FrancophonIA/ELRC3.0 huggingface dataset:
English: Benlysta significantly reduced circulating overall, transitional, naïve, and SLE B cells, as well as plasma cells at Week 52.
Danish: Ved uge 52, reducerede Benlysta signifikant cirkulerende overordnede, transitionelle, naive og SLE B-celler samt plasmaceller.
English: The study will evaluate over a minimum of 1 year the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Danish: Studiet skal evaluere incidensen af alle tilfælde af mortalitet og bivirkninger af særlig interesse hos patienter med systemisk lupus erythematosus over en periode på minimum 1 år.
English: Caution should be exercised if Benlysta is co-administered with other B cell targeted therapy or cyclophosphamide.
Danish: Der skal udvises forsigtighed, hvis Benlysta administreres sammen med andre B-celle targeterede behandlinger eller cyclophosphamid.
English: Special Patient Populations
Danish: Særlige patientpopulationer
English: Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med Benlysta og i mindst 4 måneder efter den sidste behandling.
English: *‘Hypersensitivity reactions' covers a group of terms, including anaphylaxis, and can manifest as a range of symptoms including hypotension, angioedema, urticaria or other rash, pruritus, and dyspnoea.
Danish: *'Overfølsomhedsreaktioner' dækker over en gruppe af termer, herunder anafylaksi og kan vise sig som en række af symptomer, herunder hypotension, angioødem, urticaria eller andre former for udslæt, pruritus og dyspnø.
English: There have been reports of depression, suicidal thoughts, and suicide attempts including suicide during treatment with Benlysta.
Danish: Der har været tilfælde af depression, selvmordstanker og selvmordsforsøg, herunder selvmord under behandling med Benlysta.
English: Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Danish: Belimumab binder ikke direkte til B-celler, men ved at binde sig til BLyS-proteinerne hæmmer belimumab overlevelsen af B-celler, herunder autoreaktive B-celler, og reducerer differentieringen af B-celler til immunglobulinproducerende plasmaceller.
English: Complete the injection
Danish: Færdiggør injektionen
English: These adverse events of special interest include serious infections (including nonserious and serious opportunistic infections and PML, malignancies (including nonmelanoma skin cancer), serious infusion and hypersensitivity reactions, and serious psychiatric events including mood disorders, anxiety and suicide.
Danish: Bivirkninger af særlig interesse inkluderer alvorlige infektioner (herunder ikkealvorlige og alvorlige opportunistiske infektioner og PML), maligniteter (herunder ikke-melanom hudcancer), alvorlige infusions- og overfølsomhedsreaktioner samt alvorlige psykiske bivirkninger, herunder humørsvingninger, angst og selvmord.
English: For instructions on reconstitution, dilution, and storage of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution, fortynding og opbevaring af lægemidlet før administration se pkt.
English: Failure to follow these instructions may affect proper function of the pre-filled pen.
Danish: Hvis du ikke følger disse instruktioner kan det påvirke den tiltænkte funktion af den fyldte pen.
English: Subgroup analysis of the primary endpoint demonstrated that the greatest benefit was observed in patients with higher disease activity at baseline including patients with SELENA SLEDAI scores ≥ 10 or patients requiring steroids to control their disease or patients with low complement levels.
Danish: En sub-gruppeanalyse af det primære endepunkt viste, at den største fordel blev observeret hos patienter med en højere sygdomsaktivitet ved baseline, herunder patienter med SELENA-SLEDAI-score ≥ 10 eller patienter med behov for steroider for at kontrollere deres sygdom eller patienter med lave komplementniveauer.
English: Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet (see Step-by-step instructions).
Danish: Udførlige instruktioner for subkutan administration af Benlysta i fyldt pen eller fyldt injektionssprøjte medfølger som en del af indlægssedlen (se trinvis vejledning).
English: Also contains: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections.
