FrancophonIA/ELRC3.0 huggingface dataset:
English: Do NOT push down the adaptor at an angle (see Diagram 4).
Danish: Pres IKKE adapteren skævt ned (se billede 4).
English: Similarly, the significant advantages for LIFMIOR monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Danish: Tilsvarende blev også observeret signifikante fordele ved LIFMIOR monoterapi sammenlignet med methotrexat monoterapi efter 24 måneder.
English: Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Danish: Behandling af polyartrit (reumafaktor positiv eller negativ) eller udvidet oligoartrit hos børn og unge i alderen fra 2 år, som har vist utilstrækkeligt respons på eller intolerans over for methotrexat.
English: The possibility exists for TNF-antagonists, including LIFMIOR, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Danish: Der er mulighed for, at TNF-antagonister, herunder LIFMIOR, kan påvirke patientens modstandsdygtighed over for infektioner og maligniteter, eftersom TNF formidler betændelse og modulerer celleimmunrespons.
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in LIFMIOR-treated patients.
Danish: I kliniske studier af mere end 2 års varighed med 351 patienter med ankyloserende spondylitis blev der rapporteret om 6 maligniteter hos patienter behandlet med LIFMIOR.
English: There have been rare reports of CNS demyelinating disorders in patients treated with LIFMIOR (see section 4.8).
Danish: Der har været sjældne rapporter om CNS-demyeliniseringslidelser hos patienter behandlet med LIFMIOR (se pkt.
English: In the 2-year active-controlled study where patients were treated with either LIFMIOR alone, methotrexate alone or LIFMIOR in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Danish: I det to-årige aktivt kontrollerede forsøg, hvor patienterne blev behandlet med enten LIFMIOR alene, methotrexat alene eller LIFMIOR i kombination med methotrexat, var antallet af alvorlige infektioner det samme i behandlingsgrupperne.
English: • Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
Danish: • Følelse af nervøsitet eller angst, bankende fornemmelser eller pludselig rødmen i huden og/eller en følelse af varme
English: The safety and efficacy of LIFMIOR in patients with chronic infections have not been evaluated.
Danish: Sikkerhed og effekt ved brug af LIFMIOR til patienter med kroniske infektioner er ikke blevet vurderet.
English: Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitislike ankylosis.
Danish: Patienterne var mellem 18 og 70 år gamle og havde aktiv prosiasis artrit ( 3 svulne led og  3 ømme led) i mindst en af følgende former: (1) i distale interfalangeale led, (2) polyartikulær artrit (ingen reumatoide knuder og tilstedeværelse af psoriasis), (3) arthritis mutilans, (4) asymetrisk psoriasisartrit eller (5) spondylitis-lignende ankylose.
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18).
Danish: • Pres kanylen helt ind i huden med en hurtig, kort bevægelse i en vinkel mellem 45 og 90 (se billede 18).
English: Discontinuation of treatment should be considered in patients who show no response after 4 months.
Danish: Seponering bør overvejes hos patienter, som ikke viser nogen respons efter 4 måneder.
English: The highest dose level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 administered twice weekly.
Danish: Den største dosis, der er blevet evalueret, var en intravenøs belastningsdosis på 32 mg/m2 efterfulgt af subkutane doser på 16 mg/m2, indgivet to gange ugentligt.
English: LIFMIOR is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.
Danish: Instruktioner vedrørende anvendelse og håndtering LIFMIOR rekonstitueres med 1 ml vand til injektionsvæsker før brug og indgives som en subkutan injektion.
English: Your symptoms may return upon discontinuation.
Danish: Symptomerne kan vende tilbage, hvis behandlingen stopper.
English: • Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given LIFMIOR.
Danish: • Kræft: Fortæl det til lægen, hvis du har eller har haft kræft i lymfesystemet (lymfom) eller andre former for kræft.
English: There is generally no applicable use of LIFMIOR in children aged below 2 years in the indication juvenile idiopathic arthritis.
Danish: Generelt er anvendelse af LIFMIOR til børn under 2 år med juvenil idiopatisk artrit ikke relevant.
English: Dispose of the used pen as instructed by your doctor, nurse or pharmacist.
Danish: Bortskaf den brugte pen som angivet af din læge, sygeplejerske eller apotek.
English: Green activation button
Danish: Grøn aktiveringsknap i.
English: All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on LIFMIOR, they should seek immediate medical advice.
Danish: Alle patienter og forældre/ plejere skal informeres om, at hvis patienten udvikler tegn eller symptomer, som kan pege på bloddyskrasi eller infektioner (f.eks. vedvarende feber, øm hals, blå mærker, blødning, bleghed), mens de er i behandling med LIFMIOR, skal de omgående søge læge.
