FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 - Paediatric response rate at Week 52 Response
Danish: Tabel 3 - Pædiatrisk responsrate ved Uge 52 Respons
English: Infusion reactions and hypersensitivity
Danish: Infusionsrelaterede reaktioner og overfølsomhed
English: 5% glucose intravenous solutions are incompatible with Benlysta and must not be used.
Danish: 5 % glucoseinjektions-/infusionsvæske er uforligelige med Benlysta og må ikke anvendes.
English: Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2).
Danish: Det anbefales dog at udvise forsigtighed ved administration til patienter med svært nedsat nyrefunktion på grund af manglende data (se pkt.
English: Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B).
Danish: Belimumab er et humant monoklonalt IgG1λ-antistof, der er specifikt for det opløselige humane Blymfocytstimulatorprotein (BLyS-protein, også kaldet BAFF og TNFSF13B).
English: See ‘Important information about the contents of Benlysta' in section 2 for further information.
Danish: Se 'Vigtig information om indholdet i Benlysta' i punkt 2 for mere information.
English: Physicians should exercise caution when considering the use of Benlysta in patients with severe or chronic infections or a history of recurrent infection.
Danish: Læger bør udvise forsigtighed, hvis de planlægger at anvende Benlysta til patienter med alvorlige eller kroniske infektioner eller tidligere tilbagevendende infektioner.
English: Benlysta has not been studied in the following patient groups and is not recommended in:
Danish: Behandling med Benlysta er ikke blevet undersøgt hos patientgrupper med følgende tilstande og anbefales derfor ikke hos disse:
English: Benlysta was administered intravenously to black patients in a randomised (2:1), double-blind, placebo-controlled, 52-week Phase III/IV study (EMBRACE).
Danish: Benlysta blev administreret intravenøst til sorte patienter i et randomiseret (2:1), dobbeltblindet, placebokontrolleret, 52-ugers Fase III/IV-studie (EMBRACE).
English: Percent of patients with no worsening by BILAG index
Danish: Procentdel af patienter uden forværring efter BILAG-indeks
English: Pain in extremity
Danish: Smerter i ekstremiteterne
English: Tell your doctor if you are taking any other medicines, if you have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin, har taget anden medicin for nylig eller planlægger at tage anden medicin.
English: • Use your free hand to gently pinch the skin around the injection site.
Danish: • Brug din frie hånd til forsigtigt at klemme huden omkring injektionsstedet (Figur 7).
English: Benlysta 200 mg weekly
Danish: Benlysta 200 mg ugentlig
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Benlysta subcutaneous administration in one or more subsets of the paediatric population in SLE (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Benlysta administreret subkutant i en eller flere undergrupper af den pædiatriske population ved SLE (se pkt.
English: In controlled clinical intravenous and subcutaneous studies, psychiatric disorders (depression, suicidal ideation and behaviour including suicides) have been reported more frequently in patients receiving Benlysta (see section 4.8).
Danish: I kontrollerede kliniske intravenøse og subkutane studier blev psykiske bivirkninger (depression, selvmordstanker og -adfærd inklusive selvmord) observeret hyppigere hos patienter, der fik Benlysta (se pkt.
English: If this happens, immediately contact your doctor or nurse, who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Danish: Hvis du har taget for meget Benlysta, skal du omgående kontakte din læge eller sygeplejerske, som vil undersøge dig for eventuelle tegn eller symptomer på bivirkninger og om nødvendigt behandle disse symptomer.
English: The intravenous pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies.
Danish: De intravenøse farmakokinetiske parametre, der er anført nedenfor, er baseret på estimater af populationsparametre fra de 563 patienter, der fik en Benlysta-dosis på 10 mg/kg i de to fase III-studier.
English: The efficacy and safety of Benlysta in the elderly has not been established.
Danish: Benlystas virkning og sikkerhed hos ældre er ikke klarlagt.
English: Benlysta is administered by intravenous infusion.
Danish: Benlysta administreres som en intravenøs infusion.
English: There was a higher proportion of paediatric patients achieving an SRI response in patients receiving Benlysta compared with placebo.
Danish: Der var en højere andel af pædiatriske patienter, der opnåede et SRI respons hos de patienter, der fik Benlysta sammenlignet med placebo.
English: Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended in:
Danish: Behandling med Benlysta er ikke blevet undersøgt hos voksne og pædiatriske patientgrupper med følgende tilstande og anbefales derfor ikke hos disse:
English: Odds ratio (95% CI) vs placebo
Danish: Odds ratio (95 % CI) sammenlignet med placebo
English: Inspect the Benlysta solution visually for particulate matter and discoloration prior to administration.
