FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Danish: Samtidig administration af adalimumab og andre biologiske DMARDs (f.eks., anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner.
English: • If your child receives Hulio during her pregnancy, her baby may have a higher risk for getting an infection.
Danish: • Hvis dit barn har fået Hulio, mens hun var gravid, kan spædbarnet have en højere risiko for at få en infektion.
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Danish: I en analyse af non-respondenter, defineret som patienter, som udgik af studiet på grund af bivirkninger eller manglende effekt, eller hvor dosis blev trappet op, var PASI 75- og PGA clear/minimal responsrater henholdsvis 69,6% og 55,7% efter yderligere 108 ugers åben behandling (i alt 160 uger).
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Danish: Blandt disse havde 154 patienter (90,6%) ACR 20-respons, 127 patienter (74,7%) ACR 50-respons og 102 patienter (60%) ACR 70-respons.
English: Check with child's doctor before receiving any vaccines.
Danish: Tal med lægen, før dit barn får nogen form for vaccine.
English: Supplies you will need:
Danish: Du skal bruge følgende:
English: Hulio 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: Hulio 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 over for NSAID.
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
Danish: Ikke almindelig Neurologiske infektioner (inklusive viral meningitis, opportunistiske infektioner og tuberkulose (inklusive kokcidioidomycose, histoplasmose og mycobakterium avium complex-infektion), bakterielle infektioner, øjeninfektioner, diverticulitis1)
English: Flip down the pink needle cover and remove the needle cap by pulling it straight up.
Danish: Pres det lyserøde kanylehus ned, og fjern kanylehætten ved at løfte den lige op.
English: Table 17: Efficacy Results at 12 weeks, HS Studies I and II
Danish: Tabel 17: Effektresultater ved uge 12, HS-Studie I og II
English: The syringe inside the pen is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Danish: Sprøjten inden i pennen er lavet af cyclic-olefin-copolymer-plastik med stempelprop (chlorobutylgummi) og en kanyle (rustfrit stål) med beskyttelseshætte (butyl/dieneblend polymer og polypropylen).
English: If you have questions, please ask your child's doctor.
Danish: Hvis du har spørgsmål, skal du tale med barnets læge.
English: The observed rate of nonmelanoma 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: 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 Hulio 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 Hulio-behandling.
English: • If you received Hulio during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du har fået Hulio, mens du var gravid, kan dit spædbarn have en højere risiko for at få en infektion.
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Danish: *** p<0,001 for alle sammenligninger mellem adalimumab og placebo * p<0,05 for alle sammenligninger mellem adalimumab og placebo N/A Ikke relevant
English: week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Danish: Resultaterne ved uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med adalimumab sammenlignet med placebo (tabel 14).
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis dit barn tager anden medicin eller har gjort det for nylig.
English: Hulio is used to treat Crohn's disease in adults, and children aged 6 to 17 years.
Danish: Hulio bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves), such as multiple sclerosis, your doctor will decide if you should receive or continue to receive Hulio.
Danish: • Hvis du har eller får demyeliniserende sygdom (en sygdom hvor det beskyttende lag omkring nerverne beskadiges), som f.eks. dissemineret sklerose, vil lægen afgøre, om du skal have eller fortsætte med at få Hulio.
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of the body.
Danish: Fortæl straks din læge, hvis du oplever ændringer i dit syn, svaghed i arme eller ben eller følelsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Danish: RA-studie I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge.
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Hulio.
Danish: Patienter, der får en dosis, der er mindre end 40 mg, bør anvende Hulio som 40 mg hætteglas.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Danish: I Studie nr-axSpA I blev adalimumab 40 mg hver anden uge vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med adalimumab og 6,5 for patienter i placeboarmen), som havde haft utilstrækkeligt respons på eller var intolerante over for ≥ 1 NSAID eller havde en kontraindikation mod NSAID.
English: Vision related effects were not numerically in favour of adalimumab for colour vision in Study UVI and for colour vision, peripheral vision and near vision in Study UV II.
Danish: For synsrelaterede effekter havde adalimumab ikke numerisk en fordel ved farvesyn i studie UV I eller ved farvesyn, langsyn og nærsyn i studie UV II.
English: • Do not give Hulio to children with enthesitis-related arthritis and Crohn's disease below the age of 6 years.
Danish: • Giv ikke Hulio til børn under 6 år med entesopatirelateret artrit og Crohns sygdom.
English: Table 21: Efficacy Results at 12 weeks, HS Studies I and II
Danish: Tabel 21: Effektresultater ved uge 12, HS-Studie I og II
English: If you accidentally inject your child Hulio more frequently than you should, call your child's doctor or pharmacist and explain that your child has been given more than required.
Danish: Hvis du ved en fejltagelse injicerer Hulio hyppigere end foreskrevet, kontakt da lægen eller apotekspersonalet og fortæl dem, at dit barn har fået for meget Hulio.
English: This risk may increase if your lung function is reduced.
Danish: Risikoen kan stige, hvis din lungefunktion er svækket.
