FrancophonIA/ELRC3.0 huggingface dataset:
English: To reduce the potential for immunogenicity patients should receive systemic corticosteroids before and after the subretinal injection of voretigene neparvovec to each eye (see section 4.2).
Danish: For at reducere potentialet for immunogenicitet skal patienten have systemiske kortikosteroider før og efter den subretinale injektion af voretigen neparvovec i hvert øje (se pkt.
English: Luxturna will be given to you in an operating room by surgeons experienced in performing eye surgery.
Danish: Du vil få Luxturna på en operationsstue af kirurger med erfaring i øjenoperationer.
English: Three secondary endpoints were also tested: full-field light sensitivity threshold (FST) testing using white light; the change in MLMT score for the first assigned eye; and visual acuity (VA) testing.
Danish: Der blev også testet for tre sekundære endepunkter: tærskel for fuldfeltslysfølsomhed (FST) med brug af hvidt lys, ændring i MLMT-score for det første behandlede øje samt test af synsstyrke (VA).
English: No dose adjustment is required in these patients (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos disse patienter (se pkt.
English: However, no adjustment in dosage is necessary for elderly patients.
Danish: Det er dog ikke nødvendigt at justere dosis hos ældre patienter.
English: Important information about some of the ingredients of Luxturna Luxturna contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Vigtige oplysninger om nogle af indholdsstofferne i Luxturna Luxturna indeholder mindre end 1 mmol (23 mg) natrium pr. dosis; dvs. det er i det væsentlige natrium-frit.
English: Overall, transient and low levels of vector DNA were detected in tear and occasional serum samples from 14/29 (48%) of subjects in the Phase 3 study.
Danish: Generelt blev der målt forbigående og lave niveauer af vektor-DNA i tårer og sporadiske serumprøver fra 14/29 (48 %) af forsøgsdeltagerne i fase 3-studiet.
English: Figure 2 shows the effect of the medicinal product over the three-year period in the voretigene neparvovec treatment group, as well as the effect in the control group after crossing over to receive subretinal injection of voretigene neparvovec.
Danish: Figur 2 viser lægemidlets virkning over den treårige periode i den gruppe, der fik behandling med voretigen neparvovec, samt virkningen i kontrolgruppen efter overkrydsning til at få subretinal injektion af voretigen neparvovec.
English: Pre-operative
Danish: Præ-operativt
English: What you need to know before you are given Luxturna
Danish: Det skal du vide, før du får Luxturna
English: VIAL LABEL (SOLVENT)
Danish: HÆTTEGLASETIKET (SOLVENS)
English: There were three non-serious adverse reactions of retinal deposits in three of 41 (7%) subjects that were considered to be related to voretigene neparvovec.
Danish: Der var tre ikke-alvorlige bivirkninger med retinale aflejringer hos tre ud af 41 (7 %) forsøgsdeltagere, som blev vurderet at være relateret til voretigen neparvovec.
English: Significant differences in binocular MLMT performance were observed for the voretigene neparvovec treatment group at day 30 and were maintained over the remaining follow-up visits throughout the three-year period, compared to no change in the control group.
Danish: Ved dag 30 blev der observeret signifikante forskelle i binokulære MLMT-resultater for den gruppe, der fik behandling med voretigen neparvovec, og de blev opretholdt ved de resterende opfølgningsbesøg i den treårige periode sammenlignet med ingen ændring i kontrolgruppen.
English: • You and your caregiver, especially if pregnant, breast-feeding or with a suppressed immune system, should wear gloves during dressing changes and when disposing of the dressings and other waste material.
Danish: • Du og dine omsorgspersoner skal, især i tilfælde af graviditet, amning eller nedsat immunsystem, bære handsker, når der skiftes forbinding, og når forbindinger og andet affald smides ud.
English: You and your caregiver should place any used dressings and waste material with tears and nasal secretions in sealed bags before disposing of them.
Danish: Du og dine omsorgspersoner skal lægge alle brugte forbindinger og affald med tårer og sekret fra næsen i forseglede poser, inden de smides ud.
English: Single-dose vial, 0.5 mL extractable volume
Danish: Enkeltdosishætteglas, 0,5 ml ekstraherbart volumen
English: The monocular MLMT change score significantly improved in the treatment group and was similar to the binocular MLMT results (see Table 4).
Danish: Ændring i monokulær MLMT-score var markant bedre i behandlingsgruppen og svarede til de binokulære MLMT-resultater (se tabel 4).