Danish: Benlysta-opløsningen inspiceres visuelt for partikler og misfarvning før administration.
English: Once removed from the refrigerator, the syringe must be used within 12 hours or discarded.
Danish: Når injektionssprøjten er taget ud af køleskabet skal den anvendes inden for 12 timer eller kasseres.
English: The overall incidence of serious suicidal ideation or behaviour or self-injury without suicidal intent was 0.7% (15/2002) in patients receiving Benlysta and 0.2% (5/2001) in the placebo group.
Danish: Den samlede forekomst af alvorlige selvmordstanker eller -adfærd eller selvskade uden suicidal hensigt var 0,7 % (15/2002) hos patienter, der fik Benlysta og 0,2 % (5/2001) i placebogruppen.
English: SLE patients transitioning from 10 mg/kg intravenously every 4 weeks to 200 mg subcutaneously weekly using a 1 to 4 week switching interval had pre-dose belimumab serum concentrations at their first subcutaneous dose close to their eventual subcutaneous steady-state trough concentration (see section 4.2).
Danish: De SLE-patienter, der med en overgangsperiode på 1 til 4 uger gik fra 10 mg/kg intravenøst hver 4. uge til 200 mg subkutant ugentligt, havde en prædosis belimumab-serumkoncentration ved deres første subkutane dosis, som lå tæt på deres endelige subkutane dalkoncentration ved steady-state (se pkt.
English: For anti-cardiolipin IgA antibody a 37% reduction at Week 52 was seen (p=0.0003), for anti-cardiolipin IgG antibody a 26% reduction at Week 52 was seen (p=0.0324) and for anti-cardiolipin IgM a 25% reduction was seen (p=NS,
Danish: For anti-cardiolipin IgA-antistoffer sås en reduktion på 37 % ved uge 52 (p=0,0003), for anti-cardiolipin IgG-antistoffer sås en reduktion på 26 % ved uge 52 (p=0,0324) og for anti-cardiolipin IgM-antistoffer sås en reduktion på 25 % (p=NS, 0,46).
English: In the two Phase III studies in adults, 4 of the 563 (0.7%) patients in the 10 mg/kg group and 27 out of 559 (4.8%) patients in the 1 mg/kg group tested positive for persistent presence of anti-belimumab antibodies.
Danish: I de to fase III-studier hos voksne blev 4 af de 563 (0,7 %) patienter i 10 mg/kg-gruppen og 27 ud af 559 (4,8 %) patienter i 1 mg/kg-gruppen testet positive for vedvarende tilstedeværelse af anti-belimumabantistoffer.
English: To improve the traceability of this medicine, you and your healthcare provider should record the Benlysta lot number.
Danish: For at forbedre sporbarheden af dette lægemiddel skal du og din læge notere Benlystas batchnummer.
English: Patients who had severe active lupus nephritis and patients who had severe active central nervous system (CNS) lupus were excluded.
Danish: Patienter med svær aktiv lupus nefritis og patienter med svær aktiv lupus i centralnervesystemet (CNS) blev ekskluderet.
English: Inject Benlysta Start the injection
Danish: Injicer Benlysta Påbegynd injektionen
English: As belimumab is a monoclonal antibody no genotoxicity studies have been conducted.
Danish: Da belimumab er et monoklonalt antistof, er genotoksiciteten ikke undersøgt.
English: No specific studies with Benlysta have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført specifikke studier med Benlysta hos patienter med nedsat leverfunktion.
English: • feeling sick, diarrhoea.
Danish: • kvalme, diarré.
English: For patients whose body weight is less than or equal to 40 kg, infusion bags with 100 ml of these diluents may be considered providing that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/ml.
Danish: For patienter med en kropsvægt på 40 kg og derunder, kan infusionsposer med 100 ml af disse diluenter overvejes, såfremt den endelige koncentration af belimumab i infusionsposen ikke overstiger 4 mg/ml.
English: • Choose an injection site (abdomen or thigh) as seen in Figure 4.
Danish: • Udvælg et injektionssted (maven eller låret) som vist i Figur 4.
English: • Insert the entire needle into the pinched area of the skin at a slight angle (45°), using a dart-like motion.
Danish: • Indfør hele kanylen i det klemte hudområde let vinklet (45 grader), som hvis du kastede en dartpil.
English: These adverse events of special interest include serious infections (including opportunistic infections and PML), selected serious psychiatric events, and malignancies (including non-melanoma skin cancer).
