FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with LIFMIOR compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with LIFMIOR compared to none of placebo-treated patients).
Danish: Den procentdel af patienter, som udviklede nye positive anti-dobbeltstrengede DNA-antistoffer, var også højere ved radioimmunbestemmelse (15 % af patienter, der blev behandlet med LIFMIOR, sammenlignet med 4 % af de patienter, der fik placebo) og ved Crithidia liciliae-bestemmelse (3 % af patienter, der blev behandlet med LIFMIOR sammenlignet med ingen af de patienter, der fik placebo).
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with LIFMIOR for up to approximately 6 years, including 231 patients treated with LIFMIOR in combination with methotrexate in the 2-year active-controlled study.
Danish: Der er observeret 129 nye maligniteter af forskellig type hos 4.114 patienter med reumatoid artrit, som i kliniske forsøg blev behandlet med LIFMIOR i op til ca. 6 år, inklusiv 231 patienter behandlet med LIFMIOR i kombination med methotrexat i det to-årige aktivt kontrollerede forsøg.
English: • Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg
Danish: • Tegn på nervesygdom, som f.eks. følelsesløshed eller snurren, synsforstyrrelser, øjensmerte eller pludselig svaghed i en arm eller ben.
English: Various malignancies have also been reported with use of LIFMIOR, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Danish: Der er også rapporteret om forskellige maligniteter i forbindelse med brugen af LIFMIOR, herunder cancer i bryst, lunger, hud og lymfekirtler (lymfom).
English: Concurrent treatment with sulfasalazine
Danish: Samtidig behandling med sulfasalazin
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 LIFMIOR-treated psoriatic arthritis patients.
Danish: Der blev rapporteret om ialt 2 maligniteter i kliniske studier af ca. 2 års varighed omfattende 240 patienter med psoriasisartrit behandlet med LIFMIOR.
English: Your doctor will determine if preventive treatment for chickenpox is appropriate.
Danish: Lægen vil afgøre, om forebyggende behandling mod skoldkopper er hensigtsmæssig.
English: Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available.
Danish: Der foreligger ikke tilstrækkelige data fra HBV-inficerede patienter, der har fået antiviral behandling samtidig med TNFantagonist-behandling.
English: • Blood disorders: Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Danish: • Blodsygdomme: Søg omgående læge, hvis barnet har nogen tegn eller symptomer som f.eks. vedvarende feber, øm hals, blå mærker, blødning eller bleghed.
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue
Danish: • Tegn på lupus eller lupuslignende syndrom, herunder vægtændringer, vedvarende udslæt, feber led- eller muskelsmerter, eller træthed.
English: Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Danish: Patienter med pædiatrisk plaque psoriasis (i alderen 4 til 17 år) fik indgivet 0,8 mg/kg (op til en maksimumdosis på 50 mg) etanercept en gang om ugen i op til 48 uger.
English: • Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints
Danish: • Tegn på alvorlig infektion, som f.eks. høj feber evt. ledsaget af hoste, stakåndethed, kuldegysninger, slaphed eller et varmt, rødt, ømt, smertende område på hud eller led.
English: Step 1: Setting up for an injection
Danish: Trin 1: Forberedelse til injektion
English: a. p = 0.0001.
Danish: SE = standard error a. p = 0,0001
English: • While still in the plastic package, place the vial adaptor on top of the LIFMIOR vial so that the vial adaptor spike is centered within the raised circle on top of the vial stopper (see Diagram 2).
Danish: • Placer adapteren på toppen af LIFMIOR hætteglasset, mens den stadig er i plastikbeholderen, så spidsen på adapteren er placeret midt i den markerede cirkel på toppen af hætteglassets prop (se billede 2).
English: At week 12, more patients randomised to LIFMIOR had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
Danish: Efter 12 uger havde flere patienter, der var randomiseret til LIFMIOR, positiv effekt-respons (f.eks. PASI 75) end patienter, der var randomiseret til placebo.
English: demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Danish: de polyneuropati og multifokal motorisk neuropati (se pkt 4.4), anfald
English: Pre-filled pen (MYCLIC) containing a pre-filled syringe of LIFMIOR.
Danish: Fyldt pen (MYCLIC) indeholdende en fyldte sprøjte med LIFMIOR.
English: • Nervous system and eye disorders: Tell your doctor if the child has multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Danish: • Sygdomme i nervesystemet og øjnene: Fortæl det til lægen, hvis barnet lider af dissemineret sklerose, betændelse i øjets nerver (optisk neuritis) eller betændelse i rygmarven (transversel myelitis).
English: • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with LIFMIOR.
Danish: • Infektioner/operation: Hvis du eller barnet udvikler en ny infektion eller skal gennemgå en større operation i den nærmeste fremtid, vil lægen muligvis ønske at overvåge behandlingen med LIFMIOR.
