FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: • Po posegu je treba bolniku takoj pravilno namestiti glavo v ležečem položaju in mu pri odpustu naročiti, naj, kolikor je mogoče, počiva v ležečem položaju še 24 ur.
English: The active substance in Luxturna, voretigene neparvovec, is a modified virus that contains a working copy of the RPE65 gene.
Slovenian: Učinkovina v zdravilu Luxturna, voretigen neparvovek, je spremenjen virus, ki vsebuje delujočo kopijo gena RPE65.
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.
Slovenian: Pozitivna sprememba ocene pomeni, da je preiskovanec opravil test MLMT pri nižji stopnji osvetlitve kot prej, največje možno izboljšanje ocene pri testu MLMT pa je razlika za 6 stopenj ocene osvetljenosti.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
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]).
Slovenian: Kortikosteroidi lahko zmanjšajo možnost imunske reakcije na bodisi kapsido vektorja (adenoasociacijskega virusnega vektorja serotipa 2 [AAV2]) ali na transgenski produkt (65-kilodaltonski protein pigmentnega epitelija mrežnice [protein RPE65]).
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.
Slovenian: Vodoravna črtkana črta povezuje povprečne vrednosti ocen pri testu MLMT med posameznimi obiski za kontrolno skupino in vključuje pet obiskov v prvem letu, ko preiskovanci še niso prejeli voretigen neparvoveka.
English: The concentrate (0.5 mL extractable volume in a single-dose 2 mL vial) requires a 1:10 dilution prior to administration.
Slovenian: Koncentrat (0,5 ml ekstraktabilnega volumna v 2-mililitrski viali za enkratno odmerjanje) je treba pred apliciranjem razredčiti v razmerju 1:10.
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.
Slovenian: V že prej opravljeni študiji toksičnosti pri psih je po subretinalnem apliciranju vektorja podobnega vektorju AAV2 v odmerku, ki je bil 10-krat višji od priporočenega, prišlo do lokalnega toksičnega delovanja v mrežnici in pri histološki preiskavi vidnih infiltratov vnetnih celic v predelih očesa, ki so bili izpostavljeni vektorju.
English: A total of 41 subjects (81 eyes injected [one Phase 1 subject did not meet eligibility criteria for a second injection]) participated in the clinical programme.
Slovenian: Skupaj je v kliničnem programu sodelovalo 41 preiskovancev (kar pomeni injiciranje v 81 oči [en preiskovanec v študiji faze 1 ni ustrezal kriterijem primernosti za drugo injekcijo]).
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.
Slovenian: Vi in vaš negovalec morata ves uporabljen obvezilni material in odpadni material, ki je prišel v stik s solzami ali nosnim izcedkom, zbirati v dobro zaprtih vrečah, preden jih zavržete.
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.
Slovenian: • Ustrezen volumen zdravila, ki je v brizgi na voljo za injiciranje, je zagotovljen, kadar je vrh bata poravnan z oznako za 0,3 ml.
English: Table 4 Changes in MLMT score: year 1, compared to baseline (ITT population: n=21 intervention, n=10 control)
Slovenian: Preglednica 4 Spremembe ocene pri testu MLMT po 1 letu v primerjavi z izhodiščno oceno (populacija z namenom zdravljenja (ITT): intervencijska skupina n=21, kontrolna skupina n=10)
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.
Slovenian: Zdravnik bo na očesu izvedel kirurški poseg, s katerim bo odstranil bistro želatinasto snov v vašem očesu, nato pa vam bo vbrizgal zdravilo Luxturna tik pod mrežnico, to je tanka plast, ki leži na zadajšnjem delu očesa in lahko zaznava svetlobo.
English: Single-dose vial, 0.5 mL extractable volume
Slovenian: viala za enkratno odmerjanje, 0,5 ml ekstraktabilnega volumna
English: Other findings from voretigene neparvovec non-clinical studies included occasional and isolated inflammatory cells in the retina, with no apparent retinal degeneration.
