FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U ranijem toksikološkom ispitivanju, sličan AAV2 vektor primijenjen subretinalno u pasa u dozi koja je 10 puta veća od preporučene rezultirao je fokalnom retinalnom toksičnošću i histološki potvrđenim infiltratima upalnih stanica u regijama izloženima vektoru.
English: Voretigene neparvovec has minor influence on the ability to drive and use machines.
Croatian: Voretigen neparvovek malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Dok se mjehurić u potpunosti ne apsorbira, putovanje avionom ili drugi oblici putovanja na velikim visinama mogu napraviti da se mjehurić proširi i dovede do oštećenja oka, uključujući gubitak vida.
English: Luxturna will be given to you only if genetic testing shows that your vision loss is caused by mutations in the RPE65 gene.
Croatian: Luxturnu ćete dobiti samo ako genetsko testiranje pokaže da je Vaš gubitak vida uzrokovan mutacijama u RPE65 genu.
English: Over time, accumulation of toxic precursors leads to the death of retinal pigment epithelial cells, and subsequently to progressive photoreceptor cell death.
Croatian: Tijekom vremena, nakupljanje toksičnih prekursora dovodi do smrti stanica retinalnog pigmentnog epitela te zatim do progresivne smrti fotoreceptorskih stanica.
English: vector genomes (vg).
Croatian: vektorskih genoma (vg).
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.
Croatian: Isprekidana linija povezuje srednje vrijednosti promjene rezultata za MLMT tijekom posjeta za kontrolnu skupinu, uključujući pet posjeta tijekom prve godine bez primanja voretigen neparvoveka.
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.
Croatian: Također, potrebno je pružiti obuku i upute za sigurno rukovanje i zbrinjavanje zahvaćenih materijala 14 dana nakon primjene lijeka uz informacije o isključenju iz davanja krvi, organa, tkiva i stanica za transplantaciju nakon primjene LUXTURNE.
English: o Contact information for adverse event reporting.
Croatian: o Kontakt informacije za prijavljivanje nuspojave.
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.
Croatian: Sekvence vektorske DNK bile su otkrivene u serumu u 3/29 (10%) ispitanika, uključujući dva s pozitivnim uzorcima suza, te samo do 3. dana nakon svake injekcije.
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.
Croatian: Dugoročna sigurnost i djelotvornost Luxturne procjenjivane su u ispitivanju sigurnosti i postupnog povećavanja doze faze 1 (101), u kojem je 12 ispitanika primilo subretinalnu injekciju voretigen neparvoveka u jedno oko; u pratećem ispitivanju (102) u kojem je voretigen neparvovek bio primijenjen u suprotno oko u 11 od 12 ispitanika koji su sudjelovali u ispitivanju postupnog povećanja doze; u jednogodišnjem otvorenom, kontroliranom ispitivanju faze 3 (301) u kojem je 31 ispitanik bio randomiziran u dva centra; te u nastavku ispitivanja faze 3, u kojem je 9 ispitanika koji su bili u kontrolnoj skupini prešlo u skupinu koja je primila lijek.
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;
Croatian: • Kiruršku edukaciju za primjenu LUXTURNE, uključujući opis materijala i postupaka potrebnih da se izvede LUXTURNA subretinalna injekcija ili • Priručnik za obuku ljekarnika koji uključuje informacije o pripremi i čuvanju LUXTURNE.
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.
Croatian: Okularna histopatologija očiju u pasa i ne-ljudskih primata izloženih voretigen neparvoveku pokazala je samo blage promjene, koje su uglavnom bile povezane sa zacjeljivanjem kirurške rane.
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.
Croatian: Izlučivanje i biodistribucija vektora ocijenjeni su u suzama iz oba oka, serumu i punoj krvi ispitanika u kliničkom ispitivanju faze 3.
English: You may have temporary visual disturbances after receiving Luxturna.
Croatian: Mogli biste imati privremene vidne smetnje nakon primanja Luxturne.
English: Damage to the tissues of the eye may be accompanied by bleeding and swelling and an increased risk of infection.
Croatian: Oštećenje očnih tkiva može biti popraćeno krvarenjem i oticanjem te povećanim rizikom od infekcije.
English: Adequate anaesthesia should be given to the patient prior to the procedure.
Croatian: Bolesniku treba dati odgovarajuću anesteziju prije postupka.
English: • Fluid-air exchange is performed, carefully avoiding fluid drainage near the retinotomy created for the subretinal injection.
Croatian: • Provodi se razmjena tekućine i zraka, pažljivo izbjegavajući drenažu tekućine blizu retinotomije napravljene za subretinalnu injekciju.
English: All subjects had a diagnosis of Leber's congenital amaurosis owing to RPE65 mutations confirmed by genetic analysis in a certified laboratory.
