FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be tested for HBV infection before initiating treatment with Hulio.
Danish: Patienter bør testes for HBV-infektion inden behandling med Hulio.
English: Tuberculosis can develop during therapy even if your child have had preventative treatment for tuberculosis.
Danish: Tuberkulose kan udvikles under behandlingen, også selvom dit barn har fået forebyggende behandling mod tuberkulose.
English: Usually, Hulio is used with methotrexate.
Danish: Normalt gives Hulio sammen med methotrexat.
English: For storage information, see the package leaflet.
Danish: For information vedrørende opbevaring, se indlægssedlen.
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: Treatment with Hulio must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Hulio skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hulio.
Danish: Det anbefales, at børn, om muligt, får alle planlagte vaccinationer for deres alder, inden de begynder behandling med Hulio.
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: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Danish: RA-studie III og V havde yderligere primære endepunkter ved uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hulio (see section 4.4).
Danish: Oftamologer rådes til at konsultere en passende specialist inden initiering af behandling med Hulio (se pkt.
English: Injection site reaction (including injection site erythema)
Danish: Meget almindelig Reaktioner på injektionsstedet (inklusive erytem på injektionsstedet)
English: After proper training in injection technique, patients may self-inject with Hulio if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere Hulio, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.
Danish: Tuberkulose kan udvikles under behandlingen, også selvom du har fået forebyggende behandling mod tuberkulose.
English: • DO NOT over-tighten.
Danish: • UNDGÅ at overspænde.
English: This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
Danish: Dette vil omfatte en omhyggelig gennemgang af din sygdomshistorie og relevante screeningstest (f.eks. røntgenundersøgelse af lunger og en tuberkulintest).
English: • Throw away all other used items and empty packaging into your regular household waste.
Danish: • Alle de andre anvendte genstande kan smides ud med dit husholdningsaffald.
English: • Hulio should only be used during a pregnancy if needed.
Danish: • Hulio bør kun anvendes under graviditet, hvis det er tydeligvis nødvendigt.
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Danish: Hyppigheden af alvorlige infektioner var højere hos adalimumab-behandlede patienter over 65 år (3,7%) end hos patienter under 65 år (1,5%).
English: • new or worsening psoriasis (red, flaky skin);
Danish: • nye udbrud eller forværring af psoriasis (rød, afskallende hud);
English: • 2 alcohol pads (4)
Danish: • 2 alkoholservietter (4)
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne anført efter alvorlighedsgrad.
English: • DO NOT re-cap or touch the needle with your fingers, or let the needle touch anything.
Danish: • Du må IKKE sætte hætten på kanylen igen, røre kanylen med fingrene eller lade kanylen røre noget.
English: 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 aPædiatrisk 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: - If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: Maintenance of clinical remission was evaluated in CD Study III (CHARM).
Danish: Vedligeholdelse af klinisk remission blev undersøgt i CD-studie III (CHARM).
English: The decision to stop using Hulio should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at tage Hulio skal diskuteres med din læge.
English: Do not attempt to self-inject until you are sure that you understand how to prepare and administer the injection.
Danish: Forsøg ikke at injicere dig selv, før du er sikker på, hvordan du skal klargøre og give injektionen.
English: A single Hulio pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt Hulio fyldt injektionssprøjte eller pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: If active tuberculosis is diagnosed, Hulio therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Hulio-terapi ikke påbegyndes (se pkt.
English: Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4)
Danish: Erosionsscore 3,7 (2,7-4,7) 1,7 (1,0-2,4)
English: TIME (MONTHS)
Danish: Tid (UGER)
English: The decision to stop using Hulio should be discussed with your child's doctor.
Danish: Beslutningen om at stoppe med at tage Hulio skal diskuteres med dit barns læge.
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: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Danish: Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling før 18-års alderen), inklusive adalimumab post-marketing.
English: If your child has moderate or severe heart failure.
Danish: Hvis dit barn lider af moderat eller alvorlig hjerteinsufficiens.
English: Table 6: Undesirable Effects
Danish: Tabel 6: Bivirkninger
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Danish: Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponeringsrespons-forhold hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II med 82 voksne patienter med aktiv ankyloserende spondylitis.
