FrancophonIA/ELRC3.0 huggingface dataset:
English: Quality of life and physical function
Danish: Livskvalitet og fysisk funktion
English: The decision to stop using Hefiya should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Hefiya skal diskuteres med din læge.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske præparater skal navn og batchnummeret for det administrerede præparat registreres tydeligt.
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt at informere lægen, hvis du nogensinde selv har haft tuberkulose, eller hvis du har været i tæt kontakt med nogen, som havde tuberkulose.
English: • The recommended injection site is the front of your thighs.
Danish: • Anbefalet injektionssted er på forsiden af dine lår.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomized design.
Danish: Fortolkningen af data kan være påvirket af studiets metodoligiske begrænsninger, inklusive lille prøvegruppe og ikke-randomiseret design.
English: System Organ Class
Danish: Systemorganklasser
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4 % of the eyes at week 78.
Danish: BCVA blev enten forbedret eller vedligeholdt (<5 forringelse i forhold til bogstaver) i 88,4 % af øjnene i uge 78.
English: This indicates the injection is almost complete.
Danish: Det indikerer, at injektionen næsten er færdig.
English: Autoimmune processes
Danish: Autoimmune processer
English: RA study III also had a primary endpoint of changes in quality of life.
Danish: RA-studie III havde også et primært endepunkt, som var ændringer i livskvalitet.
English: 88 and 189 patients, respectively, continued to be in clinical remission.
Danish: Henholdsvis 88 og 189 patienter forsatte med at være i klinisk remission.
English: Overall, 20 subjects were treated for 60 weeks or longer.
Danish: Samlet set blev 20 patienter behandlet i 60 uger eller længere.
English: Clinical results were assessed for induction of remission at week 8 and for maintenance of remission at week 52.
Danish: De kliniske resultater blev vurderet for induktion af remission i uge 8 og for vedligeholdelse af remission i uge 52.
English: Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.
Danish: Tuberkulose kan udvikles under behandlingen, også selv om du har fået forebyggende behandling mod tuberkulose.
English: The primary endpoint was ‘time to treatment failure'.
Danish: Det primære endepunkt var ”tid til behandlingssvigt”.
English: Adalimumab Δ Censored
Danish: Adalimumab Δ Censoreret
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Danish: • Der var ifølge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået adalimumab under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået adalimumab.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Concomitant stable doses of one non-biologic immunosuppressant were permitted.
Danish: Samtidige faste doser af ikke-biologiske immunsuppressiva var tilladt.
English: Clinical efficacy and safety
Danish: Klinisk virkning og sikkerhed
English: • if you have moderate or severe heart failure.
Danish: • hvis du lider af moderat eller alvorlig hjerteinsufficiens.
English: b 2-sided p value from log rank test.
Danish: b 2-sidet p-værdi fra log rank test.
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Danish: Klinisk respons (CR-100) blev fastholdt hos henholdsvis 102 og 233 patienter.
English: Contact your doctor if the green indicator is not visible.
Danish: Kontakt din læge, hvis du ikke kan se den grønne indikator.
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Danish: Klinisk remission (defineret som Mayo-score ≤ 2 med ingen subscore > 1) blev vurderet i uge 8.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Danish: Psoriasis formodes at være forårsaget af et problem med kroppens immunsystem, som fører til øget produktion af hudceller.
English: No other disease-modifying anti-rheumatic drugs were allowed.
Danish: Ingen andre sygdomsmodificerende antireumatiske lægemidler blev tilladt.
English: Subjects may also have previously lost response or been intolerant to infliximab.
Danish: Patienterne kunne også tidligere have mistet respons eller have været intolerante over for infliximab.
English: Place the following items on a clean, flat surface.
Danish: Læg følgende ting på et rent og fladt underlag.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Consequently, these infants may be at increased risk for infection.
Danish: Derfor kan disse spædbørn have en øget risiko for infektion.