Danish: Indeholder også: argininhydrochlorid, histidin, histidinmonohydrochlorid, polysorbat 80, natriumchlorid, vand til injektionsvæsker.
English: The mechanism of action of belimumab could increase the risk for the development of infections in adults and children with lupus, including opportunistic infections, and younger children may be at increased risk.
Danish: Belimumabs virkningsmekanisme kan øge risikoen for udviklingen af infektioner hos voksne og børn med lupus, herunder opportunistiske infektioner.
English: Increased exposure for obese subjects receiving 10 mg/kg belimumab did not lead to an overall increase in AE rates or serious AEs compared to obese subjects receiving placebo.
Danish: Øget eksponering hos svært overvægtige forsøgspersoner, der fik en dosis belimumab på 10 mg/kg, medførte ikke en samlet stigning i hyppigheden af bivirkninger eller alvorlige bivirkninger sammenlignet med svært overvægtige forsøgspersoner, der fik placebo.
English: No carcinogenicity studies or fertility studies (male or female) have been performed.
Danish: Der er ikke udført studier af carcinogent potentiale eller fertilitet (hankøn eller hunkøn).
English: • The pre-filled syringe should be used only once and then discarded.
Danish: • Den fyldte injektionssprøjte må kun bruges én gang og derefter kasseres.
English: • diarrhoea, vomiting
Danish: • diarré, opkast
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline Subgroup
Danish: Tabel 2: Patienter med lavt komplementniveau og positiv anti-dsDNA ved baseline Subgruppe
English: 12- to 17-year-old group: infections were reported in 22/43 patients receiving Benlysta and 25/37 patients receiving placebo, and serious infections were reported in 3/43 patients receiving Benlysta and 3/37 patients receiving placebo.
Danish: Gruppe for 12-17-årige: infektioner blev rapporteret hos 22/43 patienter, der fik Benlysta og hos 25/37 patienter, der fik placebo og alvorlige infektioner blev rapporteret hos 3/43 patienter, der fik Benlysta og hos 3/37 patienter, der fik placebo.
English: A single Benlysta pre-filled syringe or pre-filled pen can be stored at temperatures up to a maximum of 25°C for a period of up to 12 hours.
Danish: En enkelt Benlysta fyldt injektionssprøjte eller fyldt pen kan opbevares ved temperaturer op til højst 25 ºC i op til 12 timer.
English: The MAH shall provide the 1 year data report on a randomized, double-blind placebo-controlled large safety study, based on a protocol agreed with CHMP.
Danish: Indehaveren af markedsføringstilladelsen skal efter 1 år fremsende en studierapport med data fra et stort randomiseret, dobbeltblindet, placebokontrolleret sikkerhedsstudie baseret på en protokol, der er godkendt af CHMP.
English: The infusion must be discontinued immediately if the patient experiences a potentially life-threatening adverse reaction (see sections 4.4 and 4.8).
Danish: Infusionen skal stoppes omgående, hvis patienten oplever en potentielt livstruende bivirkning (se pkt.
English: The recommended dose is 200 mg (complete contents of one syringe) once a week, injected under your skin on the same day each week.
Danish: Den anbefalede dosis er 200 mg (hele indholdet af én injektionssprøjte) én gang om ugen injiceret under din hud på samme ugedag hver uge.
English: Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.
Danish: Patienter med en anamnese med multiple lægemiddelallergier eller signifikant overfølsomhed kan have en øget risiko.
English: Tell your doctor or nurse immediately, or go to the Emergency department of your nearest hospital, if you get any of the following symptoms of an allergic or injection-related reaction:
Danish: Du skal omgående fortælle det til lægen eller sygeplejersken eller tage på skadestuen på det nærmeste hospital, hvis du får nogen af følgende symptomer på en overfølsomhedsreaktion eller injektionsrelateret reaktion:
English: Median IgG levels at Week 52 were reduced by 11% in patients receiving Benlysta compared with an increase of 0.7% in patients receiving placebo.
