FrancophonIA/ELRC3.0 huggingface dataset:
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the LIFMIOR group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Danish: I en analyse, hvor alle patienter, som uanset grund udgik af studiet, blev anset for at have progression, var procentdelen af patienter uden progession (TSS ændring ≤ 0,5) efter 12 måneder højere i gruppen, som fik LIFMIOR, sammenlignet med placebogruppen (henholdsvis 73 % og 47 %, p ≤ 0,001).
English: Radiographic changes were assessed in the psoriatic arthritis study.
Danish: I psoriasisartrit studiet blev de røntgenologiske forandringer bedømt.
English: Your doctor may decide if the child needs less anti-diabetic medicine while taking LIFMIOR.
Danish: Lægen kan beslutte, at barnet skal have en mindre dosis medicin mod sukkersyge, mens barnet får LIFMIOR
English: Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentations (see below for dosing for specific indications).
Danish: Patienter, som vejer under 62,5 kg, skal doseres nøjagtigt ud fra mg/kg med anvendelse af præparater med pulver og solvens til injektionsvæske, opløsning eller pulver til injektionsvæske, opløsning (se herunder for dosering til specifikke indikationer).
English: • Hepatitis C: Tell your doctor if the child has hepatitis C. Your doctor may wish to monitor the treatment with LIFMIOR in case the infection worsens.
Danish: • Hepatitis C: Fortæl det til lægen, hvis barnet har hepatitis C. Lægen kan ønske at overvåge behandlingen med LIFMIOR, i tilfælde af at infektionen forværres.
English: There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with LIFMIOR from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Danish: Der har været rapporter om inflammatorisk tarmsygdom og uveitis hos JIA-patienter, som behandles med LIFMIOR, fra post-marketingkilder, herunder et meget lille antal tilfælde, som kunne tyde på genopblussen af symptomer ved genoptagelse af behandling (se pkt.
English: What you need to know before you use LIFMIOR
Danish: Det skal du vide, før du begynder at tage LIFMIOR
English: The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Danish: Typen af infektioner, som blev observeret i kliniske studier med patienter med juvenil idiopatisk artrit i alderen 2-18 år, var generelt lette til moderate og svarende til dem, som almindeligvis ses hos ambulante, pædiatriske populationer.
English: 3 months
Danish: 3 måneder
English: Clinical responses among nr-AxSpa patients who received LIFMIOR were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Danish: Det kliniske respons hos nr-AxSpa-patienter, der blev behandlet med LIFMIOR, var tydeligt ved det første besøg (2 uger) og blev opretholdt gennem 2 års behandling.
English: See section 5 for instructions on how to store LIFMIOR.
Danish: 5 vedrørende vejledning i opbevaring af LIFMIOR.
English: Birkendorfer Strasse 65
Danish: Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65
English: Diagram 18
Danish: Billede 18
English: The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate and sodium phosphate dibasic dihydrate, and water for injections.
Danish: Øvrige indholdsstoffer: saccharose, natriumchlorid, L-Argininhydrochlorid, natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat og vand til injektionsvæsker.
English: Please tell your doctor if you or the child in your care have a history of alcohol abuse.
Danish: Fortæl det til lægen, hvis du eller barnet har eller har haft et alkoholmisbrug.
English: Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10);
Danish: Indenfor organsystemklassifikationerne, er bivirkningerne opført under overskrifter om hyppighed (antal patienter der forventes at komme ud for reaktionen).
English: With experience, you will find the angle that is most comfortable for the child. Be careful not to push the needle into the skin too slowly, or with great force.
Danish: Vær forsigtig med ikke at presse nålen for langsomt eller med for stor kraft ind i huden.
English: 6 months
Danish: 6 måneder
English: Before injection, LIFMIOR single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes).
Danish: Før injektion bør LIFMIOR engangs fyldte penne opnå stuetemperatur (ca. 15-30 minutter).
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Danish: Den anbefalede dosis er 0,4 mg/kg (op til maksimalt 25 mg per dosis) indgivet to gange ugentligt som subkutan injektion med et interval på 3-4 dage mellem doserne, eller 0,8 mg/kg (op til maksimalt 50 mg per dosis) indgivet en gang om ugen.
English: Remove the needle cover by firmly pulling it straight off the syringe (see Diagram 2).
Danish: Fjern nålehætten ved at trække den bestemt og lige af kanylen (se billede 2).
English: With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 3).
Danish: • Pres kanylen helt ind i huden med en hurtig, kort bevægelse i en vinkel mellem 45 og 90 (se billede 3).
English: A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing
Danish: En omhyggelig risiko/benefit evaluering, incl.