English: The dotted line connects the mean MLMT score change over visits for the control group, including five visits during the first year without receiving voretigene neparvovec.
Danish: Den stiplede streg forbinder middelværdien for ændring i MLMT-score over besøgene for kontrolgruppen, inklusive fem besøg i løbet af det første år uden at få voretigen neparvovec.
English: There is an additional risk of cataract if the lens inside the eye is damaged by the needle used to inject the medicine into the back of the eye.
Danish: Der er en yderligere risiko for grå stær, hvis linsen inde i øjet beskadiges af den kanyle, der bruges til at indsprøjte lægemidlet i den bageste del af øjet.
English: In an earlier toxicology study, a similar AAV2 vector administered subretinally in dogs at a dose of 10 times the recommended dose resulted in focal retinal toxicity and inflammatory cell infiltrates histologically in regions exposed to the vector.
Danish: I et tidligere toksikologisk studie medførte en lignende AAV2-vektor, administreret subretinalt til hunde med en dosis på 10 gange den anbefalede dosis, fokal retinal toksicitet og inflammatoriske celleinfiltrater histologisk i områder eksponeret for vektoren.
English: Do not drive or use heavy machines until your vision has recovered.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, før dit syn igen er normalt.
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity (see section 4.4).
Danish: Det må ikke administreres i umiddelbar nærhed af fovea for at opretholde foveal integritet (se pkt.
English: Your doctor will carry out eye surgery to remove the clear gel inside the eye, and then inject Luxturna directly under your retina, the thin light-sensing layer at the back of that eye.
Danish: Din læge vil udføre en øjenoperation, hvor den gennemsigtige gel inde i dit øje fjernes, og herefter indsprøjte Luxturna direkte under nethinden, som er det tynde, lysregistrerende lag bagest i dette øje.
English: A cataract is clouding of the natural lens inside the eye that can make it harder to see clearly.
Danish: Grå stær er, når den naturlige linse inde i øjet bliver uklar, så det bliver sværere at se tydeligt.
English: Conjunctival hyperaemia, cataract
Danish: Konjunktival hyperæmi, katarakt
English: The recommended site of injection should be located along the superior vascular arcade, at least 2 mm distal to the centre of the fovea (Figure 1B).
Danish: Det anbefalede injektionssted skal befinde sig langs den superiore vaskulære arkade, mindst 2 mm distalt for centrum af fovea (figur 1B).
English: Adequate anaesthesia should be given prior to the procedure.
Danish: Der skal gives passende anæstesi inden proceduren.
English: Nonclinical biodistribution
Danish: Ikke-klinisk biofordeling
English: Table 2 Adverse reactions related to voretigene neparvovec
Danish: Tabel 2 Bivirkninger relateret til voretigen neparvovec
English: Patients should be instructed to contact their healthcare professional if visual disturbances persist.
Danish: Patienten skal instrueres om at kontakte øjenlægen, hvis synsforstyrrelserne varer ved.
English: Patients/caregivers should be advised to handle waste material generated from dressings, tears and nasal secretion appropriately, which may include storage of waste material in sealed bags prior to disposal.
Danish: Patienter/omsorgspersoner skal instrueres i at håndtere affald fra forbindinger, tårer og næsesekret på passende vis, hvilket kan omfatte opbevaring af affald i forseglede poser inden bortskaffelse.
English: Mutations in the RPE65 gene lead to reduced or absent RPE65 all-trans-retinyl isomerase activity, blocking the visual cycle and resulting in vision loss.
Danish: Mutationer i RPE65 genet fører til nedsat eller fraværende RPE65 all-trans-retinyl-isomeraseaktivitet, hvilket blokerer den visuelle cyklus og medfører synstab.
English: Following a single vector administration, dogs developed antibodies to the AAV2 vector capsid which were absent in naïve non-human primates.
Danish: Efter en enkelt vektoradministration udviklede hunde antistoffer mod AAV2-vektorkapsidet, som var fraværende hos ikke-humane primater, som ikke tidligere havde modtaget behandling.
English: Confirmed biallelic RPE65 mutations and the presence of sufficient viable retinal cells (an area of retina within the posterior pole of >100 micron thickness, as estimated by optical coherence tomography [OCT]) were established for all participants.
Danish: Biallelle RPE65-mutationer og tilstedeværelse af et tilstrækkeligt antal levedygtige retinaceller (et område af retina inden for den posteriore pol med en tykkelse på > 100 mikrometer, vurderet med optisk kohærenstomografi [OCT]), blev bekræftet for alle deltagere.