English: No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studier med adalimumab hos pædiatriske patienter med plaque-psoriasis.
English: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Danish: Psoriasis-studie IV sammenlignede adalimumabs virkning og sikkerhed over for placebo hos 217 voksne patienter med moderat til svær neglepsoriasis.
English: Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten/blisterpakningen/æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hulio 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers (fluoropolymer-laminated butyl rubber), aluminium crimps and flip-off seals.
Danish: Hulio 40 mg injektionsvæske, opløsning i engangshætteglas (type 1-glas) med gummiprop (fluoropolymer-lamineret butylgummi), aluminiumklemmer og letaftagelig forsegling.
English: Hulio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Danish: Hulio bruges til at behandle hidrosadenitis suppurativa hos unge fra 12 år.
English: Table 18: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Danish: Tabel 18: Andel af patientera, som opnåede HiSCRb ved uge 24 og 36 efter tildeling af ny behandling ved uge 12 (fra ugentlig adalimumab)
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Danish: En signifikant større andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 17) ved uge 12.
English: Table 13: Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Danish: Effekt respons i placebokontrolleret AS-studie I Reduktion af tegn og symptomer
English: Table 22: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Danish: Tabel 22: Andel af patientera, som opnåede HiSCRb ved uge 24 og 36 efter tildeling af ny behandling ved uge 12 (fra ugentlig adalimumab)
English: Step 9 - End of injection, remove pen Pull the pen straight away from injection site.
Danish: Trin 9 - Injektionen er udført, fjern pennen Løft pennen lige op og ud fra injektionsstedet.
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Danish: Hypokaliæmi, forhøjet urinsyre, unormal blod-natrium, hypokalcæmi, hyperglykæmi, hypofosfatæmi, dehydrering
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment.
Danish: Hos voksne patienter med psoriasis var den gennemsnitlige dalkoncentration ved steady state 5 μg/ml ved monoterapibehandling med 40 mg adalimumab hver anden uge.
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Hulio for patients with polyarticular juvenile idiopathic arthritis, aged from 2 years of age is based on body weight (Table 1).
Danish: Polyartikulær juvenil idiopatisk artrit hos børn fra 2 år Den anbefalede Hulio-dosis til patienter fra 2 år med polyartikulær juvenil idiopatisk artrit er baseret på legemsvægt (tabel 1).
English: If you have mild heart failure and you are being treated with Hulio your heart failure status must be closely monitored by your doctor.
Danish: Hvis du har lettere hjerteinsufficiens og bliver behandlet med Hulio skal status for din hjerteinsufficiens følges nøje af din læge.
English: Week 36
Danish: Uge 36
English: Hulio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.
Danish: Hulio er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og pan-uveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for steroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider.
English: Step 10 - Dispose pen & cap Dispose of the used pen and cap in an approved sharps disposal container.
Danish: Trin 10 - Bortskaffelse af pen & hætte Den brugte pen og hætte lægges i en særlig kanyleboks.
English: Hulio is used to treat moderate to severe plaque psoriasis in adults.
Danish: Hulio bruges til at behandle moderat til alvorlig plaque-psoriasis hos voksne.
English: Push the plunger rod all the way down.
Danish: Skub stempelstangen helt ned.
English: Gently place the syringe on a clean, flat surface.
Danish: Læg forsigtigt sprøjten på et rent, fladt underlag.
English: Adverse Reaction activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Danish: Bivirkning blødning (inklusive forlænget aktiveret partiel tromboplastintid), positiv auto-antistoftest (inklusive dobbeltstrenget DNA-antistof), forhøjet blodlactatdehydrogenase
English: Hulio is administered every other week via subcutaneous injection.
Danish: Hulio administreres hver anden uge som subkutan injektion.
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Hulio.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør du kontakte lægen, før du begynder at bruge Hulio.
English: Alternatively, if a patient has stopped Hulio and signs and symptoms of disease recur, Hulio may be re-administered.
Danish: Alternativt, kan Hulio gen-administreres, hvis patienten er stoppet behandling med Hulio, og tegn og symptomer på sygdommen kommer igen.
English: 6 months 13.3% 65.1% 19.1% 46.0% 29.5% 63.3% 12 months
Danish: 6 måneder 13,3% 65,1% 19,1% 46,0% 29,5% 63,3% 12 måneder NA NA NA
English: If these medicines do not work well enough, your child will be given Hulio to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok, vil dit barn få Hulio til behandling af hans/hendes polyartikulære juvenile idiopatiske artrit eller entesopatirelateret artrit.
English: Children and adolescents with enthesitis-related arthritis
Danish: Børn og unge med entesopatirelateret artrit
English: • 1 alcohol swab
Danish: • 1 alkoholserviet
English: The recommended dose of Hulio for patients with ankylosing spondylitis axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Hulio til patienter med ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS og til patienter med psoriasisartrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge.
English: Hulio is used to treat rheumatoid arthritis in adults.
Danish: Hulio bruges til at behandle reumatoid artrit hos voksne.