Danish: Median niveauet af IgG ved uge 52 blev reduceret med 11 % hos patienter, der fik Benlysta sammenlignet med en stigning på 0,7 % hos patienter, som fik placebo.
English: Injecting Benlysta
Danish: Injicering af Benlysta
English: The safety and efficacy of Benlysta was evaluated in a randomised, double-blind, placebo-controlled, 52-week study (PLUTO) in 93 paediatric patients with a clinical diagnosis of SLE according to the ACR classification criteria.
Danish: Sikkerheden og virkningen af Benlysta blev evalueret i et randomiseret, dobbeltblindet, placebokontrolleret, 52-ugers studie (PLUTO) hos 93 pædiatriske patienter med en klinisk SLE-diagnose i henhold til ACR klassifikationskriteriet.
English: Components of SLE responder index
Danish: Komponenter af SLE responder index
English: People taking medicines that affect their immune system may be more at risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).
Danish: Personer, der tager medicin, som påvirker deres immunsystem, kan have højere risiko for infektioner, herunder en sjælden, men alvorlig hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML).
English: Tell your doctor or nurse immediately, or go to the Emergency department of your nearest hospital, if you get any of the following symptoms of an allergic or infusion reaction:
Danish: Du skal omgående fortælle det til lægen eller sygeplejersken eller tage på skadestuen på det nærmeste hospital, hvis du får nogen af følgende symptomer på en overfølsomhedsreaktion eller infusionsrelateret reaktion:
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and
Danish: • ingen ny BILAG A-organdomænescore eller 2 nye BILAG B-organdomænescorer og
English: The data presented in the table below reflect exposure to Benlysta administered (10 mg/kg intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days for up to 52 weeks) in 674 patients with SLE, including 472 exposed for at least 52 weeks, and 556 patients exposed to 200 mg Benlysta subcutaneously once weekly for up to 52 weeks.
Danish: Data, der er præsenteret i tabellen nedenfor, afspejler eksponeringen af en Benlysta-dosis, administreret intravenøst (10 mg/kg over en periode på 1 time på dag 0, 14, 28 og herefter hver 28. dag i op til 52 uger) hos 674 patienter med SLE, herunder 472 patienter, som blev eksponeret i mindst 52 uger og 556 patienter, som blev eksponeret for 200 mg Benlysta subkutant en gang om ugen i op til 52 uger.
English: These may affect up to 1 in 10 people:
Danish: Disse kan forekomme hos op til 1 ud af 10 personer:
English: • Clean the injection site by wiping it with an alcohol swab (Figure 5).
Danish: • Rens injektionsstedet ved at tørre det med en renseserviet (Figur 5).
English: • Remove one sealed tray containing a pre-filled pen from the refrigerator.
Danish: • Fjern én forseglet pakning/bakke indeholdende en fyldt pen fra køleskabet.
English: Do not use if the expiry date has passed
Danish: Du må ikke bruge pennen, hvis udløbsdatoen er overskredet.
English: Allow 10 to 15 minutes for the vial to warm to room temperature (15°C to 25°C).
Danish: Vent 10 til 15 minutter, så hætteglasset kan opnå stuetemperatur (15 ºC til 25 ºC).
English: The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Danish: Det anbefalede doseringsregime er 10 mg/kg Benlysta på dag 0, 14 og 28 og herefter hver 4. uge.
English: You should also receive training on how to use the pre-filled pen.
Danish: Du skal desuden trænes i at bruge den fyldte pen.
English: Your doctor may decide to give you medicines which help to reduce any infusion reactions before you are given Benlysta.
Danish: Før du får Benlysta, kan lægen beslutte at give dig medicin, som medvirker til at nedsætte enhver reaktion på infusionen.
English: However, given the small number of subjects ≥65 years, an effect of age cannot be ruled out conclusively.
