FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 5- to 11-year-old-group (n=13) the SELENA-SLEDAI score ranged from 4 to 13, and in 12- to 17-year-old-group (n=79) the SELENA-SLEDAI score ranged from 4 to 20.
Danish: I gruppen for 5-11-årige (n=13) var SELENA-SLEDAI scoren mellem 4 og 13 og i gruppen for 12-17-årige (n=79) var SELENA-SLEDAI scoren mellem 4 og 20.
English: The MAH shall also provide a data report on a long-term controlled safety registry where all patients are followed for a minimum of 5 years, based on a protocol agreed with CHMP.
Danish: Indehaveren af markedsføringstilladelsen skal desuden fremsende en datarapport over et længerevarende, kontrolleret sikkerhedsregister, hvor alle patienter følges i minimum 5 år, baseret på en protokol, der er godkendt med CHMP.
English: The effects of body weight and BMI on belimumab exposure after subcutaneous administration were not considered clinically meaningful.
Danish: Indvirkningen af legemsvægt og BMI på belimumab efter subkutan eksponering blev ikke anset for at give klinisk mening.
English: The stream of water for injections should be directed toward the side of the vial to minimize foaming.
Danish: Strålen af vand til injektionsvæsker skal rettes mod siden af hætteglasset for at minimere skumdannelse.
English: • Use an effective method of contraception while you are being treated with Benlysta and for at least 4 months after the last dose.
Danish: • Brug sikker prævention, så længe du er i behandling med Benlysta og i mindst 4 måneder efter den sidste dosis.
English: Paediatric population: The pharmacokinetic parameters are based on individual parameter estimates from a population pharmacokinetic analysis of 53 patients from a study in paediatric patients.
Danish: Pædiatrisk population: De farmakokinetiske parametre er baseret på individuelle parameter-estimater fra en populations-farmakokinetisk analyse af 53 patienter fra et studie hos pædiatriske patienter.
English: • Remove the needle cap by pulling it straight off. (Figure 6b)
Danish: • Fjern hætten ved at trække den lige af (Figur 6b).
English: Do not give Benlysta as a subcutaneous injection to children or adolescents younger than 18 years of age.
Danish: Giv ikke Benlysta som injektion under huden til børn og unge under 18 år.
English: It is unknown whether Benlysta is excreted in human milk or is absorbed systemically after ingestion.
Danish: Det vides ikke, om belimumab udskilles i human mælk eller absorberes systemisk efter indtagelse.
English: ≥1/10,000 to <1/1000
Danish: ≥ 1/10.000 til < 1/1.000
English: • if your lupus affects your kidneys or nervous system
Danish: • hvis din lupus påvirker dine nyrer eller dit nervesystem
English: Patients were randomised in a 2:1 ratio to receive belimumab 200 mg or placebo subcutaneously once weekly for 52 weeks.
Danish: Patienterne blev randomiseret i en 2:1-ratio til at modtage belimumab 200 mg eller placebo subkutant en gang om ugen.
English: The B cell and IgG response to long term treatment with intravenous Benlysta was assessed in an uncontrolled extension study.
Danish: B-celle- og IgG-responset for længerevarende behandling med intravenøst Benlysta blev vurderet i et ukontrolleret opfølgningsstudie.
English: IgG1 molecules such as belimumab are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue and changes in hepatic function are unlikely to have any effect on the elimination of belimumab.
Danish: IgG1-molekyler som belimumab kataboliseres af udbredte proteolytiske enzymer, som ikke kun findes i levervæv, og det er usandsynligt, at ændringer i leverfunktionen har nogen effekt på elimineringen af belimumab.
English: Some infections can be severe and can uncommonly cause death.
Danish: Enkelte infektioner kan være alvorlige og kan i sjældne tilfælde være dødelige.
English: Infusion or injection-related systemic reactions and hypersensitivity: Infusion or injection-related systemic reactions and hypersensitivity were generally observed on the day of administration, but acute hypersensitivity reactions may also occur several days after dosing.
Danish: Infusions- eller injektionsrelaterede systemiske reaktioner og overfølsomhed: Infusions- eller injektionsrelaterede systemiske reaktioner og overfølsomhed blev generelt observeret på dagen for administration, mens akutte overfølsomhedsreaktioner også fremkom flere dage efter dosisadministration.
