FrancophonIA/ELRC3.0 huggingface dataset:
English: Take the LIFMIOR carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Danish: Tag LIFMIORæsken med de fyldte injektionssprøjter ud af køleskabet, og placer den på en plan arbejdsflade.
English: The conduct of these tests should be recorded on the Patient Alert Card.
Danish: Udførelsen af disse prøver skal noteres i 'Patientkort'.
English: There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Danish: Der er efter markedsføring rapporteret om interstitiel lungesygdom (herunder pneumonitis og lungefibrose), nogle med dødelig udgang.
English: This injection should not be mixed with any other medicine.
Danish: Denne injektion må ikke blandes med anden medicin.
English: • While holding the needle and container in one hand, pick up the syringe and insert the syringe tip into the needle opening.
Danish: • Hold kanylen og beholderen i én hånd, tag sprøjten op og sæt sprøjtespidsen ind i kanyleåbningen.
English: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including LIFMIOR, has been reported.
Danish: Der er indberetninger om reaktivering af hepatitis B hos patienter, som tidligere havde været inficeret med hepatitis B-virus (HBV), og som samtidig fik behandling med TNF-antagonister, herunder LIFMIOR.
English: Physicians should use caution when using LIFMIOR in patients who also have moderate to severe alcoholic hepatitis.
Danish: Læger bør udvise forsigtighed ved behandling med LIFMIOR af patienter, som også har moderat til svær alkoholisk hepatitis.
English: The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Danish: Den største af disse studier (n = 277) inkluderede patienter mellem 18 og 70 år, som havde aktiv ankyloserende spondylitis defineret som visuel analogskala (VAS) score på 30 for gennemsnitsvarighed og intensiteten af morgenstivhed, plus VAS score på  30 for mindst 2 af følgende 3 parametre: Patientens almene bedømmelse, gennemsnit af VAS værdier for natlig rygsmerte og total rygsmerte, gennemsnit af 10 spørgsmål om Bath Ankylosing Spondylitis Functional Index (BASFI).
English: The child should not use LIFMIOR with medicines that contain the active substance anakinra or abatacept.
Danish: Barnet bør ikke bruge LIFMIOR sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 4.8% of subjects with juvenile idiopathic arthritis.
Danish: I kliniske studier af op til 12 måneders varighed med patienter i behandling med godkendte doser af etanercept var den kumulative incidens af anti-etanercept antistoffer ca. 6 % af patienterne med reumatoid artrit, 7,5 % af patienterne med psoriasisartrit, 2 % af patienterne med ankyloserende spondylitis, 7 % af patienterne med psoriasis, 9,7 % af patienterne med pædiatrisk psoriasis og 4,8 % af patienterne med juvenil, idiopatisk artrit.
English: Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal failure.
Danish: Selvom der er eliminering af radioaktivitet i urinen efter indgivelse af radioaktivt mærket etanercept til patienter og frivillige, blev der ikke observeret forøgede etanercept-koncentrationer hos patienter med akut nyresvigt.
English: Results are summarised in the table below.
Danish: Resultaterne er opsummeret i nedenstående tabel.
English: Treatment should be discontinued in patients who show no response after 12 weeks.
Danish: Behandlingen bør stoppes hos patienter, som ikke viser respons efter 12 uger.
English: • To break the seal, bend the larger end down and then up until broken (see Diagram 13).
Danish: • For at bryde forseglingen bøjes den længste ende ned og op, indtil den brækker (se billede 13).
English: Approximately 15% of subjects who received LIFMIOR achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Danish: Ca. 15 % af de forsøgspersoner, der fik LIFMIOR, opnåede ACR 70 respons ved måned 3 og måned 6 sammenlignet med færre end 5 % af forsøgspersonerne i placebo gruppen.
English: Time
Danish: Tid
English: • Latex: The needle cap of the MYCLIC pen is made from latex (dry natural rubber).
Danish: • Latex: Nålehætten på MYCLIC pennen er lavet af latex (tørt naturgummi).
English: The syringe and needle should NEVER be re-used.
Danish: Sprøjten og kanylen må ALDRIG genbruges.
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with LIFMIOR.
Danish: Der er indberettet tilfælde af aktiv tuberkulose, herunder miliær tuberkulose og tuberkulose med ekstrapulmonal position, hos patienter i behandling med LIFMIOR.
English: Do not touch or bump the plunger.
Danish: Rør eller stød ikke stemplet.
English: A different site should be used for each new injection.
Danish: Du skal vælge et nyt sted for hver ny injektion.
