FrancophonIA/ELRC3.0 huggingface dataset:
English: This risk may increase if your child lung function is reduced.
Danish: Risikoen kan stige, hvis dit barns lungefunktion er svækket.
English: • If you have psoriasis, DO NOT inject into any raised, thick, red, or scaly skin patches, or lesions.
Danish: • Hvis du har psoriasis, MÅ DU IKKE injicere i hævede, fortykkede, røde eller skallende pletter eller læsioner.
English: Hulio contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Danish: Hulio indeholder det aktive stof adalimumab og er en medicin, som virker på kroppens immunsystem.
English: It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Danish: Sygdommen påvirker oftest bestemte områder af huden, såsom under brystet, i armhulerne, på indersiden af lårene, i lyskeområdet og på balderne.
English: DO NOT pull the white plunger rod completely out of the syringe.
Danish: Træk IKKE det hvide stempel helt ud af sprøjten.
English: 1 pre-filled pen
Danish: • 1 fyldt pen
English: Ask your doctor or nurse if there is anything you do not understand.
Danish: Spørg lægen eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: Hydrochloric acid (for pH-adjustment)
Danish: Saltsyre (til pH-justering)
English: Study nr-axSpA II was a treatment withdrawal study in nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Danish: Studie nr-axSpA II var et behandlingsseponerings-studie hos patienter med aktiv nr-axSpA, som opnåede remission i den åbne periode af behandlingen med adalimumab.
English: The active ingredient in Hulio, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Hulio, adalimumab, er et humant monoklonalt antistof.
English: In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Danish: I sjældne tilfælde, specielt hvis dit barn tager anden medicin, der undertrykker immunsystemet, kan reaktivering af HBV være livstruende.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet indeholdende adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt.
English: If the needle did not retract, carefully place the used syringe into a sharps container to avoid injury.
Danish: Hvis kanylen ikke trækker sig tilbage, skal du forsigtigt lægge den i en kanyleboks, så du ikke kommer til skade.
English: If you have COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Danish: Hvis du har KOL, eller ryger meget, bør du diskutere med din læge, om behandling med en TNFα-hæmmer er passende for dig.
English: Hulio can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Danish: Hulio har vist sig at kunne nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre de fysiske funktioner.
English: Each pack is for single use only
Danish: Begge æsker er kun til engangsbrug.
English: What Hulio contains - The active substance is adalimumab.
Danish: Hulio indeholder - Aktivt stof: adalimumab.
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: INFORMATION IN BRAILLE Hulio 40 mg
Danish: INFORMATION I BRAILLE-SKRIFT Hulio 40 mg
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hulio cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle lymfom hos patienter, der bliver behandlet med Hulio kan ikke udelukkes (se pkt.
English: Also contains: monosodium glutumate, sorbitol (E420), methionine, polysorbate 80, hydrochloric acid and water for injections.
Danish: Indeholder også: mononatriumglutamat, sorbitol (E420), methionin, polysorbat 80, saltsyre og vand til injektionsvæsker.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hulio, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres latent tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med Hulio startes.
English: Medication
Danish: Medicin
English: • signs of skin cancer such as a bump or open sore that doesn't heal;
Danish: • tegn på hudkræft som f.eks. en knude eller et åbent sår, som ikke vil hele;
English: If your doctor considers that methotrexate is inappropriate, Hulio can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Hulio anvendes alene.
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitislike psoriatic arthropathy due to the small number of patients studied.
Danish: Der foreligger utilstrækkelig evidens for adalimumabs virkning hos patienter med ankyloserende spondylitis-lignende psoriasis-artropati, da kun få patienter er blevet undersøgt.
English: Keep the pen held at a 90° angle to the injection site, and with the Viewing Window visible to you.
Danish: Hold pennen i en ret vinkel på 90° mod injektionssteder, så du kan se vinduet.
English: You should not take Hulio with medicines containing the active substances anakinra or abatacept.
Danish: Du bør ikke tage Hulio sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: If there are air bubbles in the syringe, push the plunger rod all the way back in to push the solution back into the vial.
Danish: Hvis der er luftbobler i sprøjten, skal du skubbe stempelstangen helt tilbage igen for skubbe medicinen tilbage i hætteglasset.
English: Hulio may have a minor influence on your ability to drive, cycle or use machines.