English: - Accidental exposure to voretigene neparvovec, including contact with skin, eyes and mucous membranes, is to be avoided.
Danish: - Utilsigtet eksponering for voretigen neparvovec, herunder kontakt med hud, øjne og slimhinder, skal undgås.
English: Luxturna should be inspected visually prior to administration.
Danish: Luxturna skal kontrolleres visuelt inden administration.
English: Other medicines and Luxturna Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Luxturna Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: After thawing and dilution
Danish: Efter optøning og fortynding
English: After injection it delivers this gene into the cells of the retina, the layer at the back of the eye that detects light.
Danish: Når det er blevet indsprøjtet, overføres dette gen ind i cellerne i nethinden, som er det lag bagest i øjet, der registrerer lys.
English: One of 41 (2%) subjects reported a serious event of intraocular pressure increased (secondary to administration of depo-steroid) that was associated with treatment for endophthalmitis related to the administration procedure and resulted in optic atrophy, and one of 41 (2%) subjects reported a serious event of retinal disorder (loss of foveal function) that was assessed as related to the administration procedure.
Danish: En ud af 41 (2 %) forsøgsdeltagere indberettede en alvorlig bivirkning i form af forhøjet intraokulært tryk (sekundært til administration af depo-steroid), som var forbundet med behandlingen for endoftalmitis relateret til administrationsproceduren og medførte optisk atrofi, og en ud af 41 (2 %) forsøgsdeltagere indberettede en alvorlig bivirkning i form af retinasygdom (tab af foveal funktion), som blev vurderet at være relateret til administrationsproceduren.
English: Subretinal use
Danish: Subretinal brug
English: This enables the retina to produce the proteins needed for vision.
Danish: Dette giver nethinden mulighed for at danne de proteiner, der skal bruges til synet.
English: As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Danish: For en sikkerheds skyld bør voretigen neparvovec undgås under graviditeten.
English: Local biosafety guidelines for preparation, administration and handling of voretigene neparvovec should be followed.
Danish: Lokale retningslinjer for biologisk sikkerhed ved klargøring, administration og håndtering af voretigen neparvovec skal følges.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt 4.2).
English: All subjects had a diagnosis of Leber's congenital amaurosis owing to RPE65 mutations confirmed by genetic analysis in a certified laboratory.
Danish: Alle forsøgsdeltagere havde diagnosen Lebers kongenitte amaurose som følge af RPE65-mutationer bekræftet ved genanalyse i et certificeret laboratorium.
English: Patients may experience temporary visual disturbances after receiving subretinal injection of Luxturna.
Danish: Patienten kan opleve midlertidige synsforstyrrelser efter den subretinale injektion med Luxturna.
English: Electrocardiogram T wave inversion Injury, poisoning and procedural complications Common
Danish: T-tak-inversion på elektrokardiogram Traumer, forgiftninger og behandlingskomplikationer Almindelig
English: The active substance in Luxturna, voretigene neparvovec, is a modified virus that contains a working copy of the RPE65 gene.
Danish: Det aktive stof i Luxturna, voretigen neparvovec, er en modificeret virus, som indeholder en fungerende kopi af genet RPE65.
English: The individual administration procedure to each eye should be performed on separate days within a close interval, but no fewer than 6 days apart.
Danish: Den enkelte administration i hvert øje skal udføres på forskellige dage tæt på hinanden, men med et mellemrum på mindst 6 dage.
English: Prior to initiation of the immunomodulatory regimen and prior to administration of Luxturna, the patient must be checked for symptoms of active infectious disease of any nature, and in case of such infection the start of treatment must be postponed until after the patient has recovered.
Danish: Inden indledning af det immunmoderende regime og inden administration af Luxturna skal patienten undersøges for symptomer på alle former for aktive infektioner, og i tilfælde af en sådan infektion, må behandlingen ikke påbegyndes, før patienten er blevet rask.
English: The product is slowly injected through the tubing and microcannula to eliminate any air bubbles in the system.
Danish: Injicér produktet langsomt gennem slangen og mikrokanylen for at eliminere eventuelle bobler i systemet.
English: The recommended site of injection is located along the superior vascular arcade, at least 2 mm distal to the centre of the fovea.
Danish: Det anbefalede injektionssted er langs den superiore vaskulære arkade, mindst 2 mm distalt for centrum af fovea.