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Danish: Søg straks lægehjælp, hvis du får følgende tegn på en allergisk reaktion eller hjerteinsufficiens:
English: See “8.
Danish: Se ”8.
English: Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.
Danish: De fleste tuberkulosetilfælde forekom inden for de første otte måneder efter behandlingens påbegyndelse og kan skyldes udbrud af latent sygdom.
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Danish: 19,3% af patienterne fortsatte med baseline oral antibiotikabehandling under studiet.
English: Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests.
Danish: Nogle bivirkninger, som er set med adalimumab har ikke symptomer og kan kun opdages ved blodprøver.
English: Hospitalisation or fatal outcomes associated with infections have been reported.
Danish: Der er rapporteret om indlæggelse eller letale udfald associeret med infektioner.
English: Particular attention regarding the risk for infection should be paid when treating the elderly.
Danish: Der bør udvises særlig opmærksomhed på risiko for infektioner ved behandling af ældre patienter.
English: TIME (WEEKS)
Danish: Tiden (UGER)
English: Not included in your carton are (see Figure B):
Danish: Følgende er ikke inkluderet i din pakning (se Figur B):
English: • severe allergic reaction with shock;
Danish: • alvorlig allergisk reaktion med shock
English: • On rare occasions, treatment with Hefiya could result in lupus-like syndrome.
Danish: • I sjældne tilfælde kan behandling med Hefiya resultere i lupus-lignende syndrom.
English: Component of a multipack, cannot be sold separately.
Danish: Del af en multipakning, kan ikke sælges separat.
English: N/A
Danish: N/A N/A
English: b patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders.
Danish: b patienter, som opfyldte protokol-specifikke kriterier for tab af respons eller ingen forbedring, udgik af studierne og blev talt som non-respondere.
English: without MTX
Danish: uden MTX
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: If re-treatment with adalimumab is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med adalimumab er indiceret, bør ovenstående vejledning for dosering og behandlingsvarighed følges.
English: Figure H).
Danish: (se Figur H).
English: The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.
Danish: De estimerede eksponeringer indikerer, at induktionsdosis i fravær af methotrexat kan føre til en initial stigning i systemisk eksponering.
English: The primary endpoint was the birth prevalence of major birth defects.
Danish: Det primære endepunkt var prævalensen i forekomst af fødsler med større misdannelser.
English: Serious haematological, neurological and autoimmune reactions have also been reported.
Danish: Der er også rapporteret om alvorlige hæmatologiske, neurologiske og autoimmune reaktioner.
English: Hefiya can also be given alone.
Danish: Hefiya kan også anvendes alene.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and / or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of these medications.
Danish: Samtidige faste doser af aminosalicylater, kortikosteroider og/eller immunmodulerende midler var tilladt, og 80 % af patienterne fortsatte med at få mindst et af disse lægemidler.
English: There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Danish: Det kan være nødvendigt at afbryde behandlingen, for eksempel før operation, eller hvis der forekommer alvorlige infektioner.
English: • It is important to tell your doctor if you have had or have a serious heart condition.
Danish: • Det er vigtigt at informere lægen, hvis du har eller har haft en alvorlig hjertesygdom.
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Hefiya.
Danish: Opbevar patientkortet på dig under din behandling og i 4 måneder efter din (eller dit barns) sidste injektion af Hefiya.
English: Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Danish: Manglende respons på behandling for Crohns sygdom kan være tegn på tilstedeværelse af en fikseret fibrotisk striktur, som kan kræve kirurgisk behandling.
English: • Look at the expiration date (EXP) on your pen.
Danish: • Kontroller udløbsdatoen (EXP) på din pen.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Danish: TNF-antagonister, såsom adalimumab påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: In all situations described below, the benefit / risk balance of therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor skal balancen mellem fordele/ulemper ved behandling tages meget nøje i betragtning.
English: None of these patients experienced rebound during the withdrawal period.
Danish: Ingen af disse patienter oplevede rebound-effekt i den behandlingsfri periode.
