FrancophonIA/ELRC3.0 huggingface dataset:
English: If the child has any of the above symptoms he/she may be having an allergic reaction to LIFMIOR, so you should seek immediate medical attention.
Danish: Hvis barnet har nogen af ovennævnte symptomer, kan han/hun have en allergisk reaktion over for LIFMIOR, og du skal derfor søge øjeblikkelig lægehjælp.
English: LIFMIOR was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Danish: LIFMIOR var signifikant bedre end placebo på alle mål for sygdomsaktivitet (p<0,001), og responset var det samme med og uden samtidig methotrexat behandling.
English: • Psoriatic arthritis in patients from the age of 12 years
Danish: • Psoriasisgigt hos patienter fra 12 år.
English: In patients who develop HBV infection, LIFMIOR should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Patienter, der udvikler HBV-infektion, bør stoppe behandlingen med LIFMIOR og starte effektiv antiviral behandling med passende supportiv behandling.
English: • if you or the child have, or are at risk of developing a serious blood infection called sepsis.
Danish: • hvis du eller barnet har eller er i risiko for at udvikle en alvorlig blodinfektion kaldet sepsis (blodforgiftning).
English: The long-term safety of LIFMIOR in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Danish: Sikkerheden på lang sigt ved LIFMIORbehandling i kombination med andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) er ikke fastslået.
English: Some patients receiving LIFMIOR have developed skin cancers.
Danish: • Nogle patienter i behandling med LIFMIOR har udviklet hudkræft.
English: • Remove the plastic cap from the LIFMIOR vial (see Diagram 1).
Danish: • Fjern plastikhætten fra LIFMIOR-hætteglasset (se billede 1).
English: Treatment with LIFMIOR may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Danish: Behandling med LIFMIOR kan medføre genopblussen af hepatitis B hos patienter, som tidligere har haft hepatitis B-infektion.
English: Women using LIFMIOR should not breast-feed, since LIFMIOR passes into human breast milk.
Danish: Kvinder i LIFMIOR-behandling må ikke amme, da LIFMIOR passerer over i mælken.
English: Month 12
Danish: Måned 12
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for udvikling af maligniteter hos børn og yngre voksne behandlet med TNF-antagonister.
English: 1 LIFMIOR vial
Danish: 1 LIFMIOR hætteglas
English: At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Danish: Ved baseline havde patienterne en moderat grad af handicap, med en gennemsnitlig score på 1,4 til 1,5 ud fra deres spørgeskema om helbredstilstand (SHT).
English: Patients should be tested for HBV infection before initiating treatment with LIFMIOR.
Danish: Patienter bør testes for HBV-infektion inden opstart af behandling med LIFMIOR.
English: Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Danish: Forhøjede TNF-niveauer er også fundet i synovia og psoriasis plaque hos patienter med psoriasisartrit og i serum og synovialt væv hos patienter med ankyloserende spondylitis.
English: • Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with LIFMIOR.
Danish: • Din læge vil give dig et 'Patientkort', som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandlingen med LIFMIOR.
English: Among patients receiving LIFMIOR, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.
Danish: Blandt de patienter, der fik LIFMIOR, viste de kliniske reaktioner sig generelt inden for 1-2 uger efter påbegyndelse af behandlingen og skete næsten altid senest måned 3.
English: One rheumatoid arthritis patient mistakenly self-administered 62 mg LIFMIOR subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Danish: En patient med reumatoid artrit tog ved en fejltagelse 62 mg LIFMIOR subkutant to gange om ugen i tre uger uden at registrere uønskede virkninger.
English: The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
Danish: I studiet blev 215 voksne patienter (modificeret intent-to-treat-population) i alderen 18 til 49 år med aktiv nrAxSpa, defineret som de patienter, der opfyldte ASAS-klassifikationskriterierne for aksial spondylartrit, men ikke opfyldte de modificerede New York-kriterier for AS, vurderet.
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Danish: Dette omfatter rapporter om reaktivering af hepatitis B hos patienter, som var anti-HBc-positive, men HBsAg-negative.
English: Contents of the pack and other information 7.
Danish: Pakningsstørrelser og yderligere oplysninger 7.
English: Live vaccines should not be given concurrently with LIFMIOR.
Danish: Levende vacciner bør ikke gives samtidigt med LIFMIOR.
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Danish: I de dobbeltblinde og åbne studier med psoriasis arthritis indberettede én patient en alvorlig infektion (pneumoni).