English: Monosodium glutamate
Danish: Mononatriumglutamat
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hulio in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Inden start af behandling med Hulio skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negativ test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: Do not use Hulio
Danish: Brug ikke Hulio
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 administration af empirisk antimykotisk behandling til disse patienter bør foretages i samråd med en læge med ekspertise i behandling af invasive svampeinfektioner.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Danish: Disse terapier omfatter methotrexat, leflunomid, hydroxychloroquin, sulfasalazin og/eller guldsalte.
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II.
Danish: Adalimumab havde numerisk en fordel ved de fleste af underscorerne med statistisk signifikante gennemsnitlige forskelle i generelt syn, okulær smerte, nærsyn, mental sundhed og totalscore i studie UV I og for generelt syn og mental sundhed i studie UV II.
English: Multipack containing 2 (2 packs of 1) vials.
Danish: Multipakning indeholdende 2 (2 pakninger med 1) hætteglas.
English: Your doctor may prescribe another strength of Hulio if your child needs a different dose.
Danish: Din læge kan have udskrevet Hulio i en anden styrke, hvis dit barn har behov for en anden dosis.
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Danish: c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen afs sygdom defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg.
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Danish: Patienter i behandling med adalimumab havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og livskvalitetsspørgeskema ved ankyloserende spondylitis (ASQoL).
English: Your child may first be given other medicines.
Danish: Dit barn kan først blive behandlet med andre lægemidler.
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 Hulio 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 Hulio skal omgående afbrydes.
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Danish: Adalimumab nedsætter signifikant risikoen for behandlingssvigt med 75%, som vist med hazard ratio sammenlignet med placebo (HR = 0,25 [95% CI: 0,12; 0,49]).
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Hulio and is positive for antibodies against double-stranded DNA, further treatment with Hulio should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Hulio udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbeltstrenget DNA, bør der ikke gives yderligere behandling med Hulio (se pkt.
English: Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Danish: Forsøgspersoner (n=215, 54,7%), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non-respondenter i de dobbeltblindede statistiske analyser.
English: Your child should not take Hulio with medicines containing the active substances anakinra or abatacept.
Danish: Dit barn bør ikke tage Hulio sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: During treatment with Hulio, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med Hulio bør andre samtidige behandlinger (f.eks. kortikosteroider og/eller immunmodulerende midler) optimeres.
English: • In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
Danish: • Herudover er set tilfælde af ikke-melanom hudkræft hos patienter, der tager adalimumab.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Danish: • Fortæl lægen, hvis du er bærer af hepatitis B-virus (HBV), hvis du har aktiv HBV, eller hvis du tror, du kan have risiko for at få HBV.
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Danish: Blandt de patienter, som havde et respons ved uge 8, var 47% i respons, 29% var i remission, 41% havde slimhindeheling og 20% var i steroid-fri remission i > 90 dage ved uge 52.
English: • Tell your child's doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
Danish: • Fortæl lægen, hvis dit barn er bærer af hepatitis B-virus (HBV), hvis han/hun har aktiv HBV, eller hvis du tror, han/hun kan have risiko for at få HBV.
English: • Wait for the skin to dry on its own, do not blow it dry.
Danish: • Vent til at huden er tør, du må ikke puste på huden for at få den til at tørre.
English: Hulio can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: Hulio kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Danish: Disse omfatter sjældne rapporter om pancytopeni, aplastisk anæmi, centrale og perifere demyeliniseringsforstyrrelser samt rapporter om lupus, lupus-relaterede tilstande og Stevens-Johnsons syndrom.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Danish: Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • 1 needle (5)
Danish: • 1 kanyle (5)
English: Roll back any clothing that may interfere with the injection site.
Danish: Du skal fjerne eventuelt tøj, som dækker for injektionsstedet.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Hulio should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Hulio straks ophøre og egnet behandling påbegyndes.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Danish: Der blev observeret et lignede antistofrespons på den 23-valente standard pneumokok-vaccine og den trivalente influenza virus vaccine i et studie med 226 voksne individer med reumatoid artrit, som blev behandlet med adalimumab eller placebo.
