FrancophonIA/ELRC3.0 huggingface dataset:
English: • While holding the syringe upright, remove any air bubbles by slowly pushing on the plunger until the air is removed (see Diagram 16).
Danish: • Hold sprøjten lodret og fjern eventuelle luftbobler ved langsomt at støde til stemplet, indtil luftboblerne er væk (se billede 16).
English: • The syringe and needles should NEVER be re-used.
Danish: • Sprøjten og kanylen må ALDRIG genbruges.
English: You can press a cotton ball or gauze over the injection site for 10 seconds.
Danish: Du kan trykke et stykke vat eller gaze på injektionsstedet i 10 sekunder.
English: Adult population
Danish: Voksenpopulation
English: Autoimmune hepatitis
Danish: Autoimmun hepatitis
English: The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Danish: Nålehætten på den fyldte pen indeholder tør naturgummi (et derivat af latex).
English: ACR 20 and 50 responses were higher in patients treated with LIFMIOR at 3 and 6 months than in patients treated with placebo (ACR 20: LIFMIOR 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: LIFMIOR 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 LIFMIOR vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Danish: ACR 20 og 50 respons var højere hos patienter, der blev behandlet med LIFMIOR, ved 3 og 6 måneder, end hos patienter behandlet med placebo (ACR 20: LIFMIOR 62 % og 59 %, placebo 23 % og 11 % ved henholdsvis 3 og 6 måneder; ACR 50: LIFMIOR 41 % og 40 %, placebo 8 % og 5 % ved henholdsvis 3 og 6 måneder; p<0,01 LIFMIOR versus placebo ved alle tidspunkter for både ACR 20 og ACR 50 respons.
English: Do not use the pen if it is dropped with the needle cap off.
Danish: Brug ikke pennen, hvis du taber den, efter nålehætten er taget af.
English: Step 2: Choosing an injection site
Danish: Trin 2: Valg af injektionssted
English: The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Danish: Hovedparten af tilfældene med dødelig udgang var patienter med Pneumocystis pneumoni, uspecifikke systemiske svampeinfektioner og aspergillose (se pkt.
English: Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Danish: Tuberkulose, opportunistisk infektion (herunder invasive fungale, protozoale, bakterielle, atypiske mykobakterielle og virale infektioner samt Legionellainfektion)*
English: LIFMIOR treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Danish: Behandling med LIFMIOR resulterede i forbedret fysisk funktion i den dobbeltblinde studieperiode, og denne bedring blev fastholdt i det forlængede studie på op til 2 år.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Danish: Se opbevaringsforhold for det rekonstituerede medicinske produkt i pkt.
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving LIFMIOR during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Danish: I et studie med børn i alderen 4 til 17 år med juvenil, idiopatisk artrit fik 43 af 69 (62 %) af børnene en infektion, mens de fik LIFMIOR i løbet af studiets 3 måneder (del 1, open-label), og hyppigheden og sværhedsgraden af infektioner var ens hos 58 patienter, som gennemførte 12 måneders utilsløret forlænget behandling.
English: If LIFMIOR has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Danish: Hvis der ikke er nogen effekt af LIFMIORbehandlingen efter 12 uger, fortæller lægen dig måske, at behandlingen skal stoppes.
English: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with LIFMIOR.
Danish: Der er i meget sjældne tilfælde rapporteret om Merkelcellekarcinom postmarketing hos patienter behandlet med LIFMIOR.
English: In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Danish: Ved plaque psoriasis fører infiltration med inflammatoriske celler, inklusiv T-celler, til forhøjede TNF niveauer i psoriasis læsionerne sammenlignet med niveauerne i ikke-angrebet hud.
English: Remove only the portion of liquid as directed by your child's doctor.
Danish: Træk kun den mængde væske ud, som barnets læge har anvist.
English: • While holding the vial in one hand, remove the plastic packaging from the vial adaptor (see Diagram 5).
Danish: • Hold hætteglasset i den ene hånd og fjern plastikbeholderen fra adapteren (se billede 5).
English: Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1.
Danish: Etanercept er en dimer af et chimerisk protein, som gensplejses ved sammensmeltning af det ekstracellulære, ligandbindende domæne af human tumornekrosefaktorreceptor -2 (TNFR2/p75) til Fcdomænet af human IgG1.
English: If the child in your care has Wegener's granulomatosis, talk to your doctor.
Danish: Hvis barnet lider af Wegeners granulomatose, skal du tale med din læge.
English: • The three recommended injection sites for LIFMIOR include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17).
Danish: • De tre anbefalede injektionssteder for LIFMIOR omfatter: (1) foran midt på lårene; (2) maven, undtagen i et område på 5 cm omkring navlen; og (3) bagsiden af overarmen (se billede 17).