English: disease flares at the end of 32 weeksa (n/N)
Danish: opblussen af sygdom i slutningen af de 32 ugera (n/N)
English: The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Danish: Adalimumabs sikkerhed og virkning hos børn i alderen 4-17 år er endnu ikke fastlagt.
English: Very common
Danish: Meget almindelig
English: • The green indicator shows the progress of the injection.
Danish: • Den grønne indikator viser, hvordan injektionen skrider frem.
English: Figure G: hold your pen
Danish: Figur G: hold din pen
English: You may first be given other medicines.
Danish: Du kan blive tilbudt anden medicin først.
English: The potential risk with the combination of azathioprine or 6mercaptopurine and Hefiya should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6-mercaptopurin og Hefiya bør nøje overvejes.
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl din læge, hvis du har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: Most patients continued on adalimumab after the infection resolved.
Danish: De fleste patienter fortsatte med adalimumab, efter infektionen var overstået.
English: 117 / 276 patients from CD study I and 272 / 777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Danish: 117/276 patienter fra CD-studie I og 272/777 patienter fra CD-studie II og III blev fulgt gennem mindst 3 års åben-label adalimumab-behandling.
English: You may cover the injection site with a small adhesive bandage, if needed.
Danish: Du kan dække injektionsstedet med et lille plaster, hvis det er nødvendigt.
English: analysis
Danish: analyse
English: Your injection You must read this before injecting
Danish: Din injektion Læs dette, før du injicerer
English: Your doctor may decide to stop treatment.
Danish: Din læge kan eventuelt beslutte at afbryde behandlingen.
English: STATEMENT OF ACTIVE SUBSTANCE
Danish: ANGIVELSE AF AKTIVT STOF
English: Hepatitis reactivation of hepatitis B1) autoimmune hepatitis1)
Danish: Hepatit reaktivering af hepatitis B1) autoimmun hepatit1)
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64 %.
Danish: Den gennemsnitlige absolutte biotilgængelighed af adalimumab, estimeret ud fra tre studier efter en enkelt 40 mg subkutan dosis, var 64%.
English: Touching them may cause the needle guard to be activated too early.
Danish: Hvis du rører ved dem, kan kanylebeskyttelsen blive aktiveret for tidligt.
English: UNITED STATES
Danish: USA
English: Neurological events
Danish: Neurologiske tilfælde
English: Travel / recurrent infection
Danish: Rejse/gentagne infektioner
English: Hefiya in combination with methotrexate, is indicated for:
Danish: Hefiya i kombination med methotrexat er indiceret til:
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Danish: Hvis der er mistanke om latent tuberkulose, bør en læge med ekspertise i behandling af tuberkulose konsulteres.
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-infektion blive livstruende.
English: It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Danish: Det er vigtigt at informere lægen, hvis du har eller har haft en alvorlig hjertesygdom (se ”Advarsler og forsigtighedsregler”).
English: Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Danish: Adalimumab binder specifikt til TNF og neutraliserer dennes biologiske funktion ved at blokere dens interaktion med celleoverflade-TNF-receptorerne p55 og p75.
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Danish: Samtidig administration af biologiske DMARDs eller TNF-antagonister
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Danish: Reaktioner ved injektionsstedet gjorde det normalt ikke nødvendigt at indstille behandlingen med lægemidlet.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Hefiya.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med Hefiya.
English: >32 weeks
Danish: > 32 uger
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1 % to 1 % of the maternal serum level.
Danish: Begrænset information i offentliggjort litteratur indikerer, at adalimumab udskilles i brystmælk i meget lave koncentrationer med en tilstedeværelse af adalimumab i human brystmælk i koncentrationer på 0,1 % til 1 % af det maternale serumniveau.
English: During the injection you will hear 2 loud clicks: o The 1st click indicates that the injection has started.
Danish: Mens du injicerer, vil du høre 2 høje klik: o Det første klik betyder, at injektionen er begyndt.
English: If you have COPD, or 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: No effects on the breastfed newborns / infants are anticipated.
