FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score.
Danish: I dette forsøg blev strukturel ledskade vurderet radiografisk og udtrykt som ændring i Total Sharp Score (TSS) og dets bestanddele, erosions score og score for forsnævring af ledspalter (JSN).
English: Responses were similar in patients who were or were not receiving concomitant therapies at baseline.
Danish: Responset var det samme hos patienter med og uden samtidig behandling ved baseline.
English: Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Danish: Etanercept indeholder 934 aminosyrer og har en tilsyneladende molekylevægt på ca. 150 kilodalton.
English: After cleaning, do not touch the stopper with your hands or allow it to touch any surface.
Danish: Efter rengøring må du ikke berøre proppen med fingrene eller lade den berøre nogen anden overflade.
English: If you prefer, you may alternatively use the stomach area, but make sure you choose a site at least 5 cm away from the belly button (navel).
Danish: Hvis du foretrækker det, kan du alternativt bruge maveregionen, men du skal vælge et område, der er mindst 5 cm fra navlen.
English: Needle safety shield disappears inside the pen
Danish: Sikkerhedshætten forsvinder ind i pennen
English: The side effects and their frequencies seen in children and adolescents are similar to those described above.
Danish: Bivirkninger hos børn og teenagere svarer til dem, der er beskrevet ovenfor.
English: These include rare reports of pancytopenia and very rare reports of aplastic anaemia.
Danish: Disse inkluderer sjældne rapporter om pancytopeni og meget sjældne rapporter om aplastisk anæmi.
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of LIFMIOR (10 mg, 25 mg or 50 mg).
Danish: Lægen vil beregne den rette dosis for barnet og ordinere en passende styrke af LIFMIOR (10 mg, 25 mg eller 50 mg).
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: De følgende kategorier benyttes: 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); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do NOT remove the white collar that remains on the syringe.
Danish: Fjern IKKE den hvide krave, som stadig sidder på sprøjten.
English: The safety and efficacy profiles of the two LIFMIOR treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Danish: Sikkerheds- og effektprofilerne af de to LIFMIOR behandlingsformer var sammenlignelige ved uge 8 med hensyn til effekten på tegn og symptomer ved reumatoid artrit; data fra uge 16 viste ikke sammenlignelighed (non-inferiority) mellem de to behandlingsformer.
English: Lightly pinching the skin around the injection site between the thumb and index finger of your free hand may make the injection easier and more comfortable.
Danish: • Hvis du klemmer let om huden omkring injektionsstedet mellem tommel- og pegefinger på den frie hånd, gør det injektionen lettere og mere behagelig.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Some patients have developed a reaction at an injection site that was used before.
Danish: Nogle patienter har haft en reaktion på et injektionsted, som havde været brugt før.
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Danish: Thrombocytopeni, anæmi, leukopeni, neutropeni
English: An analysis of clinical trial data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option (intermittent or continuous).
Danish: En analyse af data fra de kliniske studier afslørede ingen baseline sygdomskarakteristika, som kunne understøtte klinikerens valg af bedste dosering (intermitterende eller kontinuerlig).
English: LIFMIOR treatment may increase mortality in patients with established sepsis.
Danish: LIFMIOR behandling kan forøge dødeligheden hos patienter med etableret sepsis.
English: Mean (SE) Annualized Change from Baseline in Total Sharp Score Placebo
Danish: MIDDEL (SE) ÆNDRING FRA BASELINE I TOTAL SHARP SCORE PÅ ÅRSBASIS Placebo
English: If you feel that the effect of LIFMIOR is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af LIFMIOR er for stærk eller for svag, skal du kontakte din læge eller apotek.
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Danish: Dette studie bør omfatte en detaljeret anamnese om tuberkulose eller mulig, tidligere kontakt med tuberkulose og tidligere og/eller nuværende behandling med immunsuppressiva.
English: PASI 75, n (%)
Danish: PASI 75, n ( %) PASI 50, n ( %)
English: Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Danish: Etanercept kan også modulere biologiske reaktioner, som kontrolleres af yderligere downstream-molekyler (f.eks. cytokiner, adhesionsmolekyler eller proteinaser), som forårsages eller reguleres af TNF.
English: This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy.
Danish: Studiet viste heller ingen øget risiko for mindre alvorlige misdannelser, for tidlig fødsel, dødfødsel eller infektioner i det første år for børn, der er født af kvinder eksponeret for etanercept under graviditeten.
English: The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Danish: De observerede tal og forekomster i disse kliniske forsøg svarede til dem, der forventedes for den behandlede gruppe.
English: Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of LIFMIOR following its long-term use in patients with JIA.
Danish: Desuden er der ikke gennemført studier til vurdering af virkningen af seponering af LIFMIOR eller reduktion af den anbefalede dosis ved langvarig behandling af patienter med JIA.
English: It is recommended that you record the date that LIFMIOR is removed from the refrigerator and the date after which LIFMIOR should be discarded (no more than 4 weeks following the removal from the refrigerator).
Danish: Det anbefales, at du noterer den dato, hvor LIFMIOR tages ud af køleskabet, og den dato, hvor LIFMIOR skal kasseres (højst 4 uger efter, at det er taget ud af køleskabet).
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Danish: Indvirkning af fremskreden alder blev undersøgt i den farmakokinetiske populationsanalyse af etanerceptserumkoncentrationer.
English: Placebo N=106 to 109*
Danish: Placebo N=106 til 109*
English: Instructions for use and handling
Danish: Instruktioner vedrørende anvendelse og håndtering
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with LIFMIOR use.
Danish: Centrale og perifere demyeliniserende hændelser er blevet set henholdsvis sjældent og meget sjældent i forbindelse med brug af LIFMIOR.
English: LIFMIOR can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: LIFMIOR kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation*
Danish: Allergiske reaktioner (se Hud og subkutane væv), dannelse af autoantistoffer*
English: Please consult your doctor before you or the child receive any vaccines.
Danish: Spørg din læge, inden du eller barnet får nogen vacciner.
English: Your doctor will decide how long you should take LIFMIOR and whether retreatment is needed based on your response.
Danish: Lægen vil afgøre, hvor længe du skal tage LIFMIOR, og om gentagende behandling er nødvendig, afhængig af hvordan du reagerer på behandlingen.
English: Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age.
Danish: Clearance- og volumenvurderinger hos patienter mellem 65 og 87 år svarede til vurderinger hos patienter, som var under 65 år.
English: Patients were observed off treatment for the occurrence of rebound (PASI ≥150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Danish: Patienterne blev observeret uden behandling for at se forekomsten af rebound (PASI  150 % i forhold til baseline) og se tiden til relapse (defineret som tab af mindst halvdelen af forbedringen opnået mellem baseline og uge 24).
English: Based on current knowledge, a possible risk for the development of lymphomas, leukaemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded.
Danish: På baggrund af den nuværende viden kan en mulig risiko for udvikling af lymfomer, leukæmi eller andre hæmatopoietiske eller solide maligniteter hos patienter behandlet med en TNF-antagonist ikke udelukkes.
English: Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Danish: I studie 2 var der også en periode uden behandling, hvor patienter, som efter 24 uger havde opnået en forbedring på mindst 50 % på PASI, fik stoppet behandlingen.
English: The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria.
Danish: Resultaterne af dette kontrollerede forsøg blev angivet i procentvis forbedring af reumatoid artriti ved anvendelse af American College of Rheumatology's (ACR) kriterier for respons.
English: The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
Danish: Lægen vil give dig nøjagtige anvisninger i klargøring og afmåling af den rette dosis.
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three LIFMIOR doses.
Danish: I de første 12 uger af den dobbeltblinde behandlingsperiode fik patienterne placebo eller en af ovennævnte tre LIFMIOR doser.
English: • Remove the protective cover from the syringe tip by breaking the white cap along the perforation.
Danish: • Fjern gummibeskyttelseshætten fra sprøjtens spids ved at brække den hvide hætte af langs perforeringen.
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with LIFMIOR due to the development of neutralising antibodies in rodents.
Danish: Carcinogenitetsstudier samt standardvurderinger af fertilitet og postnatal toksicitet blev ikke udført med LIFMIOR på grund af udvikling af neutraliserende antistoffer hos gnavere.
English: With twice weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Danish: Med to ugentlige doser forventes det, at steady-state koncentrationerne er ca. to gange så høje som dem, der observeres efter enkelte doser.
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with LIFMIOR for up to 48 months.
Danish: Alvorlige infektioner forekom hos 6,3 % af patienterne med reumatoid artrit, som blev behandlet med LIFMIOR i op til 48 måneder.
English: Histiocytosis haematophagic (macrophage activation
Danish: Histiocytosis haematophagic (makrofagaktiv eringssyndrom)
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Danish: Der er en øget baggrundsrisiko for lymfom og leukæmi hos patienter med reumatoid artrit med langvarig, meget aktiv inflammatorisk sygdom, hvilket komplicerer risikovurderingen.
English: Injection advice:
Danish: Injektionsvejledning:
English: In the toxicological studies with LIFMIOR, no dose-limiting or target organ toxicity was evident.
Danish: I de toksikologiske studier med LIFMIOR var der ingen tydelig dosisbegrænsning eller målorgantoksicitet.
English: Treatment with LIFMIOR 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Danish: Behandling med LIFMIOR 25 mg resulterede i i betydelig bedring efter 12 måneder, hvor omkring 44 % af patienterne havde opnået en normal SHT score (mindre end 0,5).
English: There appears to be no correlation between antibody development and clinical response or adverse events.
Danish: Der synes ikke at være nogen sammenhæng mellem antistofdannelse og klinisk respons eller bivirkninger.
English: No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.
Danish: Der blev ikke observeret nogen klinisk betydende, farmakokinetiske lægemiddel-lægemiddelinteraktioner i studier med methotrexat, digoxin og warfarin.
English: The results are shown in the figure below.
Danish: Resultaterne er skitseret i figuren nedenfor.
English: • The needle has been placed in a plastic container to keep it sterile.
Danish: • Kanylen ligger i en plasikbeholder for at holde den steril.
English: This section is divided into the following sub-sections:
Danish: Dette afsnit er inddelt i følgende underafsnit:
English: Injection site reactions usually occurred in the first month.
Danish: Reaktioner på injektionsstedet forekom som regel i den første måned.
English: If the window is not completely purple, contact your nurse or pharmacist for assistance, since the pen may not have injected the LIFMIOR solution completely.
Danish: Hvis vinduet ikke er helt lilla, skal du spørge lægen, sygeplejersken eller apoteket om hjælp, da pennen muligvis ikke har injiceret al LIFMIOR-injektionsvæsken.
English: Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Danish: Meget af den fælles patologi inden for reumatoid artrit og ankyloserende spondylitis og hudpatologien ved plaque psoriasis formidles af pro-inflammatoriske molekyler, som er bundet i et netværk, der kontrolleres af TNF.
English: Physicians should use caution when considering combination therapy with sulfasalazine.
Danish: Læger skal være forsigtige, når de overvejer kombinationsbehandling med sulfasalazin.
English: Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC).
Danish: Klinisk respons blev udtrykt i procent af patienter, som opnåede ACR 20, 50 eller 70 respons og procenter for forbedring i Psoriatic Arthritis Respons Criteria (PsARC).
English: There have been reports of hypoglycaemia following initiation of LIFMIOR in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
Danish: Der har været indberetninger om, at hypoglykæmi er opstået, efter behandling med LIFMIOR er påbegyndt hos patienter, der får medicin mod diabetes, hvilket har nødvendiggjort en nedsættelse af dosis af den anti-diabetiske medicin hos nogle af disse patienter.
English: Alcoholic hepatitis
Danish: Alkoholisk hepatitis
English: Information in this leaflet is organised under the following 7 sections:
Danish: Oplysningerne i denne indlægsseddel er opdelt i de følgende 7 afsnit:
English: Responses observed during the open-label period were similar to those observed in the double-blind period.
Danish: Den observerede respons i den åbne studieperiode var den samme som den, der blev observeret i den dobbeltblindede periode.
English: This will help to reduce foaming (lots of bubbles) (see Diagram 8).
Danish: Det vil hjælpe med til at reducere dannelse af luftbobler (se billede 8).
English: If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose.
Danish: Hvis du ikke husker det før den dag, du skal tage den næste dosis, må du ikke tage en dobbeltdosis (to doser på samme dag) som erstatning for den glemte dosis.
English: In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: Det administrerede produkts handelsnavn og batchnummer skal registreres (eller angives) klart og tydeligt i patientjournalen.
English: In long-term (up to 34 months) open-label studies where LIFMIOR was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Danish: I åbne langtidsstudier (op til 34 måneder), hvor LIFMIOR blev givet uden afbrydelser, blev det kliniske respons opretholdt, og sikkerheden var den samme som i korttidsstudier.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating LIFMIOR therapy (see Vaccinations, above).
Danish: Det anbefales, at pædiatriske patienter om muligt bringes à jour med al immunisering i overensstemmelse med gældende retningslinjer for immunisering, før behandling med LIFMIOR påbegyndes (se Vaccinationer ovenfor).
English: You may now lift the pen from your skin (see Diagram 7).
Danish: Du kan nu tage pennen væk fra huden (se billede 7).
English: Make sure that the tip does not touch anything.
Danish: Pas på at spidsen ikke rører ved noget.
English: Another study found no increased risk of birth defects when the mother had received LIFMIOR in pregnancy.
Danish: Et andet studie fandt ingen øget risiko for misdannelser, hvis moderen havde taget LIFMIOR under graviditeten.
