FrancophonIA/ELRC3.0 huggingface dataset:
English: Enbrel contains no antibacterial preservative, and therefore, solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Danish: Enbrel indeholder ikke noget antibakterielt konserveringsmiddel, og derfor skal injektionsvæsker , som er tilberedt med vand til injektionsvæsker, indgives så hurtigt som muligt og i løbet af seks timer efter rekonstitution.
English: Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Danish: Enbrel er også indikeret til behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne, som ikke tidligere har været behandlet med methotrexat.
English: Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with Enbrel during pregnancy.
Danish: Etanercept passerer placenta og er påvist i serum hos spædbørn født af kvinder, der er blevet behandlet med Enbrel under graviditeten.
English: In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events.
Danish: I kliniske studier resulterede samtidig administration af abatacept og Enbrel i et øget antal tilfælde af alvorlige bivirkninger.
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 Enbrel 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 Enbrel skal ophøre under amning, idet fordelen ved amning for barnet og fordelen ved behandlingen af kvinden tages i betragtning.
English: Enbrel should be discarded if not used within four weeks after removal from the refrigerator.
Danish: Enbrel skal kasseres, hvis det ikke er brugt inden for 4 uger efter, at det er taget ud af køleskabet.
English: Autoantibody formation Treatment with Enbrel may result in the formation of autoimmune antibodies (see section 4.8).
Danish: Dannelse af autoantistof Behandling med Enbrel kan resultere i dannelse af autoimmunantistoffer (se pkt.
English: Live vaccines should not be given concurrently with Enbrel.
Danish: Levende vacciner bør ikke gives samtidigt med Enbrel.
English: • Inspect the expiry dates on both the Enbrel vial label and the water for injections.
Danish: • Kontroller udløbsdatoen på etiketten på både Enbrel hætteglasset og vandet til injektion.
English: Enbrel is prescribed for the treatment of the following diseases in children and adolescents
Danish: Enbrel ordineres til behandling af følgende sygdomme hos børn og unge:
English: Enbrel should be used with caution in patients with a history of hepatitis C.
Danish: Enbrel skal anvendes med forsigtighed til patienter med en anamnese med hepatitis C.
English: Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.
Danish: Sjældne tilfælde af pancytopeni og meget sjældne tilfælde af aplastisk anæmi, nogle med dødeligt udfald, er rapporteret hos patienter i behandling med Enbrel.
English: The efficacy of Enbrel versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing Enbrel with other systemic therapies.
Danish: Effekten af Enbrel 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 Enbrel overfor andre systemiske behandlinger.
English: However, your doctor may determine an alternative frequency at which to inject Enbrel.
Danish: Lægen kan dog beslutte en anden hyppighed for injicering af Enbrel.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: De følgende kategorier benyttes: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: All subdomains of the HAQ were improved in patients treated with Enbrel compared to controls at 3 and 6 months.
Danish: Alle underområder i SHT'et blev forbedret hos patienter, der var behandlet med Enbrel, ved 3 og 6 måneder sammenlignet med kontrolpersonerne.
English: In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, Enbrel was not efficacious, and the mortality rate in patients treated with Enbrel was significantly higher after 6 months.
Danish: I et fase II randomiseret, placebokontrolleret forsøg med 48 indlagte patienter behandlet med Enbrel eller placebo for moderat til svær alkoholisk hepatitis var Enbrel ikke effektivt, og mortaliteten for patienter behandlet med Enbrel var signifikant højere efter 6 måneder.
English: For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities.
Danish: Hos patienter med psoriasisgigt med flere angrebne led kan Enbrel forbedre evnen til at udføre normale daglige aktiviteter.
English: Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
Danish: Begynd igen med et nyt Enbrel hætteglas, vand til injektionsvæsker, sprøjte, nål og servietter.
English: Hepat it is B reactivation, listeria
Danish: Hepatitis B reaktivering, listeria
English: Among patients receiving Enbrel, 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 Enbrel, viste de kliniske reaktioner sig generelt inden for 1-2 uger efter påbegyndelse af behandlingen og skete næsten altid senest måned 3.