English: 48 alcohol swabs
Danish: 48 alkoholservietter
English: Patients in this study received a dose of 50 mg LIFMIOR or placebo once weekly for 12 weeks and then all patients received open-label 50 mg LIFMIOR once weekly for an additional 12 weeks.
Danish: I dette studie fik patienterne en dosis LIFMIOR på 50 mg eller placebo én gang om ugen i 12 uger, og derefter fik alle patienterne open-label LIFMIOR 50 mg én gang om ugen i yderligere 12 uger.
English: • Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes.
Danish: • Medicin mod sukkersyge (diabetes): Fortæl det til lægen, hvis du eller barnet har diabetes eller tager medicin til behandling af diabetes.
English: Your doctor will determine if LIFMIOR is an appropriate treatment.
Danish: Lægen vil afgøre, om behandling med LIFMIOR er hensigtsmæssig.
English: ACR 50 Month 3
Danish: ACR 50 Måned 3 Måned 6
English: Powder: Mannitol (E421), sucrose and trometamol Solvent: Water for injections
Danish: Øvrige indholdsstoffer: Pulver: Mannitol (E421), saccharose og trometamol Solvens: Vand til injektionsvæsker
English: Doses of 25 mg of LIFMIOR (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
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.
English: Patients in this study received a dose of 25 mg or 50 mg LIFMIOR, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg LIFMIOR twice weekly for an additional 24 weeks.
Danish: Patienterne i dette studie fik en dosis LIFMIOR på 25 mg eller 50 mg, eller placebo 2 gange om ugen i 12 uger, og derefter fik alle patienter i åbent studie 25 mg LIFMIOR to gange om ugen i yderligere 24 uger.
English: The 10 mg vial is for children prescribed a dose of 10 mg or less.
Danish: Hætteglasset med 10 mg er til børn, der har fået ordineret en dosis på 10 mg eller mindre.
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using LIFMIOR.
Danish: Inden lancering i hvert medlemsland skal indehaveren af markedsføringstilladelsen blive enig med de nationale myndigheder om uddannelsesmaterialet til alle de læger, der forventes at ordinere produktet.
English: Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.
Danish: Alternativt kan 50 mg to gange om ugen indgives i op til 12 uger, efterfulgt af, hvis nødvendigt, en dosis på 25 mg to gange om ugen eller 50 mg én gang om ugen.
English: • Place the vial upright on a clean, flat surface.
Danish: • Stil hætteglasset lodret på en ren, plan overflade.
English: • Very common (may affect more than 1 in 10 people):
Danish: • Meget almindelig (forekommer hos flere end 1 ud af 10 personer):
English: Trometamol
Danish: Saccharose Trometamol
English: If the child develops symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Danish: Hvis barnet udvikler symptomer på en infektion, f.eks. feber, forkølelse eller hoste, skal du straks fortælle det til lægen.
English: Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Danish: Alternativt kan 50 mg indgives to gange om ugen i op til 12 uger efterfulgt af 25 mg to gange om ugen eller 50 mg en gang om ugen.
English: Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound.
Danish: Etanercept serumværdier blev bestemt med en ELISA metode, som kan opdage ELISA-reaktive omdannelsesprodukter så vel som moderforbindelsen.
English: *Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p<0.001, b:<0.01 and c:<0.05, respectively between LIFMIOR and placebo
Danish: ASAS** 40 ASAS 20 ASAS 5/6 ASAS delvis remission BASDAI***50 *Nogle patienter leverede ikke fuldstændige data for alle endepunkter **ASAS=Assessment in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p<0,001; b: p<0,01 og c: p<0,05 mellem henholdsvis LIFMIOR og placebo
English: • Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Danish: • Infektioner/sukkersyge (diabetes): Fortæl det til lægen, hvis du eller barnet lider af tilbagevendende infektioner, sukkersyge eller andre tilstande, hvor risikoen for infektion kan være øget.
English: 8 pre-filled syringes of 1 ml solvent 8 stainless steel injection needles 8 vial adaptors
Danish: 8 hætteglas med pulver 8 fyldte injektionssprøjter med 1 ml solvens 8 kanyler i rustfrit stål 8 hætteglasadaptere
English: Please tell your doctor if the child in your care has a history of alcohol abuse.
Danish: Fortæl det til lægen, hvis barnet har eller har haft et alkoholmisbrug.
English: • Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with LIFMIOR in case the infection worsens.
Danish: • Hepatitis C: Fortæl det til lægen, hvis du eller barnet har hepatitis C. Lægen kan ønske at overvåge behandlingen med LIFMIOR, i tilfælde af at infektionen forværres.
English: There was some evidence to support a benefit of re-treatment with LIFMIOR in patients initially responding to treatment.
Danish: Der var tegn på at patienter, som initialt responderede på LIFMIOR-behandlingen, havde gavn af en genoptagelse af LIFMIOR-behandling.
