FrancophonIA/ELRC3.0 huggingface dataset:
English: Difference (95% CI) (Intervention-Control) -2.33 (-3.44, -1.22), p<0.001
Danish: Forskel (95 % CI) (Intervention - Kontrol) -2,33 (-3,44, -1,22), p < 0,001
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Danish: Ubrugt lægemiddel skal bortskaffes i overensstemmelse med lokale retningslinjer for biologisk sikkerhed.
English: Post-operative
Danish: Post-operativt
English: The primary endpoint of the Phase 3 study measured the mean change from baseline to one year in binocular multi-luminance mobility testing (MLMT) between the intervention and control groups.
Danish: Fase 3-studiets primære endepunkt målte middelændringen fra baseline til ét år med MLMT (binocular multi-luminance mobility)-test mellem interventions- og kontrolgrupperne.
English: o Inform healthcare professionals that the patient has received gene therapy, and the importance of reporting adverse events.
Danish: o Informerer sundhedspersonale om, at patienten har modtaget genterapi og vigtigheden af at indrapportere bivirkninger.
English: No clinical data on the effect of the medicinal product on fertility are available.
Danish: Der foreligger ingen kliniske data om lægemidlets virkning på fertilitet.
English: The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Danish: Det kvalificerede personale (dvs. vitroretinale kirurger og farmaceuter) på behandlingscentrene skal modtage uddannelsesmateriale inklusive
English: The MLMT was designed to measure changes in functional vision, specifically the ability of a subject to navigate a course accurately and at a reasonable pace at different levels of environmental illumination.
Danish: MLMT blev udarbejdet til at måle ændringer i funktionelt syn, specifikt forsøgsdeltagerens evne til at navigere en rute nøjagtigt og med rimelig hastighed ved forskellige grader af belysning i omgivelserne.
English: The control group was administered voretigene neparvovec after 1 year of observation.
Danish: Kontrolgruppen fik voretigen neparvovec efter 1 års observation.
English: Y1, Y2, Y3: one, two and three years after start of study;
Danish: Å1, Å2, Å3: et, to og tre år efter studiets start;
English: The development or worsening of cataracts is a known complication of the eye surgery that will be required before you receive Luxturna.
Danish: Udvikling eller forværring af grå stær er en kendt komplikation ved den form for øjenoperation, som er nødvendig, inden du får Luxturna.
English: The following side effects may happen with Luxturna:
Danish: Følgende bivirkninger kan forekomme med Luxturna:
English: D30, D90, D180: 30, 90 and 180 days after start of study;
Danish: D30, D90, D180: 30, 90 og 180 dage efter studiets start;
English: A rapid increase in altitude while the air bubble is still present can cause a rise in eye pressure and irreversible vision loss.
Danish: En hurtig højdestigning mens luftboblen stadig er til stede, kan medføre en stigning i trykket i øjet og irreversibelt synstab.
English: These handling precautions should be followed for 14 days after administration of voretigene neparvovec.
Danish: Disse forholdsregler skal følges i 14 dage efter administration af voretigen neparvovec.
English: • A patient card o Highlights the importance of follow-up visits and reporting side effects to the patient's physician.
Danish: • Et patientkort o Fremhæver vigtigheden af at møde op til opfølgningsbesøgene og af at indrapporte bivirkninger til patientens læge.
English: Table 4 Changes in MLMT score: year 1, compared to baseline (ITT population: n=21 intervention, n=10 control)
Danish: Tabel 4 Ændringer i MLMT-score: år 1 sammenlignet med baseline (ITT-population: intervention n = 21, kontrol n = 10)
English: • Summary of Product Characteristics (SmPC);
Danish: • Produktresumé (SmPC);
English: Voretigene neparvovec is expected to be taken up by cells through heparin sulphate proteoglycan receptors and be degraded by endogenous proteins and DNA catabolic pathways.
Danish: Voretigen neparvovec forventes at blive optaget af cellerne gennem heparinsulphat-proteoglycanreceptorer og blive nedbrudt af endogene proteiner og DNA-kataboliske veje.
English: Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3.
Danish: Efter optøning fra nedfrossen tilstand er både koncentrat og solvens klare, farveløse væsker med en pH-værdi på 7,3.
English: Luxturna is a single-use vial for a single administration in one eye only.
Danish: Luxturna er et hætteglas til engangsbrug til en enkelt administration i ét øje alene.
English: Luxturna will be stored by the healthcare professionals at your healthcare facility.