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Danish: En større del af patienterne på adalimumab havde ingen opblussen af sygdommen i den dobbeltblindede periode ved sammenligning med dem på placebo (70,4% versus 47,1%, p<0,001) (Figur 1).
English: Total Sharp Score 5.7 (4.2-7.3) 3.0 (1.7-4.3)
Danish: Total Sharp Score 5,7 (4,2-7,3) 3,0 (1,7-4,3) Erosionsscore
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Danish: Længere tids behandling med adalimumab 40 mg ugentligt i 96 uger viste ingen nye sikkerhedsfund.
English: Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Danish: Plaque-psoriasis er en betændelseslignende (inflammatorisk) hudlidelse, som forårsager røde, skællende, skorpede pletter på huden dækket med sølvfarvede skæl.
English: Talk to your doctor or pharmacist before using Hulio.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Hulio.
English: After proper training, the injection can be self-administered or given by another person, for example a family member or carer.
Danish: Efter grundig oplæring kan injektionen gives af dig selv, eller den kan gives af en anden person, f.eks. et familiemedlem eller en omsorgsperson.
English: • It is important to tell your doctor if you have had or have a serious heart condition.
Danish: • Det er vigtigt at fortælle din læge, hvis du har haft eller har alvorlige problemer med hjertet.
English: Firmly push the body of the pen down against the injection site to engage the Orange Activator and begin the injection.
Danish: Tryk pennen godt ned mod injektionsstedet for at udløse den orange aktiveringsdel og begynde injektionen.
English: Steroid-free remission for ≥ 90 days a
Danish: Klinisk remission Slimhindeheling Steroid-fri remission i ≥ 90 dage a
English: Hulio may be available in other presentations depending on the individual treatment needs.
Danish: Hulio er tilgængelig i andre styrker og/eller lægemiddelformer afhængigt af individuelt behandlingsbehov.
English: Your doctor will test you for HBV. Hulio can reactivate HBV infection in people who carry this virus.
Danish: Lægen vil teste dig for HBV. Hulio kan reaktivere HBV hos mennesker, der bærer denne virus.
English: Keep this Patient Reminder Card with you or your child at all times and for 4 months after your child's last injection of Hulio.
Danish: Opbevar altid patientkortet på dig eller dit barn og i 4 måneder efter dit barns sidste injektion med Hulio.
English: 40 mg, or placebo every other week for 12 weeks.
Danish: 40 mg eller placebo hver anden uge i 12 uger.
English: • Merkel cell carcinoma (a type of skin cancer);
Danish: • Merkelcelle-karcinom (en type hudkræft);
English: 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
Danish: 2immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske respons-kriterium 3defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: - polyarticular juvenile idiopathic arthritis in children aged 2-17 years; - enthesitis-related arthritis in children aged 6-17 years; - Crohn's disease in children aged 6-17 years - plaque psoriasis in children aged 4-17 years; - hidradenitis suppurativa in adolescents aged 12-17 years; - chronic non-infectious uveitis in children aged 2-17 years affecting the front of the eye.
Danish: - polyartikulær juvenil idiopatisk artrit hos børn i alderen 2-17 år; - entesopatirelateret artrit hos børn i alderen 6-17 år; - Crohns sygdom hos børn i alderen 6-17 år; - plaque-psoriasis hos børn i alderen 4-17 år; - hidrosadenitis suppurativa hos børn i alderen 12-17 år; - kronisk ikke-infektiøs uveitis hos børn i alderen 2-17 år, der påvirker det forreste i øjet.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer);
Danish: • hepatosplenisk T-celle lymfom (en sjælden form for blodkræft);
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 Hulio 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 Hulio overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).
English: Your doctor may prescribe another strength of Hulio if you need a different dose.
Danish: Din læge kan have udskrevet Hulio i en anden styrke, hvis du har behov for en anden dosis.
English: • DO NOT touch this area again before giving the injection.
Danish: • RØR IKKE ved området igen, før du giver injektionen.
English: Physicians should exercise caution when considering the use of Hulio 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 Hulio til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.