English: No study has been performed in patients with psoriatic arthritis using the 50 mg once weekly dosing regimen.
Danish: Der er ikke udført studier af patienter med psoriasisartrit, som blev behandlet med 50 mg en gang om ugen.
English: Mannitol (E421) Sucrose
Danish: Mannitol (E421) Saccharose Trometamol
English: However, the solution may be used for up to 6 hours when stored at a temperature up to 25°C.
Danish: Injektionsvæsken kan dog anvendes i op til 6 timer, når den opbevares ved højst 25 °C.
English: Doses of 10 mg or 25 mg LIFMIOR or placebo were administered subcutaneously twice a week for 6 consecutive months.
Danish: Der blev givet doser på 10 mg eller 25 mg LIFMIOR eller placebo subkutant to gange om ugen i 6 måneder i træk.
English: • With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level.
Danish: • Mens sprøjten stadig sidder i hætteglasset og adapteren, holdes hætteglasset på hovedet i øjenhøjde.
English: Contact your doctor before using LIFMIOR if the needle cover will be handled by, or LIFMIOR will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
Danish: Kontakt din læge før brug af LIFMIOR, hvis nålehætten skal håndteres af, eller LIFMIOR indgives til, en person med kendt eller mulig overfølsomhed (allergi) over for latex.
English: CARTON TEXT - EU/1/16/1165/002-004
Danish: YDERKARTON - EU/1/16/1165/002-004
English: Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products as well as the parent compound.
Danish: Etanercept-serumværdier blev bestemt med en ELISA-enzymimmunanalyse, som kan opdage ELISAreaktive omdannelsesprodukter så vel som moderforbindelsen.
English: • Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because LIFMIOR needs to be used with caution under these circumstances.
Danish: • Hjerteinsufficiens (hjertesvigt): Fortæl det til lægen, hvis barnet lider af hjerteinsufficiens, da LIFMIOR i så fald skal bruges med forsigtighed.
English: LIFMIOR once weekly (n=21) vs. 25 mg LIFMIOR twice weekly (n=16), respectively.
Danish: 316 mg•t/l for LIFMIOR 50 mg en gang om ugen (n=21) vs. LIFMIOR 25 mg to gange om ugen (n=16).
English: • Infections/diabetes: Tell your doctor if the child has a history of recurrent infections, or suffers from diabetes or other conditions that increase the risk of infection.
Danish: • Infektioner/sukkersyge (diabetes): Fortæl det til lægen, hvis barnet lider af tilbagevendende infektioner, sukkersyge eller andre tilstande, hvor risikoen for infektion kan være øget.
English: Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Danish: Saccharose, natriumchlorid, L-Argininhydrochlorid, natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat og vand til injektionsvæsker.
English: The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks.
Danish: Den anbefalede dosis er 0,8 mg/kg (op til et maksimum på 50 mg per dosis) en gang om ugen i op til 24 uger.
English: 8 pre-filled syringes 8 alcohol swabs
Danish: 8 fyldte injektionssprøjter 8 alkoholservietter
English: A bandage is optional.
Danish: Brug af bandage efter ønske.
English: 12 MYCLIC pre-filled pens 12 alcohol swabs
Danish: 12 MYCLIC fyldte penne 12 alkoholservietter
English: In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of LIFMIOR and methotrexate did not result in unexpected safety findings, and the safety profile of LIFMIOR when given in combination with methotrexate was similar to the profiles reported in studies of LIFMIOR and methotrexate alone.
Danish: I en kontrolleret klinisk afprøvning af to års varighed med patienter med reumatoid artrit resulterede kombinationen LIFMIOR og methotrexat ikke i uventede sikkerhedsfund, og sikkerhedsprofilen for LIFMIOR givet i kombination med methotrexat var den samme som de profiler, der er rapporteret fra studier af LIFMIOR og methotrexat alene.
English: Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy).
Danish: 4.8); Derudover har der i sjældne tilfælde været rapporteret om perifere demyeliniserende polyneuropatier (herunder Guillain-Barré-syndrom, kronisk inflammatorisk demyeliniserende polyneuropati, demyeliniserende polyneuropati og multifokal motorisk neuropati).
English: LIFMIOR in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Danish: LIFMIOR i kombination med methotrexat er indikeret til behandling af moderat til svær, aktiv reumatoid artrit hos voksne, hvor responset på sygdomsmodificerende antireumatiske lægemidler incl.
English: • Signs of blood disorders, such as bleeding, bruising, or paleness
Danish: • Tegn på blodsygdom, som f.eks. blødning, blå mærker eller bleghed.
English: Diagram 17
Danish: Billede 17
English: The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies.