Danish: På grund af det lave antal forsøgspersoner på ≥ 65 år kan alderens effekt ikke endegyldigt udelukkes.
English: • Do not use if the expiry date has passed.
Danish: • Du må ikke bruge sprøjten, hvis udløbsdatoen er overskredet.
English: Infections leading to discontinuation of treatment occurred in 0.7% of patients receiving Benlysta and 1.5% of patients receiving placebo.
Danish: Infektioner, som førte til seponering af behandlingen, forekom hos 0,7 % af de patienter, der fik Benlysta og hos 1,5 % af de patienter, der fik placebo.
English: Therefore, no dose adjustment is recommended for patients with renal impairment.
Danish: Det anbefales derfor ikke at justere dosis hos patienter med nedsat nyrefunktion.
English: Patients had active SLE disease, defined as a SELENA-SLEDAI (SELENA=Safety of Estrogens in Systemic Lupus Erythematosus National Assessment; SLEDAI=Systemic Lupus Erythematosus Disease Activity Index) score ≥6 and positive anti-nuclear antibody (ANA) test results (ANA titre ≥1:80 and/or a positive anti-dsDNA [≥30 units/ml]) at screening.
Danish: Patienterne havde aktiv SLEsygdom, defineret ved en SELENA-SLEDAI-score på ≥ 6 (SELENA = Safety of Estrogens in Systemic Lupus Erythematosus National Assessment og SLEDAI = Systemic Lupus Erythematosus Disease Activity Index) og positive resultater for antinukleært-antistof (ANA) (ANA-titer ≥ 1:80 og/eller positiv anti-dsDNA [≥ 30 enheder/ml]) ved screeningen.
English: These may affect more than 1 in 10 people:
Danish: Disse kan forekomme hos flere end 1 ud af 10 personer:
English: During clinical development, Benlysta was studied in a limited number of SLE patients with mild (creatinine clearance [CrCl] ≥60 and <90 ml/min), moderate (CrCl ≥30 and <60 ml/min), or severe (CrCl ≥15 and <30 ml/min) renal impairment: 121 patients with mild renal impairment and 30 patients with moderate renal impairment received Benlysta subcutaneously; 770 patients with mild renal impairment, 261 patients with moderate renal impairment and 14 patients with severe renal impairment received Benlysta intravenously.
Danish: Under den kliniske udvikling blev Benlysta undersøgt hos et begrænset antal SLE-patienter med mildt (kreatininclearance (CrCl) ≥ 60 og < 90 ml/min), moderat (CrCl ≥ 30 og < 60 ml/min) eller svært (CrCl ≥ 15 og < 30 ml/min) nedsat nyrefunktion: 121 patienter med mildt nedsat nyrefunktion og 30 patienter med moderat nedsat nyrefunktion fik Benlysta subkutant; 770 patienter med mildt nedsat nyrefunktion, 261 patienter med moderat nedsat nyrefunktion og 14 patienter med svært nedsat nyrefunktion fik Benlysta intravenøst.
English: Two doses up to 20 mg/kg administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.
Danish: Ved administration af to doser på op til 20 mg/kg til mennesker administreret som intravenøs infusion med 21 dages mellemrum steg incidensen eller sværhedsgraden af bivirkninger ikke sammenlignet med doser på 1, 4 eller 10 mg/kg.
English: Talk to your doctor before you use Benlysta:
Danish: Kontakt lægen, før du tager Benlysta:
English: Step-by-step instructions for using the pre-filled pen
Danish: Trinvis vejledning for brug af fyldt pen
English: However, given the small number of subjects ≥65, an effect of age cannot be ruled out conclusively.
Danish: På grund af det lave antal forsøgspersoner på ≥ 65 kan alderens effekt ikke endegyldigt udelukkes.
English: Patients should be advised that hypersensitivity reactions are possible, on the day of, or several days after infusion, and be informed of potential signs and symptoms and the possibility of recurrence.