English: If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Danish: Hvis du skulle få symptomer på tuberkulose (som f.eks. vedvarende hoste, vægttab, sløvhed, let feber) eller nogen anden infektion under eller efter behandlingen, skal du straks fortælle det til lægen.
English: Undesirable effects in paediatric patients with plaque psoriasis In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Danish: Uønskede virkninger hos pædiatriske patienter med plaque psoriasis I et studie af 48 ugers varighed med 211 børn i alderen 4 til 17 år med pædiatrisk plaque psoriasis var de indberettede bivirkninger de samme som dem, man havde set i tidligere studier hos voksne med plaque psoriasis.
English: • This medicine has been prescribed for a child in your care.
Danish: • Lægen har ordineret LIFMIOR til et barn, som du har ansvar for.
English: These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Danish: Disse infektioner omfattede f.eks. absces (forskellige steder), bakteriæmi, bronkitis, bursitis, cellulitis, cholecystitis, diaré, diverticulitis, endocarditis (mistænkt), gastroenteritis, hepatitis B, herpes zoster, sår på benene, infektioner i munden, osteomyelitis, otitis, peritonitis, pneumoni, pyelonephritis, sepsis, septisk arthritis, sinusitis, hudinfektion, sår på huden, urinvejsinfektion, vasculitis og sårinfektion.
English: The needle cover contains dry natural rubber (latex) (see section 4.4).
Danish: Nålehætten indeholder tør naturgummi (latex) (se pkt.
English: Remove one pre-filled syringe and one alcohol swab and place them on the work surface.
Danish: Tag en fyldt injektionssprøjte og en alkoholserviet og anbring dem på arbejdsfladen.
English: Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Danish: Behandling af enthesitis-relateret artrit hos unge i alderen fra 12 år, som har vist utilstrækkeligt respons på eller intolerans over for konventionel behandling.
English: • Infections/surgery: If the child develops a new infection, or is about to have any major surgery, the doctor may wish to monitor the child's treatment with LIFMIOR.
Danish: • Infektioner/operation: Hvis barnet udvikler en ny infektion eller skal gennemgå en større operation i den nærmeste fremtid, vil lægen muligvis ønske at overvåge barnets behandling med LIFMIOR.
English: Worsening of cardiac failure congestive (see section 4.4)
Danish: Forværring af hjerteinsufficiens (se pkt.
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Danish: anti-neutrofil cytoplasmatisk antistof-positiv vaskulitis)
English: No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed.
Danish: Studiet påviste ikke en øget hyppighed af spontan abort, dødsfødsel, for tidlig fødsel eller mindre misdannelser.
English: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 μg•hr/ml and 474 μg•hr/ml for 50 mg LIFMIOR once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Danish: I en farmakokinetisk populationsanalyse af patienter med ankyloserende spondylitis var etanercept steadystate-AUC henholdsvis 466 g•t/ml og 474 g•t/ml for 50 mg LIFMIOR en gang om ugen (N = 154) og 25 mg to gange om ugen (N = 148).
English: A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
Danish: Ét observationsstudie viste, at der var en øget hyppighed af alvorlige medførte misdannelser hos kvinder eksponeret for etanercept (n=370) i første trimester sammenlignet med kvinder, der ikke var blevet eksponeret for etanercept eller andre TNF-antagonister (n=164) under graviditeten (justeret oddsratio 2,4; 95 % CI: 1,0-5,5).
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, tumornekrosefaktor-alfa (TNF-α) hæmmere.
English: LIFMIOR powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Danish: LIFMIOR pulver til injektionsvæske skal rekonstitueres i 1 ml solvens inden brug (se pkt.
English: The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Danish: Den almindelige dosis er 25 mg to gange om ugen eller 50 mg en gang om ugen givet som en injektion under huden.
English: • Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Danish: • Sygdomme i nervesystemet eller øjnene: Fortæl det til lægen, hvis du eller barnet lider af dissemineret sklerose, betændelse i øjets nerver (optisk neuritis) eller betændelse i rygmarven (transversel myelitis).
English: The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of LIFMIOR in adult patients with rheumatoid arthritis, and the majority were mild.
Danish: Typerne og andelen af andre bivirkninger hos patienter med juvenil idiopatisk artrit var de samme som dem, man så i studier af LIFMIOR til voksne patienter med reumatoid artrit, og hovedparten var milde.
English: Adult patients with ankylosing spondylitis
Danish: Voksne patienter med ankyloserende spondylitis
English: LIFMIOR was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Danish: LIFMIOR blev givet i doser på 25 mg en gang om ugen, 25 mg to gange om ugen eller 50 mg to gange om ugen i 6 på hinanden følgende måneder.