English: The primary measure of efficacy (ASAS 20) was a ≥20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Danish: Det primære mål for effekt (ASAS 20) var en 20 % forbedring i mindst 3 af 4 af responskriterierne i Assessment in Ankylosing Spondylitis (ASAS) (patientens helhedsvurdering, rygsmerter, BASFI og inflammation) og ingen forringelse i det sidste af kriterierne.
English: Patients treated with LIFMIOR should be given the Patient Alert Card.
Danish: Patienter i behandling med LIFMIOR bør få udleveret et eksemplar af 'Patientkort'.
English: • Trouble swallowing or breathing
Danish: • Besvær med at synke eller trække vejret
English: The following instructions explain how to prepare and inject LIFMIOR.
Danish: Nedenstående vejledning forklarer, hvordan man tilbereder og injicerer LIFMIOR.
English: Neurological disorders
Danish: Neurologiske sygdomme
English: LIFMIOR should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
Danish: LIFMIOR må normalt ikke bruges til behandling af polyartrit eller udvidet oligoartrit hos børn under 2 år, til behandling af børn med enthesitis-relateret artrit eller psoriatisartrit under 12 år, eller til behandling af psoriasis hos børn under 6 år.
English: For children, remove only the portion of liquid as directed by your child's doctor.
Danish: Til børn trækkes kun den mængde væske ud, som barnets læge har anvist.
English: In this study, 53 patients received placebo, 214 patients received 50 mg LIFMIOR once weekly and 153 patients received 25 mg LIFMIOR twice weekly.
Danish: I dette studie fik 53 patienter placebo, 214 patienter fik 50 mg LIFMIOR en gang om ugen, og 153 patienter fik 25 mg LIFMIOR to gange om ugen.
English: Preparing the LIFMIOR dose for injection
Danish: Forberedelse af LIFMIOR dosis til injektion
English: MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.
Danish: Sakroliakaleddet (SI-leddet) og rygsøjlen blev MR-scannet for at vurdere inflammation ved baseline og i uge 12 og 104.
English: In a study of 49 adult patients with rheumatoid arthritis treated with LIFMIOR, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Danish: I et studie med 49 voksne patienter med reumatoid artrit, som blev behandlet med LIFMIOR, var der ingen tegn på nedsættelse af tardiv overfølsomhed, nedsættelse af immunoglobulin-niveauer eller ændring i optællingen af effektorcellepopulationer.
English: There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Danish: Der har været postmarketingsrapporter om pancytopeni og aplastisk anæmi, hvoraf visse havde dødelig udgang (se pkt.
English: In the double-blind period, patients received LIFMIOR 50 mg weekly or placebo for 12 weeks.
Danish: I den dobbeltblindede periode fik patienterne LIFMIOR 50 mg ugentligt eller placebo i 12 uger.
English: • if the child has, or is at risk of developing a serious blood infection called sepsis.
Danish: hvis barnet har eller er i risiko for at udvikle en alvorlig blodinfektion kaldet sepsis (blodforgiftning).
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of LIFMIOR (n=57) or placebo (n=55) twice a week for 24 weeks.
Danish: 112 patienter blev randomiseret til at få 25 mg LIFMIOR (n = 57) eller placebo (n = 55) to gange om ugen i 24 uger.
English: The safety and efficacy of LIFMIOR in patients with immunosuppression have not been evaluated.
Danish: Sikkerhed og effekt ved brug af LIFMIOR til patienter med immunosuppression er ikke blevet vurderet.
English: To help you remember, it may be helpful to write in a diary which day(s) of the week LIFMIOR should be used.
Danish: For at hjælpe dig med at huske hvilke ugedage LIFMIOR skal tages, kan det være en hjælp at skrive det i en kalender.
English: • Then, slowly pull the plunger back to draw the liquid into the syringe (see Diagram 11).
Danish: • Træk så langsomt stemplet tilbage for at trække væsken ind i sprøjten (se billede 11).
English: If you notice a spot of blood at the injection site, you should press the cotton ball or gauze over the injection site for 10 seconds.
Danish: • Hvis der kommer lidt blødning på injektionsstedet, kan du trykke et stykke vat eller gaze mod injektionsstedet i 10 sekunder.
English: Week 12 results are shown in the table below.
Danish: Resultaterne fra uge 12 er vist i tabellen nedenfor.
English: Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Danish: Patienter, som vejer 62,5 kg eller derover, kan doseres ved hjælp af en fyldt injektionssprøjte eller pen med fast dosis.
English: There is generally no applicable use of LIFMIOR in children aged below 6 years in the indication plaque psoriasis.
Danish: Generelt er anvendelse af LIFMIOR til børn under 6 år med plaque psoriasis ikke relevant.
English: Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Danish: Allergiske reaktioner har indbefattet angio-ødem og urticaria, alvorlige reaktioner er forekommet.
