FrancophonIA/ELRC3.0 huggingface dataset:
English: Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Trudexa kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: • Choose a site on your thigh or stomach
Danish: • Vælg et injektionssted på låret eller maven
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Trudexa straks ophøre og egnet behandling påbegyndes.
English: Table 1 Undesirable Effects in Clinical Studies
Danish: Tabel 1 Bivirkninger i kliniske forsøg
English: • anxiety, depression, feeling sleepy and difficulty sleeping;
Danish: • angst, depression, træthedsfornemmelse og søvnbesvær;
English: Treatment with Trudexa must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Trudexa skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
English: Trudexa has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Danish: Trudexa har vist sig at kunne nedsætte hastigheden ned for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre de fysiske funktioner.
English: With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Danish: Tryk på den blommefarvede knap i toppen med Deres pegefinger eller tommelfinger, når De er klar til at begynde injektionen (se nedenfor).
English: The infections consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections.
Danish: Infektionerne var primært øvre luftvejsinfektioner, bronkitis, og urinvejsinfektioner.
English: Each pack contains 1 pre-filled syringe with needleguard for hospital administration or administration by a caregiver, with 1 alcohol pad.
Danish: Hver pakning indeholder 1 fyldt injektionssprøjter med beskyttelseshætte til administration på hospital eller administration af en hjælper med henholdsvis 1 alkoholserviet.
English: In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Danish: I et klinisk forsøg med en anden TNF-antagonist er der observeret forværring af hjerteinsufficiens og forøget mortalitet som følge af hjerteinsufficiens.
English: Two patients out of 3441 treated with Trudexa in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Danish: To patienter ud af 3441, som blev behandlet med Trudexa i alle reumatoid artrit og psoriasisartrit forsøg, udviklede kliniske tegn, der tydede på et nyopstået lupuslignende syndrom.
English: **p < 0.01, Trudexa versus placebo
Danish: **p < 0,01, Trudexa over for placebo
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med Trudexa.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Danish: Hvis De får feber, som ikke vil forsvinde, blå mærker eller bløder meget let eller er meget bleg, skal De omgående henvende Dem til Deres læge.
English: • With the needle still inserted in the vial, check the syringe for air bubbles.
Danish: • Når kanylen sidder i hætteglasset, kontrolleres sprøjten for luftbobler.
English: If your doctor determines that methotrexate is inappropriate, Trudexa can be given alone.
Danish: Hvis Deres læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Trudexa anvendes alene.
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Danish: Lignende remissions-rater sås for 160/80 mg og 80/40 mg induktionsregimerne ved uge 8, mens bivirkninger oftere sås i gruppen med 160/80 mg.
English: • If you have mild heart failure and you are being treated with Trudexa , your heart failure status must be closely monitored by your doctor.
Danish: • Hvis De har lettere hjerteinsufficiens og bliver behandlet med Trudexa, skal status for Deres hjerteinsufficiens følges nøje af Deres læge.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler..
English: Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Trudexa kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se punkt 4.3).
English: The second received 20 mg of Trudexa every week for 52 weeks.
Danish: Den anden fik 20 mg Trudexa hver uge i 52 uger.
English: You will then hear a ‘click' as the needle is released, and you will feel a small prick as the needle advances.
Danish: De vil høre et 'klik', når kanylen udløses, og De vil føle et lille prik, når kanylen trænger ind.
English: • You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare case, be life-threatening.
Danish: • Infektioner kan opstå lettere under behandling med Trudexa herunder alvorlige infektioner, tuberkulose, opportunistiske infektioner og sepsis, som i sjældne tilfælde kan være livstruende.
English: Patients treated with Trudexa should be given the special alert card.
Danish: Patienter i Trudexa-behandling bør få udleveret et særligt patientkort.
English: Rare pancytopaenia, idiopathic thrombocytopaenia purpura
Danish: Sjælden pancytopeni, idiopatisk trombocytopenisk purpura
English: In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Danish: I forsøgne I-IV opnåede Trudexa-behandlede patienter statistisk signifikant ACR 20- og 50-respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
English: • Cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Danish: • Kræft, der er forskellig fra lymfom, er rapporteret hos patienter med en specifik lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNFhæmmer.
English: Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Danish: Adalimumab bindes til et specifikt protein (tumornekrosefaktor eller TNFα), som er til stede i forøget mængde i ledbetændelsessygdomme som reumatoid artrit, psoriasisartrit og ankyloserende spondylitis.
English: Always use Trudexa exactly as your doctor has told you.
Danish: Trudexa bør altid anvendes i nøje overensstemmelse med, hvad Deres læges har fortalt Dem.
English: Trudexa/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Trudexa/methotrexat-kombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p<0,001) og Trudexa-monoterapi (p<0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: A patient who requires surgery while on Trudexa should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med Trudexa, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
Danish: Usædvanlig hypokaliæmi, forhøjede lipider, appetitforstyrrelser (herunder anorexi), hyperuricaemia
English: Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Trudexa therapy.