Danish: Luxturna opbevares af sundhedspersonalet på klinikken.
English: Active intraocular inflammation.
Danish: Aktiv intraokulær inflammation.
English: Ocular or periocular infection.
Danish: Okulær eller periokulær infektion.
English: Difference (95% CI) Intervention-Control p-value using binocular vision using assigned first eye only using assigned second eye only
Danish: Forskel (95 % CI) Intervention - Kontrol p-værdi ved brug af binokulært syn ved brug af tildelte første øje alene ved brug af tildelte andet øje alene
English: Biodistribution of Luxturna was evaluated at three months following subretinal administration in non-human primates.
Danish: Luxturnas biofordeling blev vurderet tre måneder efter subretinal administration hos ikke-humane primater.
English: 1.7 mL extractable volume
Danish: 1,7 ml ekstraherbart volumen
English: These steps are critical in the biological conversion of a photon of light into an electrical signal within the retina.
Danish: Disse forandringer er nødvendige for den biologiske ændring af lys til et elektrisk signal i retina.
English: You should follow these precautions for 14 days.
Danish: Disse foranstaltninger skal følges i 14 dage.
English: Refer to local biosafety guidelines applicable for disposal of the product.
Danish: Der henvises til de lokale retningslinjer for biologisk sikkerhed vedrørende bortskaffelse af produktet.
English: vg (5 times the recommended per eye dose), vector DNA sequences were detected in colon, duodenum and trachea.
Danish: vg (5 gange den anbefalede dosis pr. øje) blev der påvist vektor-DNA-sekvenser i colon, duodenum og trachea.
English: Table 3 Adverse reactions related to administration procedure
Danish: Tabel 3 Bivirkninger relateret til administrationsproceduren
English: Discard unused product.
Danish: Kasser ubrugt produkt.
English: Before Luxturna treatment is started, your doctor may prescribe a medicine that will suppress your immune system (the body's natural defences) so that it will not try to fight the Luxturna when it is given.
Danish: Inden behandlingen med Luxturna startes vil din læge eventuelt ordinere et lægemiddel til dig, der vil undertrykke dit immunforsvar (kroppens naturlige forsvar) for at kroppen ikke skal bekæmpe Luxturna, når det er givet.
English: Immunomodulatory regimen
Danish: Immunmodulerende regime
English: Presence of a specialist ophthalmologist with expertise in care and treatment of patients with inherited retinal dystrophy (IRD);
Danish: Tilstedeværelse af en specialiseret øjenlæge med ekspertise inden for pleje og behandling af patienter med nedarvet retinal dystrofi (IRD)
English: The diluted solution should be clear to slightly opalescent.
Danish: Den fortyndede opløsning skal være klar til let opaliserende.
English: Store at ≤-65 ºC.
Danish: Opbevares ved ≤ -65 ºC.
English: The following adverse reactions have been observed with the administration procedure:
Danish: Følgende bivirkninger er blevet observeret i forbindelse med administrationsproceduren:
English: A positive change score reflects passing the MLMT at a lower light level and a lux score of 6 reflects the maximum possible MLMT improvement.
Danish: En positiv ændring i score betyder, at MLMT blev bestået ved lav belysning, og en luxscore på 6 betyder den størst mulige MLMT-forbedring.
English: At baseline, subjects achieved pass marks on the mobility test at between 4 and 400 ambient lux.
Danish: Ved baseline bestod forsøgsdeltagerne mobilitetstesten ved en omgivende belysning på mellem 4 og 400 lux.
English: After receiving Luxturna:
Danish: Når du har fået Luxturna:
English: Voretigene neparvovec is derived from naturally occurring AAV using recombinant DNA techniques.
Danish: Voretigen neparvovec er fremstillet af naturligt forekommende AAV ved hjælp af rekombinant-DNA-teknikker.
English: The horizontal bar within each box represents the median.
Danish: Den vandrette bjælke i hver kasse repræsenterer medianen.
English: Administration Follow the steps below to administer voretigene neparvovec to patients:
Danish: Administration Følg trinene nedenfor for at administrere voretigen neparvovec til patienten:
English: There is no information on the effect of Luxturna on male or female fertility.
Danish: Der foreligger ingen oplysninger om Luxturnas virkning på mænds eller kvinders frugtbarhed.
English: Prior to launch of LUXTURNA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Danish: Inden lancering af LUXTURNA skal indehaveren af markedsføringstilladelsen (MAH) i hver medlemsstat nå til enighed med den nationale kompetente myndighed om indhold og format af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetode og andre aspekter af programmet.