English: Efficacy Response in Placebo-Controlled nr-AxSpa Study: Percent of Patients Achieving Endpoints Double-Blind Clinical Responses at Week 12
Danish: Effektrespons i placebokontrolleret nr-AxSpa-studie: Procentdel af patienter, der opnåede endepunkterne Dobbeltblindet klinisk respons i uge 12
English: LIFMIOR is prescribed for the treatment of the following diseases in children and adolescents
Danish: LIFMIOR ordineres til behandling af følgende sygdomme hos børn og unge:
English: If you are self injecting, you should not use the outer area of the upper arms.
Danish: Hvis du skal injicere dig selv, skal du ikke anvende bagsiden af overarmen.
English: The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
Danish: Andelen af patienter, som udvikler antistoffer mod etanercept i langtidsstudier (af op til 3,5 års varighed), stiger over tid som forventet.
English: At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
Danish: I uge 104 var der 8 patienter, som havde forværring til en bilateral score grad 2 ved røntgen af rygsøjlen jf. den modificerede NewYork Radiological Grade, hvilket tyder på axial spondylartropati.
English: Whilst pushing the pen firmly against the skin to ensure that the needle safety shield is fully depressed inside the pen, press the centre of the green button on top of the pen with your thumb to start the injection (see Diagram 5).
Danish: • Mens pennen presses fast mod huden for at sikre, at sikkerhedshætten er presset helt ind i pennen, skal du trykke med tommelfingeren midt på den grønne aktiveringsknap øverst på pennen for at begynde injektionen (se billede 5).
English: However, your doctor may determine an alternative frequency at which to inject LIFMIOR.
Danish: Lægen kan dog beslutte en anden hyppighed for injicering af LIFMIOR.
English: Methotrexate (n = 228)
Danish: Methotrexat (n = 228)
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) Tηλ: +357 22 817690
Danish: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T : +357 22 817690
English: Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Danish: Blandt patienter, som gennemførte studiets 24 måneders behandling, var ikke-progressionsraterne henholdsvis 78 %, 70 % og 61 %.
English: Tell the doctor if the child develops any abdominal cramps and pain, diarrhoea, weight loss or blood in the stool.
Danish: Fortæl lægen, hvis barnet får mavekramper eller mavesmerter, diarré, vægttab eller blod i afføringen.
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Danish: Alternativt kan 50 mg indgives en gang om ugen, hvilket har vist sig at være sikkert og effektivt (se pkt.
English: • Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
Danish: • Kraftigt udslæt, kløe eller nældefeber (hævede pletter af rød eller bleg hud, som ofte klør).
English: A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Danish: Der blev besvaret et spørgeskema om helbredstilstand (SHT), omfattende handicap, vitalitet, mentalhygiejne, generel sundhedstilstand og helbredsstatus for arthritis-afhængige underområder hver 3. måned under forsøget.
English: Patients in the LIFMIOR in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Danish: Gruppen af patienter i behandling med LIFMIOR i kombination med methotrexat havde signifikant højere ACR 20, ACR 50, ACR 70 respons og forbedring af DAS og HAQ score ved både 24 og 52 uger end patienterne i hver af enkeltterapi grupperne (resultater vises neden for).
English: Non-melanoma skin cancers* (see section 4.4)
Danish: Ikke-melanom hudkræft* (se pkt.
English: If active tuberculosis is diagnosed, LIFMIOR therapy must not be initiated.
Danish: Hvis diagnosen aktiv tuberkulose stilles, må behandling med LIFMIOR ikke påbegyndes.
English: Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Danish: Etanercept udskilles i human mælk efter subkutan administration.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with LIFMIOR, relative to placebo (p < 0.001).
Danish: Scoren på invaliditetsindekset blev signifikant forbedret på alle tidspunkter hos patienter med psoriasisartrit i behandling med LIFMIOR i sammenligning med placebo (p<0,001).
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including LIFMIOR, in the postmarketing setting.
Danish: Efter markedsføring er der rapporteret om maligniteter, heraf nogle letale, hos børn, unge og unge voksne (op til 22 år), der er behandlet med TNF-antagonister (start på behandling ≤ 18 år), herunder LIFMIOR.
English: Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Danish: Fortæl det straks til lægen eller tag på skadesstuen på det nærmeste hospital.
English: • While holding the vial upright on the flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial.
Danish: • Hold hætteglasset lodret på den plane overflade og skub stemplet MEGET LANGSOMT ind, indtil al solvens er i hætteglasset.
English: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Danish: Interstitiel lungesygdom (herunder pneumonitis og lungefibrose)*
English: • Alcohol abuse: LIFMIOR should not be used for the treatment of hepatitis related to alcohol abuse.