Danish: Patienter med risiko for HBV-infektion bør undersøges for tidligere tegn på HBV-infektion inden initiering af behandling med Trudexa.
English: There have been reports of tuberculosis in patients receiving Trudexa.
Danish: Der har været rapporter om tuberkulose hos patienter, der modtog Trudexa.
English: In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1000 patient years.
Danish: Der er ved post-marketing erfaring fra januar 2003, hovedsageligt hos patienter med reumatoid artrit rapporteret en hyppighed af andre maligniteter end lymfomer og ikke-melanom hudkræft på cirka 1,7 pr. 1000 patient-år.
English: In Study IV, the ACR 20 response of patients treated with Trudexa plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Danish: I forsøg IV var ACR 20-respons for patienter behandlet med Trudexa plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p < 0,001).
English: Rare hypercalcaemia
Danish: Sjælden hypercalcæmi
English: • urinary disturbances (such as blood in urine, increased urinary frequency);
Danish: • urinvejsforstyrrelser (såsom blod i urinen, øget vandladningstendens);
English: Uncommon syncope, migraine, tremor, sleep disturbances
Danish: Usædvanlig synkope, migræne, tremor, søvnforstyrrelser
English: However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
Danish: Eftersom humane immunglobuliner udskilles i modermælken, må kvinder dog ikke amme i mindst fem måneder efter den sidste Trudexa-behandling.
English: With your other hand, pull the grey cap (1) straight off and discard cap.
Danish: Træk med den anden hånd den grå hætte (1) lige af, og kassér den.
English: The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg every other week and every week subcutaneous dosing.
Danish: Adalimumab-niveauet i serum ved steady-state-lavpunktet blev forøget omtrent proportionalt med doser på 20, 40 og 80 mg hver anden uge og hver uge ved subkutan dosering.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Danish: Disse terapier omfatter methotrexat, leflunomid, hydrozychloroquine, sulfasalazin og/eller guldsalte.
English: Trudexa can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs.
Danish: Trudexa kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), steroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler.
English: The data in Table 1 is based on the controlled Studies (I − IX,CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period.
Danish: Data i tabel 1 er baseret på de kontrollerede forsøg (I-IX, CLASSIC I, GAIN og CHARM) (beskrevet i punkt 5.1), som omfatter 3271 patienter, der fik Trudexa, og 1809 patienter, der fik enten placebo eller aktiv kontrol i den kontrollerede behandlingsperiode.
English: Slowly press the plunger to push the bubbles out of the syringe and into the vial.
Danish: Pres langsomt på stemplet for at skubbe boblerne ud af sprøjten og ind i hætteglasset.
English: There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and aspergillosis.
Danish: Der er rapporteret om alvorlige og svære opportunistiske infektioner associeret med Trudexa behandling, for eksempel pneumocystisk carinii pneumoni, dissemineret histoplasmose, listeria og aspergillose.
English: Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
Danish: Trudexa kan gives som monoterapi i tilfælde af intolerance over for kortikosteroider, eller når forsat behandling med kortikosteroider er uhensigtsmæssig (se punkt 4.2).
English: In a study of 64 patients with rheumatoid arthritis that were treated with Trudexa, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B cells and NK-cells, monocyte/macrophages, and neutrophils.
Danish: I et forsøg, hvor 64 patienter med reumatoid artrit blev behandlet med Trudexa, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T- og B-celler, NK-celler, monocytter/makrofager og neutrofiler.
English: Following subcutaneous administration of 40 mg of Trudexa every other week in rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ml (without concomitant methotrexate) and 8 to 9 µg/ml (with concomitant methotrexate), respectively.
Danish: Efter subkutan administration af 40 mg Trudexa hver anden uge hos patienter med rheumatoid artrit (RA) var middel steady-state-koncentrationerne på henholdsvis cirka 5 µg/ml (uden kombination med methotrexat) og 8-9 µg/ml (i kombination med methotrexat).
English: In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Danish: I de kontrollerede dele af de kliniske forsøg med TNF-antagonister, blev der observeret flere tilfælde af maligniteter inklusiv lymfomer blandt de patienter, som modtog TNF-antagonister, sammenlignet med kontrol patienterne.
English: Trudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: Trudexa er indiceret til behandling af svær, aktiv Crohns sygdom hos patienter, som på trods af en adækvat behandling med glukokortikoid og/eller et andet immunosuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har medicinske kontraindikationer mod sådanne behandlinger.
English: In CHARM, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Danish: I CHARM modtog 854 patienter open-label 80 mg i uge 0 og 40 mg i uge 2.
English: No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving Trudexa.
Danish: Der er ikke gennemført nogen forsøg med patienter, der tidligere har haft maligniteter, eller hvor behandling fortsættes af patienter, der udvikler maligniteter under behandling med Trudexa.
English: 113/207 of patients originally treated with 40 mg Humira every other week were evaluated radiographically at 5 years.
Danish: 133/127 patienter, der oprindeligt blev behandlet med 40 mg Trudexa hver anden uge, blev radiografisk evalueret ved 5 år.
