FrancophonIA/ELRC3.0 huggingface dataset:
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Trudexa, who are chronic carriers of this virus.
Danish: Der er forekommet reaktivering af hepatitis B hos patienter, der modtog TNF-antagonister inkluderende Trudexa, som er kroniske bærere af denne virus.
English: Take one dose tray containing a pre-filled pen of Trudexa from the refrigerator.
Danish: Tag en dosispakke, der indeholder en fyldt pen med Trudexa fra køleskabet.
English: Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have been reported with Trudexa.
Danish: Alvorlige infektioner, sepsis, tuberkulose og andre opportunistiske infektioner, herunder dødelige, er rapporteret ved brug af Trudexa.
English: Study III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Danish: Forsøgne III og V havde yderligere primære end-points i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
English: In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo.
Danish: I det største forsøg (VIII) med 315 patienter, viste resultaterne statistisk signifikant forbedring af tegn og symptomer på ankyloserende spondylitis hos patienter behandlet med Trudexa sammenlignet med placebo.
English: Check that the small grey needle cover of the syringe has been removed with the cap.
Danish: Kontroller, at kanylens lille grå beskyttelseshætte er fjernet sammen med hætten.
English: After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere Trudexa, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Trudexa and is positive for antibodies against double-stranded DNA, further treatment with Trudexa should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Trudexa udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med Trudexa (se punkt 4.8).
English: 478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Danish: Af de tilmeldte patienter blev 478 (32%) defineret som havende en svær sygdom (CDAI score > 300 og samtidig kortikosteroid og/eller immunosuppresiva) svarende til populationen defineret i indikationen (se pkt.
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase halflife was approximately two weeks.
Danish: Efter doser på 0,5 mg/kg (~ 40 mg) var clearance 11-15 ml/time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
English: Treatment with Trudexa may result in the formation of autoimmune antibodies.
Danish: Behandling med Trudexa kan medføre dannelse af autoimmune antistoffer.
English: Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Danish: Ydermere findes der en forøget baggrundsrisiko for lymfomer hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, som komplicerer estimeringen af risiko.
English: TNF-antagonists including Trudexa have been associated in rare cases with new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease.
Danish: TNF-antagonister, herunder Trudexa, er i sjældne tilfælde blevet forbundet med nyt udbrud eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniserende sygdom.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis De har yderligere spørgsmål til anvendelsen af dette produkt, skal De spørge Deres læge eller apotek.
English: With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Danish: Med den nuværende viden, kan det ikke udelukkes, at der findes en mulig risiko for udvikling af lymfomer eller andre maligniteter hos patienter, der behandles med TNF-antagonister.
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma.
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få en kræfttype, der hedder lymfom, som påvirker lymfesystemet.
English: • Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Rådfør Dem med lægen, hvis De har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der forøger risikoen for infektioner.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af forsøg af toksicitet efter enkeltdosering, gentagen dosistoksicitet og genotoksicitet.
English: Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia.
Danish: Af særlig vigtighed er infektioner som pneumoni, pyelonefritis, septisk artrit og sepsis.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving Trudexa.
Danish: Der er ingen tilgængelige data vedrørende den sekundære overførsel af infektion med levende vacciner hos patienter, der modtager Trudexa.
English: This leaflet was last approved in {MM/YYYY}
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ}
English: If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
Danish: Hvis De ikke respondere godt nok på den medicin, vil De blive tilbudt Trudexa til reduktion af tegn og symptomer på Deres sygdom.
English: In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Trudexa stoppes og effektiv anti-viral behandling med passende understøttende behandling bør initieres.
English: It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det vides ikke, om adalimumab udskilles i modermælken eller absorberes systemisk efter indgift.
English: Rare hearing loss
Danish: Sjælden høre-tab
English: • Some vaccines should not be given while receiving Trudexa.
Danish: • Nogle vacciner bør ikke gives under Trudexa-behandling.
English: There is insufficient evidence of the efficacy of Trudexa in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied (see Table 7).
