FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure-response relationship in paediatric population
Danish: Sammenhæng mellem eksponering og respons i den pædiatriske population
English: The results for the 40 mg every other week dose are summarised in table 7.
Danish: Resultaterne for 40 mg hver anden uge er opstillet i tabel 7.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hefiya treatment.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Hefiya.
English: Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Danish: Når immunglobulin G proteiner gives peroralt, sker der intestinal proteolyse, og der er meget lav biotilgængelighed.
English: • inject Hefiya 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Danish: • injicer Hefiya 15-30 minutter efter, at du har taget det ud af køleskabet for at få en mere behagelig injektion.
English: Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy.
Danish: Adalimumab kan passere placenta og findes i serum hos spædbørn født af kvinder behandlet med adalimumab under graviditeten.
English: One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Danish: Ethundrede patienter (n=100) fra det pædiatriske CD-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.
English: Of the 417 subjects included in the uncontrolled long-term extension of studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Danish: Af de 417 patienter, der indgik i den ukontrollerede langtidsforlængelse af studierne UV I og UV II, blev 46 patienter anset for ikke egnede (f.eks. udviklede komplikationer sekundært til diabetisk retinopati på grund af kataraktkirurgi eller vitrektomi) og blev udelukket fra den primære effektanalyse.
English: If you have mild heart failure and you are being treated with Hefiya, your heart failure status must be closely monitored by your doctor.
Danish: Hvis du har lettere hjerteinsufficiens og bliver behandlet med Hefiya, skal status for din hjerteinsufficiens følges nøje af din læge.
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 (SOC) 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: N failure median time to HRa CI 95 % p Value b treatment
Danish: HRa CI 95 % p Værdi b behandling
English: You can press a cotton ball or gauze over the injection site and hold it for 10 seconds.
Danish: Du kan presse en vatkugle eller et gazebind på injektionsstedet og holde det fast i 10 sekunder.
English: • Keep holding your pen firmly against your skin.
Danish: • Bliv ved med at holde pennen fast mod huden.
English: Some of those had a fatal outcome.
Danish: Nogle af disse tilfælde havde letalt udfald.
English: A single Hefiya pre-filled syringe / 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 Hefiya fyldt injektionssprøjte/fyldt pen kan opbevares ved temperaturer på op til maksimalt 25°C i en periode på op til 14 dage.
English: • Take the syringe out of the blister.
Danish: • Tag sprøjten ud af blisterkortet.
English: The impact of longterm treatment with adalimumab on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med adalimumab har på udviklingen af autoimmune sygdomme.
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 din læge, hvis du er bærer af hepatitis B-virus (HBV), hvis du har aktiv HBV-infektion eller, hvis du tror, du kan have risiko for at få HBV.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Danish: • hepatosplenisk T-cellelymfom (en sjælden form for blodkræft, som ofte er dødelig)
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikatione
English: Surgery or dental procedures
Danish: Operation eller tandbehandling
English: In the open-label extension of RA Study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Danish: I den åbne forlængelse af RA-studie III opretholdtes reduktionen i progressionshastigheden af strukturel ødelæggelse i 8 og 10 år hos en delmængde af patienterne.
English: Treatment with Hefiya may result in the formation of autoimmune antibodies.
Danish: Behandling med Hefiya kan medføre dannelse af autoimmune antistoffer.
English: This risk may increase if your lung function is reduced.
Danish: Risikoen kan stige, hvis din lungefunktion er nedsat.
English: If you have psoriasis, you should NOT inject directly into areas with psoriasis plaques.
Danish: Hvis du har psoriasis, skal du IKKE injicere direkte i områder med plaque-psoriasis.
English: failure (months)
Danish: behandlingssvigt (måneder)
English: Tuberculosis
Danish: Tuberkulose
English: clinical remission clinical response week 52
Danish: klinisk remission klinisk respons uge 52
English: With current data it is not known if adalimumab treatment influences the risk for developing dysplasia or colon cancer.
Danish: Med de nuværende data vides det ikke, om behandling med adalimumab påvirker risikoen for udvikling af dysplasi eller coloncancer.
English: Worsening of symptoms of dermatomyositis1)
Danish: Forværring af dermatomyositis-symptomer1)
English: Traceability
Danish: Sporbarhed
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Danish: Der har imidlertid også været post-marketing-rapporter om leversvigt samt mindre alvorlige leverlidelser, som kan optræde forud for leversvigt, såsom hepatit, inklusive autoimmun hepatit, hos patienter, som får adalimumab.
English: double-blind response at week 12
Danish: Dobbeltblindet respons ved uge 12
English: Before initiation of therapy with Hefiya, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Hefiya påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: • inflammations.
