tell your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Danish: • Fortæl lægen, hvis du har fast bopæl eller rejser i områder, hvor svampeinfektioner som histoplasmose, kokcidioidomykose eller blastomykose er endemisk.
English: Your doctor or nurse should make sure you can use your syringe correctly.
Danish: Lægen eller sygeplejersken skal sikre sig, at du kan bruge injektionssprøjten korrekt.
English: Adalimumab 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: Adalimumab 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: • When the syringe is empty, remove the needle from skin, being careful to pull it out at the same angle as when it was inserted.
Danish: • Når sprøjten er tom, trækkes kanylen ud af huden i den samme vinkel, som den blev ført ind i.
English: If you stop using Imraldi
Danish: Hvis du holder op med at bruge Imraldi
English: • angioedema (localized swelling of the skin);
Danish: • angioødem (lokal hævelse af huden);
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med sjældne hereditære problemer med fructoseintolerans.
English: Adalimumab 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: Adalimumab 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: Wait 15-30 minutes for your pre-filled syringe to reach to room temperature, which helps reduce your pain during injection.
Danish: Vent 15-30 minutter, så din fyldte injektionssprøjte kan nå stuetemperatur, hvilket kan medvirke til at reducere smerterne ved injektionen.
English: In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Danish: I sjældne tilfælde, specielt hvis du tager anden medicin, der undertrykker immunsystemet, kan reaktivering af HBVinfektion blive livstruende.
English: Uncommon Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Danish: Ikke almindelig Lymfom**, solide organ-neoplasmer (inklusive brystkræft, lungekræft og thyroideakræft), melanom**
English: • Use your other hand to flip the pink needle cover down toward the syringe.
Danish: • Brug din anden hånd til at presse den lyserøde kanylebeskyttelse ned mod sprøjten.
English: Table 6 Undesirable Effects
Danish: Tabel 6 Bivirkninger
English: • Hold the syringe at eye-level with the needle pointing up to see the amount clearly.
Danish: • Hold sprøjten med kanylen opad og i niveau med øjet for tydeligt at kunne se mængden.
English: • As cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will check your child for signs and symptoms of tuberculosis before starting Imraldi.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med Imraldi, vil lægen undersøge dit barn for tegn og symptomer på tuberkulose, før behandling med Imraldi påbegyndes.
English: • feeling weak or tired;
Danish: • følelse af svaghed eller træthed;
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 adalimumab 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 adalimumab, og 5,4 % for kontrolbehandlede patienter.
English: - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Danish: - behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke tidligere er blevet behandlet med methotrexat.
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Danish: Hidrosadenitis suppurativa hos unge (fra 12 år, som vejer 30 kg eller mere) Der er ingen kliniske studier med adalimumab hos unge patienter med hidrosadenitis suppurativa (HS).
English: Week 52 Open-label
Danish: Uge 52 Åbent
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Danish: Nioghalvfjerds (20,1 %) af patienterne blev samtidigt behandlet med sygdomsmodificerende antireumatiske lægemidler, og 37 (9,4 %) af patienterne med glukokortikoider.
English: 6) Throwing away supplies
Danish: 6) Bortskaffelse af udstyr
English: It is very important that you tell your doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt at informere lægen, hvis dit barn nogensinde har haft tuberkulose, eller hvis dit barn har været i tæt kontakt med nogen, som har haft tuberkulose.
English: EU/1/17/1216/005 1 pre-filled pen EU/1/17/1216/006 2 pre-filled pens EU/1/17/1216/007 4 pre-filled pens EU/1/17/1216/008 6 pre-filled pens
Danish: EU/1/17/1216/005 1 fyldt pen EU/1/17/1216/006 2 fyldte penne EU/1/17/1216/007 4 fyldte penne EU/1/17/1216/008 6 fyldte penne
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 20.
Danish: Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 20.
English: Your doctor will decide if your child should receive Imraldi.
Danish: Lægen vil tage stilling til, om dit barn skal have Imraldi.
English: • ankylosing spondylitis,
Danish: • ankyloserende spondylitis,
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Danish: Efter doser på 0,5 mg/kg (~ 40 mg) var clearance 11-15 ml/time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
English: Very common Injection site reaction (including injection site erythema) Common
Danish: Meget almindelig Reaktioner på injektionsstedet (inklusive erytem på injektionstedet)
English: Caring for your pre-filled pen
Danish: Behandling af din fyldte pen
English: • The syringe, needle, vial and vial adapter MUST NEVER be reused.
Danish: • Sprøjten, kanylen, hætteglassset og hætteglasadapteren må ALDRIG genbruges.
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: If you press the syringe plunger slowly, it may make your injection more comfortable.
Danish: Hvis sprøjtens stempel trykkes langsomt ind, kan det bevirke, at injektionen bliver mindre ubehagelig.
English: • vaccinations
Danish: • vaccinationer
English: Uncommon Inflammation
Danish: Ikke almindelig Inflammation
English: • Recheck the prescribed medication amount.
Danish: • Tjek den foreskrevne mængde igen.
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 adalimumab 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 adalimumab 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).
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [p = 0.014]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [p = 0,014]).