Danish: Der foreligger ikke tilstrækkelig dokumentation for virkningen af Trudexa hos patienter med ankyloserende spondyltitis-lignende psoriasis arthropati, da kun få patienter er blevet undersøgt (se tabel 7).
English: In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa.
Danish: Derudover er der set meget sjældne tilfælde af ikke-melanom hudkræft hos patienter, der tager Trudexa..
English: The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across trials I, II and III.
Danish: Den procent af Trudexa-behandlede patienter, der fik ACR 20-, 50- og 70-respons, var konsistent mellem forsøg I, II og III.
English: • sensation of heart beating rapidly, high blood pressure;
Danish: • fornemmelse af hurtige hjerteslag, forhøjet blodtryk;
English: Trudexa should not affect your ability to drive or use machinery.
Danish: Trudexa påvirker ikke Deres evne til at køre bil eller bruge værktøj eller maskiner.
English: Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Danish: Tilstrækkelige data for behandling af patienter, som er bærere af HBV med anti-viral behandling i forbindelse med TNF-antagonister til forebyggelse af HBV-reaktivering, er ikke tilgængelige.
English: The conduct of these tests should be recorded on your Patient Alert Card.
Danish: Disse undersøgelser bør registreres på Deres patientkort.
English: In addition, ACR response rates were maintained in the majority of patients followed in the open-label extension phase to week 104.
Danish: I tillæg hertil blev behandlingseffekt bedømt ved ACR-respons opretholdt hos størstedelen af patienterne, som blev fulgt i det åbne forlængelsesforsøg til uge 104.
English: The results for the 40 mg every other week dose are summarised in Table 3.
Danish: Resultaterne for 40 mg hver anden uge er opstillet i tabel 3.
English: Very common (≥ 1/10 patients):
Danish: Meget almindelige (≥ 1/10 patienter):
English: Among patients who were not in response at week 4, 43% of Trudexa maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Danish: Blandt de patienter, som ikke havde respons i uge 4, responderede 43 % af patienterne i Trudexa vedligeholdelsesbehandling ved uge 12 sammenlignet med 30 % af patienter i placebogruppen.
English: Trudexa treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Danish: Patienter i behandling med Trudexa havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL).
English: During treatment with Trudexa, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med Trudexa, bør andre samtidige behandlinger (f.eks., kortikosteroider og/eller immunmodulerende midler) optimeres.
English: The effects of Trudexa in pregnant women are not known and so the use of Trudexa in pregnant women is not recommended.
Danish: Virkningen af adalimumab hos gravide er ikke kendt, hvorfor Trudexa ikke anbefales til gravide.
English: ATC code: L04AA17 Mechanism of action
Danish: ATC-kode: L04AA17
English: • Show this card to any doctor involved in your treatment.
Danish: • Vis dette kort til den behandlende læge.
English: If you do not respond well enough to these medicines, you will be given Trudexa to treat your rheumatoid arthritis.
Danish: Hvis De ikke responderer tilstrækkeligt på disse lægemidler, kan De få Trudexa til behandling af Deres reumatoide artrit.
English: • increased lipid values, appetite disorders;
Danish: • forhøjede lipidværdier, appetitforstyrrelser;
English: Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease.
Danish: Andre bivirkninger observeret hos patienter i Trudexa-behandling: Tuberkulose og andre opportunistiske infektioner (infektioner, der optræder, når modstandsdygtigheden over for sygdommen er nedsat); lungesygdom.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for den aktive substans eller over for ét eller flere af hjælpestofferne.
English: What Trudexa is and what it is used for Before you use Trudexa How to use Trudexa Possible side effects 5 How to store Trudexa Further information
Danish: Hvad Trudexa er, og hvad det anvendes til Hvad De skal gøre, før De begynder at anvende Trudexa Hvordan De anvender Trudexa Hvilke mulige bivirkninger, Trudexa har 5 Hvordan De opbevarer Trudexa Yderligere oplysninger
English: • After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Danish: • Efter injektion af Trudexa bortskaffes den brugte kanyle straks i en særlig beholder som angivet af Deres læge, sygeplejerske eller apotek.
