FrancophonIA/ELRC3.0 huggingface dataset:
English: It is very important that you tell your doctor if the child has ever had tuberculosis, or has been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt, at du fortæller lægen, om barnet nogensinde har haft tuberkulose, eller været i nær kontakt med nogen, som har haft tuberkulose.
English: Step 4: Disposing of supplies
Danish: Trin 4: Bortskaffelse af udstyr
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Danish: Kutan lupus erythematosus, subakut kutan lupus erythematosus, lupus-lignende syndrom
English: • Hold the vial firmly on the flat surface with one hand.
Danish: • Hold hætteglasset fast på den plane overflade med den ene hånd.
English: LIFMIOR + Methotrexate (n = 231)
Danish: LIFMIOR + Methotrexat (n = 231)
English: Children and adults taking LIFMIOR may have an increased risk of developing lymphoma or another cancer.
Danish: • Børn og voksne, som får LIFMIOR, kan have øget risiko for at udvikle kræft i lymfesystemet eller andre former for kræft.
English: The impact of long-term treatment with LIFMIOR on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning en langvarig behandling med LIFMIOR vil have på udviklingen af autoimmunsygdomme.
English: The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain.
Danish: Det primære effektmål (ASAS 40) var en forbedring på 40 % i mindst tre af de fire ASAS-domæner og ingen forværring i det resterende domæne.
English: The combination LIFMIOR and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Danish: Kombinationen af LIFMIOR og anakinra har ikke vist øgede kliniske fordele og anbefales derfor ikke.
English: Psoriatic Arthritis Response n = 104
Danish: Psoriasisartrit respons n = 104
English: a. p < 0.0001 compared with placebo.
Danish: p < 0,0001 sammenlignet med placebo
English: Compared to placebo, treatment with LIFMIOR resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6.
Danish: I sammenligning med placebo gav behandlingen med LIFMIOR en statistisk signifikant forbedring i ASAS 40, ASAS 20 og ASAS 5/6.
English: Do NOT use any other syringe.
Danish: Brug IKKE en anden sprøjte.
English: Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available.
Danish: Der foreligger ikke prækliniske data angående peri- og postnatal etanercept-toksicitet, eller hvad angår etanercepts virkning på fertilitet og generel reproduktionsevne.
English: For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), LIFMIOR can slow down the structural damage to those joints caused by the disease.
Danish: Hos patienter med flere symmetriske, smertefulde eller opsvulmede led (f.eks. hænder, håndled og fødder) kan LIFMIOR nedsætte hastigheden, hvormed leddenes struktur ødelægges på grund af sygdommen.
English: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Danish: Fortsat behandling bør nøje revurderes hos patienter, som ikke responderer inden for dette tidsrum.
English: Be careful not to push down on the plunger.
Danish: Pas på ikke at skubbe stemplet nedad.
English: Skin cancers
Danish: Hudkræft
English: If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with LIFMIOR.
Danish: Hvis du har spørgsmål, bedes du henvende dig til en læge, sygeplejerske eller apotekspersonale, som kender til LIFMIOR.
English: If someone else is giving you the injection, the outer area of the upper arms may also be used.
Danish: Hvis det er en anden person, der injicerer, kan bagsiden af overarmene også bruges.
English: Radiographic progression at 12 months was significantly less in the LIFMIOR group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Danish: Radiografisk progession var signifikant mindre i LIFMIOR gruppen end i methotrexat gruppen ved 12 måneder, hvorimod kombinationen var signifikant bedre end begge monoterapier til at forsinke radiografisk progression (se nedenstående figur).
English: However, any of the above symptoms may indicate an allergic reaction to LIFMIOR, so you should seek immediate medical attention.
Danish: Hvilken som helst af ovennævnte symptomer kan dog tyde på en allergisk reaktion over for LIFMIOR, og du skal derfor søge øjeblikkelig lægehjælp.
English: As you lift the pen, the purple needle safety shield will automatically extend to cover the needle.
Danish: Når du løfter pennen, vil den lilla sikkerhedshætte automatisk komme frem og dække nålen.
English: The known side effects of LIFMIOR include the following in groups of decreasing frequency:
Danish: Nedenstående bivirkninger for LIFMIOR er inddelt i grupper efter faldende frekvens.
English: Fold the paper cover back over the tray and place the carton containing any remaining pre-filled syringes back into the refrigerator.
Danish: Fold papiret tilbage over bakken og stil æsken med de resterende fyldte injektionssprøjter tilbage i køleskabet.
English: Rates of serious adverse events and serious infections did not increase with long-term exposure.
Danish: Hyppigheden af alvorlige bivirkninger eller alvorlige infektioner steg ikke ved langvarig behandling.