English: If you forget to use Benlysta
Danish: Hvis du har glemt at tage Benlysta
English: Delayed-type, non-acute hypersensitivity reactions
Danish: Forsinkede, ikke-akutte overfølsomhedsreaktioner
English: Tell your doctor or nurse.
Danish: Fortæl det til lægen eller en sygeplejerske.
English: Odds ratio (95% CI) vs Placebo *The five PRINTO/ACR components were percent change at Week 52 in: Parent's Global Assessment (Parent GA), PGA, SELENA SLEDAI score, 24-hour proteinuria, and, Paediatric Quality of Life Inventory - Generic Core Scale (PedsQL GC) physical functioning domain score.
Danish: Odds ratio (95 % CI) vs placebo * De fem PRINTO/ACR komponenter var procentvis ændring ved Uge 52 i: Parent's Global Assessment (Parent GA), PGA, SELEN- SLEDAI-score, 24-timers proteinuri, og Paediatric Quality of Life InventoryGeneric Core Scale (PedsQL GC) fysisk funktion domæne-score.
English: The relative contribution of BLyS levels to the pathophysiology of SLE is not fully understood.
Danish: Det relative bidrag af BLyS-proteinniveauet til patofysiologien ved SLE er ikke fuldstændigt kortlagt.
English: Your doctor will discuss with you whether you should stop treatment with Benlysta while you are breast-feeding, or if you should stop breast-feeding.
Danish: Lægen vil drøfte med dig, om du skal stoppe behandlingen med Benlysta, mens du ammer, eller om du skal stoppe med at amme.
English: Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Danish: Benlysta bør ikke anvendes under graviditet, medmindre den forventede fordel opvejer den potentielle risiko for barnet.
English: It is recommended that the first subcutaneous injection of Benlysta should be under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary.
Danish: Det anbefales, at den første subkutane injektion af Benlysta foretages under overvågning af sundhedspersonale i omgivelser, der er tilstrækkeligt kvalificerede til at håndtere overfølsomhedsreaktioner, om nødvendigt.
English: Very common Bacterial infections, e.g. bronchitis, urinary tract infection
Danish: Meget almindelig Bakterielle infektioner, f.eks. bronkitis, urinvejsinfektion
English: Paediatric population: No pharmacokinetic data are available for subcutaneous administration of Benlysta in paediatric patients.
Danish: Pædiatrisk population: Der foreligger ingen farmakokinetiske data om subkutan administration af Benlysta til pædiatriske patienter.
English: After use - needle is covered by needle guard
Danish: Efter brug - kanylen er beskyttet af en sikkerhedshætte
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Danish: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irland
English: Patients with malignant neoplasm within the last 5 years have not been studied, with the exception of those with basal or squamous cell cancers of the skin, or cancer of the uterine cervix, that has been fully excised or adequately treated.
Danish: Patienter med malign neoplasme inden for de sidste 5 år er ikke undersøgt, med undtagelse af patienter med basalcelle- eller planocellulær cancer i huden eller uterin cervixcancer, der er fjernet fuldstændig eller er tilstrækkeligt behandlet.
English: In a substudy, a small group of patients who had previously received either tetanus, pneumococcal or influenza vaccinations were found to maintain protective titres after treatment with Benlysta.
Danish: I et substudie opretholdte en lille gruppe patienter, der tidligere var blevet vaccineret mod tetanus, pneumokokker eller influenza, beskyttende titer efter behandling med Benlysta.
English: • if your lupus affects your kidneys or nervous system • if you are HIV positive or have low immunoglobulin levels
Danish: • hvis din lupus påvirker dine nyrer eller dit nervesystem • hvis du er hiv positiv eller har et lavt niveau af immunglobulin
English: Contact your doctor or go to a hospital straight away.
Danish: Kontakt lægen eller tag på skadestuen med det samme.
English: These are very common and may affect more than 1 in 10 people.
Danish: Disse er meget almindelige og kan forekomme hos flere end 1 ud af 10 personer.
English: In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres.
English: Patients had active SLE disease, defined as a SELENA-SLEDAI score ≥6 and positive autoantibodies at screening as described in the adult trials.
Danish: Patienterne havde aktiv SLE sygdom, defineret ved en SELENA-SLEDAI-score ≥ 6 og positive autoantistoffer ved screening som beskrevet i studierne med voksne.
English: • Do not inject in areas where the skin is tender, bruised, red or hard.
Danish: • Du må ikke injicere i områder, hvor huden er øm, med blå mærker, rød eller hård.
