FrancophonIA/ELRC3.0 huggingface dataset:
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 Idacio 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 Idacio overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Idacio and is positive for antibodies against double-stranded DNA, further treatment with Idacio should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Idacio 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 Idacio (se pkt.
English: If you receive Idacio while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Idacio, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Idacio therapy, your doctor may decide to give Idacio 40 mg every week or 80 mg every other week.
Danish: Hvis du har rheumatoid artrit og ikke får methotrexat sammen med din Idacio behandling, kan din læge beslutte at give Idacio 40 mg hver uge eller 80 mg hver anden uge.
English: Cerebrovascular accident1), tremor, neuropathy
Danish: Cerebrovaskulært attak1),tremor, neuropati
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Danish: Adalimumab-dosis hos disse patienter er fastlagt ud fra farmakokinetiske modeller og simulering (se pkt.
English: Physicians should exercise caution when considering the use of Idacio 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 Idacio til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
Danish: PGA: clear/minimalc a MTX = methotrexat b P=0,027, adalimumab 0,8 mg/kg versus MTX c P=0,083, adalimumab 0,8 mg/kg versus MTX
English: • Idacio pre-filled syringe has a clear needle guard that covers the needle after the injection is complete.
Danish: • Idacio fyldt injektionssprøjte har en gennemsigtig kanylebeskyttelse, der dækker kanylen, når injektionen er udført.
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 to uger fortsættes med en dosis på 40 mg hver uge eller 80 mg hver anden uge som foreskrevet af din læge.
English: A patient who requires surgery while on Idacio 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 Idacio, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: In rheumatoid arthritis, methotrexate is continued while using Idacio.
Danish: Ved rheumatoid artrit kan du fortsætte med methotrexat, imens du bruger Idacio.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Danish: Sammenlignet med placebo blev der ved uge 12 påvist større forbedringer i forhold til baseline i hudspecifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), globale patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
English: A 40 mg pre-filled syringe and a 40 mg pre-filled pen are also available for use.
Danish: En 40 mg fyldt injektionssprøjte og en 40 mg fyldt pen er også tilgængelig til brug.
English: Idacio 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: Idacio 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: * P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients.
Danish: * p < 0,05, ***p < 0,001, adalimumab versus placebo a Blandt alle randomiserede patienter.
English: Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Idacio kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: • Do not use an Idacio pre-filled pen that has been frozen or left in direct sunlight.
Danish: • Du må ikke bruge en Idacio fyldt pen, der har været frossen eller har ligget i direkte sollys.
English: • The Idacio pre-filled pen comes as a ready to use single-use pre-filled pen to give a full dose of adalimumab.
Danish: • Idacio fyldt pen er en engangspen, som er klar til brug og giver en fuld dosis adalimumab.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Idacio (see section 4.4).
Danish: Oftamologer rådes til at konsultere en passende specialist inden initering af behandling med Idacio (se pkt.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Idacio in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for sygdomsfremkaldende bakterier eller virusser og bør ikke gives under behandling med Idacio i tilfælde af, at de giver infektioner.
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: Idacio can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Idacio kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), kortikosteroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: • Certain vaccines contain living but weakened forms of bacteria or disease-causing bacteria or viruses and should not be given during treatment with Idacio in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for bakterier eller sygdomsfremkaldende bakterier eller virusser og bør ikke gives under behandling med Idacio i tilfælde af, at de giver infektioner.
English: cAnkylosing Spondylitis Disease Activity Score dPartial 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: Idacio is used to treat:
Danish: Idacio bruges til at behandle
English: Corticosteroids or other medicines that influence the immune system may be continued while using Idacio.
Danish: Du kan fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, imens du tager Idacio.
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Danish: Kolecystit og cholelithiasis, hepatisk steatose, forhøjet bilirubin
English: What Idacio contains
Danish: Idacio indeholder
English: Age or body weight
Danish: Alder eller vægt
English: Idacio can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Danish: Idacio kan nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre de fysiske funktioner.
