FrancophonIA/ELRC3.0 huggingface dataset:
English: Prescribers should exercise caution in considering the use of Trudexa in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
Danish: Lægen bør udvise forsigtighed, når behandling med Trudexa overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet.
English: The Trudexa pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass syringe with Trudexa.
Danish: Trudexa fyldt pen er en engangs grå- og blommefarvede pen, som indeholder en glassprøjte med Trudexa.
English: THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; punkt.
English: Common (≥ 1/100 and < 1/10 patients):
Danish: Almindelige (≥ 1/100 og < 1/10 patienter):
English: Instructions for preparing and giving an injection of Trudexa:
Danish: Vejledning til forberedelse og injektion af Trudexa::
English: NAME OF THE MARKETING AUTHORISATION HOLDER Abbott Laboratories Ltd
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Abbott Laboratories Ltd
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Danish: Nioghalvfjerds (20,1%) af patienterne blev samtidigt behandlet med sygdomsmodificerende antireumatiske lægemidler, og 37 (9,4 %) af patienterne med glukokortikoider.
English: If you have questions, please ask your doctor.
Danish: Hvis De har spørgsmål, skal De tale med Deres læge.
English: Study Ia**
Danish: Forsøg Ia**
English: Mean steady-state trough levels of approximately 7 µg/ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg Trudexa every other week.
Danish: Gennemsnitlige steady-state laveste niveauer på omtrent 7 µg/ml blev set hos patienter med Crohns sygdom, som modtog vedligeholdelsesdosis på 40 mg Trudexa hver anden uge.
English: In Study III, where Trudexa treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
Danish: I forsøg III, hvor de Trudexa-behandlede patienter havde haft reumatoid artrit gennemsnitlig i 11 år, blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer i den totale modificerede Sharpscore og dennes delkomponenter, erosionsscore og ledspalteforsnævring (JSN).
English: At week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Danish: Ved uge 4 blev patienterne randomiseret til 40 mg hver anden uge, 40 mg hver uge, eller placebo gennem hele forsøgsforløbet på 56 uger.
English: In postmarketing, serious allergic reactions including anaphylaxis have been reported very rarely following Trudexa administration.
Danish: Postmarketing er der meget sjældent rapporteret om alvorlige allergiske reaktioner, inklusive anafylaksi, efter administration af Trudexa.
English: Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Danish: Forsøg IV vurderede primært sikkerheden hos 636 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit.
English: • The needle cover of the syringe contains natural rubber (latex).
Danish: • Kanylens beskyttelseshætte indeholder en pakning af naturgummi (latex).
English: − Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
Danish: - De vil af lægen få udleveret et patientkort, der indeholder vigtige sikkerhedsinformationer, som de skal være opmærksom på før og under Deres behandling med Trudexa.
English: 40 mg Trudexa every week
Danish: 40 mg Trudexa hver uge
English: In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Trudexa and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Trudexa monotherapy at week 52 and responses were sustained at week 104 (see Table 4).
Danish: I forsøg V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med Trudexa og methotrexat til hurtigere og signifikant større ACR respons end methotrexat-monoterapi og Trudexa-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 4).
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af midlets indvirkning på evnen til at føre bil eller betjene maskiner.
English: Table 4: ACR Responses in Study V (percent of patients)
Danish: Tabel 4: ACR Respons i studie V (Procentdel af patienter)
English: Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Trudexa er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen..
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Trudexa therapy, your doctor may decide to give 40 mg adalimumab every week.
Danish: Hvis De har reumatoid artrit og ikke får methotrexat i kombination med Deres Trudexa-behandling, kan lægen vælge at ordinere 40 mg adalimumab hver uge.
English: Do not use Trudexa:
Danish: De bør ikke anvende Trudexa:
English: In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Danish: I et eksplorativt klinisk forsøg, hvor anvendelsen af et andet anti-TNF-stof infliximab blev undersøgt hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om flere maligniteter, primært i lunger eller hoved og hals, hos infliximab-behandlede patienter end hos kontrol-patienter.