English: If any of the following happen to the child, do not give the child more Enbrel.
Danish: Hvis en eller flere af følgende reaktioner optræder hos barnet, må du ikke give barnet mere Enbrel.
English: Introduction b.
Danish: Indledning b.
English: Although no clinical trials have been performed evaluating Enbrel therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Danish: Selvom der ikke har været foretaget nogle kliniske studier for at evaluere Enbrel-behandling af patienter med multipel sclerose, har kliniske studier af andre TNF antagonister hos patienter med multipel sclerose vist forøgelse i sygdoms aktiviteten.
English: If the child has any of the above symptoms he/she may be having an allergic reaction to Enbrel, so you should seek immediate medical attention.
Danish: Hvis barnet har nogen af ovennævnte symptomer, kan han/hun have en allergisk reaktion over for Enbrel, og du skal derfor søge øjeblikkelig lægehjælp.
English: In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
Danish: Data fra flere kliniske studier viste, at den samlede forekomst af opportunistiske infektioner var 0,09 % for de 15.402 patienter, som blev behandlet med Enbrel.
English: There is insufficient evidence of the efficacy of Enbrel 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 Enbrel hos patienter med ankyloserende spondylitislignende og artritis mutilans psoriasis artropatier på grund af det lille antal patienter, der er undersøgt.
English: From the start of part 2, the median time to flare was ≥ 116 days for patients who received Enbrel and 28 days for patients who received placebo.
Danish: Fra anden dels begyndelse var mediantiden til sygdomsopblussen  116 dage for patienter, som fik Enbrel, og 28 dage for patienter, som fik placebo.
English: If active tuberculosis is diagnosed, Enbrel therapy must not be initiated.
Danish: Hvis diagnosen aktiv tuberkulose stilles, må behandling med Enbrel ikke påbegyndes.
English: Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel 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 Enbrel, og profylaktisk behandling med varicella zoster immunglobulin bør overvejes.
English: If Enbrel has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Danish: Hvis Enbrel ikke har nogen virkning på barnets tilstand efter 12 uger, kan lægen fortælle dig, at behandlingen stoppes.
English: • Alcohol abuse: Enbrel should not be used for the treatment of hepatitis related to alcohol abuse.
Danish: • Alkoholmisbrug: Enbrel må ikke bruges til behandling af hepatitis i forbindelse med alkoholmisbrug.
English: • Take the ENBREL vial out of the refrigerator and place it on a flat surface.
Danish: • Tag Enbrel hætteglasset ud af køleskabet og stil det på en plan overflade.
English: Treatment with Enbrel may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Danish: Behandling med Enbrel kan medføre genopblussen af hepatitis B hos patienter, som tidligere har haft hepatitis B-infektion.
English: The differences in TSS and JSN were not statistically significant between methotrexate and Enbrel 25 mg.
Danish: Forskellene i TSS og JSN mellem methotrexat og Enbrel 25 mg var ikke statistisk signifikant.
English: Enbrel 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: Enbrel 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: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Danish: Alvorlige infektioner forekom hos 6,3 % af patienterne med reumatoid artrit behandlet med Enbrel i op til 48 måneder.
English: • Check your syringe contains 1 ml of water for injections.
Danish: • Kontroller at sprøjten indeholder 1 ml vand til injektionsvæsker.
English: Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Enbrel therapy and for three weeks after discontinuation of therapy.
Danish: Kvinder i den fertile alder skal overveje at anvende sikker kontraception under behandlingen med Enbrel og i 3 uger efter behandlingen for at undgå graviditet.
English: Patients should be tested for HBV infection before initiating treatment with Enbrel.
Danish: Patienter bør testes for HBV-infektion inden opstart af behandling med Enbrel.
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Danish: I et studie med børn i alderen 4 til 17 år med juvenil, idiopatisk artrit fik 43 af 69 (62 %) af børnene en infektion, mens de fik Enbrel i løbet af studiets 3 måneder (del 1, open-label), og hyppigheden og sværhedsgraden af infektioner var ens hos 58 patienter, som gennemførte 12 måneders utilsløret forlænget behandling.