English: If your child takes Idacio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når dit barn tager Idacio, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: When Idacio 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 Idacio 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: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Idacio cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle lymfom hos patienter, der bliver behandlet med Idacio kan ikke udelukkes (se pkt.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check your child for signs and symptoms of tuberculosis before starting Idacio.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil din læge undersøge dit barn for tegn og symptomer på tuberkulose, før behandling med Idacio påbegyndes.
English: Based on the observed data approach, 216 (80.3%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 178 (66.2 %) were in steroid-free quiescence.
Danish: Baseret på anvendelse af observerede data var 216 (80,3%) inaktive (ingen aktive inflammatoriske læsioner, AC cell grade ≤ 0,5+, VH grad ≤ 0,5+) med en samtidig steroiddosis ≤ 7,5 mg pr. dag og 178 (66,2% ) var både steroidfri og inaktive.
English: ASASa,b 20 ASASa,b 40
Danish: ASASa,b 20
English: Idacio may have a minor influence on the ability to drive and use machines.
Danish: Idacio kan have en mindre påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: 1.1 Remove the Idacio Vial Kit from the refrigerator.
Danish: Tag Idacio hætteglassættet ud af køleskabet.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Idacio.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil din læge undersøge dig for tegn og symptomer på tuberkulose, før behandling med Idacio påbegyndes.
English: Idacio is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: Idacio bruges til at behandle børn fra 2 år med kronisk ikke-infektiøs uveitis med inflammation, som påvirker forreste del af øjet.
English: Usually, Idacio is used with methotrexate.
Danish: Normalt gives Idacio sammen med methotrexat.
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Danish: • tegn og symptomer på infektion, såsom feber, kvalme, sår, tandproblemer, smerter ved vandladning, følelse af svaghed eller træthed eller hoste
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Danish: Adalimumabs sikkerhed og virkning blev undersøgt i randomiserede, dobbeltblinde, placebokontrollerede studier og et åbent forlængelsesstudie hos voksne patienter med moderat til svær hidrosadenitis suppurativa (HS), som var intolerante, havde en kontraindikation eller et utilstrækkeligt respons på mindst 3 månders forsøg med systemisk antibiotikabehandling.
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 Idacio 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 Idacio skal omgående afbrydes.
English: It is important that you tell your baby's doctors and other health care professionals about your Idacio use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Idacio under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: INFORMATION IN BRAILLE Idacio 40 mg/0.8 mL
Danish: INFORMATION I BRAILLE-SKRIFT Idacio 40 mg/0,8 ml
English: If you take Idacio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager Idacio, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: > 32 weeks 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Danish: 14 uger a Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebobehandlede patienter b p = 0,015 c p = 0,031
English: Keep this patient reminder card with you during your treatment and for 4 months after your (or your child's) last injection of Idacio.
Danish: Opbevar patientkortet på dig i løbet af din behandling og i 4 måneder efter din (eller dit barns) sidste injektion med Idacio.
English: Axial spondyloarthritis without radiographic evidence of AS Idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Danish: Aksial spondyloartritis uden radiografiske tegn på AS Idacio er indiceret til behandling af voksne med alvorlig aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation ved forhøjet CRP og/eller MRI, som ikke har responderet tilstrækkeligt på eller er intolerante overfor NSAID.
English: - Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before you are given Idacio and during treatment with Idacio.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Idacio.
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centeradjusted 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: Figure D Put it on a clean flat surface.
Danish: Figur D Læg den på en ren, plan flade.
English: If these medicines do not work well enough, you will be given Idacio.
Danish: Hvis denne medicin ikke virker godt nok, vil du blive tilbudt Idacio.
English: By Week 68, patients receiving continuous Idacio 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: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Idacio treatment.
Danish: Kvinder i den fertile alder bør overveje at anvende passende prævention for at forebygge graviditet og fortsætte med at anvende prævention i mindst fem måneder efter den sidste Idacio-behandling.
English: 2.2 Check the label on the vial for Idacio and expiration date.