English: Rare intestinal stenosis, colitis, enteritis, oesophagitis
Danish: Sjælden intestinal stenose, colitis, enteritis, oesophagitis
English: Rare multiple sclerosis
Danish: Sjælden dissemineret sclerose
English: NA NA 4.5% 23.2% a Study I at 24 weeks, Study II at 26 weeks , and Study III at 24 and 52 weeks b 40 mg Trudexa administered every other week c MTX = methotrexate
Danish: a Forsøg I efter 24 uger, Forsøg II efter 26 uger og Forsøg III efter 24 og 52 uger b 40 mg Trudexa givet hver anden uge c MTX = methotrexat
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 ml
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 40 mg/0.8 ml
English: Common lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection
Danish: Almindelig nedre luftvejsinfektioner (herunder pneumoni, bronkitis), virusinfektioner (herunder influenza, herpesinfektioner), candidiasis, bakterielle infektioner (herunder urinvejsinfektioner), øvre luftvejsinfektioner
English: Table 5: Radiographic Mean Changes Over 12 Months in Study III
Danish: Tabel 5: Gennemsnitlige radiografiske ændringer gennem 12 måneder i Forsøg III
English: Respiratory, thoracic and mediastinal disorders interstitial lung disease, including pulmonary fibrosis
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum interstitiel lungesygdom, herunder pulmonal fibrose
English: Cases of worsening congestive heart failure have also been reported in patients receiving Trudexa.
Danish: Tilfælde af forværret hjerteinsufficiens er også rapporteret for patienter i behandling med Trudexa.
English: If the needle is correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper.
Danish: Hvis kanylen er i korrekt stilling, vil De mærke en let modstand og derpå et smæld, når kanylen går igennem proppens centrum.
English: • If you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Trudexa and contact your doctor immediately.
Danish: • Hvis De oplever allergiske reaktioner, såsom trykken i brystet, hvæsen, svimmelhed, hævelser eller udslæt, undlad at injicere mere Trudexa, og straks kontakte lægen.
English: Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn's disease.
Danish: Behandling med Trudexa bør initieres og overvåges af speciallæger med erfaring i diagnosticering og behandling af reumatoid artrit, psoriasisartrit, ankolyserende spondylitis eller Crohns sygdom.
English: Each pack contains 1 vial with an empty sterile syringe and 2 alcohol pads.
Danish: Hver pakning indeholder 1 hætteglas med en tom steril injektionssprøjte og 2 alkoholservietter.
English: Usually, Trudexa is used with methotrexate.
Danish: Normalt gives Trudexa sammen med methotrexat.
English: Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Danish: I kliniske forsøg er der observeret alvorlige infektioner i forbindelse med samtidig administration af anakinra og en anden TNF-antagonist, etanercept, uden yderligere klinisk virkning end ved anvendelse af etanercept alene.
English: • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
Danish: • Sørg for at medbringe en oversigt over den medicin, De måtte tage, ved enhver henvendelse til lægen.
English: Reproductive system and breast disorders
Danish: Lidelser i det reproduktive system og brystsygdomme
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified total Sharp score ≤ 0.5) was significantly higher with Trudexa/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Danish: Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i den modificerede totale Sharp score ≤ 0,5) signifikant højere med Trudexa/methotrexat-kombinationsterapi (henholdsvis 63,8% og 61,2%) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4% og 33,5%, p<0,001) og Trudexa monoterapi (henholdsvis 50,7%, p<0,002 og 44,5%, p<0,001).
English: • Pull the needle completely out of the vial.
Danish: • Træk kanylen fuldstændigt ud af hætteglasset.
English: • If you have moderate or severe heart failure.
Danish: • Hvis De lider af moderat til alvorlig hjerteinsufficiens.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Danish: Hvis De udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f. eks. stakåndethed eller hævede fødder), skal De kontakte Deres læge øjeblikkeligt.
English: Doses of 20 or 40 mg of Trudexa were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Danish: Doser på 20 eller 40 mg Trudexa blev givet ved subkutan injektion hver anden uge med placebo i de øvrige uger eller hver uge i 26 uger; placebo blev givet hver uge i samme periode.
English: CLASSIC I: Infliximab Naive Patients
Danish: CLASSIC I: Infliximab Naive Patienter GAIN: Infliximab Erfarne Patienter Placebo N=74
English: Crohn's disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
Danish: Kliniske forsøg med Crohns sygdom: i kontrollererde kliniske forsøg var forhøjelse af ALAT sammenlignelig hos patienter, der modtog adalimumab eller placebo.