Danish: • inflammationer.
English: Your doctor may recommend temporarily stopping Hefiya.
Danish: Din læge kan anbefale midlertidig afbrydelse af Hefiya.
English: 40 mg every other week in combination with methotrexate
Danish: 40 mg hver anden uge i kombination med methotrexat
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Danish: Administration af levende vacciner (f.eks. BCG vaccine) til spædbørn, som har været eksponeret for adalimumab i utero, anbefales ikke i 5 måneder efter moderens sidste adalimumab-injektion under graviditeten.
English: In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
Danish: Der er ved post-marketing erfaring fra januar 2003 til december 2010, hovedsageligt hos patienter med reumatoid artrit rapporteret en hyppighed af maligniteter på cirka 2,7 pr. 1.000 patient-behandlingsår.
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hefiya and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
Danish: • Hvis du får allergiske reaktioner med symptomer som trykken for brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Hefiya, og kontakt straks lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in table 27.
Danish: Rater for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 27.
English: • In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
Danish: • Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som hjælper kroppen med at bekæmpe infektioner eller stoppe blødninger.
English: After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Danish: Efter subkutan administration af en enkelt 40 mg dosis var absorption og distribution af adalimumab langsom, og maksimal serumkoncentration blev nået omkring 5 dage efter administration.
English: • be careful not to touch the needle guard wings before use.
Danish: • passer på ikke at røre ved kanylebeskyttelsesvingerne før brug.
English: Administration of Hefiya should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af Hefiya bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: • never leave the pen unattended where others might tamper with it.
Danish: • aldrig efterlader pennen uden opsyn, hvor andre kan komme i kontakt med den.
English: 73 % of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
Danish: 73 % af patienterne i Psoriasis-studie I og II havde tidligere fået systemisk behandling eller lysbehandling.
English: • It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Danish: • Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner om din brug af Hefiya under graviditeten, før dit barn får nogen vaccinationer (for mere information om vacciner, se afsnittet vedrørende "Advarsler og forsigtighedsregler").
English: If you receive Hefiya 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 Hefiya, 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: Available data suggest that adalimumab does not worsen or cause strictures.
Danish: Foreliggende data tyder ikke på, at adalimumab forværrer eller forårsager forsnævringer.
English: 6336 Langkampfen Austria
Danish: 6336 Langkampfen Østrig
English: Before your injection Preparing the pen
Danish: Før injektion Forberedelse af pennen
English: See “4.
Danish: Se ”4.
English: Adalimumab has not been studied in these patient populations.
Danish: Adalimumab er ikke undersøgt hos disse patientpopulationer.
English: Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by week 19.
Danish: Efterfølgende fulgte patienterne en obligatorisk nedtrapningsplan med komplet seponering af kortikosteroid i uge 19.
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Danish: Den procentdel af adalimumab-behandlede patienter, der fik ACR 20-, 50- og 70-respons, var konsistent mellem RA-studie I, II og III.
English: There were no distinct differences between adalimumab-treated and untreated women for the secondary endpoints spontaneous abortions, minor birth defects, preterm delivery, birth size and serious or opportunistic infections and no stillbirths or malignancies were reported.
Danish: Der var ingen klar forskel mellem adalimumab-behandlede og ubehandlede kvinder i forhold til de sekundære endepunkter spontan abort, mindre misdannelser, for tidlig fødsel, fødselsvægt eller alvorlige eller opportunistiske infektioner, og der blev ikke rapporteret om dødsfødsler eller maligniteter.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 19).
Danish: Vurdering af neglepsoriasis inkluderede the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og the Nail Psoriasis Severity Index (NAPSI) (se tabel 19).
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before 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: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Danish: Der blev anvendt en modificeret Total Sharp-score (mTSS), som medtog distale interfalangealled (dvs. ikke identisk med den TSS, som anvendes ved reumatoid artritis).
English: Treatment with Hefiya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Hefiya bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Danish: Det primære endepunkt i RA-studie V var procentdelen af patienter, som opnåede et ACR 50-respons i uge 52.
English: • high blood pressure;
Danish: • højt blodtryk
English: Carriers of HBV who require treatment with Hefiya should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Hefiya, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: No clinical exposure data are available on the use of a loading dose in children < 6 years.
Danish: Der foreligger ingen kliniske eksponeringsdata for brugen af en induktionsdosis hos børn < 6 år.
English: Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Danish: Statistisk signifikant øgning (forbedring) fra baseline til uge 26 og 52 i Body Mass Index og højdevækst blev set i begge behandlingsgrupper.
