FrancophonIA/ELRC3.0 huggingface dataset:
English: The dot within each box represents the mean.
Danish: Prikken i hver kasse repræsenterer middelværdien.
English: • You should avoid swimming because of an increased risk of infection in the eye.
Danish: • Du skal undgå svømning på grund af en øget risiko for infektion i øjet.
English: Visual acuity (LogMAR) of the first eye of these subjects at baseline was 1.18 (0.14), mean (SE).
Danish: Synsstyrken (LogMAR) i første øje hos disse personer var ved baseline 1,18 (0,14), middelværdi (SE).
English: Local biosafety guidelines for preparation, administration and handling of Luxturna should be followed.
Danish: Lokale retningslinjer for biologisk sikkerhed skal følges ved klargøring, administration og håndtering af Luxturna.
English: Transient and low-level vector shedding may occur in patient tears (see section 5.2).
Danish: Der kan forekomme forbigående ekskretion af lave mængder vektor i patientens tårer (se pkt.
English: Preparation of Luxturna should be performed within 4 hours of beginning the administration procedure, in accordance with the following recommended procedure performed under aseptic conditions.
Danish: Luxturna skal klargøres inden for 4 timer før administrationsprocedurens påbegyndelse i overensstemmelse med følgende anbefalede procedure og udført under aseptiske forhold.
English: Full-field light sensitivity testing - First assigned eye (ITT) Intervention, N = 21
Danish: Test af fuldfeltslysfølsomhed - første tildelte øje (ITT) Intervention, N = 21
English: Preparation of Luxturna should be performed, within 4 hours of beginning the administration procedure, in accordance with the following recommended procedures performed under aseptic conditions.
Danish: Luxturna skal klargøres inden for 4 timer før administrationsprocedurens påbegyndelse, i overensstemmelse med følgende anbefalede procedurer og udført under aseptiske forhold.
English: Patients will receive a single dose of 1.5 x 10
Danish: Patienterne får en enkelt dosis på 1,5 x 10
English: The highest levels of vector DNA sequences were detected in intraocular fluids (anterior chamber fluid and vitreous) of vector-injected eyes.
Danish: De højeste niveauer af vektor-DNA-sekvenser blev påvist i intraokulære væsker (i forkammeret samt i glaslegemet) i vektorinjicerede øjne.
English: Luxturna has not been studied in breast-feeding women.
Danish: Luxturna er ikke undersøgt hos ammende kvinder.
English: Clinical pharmacokinetics and shedding
Danish: Klinisk farmakokinetik og ekskretion
English: • You should avoid air travel or other travel to high elevations until advised by your doctor.
Danish: • Du må ikke flyve eller rejse til højtliggende steder, før din læge har sagt, at det er i orden.
English: Visual acuity (LogMAR) of the first eye of these subjects at baseline was 1.29 (0.21), mean (SE).
Danish: Synsstyrken (LogMAR) i første øje hos disse personer var ved baseline 1,29 (0,21), middelværdi (SE).
English: • Retinal disorder (foveal thinning, loss of foveal function), macular hole, maculopathy (epiretinal membrane, macular pucker) and eye disorder (foveal dehiscence).
Danish: • Retinasygdom (udtynding af fovea, tab af foveal funktion), makulahul, makulopati (epiretinal membran, makularynkning) samt øjensygdom (fovearuptur).
English: The solid line connects the mean MLMT score changes over visits for the treatment group.
Danish: Den ubrudte streg forbinder middelværdien for ændringer i MLMT-score over besøgene for behandlingsgruppen.
English: Full-field light sensitivity testing - Second assigned eye (ITT) Intervention, N = 21
Danish: Test af fuldfeltslysfølsomhed - andet tildelte øje (ITT) Intervention, N = 21
English: The most common adverse reactions (incidence ≥5%) related to the administration procedure were conjunctival hyperaemia, cataract, increased intraocular pressure, retinal tear, dellen, macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain and maculopathy (wrinkling on the surface of the macula).
Danish: De mest almindelige bivirkninger (forekomst ≥ 5 %) relateret til administrationsproceduren var konjunktival hyperæmi, katarakt, forhøjet intraokulært tryk, retinale rifter, reduktion af corneas tykkelse, makulahul, subretinale aflejringer, øjenbetændelse, øjenirritation, øjensmerter og makulopati (rynker på makulas overflade).
English: The pupil of the eye to be injected must be dilated, and a broad-spectrum microbiocide should be topically administered prior to the surgery according to standard medical practice.