English: In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Danish: In CLASSIC I, blev 299 TNF-antagonist-naive patienter randomiseret til en af fire behandlingsgrupper; placebo i uge 0 og 2, 160 mg Trudexa i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
English: In the twelve controlled trials, the rate of infection was 1.49 per patient year in the Trudexa treated patients and 1.42 per patient year in the placebo and active control-treated patients.
Danish: I de tolv kontrollerede forsøg var infektionshyppigheden 1,49 pr. patientår hos Trudexa-behandlede patienter og 1,42 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: ASASa 20 Week 2
Danish: ASASa 20 Uge 2
English: A. MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Study IIIa**
Danish: Forsøg IIIa**
English: In GAIN, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Trudexa at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Danish: I GAIN, blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at modtage enten 160 mg Trudexa i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
English: Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Danish: Trudexa 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt-blinde placebokontrollerede forsøg med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling.
English: At week 52, 42.9% of patients who received Trudexa/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Trudexa monotherapy.
Danish: I uge 52 opnåede 42,9% af patienterne, som fik Trudexa/methotrexat-kombinationsterapi, klinisk remission (DAS28 < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexat-monoterapi og 23,4% af patienterne, som fik Trudexa-monoterapi.
English: Study IIa**
Danish: Forsøg IIa**
English: Rare cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion
Danish: Sjælden hjertestop, koronar arteriel insufficiens, angina pectoris, pericardieekssudat
English: Trudexa has not been studied in children or in patients with hepatic or renal impairment.
Danish: Trudexa er ikke undersøgt hos børn eller hos patienter med nedsat lever- eller nyrefunktion.
English: Study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Danish: Forsøg V vurderede 799 methotrexat-naive voksne patienter med moderat til alvorlig aktiv reumatoid artrit i tidligt stadium (gennemsnitlig sygdomsvarighed på mindre end 9 måneder).
English: • If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.
Danish: • Hvis De skal opereres eller have tandbehandling, bør De informere Deres læge om, at De tager Trudexa.
English: The following instructions explain how to inject Trudexa.
Danish: Følgende er en vejledning i, hvordan man injicerer Trudexa.
English: Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week.
Danish: Nogle patienter, som oplever en nedgang i deres respons, kan have fordel af en stigning i dosis til 40 mg Trudexa hver uge.
English: This study evaluated the efficacy of Trudexa 40 mg every other week/methotrexate combination therapy, Trudexa 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Danish: Dette forsøg vurderede virkningen af Trudexa 40 mg hver anden uge/methotrexat-kombinationsterapi, Trudexa monoterapi 40 mg hver anden uge og methotrexat-monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger.
English: Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield.
Danish: Patienter med kendt overfølsomhed over for latex rådes til at undgå at røre ved gummipakningen inde i beskyttelseshætten.
English: The needle cover of the syringe contains natural rubber (latex).
Danish: Kanylens beskyttelseshætte indeholder naturgummi (latex).
English: Tell your doctor immediately if you notice any of the following:
Danish: Kontakt omgående lægen, hvis De får følgende symptomer::
English: If this happens, do not use the syringe or vial.
Danish: Hvis dette sker, må sprøjte eller hætteglas ikke anvendes.
English: All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001
Danish: Alle p-værdier er parvise sammenligninger af forholdet for Trudexa vs. placebo * p<0,001
English: All doses/schedules of Trudexa in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
Danish: Alle doser/skemaer for Trudexa i alle fire forsøg viste statistisk signifikant større forbedring ifølge HAQ's fysiske funktionsevneindeks fra baseline til 6. måned sammenlignet med placebo, og i forsøg III blev det samme set efter 52 uger.
English: Keep this Patient Alert Card together with the package leaflet.
Danish: Opbevar patientkortet sammen med denne indlægsseddel.
English: For induction treatment, Trudexa should be given in combination with corticosteroids.
Danish: Til induktionsbehandling bør Trudexa gives i kombination med kortikosteroider.
English: The incidence of serious infections was 0.03 per patient year in Trudexa treated patients and 0.03 per patient year in placebo and active control − treated patients.
Danish: Incidensen af alvorlige infektioner var 0,03 pr. patientår hos Trudexa-behandlede patienter og 0,03 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: Uncommon asthma, dyspnoea, dysphonia, nasal congestion
Danish: Usædvanlig astma, dyspnø, dysfoni, nasal kongestion
English: Wipe your skin by using the enclosed alcohol pad, using a circular motion.
Danish: Tør Deres hud af med den medfølgende alkoholserviet ved hjælp af cirklende bevægelser.
English: Tell your doctor as soon as possible if you notice any of the following:
Danish: Kontakt lægen så hurtigt som muligt, hvis De får følgende symptomer:
English: Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Trudexa har vist sig at hæmme udviklingen af leddestruktion bedømt ved måling med røntgen og at forbedre den fysiske funktion, når det gives i kombination med methotrexat.
English: Nervous system disorders demyelinating disorders (e.g. optic neuritis)
Danish: Sygdomme i nervesystemet demyeliniserende sygdomme (f.eks. optisk neuritis)