English: Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in RA study III.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrollerede studier, som var et allerede specificeret primært endepunkt ved uge 52 i RA-studie III.
English: ≥30% reduction in skin painb
Danish: ≥30% reduktion af hudsmerterb
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Danish: • autoimmun hepatit (leverbetændelse forårsaget af kroppens eget immunsystem)
English: Check with your doctor before you receive any vaccines.
Danish: Tal med lægen, før du får nogen form for vaccine.
English: Radiographic response
Danish: Radiografisk respons
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Danish: I RA-studie III opretholdt de fleste af de patienter, der opnåede forbedringer i fysisk funktion og fortsatte behandlingen, forbedring gennem 520 uger (120 måneder) med åben behandling.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Danish: Et statistisk signifikant fald i værdierne for træthed, målt ved funktionel vurdering af kronisk sygdomsbehandling (FACIT), blev set i alle tre studier (RA-studie I, III, IV).
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Danish: Der er en forøget baggrundsrisiko for lymfomer og leukæmi hos patienter med reumatoid artrit med længerevarende, højaktiv, inflammatorisk sygdom, hvilket komplicerer risikoestimeringen.
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNF-α was seen.
Danish: Hos patienter med Crohns sygdom sås en reduktion i antallet af celler med ekspression af inflammatoriske markører i colon, inklusive en betydelig reduktion i antallet af celler med TNFα ekspression.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)*
English: Taking these results into consideration, Hefiya is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Danish: I betragtning af disse resultater anbefales Hefiya til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se afsnit 4.2).
English: • do not use the pen if either the seal on the outer carton or the safety seal on the pen is broken.
Danish: • ikke bruger pennen, hvis enten forseglingen på den ydre emballage eller sikkerhedsforseglingen på pennen er itu.
English: • The 1st click indicates the injection has started.
Danish: • Det første klik betyder, at injektionen er begyndt.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer og leukæmi (kræfttyper, som påvirker blodlegemer og knoglemarv).
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see tables 17 and 18).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se Tabel 17 og 18).
English: Keep Hefiya and all medicines out of the reach of children.
Danish: Hefiya og andre lægemidler skal opbevares uden for børns rækkevidde.
English: Figure D: needle guard is activated - do not use o In this configuration the needle guard is
Danish: Figur D: kanylebeskyttelse er aktiveret - brug den ikke o I denne konfiguration er kanylebeskyttelsen IKKE
English: Treatment with Hefiya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Hefiya kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: 10 6250 Kundl Austria
Danish: 10 6250 Kundl Østrig
English: During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Danish: I den behandlingsfri periode vendte psoriasissymptomer tilbage over tid med en gennemsnitstid til tilbagefald (fald til PGA “moderat” eller værre) på omkring 5 måneder.
English: OTHER SPECIAL WARNING, IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84 % continued to show no radiographic progression through 144 weeks of treatment.
Danish: Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n=102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
English: • unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
Danish: • usædvanlige infektioner (som inkluderer tuberkulose og andre infektioner), som forekommer, når modstandskraften mod sygdom er nedsat
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.452.73) with RA and CD combined.
Danish: Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95% KI 0,45-2,73) for RA og CD kombineret.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Danish: I studie UC-II resulterede behandling med adalimumab i forbedringer i score i det tarmsygdomsspecifikke spørgeskema (IBDQ).
English: Injection site reaction (including injection site erythema)
Danish: Reaktioner på injektionsstedet (inklusive erytem på injektionsstedet)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TEXT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERTEKST
English: • allergic reactions (including seasonal allergy);
Danish: • allergiske reaktioner (inklusive sæsonbestemt allergi)
English: The first received placebo injections every week for 52 weeks.
Danish: Den første fik placeboinjektioner hver uge i 52 uger.
English: If you accidentally inject Hefiya more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Danish: Hvis du ved en fejltagelse injicerer Hefiya hyppigere end forskrevet af lægen eller apotekspersonalet, kontakt lægen eller apotekspersonalet og forklar, at du har taget mere medicin end nødvendigt.
English: Tell your doctor as soon as possible, if you notice any of the following:
Danish: Kontakt lægen så hurtigt som muligt, hvis du får følgende symptomer:
English: Patients treated with adalimumab had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Danish: Patienter i behandling med adalimumab havde signifikant lavere risiko for opblussen af sygdom i de første 12 ugers behandling.
English: • You may see a few drops of liquid come out of the needle.
Danish: • Måske ser du et par dråber væske komme ud af kanylen.
English: Lupus-like syndrome1)
Danish: Lupus-lignende syndrom1)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER