FrancophonIA/ELRC3.0 huggingface dataset:
English: Please record the dates of the last screening for tuberculosis below: Tuberculin test: _______________ Chest X-ray:
Danish: Angiv venligst datoen for seneste tuberkulosescreening nedenfor: Tuberkulintest: _______________ Røntgenundersøgelse af lunger:
English: • Only use each pre-filled pen for one injection.
Danish: • Anvend kun hver fyldte pen til én injektion.
English: You will see a yellow indicator move into the windows during the injection.
Danish: De kan se en gul indikator bevæge sig i vinduet under injektionen.
English: • If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.
Danish: • Hvis De er allergisk (overfølsom) over for adalimumab eller et af de øvrige indholdsstoffer i Trudexa.
English: After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Danish: Efter grundig oplæring kan injektionen gives af Dem selv eller af en anden person, f.eks. et familiemedlem eller en ven.
English: In all studies (I-VII), patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Danish: I alle forsøg (I-VII) var patienter med forhøjede ALAT-værdier asymptomatiske, og i de fleste tilfælde var forhøjelserne forbigående og forsvandt ved fortsat behandling.
English: ACR response
Danish: ACR respons
English: This may cause severe allergic reactions in patients sensitive to latex.
Danish: Dette kan forårsage alvorlige allergiske reaktioner hos patienter, som er overfølsomme over for latex.
English: • Never put the pre-filled pens that you have used into your normal household rubbish bin.
Danish: • Læg aldrig brugte fyldte penne i Deres normale husholdningsaffald.
English: Since Trudexa is given subcutaneously, food and drink should not affect Trudexa.
Danish: Da Trudexa gives subkutant, burde mad og drikke ikke have nogen effekt på Trudexa.
English: Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window.
Danish: Hold den hvide ende af den fyldte pen i en ret vinkel (90 grader) mod huden, så De kan se vinduet.
English: Rare (< 1/1000)
Danish: Sjælden (< 1/1000)
English: It is not known whether adalimumab passes into breast milk.
Danish: Det vides ikke, om adalimumab passerer over i modermælken.
English: In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
Danish: I sjældne tilfælde, specielt hvis De tager anden medicin, der undertrykker immun-systemet, kan reaktivering af HBV blive livstruende.
English: Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
Danish: Data fra det åbne forlængelsesforsøg indikerer, at reduktionen i hastigheden af progression af strukturel ødelæggelse opretholdes i 60 måneder i en delmængde af patienterne.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section
Danish: Behandling længere end uge 12 resulterede ikke i signifikant flere respondere (se pkt.
English: • increased menstrual bleeding;
Danish: • forøget menstruationsblødning;
English: Rare rhabdomyolysis
Danish: Sjælden rhabdomyolysis
English: • allergic reactions;
Danish: • allergiske reaktioner;
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 79% 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 79 % af patienterne fortsatte med at modtage mindst et af disse lægemidler.
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg.
Danish: Det højeste dosisniveau, som er evalueret, har været adskillige intravenøse doser på 10 mg/kg.
English: Administration of adalimumab is not recommended during pregnancy.
Danish: Administration af adalimumab kan ikke anbefales under graviditet.
English: Concurrent administration of TNF-antagonists and anakinra
Danish: Samtidig administration af TNF antagonister og anakinra
English: If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Danish: Hvis De har KOL, eller ryger meget, bør De diskutere med Deres læge, om behandling med en TNF-hæmmer er passende for Dem.
English: Injury and poisoning
Danish: Skader, forgiftninger
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 i 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: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de forsøg og yderligere pharmacovigilance-aktiviteter, som er beskrevet i detaljer i pharmacovigilance-planen.
English: In Study III, improvement in physical function was maintained through week 260 (60 months) of open-label treatment.
Danish: I forsøg III blev forbedringer i fysisk funktion opretholdt gennem 260 uger (60 måneder) med åben behandling.
English: Please check with your doctor before you receive any vaccines.
Danish: Tal venligst med lægen, før De får nogen form for vaccine.
English: You may notice a spot of blood at the injection site.
Danish: De kan måske se en plet af blod på injektionsstedet.
English: Check the appearance of the Trudexa solution through the windows on the sides of the pre-filled pen.
Danish: Kontrollér Trudexaopløsningens udseende gennem vinduerne på siderne af den fyldte pen.
English: If you have Crohn's disease you will first be given other medicines.
Danish: Hvis De har Crohns sygdom, vil De først modtage anden medicin.
English: Trudexa is injected under the skin (subcutaneous use).
Danish: Trudexa injiceres under huden (subkutan anvendelse).
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Danish: På grund af sin TNFα-hæmmende virkning kan adalimumab administreret under graviditet påvirke normal immunrespons hos nyfødte.
English: You should not take Trudexa with medicines containing the active substance, anakinra.
Danish: De bør ikke tage Trudexa sammen med medicin, der indeholder det aktive stof anakinra.
English: • See the Trudexa package leaflet for more information.
Danish: • Se indlægssedlen til Trudexa for yderligere oplysninger.
English: • Use a new alcohol pad to clean the grey stopper on the vial.
Danish: • Anvend en ny alkoholserviet til at rengøre den grå prop på hætteglasset.
English: Using Trudexa with food and drink
Danish: Hvordan man anvender Trudexa sammen med mad og drikkevarer
English: There is a window on each side of the pen through which you can see the Trudexa solution inside the syringe.
Danish: Der er et vindue på hver side af pennen, gennem hvilket De kan se Trudexa-opløsningen inden i sprøjten.
English: In CHARM, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Danish: I CHARM var 58% (499/854) af patienterne i klinisk respons i uge 4 og blev vurderet i den primære analyse.
English: PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE PACKAGE LEAFLET)
Danish: TEKST TIL PATIENTKORT (ikke vedlagt i pakningen og indgår ikke i indlægssedlen)
English: Trudexa in combination with methotrexate, is indicated for:
Danish: Trudexa i kombination med methotrexat er indiceret til:
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and GAIN.
Danish: Induktion af klinisk remission (defineret som CDAI < 150) blev undersøgt i to forsøg, CLASSIC I og GAIN.
English: Rare erythema multiforme, panniculitis
Danish: Sjælden erythema multiforme, panniculitis
English: DATE OF FIRST AU`THORISATION/RENEWAL OF THE AUTHORISATION 1 September 2003
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 1 september 2003
English: This will include a thorough medical history, a chest X-ray and a tuberculin test.
Danish: Dette vil omfatte en omhyggelig sygdomshistorie, røntgenundersøgelse af lunger og en tuberkulintest.
English: Most patients continued on Trudexa after the infection resolved.
Danish: De fleste patienter fortsatte med Trudexa, efter infektionen var overstået.
English: Common infection, irritation or inflammation of the eye
Danish: Almindelig infektion, irritation eller inflammation i øjet
English: It is important to tell your doctor if you have had or have a serious heart condition (see “Take special care with Trudexa”).
Danish: Det er vigtigt at informere lægen, hvis De har eller har haft en alvorlig hjertesygdom (se ”Vær særligt forsigtig med at anvende Trudexa”).
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel eller affald heraf bør bortskaffes i overensstemmelse med lokale bestemmelser.
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M).
Danish: Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM1, VCAM-1 og ICAM-1 med en IC50 på 1-2 x 10-10 M).
English: • eye inflammation;
Danish: • øjen-inflammation;
English: Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
Danish: Blandt patienter med klinisk respons i uge 4 havde 48% tidligere været eksponeret for anden anti-TNF-behandling.
English: Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
Danish: Patienterne i forsøg I, II og III blev testet på forskellige tidspunkter for antistoffer mod adalimumab fra 6. til 12. måned.
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 De nogensinde selv har haft tuberkulose, eller hvis De har været i tæt kontakt med nogen, som havde tuberkulose.
English: • anaemia, low white blood cell counts;
Danish: • anæmi, lavt antal hvide blodlegemer;
English: • Do not put either of the caps back on the pre-filled pen.
Danish: • Sæt ikke nogen af hætterne tilbage på den fyldte pen..
English: Check the expiry date on the pre-filled pen label (EXP:).
Danish: Kontrollér udløbsdatoen på etiketten på den fyldte pen (EXP:).
English: • Make sure that the plunger is fully inserted into the syringe.
Danish: • Kontrollér, at stemplet er sat fuldstændigt ind i sprøjten.
English: In clinical trials an increased risk of serious infections in patients receiving Trudexa has been shown, and reports from the post-marketing setting support this finding.
Danish: I kliniske forsøg er der vist en forøget risiko for alvorlige infektioner hos patienter, der modtog Trudexa, og rapporter fra post-marketing støtter disse fund.
English: A rapid decrease in CRP levels was also observed in patients with Crohn's disease.
Danish: Der blev også fundet et hurtigt fald i CRP hos patienter med Crohns sygdom.
English: When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe.
Danish: Hvis De, når De gør dette, kommer til at presse noget opløsning tilbage i hætteglasset, trækkes stemplet langsomt tilbage for at få hele indholdet af hætteglasset tilbage i sprøjten.
English: • If you have a severe infection, including active tuberculosis (see “Take special care with Trudexa”).
Danish: • Hvis De har en alvorlig infektion, herunder aktiv tuberkulose (se ”Vær særligt forsigtig med at anvende Trudexa”).
English: Erosion score JSNd score amethotrexate b95% confidence intervals for the differences in change scores between methotrexate and Trudexa.
Danish: Erosion score JSNd score amethotrexat b95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og Trudexa.
English: If you forget to take Trudexa:
Danish: Hvis De glemmer at tage Trudexa:
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 forsøg efter en enkelt 40 mg subkutan dosis, var 64%.
English: Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with Trudexa.
Danish: Patienter skal monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Trudexa.
English: Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
Danish: Administration af Trudexa bør ophøre, hvis en patient udvikler en ny alvorlig infektion, indtil denne infektion er under kontrol.
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. hudtest med tuberkulin og røntgen af thorax, bør foretages for alle patienter (i henhold til lokale anbefalinger).
English: In Study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score (see Table 6).
Danish: I forsøg V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i den modificrede totale Sharp score (se tabel 6).
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Trudexa administration.
Danish: Serumniveauer af matrixmetalloproteinaser (MMP-1 og MMP-3), som forårsager vævsomdannelse, der er ansvarlig for bruskdestruktionen, var også nedsatte efter Trudexa-administration.
English: Pharmacotherapeutic group: Selective immunosuppressive agents.
Danish: Farmakoterapeutisk klassifikation: Selektive immunsuppressive stoffer.
English: • The Trudexa syringe should NEVER be reused.
Danish: • Trudexa-sprøjter må ALDRIG genbruges.
English: • Trudexa should not be used if you have moderate to severe heart failure.
Danish: • Trudexa bør ikke anvendes, hvis De har moderat til alvorlig hjerteinsufficiens.
English: The primary endpoint in Study V was the percent of patients who achieved an ACR 50 response at week 52.
Danish: Det primære end-point i forsøg V var procentdelen af patienter, som opnåede et ACR 50 respons i uge 52.
English: The impact of longterm treatment with Trudexa on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med Trudexa har på udviklingen af autoimmune sygdomme.
English: In this situation, the benefit/risk balance of therapy with Trudexa should be very carefully considered.
Danish: I denne situation bør balancen fordele/ulemper ved behandling med Trudexa overvejes meget nøje.
English: Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Danish: Før behandling med Trudexa påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkuloseinfektion.
English: The Trudexa pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens.
Danish: Trudexa fyldt pen findes i pakninger indeholdende 1, 2, 4 og 6 fyldte penne.
English: If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Trudexa-terapi ikke påbegyndes (se punkt 4.3).
English: What Trudexa contains
Danish: Hvad Trudexa indeholder
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 De har eller har haft en alvorlig hjertesygdom.
English: Trudexa Mark your calendar with the stickers provided to remind you of the date for your next dose.
Danish: Trudexa Sæt de vedlagte mærkater ind i Deres kalender som en påmindelse om tidspunktet for næste dosis.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede forsøg (IX) på 82 voksne patienter med aktiv ankyloserende spondylitis.
English: • Each new injection should be given at least 3 cm from the last injection site.
Danish: • Hver ny injektion bør gives mindst 3 cm fra det senest anvendte injektionssted.
English: • Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. Trudexa can cause reactivation of
Danish: • Rådfør Dem med Deres læge, hvis De er bærer af hepatitis B-virus (HBV), hvis De har aktiv HBV eller, hvis De tror, De kan have risiko for at få HBV. Trudexa kan forårsage reaktivering af HBV hos mennesker, der bærer denne virus.
English: Your doctor will decide if you should receive Trudexa.
Danish: Lægen vil afgøre, om De skal have Trudexa.
English: This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/or current immunosuppressive therapy.
Danish: Denne undersøgelse bør omfatte en detaljeret sygdomshistorie med personlig tuberkuloseanamnese eller eventuel tidligere eksponering for patienter med aktiv tuberkulose samt tidligere og/eller samtidig immunsuppressiv behandling.
English: OUTER CARTON
Danish: YDRE CARTON
English: Trudexa should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Trudexa bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your doctor and tell him/her that you have taken more.
Danish: Hvis De ved en fejltagelse injicerer Trudexa hyppigere end forskrevet af lægen, bør De kontakte lægen og fortælle ham/hende, at De har taget mere.
English: The white needle sleeve is there to protect you from touching the needle.
Danish: Det hvide beskyttelseshylster til kanylen er der for at beskytte Dem mod at røre ved kanylen.
English: If you have ankylosing spondylitis you will first be given other medicines.
Danish: Hvis De har ankyloserende spondylitis, vil De først modtage anden medicin.
English: Moderate to severe heart failure (NYHA class III/IV) (see section 4.4).
Danish: Moderat til alvorlig hjerteinsufficiens (NYHA, klasse III/IV) (se punkt 4.4).
English: Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med Trudexa overvejes til sådanne patienter (se punkt 4.8).
English: Available data suggest that Trudexa does not worsen or cause strictures.
Danish: Foreliggende data tyder ikke på, at Trudexa forværrer eller forårsager forsnævringer.
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Danish: I et toksicitetforsøg, hvor man undersøgte udviklinger på aber, var der ingen tegn på maternel toksicitet, embryotoksicitet eller teratogenicitet.
English: Health-related quality of life and physical function was 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 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 forsøg, som var et allerede specificeret primært end-point ved uge 52 i forsøg III.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør konsultere Deres læge eller apotek, hvis De er i tvivl.
English: Adverse events at least possibly causally-related to adalimumab for Studies I − IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common≥ 1/100 < 1/10; uncommon≥ 1/1000 to ≤ 1/100) and rare < 1/1000 in Table 1 below.
Danish: Bivirkninger, hvor kausaliteten er mindst muligt relateret til adalimumab for forsøgne I-IX, CLASSIC I, GAIN og CHARM både klinisk og laboratoriemæssigt, er opført efter organklassesystem og hyppighed (meget almindelig ≥ 1/10; almindelig ≥ 1/100 < 1/10; usædvanlig ≥ 1/1.000 til ≤ 1/100 og sjælden <1/1000) i tabel 1 nedenfor.
English: Check that the needle is below the surface of the solution.
Danish: Kontrollér, at kanylen er under opløsningens overflade.
English: Patients on Trudexa may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i Trudexa behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: • As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will check you for signs and symptoms of tuberculosis before starting Trudexa.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med Trudexa, vil lægen undersøge Dem for tegn og symptomer på tuberkulose, før behandling med Trudexa påbegyndes.
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 (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 forsøg (forsøg I, III, IV).
English: • Severe rash, hives or other signs of allergic reaction;
Danish: • Alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion;
English: The primary end point in Studies I, II and III and the secondary endpoint in Study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Danish: Det primære end-point i forsøg I, II og III og det sekundære end-point i forsøg IV var den procentdel af patienter, som fik ACR 20-respons i uge 24 eller 26.
English: Study VII
Danish: Forsøg VII
English: ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
Danish: ACR respons i forsøg VI var det samme med og uden methotrexat-kombinationsbehandling.
English: If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local recommendations must be initiated before starting treatment with Trudexa.
Danish: Hvis der diagnosticeres latent tuberkulose, skal passende antituberkuloseprofylakse initieres i overensstemmelse med lokale anbefalinger, før behandling med Trudexa påbegyndes.
English: Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled.
Danish: Behandling med Trudexa bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: • There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other TNF blockers.
Danish: • Der er set meget sjældne tilfælde af visse kræfttyper hos patienter, som tager Trudexa eller andre TNF-hæmmere.