English: In a long-term psoriasis study in which patients received 50 mg twice weekly for 96 weeks, the incidence of antibodies observed at each assessment point was up to approximately 9%.
Danish: I et langtidsstudie med psoriasispatienter, som fik 50 mg to gange om ugen i 96 uger, var incidensen af antistoffer ved hvert bedømmelsespunkt op til ca. 9 %.
English: Hypoglycaemia in patients treated for diabetes
Danish: Hypoglykæmi hos patienter i diabetesbehandling
English: This is done by holding the collar of the white cap while grasping the end of the white cap with the other hand and bending it down and then up until it is broken (see Diagram 6).
Danish: Dette gøres ved at holde på kraven af den hvide hætte samtidig med at man tager fat om den hvide hætte med den anden hånd og bøjer den op og ned, indtil den brækker af (se billede 6).
English: Push the open end of the pen firmly against the skin, so that the needle safety shield is pushed completely inside of the pen.
Danish: Pres den åbne ende af pennen fast ned mod huden, så nålens sikkerhedshætte presses helt ind i pennen.
English: No rebound flare of disease and no psoriasis-related serious adverse events were observed.
Danish: Der blev ikke observeret nogen rebound opblussen af sygdommen og ingen psoriasis-relaterede alvorlige bivirkninger.
English: There have been reports of worsening of hepatitis C in patients receiving LIFMIOR.
Danish: Der er indberetninger om forværring af hepatitis C hos patienter i behandling med LIFMIOR.
English: Inspection window will have turned purple
Danish: Inspektionsvinduet er blevet lilla
English: Read all (both sides) of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: For adult patients, withdraw the entire volume.
Danish: Til voksne patienter trækkes al væsken ud.
English: LIFMIOR showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Danish: LIFMIOR viste en statistisk signifikant større forbedring fra baseline til uge 12 sammenlignet med placebo i de fleste helbredsrelaterede vurderinger af livskvalitet og fysisk funktion, herunder BASFIfunktionsindekset (Bath Ankylosing Spondylitis Functional Index) og EuroQol 5D-spørgeskemaerne Overall Health State Score og SF-36 Physical Component Score.
English: Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter.
Danish: Patienterne havde også plaque psoriasis med et læsionsmål på  2 cm i diameter.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of LIFMIOR, and in accordance with local recommendations.
Danish: Hvis diagnosen inaktiv (latent) tuberkulose stilles, skal behandling af latent tuberkulose påbegyndes med antituberkulosebehandling i overensstemmelse med nationale anbefalinger, før behandling med LIFMIOR påbegyndes.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of LIFMIOR.
Danish: Sådanne symptomer kan pege på tilstedeværelsen af en potentiel livstruende blodsygdom, som kan kræve, at behandling med LIFMIOR ophører.
English: PASI 50 14 58* 70 74* 77 9 PASI 75 4 34* 44 49* 59 3
Danish: PASI 50 14 58* 70 74* 77 9 64* 77* 9 69* 83
English: a. One MYCLIC pre-filled pen and one alcohol swab (take these from the carton of pens you keep in your refrigerator).
Danish: En MYCLIC fyldt pen og en alkoholserviet (tages fra æsken med penne i køleskabet).
English: Hampshire, PO9 2NG
Danish: Havant, Hampshire PO9 2NG
English: LIFMIOR did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/kg or a single intravenous dose of 1000 mg/kg.
Danish: LIFMIOR forårsagede ikke letalitet eller genkendelige tegn på toksicitet hos mus eller rotter efter en enkelt subkutan dosis på 2000 mg/kg eller en enkelt intravenøs dosis på 1000 mg/kg.
English: After a single subcutaneous dose of 25 mg LIFMIOR, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 μg/ml, and the area under the curve was 235 ± 96.6 μg•hr/ml.
Danish: Efter en enkelt subkutan dosis med 25 mg etanercept, var den gennemsnitlige maksimale serumkoncentration, som blev observeret hos sunde frivillige, 1,65 ± 0,66 g/ml, og arealet under kurven var 235 ± 96,6 g•t/ml.
English: Then continue to inject the medicine on the usual day(s).
Danish: Fortsæt dernæst med at injicere medicinen på de sædvanlige dage.
English: Studies have not been done in patients with juvenile idiopathic arthritis to assess the effects of continued LIFMIOR therapy in patients who do not respond within 3 months of initiating LIFMIOR therapy.
Danish: Der er ikke udført studier med patienter med juvenil idiopatisk artrit til evaluering af fortsat LIFMIOR-behandling til patienter, som ikke responderede inden for 3 måneder efter påbegyndelse af LIFMIOR-behandling.