English: BLISS-52 was conducted in South America, Eastern Europe, Asia, and Australia.
Danish: BLISS-52 blev udført i Sydamerika, Østeuropa, Asien og Australien.
English: The intravenous studies did not exclude patients with a history of psychiatric disorders.
Danish: De intravenøse studier ekskluderede ikke patienter med tidligere psykiske lidelser.
English: The reconstituted solution, if not used immediately, should be protected from direct sunlight and stored refrigerated at 2°C to 8°C.
Danish: Den rekonstituerede opløsning skal - hvis den ikke bruges med det samme - beskyttes mod direkte sollys og opbevares i køleskab ved 2 ºC til 8 ºC.
English: Tell your doctor or nurse immediately.
Danish: Fortæl det straks til lægen eller sygeplejersken.
English: Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered.
Danish: Det har været indrapporteret, at patienter har udviklet symptomer på akut overfølsomhed flere timer efter infusionen.
English: After 7 and a half years of treatment (including the 72-week parent study), a substantial and sustained decrease in various B cell subsets was observed leading to 87% median reduction in naïve B cells, 67% in memory B cells, 99% in activated B cells, and 92% median reduction in plasma cells after more than 7 years of treatment.
Danish: Efter 7 og et halvt års behandling (inklusive det oprindelige studie på 72 uger) blev et betydeligt og vedvarende fald i forskellige B-celle-subgrupper set, hvilket medførte 87 % median reduktion i naive B-celler, 67 % i memory B-celler, 99 % i aktiverede B-celler og 92 % i plasmaceller efter mere end 7 års behandling.
English: Thereafter, patients can resume dosing on their usual day of administration, or start a new weekly schedule from the day that the missed dose was administered.
Danish: Herefter kan patienterne genoptage dosering på deres sædvanlige dag for administration, eller de kan begynde en ny ugentlig rutine fra den dag, den glemte dosis blev administreret.
English: Infections: The overall incidence of infections in intravenous and subcutaneous studies was 63% in both groups receiving Benlysta or placebo.
Danish: Infektioner: Den samlede incidens af infektioner i intravenøse og subkutane studier var 63 % i begge grupper, der fik Benlysta eller placebo.
English: If a patient is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose (see section 5.2).
Danish: Hvis en patient overgår fra intravenøst administreret Benlysta til subkutan administration, skal den første subkutane injektion administreres 1 til 4 uger efter den sidste intravenøse dosis (se pkt.
English: The proportion of black patients achieving an SRI-S2K response was higher in patients receiving Benlysta but the difference was not statistically significant compared with placebo.
Danish: Andelen af sorte patienter der opnåede et SRI-S2K-respons var højere for patienter, der fik Benlysta men forskellen var ikke statistisk signifikant sammenlignet med placebo.
English: • memory loss
Danish: • hukommelsestab
English: These are common side effects (may affect up to 1 in 10 people).
Danish: Disse er almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer).
English: Proportion of patients with at least 50% improvement in any 2 of 5 components* and no more than one of the remaining worsening by more than 30%
Danish: Andel af patienter med mindst 50 % forbedring i vilkårlige 2 ud af 5 komponenter* og ikke flere end én komponent med mere end 30 % forværring i de resterende
English: Serum belimumab concentrations declined in a bi-exponential manner, with a distribution half-life of 1.75 days and terminal half-life 19.4 days.
Danish: Serumkoncentrationen af belimumab faldt bieksponentielt med en fordelingshalveringstid på 1,75 dage og en terminal halveringstid på 19,4 dage.
English: Weight-normalised belimumab dosing leads to decreased exposure for underweight subjects (BMI <18.5) and to increased exposure for obese subjects (BMI ≥30).
Danish: Vægtnormaliseret dosering af belimumab fører til en nedsat eksponering hos undervægtige forsøgspersoner (BMI < 18,5) og til en øget eksponering hos svært overvægtige forsøgspersoner (BMI ≥ 30).
English: Belimumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Danish: Belimumab er et protein, der forventes at blive metaboliseret ved nedbrydning til små peptider og individuelle aminosyrer af proteolytiske enzymer forekommende vidt udbredt i organismen.
English: Besides an expected pharmacological effect i.e. reduction of B cells, animal studies in monkeys do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section
Danish: Ud over den forventede farmakologiske effekt, dvs. reduktion i antallet af B-celler, indikerer dyrestudier med aber hverken direkte eller indirekte skadelige effekter hvad angår reproduktionstoksicitet (se pkt.
