FrancophonIA/ELRC3.0 huggingface dataset:
English: Immunomodulatory regimen
Croatian: Imunomodulacijski režim
English: No dose adjustment is required in these patients (see section 5.2).
Croatian: Nije potrebna prilagodba doze u tih bolesnika (vidjeti dio 5.2).
English: Accidental exposure must be avoided.
Croatian: Mora se izbjegavati slučajno izlaganje.
English: It is important that you take this medicine according to the instructions given.
Croatian: Važno je da uzimate lijek prema uputama koje dobijete.
English: o Inform healthcare professionals that the patient has received gene therapy, and the importance of reporting adverse events.
Croatian: o Obavještava zdravstvene radnike da je bolesnik primio gensku terapiju i o važnosti prijavljivanja štetnih događaja.
English: As a precaution, you should not receive Luxturna while you are pregnant.
Croatian: Kao predostrožnost, ne smijete primiti Luxturnu tijekom trudnoće.
English: Your doctor may delay your treatment until your infection is gone because this medicine may make it more difficult for you to fight an infection.
Croatian: Liječnik bi mogao odgoditi Vaše liječenje dok se infekcija ne povuče zato što bi ovaj lijek mogao otežati borbu protiv infekcije.
English: You will need to stay for post-operative observation for a few hours after each procedure to monitor your recovery and watch for any side effects from the surgery or the anaesthesia.
Croatian: Morat ćete ostati radi postoperativnog promatranja nekoliko sati nakon svakog zahvata kako bi se pratio Vaš oporavak i nuspojave operacije ili anestezije.
English: Repeat the same procedure to prepare a backup syringe.
Croatian: Ponovite isti postupak za pripremu rezervne štrcaljke.
English: • Tell your doctor if you have an active infection of any sort.
Croatian: • Obavijestite liječnika ako imate bilo kakvu aktivnu infekciju.
English: Each box represents the middle 50% of distribution of MLMT score change.
Croatian: Svaki pravokutnik predstavlja srednjih 50% distribucije promjene rezultata za MLMT.
English: Children and adolescents Luxturna has not been studied in children under four years of age.
Croatian: Djeca i adolescenti Luxturna nije bila ispitivana u djece ispod četiri godine starosti.
English: Do not drive or use heavy machines until your vision has recovered.
Croatian: Nemojte upravljati vozilima ili teškim strojevima dok Vam se vid ne oporavi.
English: What you need to know before you are given Luxturna
Croatian: Što morate znati prije nego dobijete Luxturnu
English: Nonclinical biodistribution
Croatian: Neklinička biodistribucija
English: This enables the retina to produce the proteins needed for vision.
Croatian: To omogućuje mrežnici da proizvede proteine koji su potrebni za vid.
English: If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before being treated with Luxturna.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili medicinskoj sestri za savjet prije liječenja Luxturnom.
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Luxturna.
Croatian: Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni oko nečega od navedenog, obratite se svom liječniku prije nego primite Luxturnu.
English: Tell your doctor or nurse if you have any visual problems.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako imate bilo kakve probleme s vidom.
English: Information on how to obtain the special formats will be provided in the patient card.
Croatian: Informacija kako doći do posebnih formata bit će navedena u kartici za bolesnika.
English: This leaflet is available as an audio file and in a large print from the web site: http://www.voretigeneneparvovec.support
Croatian: Ova je uputa dostupna kao audio datoteka i s većim slovima na internetskoj stranici: http://www.voretigeneneparvovec.support
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common ≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti prema sljedećoj konvenciji: vrlo često (≥1/10), često ≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Patients and their caregivers should be provided with the patient information pack, including:
Croatian: Bolesnike i njihove skrbnike je potrebno opskrbiti paketom informacija za bolesnika, koji uključuje:
English: The development or worsening of cataracts is a known complication of the eye surgery that will be required before you receive Luxturna.
Croatian: Razvoj ili pogoršanje mrena poznata je komplikacija operacije oka koja će biti potrebna prije nego primite Luxturnu.
English: This medicinal product must not be administered by intravitreal injection.