Slovenian: Med drugimi izsledki v nekliničnih študijah voretigen neparvoveka so bili naključni posamezni primeri pojavljanja vnetnih celic v mrežnici brez očitne degeneracije mrežnice.
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.
Slovenian: XBL; XD30; XD90; XD180: izhodišče in 30, 90 oziroma 180 dni po začetku študije za preiskovance v kontrolni skupini s prehodom;
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.
Slovenian: - Če pride do nenamerne poklicne izpostavljenosti zdravilu (na primer do oškropitve oči ali sluznic), prizadeti predel najmanj 5 minut izpirajte s čisto vodo.
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.
Slovenian: 65-kilodaltonski protein (RPE65), specifičen za pigmentni epitelij mrežnice, je prisoten v celicah pigmentnega epitelija mrežnice in pretvarja vse-trans-retinol v 11-cis-retinol, iz katerega nato v procesu vidnega (retinoidnega) cikla nastane kromoforni 11-cis-retinal.
English: Luxturna has not been studied in breast-feeding women.
Slovenian: Zdravila Luxturna niso proučevali pri ženskah, ki dojijo.
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.
Slovenian: Bolnikom oziroma njihovim negovalcem je treba naročiti, naj ustrezno ravnajo z odpadnim obvezilnim materialom in materialom, ki je bil v stiku s solzami ali nosnim izcedkom, kar lahko vključuje shranjevanje teh odpadkov v dobro zaprtih vrečah, preden jih zavržejo.
English: The recommended site of injection is located along the superior vascular arcade, at least 2 mm distal to the centre of the fovea.
Slovenian: Priporočeno mesto injiciranja je treba izbrati vzdolž zgornjega žilnega loka, najmanj 2 mm distalno od središča fovee.
English: Each mL of concentrate contains 5 x 10
Slovenian: En mililiter koncentrata vsebuje 5 x 10
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity.
Slovenian: Zdravila se ne sme aplicirati v neposredno bližino centralne fovee, da fovee ne bi kakor koli poškodovali.
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).
Slovenian: Najprej je treba počasi injicirati majhno količino zdravila, tako da se oblikuje začetni subretinalni mehurček, nato pa je treba počasi injicirati še preostalo količino zdravila, dokler ni apliciran celoten 0,3-mililitrski volumen (slika 1).
English: • Fluid-air exchange is performed, carefully avoiding fluid drainage near the retinotomy created for the subretinal injection.
Slovenian: • Izvesti je treba izmenjavo tekočine z zrakom in pri tem paziti, da ne pride do drenaže tekočine ob vbodnem mestu, ki je bilo narejeno za subretinalno injekcijo.
English: The following side effects may happen with the injection procedure:
Slovenian: Zaradi postopka injiciranja lahko pride do naslednjih neželenih učinkov:
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.
Slovenian: • Ves material, ki je bil lahko v stiku z voretigen neparvovekom (kot so viala, brizga, igla, zloženci iz vate, rokavice, maske ali obvezilni material), je treba zavreči v skladu z lokalno sprejetimi predpisi za zagotavljanje biološke varnosti.
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).
Slovenian: Najbolj pogosti neželeni učinki (s pogostnostjo ≥ 5 %), ki so bili povezani s postopkom apliciranja, so bili veznična hiperemija, katarakta, zvišan intraokularni tlak, raztrganina mrežnice, tanjšanje roženične strome, foramen makule, subretinalni depoziti, vnetje v očesu, draženje očesa, bolečine v očesu in makulopatija (gubanje na površini makule).
English: • Nausea (feeling sick), vomiting, abdominal (belly) pain, lip pain
Slovenian: • navzea (občutek slabosti), bruhanje, bolečine v trebuhu, bolečine v ustnicah
English: • Headache, dizziness
Slovenian: • glavobol, omotičnost
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.