English: Sodium chloride Water for injections
Danish: Natriumchlorid Vand til injektionsvæsker.
English: The safety registry will evaluate the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Danish: Sikkerhedsregisteret skal evaluere incidensen af alle tilfælde af mortalitet og bivirkninger af særlig interesse hos patienter med systemisk lupus erythematosus.
English: Gently swirl the vial for 60 seconds.
Danish: Hætteglasset roteres forsigtigt i 60 sekunder.
English: Assay sensitivity for neutralising antibodies and non-specific anti-drug antibody (ADA) is limited by the presence of active drug in the collected samples.
Danish: Analysefølsomheden for neutraliserende antistoffer og uspecifikt anti-lægemiddel-antistof (ADA) er begrænset på grund af tilstedeværelsen af aktivt lægemiddel i de indsamlede prøver.
English: • Do not use if left out at room temperature for more than 12 hours.
Danish: • Må ikke bruges, hvis den har stået uden for køleskab i mere end 12 timer.
English: Among patients experiencing a severe flare, the median study day of the first severe flare was Day 159.5 in the Benlysta group and Day 82 in the placebo group.
Danish: Blandt de patienter, der oplevede et alvorligt flare var den mediane studiedag for første alvorlige flare Dag 159,5 i Benlystagruppen og Dag 82 i placebogruppen.
English: Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology.
Danish: Belimumab er et humant monoklonalt IgG1λ-antistof produceret i mammale cellelinjer (NS0) ved hjælp af rekombinant DNA-teknologi.
English: The majority of patients were also receiving one or more of the following concomitant treatments for SLE: corticosteroids, immunomodulatory medicinal products, anti-malarials, non-steroidal anti-inflammatory medicinal products.
Danish: Størstedelen af patienterne fik også sideløbende ét eller flere af følgende lægemidler til behandling af SLE: kortikosteroider, immunmodulerende lægemidler, malariamidler eller non-steroide antiinflammatoriske lægemidler.
English: The primary efficacy endpoint was a composite endpoint (SLE Responder Index) that defined response as meeting each of the following criteria at Week 52 compared with baseline:
Danish: Det primære effekt-endepunkt var et sammensat endepunkt (SLE Responder Index [SRI]), hvor definitionen på et respons var, at patienten opfyldte hvert af følgende kriterier ved 52 uger sammenlignet med baseline:
English: • severe active central nervous system lupus
Danish: • svær aktiv lupus i centralnervesystemet
English: Intravenous and subcutaneous administration to monkeys resulted in the expected reduction in the number of peripheral and lymphoid tissue B cell counts with no associated toxicological findings.
Danish: Intravenøs og subkutan administration hos aber resulterede i den forventede reduktion i antallet af B-celler i perifert og lymfoidt væv uden relaterede toksikologiske fund.
English: Because maternal antibodies (IgG) are excreted in breast milk, it is recommended that a decision should be made whether to discontinue breast-feeding or to discontinue Benlysta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Da maternelle antistoffer (IgG) udskilles i mælk, skal det besluttes, om amning eller behandling med Benlysta skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Patients who develop an infection while undergoing treatment with Benlysta should be monitored closely and careful consideration given to interrupting immunosuppressant therapy including belimumab until the infection is resolved.
Danish: Patienter, som udvikler en infektion, mens de er i behandling med Benlysta, skal monitoreres nøje og det skal overvejes nøje at afbryde immunsuppressiv-behandling, inklusive belimumab indtil infektionen er væk.
English: In the subcutaneous study where serum samples from more than 550 patients with SLE were tested, no antibelimumab antibodies were detected during or after treatment with belimumab 200 mg subcutaneously.
Danish: Serumprøver fra flere end 550 patienter med SLE blev testet i subkutanstudiet, og ingen anti-belimumab antistoffer blev fundet under eller efter behandling med belimumab 200 mg subkutant.
English: Caution should be exercised when considering Benlysta therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Danish: Der skal udvises forsigtighed, hvis det overvejes at administrere Benlysta til patienter med tidligere maligniteter, eller hvis det overvejes at fortsætte behandlingen hos patienter, der udvikler en malignitet.
English: After reconstitution, the solution contains 80 mg belimumab per ml.
Danish: Efter rekonstitution indeholder opløsningen 80 mg belimumab pr. ml.