English: Physicians should exercise caution when considering the use of LIFMIOR in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Danish: Læger skal være forsigtige, når de overvejer brug af LIFMIOR til patienter, der har en anamnese med tilbagevendende eller kroniske infektioner eller med tilgrundliggende sygdomstilstande, som kan prædisponere patienterne til infektioner, for eksempel fremskreden eller dårligt kontrolleret diabetes.
English: Adult patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either LIFMIOR or anakinra alone (historical data).
Danish: For voksne patienter i behandling med LIFMIOR og anakinra blev der observeret en større hyppighed af alvorlige infektioner sammenlignet med patienter behandlet med enten LIFMIOR eller anakinra alene (historiske data).
English: Side effects in children and adolescents
Danish: Bivirkninger hos børn og teenagere
English: Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Danish: Det bør udvises forsigtighed, hvis behandling med en TNF-antagonist overvejes hos patienter med malign sygdom i anamnesen, eller hvis det overvejes at fortsætte behandlingen hos patienter, der udvikler maligne tilstande.
English: The double-blind period was followed by an open-label period during which all patients receive LIFMIOR 50 mg weekly for up to an additional 92 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben studieperiode, hvor alle patienter fik LIFMIOR 50 mg ugentligt i op til yderligere 92 uger.
English: In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists.
Danish: Efter markedsføring af lægemidlet er der rapporteret leukæmitilfælde hos patienter, der har fået behandling med TNF-antagonister.
English: These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Danish: Disse omfattede hovedpine (19 % af patienterne, 1,7 forekomst pr. patientår), kvalme (9 %, 1,0 forekomst pr. patientår), abdominal smerte (19 %, 0,74 forekomst pr. patientår), og opkastning (13 %, 0,74 forekomst pr. patientår).
English: LIFMIOR should not be used if all the powder in the vial is not dissolved within 10 minutes.
Danish: LIFMIOR må ikke anvendes, hvis ikke alt pulveret i glasset er opløst inden for 10 minutter.
English: Whether used alone or in combination with methotrexate, LIFMIOR can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Danish: Hvad enten LIFMIOR anvendes alene eller i kombination med methotrexat, kan hastigheden, hvormed leddene beskadiges på grund af reumatoid artrit nedsættes, og dermed forbedres din evne til at udføre daglige aktiviteter.
English: This may include a thorough medical history, a chest X-ray and a tuberculin test.
Danish: Undersøgelsen kan omfatte en grundig gennemgang af barnets helbredstilstand, røntgenbillede af brystkassen og en tuberkulinundersøgelse.
English: • if the child has an infection of any kind.
Danish: hvis barnet lider af nogen form for infektion.
English: Patients currently on methotrexate therapy (stable for ≥ 2 months) could continue at a stable dose of ≤ 25 mg/week methotrexate.
Danish: Patienter, som var i gang med methotrexat-behandling (stabile  2 måneder) kunne fortsætte på en fast dosis på  25 mg/uge methotrexat.
English: These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Danish: Disse infektioner skyldtes bakterier, mykobakterier, svampe, vira og parasitter (herunder protozoer).
English: If any serious allergic or anaphylactic reaction occurs, LIFMIOR therapy should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en alvorlig allergisk reaktion eller anafylaksi, skal behandling med LIFMIOR ophøre med det samme, og en egnet behandling skal begynde.
English: Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.
Danish: To patienter med juvenil, idiopatisk artrit udviklede varicellainfektion og tegn og symptomer på aseptisk meningitis, som forsvandt uden følgetilstande.
English: LIFMIOR, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Danish: LIFMIOR, alene eller i kombination med methotrexat, er vist at reducere udviklingen af ledskader, målt ved hjælp af røntgen, og at forbedre den fysiske funktion.
English: At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving LIFMIOR.
Danish: I uge 12 var der en statistisk signifikant forbedring i SPARCC-scoren (Spondyloarthritis Research Consortium of Canada) for SI-leddet målt ved hjælp af MR hos patienter, der fik LIFMIOR.
English: Paediatric plaque psoriasis (age 6 years and above)
Danish: Pædiatrisk plaque psoriasis (fra 6 år og ældre)
English: • With the syringe still attached, gently move the vial in circles a few times, to dissolve the powder (see Diagram 9).
Danish: • Mens sprøjten stadig sidder fast, bevæges hætteglasset med cirkelformede bevægelser et par gange, således at pulveret opløses (se billede 9).
English: Adjusted mean change from baseline was 3.8 for LIFMIOR treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Danish: Den korrigerede gennemsnitlige ændring fra baseline var 3,8 for patienter i LIFMIOR-armen (n=95) i forhold til 0,8 for patienter i placebo-armen (n=105) (p<0,001).