English: • Fluid-air exchange is performed, carefully avoiding fluid drainage near the retinotomy created for the subretinal injection.
Danish: • Der udføres væske/luft-udveksling, idet væskedrænage omhyggeligt undgås i nærheden af retinotomien, der blev skabt til den subretinale injektion.
English: Luxturna is a gene therapy product that contains the active substance voretigene neparvovec.
Danish: Luxturna er et genterapiprodukt, som indeholder det aktive stof voretigen neparvovec.
English: Treatment should be initiated and administered by a retinal surgeon experienced in performing macular surgery.
Danish: Behandlingen skal indledes og administreres af en øjenkirurg med erfaring i makulakirurgi.
English: The nine subjects who were randomised to the control group were crossed over to receive subretinal injection of voretigene neparvovec after one year of observation.
Danish: De ni forsøgsdeltagere, som blev randomiseret til kontrolgruppen, krydsede over til at få den subretinale injektion af voretigen neparvovec efter ét års observation.
English: Each mL of concentrate contains 5 x 10
Danish: Hver ml koncentrat indeholder 5 x 10
English: • Supine head positioning is initiated immediately in the post-operative period and, upon discharge, patients should be advised to rest in a supine position as much as possible for 24 hours.
Danish: • Patientens anbringes i rygliggende stilling, så snart den post-operative periode begynder, og efter udskrivning skal patienten instrueres om at hvile liggende på ryggen så meget som muligt i 24 timer.
English: Intraocular pressure should be monitored prior to and following administration of the product, and managed appropriately.
Danish: Det intraokulære tryk skal overvåges før og efter administration af produktet og behandles på passende vis.
English: The individual administration procedure to each eye is performed on separate days within a close interval, but no fewer than 6 days apart.
Danish: Den enkelte administration i hvert øje udføres på forskellige dage tæt på hinanden, men med et mellemrum på mindst 6 dage.
English: Please talk to your doctor before beginning to engage in strenuous physical activity after receiving Luxturna.
Danish: Tal med lægen, inden du giver dig ud i anstrengende fysisk aktivitet, når du har fået Luxturna.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from voretigene neparvovec therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med voretigen neparvovec skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The solvent is a clear, colourless liquid supplied in a clear plastic vial.
Danish: Solvenset er en klar, farveløs væske, der leveres i et gennemsigtigt hætteglas af plast.
English: Each eye was administered a single subretinal injection of 1.5 x 10
Danish: Der blev administreret en enkelt subretinal injektion af 1,5 x 10
English: AAV2-hRPE65v2-LTFU-01: In order to further evaluate the long-term efficacy and safety outcomes of Luxturna in adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations, the applicant should submit the long-term efficacy and safety follow-up of trial participants who received Luxturna in the clinical programme (15-year follow-up).
Danish: AAV2-hRPE65v2-LTFU-01: For yderligere at evaluere langtidseffekten og sikkerheden af Luxturna hos voksne og pædiatriske patienter med synstab pga. nedarvet retinal dystrofi, der skyldes bekræftede biallele RPE65mutationer, skal ansøgeren indsende opfølgningsdata for langtidseffekten og sikkerheden for forsøgsdeltagere, som modtog Luxturna i det kliniske program (15 års opfølgning).
English: For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter optøning og fortynding af lægemidlet, se pkt.
English: It is recommended that patients/caregivers wear gloves for dressing changes and waste disposal, especially in case of underlying pregnancy, breast-feeding and immunodeficiency of caregivers.
Danish: Det anbefales, at patienten/omsorgspersoner bærer handsker ved skift af forbindinger og bortskaffelse af affald, især hvis omsorgspersonen er gravid, ammer eller har nedsat immunforsvar.
English: You may have temporary visual disturbances after receiving Luxturna.
Danish: Du kan få midlertidige synsforstyrrelser, når du har fået Luxturna.
English: Intraocular pressure should be monitored prior to and following administration of the medicinal product and managed appropriately.
Danish: Det intraokulære tryk skal overvåges før og efter administration af lægemidlet og behandles på passende vis.
English: One of 41 (2%) subjects reported a serious event of retinal detachment that was assessed as related to the administration procedure.
Danish: En ud af 41 (2 %) forsøgsdeltagere indberettede en alvorlig bivirkning i form af retinaløsning, som blev vurderet at være relateret til administrationsproceduren.
English: Inspect for any visual particulates or any anomalies.