English: When combining controlled portions of ten trials (I-IX and CHARM) and ongoing open label extension studies with a median duration of approximately 2. years including 4843 patients and over 13000 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 13.6 per 1000 patient years.
Danish: Når de kontrollerede dele af ti forsøg (I-IX og CHARM) og igangværende åbne opfølgningsforsøg kombineres med en gennemsnitlig varighed på omkring 2 år, inklusive 4843 patienter og over 13000 patient-års behandling, er den observerede hyppighed af maligniteter, fraset lymfomer og ikkemelanom hudkræft, cirka 13.6 pr. 1000 patient år.
English: Study VI with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
Danish: I forsøg VI blev 313 voksne patienter , som havde et utilstrækkeligt respons over for nonsteroid anti-inflammatorisk behandling, behandlet i 24 uger, af disse patienter tog ca. 50% methorexate.
English: If you forget to give yourself an injection, you should inject the next dose of Trudexa as soon as you remember.
Danish: Hvis De glemmer at give Dem selv en injektion, bør De injicere den næste dosis af Trudexa, så snart De kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindelig fastlagte dag, som om De ikke havde glemt en dosis.
English: Uncommon skin papilloma
Danish: Usædvanlig Hudpapillom
English: Hold the pre-filled pen with one hand with the grey cap (1) pointed down.
Danish: Hold den fyldte pen med den ene hånd med den grå hætte (mærket '1') pegende nedad.
English: Preparing the Trudexa dose for injection
Danish: Forberedelse af Trudexa til injektion
English: Table 9: Induction of Clinical Remission and Response (Percent of Patients)
Danish: Table 9: Induktion af Klinisk Remission og Respons (Procent af Patienterne)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Abbott Laboratories Ltd.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Abbott Laboratories Ltd.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Trudexa.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de, under behandling med Trudexa, udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: • lower respiratory tract infections (such as bronchitis, pneumonia);
Danish: • nedre luftvejsinfektioner (herunder bronkitis, lungebetændelse);
English: Panophthalmitis, iritis, glaucoma
Danish: Sjælden panoftalmitis, iritis, glaukom
English: Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Trudexa treatment.
Danish: Kvinder i den fertile alder anbefales kraftigt at anvende passende kontraception for at forebygge graviditet og fortsætte med at anvende den i mindst fem måneder efter den sidste Trudexa-behandling.
English: • Feeling weak or tired;
Danish: • Følelse af svaghed eller træthed;
English: In the pivotal trials, anti-adalimumab antibodies were identified in 58/1053 (5.5%) patients treated with adalimumab, compared to 2/370 (0.5%) on placebo.
Danish: I de pivotale forsøg blev der identificeret anti-adalimumab-antistoffer hos 58/1.053 (5,5%) af de patienter, der blev behandlet med adalimumab, sammenlignet med 2/370 (0,5%) af de patienter, der fik placebo.
English: Trudexa, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, Studies VI and VII.
Danish: Trudexa givet i doser af 40 mg hver anden uge blev undersøgt hos patienter med moderat til alvorlig aktiv psoriasisartrit i to placebokontrollerede forsøg, forsøgne VI og VII.
English: Study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Danish: Forsøg II evaluerede 544 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel.
English: The usual dose regimen for Crohn's disease is 80 mg at week 0 and followed by 40 mg every other week starting at week 2.
Danish: Startbehandlingen for Crohns sygdom er sædvanligvis 80 mg i uge 0 fulgt af 40 mg hver anden uge startende i uge 2.
English: Gently tap the syringe to make any bubbles rise to the top of the syringe near the needle.
Danish: Bank forsigtigt på sprøjten for at få boblerne op til toppen af sprøjten nær kanylen.
English: Study VII with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Danish: I forsøg VII blev 100 patienter, som havde utilstrækkelig respons over for DMARD-terapi, behandlet i 12 uger.
English: • serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections;
Danish: • Alvorlige infektioner (såsom sepsis [blodforgiftning]), ledinfektion, svampeinfektion;
English: In patients with Crohn's disease, adalimumab antibodies were identified in 7/269 subjects (2.6%) treated with adalimumab.
Danish: Hos patienter med Crohns sygdom, blev der identificeret adalimumab-antistoffer hos 7/269 individer (2,6%) behandlet med adalimumab.