English: Some white foam may remain in the vial - this is normal.
Danish: Der kan stadig være hvidt skum i hætteglasset - dette er normalt.
English: When the needle is completely inserted into the skin, release the skin that you are holding.
Danish: Når nålen er helt inde i huden, giv da slip på det sammenklemte hudområde.
English: 4 years.
Danish: 4 år
English: If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Danish: Hvis du glemmer en dosis, skal du injicere, så snart du kommer i tanke om det, medmindre at den næste planlagte dosis er den følgende dag.
English: In a group of 2,711 plaque psoriasis patients treated with LIFMIOR in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Danish: I dobbeltblinde og åbne studier af op til 2,5 års varighed omfattende 2.711 patienter med plaque psoriasis behandlet med LIFMIOR blev der rapporteret om 30 maligniteter og 43 tilfælde af ikkemelanom hudkræft.
English: In addition, one study found more birth defects when the mother had received LIFMIOR in pregnancy, compared with mothers who had not received LIFMIOR or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Danish: Desuden viste et studie, at barnet hyppigere havde medfødte misdannelser, når kvinden havde taget LIFMIOR under graviditeten, sammenlignet med kvinder, der ikke havde taget LIFMIOR eller andre tilsvarende lægemidler (TNF-antagonister) under graviditet.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of LIFMIOR (see section 4.8).
Danish: Der er blevet rapporteret om alvorlige infektioner, sepsis, tuberkulose og opportunistiske infektioner, herunder invasive svampeinfektioner, listeriose og legionærsygdom i forbindelse med brugen af LIFMIOR (se pkt.
English: Adult patients with rheumatoid arthritis
Danish: Voksne patienter med reumatoid artrit
English: The instructions below explain how to use the MYCLIC pen to inject LIFMIOR.
Danish: Nedenstående vejledning forklarer, hvordan MYCLIC pennen bruges til injektion af LIFMIOR.
English: Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ.
Danish: Livskvaliteten hos patienterne med psoriasis arthritis blev bedømt på hvert tidspunkt ved brug af HAQs invaliditetsindeks.
English: The active substance in LIFMIOR is etanercept.
Danish: Aktivt stof: etanercept.
English: Disease flare was defined as a ≥ 30% worsening in three of six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Danish: Sygdomsopblussen blev defineret som en 30 % forværring af tre af seks JRA kernekriterier og 30 % forbedring i højst en af seks JRA kernekriterier, og et minimum af to aktive led.
English: Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection along with the simultaneous appearance of injection site reactions at previous injection sites.
Danish: Derudover udviklede nogle patienter fornyede injektionsstedsreaktioner karakteriseret af en hudreaktion på det nyeste injektionssted og en samtidig fremkomst af injektionsstedsreaktioner på tidligere injektionssteder.
English: Allergic reactions associated with LIFMIOR administration have been reported commonly.
Danish: Der er hyppigt rapporteret om allergiske reaktioner associeret med indgivelse af LIFMIOR.
English: In clinical trials, no interactions have been observed when LIFMIOR was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Danish: Samtidig behandling hvor interaktioner ikke er observeret Der er ikke observeret nogen interaktion i kliniske forsøg, hvor LIFMIOR blev indgivet sammen med glukocorticoider, salicylater (undtagen sulfasalazin), non-steroide antiinflammatoriske lægemidler (NSAID), smertestillende midler eller methotrexat.
English: In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Danish: I et dobbeltblindt, placebo-kontrolleret, randomiseret klinisk studie med voksne patienter med psoriasisartrit, modtog 184 af patienterne også en multivalent pneumokok polysakkarid vaccine i uge 4.
English: However, the solution may be used for up to 6 hours when stored at temperatures of up to 25°C.
Danish: Injektionsvæsken kan dog anvendes i op til 6 timer, når den opbevares ved temperaturer på op til 25 °C.
English: Push the plunger all the way into the syringe (see Diagram 10).
Danish: Skub stemplet helt ind i sprøjten (se billede 10).
English: In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Danish: I et åbent, enkeltdosis, dobbeltbehandling, cross-over studie med raske frivillige blev etanercept givet som en enkelt 50 mg/ml injektion fundet at være bioækvivalent med to samtidige injektioner af 25 mg/ml.
English: In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive LIFMIOR for up to 10 years.
Danish: I et åbent, udvidet sikkerhedsstudie fortsatte 58 pædiatriske patienter fra ovenstående studie (i alderen fra 4 år ved studiestart) med at få LIFMIOR i op til 10 år.
English: Solution for injection in a pre-filled pen (MYCLIC)
Danish: Injektionsvæske, opløsning i fyldt pen (MYCLIC)
English: On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6).