Danish: Bivirkninger af særlig interesse inkluderer alvorlige infektioner (herunder opportunistiske infektioner og PML), udvalgte alvorlige psykiske bivirkninger samt maligniteter (herunder ikke-melanom hudcancer).
English: Components of SLE responder index Percent of patients with reduction in SELENASLEDAI ≥4
Danish: Komponenter af SLE responder index Procentdel af patienter med en reduktion i SELENA SLEDAI-scoren på ≥ 4
English: • wheezing, difficulty in breathing or shortness of breath
Danish: • hvæsende vejrtrækning, vejrtrækningsbesvær eller åndenød
English: Any unused solution in the vials must be discarded.
Danish: Eventuel ubrugt opløsning i hætteglassene skal kasseres.
English: Discard the solution if any particulate matter or discoloration is observed.
Danish: Opløsningen skal kasseres, hvis der observeres partikler eller misfarvning.
English: The safety and efficacy of Benlysta in children aged below 5 years has not been established.
Danish: Benlystas sikkerhed og virkning hos børn under 5 år er ikke klarlagt.
English: Effects on male and female fertility in monkeys were assessed in the 6-month repeat dose toxicology studies of belimumab at doses up to and including 50 mg/kg.
Danish: Påvirkningen af fertiliteten hos han- og hunaber blev vurderet i et studie af 6 måneders varighed, hvor toksiciteten af gentagne doser af belimumab i doser op til og med 50 mg/kg blev undersøgt.
English: • Do not share your Benlysta pre-filled pen with another person.
Danish: • Du må ikke dele din Benlysta fyldte pen med andre personer.
English: Concomitant use with B cell targeted therapy or cyclophosphamide
Danish: Samtidig brug af B-celle targeteret behandling eller cyclophosphamid
English: Inspect the injection site
Danish: Undersøg injektionsstedet
English: The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4).
Danish: Sundhedspersonalet skal træne og uddanne patienten i subkutan injektionsteknik samt tegn og symptomer på overfølsomhedsreaktioner (se pkt.
English: Benlysta should be infused over a 1-hour period.
Danish: Benlysta skal gives som en infusion over en periode på 1 time.
English: • If needed, press a cotton ball or gauze pad on the injection site.
Danish: • Om nødvendigt kan du presse en vattot eller gaze på injektionsstedet.
English: Treatment-related findings were limited to the expected reversible reduction of B cells in both dams and infants and reversible reduction of IgM in infant monkeys.
Danish: Behandlingsrelaterede fund var begrænset til den forventede reversible reduktion af antallet af B-celler hos både moderdyrene og de nyfødte unger samt en reversible reduktion af IgM-niveauet hos nyfødte abeunger.
English: Age did not affect belimumab exposure in the subcutaneous population pharmacokinetic analysis.
Danish: Alderen påvirkede ikke eksponeringen for belimumab i den subkutane farmakokinetiske populationsanalyse.
English: The adverse reaction profile in paediatric patients is based on 52-week safety data from a placebo-controlled study in which 53 patients (6 to 17 years of age) with SLE received Benlysta (10 mg/kg intravenously on Days 0, 14, 28, and then every 28 days, on a background of concomitant treatments).
Danish: Bivirkningsprofilen hos pædiatriske patienter er baseret på 52 ugers sikkerhedsdata fra et placebokontrolleret studie, hvori 53 patienter (i alderen 6-17 år) med SLE fik Benlysta (10 mg/kg intravenøst på Dag 0, 14, 28 og herefter hver 28. dag, i tillæg til sideløbende behandling).
English: Benlysta can have side effects which may make you less able to drive or use machines.
Danish: Benlysta kan have bivirkninger, der påvirker din evne til at føre motorkøretøj eller betjene maskiner.
English: Arginine hydrochloride Histidine
Danish: Argininhydrochlorid Histidin
English: Gently invert the bag or bottle to mix the solution.
Danish: Posen eller flasken vendes forsigtigt op og ned for at blande opløsningen.
English: Benlysta is for use under the skin only (subcutaneous).
Danish: Benlysta skal udelukkende injiceres under huden (subkutant).
English: Belimumab blocks the binding of soluble BLyS, a B cell survival factor, to its receptors on B cells.
Danish: Belimumab blokerer bindingen af opløseligt BLyS-protein, der er en B-celle-overlevelsesfaktor, til dets receptorer på B-celler.
English: Steady-state geometric mean Cmax, Cmin, and AUC values were 305 µg/mL, 42 µg/mL, and 2569 day•µg/mL in the 5- to 11-year-old-group, and 317 µg/mL, 52 µg/mL, and 3126 day•µg/mL in the 12- to 17-year-old-group (n=43).