Danish: • Alkoholmisbrug: LIFMIOR må ikke bruges til behandling af hepatitis i forbindelse med alkoholmisbrug.
English: Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months.
Danish: Methotrexatdoser blev gradvist øget fra 7,5 mg/uge til en maksimal dosis på 20 mg/uge over de første 8 uger af forsøget og fortsatte herefter i op til 24 uger.
English: After you have withdrawn the LIFMIOR from the vial, you may have some air in the syringe.
Danish: Efter at have trukket LIFMIOR ud af hætteglasset kan der være noget luft i sprøjten.
English: However, due to their transient nature, the incidence of antibodies detected at each assessment point was typically less than 7% in rheumatoid arthritis subjects and psoriasis subjects.
Danish: Da antistofferne er forbigående af natur, var incidensen af antistofdannelse ved hvert bedømmelsespunkt typisk mindre end 7 % af patienterne med reumatoid artrit og psoriasis.
English: There were no differences in rates of infection among patients treated with LIFMIOR and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Danish: Der var ingen forskel i infektionsraten blandt patienter behandlet med LIFMIOR og patienter, som fik placebo mod plaque psoriasis, i placebokontrollerede studier af op til 24 ugers varighed.
English: DSGA b, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving LIFMIOR 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Danish: b, klar eller næsten klar *p  0,0001 sammenlignet med placebo a. Der blev ikke foretaget nogen statistisk sammenligning med placebo ved uge 24 i studie 2 og 4, fordi den oprindelige placebogruppe begyndte at få LIFMIOR 25 mg to gange om ugen eller 50 mg én gang om ugen fra uge 13 til uge 24. b. Dermatologist Static Global Assessment.
English: †Please see sub-section ‘Undesirable effects in paediatric patients with juvenile idiopathic arthritis' above.
Danish: † Se ovenstående afsnit om ”Uønskede virkninger hos pædiatriske patienter med juvenil idiopatisk arthrit.”
English: In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with LIFMIOR developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
Danish: I kontrollerede studier med patienter med plaque psoriasis fik ca. 13,6 % af patienterne behandlet med LIFMIOR reaktioner på injektionsstedet i løbet af de første 12 ugers behandling sammenlignet med 3,4 % af patienterne behandlet med placebo.
English: • if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of LIFMIOR (listed in section 6).
Danish: • hvis du eller dit barn, er allergiske over for etanercept eller et af de øvrige indholdsstoffer i LIFMIOR (angivet i afsnit 6).
English: • Wegener's granulomatosis: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Danish: • Wegeners granulomatose: LIFMIOR anbefales ikke til behandling af Wegeners granulomatose, en sjælden betændelsessygdom.
English: 25 mg LIFMIOR administered twice weekly is the recommended dose.
Danish: 25 mg LIFMIOR, indgivet to gange om ugen, er den anbefalede dosis.
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Danish: Etanercepts specifikke aktivitet er 1,7 x 10
English: Do not touch the needle or allow it to touch any surface.
Danish: Rør ikke nålen og undgå at nålen rører nogen overflader.
English: However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Danish: Begrænsede sikkerhedsdata fra et patientregister tyder dog på, at sikkerhedsprofilen hos børn i alderen 2-3 år svarer til sikkerhedsprofilen hos voksne og børn på 4 år og derover ved doser på 0,8 mg/kg s.c. ugentligt (se pkt.
English: Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during LIFMIOR therapy and for three weeks after discontinuation of therapy.
Danish: Kvinder i den fertile alder skal overveje at anvende sikker kontraception under behandlingen med LIFMIOR og i 3 uger efter behandlingen for at undgå graviditet.
English: The use of LIFMIOR in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Danish: Brugen af LIFMIOR i kombination med andre systemiske behandlinger eller lysbehandling til behandling af psoriasis er ikke undersøgt.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all LIFMIOR-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Danish: I uge 104 var den gennemsnitlige ændring fra baseline i SPARCC-scoren målt ved hjælp af MR hos alle patienter, der fik LIFMIOR 4,64 for SI-leddet (n=153) og 1,40 for rygsøjlen (n=154).
English: Keep the pre-filled pens in the outer carton in order to protect from light.
Danish: Opbevar den fyldte pen i den ydre karton for at beskytte mod lys.
English: The pen can only be activated when the needle shield is completely pushed inside the pen.
Danish: Pennen kan kun aktiveres, når sikkerhedshætten er presset helt ind i pennen.
English: However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections.