Danish: • Injektionen er færdig, når det andet klik lyder (eller efter at der er gået 10 sekunder) (se billede 6).
English: In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with LIFMIOR at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Danish: I et andet åbent, enkelt-arm studie med 60 patienter med udvidet oligoartrit (15 patienter i alderen 2-4 år, 23 patienter i alderen 5-11 år og 22 patienter i alderen 12-17 år), 38 patienter med enthesitisrelateret artrit (i alderen 12-17 år) og 29 patienter med psoriasisartrit (i alderen 12-17 år) blev behandlet med 0,8 mg/kg LIFMIOR (op til maksimalt 50 mg per dosis) indgivet en gang om ugen i 12 uger.
English: Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Danish: Fortæl det til lægen, hvis din eller barnets hud på nogen måde ændrer udseende, eller der kommer udvækster.
English: The efficacy of LIFMIOR was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate.
Danish: Effekten af LIFMIOR blev sammenlignet med methotrexat i et randomiseret, aktivt-kontrolleret forsøg med blindet radiografisk evaluering som primært mål hos 632 vosne patienter med aktiv reumatoid artrit (<3 års varighed), som ikke tidligere var blevet behandlet med methotrexat.
English: • if the child you are caring for is allergic to etanercept or any of the other ingredients of LIFMIOR (listed in section 6).
Danish: hvis dit barn er allergisk over for etanercept eller nogle af de andre indholdsstoffer i LIFMIOR (angivet i afsnit 6).
English: After preparing the LIFMIOR solution, immediate use is recommended.
Danish: Efter tilberedning af LIFMIOR-injektionsvæsken anbefales umiddelbar brug.
English: • When the syringe is empty, remove the needle from the skin; being careful to keep it at the same angle it was when it was inserted.
Danish: • Når sprøjten er tom, skal du trække kanylen ud af huden og sørge for at holde den i den samme vinkel, som da du førte den ind.
English: The proportion of patients treated with LIFMIOR who developed anticardiolipin antibodies was similarly increased compared to placebotreated patients.
Danish: Den andel af patienter, der fik behandling med LIFMIOR, og som udviklede anticardiolipin-antistoffer, steg i samme omfang som for patienter, der fik placebo.
English: Inject slowly, at an angle of 45° to 90° to the skin.
Danish: Injicer langsomt, med en vinkel på 45
English: Non-radiographic axial spondyloarthritis
Danish: Nonradiografisk aksial spondylartrit
English: These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice weekly.
Danish: Disse middelkoncentrationer var de samme som dem, der blev observeret hos voksne patienter med plaque psoriasis behandlet med 25 mg etanercept to gange om ugen.
English: 1 Pre-filled syringe containing clear, colourless solvent (water for injections) 1 Needle
Danish: 1 fyldt injektionssprøjte indeholdende klar, farveløs solvens (vand til injektionsvæsker) 1 kanyle
English: • The pre-filled syringe is for single-use administration only.
Danish: • De fyldte injektionssprøjter er kun til engangsbrug.
English: • Press a cotton ball over the injection site for 10 seconds.
Danish: • Pres et stykke vat over injektionsstedet i 10 sekunder.
English: Compared to placebo, patients with rheumatic diseases treated with LIFMIOR had a significantly higher incidence of injection site reactions (36% vs. 9%).
Danish: Sammenlignet med placebo, forekom der en betydeligt højere procentdel af reaktioner på injektionsstedet blandt patienter med reumatiske sygdomme, som blev behandlet med LIFMIOR (36 % versus 9 %).
English: Clinical improvement including onset of action within 2 weeks with LIFMIOR 25 mg was similar to that seen in the previous trials, and was maintained for up to 24 months.
Danish: virkningsstart inden for 2 uger for LIFMIOR 25 mg var det samme, som man havde set i de tidligere forsøg, og blev vedligeholdt i op til 24 måneder.
English: The safety and efficacy profiles of the 50 mg once weekly and 25 mg twice weekly regimens were similar.
Danish: Profilerne for sikkerhed og effekt for 50 mg en gang ugentligt og 25 mg to gange ugentligt var ens.
English: • Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Danish: • Blodsygdomme: Søg omgående læge, hvis du eller barnet har nogen tegn eller symptomer som f.eks. vedvarende feber, øm hals, blå mærker, blødning eller bleghed.
English: • Place the filled syringe on the clean, flat surface.
Danish: • Stil den fyldte sprøjte på en ren, plan overflade.