Danish: Patienterne skal informeres om, at overfølsomhedsreaktioner kan forekomme på dagen eller flere dage efter infusionen, og de skal informeres om potentielle tegn og symptomer og om risikoen for tilbagefald.
English: • After the needle is completely inserted, release the pinched skin.
Danish: • Efter at kanylen er helt indført, skal du ikke længere klemme på huden.
English: Leucopenia: The incidence of leucopenia reported as an adverse event was 3% in the group receiving Benlysta and 2% in the group receiving placebo.
Danish: Leukopeni: Incidensen af leukopeni, der blev rapporteret som en bivirkning, var 3 % i gruppen, der fik Benlysta og 2 % i gruppen, der fik placebo.
English: In a randomised, double-blind, placebo-controlled, post-marketing study with Benlysta 10 mg/kg administered intravenously, serious psychiatric events were reported in 1.0% (20/2002) of patients receiving Benlysta and 0.3% (6/2001) of patients receiving placebo.
Danish: I et randomiseret, dobbeltblindet, placebokontrolleret, post-marketing studie med 10 mg/kg Benlysta administreret intravenøst, blev alvorlige psykiske bivirkninger rapporteret hos 1,0 % (20/2002) af patienterne, der fik Benlysta og hos 0,3 % (6/2001) af patienterne, der fik placebo.
English: Available in packs of 1 or 4 pre-filled syringes in each pack.
Danish: Tilgængelig i pakningsstørrelser á 1 eller 4 fyldte injektionssprøjter i hver pakning.
English: Observed difference vs Placebo
Danish: Observeret forskel vs placebo
English: Instructions for using the pre-filled pen are given at the end of this leaflet.
Danish: Instruktioner for brug af den fyldte pen er angivet til slut i denne indlægsseddel.
English: At baseline 52% of patients had high disease activity (SELENA SLEDAI score ≥10), 59% of patients had mucocutaneous, 60% had musculoskeletal, 16% had haematological, 11% had renal and 9% had vascular organ domain involvement (BILAG A or B at baseline).
Danish: Ved baseline havde 52 % af patienterne høj sygdomsaktivitet (en SELENA-SLEDAI-score på ≥ 10), 59 % af patienterne havde mukokutan, 60 % muskuloskeletal, 16 % hæmatologisk, 11 % renal og 9 % vaskulær organdomæne-involvering (BILAG [British Isles Lupus Assessment Group] A eller B ved baseline).
English: Follow these instructions on how to use the pre-filled pen correctly.
Danish: Følg disse instruktioner for korrekt brug af den fyldte pen.
English: • Ask your doctor or pharmacist for instructions on how to properly dispose of a used pen or container of used pens.
Danish: • Spørg din læge eller på apoteket, hvordan du skal bortskaffe den brugte pen eller beholder med brugte penne.
English: • Do not warm the syringe in any other way.
Danish: • Du må ikke opvarme injektionssprøjten på anden måde.
English: Prepare and inspect the pre-filled pen Allow to come to room temperature
Danish: Forbered og inspicer den fyldte pen Lad pennen opnå stuetemperatur
English: Benlysta in pre-filled pen or pre-filled syringe is administered by subcutaneous injection.
Danish: Benlysta i fyldt pen eller fyldt injektionssprøjte administreres som en subkutan injektion.
English: Medicines that weaken your immune system, such as Benlysta, may put you at higher risk of getting a rare but serious and life-threatening brain infection called progressive multifocal leukoencephalopathy (PML).
Danish: Medicin, som svækker dit immunsystem, såsom Benlysta, kan øge din risiko for at få en sjælden, men alvorlig og livstruende hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML).
English: Benlysta has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide.
Danish: Benlysta er ikke blevet undersøgt i kombination med andre B-celle targeterede behandlinger eller cyclophosphamid administreret intravenøst.