English: If re-treatment with LIFMIOR is indicated, the above guidance on treatment duration should be followed.
Danish: Ovenstående anbefalinger vedrørende behandlingsvarighed bør følges, hvis gentagen behandling med LIFMIOR er indiceret.
English: Disposing of supplies
Danish: Bortskaffelse af udstyr
English: Do NOT inject into areas where the skin is tender, bruised, red, or hard.
Danish: Du må ikke give en injektion på et område, hvor huden er øm, stødt, rød eller hård.
English: It is recommended that the conduct of these tests should be recorded in the patient's alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: Receptudstedernes opmærksomhed henledes på risikoen for falsk negative resultater af Mantoux-testen, specielt hos patienter som er alvorligt syge eller immunforsvarskompromitterede.
English: LIFMIOR 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Danish: LIFMIOR 25 mg leveres som et hvidt pulver og solvens til opløsning til injektion (pulver til injektion).
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients (see below, Undesirable effects in adults).
Danish: Uønskede virkninger hos pædiatriske patienter med juvenil idiopatisk arthrit Generelt var bivirkningerne hos de pædiatriske patienter af samme hyppighed og type som dem, man så hos voksne patienter (se nedenfor, Uønskede virkninger hos voksne).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: This section presents data from three studies in juvenile idiopathic arthritis, one study in paediatric patients with plaque psoriasis, four studies in adults with rheumatoid arthritis, and four studies in adults with plaque psoriasis.
Danish: Dette afsnit indeholder data fra tre studier hos patienter med juvenil idiopatisk artrit, et studie hos pædiatriske patienter med plaque psoriasis, fire studier med reumatoid artrit hos voksne og fire studier med plaque psoriasis hos voksne.
English: In study 4, the LIFMIOR-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
Danish: I studie 4 havde gruppen, som blev behandlet med LIFMIOR, en højere andel af patienter med PASI 75 i uge 12 (38 %) sammenlignet med gruppen, som fik placebo (2 %) (p<0,0001).
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 24 months was higher in the LIFMIOR in combination with methotrexate group compared with the LIFMIOR alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
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 24 måneder højere i gruppen, som fik LIFMIOR i kombination med methotrexat sammenlignet med grupperne som fik LIFMIOR alene og methotrexat alene (henholdsvis 62 %, 50 %, og 36 %; p<0,05).
English: Do NOT remove the needle cover while allowing it to reach room temperature.
Danish: FJERN IKKE nålehætten mens det opnår stuetemperatur.
English: Whilst waiting for the solution in the pen to reach room temperature, read Step 2 (below), and choose an injection site.
Danish: Læs trin 2 (neden for), mens du venter på, at pennen opnår stuetemperatur, og vælg et injektionssted.
English: Step 1: Setting up for an injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of supplies
Danish: Trin 1: Forberedelse til injektion Trin 2: Valg af injektionssted Trin 3: Injektion af LIFMIOR injektionsvæsken Trin 4: Bortskaffelse af udstyr
English: The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
Danish: Dosis bør være 0,8 mg/kg (op til et maksimum på 50 mg per dosis) en gang om ugen.
English: In a polyarticular-course juvenile idiopathic arthritis trial with LIFMIOR, 69 patients (aged 4 to 17 years) were administered 0.4 mg LIFMIOR/kg twice weekly for three months.
Danish: I et forsøg med etanercept til patienter med et polyartikulært forløb af juvenil idiopatisk artrit, fik 69 patienter (i alderen 4 til 17 år) 0,4 mg/kg to gange om ugen i tre måneder.
English: Step 1: Preparing for an LIFMIOR injection
Danish: Trin 1: Forberedelse til injektion af LIFMIOR
English: What LIFMIOR contains
Danish: LIFMIOR indeholder:
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Danish: Etanercepts virkningsmekanisme menes at være dens kompetitive hæmning af TNF-bindingen til celleoverflade TNF-receptorer, hvilket forhindrer TNF-formidlede cellereaktioner ved at gøre TNF biologisk inaktiv.
English: Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Danish: Bortskaf kanyle og sprøjte som angivet af din læge, sygeplejerske eller apotek.
English: Additionally, the pharmacokinetics of LIFMIOR in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Danish: Herudover er LIFMIORs farmakokinetik den samme for patienter med reumatoid artrit, ankyloserende spondylitis og plaque psoriasis.
English: While neutropenic, one patient developed cellulitis that resolved after hospitalisation (see sections 4.4 and 4.5).
Danish: En patient med neutropeni udviklede cellulitis, som svandt efter hospitalsindlæggelse (se pkt.
English: Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.