Danish: Pupillen i det øje, der skal injiceres, skal være dilateret, og et bredspektret mikrobiocid skal administreres topikalt inden operationen i henhold til den medicinske standardpraksis.
English: The concentrate (0.5 mL extractable volume in a single-dose 2 mL vial) requires a 1:10 dilution prior to administration.
Danish: Koncentratet (0,5 ml ekstraherbart volumen i et 2 ml-enkeltdosishætteglas) skal fortyndes i forholdet 1:10 inden administration.
English: - Treat all Luxturna spills with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
Danish: - Alle spild af Luxturna skal behandles med et virusdræbende middel som for eksempel 1 % natriumhypochlorit og opsuges med absorberende materialer.
English: Patients should avoid swimming because of an increased risk of infection in the eye.
Danish: Patienten skal undgå svømning på grund af en øget risiko for infektion i øjet.
English: Figure 1A Subretinal injection cannula introduced via pars plana
Danish: Figur 1A Kanyle til subretinal injektion indført via pars plana
English: Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
Danish: Luxturna er indiceret til behandling af voksne og pædiatriske patienter med synstab som følge af nedarvet retinal dystrofi, der skyldes bekræftede biallele RPE65-mutationer, og som har et tilstrækkeligt antal levedygtige retinaceller.
English: Voretigene neparvovec is a gene transfer vector that employs an adeno-associated viral vector serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina.
Danish: Voretigen neparvovec er en genvektor, som anvender et adeno-associeret virusvektor serotype 2 (AAV2)-kapsid som fremføringsmiddel til det humane retinal pigmentepitel 65 kDa-protein (hRPE65) cDNA til retina.
English: For instructions for preparation, accidental exposure to and disposal of Luxturna, see section 6.6.
Danish: For instruktioner om klargøring, utilsigtet eksponering og bortskaffelse af Luxturna, se pkt.
English: What Luxturna is and what it is used for What you need to know before you are given Luxturna How Luxturna is given to you Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Luxturna Sådan vil du få Luxturna Bivirkninger
English: Unopened frozen vials
Danish: Uåbnede frosne hætteglas
English: • Supine head positioning is initiated immediately in the post-operative period and upon discharge should be maintained by the patient for 24 hours.
Danish: • Patientens anbringes i rygliggende stilling, så snart den post-operative periode begynder, og skal fortsættes af patienten i 24 timer efter udskrivning.
English: Do not prepare syringes for injection if the vials show any damage or if any visual particulates are observed.
Danish: Klargør ikke sprøjterne til injektion, hvis hætteglassene viser tegn på skader, eller hvis der observeres synlige partikler.
English: A small amount of the product is slowly injected until an initial subretinal bleb is observed, and then, the remaining volume is slowly injected until the total 0.3 mL is delivered (Figure 1).
Danish: Injicér langsomt en lille mængde af produktet, indtil der ses en indledende subretinal blære, og injicér derefter det resterende volumen, indtil alle 0,3 ml er administreret (figur 1).
English: The product-filled syringes should then be transferred in a designated transport container to the surgical suite.
Danish: Sprøjterne med produktet skal derefter overføres i en egnet transportbeholder til operationsstuen.
English: • At the completion of the injection, the subretinal injection cannula is removed from the eye.
Danish: • Når injektionen er fuldført, fjernes kanylen til subretinal injektion fra øjet.
English: vector genomes of voretigene neparvovec in a deliverable volume of 0.3 mL.
Danish: vektorgenomer af voretigen neparvovec i et leverbart volumen på 0,3 ml.
English: The product is slowly injected through the extension tube and subretinal injection cannula to eliminate any air bubbles.
Danish: Injicér produktet langsomt gennem forlængerslangen og kanylen til subretinal injektion for at eliminere eventuelle luftbobler.
English: The safety and efficacy of voretigene neparvovec have not been established in patients with hepatic or renal impairment.
Danish: Voretigen neparvovecs sikkerhed og virkning er ikke klarlagt hos patienter med nedsat lever- eller nyrefunktion.
English: Low levels of vector DNA sequences were detected in the optic nerve of the vector-injected eye, optic chiasm, spleen and liver, and sporadically in the stomach and lymph nodes.
Danish: Der blev påvist lave niveauer af vektorDNA-sekvenser i synsnerven i det vektorinjicerede øje, i øjets chiasma, i milt og lever samt sporadisk i mavesæk og lymfeknuder.
English: Each single dose of 1.5 x 10
Danish: Hver enkeltdosis på 1,5 x 10
English: Patients should avoid strenuous physical activity because of an increased risk of injury to the eye.
Danish: Patienten skal undgå anstrengende fysisk aktivitet grund af en øget risiko for øjenskader.