Danish: Der forventes ingen effekt hos den/det brysternærede nyfødte/spædbarn.
English: Your symptoms may return upon stopping treatment.
Danish: Dine symptomer kan komme igen efter ophør af behandlingen.
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 % respectively.
Danish: Den tilsvarende andel af patienter uden radiografisk progression var henholdsvis 31,3 %, 23,7 % og 36,7 %.
English: A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an openlabel extension study.
Danish: I alt 347 stabile respondenter deltog i en evaluering af behandlingsafbrydelse og genbehandling i et åbent forlængelsesstudie.
English: Radiographic changes were assessed in the psoriatic arthritis studies.
Danish: De radiografiske forandringer blev evalueret i psoriasisartrit-studierne.
English: • Use your pen within 5 minutes of removing the cap.
Danish: • Brug pennen inden for 5 minutter efter, at du har fjernet hætten.
English: The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Danish: Patienterne i HS-I- og HS-II-studierne havde sygdommen i Hurley-stadie II eller III med mindst 3 abscesser eller inflammatoriske noduli.
English: Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Danish: Patienter med klinisk respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde klinisk respons ved uge 4.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev vurderet ved brug af HAQ-S og SF-36 spørgeskemaer.
English: You should continue to inject Hefiya for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Hefiya så længe, din læge har fortalt dig.
English: Serious infections
Danish: Alvorlige infektioner
English: • Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Danish: • Hold stemplet presset helt ned, mens du holder sprøjten stille i 5 sekunder.
English: 13 to 17 years
Danish: 13-17 år
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Danish: I alt blev 19 forsøgspersoner, heraf 11 fra baseline-aldersgruppen 4 til 12 år og 8 fra baseline-aldersgruppen 13 til 17 år, behandlet i 6 år eller mere.
English: Impaired lung function may increase the risk for developing infections.
Danish: Nedsat lungefunktion kan øge risikoen for udvikling af infektioner.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Danish: 4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudie inklusive data fra spontane rapporter
English: Some cases have had a fatal outcome.
Danish: Nogle tilfælde havde et letalt udfald.
English: • If you are over 65 years you may be more susceptible to infections while taking Hefiya.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Hefiya.
English: o Several seconds later a 2nd click will indicate that the injection is almost finished.
Danish: o Flere sekunder senere vil det andet klik betyde, at injektionen næsten er færdig.
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: Hefiya is a biosimilar medicinal product.
Danish: Hefiya er et biosimilært lægemiddel.
English: • Check the green indicator fills the window and has stopped moving (see Figure I).
Danish: • Kontroller, at den grønne indikator fylder vinduet og er holdt op med at bevæge sig (se Figur I).
English: The response for the two monotherapy arms was similar (p = 0.447).
Danish: Responset i de to monoterapi-arme var ens (p=0,447).
English: Hypersensitivity, allergies (including seasonal allergy)
Danish: Hypersensitivitet, allergier (inklusive sæsonbestemt allergi)
English: No dose adjustment is required.
Danish: Dosisjustering er ikke nødvendig.
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Danish: Rapporterne indeholder tilfælde af lungetuberkulose og ekstra-pulmonal (f.eks. dissemineret) tuberkulose.
English: Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply).
Danish: Passende screeningsundersøgelser (dvs. tuberkulinhudtest og røntgen af thorax) bør foretages hos alle patienter (i henhold til lokale anbefalinger).
English: Mean exposure in all adalimumab population was 762 days.
Danish: Den gennemsnitlige eksponering hos alle adalimumab-patienter var 762 dage.
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 screeningstest (f.eks. røntgenundersøgelse af lunger og en tuberkulintest).
English: • new onset or worsening of psoriasis;
Danish: • nye udbrud eller forværring af psoriasis
English: Approximately 40 % of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Danish: Omkring 40 % af patienterne i UC-studie II havde tidligere haft mislykket anti-TNF-behandling med infliximab.