Danish: AUC værdier var 305 µg/ml, 42 µg/ml, og 2.569 dag•µg/ml i gruppen af 5-11-årige, og 317 µg/ml, 52 µg/ml, and 3.126 dag•µg/ml i gruppen af 12-17-årige (n=43).
English: Serious infections occurred in 5% of patients in both groups receiving Benlysta or placebo; serious opportunistic infections accounted for 0.4% and 0% of these, respectively.
Danish: Der forekom alvorlige infektioner hos 5 % af de patienter, der fik Benlysta eller placebo, hvoraf andelen af alvorlige opportunistiske infektioner var på henholdsvis 0,4 % og 0 %.
English: Immunisation
Danish: Immunisering
English: The safety of belimumab in patients with SLE has been evaluated in 3 pre-registration, placebo-controlled intravenous studies, 1 placebo-controlled subcutaneous study, and one post-marketing, placebo-controlled intravenous study.
Danish: Belimumabs sikkerhed hos patienter med SLE er blevet vurderet i tre placebokontrollerede intravenøsestudier før markedsføring, placebokontrollerede intravenøse studier, et placebokontrolleret subkutant studie og et placebokontrolleret intravenøst studie post-marketing.
English: The risk of hypersensitivity reactions is greatest with the first two infusions; however the risk should be considered for every infusion administered.
Danish: Risikoen for overfølsomhedsreaktioner er størst ved de to første infusioner, men der skal tages hensyn til risikoen ved hver infusion.
English: You will see the purple indicator start to move through the inspection window.
Danish: Du vil se, at den lilla indikator bevæger sig ned gennem inspektionsvinduet (Figur 9).
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Benlysta.
Danish: Der har været tilfælde af depression, selvmordstanker og selvmordsforsøg under behandling med Benlysta.
English: At baseline 62.2% of patients had high disease activity (SELENA SLEDAI score ≥10), 88% of patients had mucocutaneous, 78% had musculoskeletal, 8% had haematological, 12% had renal, and 8% had vascular organ involvement.
Danish: Ved baseline havde 62,2 % af patienterne høj sygdomsaktivitet (en SELENA-SLEDAI-score på ≥ 10), 88 % af patienterne havde mukokutan, 78 % muskuloskeletal, 8 % hæmatologisk, 12 % renal og 9 % vaskulær organ-involvering.
English: There were too few patients ≥65 years of age enrolled in the controlled clinical trials to draw meaningful conclusions about the effects of age on clinical outcomes.
Danish: I de kontrollerede kliniske studier var inkluderet for få patienter ≥ 65 år til at drage meningsfulde konklusioner om effekten af alder på de kliniske udfald.
English: Your first injection with the Benlysta pre-filled syringe will be supervised by your doctor or nurse.
Danish: Din første injektion med Benlysta fyldt injektionssprøjte vil blive overvåget af din læge eller sygeplejerske.
English: Univariate and multivariate analysis of the primary endpoint in pre-specified subgroups demonstrated that the greatest benefit was observed in patients with higher disease activity including patients with SELENA SLEDAI scores ≥ 10, or patients requiring steroids to control their disease, or patients with low complement levels.
Danish: En univariat- og multivariatanalyse af det primære endepunkt hos prædefinerede subgrupper viste, at den største fordel blev observeret hos patienter med en højere sygdomsaktivitet, herunder patienter med SELENA-SLEDAI-score ≥ 10, eller patienter med behov for steroider for at kontrollere deres sygdom, eller patienter med lave komplementniveauer.
English: The pre-filled pen or pre-filled syringe should be used for subcutaneous injection only.
Danish: Den fyldte pen eller fyldte injektionssprøjte må kun bruges til subkutan injektion.
English: Following intravenous administration of 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter, belimumab exposures were similar between paediatric and adult SLE subjects.
Danish: Efter intravenøs administration af 10 mg/kg på Dag 0, 14 og 28 og 4-ugers intervaller herefter, var belimumab-eksponeringer ens mellem pædiatriske og voksne SLE-patienter.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AT DET BIOLOGISKE AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Based on simulations with population PK parameters the steady-state average belimumab concentrations for 200 mg subcutaneous every week were similar to 10 mg/kg intravenous every 4 weeks.
Danish: Baseret på simulerede populations-PK-parametre var den gennemsnitlige belimumab steady-statekoncentration for 200 mg subkutant hver uge sammenlignelig med 10 mg/kg intravenøst hver 4. uge.
English: Benlysta contains belimumab (a monoclonal antibody).
Danish: Benlysta indeholder belimumab (et monoklonalt antistof).