English: Long-term safety of Enbrel monotherapy (n=103), Enbrel 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 Enbrel som monoterapi (n=103), Enbrel 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 218 år med juvenil idiopatisk artrit; heraf var 39 i alderen 2-3 år.
English: Green activation button
Danish: Grå aktiveringsknap
English: Clean the injection site with the alcohol swab using a circular motion, and allow it to dry.
Danish: Tør injektionsområdet af med en alkoholserviet med cirkulære bevægelser og lad det tørre.
English: As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid.
Danish: Når væskeniveauet falder i glasset, kan det være nødvendigt at trække kanylen delvist ud for at holde kanylens spids i væsken.
English: No treatment was given for the majority of injection site reactions in the Enbrel treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Danish: Der blev ikke givet nogen behandling for størstedelen af injektionsstedsreaktioner hos Enbrelbehandlingsgrupperne, og størstedelen af de patienter, som fik behandling, modtog topiske præparater som for eksempel cortikosterioder eller antihistaminer til oral indtagelse.
English: Enbrel + Methotrexate (n = 231)
Danish: Enbrel + Methotrexat (n = 231)
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Enbrel was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Danish: Man så en dosisrespons: resultater med 10 mg lå mellem placebo og 25 mg. Enbrel var betydeligt bedre end placebo i alle dele af ACR-kriterierne såvel som andre mål for sygdomsaktiviteten af reumatoid artrit, der ikke er medtaget i ACRresponskriterierne, som f.eks. morgenstivhed.
English: Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone.
Danish: Samtidig administration af Enbrel og anakinra er blevet forbundet med en øget risiko for alvorlige infektioner og neutropeni sammenlignet med Enbrel alene.
English: Adding water for injections e.
Danish: Tilsætning af vand til injektionsvæsker e.
English: The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Danish: Brugen af Enbrel i kombination med andre systemiske behandlinger eller lysbehandling til behandling af psoriasis er ikke undersøgt.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.
Danish: Bivirkninger opstillet i tabelform Følgende liste over bivirkninger er baseret på erfaringer fra kliniske forsøg og på postmarketing erfaring.
English: • if the child has, or is at risk of developing a serious blood infection called sepsis.
Danish: • hvis barnet har eller er i risiko for at udvikle en alvorlig blodinfektion kaldet sepsis (blodforgiftning).
English: • Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Danish: • Wegeners granulomatose: Enbrel anbefales ikke til behandling af Wegeners granulomatose, en sjælden betændelsessygdom.
English: 25 mg Enbrel administered twice weekly is the recommended dose.
Danish: 25 mg Enbrel, indgivet to gange om ugen, er den anbefalede dosis.
English: There were no differences in rates of infection among patients treated with Enbrel 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 Enbrel og patienter, som fik placebo mod plaque psoriasis, i placebokontrollerede studier af op til 24 ugers varighed.
English: Physicians should use caution when using Enbrel in patients who also have moderate to severe alcoholic hepatitis.
Danish: Læger bør udvise forsigtighed ved behandling med Enbrel af patienter, som også har moderat til svær alkoholisk hepatitis.
English: If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en alvorlig allergisk reaktion eller anafylaksi, skal behandling med Enbrel ophøre med det samme, og en egnet behandling skal begynde.
English: Inspection window will have turned purple
Danish: Inspektionsvindue er blevet lilla
English: Patients in the Enbrel 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 Enbrel 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: A single 50 mg/ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Danish: En enkelt 50 mg/ml injektion med etanercept vistes at være bioekvivalent til to samtidige injektioner med 25 mg/ml.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p < 0.001).
Danish: Scoren på invaliditetsindekset blev signifikant forbedret på alle tidspunkter hos patienter med psoriasisartrit i behandling med Enbrel i sammenligning med placebo (p<0,001).
English: The child should not use Enbrel with medicines that contain the active substance anakinra or abatacept.
Danish: Barnet bør ikke bruge Enbrel sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: • Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
Danish: • Brug en ny alkoholserviet til at rense den grå prop på Enbrel-hætteglasset.