Danish: Egnede patienter havde tidligere fået lysbehandling eller systemisk behandling, eller de havde haft utilstrækkelig effekt af topisk behandling.
English: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Danish: Behandling af kronisk svær plaque psoriasis hos børn og unge i alderen fra 6 år, som er utilstrækkeligt behandlede med eller intolerante over for andre systemiske behandlinger eller lysbehandlinger.
English: 24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors
Danish: 24 hætteglas med pulver 24 fyldte injektionssprøjter med 1 ml solvens 24 kanyler i rustfrit stål 24 hætteglasadaptere
English: If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Danish: Hvis du eller barnet udvikler symptomer på en infektion, f.eks. feber, forkølelse eller hoste, skal du straks fortælle det til lægen.
English: Paediatric Plaque Psoriasis Outcomes at 12 Weeks
Danish: Resultater for pædiatrisk plaque psoriasis efter 12 uger LIFMIOR
English: Thus, the combined use of LIFMIOR and anakinra is not recommended (see sections 4.5 and 4.8).
Danish: Derfor anbefales denne kombinerede brug af LIFMIOR og anakinra ikke (se pkt.
English: This injection should not be mixed in the same syringe or vial with any other medicine.
Danish: Denne injektion må ikke blandes med anden medicin i samme sprøjte eller hætteglas.
English: In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) LIFMIOR subcutaneously twice weekly.
Danish: I første del af studiet fik alle patienter 0,4 mg/kg (maksimum 25 mg per dosis) LIFMIOR subkutant to gange om ugen.
English: Instead, the safety and efficacy of LIFMIOR were assessed in four randomised, double-blind, placebo-controlled studies.
Danish: Sikkerheden og effekten af LIFMIOR er i stedet for blevet evalueret i fire randomiserede, dobbeltblinde, placebo-kontrollerede studier.
English: • Anti-diabetic medicines: Tell your doctor if the child has diabetes or is taking medicines to treat diabetes.
Danish: • Medicin mod sukkersyge (diabetes): Fortæl det til lægen, hvis barnet har diabetes eller tager medicin til behandling af diabetes.
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mgh/l vs. 316 mgh/l for 50 mg
Danish: Middelserumkoncentrationsprofilerne ved steady-state hos behandlede patienter med reumatoid artrit var henholdsvis Cmax på 2,4 mg/l vs. 2,6 mg/l, Cmin på 1,2 mg/l vs. 1,4 mg/l og partiel AUC på 297 mg•t/l vs.
English: Caution should be exercised in patients being treated with LIFMIOR who have a previous history of blood dyscrasias.
Danish: Der bør udvises forsigtighed hos patienter i behandling med LIFMIOR, som tidligere har haft bloddyskrasi.
English: The efficacy of LIFMIOR in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice weekly administration of 25 mg LIFMIOR with placebo.
Danish: Effekten af LIFMIOR over for ankyloserende spondylitis blev bedømt i 3 randomiserede, dobbeltblinde studier, hvor indgivelse af 25 mg LIFMIOR to gange om ugen blev sammenlignet med placebo.
English: 24 pre-filled syringes 24 alcohol swabs
Danish: 24 fyldte injektionssprøjter 24 alkoholservietter
English: Using the MYCLIC pre-filled pen to inject LIFMIOR
Danish: Brug af MYCLIC fyldt pen til at injicere LIFMIOR
English: Your doctor may decide if you or the child need less anti-diabetic medicine while taking LIFMIOR.
Danish: Lægen kan beslutte, at du eller barnet skal have en mindre dosis medicin mod sukkersyge, mens du eller barnet får LIFMIOR.
English: ACR 70 Month 3
Danish: ACR 70 Måned 3 Måned 6
English: LIFMIOR to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Danish: neurologisk vurdering, anbefales, når LIFMIOR udskrives til patienter med eksisterende eller begyndende demyeliniseringssygdomme, eller til patienter som vurderes at have en øget risiko for at udvikle demyeliniseringssygdom.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
Danish: Reumatoid artrit (leddegigt), psoriasisartrit (psoriasisgigt) og aksial spondylartrit, herunder ankyloserende spondylitis (rygsøjlegigt):
English: When reconstituted, the solution contains 10 mg/ml of etanercept.
Danish: Efter rekonstitution indeholder injektionsvæsken 10 mg/ml etanercept.
English: Other medicines and LIFMIOR
Danish: Brug af anden medicin sammen med LIFMIOR
English: If you notice any of the following, you or the child may need urgent medical attention.
Danish: Hvis du eller dit barn får en eller flere af følgende bivirkninger, kan du eller barnet have brug for omgående lægehjælp.
English: Uncommon ≥ 1/1,000 to < 1/100
Danish: Ikke almindelig ≥ 1/1.000 to