English: • Some people develop cataracts.
Danish: • Nogle personer udvikler grå stær (katarakt).
English: • Some medicine may be present in your tears.
Danish: • Dine tårer kan indeholde lægemiddel.
English: You will need to stay for post-operative observation for a few hours after each procedure to monitor your recovery and watch for any side effects from the surgery or the anaesthesia.
Danish: Du skal blive til observation efter operationen i et par timer efter hvert indgreb for at se, hvordan du kommer dig og for at tjekke for eventuelle bivirkninger fra operationen eller bedøvelsen.
English: • You may have temporary visual disturbances, such as light sensitivity, and blurred vision.
Danish: • Du kan få midlertidige synsforstyrrelser, som for eksempel lysfølsomhed og sløret syn.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: VIAL LABEL (CONCENTRATE)
Danish: HÆTTEGLASETIKET (KONCENTRAT)
English: Please talk to your doctor before travelling.
Danish: Tal med lægen, inden du tager ud at rejse.
English: At one year after exposure to voretigene neparvovec, improvement in visual acuity of at least 0.3 LogMAR occurred in 11/20 (55%) of the first-treated eyes and 4/20 (20%) of the second-treated eyes in the intervention group; no one in the control group displayed such an improvement of visual acuity in either the first or second eye.
Danish: Ét år efter eksponering for voretigen neparvovec var der forbedring i synsstyrke på mindst 0,3 LogMAR hos 11/20 (55 %) for det første øje behandlet og 4/20 (20 %) for det andet øje behandlet i interventionsgruppen; ingen i kontrolgruppen havde en sådan forbedring af synsstyrken i hverken det første eller andet øje.
English: XBL; XD30; XD90; XD180: baseline, 30, 90 and 180 days after start of study for control crossover group; XY1; XY2: one and two years after start of study for control crossover group.
Danish: XBL; XD30; XD90; XD180: baseline, 30, 90 og 180 dage efter studiets start for kontrol/overkrydsningsgruppen; XÅ1; XÅ2: et og to år efter studiets start for kontrol/overkrydsningsgruppen.
English: No pharmacokinetic studies with voretigene neparvovec have been conducted in special populations.
Danish: Der er ikke udført farmakokinetiske studier med voretigen neparvovec hos særlige populationer.
English: The product is administered as a subretinal injection after vitrectomy in each eye.
Danish: Produktet administreres som en subretinal injektion efter vitrektomi i hvert øje.
English: Inspect for any visual particulates.
Danish: Kontroller for eventuelle synlige partikler.
English: Vector DNA sequences were detected in serum in 3/29 (10%) subjects, including two with positive tear samples, and only up to day 3 following each injection.
Danish: Der blev påvist vektor-DNA-sekvenser i serum hos 3/29 (10 %) af forsøgsdeltagerne, herunder to med positive tåreprøver, og kun op til dag 3 efter hver injektion.
English: Vector DNA sequences were not detected in gonads.
Danish: Der blev ikke påvist vektor-DNA-sekvenser i gonader.
English: The long-term safety and efficacy of Luxturna were assessed in a Phase 1 safety and dose escalation study (101), in which 12 subjects received unilateral subretinal injections of voretigene neparvovec; a follow-on study (102) in which voretigene neparvovec was administered to the contralateral eye in 11 of the 12 subjects who participated in the dose escalation study; a one-year, open-label Phase 3 controlled study (301) in which 31 subjects were randomised at two sites; and the continuation of the Phase 3 study, in which the 9 control subjects crossed over and received the intervention.
Danish: Luxturnas sikkerhed og virkning på længere sigt blev vurderet i et fase 1-studie af sikkerhed og dosiseskalering (101), i hvilket 12 forsøgsdeltagere fik unilaterale subretinale injektioner af voretigen neparvovec; et opfølgende studie (102), hvor voretigen neparvovec blev administreret til det kontralaterale øje hos 11 af de 12 forsøgsdeltagere, der deltog i dosiseskaleringsstudiet; et etårigt, åbent, kontrolleret fase 3-studie (301), hvor 31 forsøgsdeltagere blev randomiseret på to klinikker; samt fortsættelsen af fase 3-studiet, hvor de 9 kontrolforsøgsdeltagere krydsede over og fik foretaget interventionen.