English: TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
Danish: TNF og lymfotoksin eksisterer hovedsageligt som homotrimere, og deres biologiske aktivitet er afhængig af tværbinding af celleoverflade TNF-receptorer.
English: Soluble TNFRs are thought to regulate TNF biological activity.
Danish: Opløselige TNF-receptorer menes at regulere biologisk TNF-aktivitet.
English: Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Danish: Der blev taget røntgenbilleder af hænder og håndled ved baseline og måned 6, 12 og 24.
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Danish: TNF og lymfotoksin er pro-inflammatoriske cytokiner, som binder sig til to adskilte celleoverfladereceptorer: 55-kilodalton (p55) og 75-kilodalton (p75) tumornekrosefaktorreceptorer (TNFR).
English: It is important that the vial adaptor spike completely penetrates the vial stopper.
Danish: Det er vigtigt, at adapterspidsen trænger fuldstændigt igennem proppen på hætteglasset.
English: Overall, infections were more commonly reported in patients treated with etanercept compared to methotrexate alone (3.8 versus 2%), and the infections associated with etanercept use were of a more severe nature.
Danish: Generelt blev der hyppigere indberettet infektioner hos patienter, som blev behandlet med etanercept i forhold til methotrexat alene (3,8 % versus 2 %), og de infektioner, der var forbundet med brug af etanercept, var alvorligere.
English: Significant advantages for LIFMIOR in combination with methotrexate compared with LIFMIOR monotherapy and methotrexate monotherapy were also observed after 24 months.
Danish: Signifikante fordele ved LIFMIOR i kombination med methotrexat sammenlignet med LIFMIOR monoterapi og methotrexat monoterapi blev også observeret efter 24 måneder.
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with LIFMIOR (see section
Danish: Inflammatorisk tarmsygdom (IBD) og uveitis hos patienter med juvenil idiopatisk artrit (JIA) Der har været rapporter om IBD og uveitis hos JIA-patienter, som behandles med LIFMIOR (se pkt.
English: Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Danish: Serumkoncentrationsprofilerne svarede til dem, der blev registreret hos voksne patienter med reumatoid artrit.
English: Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Behandling af voksne med alvorlig aktiv ankyloserende spondylitis, hvor responset på konventionel behandling har været utilstrækkeligt.
English: Be careful not to bend or twist the cover during removal to avoid damage to the needle.
Danish: Vær omhyggelig med ikke at bøje eller vride hætten, når den trækkes af, så nålen ikke bliver beskadiget.
English: Refer to package leaflet for alternative storage details.
Danish: Der henvises til indlægssedlen vedrørende oplysninger om anden opbevaring.
English: Do not touch this area again before injecting.
Danish: RØR IKKE dette område igen før injektionen.
English: No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
Danish: Der blev ikke observeret dosisbegrænsende toksiciteter under kliniske forsøg med patienter med rheumatoid arthritis.
English: In each of the JIA subtypes, the majority of patients met ACR Pedi 30 criteria and demonstrated clinical improvement in secondary endpoints such as number of tender joints and physician global assessment.
Danish: For hver JIA-undertype opfyldte størstedelen af patienterne ACR Pedi 30-kriteriet og viste en klinisk forbedring på sekundære endepunkter, herunder antallet af ømme led og lægens samlede vurdering.
English: These include the alcohol swab from the LIFMIOR carton and a cotton ball or gauze.
Danish: Det er en alkoholserviet fra LIFMIOR-æsken eller et stykke gaze.
English: Radiographs of hands/wrists and feet were read at baseline and 6, 12, and 24 months.
Danish: Røntgenbilleder af hænder/håndled og fødder blev vurderet ved baseline og efter hhv. 6, 12 og 24 måneder.
English: Each vial of LIFMIOR 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Danish: Hvert 10 mg hætteglas LIFMIOR bør kun anvendes én gang til en enkelt patient og resterende indhold i hætteglasset bør bortkastes.
English: In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their LIFMIOR dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Danish: I studie 3 opretholdt hovedparten af de patienter (77 %), som initialt blev randomiseret til 50 mg to gange om ugen og som fik nedsat deres LIFMIOR dosis til 25 mg to gange om ugen efter 12 uger, deres PASI 75-respons til uge 36.
English: In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
Danish: Et andet observationeltregisterstudie omfattende flere lande sammenlignede risikoen for negative graviditetsudfald hos kvinder, der blev eksponeret for etanercept i de første 90 dage af graviditeten (n=425) sammenlignet med dem, der blev eksponeret for ikkebiologiske lægemidler (n=3497), og her blev der ikke observeret en øget risiko for alvorlige misdannelser (odds ratio [OR]= 1,22, 95 % CI: 0,79-1,90; justeret OR = 0,96, 95 % CI: 0,58-1,60 efter justering efter land, maternel sygdom, paritet, maternel alder og rygning tidligt i graviditeten).