Danish: Hulio kan påvirke dit barns evne til at føre motorkøretøj, cykle eller betjene maskiner i mindre grad.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY BACKING TEXT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP TEKST PÅ BAGSIDE AF BAKKEN
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/ml (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Danish: PASI 75 og PGA clear eller minimal steg med stigende adalimumab-koncentration, begge med sammenlignelig tilsyneladende EC50 på omkring 4,5 μg/ml (henholdsvis 95% CI 0,4-47,6 og 1,9
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Danish: Opportunistiske infektioner inklusive invasive fungicide infektioner, er observeret hos patienter, som modtog adalimumab.
English: • Check the viewing window to make sure the medication is at or near the Fill Marker (you may need to shake gently to see this), and the liquid is clear, colourless and has no particles.
Danish: • Kontrollér vinduet på pennen for at sikre, at medicinen er ved eller næsten ved markeringen (du skal måske ryste pennen forsigtigt for at kunne se det) og at væsken er klar, farveløs og ikke indeholder partikler.
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1), lichenoid skin reaction1)
Danish: Erythema multiforme1), Stevens-Johnsons syndrom1), angioødem1), kutan vasculitis1), lichenoid hudreaktion1)
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; HSstudie 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: 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 HBV være livstruende.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 8.5 per 1,000 patient years.
Danish: Når kontrollerede dele af disse studier og igangværende og afsluttede åbne opfølgningsstudier med en gennemsnitlig varighed på omkring 3,3, inkluderende 6.427 patienter og med over 26.439 patientårs behandling kombineres, er den observerede hyppighed af maligniteter, fraset lymfomer og ikkemelanom hudkræft, cirka 8,5 pr. 1.000 patient-år.
English: Table 1: Hulio Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Danish: Tabel 1: Hulio-dosis til patienter med polyartikulær juvenil idiopatisk artrit
English: Your child's symptoms may return upon stopping treatment.
Danish: Dit barns symptomer kan komme igen, hvis barnet stopper behandlingen.
English: Among patients who were not in response at week 4, 43% of adalimumab maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Danish: Blandt de patienter, som ikke oplevede respons ved uge 4, responderede 43% af patienterne i adalimumab-vedligeholdelsesbehandling ved uge 12 sammenlignet med 30% af patienter i placebogruppen.
English: Table 14: Ps Study I (REVEAL) - Efficacy Results at 16 weeks
Danish: Tabel 14: Ps-studie I (REVEAL) - Effektresultater ved uge 16
English: This inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Danish: Inflammationen kan føre til nedsat syn og/eller ”fluer” i øjet (sværm af uklarheder i øjet, som bevæger sig i synsfeltet).
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: This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Danish: Dette studie vurderede virkningen af adalimumab 40 mg hver anden uge/methotrexat-kombinationsterapi, adalimumab-monoterapi 40 mg hver anden uge og methotrexat-monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger.
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa Week 56
Danish: Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea Uge 56
English: • tuberculosis
Danish: • tuberculose
English: Place the Orange Activator end of the pen onto the injection site.
Danish: Placer den orange aktiveringsdel af pennen mod injektionsstedet.
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Danish: • ≥ 40 kg: 40 mg hver uge eller 80 mg hver anden uge Fortsat behandling bør overvejes nøje hos patienter, som ikke responderer inden for 12 uger.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Danish: Der kan dannes adalimumab-antistoffer under behandlingen med adalimumab.
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Danish: Blandt disse viste 40 patienter ingen progression af strukturel ødelæggelse defineret som ændring af mTSS på 0,5 eller mindre.
English: ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Danish: ***,** Statistisk signifikant med p < 0,001, < 0,01 for alle sammenligninger mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: Chronic non-infectious uveitis affecting the front of the eye
Danish: Kronisk ikke-infektiøs uveitis, der påvirker det forreste i øjet
English: If your child takes Hulio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når dit barn tager Hulio, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl det til lægen, hvis du har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: The Hulio vial is a glass vial with a rubber stopper.
Danish: Hulio hætteglasset er et hætteglas af glas med en gummiprop.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hulio.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Hulio.
English: In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
Danish: I det åbne forlængelsesstudie RA III bibeholdt de fleste af de patienter, som var ACR-respondenter, respons, når de blev fulgt i op til 10 år.