English: Patients treated with Benlysta should be made aware of the potential risk of severe or life-threatening hypersensitivity and the potential for delayed onset or recurrence of symptoms.
Danish: Patienter behandlet med Benlysta skal gøres opmærksomme på den potentielle risiko for alvorlig eller livstruende overfølsomhed og om risikoen for forsinket indtræden eller tilbagefald af symptomer.
English: However, higher rates of nausea, vomiting and diarrhoea were observed in obese patients.
Danish: Der blev imidlertid observeret en højere hyppighed af kvalme, opkastning og diarré hos svært overvægtige patienter.
English: Pregnancy and breast-feeding Contraception in women of childbearing potential
Danish: Graviditet og amning Prævention til kvinder i den fødedygtige alder
English: There is an association between plasma BLyS levels and SLE disease activity.
Danish: Der er en sammenhæng mellem plasmaniveauet af BLyS-protein og sygdomsaktiviteten af SLE.
English: Pregnancy Benlysta is not usually recommended if you are pregnant.
Danish: Graviditet Benlysta frarådes, hvis du er gravid.
English: After reconstitution with water for injections, the reconstituted solution, if not used immediately, should be protected from direct sunlight, and stored refrigerated at 2°C to 8°C.
Danish: Efter rekonstitution med vand til injektionsvæsker skal den rekonstituerede opløsning - hvis den ikke bruges med det samme - beskyttes mod direkte sollys og opbevares i køleskab ved 2 °C til 8 ºC.
English: The subcutaneous pharmacokinetic parameters below are based on population parameter estimates from 661 subjects, comprised of 554 SLE patients and 107 healthy subjects, who received Benlysta subcutaneously.
Danish: De subkutane farmakokinetiske parametre, der er anført nedenfor, er baseret på estimater af populationsparametre fra de 661 patienter bestående af 554 SLE-patienter og 107 raske personer, der fik Benlysta subkutant.
English: Proportion of SRI responders by visit
Danish: Figur 1: Fordelingen af SRI respondenter målt på besøg
English: SRI response rate (excluding complement and anti-dsDNA changes) at week 52 (%)
Danish: SRI-responsrate (eksklusive ændringer i komplement- og anti-dsDNA-niveauet) ved 52 uger (%)
English: • Do not use if dropped onto a hard surface.
Danish: • Må ikke bruges, hvis den er blevet tabt på et hårdt underlag.
English: The true occurrence of neutralising antibodies and non-specific anti-drug antibody in the study population is therefore not known.
Danish: Den reelle forekomst af neutraliserende antistoffer og uspecifikt anti-lægemiddel-antistof hos forsøgspopulationen er derfor ikke kendt.
English: Choose and clean the injection site Choose the injection site
Danish: Udvælg og rens injektionsstedet Udvælg injektionsstedet
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This study was conducted in the US, South America, Europe and Asia.
Danish: Studiet blev udført i USA, Sydamerika, Europa og Asien.
English: Infusion or injection-related systemic reactions*, pyrexia
Danish: Infusions- eller injektionsrelaterede systemiske reaktioner*, feber
English: The mechanism of action of belimumab could increase the risk for the development of infections, including opportunistic infections.
Danish: Belimumabs virkningsmekanisme kan øge risikoen for udviklingen af infektioner, herunder opportunistiske infektioner.
English: However, belimumab was detected in the milk from female monkeys administered 150 mg/kg every 2 weeks.
Danish: Belimumab blev imidlertid fundet i mælken fra hunaber, når det blev administreret i doser på 150 mg/kg hver 2. uge.
English: Patients who had severe active lupus nephritis, severe active CNS lupus, primary immunodeficiency, IgA deficiency or acute or chronic infections requiring management were excluded from the study.
Danish: Patienter med alvorlig aktiv lupus nephritis, alvorlig aktiv CNS lupus, primær immundefekt, IgAmangel eller akutte eller kroniske infektioner, der kræver behandling blev ekskluderet fra studiet.
English: Your first injection with the Benlysta pre-filled pen will be supervised by your doctor or nurse.
Danish: Din første injektion med Benlysta fyldt pen vil blive overvåget af din læge eller sygeplejerske.
English: Inspection window
Danish: Inspektions -vindue i d
English: Benlysta infusions should be administered by a qualified healthcare professional trained to give infusion therapy.
Danish: Infusion af Benlysta skal administreres af kvalificeret sundhedspersonale, der er uddannet i at give infusionsbehandling.