English: Antibody formation was lower when Trudexa was given together with methotrexate in comparison with use as monotherapy.
Danish: Antistofdannelsen var lavere ved Trudexa i kombination med methotrexat i forhold til ved behandling med Trudexa alene.
English: Trudexa treated patients demonstrated improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36), from base-line to week 24.
Danish: Hos patienter behandlet med Trudexa var der signifikant større bedring ifølge HAQ's fysiske funktionsevneindeks og Short Form Health Survey (SF 36) fra baseline til uge 24.
English: The recommended Trudexa induction dose regimen for adult patients with severe Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Danish: Det anbefalede Trudexa induktions-dosis-regime til voksne patienter med svær Crohns sygdom er 80 mg i uge 0 efterfulgt af 40 mg i uge 2.
English: In controlled and open label studies with Trudexa, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
Danish: I kontrollerede og åbne forsøg med Trudexa blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. histoplasmose, pneumocystis carinii pneumoni, aspergillose og nocardiose).
English: The blinded period was followed by an open − label period during which patients received Trudexa 40 mg every other week subcutaneously for up to an additional 28 weeks.
Danish: Den blindede periode blev efterfulgt af en åben periode, hvor patienterne modtog Trudexa 40 mg hver anden uge subkutant i op til yderligere 28 uger.
English: • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Danish: • Tegn og symptomer, som kan tyde på blodsygdomme så som vedvarende feber, blå mærker,
English: BASDAIb 50 Week 2
Danish: BASDAIb 50 Uge 2
English: Skin and subcutaneous tissue disorders
Danish: Sygdomme i hud og subkutant væv
English: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF blocking agents.
Danish: Sjældne tilfælde af pancytopeni herunder aplastisk anæmi er rapporteret efter behandling med TNFantagonister.
English: Trudexa can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: Trudexa kan også anvendes til behandling af alvorlig aktiv og progressiv reumatoid artrit, der ikke tidligere er behandlet med methotrexat.
English: Uncommon mood disorders, anxiety (including nervousness and agitation)
Danish: Usædvanlig humørforstyrrelser, angst (herunder nervøsitet og agitation)
English: Uncommon systemic lupus erythematosus, angioedema, drug hypersensitivity, seasonal allergy
Danish: Usædvanlig systemisk lupus erythematosus, angioødem, lægemiddel-allergi, sæsonbestemt allergi
English: HOW TO USE TRUDEXA
Danish: HVORDAN DE ANVENDER TRUDEXA
English: Serious allergic adverse reactions have not been reported with subcutaneous administration of Trudexa during clinical trials.
Danish: Alvorlige allergiske reaktioner er ikke rapporteret under de kliniske forsøg ved subkutan administration af Trudexa.
English: Table 3: ACR Responses in Placebo-Controlled Trials
Danish: Tabel 3: ACR-respons i placebokontrollerede forsøg
English: • Signs of infection such as fever, malaise, wounds, dental problems, burning on urination;
Danish: • Tegn på infektion, såsom feber, ildebefindende, sår, tandproblemer eller smerter ved vandladning;
English: It is recommended that the conduct of these tests should be recorded in the patient alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, særligt hos patienter, der er alvorligt syge eller immunkompromitterede.
English: Malignancies and lymphoproliferative disorders
Danish: Maligniteter og lymfeproliferative sygdomme
English: This alert card contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
Danish: Dette patientkort indeholder vigtige sikkerhedsinformationer, som De bør være opmærksom på før og under behandling med Trudexa.
English: After treatment with Trudexa, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis.
Danish: Efter behandling med Trudexa blev der hos patienter med reumatoid artrit observeret et hurtigt fald i niveauet af inflammatoriske akutfasereaktanter (C-reaktivt protein (CRP) og erytrocytsænkningshastighed (ESR)) og serumcytokiner (IL-6) sammenholdt med baseline.
English: • Wash your hands thoroughly • Set up the following items on a clean surface o One pre-filled syringe of Trudexa for injection o One alcohol pad
Danish: • Vask hænderne grundigt • Læg følgende ting på et rent underlag o En fyldt Trudexa-injektionssprøjte o En alkoholserviet
English: 3) Injecting Trudexa
Danish: 3) Injektion af Trudexa