Danish: To observationskohortestudier har undersøgt etanercepts virkning på graviditet.
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because LIFMIOR needs to be used with caution under these circumstances.
Danish: • Hjerteinsufficiens (hjertesvigt): Fortæl det til lægen, hvis du eller barnet lider af hjerteinsufficiens, da LIFMIOR i så fald skal bruges med forsigtighed.
English: Axial spondyloarthritis
Danish: Aksial spondylartrit
English: Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
Danish: Etanercept er en kompetitiv inhibitor af TNF-binding til celleoverfladereceptorer og hæmmer dermed TNF's biologiske aktivitet.
English: In study 1, the LIFMIOR-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001).
Danish: I studie 1 var der efter 12 uger et signifikant større antal patienter med PASI 75-respons i den LIFMIOR behandlede gruppe (30 %) sammenlignet med den placebo behandlede gruppe (2 %) (p<0,0001).
English: Renal and hepatic impairment No dose adjustment is required.
Danish: Nyre- eller leversvækkelse Der kræves ingen dosisjustering.
English: 16 alcohol swabs
Danish: 16 alkoholservietter
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with LIFMIOR alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of LIFMIOR and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Danish: I et andet aktivt kontrolleret, dobbeltblindt, randomiseret studie blev klinisk effekt, sikkerhed og radiografisk progession hos patienter med reumatoid artrit behandlet med LIFMIOR alene (25 mg to gange om ugen), methotrexat alene (7,5 til 20 mg om ugen, median dosis 20 mg) og en kombination af LIFMIOR og methotrexat påbegyndt samtidig, sammenlignet hos 682 voksne patienter med aktiv reumatoid artrit af 6 måneder til 20 års varighed (median 5 år), som havde en mindre end tilfredsstillende respons på mindst et sygdomsmodificerende antireumatisk lægemiddel (DMARD) bortset fra methotrexat.
English: In adults (aged 18 and over), LIFMIOR can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Danish: Hos voksne (18 år eller derover) kan LIFMIOR anvendes til moderat til svær reumatoid artrit (leddegigt), psoriasisartrit (psoriasisgigt), svær aksial spondylartrit, herunder ankyloserende spondylitis (rygsøjlegigt), og moderat eller svær psoriasis.
English: The needle cover should not be removed while allowing the prefilled pen to reach room temperature.
Danish: Nålehætten skal ikke fjernes, imens den fyldte pen opnår stuetemperatur.
English: Diagram 5
Danish: Billede 5
English: Before injection, LIFMIOR single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes).
Danish: Før injektion bør LIFMIOR engangs fyldte injektionssprøjter få stuetemperatur (ca. 15-30 minutter).
English: Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving ≥ 10% of the body surface area that were ≥ 18 years old.
Danish: Studie 1, som er et fase 2 studie med patienter med aktiv, men klinisk stabil plaque psoriasis omfattende  10 % af kroppens overflade areal.
English: 45a
Danish: 4.5 og
English: Solvent Water for injections
Danish: Solvens Vand til injektionsvæsker
English: LIFMIOR is available in strengths of 10, 25 and 50 mg.
Danish: LIFMIOR findes i styrkerne 10 mg, 25 mg og 50 mg.
English: Respiratory, thoracic, and mediastinal disorders
Danish: Luftveje, thorax og mediastinum
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using LIFMIOR in patients who have congestive heart failure (CHF).
Danish: Læger bør udvise forsigtighed ved brug af LIFMIOR i patienter med kongestiv hjerteinsufficiens (CHF).
English: Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with LIFMIOR (11%) than in placebo-treated patients (5%).
Danish: Af de patienter med reumatoid artrit, som blev evalueret for antinukleare antistoffer (ANA), var den procentdel af patienter, som udviklede nye positive antinukleare antistoffer (1:40), højere hos patienter, som modtog behandling med LIFMIOR (11 %), end hos patienter med placebo-behandling (5 %).
English: 2 Alcohol swabs
Danish: 2 alkoholservietter
English: Diagram 9
Danish: Billede 9
English: LIFMIOR 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Danish: Dosen på 10 mg LIFMIOR havde gennemgående mindre effekt på den strukturelle skade end dosen på 25 mg. LIFMIOR 25 mg var signifikant bedre end methotrexat med hensyn til erosion score efter både 12 og 24 måneder.
English: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Danish: Behandling af voksne med moderat til svær plaque psoriasis, som har vist utilstrækkeligt respons på, eller viste sig at være intolerante overfor, anden systemisk behandling inklusiv ciclosporin, methotrexat eller psoralen og ultraviolet-A lys (PUVA) eller hvor den systemiske behandling inklusiv ciclosporin, methotrexat eller PUVA er kontraindiceret (se pkt.