Slovenian: Na osnovi podatkov iz predkliničnih študij in kliničnih podatkov iz študij virusnega vektorja AAV2 ter ob upoštevanju subretinalnega načina vnosa zdravila Luxturna je nehoten prenos genov z adenoasociacijskim virusnim vektorjem v linijo zarodnih celic skrajno malo verjeten.
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.
Slovenian: Zdravilo Luxturna je indicirano za zdravljenje odraslih in pediatričnih bolnikov z izgubo vida zaradi dedne mrežnične distrofije, ki jo je povzročila potrjena bialelna mutacija gena RPE65, in imajo dovolj viabilnih mrežničnih celic.
English: Difference (95% CI) (Intervention-Control) -2.33 (-3.44, -1.22), p<0.001
Slovenian: razlika med intervencijsko in kontrolno skupino (95-odstotni IZ) -1,89 (-3,03; -0,75), p=0,002
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.
Slovenian: Jetrna in ledvična funkcija, polimorfizem citokroma P450 in staranje predvidoma ne vplivajo na klinično učinkovitost in varnost zdravila, zato pri bolnikih z okvaro jeter ali ledvic prilagajanje odmerka ni potrebno.
English: Patients will receive a single dose of 1.5 x 10
Slovenian: Bolniki prejmejo en odmerek 1,5 x 10
English: The product is slowly injected through the tubing and microcannula to eliminate any air bubbles in the system.
Slovenian: Zdravilo je treba skozi cevko in mikrokanilo injicirati počasi, da se v sistemu ne bi pojavili zračni mehurčki.
English: The safety and efficacy of voretigene neparvovec in children aged up to 4 years have not been established.
Slovenian: Varnost in učinkovitost voretigen neparvoveka pri otrocih, starih manj kot 4 leta, nista bili dokazani.
English: Treatment should be initiated and administered by a retinal surgeon experienced in performing macular surgery.
Slovenian: Zdravljenje sme uvesti in zdravilo odmerjati samo retinalni kirurg, ki ima izkušnje z izvajanjem operacij makule.
English: Subretinal use after dilution.
Slovenian: Za subretinalno uporabo po razredčenju.
English: There is no clinical experience with overdose of voretigene neparvovec.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem voretigen neparvoveka ni.
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.
Slovenian: Nizko koncentracijo segmentov vektorske DNA so v očeh, v katere so injicirali vektorje, izmerili v vidnem živcu, v optični kiazmi, vranici in jetrih ter v posameznih primerih v želodcu in bezgavkah.
English: Concentrate and solvent must be stored and transported frozen at ≤-65 ºC.
Slovenian: Koncentrat in vehikel je treba shranjevati in prevažati v zamrznjenem stanju pri temperaturi -65 ºC ali manj.
English: After dilution each dose of Luxturna contains 1.5 x 10
Slovenian: Po razredčenju en odmerek zdravila Luxturna vsebuje 1,5 x 10
English: Luxturna is a single-use vial for a single administration in one eye only.
Slovenian: Zdravilo Luxturna v viali za enkratno uporabo je namenjeno enkratnemu odmerjanju v eno samo oko.
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.
Slovenian: Po prehodu na prejem subretinalne injekcije voretigen neparvoveka pa je pri preiskovancih iz kontrolne skupine prišlo do podobnega odziva na voretigen neparvovek kot v skupini preiskovancev, zdravljenih z voretigen neparvovekom.
English: • Eye inflammation (including endophthalmitis), retinal tear and retinal detachment.
Slovenian: • vnetje v očesu (vključno z endoftalmitisom), raztrganina mrežnice in odstop mrežnice.
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.
Slovenian: Pri vseh preiskovancih so pridobili izvide o potrjeni bialelni mutaciji gena RPE65 in prisotnosti zadostne količine viabilnih mrežničnih celic (debelina predela mrežnice na posteriornem polu več kot 100 mikrometrov, ocenjena z uporabo optične koherentne tomografije [OCT]).