English: LIFMIOR did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Danish: LIFMIOR fremkaldte ikke dosisbegrænsende eller målorgantoksicitet hos cynomolgus-aber efter subkutan indgivelse to gange ugentligt i 4 eller 26 uger i træk med en dosis (15 mg/kg), som resulterede i AUCbaserede serumkoncentrationer af stoffet, der var over 27 gange højere end dem, der blev opnået hos mennesker ved den anbefalede dosis på 25 mg.
English: LIFMIOR is administered by subcutaneous injection.
Danish: LIFMIOR indgives ved subkutan injektion.
English: The efficacy of LIFMIOR in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Danish: Voksne patienter med nonradiografisk aksial spondylartrit Effekten af LIFMIOR hos patienter med nonradiografisk aksial spondylartrit (nr-AxSpa) blev vurderet i et randomiseret, placebokontrolleret studie, der var dobbeltblindet i 12 uger.
English: L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
Danish: L-Argininhydrochlorid Natriumdihydrogenphosphatdihydrat Dinatriumphosphatdihydrat Vand til injektionsvæsker
English: Doses of 25 mg of LIFMIOR (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Danish: Doser på 25 mg LIFMIOR (baseret på dosisstudier hos patienter med reumatoid artrit) eller placebo blev indgivet subkutant to gange om ugen i 6 måneder hos 138 patienter.
English: The three recommended injection sites for LIFMIOR using a pre-filled syringe 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 1).
Danish: De tre anbefalede injektionssteder for LIFMIOR fyldt injektionssprøjte omfatter: (1) foran midt på lårene; (2) maven, undtagen i et område på 5 cm omkring navlen; og (3) bagsiden af overarmen (se billede 1).
English: 0.8†,φ a: Patients who did not complete 12 months in the study were considered to be non-responders.
Danish: Uge 52 a: Patienter, som ikke gennemførte 12 måneder af studiet, blev betragtet som ikkeresponderende.
English: Powder and solvent for solution for injection (powder for injection).
Danish: Pulver og solvens til injektionsvæske, opløsning (pulver til injektion).
English: Diagram 8
Danish: Billede 8
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys.
English: Paediatric patients with juvenile idiopathic arthritis
Danish: Pædiatriske patienter med juvenil idiopatisk artrit
English: ACR 20 Month 3
Danish: ACR 20 Måned 3 Måned 6
English: Increased etanercept concentrations were not observed in patients with acute hepatic failure.
Danish: Der blev ikke set øgede etanercept-koncentrationer hos patienter med akut leversvigt.
English: Placing the needle on the syringe
Danish: Placering af kanylen på sprøjten
English: The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma.
Danish: De mest almindeligt indberettede invasive svampeinfektioner var forårsaget af Candida, Pneumocystis og Aspergillus og Histoplasma.
English: • Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips
Danish: • Tegn på hjerteinsufficiens eller forværring af hjerteinsufficiens, som f.eks. træthed eller stakåndethed ved aktivitet, opsvulmen af anklerne, en følelse af oppustethed i nakken eller maven, stakåndethed eller hosten om natten, blåligfarvning af neglene eller rundt om læberne.
English: Wegener's granulomatosis
Danish: Wegeners granulomatose
English: Serious infections experienced by LIFMIOR-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Danish: Blandt de alvorlige infektioner, som patienter i behandling med LIFMIOR kunne blive ramt af, var cellulitis, gastroenteritis, pneumoni, kolecystit, osteomyelitis, gastritis, appendicitis, streptokok-fasciitis, myositis, septisk chok, diverticulitis og absces.
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with LIFMIOR.
Danish: • Betændelse i tarmsystemet (inflammatorisk tarmsygdom): Der har været rapporter om betændelse i tarmsystemet hos patienter med juvenil idiopatisk artrit (JIA) (børnegigt), som behandles med LIFMIOR.
English: In this study, most psoriatic arthritis patients receiving LIFMIOR were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving LIFMIOR.
Danish: I dette studie var de fleste psoriasisartrit patienter behandlet med LIFMIOR i stand til at rejse en effektivt B-celle immunrespons mod pneumokok polysakkarid vaccine, men aggregrattitrene var moderat lavere, og få patienter havde dobbelt stigning i titrene i sammenligning med patienter, som ikke fik LIFMIOR.
English: LIFMIOR is administered by an injection under the skin (by subcutaneous injection).
Danish: LIFMIOR indgives som en injektion under huden (subkutan injektion).
English: Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash
Danish: Angioedem, psoriasis (herunder nyt udbrud eller forværring og pustuløst, primært håndflader og fodsåler), urticaria, psoriasisagtigt udslæt
English: The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and plastic plunger.
Danish: Sprøjten i pennen er lavet af klar type I glas med rustfri stålkanyle (27 gauge), gumminålehætte og plastikstempel.