English: • Connect the syringe containing the diluted product to the tubing and microcannula.
Danish: • Tilslut sprøjten med det fortyndede produkt til slangen og mikrokanylen.
English: Patients should not drive or use heavy machines until visual function has recovered sufficiently, as advised by their ophthalmologist.
Danish: Patienten må ikke føre motorkøretøj eller betjene maskiner, indtil synsevnen er tilstrækkeligt bedret efter øjenlægens skøn.
English: N Mean (SE)
Danish: N Middelværdi (SE)
English: • Cataract (clouding of the lens)
Danish: • Grå stær (sløring af linsen)
English: • You should avoid strenuous physical activity because of an increased risk of injury to the eye.
Danish: • Du skal undgå anstrengende fysisk aktivitet på grund af en øget risiko for øjenskader.
English: Do not prepare syringe if the vial shows any damage or if any visual particulates are observed.
Danish: Klargør ikke sprøjten, hvis hætteglasset viser tegn på skader, eller hvis der observeres synlige partikler.
English: - All materials that may have come in contact with Luxturna (e.g. vial, syringe, needle, cotton gauze, gloves, masks or dressings) must be disposed of in accordance with local biosafety guidelines.
Danish: - Alle materialer, der kan være kommet i kontakt med Luxturna (fx hætteglas, sprøjte, kanyle, gaze, handsker, masker eller forbindinger), skal bortskaffes i overensstemmelse med lokale retningslinjer for biologisk sikkerhed.
English: Retinal tear, dellen, macular hole, eye inflammation, eye irritation, eye pain, maculopathy, choroidal haemorrhage, conjunctival cyst, eye disorder, eye swelling, foreign body sensation in eyes, macular degeneration, endophthalmitis, retinal detachment, retinal disorder, retinal haemorrhage
Danish: Retinal rift, reduktion af corneas tykkelse, makulahul, øjenbetændelse, øjenirritation, øjensmerter, makulopati, choroideal blødning, konjunktival cyste, øjensygdom, hævede øjne, følelse af et fremmedlegeme i øjet, makuladegeneration, endoftalmitis, retinaløsning, retinasygdom, retinal blødning
English: Luxturna is used for the treatment of adults and children with vision loss due to inherited retinal dystrophy caused by mutations in the RPE65 gene.
Danish: Luxturna bruges til at behandle voksne og børn med synstab, der skyldes nedarvet retinal dystrofi, der skyldes mutationer i genet RPE65.
English: A small amount of the product is slowly injected until an initial subretinal bleb is observed, and then the remaining volume is slowly injected until the total 0.3 mL is delivered.
Danish: Injicér langsomt en lille mængde af produktet, indtil der ses en indledende subretinal blære, og injicér derefter det resterende volumen, indtil alle 0,3 ml er administreret.
English: Luxturna is a concentrate for solution for subretinal injection that requires thawing and dilution prior to administration.
Danish: Luxturna er et koncentrat til opløsning til subretinal injektion, som skal optøs og fortyndes inden administration.
English: The safety and efficacy of voretigene neparvovec in patients ≥65 years old have not been established.
Danish: Voretigen neparvovecs sikkerhed og virkning hos patienter ≥65 år er ikke klarlagt.
English: Store and transport frozen at ≤-65 ºC.
Danish: Opbevares og transporteres nedfrosset ved ≤ -65 ºC.
English: Prednisone (or equivalent) 0.5 mg/kg/day (maximum of 20 mg/day)
Danish: Prednison (eller tilsvarende) 0,5 mg/kg/dag (maksimalt 20 mg/dag)
English: Subretinal use.
Danish: Subretinal brug.
English: vg will be delivered into the subretinal space in a total volume of 0.3 mL per eye.
Danish: vg administreres til det subretinale rum med et samlet volumen på 0,3 ml pr. øje.
English: Prednisone (or equivalent) 0.5 mg/kg every other day (maximum of 20 mg/day)
Danish: Prednison (eller tilsvarende) 0,5 mg/kg hver anden dag (maksimalt 20 mg/dag)
English: Following dilution under aseptic conditions, the solution must be used immediately; if not used immediately, the storage time at room temperature (below 25 °C) should be no longer than 4 hours.
Danish: Hvis den ikke bruges med det samme, må opbevaringstiden ved stuetemperatur (under 25 °C) ikke overskride 4 timer.
English: Therefore, no adjustment in dosage is necessary for patients with hepatic or renal impairment.
Danish: Det er derfor ikke nødvendigt at justere dosis hos patienter med nedsat lever- eller nyrefunktion.