English: Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Danish: Hvad enten Enbrel anvendes alene eller i kombination med methotrexat, kan hastigheden, hvormed leddene beskadiges på grund af reumatoid artrit nedsættes, og dermed forbedres din evne til at udføre daglige aktiviteter.
English: • If you are not sure how to fill your syringe ask your doctor or nurse.
Danish: • Hvis ikke ved, hvordan du skal fylde sprøjten, spørg din læge eller sygeplejerske.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all Enbrel-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 Enbrel 4,64 for SI-leddet (n=153) og 1,40 for rygsøjlen (n=154).
English: Enbrel 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 Enbrel bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af juvenil idiopatisk artrit eller pædiatrisk plaque psoriasis.
English: Serious allergic/anaphylactic react ions (including angioedema, bronchospasm), sarcoidosis
Danish: Alvorlige allergiske/anafyl aktiske reaktioner (inklusive angioødem, bronkospasme), sarkoidose
English: In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone.
Danish: I et klinisk studie med voksne patienter i behandling med sulfasalazin, hvortil Enbrel blev tilføjet, havde patienterne i kombinationsgruppen et statistisk signifikant fald i middelværdierne for hvide blodlegemer sammenlignet med grupperne, der blev behandlet med enten Enbrel eller sulfasalazin.
English: Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on Enbrel 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 Enbrel, fra måned 3 til måned 7, mens de, der fik placebo, ikke blev bedre.
English: Significant advantages for Enbrel in combination with methotrexate compared with Enbrel monotherapy and methotrexate monotherapy were also observed after 24 months.
Danish: Signifikante fordele ved Enbrel i kombination med methotrexat sammenlignet med Enbrel monoterapi og methotrexat monoterapi blev også observeret efter 24 måneder.
English: • if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6).
Danish: • hvis du eller dit barn, er allergiske over for etanercept eller et af de øvrige indholdsstoffer i Enbrel (angivet i afsnit 6).
English: You or the child should not use Enbrel with medicines that contain the active substance anakinra or abatacept.
Danish: Du eller barnet bør ikke bruge Enbrel sammen med medicin, som indeholder de aktive stoffer anakinra eller abatacept.
English: The long-term safety and effectiveness of Enbrel 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Danish: Langtidssikkerhed og -virkning af Enbrel 0,8 mg/kg (op til 50 mg) én gang ugentligt blev vurderet i et open-label forlængelsesstudie med 181 pædiatriske patienter med plaque psoriasis i op til 2 år ud over det 48-ugers studie, der er nævnt herover.
English: Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the 349 adult rheumatoid arthritis patients.
Danish: Flere bivirkninger blev rapporteret hyppigere hos 69 patienter med juvenil idiopatisk artrit, som fik Enbrel i 3 måneder, i sammenligning med 349 voksne patienter med reumatoid artrit.
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with Enbrel.
Danish: Der er indberettet tilfælde af aktiv tuberkulose, herunder miliær tuberkulose og tuberkulose med ekstrapulmonal position, hos patienter i behandling med Enbrel.
English: The double-blind period was followed by an open-label period during which all patients receive Enbrel 50 mg weekly for up to an additional 92 weeks.
Danish: Den dobbeltblindede periode blev efterfulgt af en åben studieperiode, hvor alle patienter fik Enbrel 50 mg ugentligt i op til yderligere 92 uger.
English: One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Danish: En patient med reumatoid artrit tog ved en fejltagelse 62 mg Enbrel subkutant to gange om ugen i tre uger uden at registrere uønskede virkninger.
English: Enbrel is supplied with pre-filled syringes containing water for injection.
Danish: Enbrel leveres med fyldte injektionssprøjter, som indeholder vand til injektionsvæsker.
English: Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Danish: Bortskaf omhyggeligt eventuel resterende Enbrel-injektionsvæske, der ikke er blevet injiceret i løbet af 6 timer.
English: Histiocytosis haematophagic (macrophage activation syndrome)†
Danish: Histiocytosis haematophagic (makrofagaktiv eringssyndrom)