Croatian: Svi su ispitanici imali dijagnozu Leberove kongenitalne amauroze zbog RPE65 mutacija potvrđenih genetskom analizom u ovlaštenom laboratoriju.
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.
Croatian: • U slučaju izlaganja raspuknute kože ili ozljede ubodom igle, temeljito očistite zahvaćeno područje sapunom i vodom i/ili dezinficirajućim sredstvom.
English: Table 5 Full-field light sensitivity testing
Croatian: Tablica 5 Testiranje fotoosjetljivosti u punom vidnom polju
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.
Croatian: • Volumen lijeka raspoloživ za injekciju potvrđuje se u štrcaljki tako da se vrh klipa poravna s linijom koja označava 0,3 ml.
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.
Croatian: Tri mjere sekundarnih ishoda također su bile testirane: testiranje praga fotoosjetljivosti u punom vidnom polju (engl. full-field light sensitivity threshold, FST) korištenjem bijelog svjetla; promjena u rezultatu za MLMT za prvo oko; te testiranje vidne oštrine.
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.
Croatian: Jedan od 41 (2%) ispitanika prijavio je ozbiljan događaj povišenog intraokularnog tlaka (nakon primjene depo steroida) koji je bio povezan s liječenjem endoftalmitisa povezanog s postupkom primjene i rezultirao je optičkom atrofijom, a jedan od 41 (2%) ispitanika prijavio je ozbiljan događaj poremećaja mrežnice (gubitak fovealne funkcije) za koji je bilo procijenjeno da je povezan s postupkom primjene.
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.
Croatian: U pojedinaca s retinalnom distrofijom povezanom s bialelnom RPE65 mutacijom dolazi do gubitka vida, što uključuje smanjene parametre vidne funkcije kao što su vidna oštrina i vidna polja, često tijekom djetinjstva ili adolescencije; ovaj gubitak vida na kraju progredira do potpune sljepoće.
English: o Patient card will be available in alternative formats including large print and as an audio file.
Croatian: o Kartica za bolesnike će biti dostupna u alternativnim formatima koji uključuju ispis velikim slovima i audio datoteku.
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity.
Croatian: Ne smije se primijeniti u neposrednoj blizini fovee kako bi se očuvala cjelovitost fovee.
English: At baseline, subjects achieved pass marks on the mobility test at between 4 and 400 ambient lux.
Croatian: Na početku su ispitanici postizali prolazne ocjene na testu mobilnosti na između 4 i 400 luksa ambijentalnog osvjetljenja.
English: For instructions for preparation, accidental exposure to and disposal of Luxturna, see section 6.6.
Croatian: Za upute o pripremi, slučajnom izlaganju Luxturni i zbrinjavanju, vidjeti dio 6.6.
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.
Croatian: Ne očekuje se da će jetrena i bubrežna funkcija, polimorfizmi citokroma P450 i starenje utjecati na kliničku djelotvornost ili sigurnost lijeka.
English: Starting 3 days prior to the administration of Luxturna to the first eye, it is recommended that an immunomodulatory regimen is initiated following the schedule below (Table 1).
Croatian: Počevši 3 dana prije primjene Luxturne u prvo oko, preporučuje se započeti imunomodulacijski režim prema rasporedu prikazanom u nastavku (Tablica 1).
English: Patients may experience temporary visual disturbances after receiving subretinal injection of Luxturna.
Croatian: Bolesnici mogu doživjeti privremene smetnje vida nakon primanja subretinalne injekcije Luxturne.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Croatian: Neiskorišteni lijek mora se zbrinuti u skladu s lokalnim smjernicama za biosigurnost.
English: • Tell your doctor if you have signs of an eye infection or eye inflammation, for example if you have eye redness, sensitivity to light, eye swelling or eye pain.
Croatian: • Obavijestite liječnika ako imate znakove infekcije oka ili aktivnu upalu oka, na primjer, ako imate crvenilo oka, osjetljivost na svjetlost, oticanje oka ili bol u oku.
English: Please talk to your doctor before going to swim after receiving treatment with Luxturna.
Croatian: Razgovarajte sa svojim liječnikom prije plivanja nakon što ste primili liječenje Luxturnom.
English: Improvement in full-field light sensitivity was maintained for up to 3 years after exposure to voretigene neparvovec.
Croatian: Poboljšanje u fotoosjetljivosti u punom vidnom polju bilo je održano do 3 godine nakon izloženosti voretigen neparvoveku.
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.
Croatian: Vaš liječnik će izvesti operaciju oka za uklanjanje bistrog gela unutar oka, i onda ubrizgati Luxturnu neposredno ispod Vaše mrežnice, tankog sloja osjetljivog na svjetlo u pozadini oka.
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.