English: Injection of voretigene neparvovec into the subretinal space results in transduction of retinal pigment epithelial cells with a cDNA encoding normal human RPE65 protein (gene augmentation therapy), providing the potential to restore the visual cycle.
Danish: Injektion af voretigen neparvovec i det subretinale rum resulterer i transduktion af retinale pigmentepitelceller med et cDNA indkodende, normalt humant RPE65-protein (genterapi), som potentielt kan genoprette synscyklussen.
English: The safety and efficacy of voretigene neparvovec in children aged up to 4 years have not been established.
Danish: Voretigen neparvovecs sikkerhed og virkning hos børn i alderen op til 4 år er ikke klarlagt.
English: • After vitrectomy is completed, Luxturna is administered by subretinal injection using a subretinal injection cannula introduced via pars plana (Figure 1A).
Danish: • Når vitrektomien er gennemført, administreres Luxturna ved subretinal injektion med en kanyle til subretinal injektion, der indføres via pars plana (figur 1A).
English: Training and instructions for safe handling and disposal of affected materials for 14 days following product administration should also be provided along with information regarding exclusion from donation of blood, organs, tissues, and cells for transplantation after LUXTURNA administration.
Danish: Sammen med information omkring udelukkelse fra donation af blod, organer, væv og celler til transplanation efter administration af LUXTURNA, bør der samtidig gives træning og instruktioner i sikker håndtering og bortskaffelse af berørte materialer i 14 dage efter administration af lægemidlet.
English: After dilution each dose of Luxturna contains 1.5 x 10
Danish: Efter fortynding indeholder en dosis Luxturna 1,5 x 10
English: Luxturna will be given to you only if genetic testing shows that your vision loss is caused by mutations in the RPE65 gene.
Danish: Du vil kun få Luxturna, hvis gentest viser, at dit synstab skyldes mutationer i genet RPE65.
English: Following the administration, patients should be instructed to report any symptoms suggestive of retinal detachment or endophthalmitis without delay and should be managed appropriately.
Danish: Efter administration skal patienten instrueres om straks at indberette alle symptomer, der tyder på retinaløsning eller endoftalmitis, og sådanne symptomer skal behandles på passende vis.
English: o Contact information for adverse event reporting.
Danish: o Kontaktinformation til indrapportering af bivirkninger.
English: Individuals with biallelic RPE65 mutation-associated retinal dystrophy exhibit vision loss, including impaired visual function parameters such as visual acuity and visual fields often during childhood or adolescence; this loss of vision ultimately progresses to complete blindness.
Danish: Personer med biallel RPE65-mutationsassocieret retinal dystrofi oplever synstab, herunder nedsatte synsfunktionsparametre som for eksempel synsstyrke og synsfelt, som ofte forekommer i barn- eller ungdommen.
English: • All materials that may have come in contact with voretigene neparvovec (e.g. vial, syringe, needle, cotton gauze, gloves, masks or dressings) must be disposed of in accordance with local biosafety guidelines.
Danish: - Alle materialer, der kan være kommet i kontakt med voretigen neparvovec (fx hætteglas, sprøjte, kanyle, gaze, handsker, masker eller forbindinger), skal bortskaffes i overensstemmelse med lokale retningslinjer for biologisk sikkerhed.
English: • Surgical education for LUXTURNA administration, including description of materials and procedures needed to perform LUXTURNA subretinal injection or • Pharmacy training manual, including information on LUXTURNA preparation and storage;
Danish: • Kirurgisk uddannelse til administration af LUXTURNA, inklusive beskrivelse af materialer og procedurer, som er nødvendige for at udføre subretinal injektion af LUXTURNA
English: After injection, any unused product must be discarded.
Danish: Alt ubrugt produkt skal kasseres efter injektion.
English: What Luxturna contains The active substance is voretigene neparvovec.
Danish: Luxturna indeholder: Aktivt stof: voretigen neparvovec.
English: • Connect the syringe containing the diluted product to the extension tube and subretinal injection cannula.
Danish: • Tilslut sprøjten med det fortyndede produkt til forlængerslangen og kanylen til subretinal injektion.
English: Luxturna is a sterile concentrate solution for subretinal injection that requires thawing and dilution prior to administration (see section 6.6).
Danish: Luxturna er en steril koncentratopløsning til subretinal injektion, som skal optøs og fortyndes inden administration (se pkt.