English: In a pooled analysis of the two studies, the percentage of patients receiving >7.5 mg/day prednisone (or equivalent) at baseline, whose average corticosteroid dose was reduced by at least 25% to a dose equivalent to prednisone ≤7.5 mg/day during Weeks 40 through 52, was 17.9% in the group receiving Benlysta and 12.3% in the group receiving placebo (p=0.0451).
Danish: I en samlet analyse af de to studier var procentdelen af patienter, der ved baseline fik en prednisondosis på > 7,5 mg/dag (eller tilsvarende) og som fik reduceret den gennemsnitlige kortikosteroiddosis med mindst 25 % til en dosis svarende til en prednisondosis på ≤ 7,5 mg/dag i løbet af uge 40 til og med uge 52, 17,9 % i gruppen, der fik Benlysta, og 12,3 % i gruppen, der fik placebo (p=0,0451).
English: In case administration of Benlysta to elderly patients is deemed necessary, dose adjustment is not required (see section 5.2).
Danish: Hvis det vurderes nødvendigt at administrere Benlysta til ældre patienter, er en dosisjustering ikke nødvendig (se pkt.
English: The efficacy of Benlysta administered subcutaneously was evaluated in a randomised, double-blind, placebo-controlled 52-week Phase III study (HGS1006-C1115; BEL112341) in 836 adult patients with a clinical diagnosis of SLE according to the American College of Rheumatology classification criteria.
Danish: Benlystas virkning ved subkutan administration blev vurderet i et randomiseret, dobbeltblindet, placebokontrolleret 52-ugers fase III studie (HGS1006-C1115; BEL112341) hos 836 voksne patienter med en klinisk SLE-diagnose i henhold til klassifikationskriterierne fra American College of Rheumatology.
English: However, consistent with results from other studies, in black patients with high disease activity (low complement and positive anti-dsDNA at baseline, n=141) the SRI-S2K response was 45.1% for Benlysta 10 mg/kg compared with 24.0% for placebo (odds ratio 3.00; 95% CI: 1.35, 6.68).
Danish: Hos sorte patienter med høj sygdomsaktivitet (lav komplement og positiv anti-dsDNA ved baseline, n=141) var SRI-S2K-responset dog 45,1 % for Benlysta 10 mg/kg sammenlignet med 24,0 % for placebo (odds ratio 3,00, 95 % CI: 1,35, 6,68), hvilket er konsistent med resultater fra andre studier.
English: Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.4 and 4.8).
Danish: Der er også set tilbagefald af klinisk relevante reaktioner efter, at der initialt er givet relevant behandling for symptomerne (se pkt.
English: Prepare for the injection
Danish: Forbered injektionen
English: • Check the expiry date on the pre-filled pen.
Danish: • Tjek udløbsdatoen på den fyldte pen (Figur 1).
English: Belimumab has been studied in a limited number of SLE patients with renal impairment.
Danish: Behandling med belimumab er blevet undersøgt hos et begrænset antal SLE-patienter med nedsat nyrefunktion.
English: What is in this leaflet:
Danish: Se nedenfor:
English: • Do not inject within 5 cm (2 inches) of the navel (belly button).
Danish: • Du må ikke injicere inden for et område på 5 cm fra navlen.
English: Patients were on a stable SLE treatment regimen consisting of (alone or in combination): corticosteroids, anti-malarials, NSAIDs or other immunosuppressives.
Danish: Patienterne var på et stabilt SLE-behandlingsregime, der bestod af (alene eller i kombination): kortikosteroider, malariamidler, NSAIDs eller andre immunsuppressiva.
English: In clinical studies, serious infusion and hypersensitivity reactions affected approximately 0.9% of adult patients, and included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Danish: I kliniske studier forekom alvorlige infusionsrelaterede reaktioner og alvorlige overfølsomhedsreaktioner hos ca. 0,9 % af voksne patienter, herunder anafylaktisk reaktion, bradykardi, hypotension, angioødem og dyspnø.