English: Not Known Worsening of symptoms of dermatomyositis1)
Danish: Forværring af dermatomyositis-symptomer1)
English: By Week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Danish: Ved uge 68, viste patienter, som fik forsat behandling med adalimumab statistisk signifikant større forbedring af tegn og symptomer på aktiv nr-axSpA sammenlignet med patienter, som blev allokeret til seponering af behandling i studiets dobbeltblindede periode (Tabel 15).
English: 506 (62.2)b a Percent of patients achieving PASI 75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
Danish: 506 (62,2)b a Procentdel af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p < 0,001; Adalimumab versus placebo
English: You will see the liquid medication from the vial go into the syringe.
Danish: Du kan se den flydende medicin blive trukket fra hætteglasset over i sprøjten.
English: • low blood measurements for calcium;
Danish: • lave blodmålinger af calcium;
English: DO NOT push the white plunger rod past the dose position.
Danish: Skub IKKE den hvide stempelstang forbi mærket for dosen.
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Imraldi.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Imraldi.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Imraldi cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle lymfom hos patienter , der bliver behandlet med Imraldi kan ikke udelukkes (se pkt.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Imraldi.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Imraldi.
English: • As cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will check you for signs and symptoms of tuberculosis before starting Imraldi.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med Imraldi, vil lægen undersøge dig for tegn og symptomer på tuberkulose, før behandling med Imraldi påbegyndes.
English: If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for your child.
Danish: Hvis dit barn har KOL eller ryger meget, bør du diskutere med din læge, om behandling med en TNFα-hæmmer er passende for dit barn.
English: • myocardial infarction;
Danish: • myokardieinfarkt;
English: Study nr-axSpA I evaluated patients with active nr-axSpA.
Danish: Studie nraxSpA I evaluerede patienter med aktiv nr-axSpA.
English: Table 28 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Danish: Tabel 28 Respons, remission og slimhindeheling i studie UC-II (Procent patienter)
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Danish: En stjerne (*) i systemorganklassekolonnen indikerer, at der findes yderligere information andre steder i pkt.
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
Danish: Den fundne hyppighed af ikke-melanom hudkræft er cirka 9,6 pr. 1.000 patientår og den fundne hyppighed af lymfomer er cirka 1,3 pr. 1.000 patientår.
English: Once removed from the refrigerator for room temperature storage, the pen must be used within 28 days or discarded, even if it is returned to the refrigerator.
Danish: Når pennen er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal pennen bruges indenfor 28 dage eller kasseres, også selv om den lægges tilbage i køleskab.
English: After 12 weeks of therapy, patients who had received adalimumab in Period A were re-randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Danish: Efter 12 ugers behandling blev patienterne, som havde fået adalimumab i periode A, randomiseret på ny i periode B til 1 af 3 behandlingsgrupper (adalimumab 40 mg hver uge, adalimumab 40 mg hver anden uge eller placebo fra uge 12 til uge 35).
English: • DO NOT set the syringe down at any time after the clear needle cap is off.
Danish: • Læg IKKE på noget tidspunkt sprøjten fra dig, når den klare kanylehætte er taget af.
English: • Push the white plunger rod all the way back in to push the liquid medication back into the vial.
Danish: • Skub den hvide stempelstang hele vejen tilbage igen for at få den flydende medicin tilbage i hætteglasset.
English: Your symptoms may return upon stopping treatment.
Danish: Dine symptomer kan komme igen, hvis du stopper behandlingen.
English: In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control.
Danish: I de pivotale kontrollerede studier med voksne og børn havde 12,9 % af de patienter, som blev behandlet med adalimumab, reaktioner ved injektionsstedet (erythem og/eller kløe, blødning, smerter eller hævelse) sammenlignet med 7,2 % af de patienter, som fik placebo eller aktiv kontrol.
English: Imraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Danish: Imraldi er i kombination med methotrexat indiceret til behandling af aktiv polyartikulær juvenil idiopatisk artrit hos patienter fra 2 år, som har haft et utilstrækkeligt respons på en eller flere sygdomsmodificerende anti-reumatiske lægemidler (DMARDs).
English: If your child takes Imraldi the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når dit barn får Imraldi, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
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 Imraldi.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med Imraldi, udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 %[123/178] and 88.8 % [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Danish: I alt 76,5 % (218/285) af de patienter, som fik genbehandling, havde et PGA-respons på eller “minimal” efter 16 ugers genbehandling, uanset om de fik tilbagefald i den behandlingsfri periode (69,1 % [123/178] for patienter, som fik tilbagefald, og 88,8 % [95/107] for patienter, som ikke fik tilbagefald).
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Danish: Diagnosticering og empirisk antimykotisk behandling af disse patienter bør foretages i samråd med en læge med ekspertise i behandling af invasive svampeinfektioner.
English: When needed (for example when you are travelling), a single Imraldi pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 28 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan en enkelt Imraldi fyldt pen opbevares ved stuetemperatur (op til 25 °C) i en periode på højst 28 dage - vær sikker på at beskytte den mod lys.
English: Very common Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Danish: Meget almindelig Luftvejsinfektioner (inklusive nedre og øvre luftvejsinfektioner, pneumoni, sinuitis, pharyngitis, nasopharyngitis og viral herpespneumoni)
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered);
Danish: • opportunistiske infektioner (som inkluderer tuberkulose og andre infektioner, som forekommer,