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.
Slovenian: Pri drugem očesu je treba z imunomodulatornim režimom začeti po enakem razporedu tako, da drugi režim nadomesti imunomodulatorno zdravljenje prvega očesa.
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.
Slovenian: Najprej je treba počasi injicirati majhno količino zdravila, tako da se oblikuje začetni subretinalni mehurček, nato pa je treba počasi injicirati še preostalo količino zdravila, dokler ni apliciran celoten 0,3-mililitrski volumen.
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.
Slovenian: Injiciranje voretigen neparvoveka v subretinalni prostor omogoči transdukcijo cDNA z zapisom za normalni humani protein RPE65 v celice pigmentnega epitelija (zdravljenje z gensko avgmentacijo), zaradi česar je mogoča ponovna vzpostavitev vidnega cikla.
English: XY1
Slovenian: XL1
English: Following a single vector administration, dogs developed antibodies to the AAV2 vector capsid which were absent in naïve non-human primates.
Slovenian: Pri psih so se po enkratnem odmerjanju vektorja razvila protitelesa proti kapsidi vektorja AAV2, pri predhodno nezdravljenih nečloveških primatih pa takih protiteles ni bilo.
English: Store and transport frozen at ≤-65 ºC.
Slovenian: Shranjujte in prevažajte zamrznjeno pri temperaturi ≤ -65 ºC.
English: Prednisone (or equivalent) 1 mg/kg/day (maximum of 40 mg/day)
Slovenian: prednizon (ali ekvivalent) 1 mg/kg/dan (največ 40 mg/dan)
English: • After vitrectomy is completed, Luxturna is administered by subretinal injection using a subretinal injection cannula introduced via pars plana (Figure 1A).
Slovenian: • Po zaključenem postopku vitrektomije je treba zdravilo Luxturna aplicirati s subretinalno injekcijo s pomočjo kanile za subretinalno injiciranje, ki je vstavljena v oko skozi ravni del ciliarnika (pars plana) (slika 1A).
English: vg (5 times the recommended per eye dose), vector DNA sequences were detected in colon, duodenum and trachea.
Slovenian: vg (kar je 5-krat več od priporočenega odmerka za eno oko), so segmente vektorske DNA našli v debelem črevesu, dvanajstniku in sapniku.
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.
Slovenian: 0,5 ml ekstraktabilnega volumna koncentrata v 2-mililitrski viali iz cikličnega olefinskega polimera s klorobutilnim gumijastim zamaškom, zatesnjenim z aluminijasto snemno (flip-off) zaporko.
English: Table 2 Adverse reactions related to voretigene neparvovec
Slovenian: Preglednica 2 Neželeni učinki voretigen neparvoveka
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;
Slovenian: • izobraževalno gradivo za kirurge za apliciranje zdravila LUXTURNA, ki vključuje opis materiala in postopkov, ki so potrebni za izvedbo subretinalne injekcije zdravila LUXTURNA, oziroma
English: vg voretigene neparvovec in a total volume of 300 μL.
Slovenian: vektorskih genomov voretigen neparvoveka v skupnem volumnu 300 μl.
English: Each foil pouch includes a carton containing 1 vial of concentrate and 2 vials of solvent.
Slovenian: En mošnjiček iz folije vključuje škatlo, ki vsebuje 1 vialo s koncentratom in 2 viali z vehiklom.
English: One of 41 (2%) subjects reported a serious event of retinal detachment that was assessed as related to the administration procedure.
Slovenian: Pri eni od 41 oseb (2 %) so poročali o resnem neželenem dogodku z odstopom mrežnice, ki je bil ocenjen kot vzročno povezan s postopkom apliciranja.
English: The safety and efficacy of voretigene neparvovec have not been established in patients with hepatic or renal impairment.
Slovenian: Varnost in učinkovitost voretigen neparvoveka pri bolnikih z okvaro jeter ali ledvic nista bili dokazani.