English: CD Study II: Infliximab Experienced Patients
Danish: CD-studie II: Infliximaberfarne patienter
English: With the vial adapter still in the clear package, attach it to the vial stopper by pushing the adapter over the vial until it snaps in place.
Danish: Mens hætteglasadapteren stadig er i den klare indpakning, placeres den ovenpå hætteglassets prop og skubbes ned til den klikker på plads.
English: Partially peel open the needle package from the end closest to the yellow syringe connector.
Danish: Åbn emballagen med kanylen halvt fra enden tættest på den gule vedhæftning til sprøjten.
English: If you don't know this, STOP HERE and ask your child's doctor.
Danish: Hvis du ikke kender dosis, STOP HER og kontakt lægen for yderligere instruktioner.
English: Your doctor may recommend temporarily stopping Hulio.
Danish: Din læge kan anbefale midlertidig afbrydelse af behandling med Hulio.
English: • DO NOT inject into scars or stretch marks.
Danish: • INJICER IKKE i ar eller strækmærker.
English: Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Danish: Hulio kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig (for effektivitet ved monoterapi se pkt.
English: Each pre-filled pen is for single-use only and contains one 40 mg dose of adalimumab.
Danish: Hver fyldt pen er kun til engangsbrug og indeholder en 40 mg dosis adalimumab.
English: Adalimumab n=274 confidence interval)
Danish: Adalimumab n=274 konfidensinterv al)
English: Hulio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years, and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Hulio bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen fra 2 til 17 år og entesopatirelateret artrit hos børn og unge i alderen 6-17 år.
English: • If your child have an infection, including long-term or localised infection (for example, leg ulcer) consult your child's doctor before starting Hulio.
Danish: • Hvis dit barn har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør du kontakte lægen, før dit barn begynder at bruge Hulio.
English: The syringe is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Danish: Injektionssprøjten er lavet af cyclic-olefin-copolymer-plastik med en stempelprop (chlorobutylgummi) og en kanyle (rustfrit stål) med kanylehætte (butyl/dieneblend polymer og polypropylen).
English: Table 21: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Danish: Tabel 21: Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler
English: • If your child has or develops demyelinating disease (a disease that affects the insulating layer around the nerves), such as multiple sclerosis, your child's doctor will decide if he/she should receive or continue to receive Hulio.
Danish: • Hvis dit barn har eller får en demyeliniserende sygdom (en sygdom hvor det beskyttende lag omkring nerverne beskadiges, som f.eks. dissemineret sklerose), vil lægen afgøre, om han/hun skal have Hulio eller fortsætte med at få Hulio.
English: PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX
Danish: PGA: clear/minimalc c MTX = methotrexat b P=0,027, adalimumab 0.8 mg/kg versus MTX
English: If these medicines do not work well enough, you will be given Hulio to treat your rheumatoid arthritis.
Danish: Hvis du ikke responderer tilstrækkeligt på disse lægemidler, kan du få Hulio til behandling af din reumatoide artrit.
English: Study UV II
Danish: Studie UV II Behandling
English: • If your child is about to have surgery or dental procedures, tell your child's doctor that your child is taking Hulio.
Danish: • Hvis dit barn skal opereres eller have tandbehandling, bør du informere lægen om, at han/hun tager Hulio.
English: Tell your child's doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Danish: Fortæl straks din læge, hvis dit barn oplever ændringer i sit syn, svaghed i arme eller ben eller følelsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: • slow healing of wounds.
Danish: • langsom sårheling.
English: Hulio is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Danish: Hulio bruges til at behandle ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne.
English: Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in period B.
Danish: Patienter, som var randomiseret til placebo i periode A, blev tildelt adalimumab 40 mg hver uge i periode B.
English: • If the white plunger rod is pulled out of the syringe, discard the syringe and contact your Hulio provider for a replacement.
Danish: • Hvis du trækker det hvide stempel helt ud af sprøjten, skal du kassere sprøjten og kontakte det sted hvor du fik Hulio, for at få en ny sprøjte.
English: The blinded period was followed by an open − label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Danish: Den blindede periode blev efterfulgt af en åben periode, hvor patienterne modtog adalimumab 40 mg hver anden uge subkutant i op til yderligere 28 uger.
English: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Danish: I den åbne indkøringsfase fik alle patienter 24 mg/m2 op til maksimalt på 40 mg adalimumab hver anden uge i 16 uger.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 μg/ml for the Standard Dose group and 3.5 ± 2.2 μg/ml for the Low Dose group.
Danish: Hos patienter, som blev på deres randomiserede behandling, var den gennemsnitlige dalkoncentration (±SD) af adalimumab 9,5 ± 5,6 μg/ml for standard-dosis-gruppen og 3,5 ± 2,2 μg/ml for lav-dosisgruppen ved uge 52.
English: At a 45° angle to the injection site, use a quick, short motion and push the needle all the way into skin.
Danish: Hold sprøjten i en vinkel på 45° mod huden og pres kanylen med en hurtig, kort bevægelse helt ind i huden.