English: The long-term safety and effectiveness of LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Danish: Langtidssikkerhed og -virkning af LIFMIOR 0,8 mg/kg (op til 50 mg) én gang ugentligt blev vurderet i et open-label forlængelsesstudie med 181 pædiatriske patienter med plaque psoriasis i op til 2 år ud over det 48-ugers studie, der er nævnt herover.
English: Each vial should be used for just one dose in one patient, and any remaining solution should be discarded.
Danish: Hvert hætteglas bør kun anvendes til én dosis til én patient, og al overskydende medicin skal kasseres.
English: Significant improvement was also observed for the ASAS partial remission and BASDAI 50.
Danish: Der blev også iagttaget en signifikant forbedring for ASAS på partiel remission og BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) 50.
English: If you stop using LIFMIOR
Danish: Hvis du holder op med at tage LIFMIOR
English: In studies when adult patients received concurrent treatment with LIFMIOR plus anakinra, a higher rate of serious infections compared to LIFMIOR alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1000/mm3).
Danish: I studier, hvor voksne patienter blev behandlet samtidig med LIFMIOR og anakinra, blev der observeret en større hyppighed af alvorlige infektioner sammenlignet med LIFMIOR alene, og 2 % af patienterne (3/139) udviklede neutropeni (absolut neutrofiltælling < 1000/mm
English: If you or the child in your care have Wegener's granulomatosis, talk to your doctor.
Danish: Hvis du eller dit barn lider af Wegeners granulomatose, skal du tale med din læge.
English: • Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision
Danish: • Tegn på autoimmune reaktioner (hvor der dannes antistoffer, der kan skade normalt væv i kroppen), som f.eks. smerter, kløe, svaghed og unormal vejrtræking, tankegang, følesans eller syn.
English: Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution.
Danish: Kemisk og fysisk stabilitet er vist at være 6 timer ved temperaturer op til 25 °C efter rekonstitution.
English: Please see section 5 for instructions on how to store LIFMIOR.
Danish: Se venligst afsnit 5 vedrørende opbevaring af LIFMIOR.
English: Dimeric soluble receptors, such as etanercept, possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Danish: Dimerisk opløselige receptorer som for eksempel etanercept har en højere affinitet for TNF end monomeriske receptorer og er betydeligt mere potent kompetitive inhibitorer af TNF-binding til cellereceptorerne.
English: The MYCLIC pen contains a clear, colourless to pale yellow or pale brown, solution for injection.
Danish: MYCLIC pennen indeholder en klar, farveløs til svagt gul eller lysebrun opløsning til injektion.
English: Pick up the pen, and remove the white needle cap by pulling it straight off (see Diagram 3).
Danish: • Tag pennen op og fjern den hvide nålehætte ved at trække den lige af (se billede 3).
English: In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Danish: I de kontrollerede dele af de kliniske studier med TNF-antagonister blev der observeret flere tilfælde af lymfom blandt patienter, der fik en TNF-antagonist, sammenlignet med kontrolpatienterne.
English: These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis (treated with 0.4 mg/kg etanercept twice weekly, up to maximum dose of 50 mg per week).
Danish: Disse middelkoncentrationer hos patienter med pædiatrisk plaque psoriasis var de samme som de koncentrationer, der blev observeret hos patienter med juvenil idiopatisk artrit (behandlet med 0,4 mg/kg etanercept to gange om ugen, op til en maksimumdosis på 50 mg om ugen).
English: Do not pass it on to others.
Danish: Lad være med at give medicinen til andre.
English: During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to LIFMIOR.
Danish: I løbet af en randomiseret aftrapningsperiode fik signifikant flere patienter, som var gen-randomiseret til placebo, sygdomstilbagefald (tab af PASI 75-respons) sammenlignet med patienter, som var genrandomiseret til LIFMIOR.
English: Patients received LIFMIOR 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Danish: Patienterne fik 0,8 mg/kg LIFMIOR (op til 50 mg) eller placebo en gang om ugen i 12 uger.
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Danish: Alvorlige infektioner (inklusive lungebetændelse, cellulitis, bakteriel arthritis, sepsis og parasitinfektion)*
English: Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using LIFMIOR.
Danish: Lægen kan beslutte at fortsætte med at kontrollere, om du eller barnet har infektioner, efter at du eller barnet er holdt op med at bruge LIFMIOR.
English: The safety and efficacy of LIFMIOR were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Danish: LIFMIORs sikkerhed og virkning blev vurderet i et to-delt studie med 69 børn med et polyartikulært forløb af juvenil idiopatisk artrit, som havde forskellige begyndelsestyper af juvenil idiopatisk artrit (polyartrit, pauciartrit, systemisk frembrud).
English: • When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Danish: • Når det rensede hudområde er tørt, klemmes det forsigtigt sammen med den ene hånd og holdes fast.