English: Hulio 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: Hulio 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: Read all of this leaflet carefully before giving your child this medicine because it contains important information for him/her.
Danish: Læs denne indlægsseddel grundigt, inden dit barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
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 ved uge 52.
English: If your child has COPD, or is a heavy smoker, you should discuss with your child's 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 barnets læge, om behandling med en TNFα-hæmmer er passende for dit barn.
English: Hulio 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: Hulio kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (f.eks. sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), kortikosteroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: 1 p value for Standard Dose versus Low Dose comparison.
Danish: Uge 52 1 p-værdi for sammenligning af standard-dosis versus lav-dosis.
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Danish: Blandt disse viste 48 patienter ingen progression af strukturel ødelæggelse defineret som ændring af mTSS på 0,5 eller mindre.
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 kolonnen med systemorganklasserne indikerer, at der findes yderligere information andre steder i pkt.
English: • Certain vaccines contain living but weakened forms of bacteria or viruses that cause diseases and should not be given during treatment with Hulio in case they cause infections.
Danish: • Nogle vacciner kan indeholde levende men svækkede former for bakterier eller virusser, som forårsager sygdomme og bør ikke gives under Hulio-behandling.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Adalimumab /MTX 40 mg every other week
Danish: Adalimumab /MTX 40 mg hver anden uge
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: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hulio.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager Hulio.
English: Should treatment be interrupted, Hulio may be re-introduced as appropriate.
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Hulio efter behov.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Danish: • sygdomme i immunsystemet som kan påvirke lungerne, huden og lymfeknuderne (viser sig oftest som sarkoidose);
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Danish: I et åbent forlængelsesstudie med patienter, hvis dosis blev trappet op fra 40 mg hver anden uge til 40 mg ugentlig på grund af PASI-respons under 50%, opnåede 26,4% (92/349) og 37,8% (132/349) af patienterne PASI 75-respons ved henholdsvis uge 12 og 24.
English: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Danish: • behandling af moderat til alvorlig aktiv reumatoid artrit hos voksne patienter, hvor responset på sygdomsmodificerende antireumatiske lægemidler, herunder methotrexat, har været utilstrækkelig.
English: o DO NOT use the pen if the medication is not near the Fill Marker.
Danish: o BRUG IKKE pennen, hvis medicinen ikke er i nærheden af markeringen.
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 Hulio and during treatment with Hulio.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på, før du begynder at tage Hulio og under din behandling med Hulio.
English: A patient who requires surgery while on Hulio 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 Hulio, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Time to Treatment Failure At or After week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab Time to Treatment Failure At or After week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab
Danish: Tid til behandlingssvigt ved eller efter uge 6 i Studie UV I Primær analyse (ITT) Placebo Adalimumab Tid til behandlingssvigt ved eller efter uge 2 i Studie UV II Primær analyse (ITT) Placebo Adalimumab
English: Table 29: Time to Treatment Failure in Studies UV I and UV II
Danish: Tabel 29: Tid til behandlingssvigt i studie UV I og UV II
English: Hidradenitis suppurativa (sometimes called ‘acne inversa') is a long-term and often painful inflammatory skin disease.
Danish: Hidrosadenitis suppurativa (kaldes somme tider svedkirtelbetændelse) er en kronisk, ofte smertefuld betændelseslignende (inflammatorisk) hudsygdom.
English: When Hulio 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 Hulio-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: • Tell your child's doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl det til lægen, hvis dit barn har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: • itching, inflammation of the skin (including eczema);
Danish: • kløe, inflammation i huden (herunder eksem);
English: Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; * p<0.05 for adalimumab vs. placebo pairwise comparison of proportions **p<0.001 for adalimumab vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Danish: Klinisk respons er fald fra baseline i Mayo score på > 3 point og > 30% samt et fald i rektal blødningsubscore [RBS] på > 1 eller en absolut RBS på 0 eller 1; * p<0,05 for adalimumab vs. placebo ved parvis sammenligning af andelene **p<0,001 for adalimumab vs. placebo ved parvis sammenligning af andelene a Af de patienter, der fik kortikosteroid ved baseline
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Hulio therapy, your doctor may decide to give you 40 mg adalimumab every week or 80 mg every other week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din Hulio-behandling, kan lægen vælge at ordinere 40 mg adalimumab hver uge eller 80 mg hver anden uge.