English: Presence of or affiliation with a retinal surgeon experienced in sub-retinal surgery and capable of administrating LUXTURNA;
Danish: Tilstedeværelse af eller tilknytning til en retinal kirurg med erfaring i sub-retinale operationer, og som er i stand til at administrere LUXTURNA Tilstedeværelse af et klinisk apotek, som er i stand til at håndtere og forberede genterapilægemidler baseret på AAV-vektorer.
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
Danish: Patienten skal instrueres om straks at indberette alle symptomer, der tyder på endoftalmitis eller retinaløsning, og sådanne symptomer skal behandles på passende vis.
English: 0.5 mL extractable volume of concentrate in 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.
Danish: 0,5 ml ekstraherbart volumen af koncentrat i et 2 ml hætteglas af cyklisk olefinpolymer med prop af klorbutylgummi forseglet med en aluminuim afrivningskapsel.
English: vg voretigene neparvovec in a total volume of 300 μL.
Danish: vg voretigen neparvovec i hvert øje; det samlede volumen var 300 μl.
English: Each carton containing 1 vial of concentrate and 2 vials of solvent is for single use only.
Danish: Hver æske med 1 hætteglas med koncentrat og 2 hætteglas med solvens er kun til engangsbrug.
English: Gently invert the 10 mL glass vial at least five times for proper mixing.
Danish: Vend forsigtigt 10 ml-hætteglasset af glas på hovedet mindst fem gange for at blande indholdet.
English: There is reduced vision in the days after surgery that usually improves; tell your doctor if vision does not return.
Danish: Dit syn vil være nedsat i dagene efter operationen, og det bliver som regel bedre igen.
English: Each single-dose 2 mL vial of Luxturna contains 0.5 extractable mL of concentrate which requires a 1:10 dilution prior to administration, see section 6.6.
Danish: Et 2 ml hætteglas med en enkelt dosis Luxturna indeholder 0,5 ekstraherbart ml koncentrat, som kræver en 1:10-fortynding inden administration.
English: Precaution to be taken before manipulating or administering the product Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering eller administration af produktet Der skal bæres personligt sikkerhedsudstyr (herunder laboratoriekittel, beskyttelsesbriller og handsker) under klargøring eller administration af voretigen neparvovec.
English: Sodium dihydrogen phosphate monohydrate (for pH adjustment) Disodium hydrogen phosphate dihydrate (for pH adjustment) Poloxamer 188
Danish: Natriumdihydrogenphosphatmonohydrat (til justering af pH-værdi) Dinatriumhydrogenphosphatdihydrat (til justering af pH-værdi) Poloxamer 188
English: Figure 1 Tip of the subretinal injection cannula placed within recommended injection site (surgeon's view)
Danish: Figur 1 Spidsen af kanylen til subretinal injektion anbragt på det anbefalede injektionssted (set fra kirurgens side)
English: Tell your doctor or nurse if you have any visual problems.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Patients should be instructed to avoid air travel or other travel to high elevations until the air bubble formed as a result of administration of Luxturna has completely dissipated from the eye. A time period of up to one week or more following injection may be required before dissipation of the air bubble; this should be verified on ophthalmic examination.
Danish: Patienten skal instrueres om at undgå flyrejser eller at rejse til højtliggende steder, indtil den luftboble, der er dannet som følge af administration af Luxturna, er helt forsvundet fra øjet.
English: Excipients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, poloxamer 188, water for injections.
Danish: Hjælpestoffer: natriumchlorid, natriumdihydrogenphosphatmonohydrat, dinatriumhydrogenphosphatdihydrat, poloxamer 188, vand til injektionsvæsker.
English: 1.7 mL extractable volume of solvent in a 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.
Danish: 1,7 ml ekstraherbart volumen af solvens i et 2 ml hætteglas af cyklisk olefinpolymer med prop af klorbutylgummi forseglet med en aluminuim afrivningskapsel.
English: Figure 1B Tip of the subretinal injection cannula placed within the recommended site of injection (surgeon's view)
Danish: Figur 1B. Spidsen af kanylen til subretinal injektion anbragt på det anbefalede injektionssted (set fra kirurgens synsvinkel)
English: Each foil pouch includes a carton containing 1 vial of concentrate and 2 vials of solvent.
Danish: En foliepose indeholder en æske med 1 hætteglas med koncentrat og 2 hætteglas med solvens.
English: Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into each sterile 1 mL syringe.
Danish: Sprøjterne til injektion klargøres ved at trække 0,8 ml fortyndet opløsning op i hver steril 1 ml sprøjte.
English: Y1
Danish: Å1
English: If particulates, cloudiness, or discoloration are visible, the medicinal product must not be used.
Danish: Hvis der ses partikler, uklarheder eller misfarvning, må lægemidlet ikke anvendes.