English: After the 12-week double-blind treatment period, all patients received LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Danish: Efter den 12 uger lange dobbeltblinde behandlingsperiode fik alle patienter 0,8 mg/kg LIFMIOR (op til 50 mg) en gang om ugen i yderligere 24 uger.
English: • Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15).
Danish: • Fjern kanylehætten ved at trække den lige af med et fast tag, og sørg for ikke at berøre kanylen, og for at kanylen ikke berører nogen anden overflade (se billede 15).
English: A single 50 mg/ml injection of LIFMIOR was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Danish: En enkelt 50 mg/ml injektion med LIFMIOR viste sig at være bioækvivalent med to samtidige injektioner af 25 mg/ml.
English: Do not rub the injection site.
Danish: Gnub ikke på injektionsstedet.
English: Select a clean, well-lit, flat working surface.
Danish: Vælg en ren, godt belyst, plan arbejdsflade.
English: Antibodies to etanercept have been detected in the sera of some subjects treated with etanercept.
Danish: Antistoffer mod etanercept er blevet konstateret i sera hos nogle patienter i behandling med etanercept.
English: Pancytopenia and aplastic anaemia
Danish: Pancytopeni og aplastisk anæmi
English: Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using LIFMIOR.
Danish: Lægen kan beslutte at fortsætte med at kontrollere, om barnet har infektioner, efter at barnet er holdt op med at bruge LIFMIOR.
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Danish: Effekten af LIFMIOR blev bedømt i et randomiseret, dobbeltblindt placebokontrolleret studie med 205 patienter med psoriasisartrit.
English: With the other hand, push STRAIGHT DOWN FIRMLY on the adaptor package until you feel the adaptor spike penetrate the vial stopper and FEEL AND HEAR THE ADAPTOR RIM LOCK INTO PLACE (see Diagram 3).
Danish: Med den anden hånd presses FAST NED på adapterbeholderen, indtil det kan mærkes, at adapterspidsen trænger igennem hætteglassets prop, og FØLES OG HØRES AT ADAPTERKRAVEN KLIKKER PÅ PLADS (se billede 3).
English: In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
Danish: I placebo-kontrollerede forsøg blev der ikke observeret nogen stigning i forekomsten af alvorlige infektioner (dødelige, livstruende, eller som kræver hospitalsindlæggelse eller intravenøs antibiotikabehandling).
English: Some children and teenage patients who have received LIFMIOR or other medicines that work the same way as LIFMIOR have developed cancers, including unusual types, which sometimes resulted in death.
Danish: • Nogle børne- og teenage-patienter, som har fået LIFMIOR eller anden medicin, der virker på samme måde som LIFMIOR, har udviklet kræft, inkl.
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Danish: Allergiske reaktioner, feber, udslæt, kløe, antistoffer mod normalt væv (autoantistofdannelse).
English: The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Danish: Den forsinkede skade på perifere led blev observeret hos patienter med polyartikulær, symmetrisk artrit.
English: The 10 mg presentation is for paediatric patients prescribed a dose of 10 mg or less.
Danish: Præparatstørrelsen med 10 mg er til pædiatriske patienter, der har fået ordineret en dosis på 10 mg eller mindre.
English: Do not mix the LIFMIOR solution with any other medicine.
Danish: Bland ikke LIFMIOR opløsningen med andre lægemidler.
English: LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Danish: Behandling med LIFMIOR bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af reumatoid artrit, juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylitis, nonradiografisk aksial spondylartrit, plaque psoriasis eller pædiatrisk plaque psoriasis.
English: LIFMIOR has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Danish: Hos patienter med psoriasisartrit har LIFMIOR vist sig at forbedre den fysiske funktion og at reducere udviklingen af perifere ledskader, målt ved hjælp af røntgen, hos patienter med polyartikulære, symmetriske undertyper af sygdommen.
English: Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving LIFMIOR compared with control patients, particularly in patients with psoriasis.
Danish: Ved kombination af resultater fra kontrollerede kliniske forsøg blev der observeret flere tilfælde af NMSC hos patienter behandlet med LIFMIOR, specielt psoriasispatienter, sammenlignet med kontrolpatienterne.
English: Clean the injection site with the alcohol swab using a circular motion, and allow it to dry.
Danish: • Tør injektionsområdet af med en alkoholserviet med cirkulære bevægelser og lad det tørre.
English: Do not use LIFMIOR
Danish: Tag ikke LIFMIOR:
English: Tell the doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du eller barnet bruger anden medicin eller har brugt det for nylig (herunder anakinra, abatacept eller sulfasalazin).
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after LIFMIOR treatment.
Danish: Alle patienter skal informeres om at søge lægelig rådgivning, hvis der viser sig tegn/symptomer, som kunne tyde på tuberkulose (f.eks. vedvarende hoste, vægtøgning/vægttab, let feber) under eller efter behandling med LIFMIOR.