English: • Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults.
Danish: De yngste børn (på 4 år) havde nedsat clearance (øget clearance hvis vægten var normaliseret) sammenlignet med ældre børn (12 år gamle) og voksne.
English: For psoriatic arthritis patients with multiple joint involvement, LIFMIOR can improve your ability to do normal daily activities.
Danish: Hos patienter med psoriasisgigt med flere angrebne led kan LIFMIOR forbedre evnen til at udføre normale daglige aktiviteter.
English: What you need to know before you use LIFMIOR 3.
Danish: Det skal du vide, før du begynder at tage LIFMIOR 3.
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Danish: Der bør udføres hensigtsmæssige screeningsstudier, dvs Mantoux' intrakutane tuberkulinreaktion og røntgen af thorax, på alle patienter (nationale anbefalinger kan være gældende).
English: Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Danish: • Patienter med alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have større risiko end gennemsnittet for at udvikle lymfom.
English: LIFMIOR is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Danish: LIFMIOR er også indikeret til behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne, som ikke tidligere har været behandlet med methotrexat.
English: After preparing the LIFMIOR solution, immediate use is recommended (up to a maximum of 6 hours).
Danish: Efter at have gjort LIFMIOR injektionsvæsken klar anbefales umiddelbar anvendelse (op til højst 6 timer).
English: Linearity
Danish: Linearitet
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including LIFMIOR.
Danish: Der er indberetninger om melanom og ikke-melanom hudkræft (NMSC) hos patienter behandlet med TNF-antagonister, herunder LIFMIOR.
English: Re-introduction of treatment with LIFMIOR after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received LIFMIOR without interruption of therapy based on results of open-label studies.
Danish: Gentoptaget behandling med LIFMIOR efter ophør i op til 24 måneder resulterede i samme størrelse af respons som hos patienter, som fik LIFMIOR uden behandlingsafbrydelse, baseret på resultater fra åbne studier.
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to LIFMIOR treatment.
Danish: Selvom de ikke er endelige, antyder data fra ét af disse forsøg en mulig tendens til forværret CHF hos de patienter, der var anvist til LIFMIORbehandling.
English: There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Danish: Der har været sjældne rapporter om patienter, herunder rheumatoid faktor positive patienter, som har udviklet andre autoantistoffer i forbindelse med lupus-lignende syndrom eller udslæt, som er kompatibel med subaktiv kutan lupus eller diskoid lupus ved klinisk præsentation og biopsi.
English: It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt, at du fortæller lægen, om du eller barnet nogensinde har haft tuberkulose, eller været i nær kontakt med nogen, som har haft tuberkulose.
English: LIFMIOR was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Danish: LIFMIOR blev anset for at være non-genotoksisk på grundlag af en serie in vitro- og in vivo-studier.
English: d. Adding solvent
Danish: Tilsætning af solvens
English: During the withdrawal period, symptoms of psoriasis gradually returned with a median time to disease relapse of 3 months.
Danish: I den behandlingsfrie periode vendte symptomerne på psoriasis gradvist tilbage med en mediantid til sygdoms relapse på 3 måneder.
English: Autoantibody formation Treatment with LIFMIOR may result in the formation of autoimmune antibodies (see section 4.8).
Danish: Dannelse af autoantistof Behandling med LIFMIOR kan resultere i dannelse af autoimmunantistoffer (se pkt.
English: • A different site should be used for each new injection.
Danish: • Du skal vælge et nyt sted for hver ny injektion.
English: Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with LIFMIOR during pregnancy.
Danish: Etanercept passerer placenta og er påvist i serum hos spædbørn født af kvinder, der er blevet behandlet med LIFMIOR under graviditeten.
English: Autoimmune hepatitis*
Danish: Autoimmun hepatitis*
English: LIFMIOR should be used with caution in patients with a history of hepatitis C.
Danish: LIFMIOR skal anvendes med forsigtighed til patienter med en anamnese med hepatitis C.
English: Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Danish: Etanercept er et humant tumornekrosefaktorreceptor p75 Fc-fusionsprotein, som er fremstillet ved rekombinant dna-teknologi i et mammalt ekspressionssystem fra kinesiske hamstres ovarier (CHO).
English: Ankylosing Spondylitis Response
Danish: Ankyloserende spondylitis Respons
English: After waiting approximately 15-30 minutes for the solution in the pen to warm to room temperature, wash your hands with soap and water.
Danish: • Efter at have ventet ca. 15-30 minutter på at injektionsvæsken i pennen har opnået stuetemperatur, skal du vaske hænder med vand og sæbe.
English: Adult patients had serum samples tested for autoantibodies at multiple timepoints.