Danish: 2.2 Tjek, at der står Idacio på hætteglassets etiket, og tjek udløbsdatoen.
English: Other medicines and Idacio
Danish: Brug af anden medicin sammen med Idacio
English: If you have mild heart failure and you are being treated with Idacio, your heart failure status must be closely monitored by your doctor.
Danish: Hvis du har lettere hjerteinsufficiens og bliver behandlet med Idacio, skal status for din hjerteinsufficiens følges nøje af din læge.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome) 1)
Danish: Multipel sklerose, demyeliniserende sygdomme (f.eks. opticus neuritis, Guillain-Barré syndrom) 1)
English: Methotrexate should be continued during treatment with Idacio.
Danish: Der fortsættes med methotrexat under behandling med Idacio.
English: Week 36 a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Danish: Uge 24 Uge 36 a Patienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling.
English: • Do not give Idacio to children with polyarticular juvenile idiopathic arthritis below the age of 2
Danish: • Giv ikke Idacio til børn under 2 år med polyartikulær juvenil idiopatisk artrit.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Idacio.
Danish: I overensstemmelse med klinisk praksis kan samtidig steroidbehandling nedtrappes med start to uger efter initiering af Idacio-behandling.
English: CI 95% for HRa p Value b
Danish: CI 95% for HRa
English: ASASa partial remission ASDASc inactive disease Partial flared aAssessment of SpondyloArthritis international Society bBaseline is defined as open label baseline when patients have active disease.
Danish: Delvis opblussen af sygdomd a Assessment of SpondyloArthritis international Society b Baseline er defineret som åben periode baseline, når patienterne har aktiv sygdom.
English: Idacio 40 mg solution for injection in pre-filled pen EU/1/19/1356/003
Danish: Idacio 40 mg injektionsvæske, opløsning i fyldt pen EU/1/19/1356/003
English: Thus additional caution should be exercised in considering Idacio treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med Idacio overvejes til sådanne patienter (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 Idacio and during treatment with Idacio.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under dit barns behandling med Idacio.
English: SPARCCh MRI sacroiliac jointsd,i SPARCC MRI spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Danish: SPARCC MRI rygsøjlend,j a Assessments of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo og adalimumab j n=82 placebo og n=85 adalimumab ***, **, * Statistisk signifikant ved henholdvis p < 0,001, < 0,01 og < 0,05 for alle sammenligninger mellem adalimumab og placebo.
English: The Idacio pre-filled pen contains a pre-filled syringe with Idacio.
Danish: Idacio fyldt pen indeholder en fyldt injektionssprøjte med Idacio.
English: Idacio is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Danish: Idacio kan anvendes til behandling af Crohns sygdom hos børn i alderen 6 til 17 år.
English: If your child has mild heart failure and is being treated with Idacio, his/her heart failure status must be closely monitored by your doctor.
Danish: Hvis dit barn har lettere hjerteinsufficiens og bliver behandlet med Idacio, skal status for hans/hendes hjerteinsufficiens følges nøje af din læge.
English: Tell your doctor if your child is taking azathioprine or mercaptopurine with Idacio.
Danish: Fortæl din læge, hvis dit barn får lægemidlerne azathioprin eller mercaptopurin sammen med Idacio.
English: Idacio can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: Idacio kan også anvendes til behandling af alvorlig aktiv og progressiv reumatoid artrit, der ikke tidligere er behandlet med methotrexat.
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Idacio.
Danish: • Hvis du skal opereres eller have tandbehandling, skal du fortælle din læge, at du tager Idacio.
English: OTHER For single use only
Danish: ANDET Kun til engangsbrug
English: Idacio is injected under the skin (subcutaneous use).
Danish: Idacio injiceres under huden (subkutan anvendelse).
English: Idacio is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Idacio kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Danish: Hepatosplenisk T-celle-lymfom, Merkelcelle karcinom (neuroendokrint karcinom)1)
English: Should treatment be interrupted, Idacio may be re-introduced as appropriate.
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Idacio efter behov.