Croatian: Općenito su prolazne i niske razine vektorske DNK bile otkrivene u uzorcima suza i ponekom uzorku seruma od 14/29 (48%) ispitanika u ispitivanju faze 3.
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.
Croatian: Očekuje se da će voretigen neparvovek ući u stanice putem receptora heparan sulfat proteoglikana te da će ga razgraditi endogeni proteini i katabolički putevi DNK.
English: Patients should be instructed to contact their healthcare professional if visual disturbances persist.
Croatian: Bolesnike je potrebno uputiti da se obrate svom zdravstvenom radniku u slučaju perzistentnih vidnih smetnji.
English: Any exposed wounds should be covered before handling.
Croatian: Ako postoji kakva izložena rana, potrebno ju je prekriti prije rukovanja.
English: Y1, Y2, Y3: one, two and three years after start of study;
Croatian: G1, G2, G3: jedna, dvije i tri godine nakon početka ispitivanja.
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.
Croatian: Vi i Vaš njegovatelj trebate spremiti sve korištene zavoje i otpadni materijal sa suzama i izlučevinama iz nosa u zapečaćene vrećice prije nego što ih odložite.
English: Presence of or affiliation with a retinal surgeon experienced in sub-retinal surgery and capable of administrating LUXTURNA;
Croatian: Prisutnost ili povezanost s retinalnim kirurgom iskusnim u subretinalnoj kirurgiji i sposobnim primijeniti LUXTURNU;
English: Inspect for any visual particulates or any anomalies.
Croatian: Pregledajte ima li kakvih vidljivih čestica ili anomalija.
English: After injection it delivers this gene into the cells of the retina, the layer at the back of the eye that detects light.
Croatian: Nakon injekcije dostavlja ovaj gen u stanice mrežnice, sloj u pozadini oka koji detektira svjetlost.
English: As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu voretigen neparvoveka tijekom trudnoće.
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.
Croatian: Značajne razlike u izvođenju binokularnog MLMT-a bile su uočene za terapijsku skupinu liječenu voretigen neparvovekom 30. dana i održale su se tijekom preostalih kontrolnih posjeta u trogodišnjem razdoblju, u usporedbi s izostankom promjene u kontrolnoj skupini.
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.
Croatian: Prije početka imunomodulacijskog režima i prije primjene Luxturne, kod bolesnika se mora provjeriti ima li simptoma aktivne infektivne bolesti bilo koje vrste, a u slučaju takve infekcije početak liječenja mora se odgoditi dok se bolesnik ne oporavi.
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.
Croatian: Ukupno je 41 ispitanik sudjelovao u kliničkom programu (81 oko u koje je primijenjena injekcija [jedan ispitanik u fazi 1 nije ispunio kriterije prihvatljivosti za primjenu injekcije u drugo oko]).
English: • A patient card o Highlights the importance of follow-up visits and reporting side effects to the patient's physician.
Croatian: • Karticu za bolesnika o Naglašava važnost posjeta zbog praćenja i prijavljivanja nuspojava bolesnikovom liječniku.
English: • Problems associated with the placement of a breathing tube in the windpipe
Croatian: • Tegobe povezane s postavljanjem cijevi za disanje u dušnik
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.
Croatian: Preporučuje se da bolesnici/njegovatelji nose rukavice kod mijenjanja zavoja i odlaganja otpada, osobito u slučaju trudnoće, dojenja ili imunodeficijencije kod njegovatelja.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni voretigen neparvoveka u trudnica ograničeni (manje od 300 trudnoća).
English: • After injection, any unused product must be discarded.
Croatian: • Nakon injekcije, neiskorišteni lijek mora se odbaciti.
English: • Patient Information Leaflet (PIL), which should also be available in alternative formats (including large print and as audio file);
Croatian: • Uputu o lijeku koja također treba biti dostupna u alternativnim formatima (uključujući ispis velikim slovima i audio datoteku);
English: 1.7 mL extractable volume
Croatian: 1,7 ml raspoloživog volumena
English: Figure 2 Change in MLMT score using binocular vision versus time before / after exposure to voretigene neparvovec
Croatian: Slika 2 Promjena u rezultatu za MLMT uz korištenje binokularnog vida u odnosu na vrijeme prije / nakon izloženosti voretigen neparvoveku
English: Following a single vector administration, dogs developed antibodies to the AAV2 vector capsid which were absent in naïve non-human primates.
Croatian: Nakon jednokratne primjene vektora u pasa, razvila su se protutijela na kapsidu AAV2 vektora koja nisu bila prisutna u ne-ljudskih primata koji nisu bili izloženi.
English: Each eye was administered a single subretinal injection of 1.5 x 10
Croatian: U svako oko bila je primijenjena jednokratna subretinalna injekcija od 1,5 x 10
English: In 13/29 (45%) subjects receiving bilateral administrations, Luxturna vector DNA sequences were detected in tear samples; most of these subjects were negative after the day 1 post-injection visit, however, four of these subjects had positive tear samples beyond the first day, one subject up to day 14 post-second eye injection.