Danish: Der skal dog udvises forsigtighed ved behandling af ældre patienter, specielt med henblik på forekomst af infektioner.
English: LIFMIOR is supplied with pre-filled syringes containing water for injection.
Danish: LIFMIOR leveres med fyldte injektionssprøjter, som indeholder vand til injektionsvæsker.
English: Always use this medicine exactly as the doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: You or the child should not use LIFMIOR with medicines that contain the active substance anakinra or abatacept.
Danish: Du eller barnet bør ikke bruge LIFMIOR sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: The differences in TSS and JSN were not statistically significant between methotrexate and LIFMIOR 25 mg.
Danish: Forskellene i TSS og JSN mellem methotrexat og LIFMIOR 25 mg var ikke statistisk signifikant.
English: • Infections/monitoring: Tell your doctor of any recent travel outside the European region.
Danish: • Infektioner/overvågning: Fortæl det til lægen, hvis barnet for nylig har rejst uden for Europa.
English: Do NOT touch this area again before giving the injection.
Danish: Rør ikke dette område igen før injektionen.
English: • Do not use the syringe if the perforation between the tip and collar is already broken.
Danish: • Brug ikke sprøjten, hvis perforeringen mellem spidsen og kraven allerede er brudt.
English: In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which LIFMIOR was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with LIFMIOR or sulfasalazine alone.
Danish: I et klinisk studie med voksne patienter i behandling med sulfasalazin, hvortil LIFMIOR blev tilføjet, havde patienterne i kombinationsgruppen et statistisk signifikant fald i middelværdierne for hvide blodlegemer sammenlignet med grupperne, der blev behandlet med enten LIFMIOR eller sulfasalazin.
English: The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
Danish: Studiet evaluerede 234 voksne patienter med aktiv reumatoid artrit, hvor behandlingen var mislykkedes med mindst ét men ikke flere end fire sygdomsmodificerende antireumatiske lægemidler (DMARDs).
English: Step 2: Choosing an injection site (see Diagram 2)
Danish: Trin 2: Valg af injektionssted (se billede 2)
English: Carefully dispose of any LIFMIOR solution that has not been injected within 6 hours.
Danish: Bortskaf omhyggeligt eventuel resterende LIFMIOR-injektionsvæske, der ikke er blevet injiceret i løbet af 6 timer.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Danish: Behandling af aktiv og progressiv psoriasisartrit hos voksne, hvor responset på tidligere sygdomsmodificerende antireumatisk medicinsk behandling har været utilstrækkeligt.
English: Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis.
Danish: Tumornekrosefaktor (TNF) er et dominerende cytokin i betændelsesprocessen ved reumatoid artrit.
English: Evidence of efficacy for the once weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis.
Danish: Evidens for effekt af behandlingen med én ugentlig dosis hos denne patientgruppe er baseret på data fra studiet af patienter med ankyloserende spondylitis.
English: Always leave the pen out of sight and reach of children.
Danish: Pennen må aldrig efterlades inden for børns syns- og rækkevidde.
English: Doing so could cause the liquid to leak out.
Danish: Det kan få væsken til at løbe ud.
English: LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of juvenile idiopathic arthritis or paediatric plaque psoriasis.
Danish: Behandling med LIFMIOR bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af juvenil idiopatisk artrit eller pædiatrisk plaque psoriasis.
English: Compared to placebo, treatment with LIFMIOR resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Danish: Sammenlignet med placebo resulterede behandling med LIFMIOR i signifikante forbedringer i ASAS 20, ASAS 50 og ASAS 70 så tidligt som 2 uger efter påbegyndelse af behandling.
English: Do not attempt to recap the pen.
Danish: Forsøg ikke at sætte hætten på pennen igen.
English: Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept.
Danish: Udviklingstoksicitetsstudier på rotter og kaniner har ikke afsløret nogen tegn på skader på fostre eller nyfødte rotter på grund af etanercept.
English: Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of LIFMIOR compared to the 349 adult rheumatoid arthritis patients.
Danish: Flere bivirkninger blev rapporteret hyppigere hos 69 patienter med juvenil idiopatisk artrit, som fik LIFMIOR i 3 måneder, i sammenligning med 349 voksne patienter med reumatoid artrit.
English: Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on LIFMIOR continued to improve from month 3 through month 7, while those who received placebo did not improve.
Danish: Af de patienter, som viste klinisk respons på 90 dage og indgik i anden del af studiet, fortsatte forbedringen hos nogle af patienterne, som fortsatte med LIFMIOR, fra måned 3 til måned 7, mens de, der fik placebo, ikke blev bedre.