English: Serious allergic/anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis
Danish: Alvorlige allergiske/anafylaktiske reaktioner (inklusive angioødem, bronkospasme), sarkoidose
English: Step 1: Preparing for an LIFMIOR injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of the used MYCLIC pen
Danish: Trin 1: Forberedelse til injektion af LIFMIOR Trin 2: Valg af injektionssted Trin 3: Injektion af LIFMIOR-injektionsvæsken Trin 4: Bortskaffelse af den brugte MYCLIC pen
English: Antibodies to LIFMIOR
Danish: Antistoffer mod LIFMIOR
English: UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
Danish: Hvis disse tegn forekommer, skal du omgående fortælle det til lægen eller tage på skadestuen på det nærmeste hospital.
English: • Latex: The needle cover is made from latex (dry natural rubber).
Danish: • Latex: Nålehætten er lavet af latex (tørt naturgummi).
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received LIFMIOR.
Danish: Data fra flere kliniske studier viste, at den samlede forekomst af opportunistiske infektioner var 0,09 % for de 15.402 patienter, som blev behandlet med LIFMIOR.
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Danish: Man så en dosisrespons: resultater med 10 mg lå mellem placebo og 25 mg. LIFMIOR var betydeligt bedre end placebo i alle dele af ACR-kriterierne såvel som andre mål for sygdomsaktiviteten af reumatoid artrit, der ikke er medtaget i ACRresponskriterierne, som f.eks. morgenstivhed.
English: OTHER MYCLIC Pre-filled pen
Danish: MYCLIC fyldt pen
English: For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Danish: For patienter som fik 25 mg to gange om ugen igennem hele studiet, fortsatte PASI 75-responset med at forbedres mellem uge 12 og 36.
English: PsARC Month 3
Danish: PsARC Måned 3 Måned 6
English: For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Danish: For de patienter, som fik 50 mg én gang om ugen i hele studiet, fortsatte effekt-responset med at forbedres, så 71 % opnåede PASI 75 i uge 24.
English: UNIQUE IDENTIFIER-HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Danish: 5.2) er dosisjustering til patienter med renal eller hepatisk svækkelse ikke nødvendig; klinisk erfaring med disse patienter er begrænset.
English: No treatment was given for the majority of injection site reactions in the LIFMIOR treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Danish: Der blev ikke givet nogen behandling for størstedelen af injektionsstedsreaktioner hos LIFMIORbehandlingsgrupperne, og størstedelen af de patienter, som fik behandling, modtog topiske præparater som for eksempel cortikosterioder eller antihistaminer til oral indtagelse.
English: Consequently, LIFMIOR should not be used in patients for the treatment of alcoholic hepatitis.
Danish: LIFMIOR bør derfor ikke anvendes til behandling af patienter med alkoholisk hepatitis.
English: If any of the following happen, do not inject more LIFMIOR.
Danish: Hvis en eller flere af følgende reaktioner optræder, må du ikke injicere mere LIFMIOR.
English: Although no clinical trials have been performed evaluating LIFMIOR therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Danish: Selvom der ikke har været foretaget nogle kliniske studier for at evaluere LIFMIOR-behandling af patienter med multipel sclerose, har kliniske studier af andre TNF antagonister hos patienter med multipel sclerose vist forøgelse i sygdoms aktiviteten.
English: At 24 weeks, 56% of patients in the LIFMIOR-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
Danish: Efter 24 uger havde 56 % af patienterne i den LIFMIOR behandlede gruppe opnået PASI 75 sammenlignet med 5 % i den placebo behandlede gruppe.
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received LIFMIOR were observed compared with younger patients.
Danish: I fase 3-forsøgene med reumatoid artrit, psoriasisartrit og ankyloserende spondylitis blev der ikke observeret nogen overordnede forskelle i bivirkninger, alvorlige bivirknnger og alvorlige infektioner hos patienter over 65 år, som fik LIFMIOR, sammenlignet med yngre patienter.
English: TNF-antagonists, such as LIFMIOR, affect the immune system and their use may affect the body's defenses against infection and cancer.
Danish: Der er også rapporteret om alvorlige bivirkninger for LIFMIOR: TNF-antagonister som LIFMIOR påvirker immunsystemet, og brugen af dem kan påvirke kroppens forsvar mod infektioner og cancer.
English: Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received LIFMIOR without interruption.
Danish: Fortsat, varigt respons er set i op til 10 år i åbne, forlængede studier hos patienter, som fik LIFMIOR unden afbrydelse.