Croatian: U 13/29 (45%) ispitanika kojima je lijek primijenjen u oba oka, sekvence vektorske DNK Luxturne bile su otkrivene u uzorcima suza; većina tih ispitanika bila je negativna nakon posjeta 1. dana nakon injekcije, međutim, četvero od tih ispitanika imalo je pozitivne uzorke suza i nakon prvog dana, jedan ispitanik do 14. dana nakon injekcije u drugo oko.
English: Please talk to your doctor before beginning to engage in strenuous physical activity after receiving Luxturna.
Croatian: Razgovarajte sa svojim liječnikom prije nego se upustite u napornu fizičku aktivnost nakon primanja Luxturne.
English: A cataract is clouding of the natural lens inside the eye that can make it harder to see clearly.
Croatian: Mrena je zamućenje prirodne leće u oku koje može otežati jasan vid.
English: Each mL of concentrate contains 5 x 10
Croatian: Jedan ml koncentrata sadrži 5 x 10
English: One of 41 (2%) subjects reported a serious event of retinal detachment that was assessed as related to the administration procedure.
Croatian: Jedan od 41 (2%) ispitanika prijavio je ozbiljan događaj ablacije mrežnice za koji je bilo procijenjeno da je povezan s postupkom primjene.
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'.
Croatian: Važne informacije o nekim sastojcima Luxturne Luxturna sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: In one animal administered with Luxturna at 7.5 x 10
Croatian: U jedne životinje kojoj je primijenjena Luxturna u dozi od 7,5 x 10
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.
Croatian: Potvrđene bialelne RPE65 mutacije i prisutnost dostatnog broja vijabilnih stanica mrežnice (područje mrežnice unutar stražnjeg pola debljine od > 100 mikrona, procijenjeno optičkom koherentnom tomografijom [OCT]) bile su utvrđene za sve sudionike.
English: Phase 3 study
Croatian: Ispitivanje faze 3
English: The product is slowly injected through the tubing and microcannula to eliminate any air bubbles in the system.
Croatian: Lijek se polako injicira kroz cjevčicu i mikrokanilu kako bi se uklonili mogući mjehurići zraka u sustavu.
English: Any anomalies or appearance of visual particulates should be reported to the Marketing Authorisation Holder and product should not be used.
Croatian: Svaku anomaliju ili pojavu vidljivih čestica treba prijaviti nositelju odobrenja, a lijek se u tom slučaju ne smije koristiti.
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).
Croatian: Preporučeno mjesto primjene injekcije treba biti smješteno uz gornju vaskularnu arkadu, najmanje 2 mm distalno od središta fovee (Slika 1B).
English: Luxturna should be inspected visually prior to administration.
Croatian: Luxturnu treba vizualno pregledati prije primjene.
English: This ability depends on the subject's visual acuity, visual field and the extent of nyctalopia (decreased ability to perceive and/or see in dim light), each of which are functions specifically affected by the retinal disease associated with RPE65 mutations.
Croatian: Ta sposobnost ovisi o ispitanikovoj vidnoj oštrini, vidnom polju i razmjeru niktalopije (smanjene sposobnosti percipiranja i/ili gledanja pri prigušenom svjetlu), što su sve funkcije na koje specifično utječe bolest mrežnice povezana s RPE65 mutacijama.
English: Patients should not drive or use heavy machines until visual function has recovered sufficiently, as advised by their ophthalmologist.
Croatian: Bolesnici ne smiju upravljati vozilima ili raditi s teškim strojevima dok se vidna funkcija dostatno ne oporavi, prema savjetu oftalmologa.
English: • Diluted Luxturna should be inspected visually prior to administration.
Croatian: • Razrijeđenu Luxturnu potrebno je vizualno pregledati prije primjene.
English: No adjustment in dosage is necessary for paediatric patients.
Croatian: Nije potrebna prilagodba doze za pedijatrijske bolesnike.
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.
Croatian: • Ako dođe do slučajnog izlaganja tijekom rada (npr. putem prskanja u oči ili na sluznice), ispirite čistom vodom najmanje 5 minuta.
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.
Croatian: Bile su tri nuspojave retinalnih depozita u tri od 41 (7%) ispitanika koje nisu bile ozbiljne a smatralo se da su povezane s voretigen neparvovekom.
English: Follow the steps below to administer Luxturna to patients:
Croatian: Slijedite korake u nastavku za primjenu Luxturne bolesnicima:
English: The control group was administered voretigene neparvovec after 1 year of observation.
Croatian: U kontrolnoj skupini primijenjen je voretigen neparvovek nakon 1 godine promatranja.