English: The solvent is a clear, colourless liquid supplied in a clear plastic vial.
Slovenian: Vehikel je bistra brezbarvna tekočina in je na voljo v prozorni plastični viali.
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.
Slovenian: Pred uvedbo imunomodulatornega režima in pred apliciranjem zdravila Luxturna je treba preveriti, ali ima bolnik simptome kakršne koli aktivne infekcijske bolezni.
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.
Slovenian: Devet preiskovancev, ki so bili randomizirani v kontrolno skupino, je po enoletnem obdobju opazovanja prešlo na prejem subretinalne injekcije voretigen neparvoveka.
English: Luxturna is a gene therapy product that contains the active substance voretigene neparvovec.
Slovenian: Luxturna je zdravilo za gensko zdravljenje, ki vsebuje učinkovino voretigen neparvovek.
English: Subretinal use.
Slovenian: Način uporabe subretinalna uporaba
English: • Connect the syringe containing the diluted product to the tubing and microcannula.
Slovenian: • Brizgo z razredčenim zdravilom spojite s cevko in mikrokanilo.
English: Each carton containing 1 vial of concentrate and 2 vials of solvent is for single use only.
Slovenian: Ena škatla, ki vsebuje 1 vialo s koncentratom in 2 viali z vehiklom, je namenjena samo enkratni uporabi.
English: The horizontal bar within each box represents the median.
Slovenian: Vodoravna črtica v vsakem okvirju predstavlja mediano vrednost.
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.
Slovenian: V skupini z voretigen neparvovekom so po 30 dneh opažali statistično značilne spremembe pri izvajanju testa MLMT ob gledanju z obema očesoma, ki so se ohranile tudi pri preostalih kontrolnih obiskih v obdobju treh let, v primerjavi z bolniki iz kontrolne skupine, pri katerih niso opažali sprememb pri izvajanju testa.
English: The solid line connects the mean MLMT score changes over visits for the treatment group.
Slovenian: Neprekinjena črta povezuje povprečne vrednosti ocen pri testu MLMT med posameznimi obiski za zdravljeno skupino.
English: • After vitrectomy is completed, Luxturna is administered by subretinal injection using a commercially available subretinal injection cannula introduced via pars plana.
Slovenian: • Po zaključenem postopku vitrektomije je treba zdravilo Luxturna aplicirati s subretinalno injekcijo s pomočjo komercialno dostopne kanile za subretinalno injiciranje, ki je vstavljena v oko skozi ravni del ciliarnika (pars plana).
English: Table 1 Pre- and post-operative immunomodulatory regimen for each eye
Slovenian: Preglednica 1 Imunomodulatoren režim pred posegom in po njem za vsako od obeh očes pred posegom
English: The product is administered as a subretinal injection after vitrectomy in each eye.
Slovenian: Zdravilo je treba po opravljeni vitrektomiji v posamezno oko aplicirati s subretinalno injekcijo.
English: Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Slovenian: V primeru prevelikega odmerjanja je priporočena uvedba simptomatskega in podpornega zdravljenja po presoji lečečega zdravnika.
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.
Slovenian: Voretigen neparvovek je vektor za prenos genov, ki z uporabo kapside adenoasociacijskega virusnega vektorja serotipa 2 (AAV2) kot nosilca omogoča prenos cDNA za humani 65-kilodaltonski protein pigmentnega epitelija mrežnice (angl. human retinal pigment epithelium 65 kDa protein, protein hRPE65) v mrežnico.
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.
Slovenian: Pri eni od 41 oseb (2 %) so poročali o resnem neželenem dogodku z zvišanjem intraokularnega tlaka (kot posledico odmerjanja dolgodelujočega (depo) steroida), ki je bilo povezano z zdravljenjem endoftalmitisa, do katerega je prišlo zaradi postopka apliciranja zdravila in je povzročil atrofijo vidnega živca.
English: • Redness of the eye
Slovenian: • otekanje očesa