English: Using other medicines
Danish: Anvendelse af andre lægemidler
English: Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Danish: Administration af Trudexa uden methotrexat øgede antistofdannelsen, clearance og reducerede effekten af adalimumab (se punkt 5.1).
English: Results from the Short Form Health Survey (SF 36) for all doses/schedules of Trudexa in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Danish: Resultater fra Short Form Health Survey (SF 36) for alle doser/skemaer for Trudexa i alle fire forsøg understøtter disse resultater med statistisk signifikant værdi for physical component summary (PCS) såvel som med statistisk signifikant værdi for smerte- og vitalitetsområde for 40 mg dosering hver anden uge.
English: Patients who develop a new infection while undergoing treatment with Trudexa should be monitored closely.
Danish: Patienter, der udvikler en ny infektion under behandling med Trudexa, bør monitoreres nøje.
English: • If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa.
Danish: • Hvis De har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør de kontakte Deres læge, før De begynder at bruge Trudexa.
English: If a patient receiving Trudexa shows prolonged/atypical symptoms/signs of infections or general deterioration, prevalent opportunistic conditions must be considered.
Danish: Hvis en patient, der modtager Trudexa viser forlængede/atypiske symptomer/tegn på infektion eller almindelig svækkelse, skal en florerende opportunistisk infektion overvejes.
English: • Keep this card with you for 5 months after the last Trudexa dose, since side effects may occur a long time after your last dose of Trudexa.
Danish: • Behold dette kort mindst 5 måneder efter sidste Trudexa-dosis, da bivirkninger kan forekomme i denne periode.
English: Table 8 - Efficacy Responses in Placebo-Controlled AS Study - Study VIII Reduction of Signs and Symptoms
Danish: Tabel 8 - Effekt respons i placebo-kontrolleret AS forsøg - forsøg VIII Reduktion af tegn og symptomer
English: Trudexa was studied in 5293 patients in controlled and open label trials for up to 60 months.
Danish: Trudexa blev undersøgt hos 5293 patienter i kontrollerede og åbne forsøg i op til 60 måneder.
English: The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:
Danish: Ovennævnte symptomer kan være tegn på følgende bivirkninger, som er observeret ved brug af Trudexa:
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se punkt 4.4).
English: The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells.
Danish: Det aktive stof, adalimumab, er et humant monoklonalt antistof, der er fremstillet ved dyrkning i celler.
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomologous monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Danish: Et embryoføtalt udviklingstoksicitet-/perinatalt udviklingsforsøg foretaget på cynomolgusaber med 0,30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
English: In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
Danish: I forsøg I-IV forbedredes alle individuelle komponenter af ACR-responskriterierne (antal af ømme og hævede led, læge- og patientvurderinger af sygdomsaktivitet og smerter, fysisk funktionsevneindeksværdier (HAQ) og CRP (mg/dl)-værdier) efter 24 eller 26 uger sammenlignet med placebo.
English: There were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months.
Danish: Der var 114 ud af 207 patienter, som fortsatte med Trudexa 40 mg hver anden uge i 60 måneder.
English: With your free hand, gently grasp a sizable area of the cleaned skin at the injection site and hold firmly (see below).
Danish: Klem forsigtigt med Deres frie hånd om et passende område af den rensede hud på injektionsstedet, og hold fast (se nedenfor).
English: Uncommon blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
Danish: Usædvanlig forhøjet blod-keratin-fosforkinase, forlænget aktiveret partiel thromboplastin tid, tilstedeværelse af autoantistoffer
English: There is no apparent correlation between the presence of anti-adalimumab antibodies and adverse events.
Danish: Der er ikke nogen tydelig sammenhæng mellem tilstedeværelse af antistoffer og bivirkninger.
English: DO NOT RECAP as you may damage the needle inside.
Danish: SÆT IKKE HÆTTEN PÅ, da De kan beskadige kanylen indeni.
English: INFORMATION IN BRAILLE Trudexa 40 mg
Danish: INFORMATION I BRAILLE-SKRIFT Trudexa 40 mg
English: Carcinogenicity studies, and standard assessment of fertility and postnatal toxicity, were not performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and the development of neutralizing antibodies in rodents.