English: • Do not expel any air bubbles from the syringe.
Danish: • Du må ikke trykke eventuelle luftbobler ud af injektionssprøjten.
English: However, in a small study evaluating the response to a 23-valent pneumococcal vaccine, overall immune responses to the different serotypes were similar in SLE patients receiving Benlysta compared with those receiving standard immunosuppressive treatment at the time of vaccination.
Danish: I et lille studie, der evaluerede responset af en 23-valent pneumokokvaccine, var det samlede immunrespons til de forskellige serotyper ens hos SLE-patienter, som fik Benlysta sammenlignet med de patienter, som modtog standard immunsuppressiv-behandling ved tidspunktet for vaccinationen.
English: The currently available data are described in the Summary of Product Characteristics of Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion.
Danish: De nuværende tilgængelige data er beskrevet i produktresuméet for Benlysta 120 mg og 400 mg pulver til koncentrat til infusion, opløsning.
English: The recommended dose is 200 mg (complete contents of one pen) once a week, injected under your skin on the same day each week.
Danish: Den anbefalede dosis er 200 mg (hele indholdet af én pen) én gang om ugen injiceret under din hud på samme ugedag hver uge.
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline
Danish: Tabel 2: Patienter med lavt komplementniveau og positiv anti-dsDNA ved baseline
English: Within the overall SLE intravenous study population, age did not affect belimumab exposure in the population pharmacokinetic analysis.
Danish: Af den samlede forsøgspopulation med SLE, der fik belimumab intravenøst, påvirkede alderen ikke eksponeringen for belimumab i den farmakokinetiske populationsanalyse.
English: Reconstituted and diluted solution for infusion
Danish: Rekonstitueret og fortyndet opløsning til infusion
English: Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an injection.
Danish: I sjældne tilfælde kan også mindre alvorlige bivirkninger optræde senere med Benlysta, generelt 5 til 10 dage efter du har fået en injektion.
English: • If you become pregnant while being treated with Benlysta, tell your doctor.
Danish: • Fortæl det til lægen, hvis du bliver gravid, mens du er i behandling med Benlysta.
English: Gather and check supplies Gather supplies
Danish: Saml og kontroller delene Saml delene
English: Contents of the pack and other information What Benlysta contains
Danish: Pakningsstørrelser og yderligere oplysninger Benlysta indeholder:
English: • Do not put the ring cap back onto the pen.
Danish: • Du må ikke sætte hætten på pennen igen.
English: • Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour.
Danish: • Kig i inspektionsvinduet for at sikre at farven på Benlysta-opløsningen er farveløs til svagt gullig (Figur
English: No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Benlysta with other agents.
Danish: Der er ikke udført fysiske eller biokemisk kompatibilitetsstudier med henblik på at vurdere samtidig administration af Benlysta med andre lægemidler eller intravenøse opløsninger.
English: The rates of infusion reactions among persistent-positive subjects were comparable to the rates for ADA negative patients of 75/552 (14%), 78/523 (15%), and 83/559 (15%) in the placebo, 1 mg/kg and 10 mg/kg groups, respectively.
Danish: Hyppigheden af infusionsrelaterede reaktioner var sammenlignelige hos forsøgspersoner med vedvarende tilstedeværelse af anti-belimumab-antistoffer og hos ADA-negative patienter, idet hyppigheden var 75/552 (14 %), 78/523 (15 %) og 83/559 (15 %) i henholdsvis placebo-, 1 mg/kg- og 10 mg/kg-gruppen.
English: • Do not touch this area again before giving the injection.
Danish: • Du må ikke røre området igen, før du giver injektionen.
English: In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered (see section 4.2).
Danish: I tilfælde af en svær reaktion skal administrationen af Benlysta afbrydes, og der skal iværksættes relevant behandling (se pkt.
English: Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an infusion.
Danish: I sjældne tilfælde kan også mindre alvorlige bivirkninger optræde senere med Benlysta, generelt 5 til 10 dage efter du har fået en infusion.
English: Serious depression was reported in 0.3% (7/2002) of patients receiving Benlysta and <0.1% (1/2001) of patients receiving placebo.
Danish: Alvorlig depression blev rapporteret hos 0,3 % (7/2002) af patienterne, der fik Benlysta og hos < 0,1 % (1/2001) af patienterne, der fik placebo.
English: • Do not let the needle touch any surface.
Danish: • Du må ikke lade kanylen røre noget.
English: A clear to opalescent, colourless to pale yellow solution, with a pH of 6.
Danish: Klar til opaliserende, farveløs til svag gul opløsning, med en pH på 6.