English: This leaflet is available as an audio file and in a large print from the web site: http://www.voretigeneneparvovec.support
Danish: Denne indlægsseddel fås som lydfil og med stor skriftstørrelse på webstedet: http://www.voretigeneneparvovec.support
English: Follow the steps below to administer Luxturna to patients:
Danish: Følg trinene nedenfor for at administrere Luxturna til patienten:
English: Temporary visual disturbances, such as blurred vision and photophobia, may occur during the weeks that follow the treatment.
Danish: Der kan forekomme midlertidige synsforstyrrelser, som for eksempel sløret syn og fotofobi, i ugerne efter behandlingen.
English: • Problems associated with the placement of a breathing tube in the windpipe
Danish: • Problemer i forbindelse med anbringelse af en tube i luftrøret
English: If you are given more Luxturna than you should be As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Danish: Da du får denne medicin af en læge, er det usandsynligt, at du vil få for meget.
English: • Get immediate care from your doctor if your eye or eyes become red, painful, sensitive to light, you see flashes or floaters in your vision, or if you notice any worsening or blurred vision.
Danish: • Søg læge med det samme, hvis det ene eller begge øjne bliver røde, ømme, lysfølsomme, hvis du ser lysglimt eller uklarheder i synsfeltet, eller hvis du bemærker, at dit syn bliver værre eller sløret.
English: o Patient card will be available in alternative formats including large print and as an audio file.
Danish: o Patientkortet vil være tilgængeligt i alternative formater inklusive stort format og som lydfil.
English: • Increase in intraocular pressure.
Danish: • Stigning i det intraokulære tryk.
English: Figure 2 Change in MLMT score using binocular vision versus time before / after exposure to voretigene neparvovec
Danish: Figur 2 Ændring i MLMT-score med brug af binokulært syn kontra tid før/efter eksponering for voretigen neparvovec
English: Until the bubble is fully absorbed, air travel or other travel to high elevations may make the bubble expand and lead to eye damage, including vision loss.
Danish: Indtil boblen er helt væk, kan flyrejser eller rejser til højtliggende steder få boblen til at udvide sig og føre til øjenskader, herunder synstab.
English: Difference (95% CI) (Intervention-Control) -1.89 (-3.03, -0.75), p=0.002 Full-field light sensitivity testing - Averaged across both eyes (ITT) Difference (95% CI) (Intervention-Control): -2.11 (-3.19, -1.04), p<0.001
Danish: Forskel (95 % CI) (Intervention - Kontrol) -1,89 (-3,03, -0,75), p = 0,002 Test af fuldfeltslysfølsomhed - gennemsnit af begge øjne (ITT) Forskel (95 % CI) (Intervention - Kontrol): -2,11 (-3,19, -1,04), p < 0,001
English: Effects on male and female fertility have not been evaluated in animal studies.
Danish: Virkningen på handyrs og hundyrs fertilitet er ikke blevet undersøgt i dyreforsøg.
English: All three of these events were a transient appearance of asymptomatic subretinal precipitates inferior to the retinal injection site, 1-6 days after injection and resolved without sequelae.
Danish: Alle tre hændelser var en forbigående forekomst af asymptomatiske subretinale udfældninger inferiort for det retinale injektionssted, opstod 1-6 dage efter injektion og gik i sig selv uden følgevirkninger.
English: Follow these precautions for 14 days after the treatment.
Danish: Disse foranstaltninger skal følges i 14 dage efter behandlingen.
English: Based on non-clinical studies and clinical data from trials of AAV2 vectors, and considering the subretinal route of administration of Luxturna, inadvertent germ-line transmission with AAV vectors is highly unlikely.
Danish: Baseret på ikke-kliniske studier og kliniske data fra forsøg med AAV2-vektorer, og under hensyntagen til Luxturnas subretinale administrationsvej, er utilsigtet kimcelletransmission med AAV-vektorer meget usandsynlig.
English: Initiation of the immunomodulatory regimen for the second eye should follow the same schedule and supersede completion of the immunomodulatory regimen of the first eye.
Danish: Indledning af det immunmodulerende regime for det andet øje skal følge samme plan og skal erstatte fuldførelse af det immunmodulerende regime for det første øje.
English: Over time, accumulation of toxic precursors leads to the death of retinal pigment epithelial cells, and subsequently to progressive photoreceptor cell death.
Danish: Med tiden fører akkumulation af toksiske prækursorer til celledød for de retinale pigmentepitelceller og efterfølgende til progressiv fotoreceptorcelledød.