Danish: Karcinogenicitetsforsøg og standardvurdering af fertilitet og postnatal toksicitet blev ikke udført med adalimumab, da der ikke findes passende modeller for et antistof med begrænset krydsreaktivitet over for gnaver-TNF og udviklingen af neutraliserende antistoffer hos gnavere.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Danish: Der blev observeret et lignede antistof respons på den 23-valente standard pneumokok vaccine og den trivalente influenza virus vaccine i et forsøg med 226 voksne individer med reumatoid artrit, som blev behandlet med adalimumab eller placebo.
English: Carriers of HBV who require treatment with Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Trudexa, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: • Arm or leg weakness.
Danish: • Svaghed i arme og ben.
English: Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Danish: Adalimumab er et rekombinant humant monoklonalt antistof fremstillet ved ekspression i ovarieceller fra kinesiske hamstre.
English: Trudexa was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
Danish: Trudexa er vurderet hos mere end 3000 patienter i de kliniske reumatoid artrit forsøg.
English: Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3).
Danish: Prækliniske data for adalimumab om postnatal toksicitet og virkning på fertilitet findes ikke (se punkt 5.3).
English: With the vial upright on a flat surface, such as a table, insert the needle straight through the centre ring of the grey stopper.
Danish: Stil hætteglasset på et fladt underlag, f.eks. et bord, og indfør kanylen lige i centerringen på den grå prop.
English: Non-serious allergic reactions associated with Trudexa were uncommon during clinical trials.
Danish: Ikkealvorlige allergiske reaktioner relateret til Trudexa var ualmindelige under de kliniske forsøg.
English: • Swollen face, hands, feet;
Danish: • Hævelser i ansigt, hænder eller fødder;
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Danish: Hvis De har moderat til alvorlig aktiv reumatoid artrit, vil De evt. først få andre sygdomsmodificerende antireumatiske lægemidler, såsom methotrexat.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of Studies I − IX, CLASSIC I, GAIN and CHARM was 5.7% for patients taking Trudexa and 5.3% for control treated patients.
Danish: Den del af patienterne, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af forsøg I-IX, CLASSIC I, GAIN og CHARM udgjorde 5.7 % for patienter, der fik Trudexa, og 5.3 % for kontrolbehandlede patienter.
English: Rare necrotising fasciitis, viral meningitis, diverticulitis
Danish: Sjælden nekrotiserende fascitis, viral meningitis, diverticulitis
English: Clinical remission Clinical response (CR-100)
Danish: Klinisk remission Klinisk respons (CR-100)
English: D - 65205 Wiesbaden Germany
Danish: D - 65205 Wiesbaden Tyskland
English: The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
Danish: Trudexas virkning og bivirkningsprofil ved behandling af reumatoid artrit blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede forsøg.
English: TRUDEXA/MTX 40 mg every other week
Danish: TRUDEXA/MTX 40 mg hver anden uge
English: Physicians should exercise caution when considering the use of Trudexa in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af Trudexa til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: Always take the outer carton or the vial of medicine with you, even if it is empty.
Danish: Tag altid den ydre karton eller hætteglasset fra medicinen med, også selvom den er tom.
English: • Remove the plastic cap from the Trudexa vial.
Danish: • Fjern plastikhætten fra hætteglasset med Trudexa.
English: Among those, 86, 72, and 41 patients had ACR 20/50/70 response, respectively at month 60.
Danish: Blandt disse havde 86, 72 og 41 patienter ACR response på henholdvis 20/50/70 ved 60 måneder.
English: N/A N/A *** p < 0.001 for all comparisons between Trudexa and placebo * p < 0.05 for all comparisons between Trudexa and placebo N/A not applicable
Danish: N/A N/A *** p<0,001 for alle sammenligninger mellem Trudexa og placebo * p<0,05 for alle sammenligninger mellem Trudexa og placebo N/A not applicable
English: Important information about some of the ingredients of Trudexa This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, d.v.s. grundlæggende 'natriumfri'.
English: • dizziness, including vertigo, headache;
Danish: • svimmelhed, herunder vertigo, hovedpine;