Danish: Kontroller for eventuelle synlige partikler eller andre anormalier.
English: SPKRPE-EUPASS: Non-interventional PASS: In order to further characterise the safety including long-term safety of Luxturna, the applicant should conduct and submit a study based on data from a disease registry in patients vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations.
Danish: SPKRPE-EUPASS: Ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring (PASS): For yderligere at karakterisere sikkerheden inklusive langtidssikkerheden af Luxturna skal ansøgeren udføre og indsende et studie baseret på data fra en sygdomsdatabase over patienter med synstab pga. nedarvet retinal dystrofi, der skyldes bekræftede biallele RPE65-mutationer.
English: However, after crossing-over to receive subretinal injection of voretigene neparvovec, the subjects in the control group showed a similar response to the voretigene neparvovec as compared to the subjects in the voretigene neparvovec treatment group.
Danish: Efter overkrydsning til at få den subretinale injektion af voretigen neparvovec viste forsøgsdeltagerne i kontrolgruppen imidlertid et lignende respons på voretigen neparvovec som forsøgsdeltagerne i den gruppe, der blev behandlet med voretigen neparvovec.
English: The corticosteroids may decrease the potential immune reaction to either vector capsid (adeno-associated virus serotype 2 [AAV2] vector) or transgene product (retinal pigment epithelial 65 kDa protein [RPE65]).
Danish: Kortikosteroiderne kan mindske den potentielle immunreaktion på enten vektorkapsid (adeno-associeret virus serotype 2 [AAV2]-vektor) eller transgent produkt (retinal pigment-epitelial 65 kDa-protein [RPE65]).
English: vector genomes of voretigene neparvovec.
Danish: vektorgenomer af voretigen neparvovec.
English: 21 subjects were randomised to receive subretinal injection of voretigene neparvovec.
Danish: 21 forsøgsdeltagere blev randomiseret til at få den subretinale injektion af voretigen neparvovec.
English: No adjustment in dosage is necessary for paediatric patients.
Danish: Det er ikke nødvendigt at justere dosis hos pædiatriske patienter.
English: The retinal pigment epithelium-specific 65 kilodalton protein (RPE65) is located in the retinal pigment epithelial cells and converts all-trans-retinol to 11-cis-retinol, which subsequently forms the chromophore, 11-cis-retinal, during the visual (retinoid) cycle.
Danish: RPE65 er et retinapigment-specifikt 65 kilodalton protein, der er lokaliseret i retinapigment epithelcellerne og konverterer all-trans-retinol til 11-cis-retinol, som efterfølgende danner det chromofore 11-cis-retinal, under den visuelle (retinoide) cyklus.
English: • Eye inflammation (including endophthalmitis), retinal tear and retinal detachment.
Danish: • Øjenbetændelse (herunder endoftalmitis), rifter i retina og retinaløsning.
English: Prednisone (or equivalent) 1 mg/kg/day (maximum of 40 mg/day)
Danish: Prednison (eller tilsvarende) 1 mg/kg/dag (maksimalt 40 mg/dag)
English: Once thawed, the medicinal product should not be re-frozen and be left at room temperature (below 25 °C).
Danish: Når lægemidlet er optøet, må det ikke nedfryses igen og skal opbevares ved stuetemperatur (under 25 °C).
English: • After injection, any unused product must be discarded.
Danish: • Alt ubrugt produkt skal kasseres efter injektion.
English: • Increased pressure in the eye
Danish: • Forhøjet tryk i øjet.
English: In one animal administered with Luxturna at 7.5 x 10
Danish: Hos ét dyr, der havde fået administreret Luxturna med en dosis på 7,5 x 10
English: Endotracheal intubation complication, wound dehiscence
Danish: Komplikationer ved endotracheal intubation, sårruptur
English: • All spills of voretigene neparvovec must be treated with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
Danish: - Alle spild af voretigen neparvovec skal behandles med et virusdræbende middel som for eksempel 1 % natriumhypochlorit og opsuges med absorberende materialer.
English: Subretinal use after dilution.
Danish: Subretinal brug efter fortynding.
English: - In the event of an accidental occupational exposure (e.g. through a splash to the eyes or mucous membranes), flush with clean water for at least 5 minutes.
Danish: - I tilfælde af utilsigtet eksponering (fx i form af stænk i øjne eller slimhinder) skal der skylles med rent vand i mindst 5 minutter.
English: Retinal deposits
Danish: Retinale aflejringer