Danish: Voksne patienter fik testet serumprøver for autoantistoffer på flere tidspunkter.
English: To avoid damaging the needle inside the pen, do not bend the white needle cap while you are removing it, and do not re-attach it once it has been removed.
Danish: For at undgå at nålen i pennen bliver beskadiget, må den hvide nålehætte ikke bøjes eller vrides, når den tages af, og du må ikke sætte den på igen, når først den er taget af.
English: Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue LIFMIOR therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Da immunglobuliner lige som mange andre lægemidler kan udskilles i human mælk, skal der tages en beslutning om, hvorvidt amning skal ophøre, eller brugen af LIFMIOR skal ophøre under amning, idet fordelen ved amning for barnet og fordelen ved behandlingen af kvinden tages i betragtning.
English: All subdomains of the HAQ were improved in patients treated with LIFMIOR compared to controls at 3 and 6 months.
Danish: Alle underområder i SHT'et blev forbedret hos patienter, der var behandlet med LIFMIOR, ved 3 og 6 måneder sammenlignet med kontrolpersonerne.
English: This combination has not demonstrated increased clinical benefit.
Danish: Denne kombination har ikke vist øget klinisk udbytte.
English: A slight depression in the skin will be seen (see Diagram 4).
Danish: En lille hulning vil kunne ses i huden (se billede 4).
English: • Remove the paper backing from the vial adaptor package.
Danish: • Fjern papirbagsiden fra adapteræsken.
English: Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Danish: Behandling af voksne med svær nonradiografisk aksial spondylartrit med objektive tegn på inflammation indikeret ved forhøjet C-reaktivt protein (CRP) og/eller magnetisk resonans scanning (MRI), der har vist utilstrækkeligt respons på nonsteroide antiinflammatoriske lægemidler (NSAID).
English: In clinical studies, concurrent administration of abatacept and LIFMIOR resulted in increased incidences of serious adverse events.
Danish: I kliniske studier resulterede samtidig administration af abatacept og LIFMIOR i et øget antal tilfælde af alvorlige bivirkninger.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier om indflydelsen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Patients who “failed to respond to” in the target population is defined by insufficient response (PASI<50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Danish: Patienter, som ”ikke responderer” er defineret ved utilstrækkeligt respons (PASI<50 eller PGA mindre end god) eller forværring af sygdommen under behandling med mindst én af de tre systemiske behandlinger i tilstrækkelige doser og af tilstrækkelig varighed for at opnå respons.
English: If LIFMIOR has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Danish: Hvis LIFMIOR ikke har nogen virkning på barnets tilstand efter 12 uger, kan lægen fortælle dig, at behandlingen stoppes.
English: Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with LIFMIOR.
Danish: Sjældne tilfælde af pancytopeni og meget sjældne tilfælde af aplastisk anæmi, nogle med dødeligt udfald, er rapporteret hos patienter i behandling med LIFMIOR.
English: If any of the following happen to the child, do not give the child more LIFMIOR.
Danish: Hvis en eller flere af følgende reaktioner optræder hos barnet, må du ikke give barnet mere LIFMIOR.
English: At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
Danish: Ved afslutningen af det dobbeltblinde studie kunne patienterne indgå i et langtids-, åbent, forlænget studie med en samlet varighed på op til 2 år.
English: LIFMIOR is not recommended for the treatment of Wegener's granulomatosis.
Danish: LIFMIOR anbefales ikke til behandling af Wegeners granulomatose.
English: Do not shake the pen.
Danish: Ryst ikke pennen.
English: The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Danish: Det primære slutmål for effekt var i alle fire studier antallet af patienter i hver gruppe, som opnåede PASI 75 (dvs mindst 75 % forbedring i Psorisis Arealet og på Severity Index scoren i forhold til baseline) efter 12 ugers behandling.
English: LIFMIOR should be discarded if not used within four weeks after removal from the refrigerator.
Danish: LIFMIOR skal kasseres, hvis det ikke er brugt inden for 4 uger efter, at det er taget ud af køleskabet.
English: LIFMIOR is also prescribed for the treatment of the following diseases in children and adolescents
Danish: LIFMIOR ordineres også til behandling af følgende sygdomme hos børn og unge:
English: • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Danish: • til følgende typer af juvenil idiopatisk artrit (børnegigt), hvor behandling med methotrexat har været utilstrækkelig eller ikke kan anvendes:
English: The efficacy of LIFMIOR versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing LIFMIOR with other systemic therapies.
Danish: Effekten af LIFMIOR versus andre systemiske behandlinger til patienter med moderat til svær psorisis (responderende på andre systemiske behandlinger) er endnu ikke evalueret i direkte sammenlignende studier med LIFMIOR overfor andre systemiske behandlinger.