English: Adequate anaesthesia should be given to the patient prior to the procedure.
Danish: Patienten skal gives passende anæstesi inden proceduren.
English: • Patient Information Leaflet (PIL), which should also be available in alternative formats (including large print and as audio file);
Danish: • Indlægssedlen (PIL), som også bør være tilgængelig i alternative formater (inklusive stort format og som lydfil);
English: The vector shedding and biodistribution were evaluated in tears from both eyes, serum and whole blood of subjects in the Phase 3 clinical study.
Danish: Vektorekskretion og biofordeling blev evalueret i tårer fra begge øjne, serum og fuldblod hos forsøgsdeltagere i det kliniske fase 3-studie.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: vector genomes (vg).
Danish: vektorgenomer (vg).
English: Please talk to your doctor before going to swim after receiving treatment with Luxturna.
Danish: Tal med lægen, inden du svømmer, når du har fået behandling med Luxturna.
English: Instructions for preparation, accidental exposure and disposal of Luxturna
Danish: Anvisninger om klargøring, utilsigtet eksponering og bortskaffelse af Luxturna
English: For single administration by subretinal injection into one (1) eye.
Danish: Til en enkelt administration ved subretinal injektion i ét (1) øje.
English: Label the 10 mL glass vial containing the diluted concentrate as follows: ‘Diluted Luxturna'.
Danish: Mærk 10 ml hætteglasset med det fortyndede koncentrat som følger: "Fortyndet Luxturna".
English: Luxturna is injected directly into the eye. Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of the product.
Danish: Lever- og nyrefunktion, cytochrom P450-polymorfi og stigende alder forventes ikke at påvirke produktets kliniske virkning eller sikkerhed.
English: Concentrate and solvent must be stored and transported frozen at ≤-65 ºC.
Danish: Koncentrat og solvens skal opbevares og transporteres nedfrosset ved ≤ -65 ºC.
English: • The volume of product available for injection is confirmed in the syringe, by aligning the plunger tip with the line that marks 0.3 mL.
Danish: • Det tilgængelige volumen til injektion i sprøjten bekræftes ved at rette stemplets spids ind efter den streg, der markerer 0,3 ml.
English: The administration of voretigene neparvovec should be carried out in the surgical suite under controlled aseptic conditions.
Danish: Administration af voretigen neparvovec skal udføres på en operationsstue under kontrollerede aseptiske forhold.
English: Repeat the same procedure to prepare a backup syringe.
Danish: Gentag den samme procedure for at klargøre en reservesprøjte.
English: 1 vial concentrate 2 vials solvent
Danish: 1 hætteglas koncentrat 2 hætteglas solvens
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis; dvs. det er i det væsentlige natrium-frit.
English: Ocular histopathology of dog and non-human primate eyes exposed to voretigene neparvovec showed only mild changes, which were mostly related to healing from surgical injury.
Danish: Okulær histopatologi af øjne fra hunde og ikke-humane primater, som var blevet eksponeret for voretigen neparvovec, viste kun lette ændringer, som for det meste var relateret til heling efter kirurgisk skade.
English: There is no clinical experience with overdose of voretigene neparvovec.
Danish: Der er ingen klinisk erfaring med overdosering af voretigen neparvovec.
English: Any anomalies or appearance of visual particulates should be reported to the Marketing Authorisation Holder and product should not be used.
Danish: Anormalier af enhver art eller synlige partikler skal indberettes til indehaveren af markedsføringstilladelsen, og produktet må ikke anvendes.
English: • Diluted Luxturna should be inspected visually prior to administration.
Danish: • Fortyndet Luxturna skal kontrolleres visuelt inden administration.
English: Other findings from voretigene neparvovec non-clinical studies included occasional and isolated inflammatory cells in the retina, with no apparent retinal degeneration.
Danish: Andre fund fra ikkekliniske studier af voretigen neparvovec omfattede sporadiske og isolerede inflammatoriske celler i retina uden tilsyneladende retinal degeneration.
English: Proper aseptic techniques should always be used for the preparation and administration of Luxturna.
Danish: Anvend altid korrekt aseptisk teknik ved klargøring og administration af Luxturna.
English: - In the event of exposure to broken skin or needlestick injury, clean the affected area thoroughly with soap and water and/or a disinfectant.
Danish: - I tilfælde af eksponering af beskadiget hud eller ved kanylestikskader skal det berørte område renses grundigt med sæbe og vand og/eller et desinfektionsmiddel.