English: Some have occurred within a few weeks after initiating treatment with LIFMIOR in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Danish: Nogle forekom i løbet af et par uger efter start af behandling med LIFMIOR hos patienter, som har tilgrundliggende sygdomsforhold (for eksempel diabetes, hjertestop, patienthistorie med aktive eller kroniske infektioner) ud over reumatoid artrit (se pkt.
English: • Swelling of the face, throat, hands, or feet
Danish: • Opsvulmen af ansigt, hals, hænder eller fødder
English: Patients with a significant exposure to varicella virus should temporarily discontinue LIFMIOR therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Danish: Patienter, som er signifikant udsat for varicellavirus, bør midlertidigt stoppe behandlingen med LIFMIOR, og profylaktisk behandling med varicella zoster immunglobulin bør overvejes.
English: • The doctor or his/her assistant should have instructed you on the proper amount of solution to be withdrawn from the vial.
Danish: • Lægen eller hans/hendes assistent skal have instrueret dig i den korrekte mængde injektionsvæske, der skal trækkes ud af hætteglasset.
English: If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Danish: Hvis du er bekymret over opløsningens udseende, skal du kontakte dit apotek for assistance.
English: From the start of part 2, the median time to flare was ≥ 116 days for patients who received LIFMIOR and 28 days for patients who received placebo.
Danish: Fra anden dels begyndelse var mediantiden til sygdomsopblussen  116 dage for patienter, som fik LIFMIOR, og 28 dage for patienter, som fik placebo.
English: • if you or the child have an infection of any kind.
Danish: • hvis du eller barnet lider af nogen form for infektion.
English: However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Danish: Forekomsten var dog sjælden, og opfølgningstiden for placebopatienter var kortere end for patienter, der fik TNFantagonistbehandling.
English: If you forget to inject LIFMIOR
Danish: Hvis du har glemt at injicere LIFMIOR
English: Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator).
Danish: Injicer opløsningen efter den har opnået stuetemperatur (15-30 minutter efter produktet er taget ud af køleskabet).
English: • Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Danish: Kræft kan påvirke hele kroppen, herunder hud og blod, og mulige tegn på kræft afhænger af typen og lokalisering i kroppen.
English: In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups.
Danish: Efter subkutan administration til diegivende rotter blev etanercept udskilt i mælken og påvist i serum hos ungerne.
English: Long-term safety of LIFMIOR monotherapy (n=103), LIFMIOR plus methotrexate (n=294), or methotrexate monotherapy (n=197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Danish: Langtidssikkerhedsdata for LIFMIOR som monoterapi (n=103), LIFMIOR plus methotrexat (n=294) eller methotrexat som monoterapi (n=197) blev vurderet i op til 3 år i et register med 594 børn i alderen 2-18 år med juvenil idiopatisk artrit; heraf var 39 i alderen 2-3 år.
English: Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
Danish: Opløsningen må ikke bruges, hvis den er misfarvet eller uklar, eller hvis den indeholder andre partikler end dem, der er beskrevet ovenfor.
English: There is no known antidote to LIFMIOR.
Danish: Der er ingen kendt modgift mod LIFMIOR.
English: In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with LIFMIOR or placebo for moderate to severe alcoholic hepatitis, LIFMIOR was not efficacious, and the mortality rate in patients treated with LIFMIOR was significantly higher after 6 months.
Danish: I et fase II randomiseret, placebokontrolleret forsøg med 48 indlagte patienter behandlet med LIFMIOR eller placebo for moderat til svær alkoholisk hepatitis var LIFMIOR ikke effektivt, og mortaliteten for patienter behandlet med LIFMIOR var signifikant højere efter 6 måneder.
English: Concurrent administration of LIFMIOR and anakinra has been associated with an increased risk of serious infections and neutropenia compared to LIFMIOR alone.
Danish: Samtidig administration af LIFMIOR og anakinra er blevet forbundet med en øget risiko for alvorlige infektioner og neutropeni sammenlignet med LIFMIOR alene.
English: Inspect the solution in the pen by looking through the clear inspection window.
Danish: Kontroller injektionsvæsken i pennen ved at se gennem inspektionsvinduet.
English: There is insufficient evidence of the efficacy of LIFMIOR in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Danish: Der er ikke tilstrækkeligt bevis for effekten af LIFMIOR hos patienter med ankyloserende spondylitislignende og artritis mutilans psoriasis artropatier på grund af det lille antal patienter, der er undersøgt.
English: The pen's inspection window should now be completely purple, confirming that the dose has been injected correctly (see Diagram 8).
Danish: • Inspektionsvinduet i pennen skal nu være helt lilla som tegn på at injektionen er udført korrekt (se billede 8).