Croatian: Ovaj se lijek ne smije primjenjivati intravitrealnom injekcijom.
English: Temporary visual disturbances, such as blurred vision and photophobia, may occur during the weeks that follow the treatment.
Croatian: Privremene vidne smetnje, kao što su zamućeni vid i fotofobija, mogu nastupiti tijekom tjedana koji uslijede nakon liječenja.
English: You should follow these precautions for 14 days.
Croatian: Tih mjera opreza trebate se pridržavati 14 dana.
English: In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
Croatian: U ispitivanju faze 3, MLMT je koristio sedam razina osvjetljenja u rasponu od 400 luksa do 1 luksa (što odgovara, primjerice, rasponu od dobro osvijetljenog ureda do ljetne večeri bez mjesečine).
English: You will not be given Luxturna if you are allergic to voretigene neparvovec or any of the other ingredients of this medicine (listed in section 6) if you have an eye infection if you have eye inflammation
Croatian: Nećete dobiti Luxturnu ako ste alergični na voretigen neparvovek ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) ako imate infekciju oka ako imate upalu oka
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
Croatian: Što je Luxturna i za što se koristi Što morate znati prije nego dobijete Luxturnu Kako se Luxturna primjenjuje Moguće nuspojave
English: Ocular or periocular infection.
Croatian: Okularna ili periokularna infekcija.
English: During treatment with this medicine, the doctor inserts an air bubble in the eye, which is slowly absorbed by your body.
Croatian: Tijekom liječenja ovim lijekom, liječnik uvodi mjehurić zraka u oko, koji Vaše tijelo polako apsorbira.
English: Results of full-field light sensitivity testing at the first study year: white light [Log10(cd.s/m2)] are shown in Table 5 below.
Croatian: Rezultati testiranja fotoosjetljivosti u punom vidnom polju u prvoj godini ispitivanja: bijela svjetlost [Log10(cd.s/m2)] prikazani su u Tablici 5 u nastavku.
English: One subject in the control group withdrew consent and was discontinued from the study.
Croatian: Jedan je ispitanik u kontrolnoj skupini povukao pristanak i prekinuo sudjelovanje u ispitivanju.
English: Effects on male and female fertility have not been evaluated in animal studies.
Croatian: Učinci na mušku i žensku plodnost nisu bili procjenjivani u ispitivanjima na životinjama.
English: Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme.
Croatian: Ozbiljne nuspojave povezane s postupkom primjene bile su zabilježene u tri ispitanika tijekom kliničkog programa.
English: Tell your doctor about any visual disturbances that you experience.
Croatian: Obavijestite svoga liječnika o vidnim smetnjama koje primijetite.
English: D30, D90, D180: 30, 90 and 180 days after start of study;
Croatian: D30, D90, D180: 30, 90 i 180 dana nakon početka ispitivanja;
English: Follow these precautions for 14 days after the treatment.
Croatian: Slijedite ove mjere opreza tijekom 14 dana nakon liječenja.
English: There is no information on the effect of Luxturna on male or female fertility.
Croatian: Nema informacija o učinku Luxturne na mušku i žensku plodnost.
English: 30 June 2030
Croatian: 30. lipanj 2030.
English: The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Croatian: Kvalificiranom osoblju (tj. vitreoretinalnom kirurgu i ljekarniku) u centru za liječenje potrebno je osigurati edukacijske materijale koji uključuju:
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.
Croatian: Započinjanje imunomodulacijskog režima za drugo oko treba pratiti isti raspored i zamijeniti dovršetak imunomodulacijskog režima za prvo oko.
English: Patients treated with Luxturna should not donate blood, organs, tissues and cells for transplantation.
Croatian: Bolesnici liječeni Luxturnom ne smiju donirati krv, organe, tkiva i stanice za transplantaciju.
English: • You will not be able to donate blood, organs, tissues and cells for transplantation after you have been treated with Luxturna.
Croatian: • Nećete moći donirati krv, organe, tkiva i stanice za presađivanje nakon liječenja Luxturnom.
English: Luxturna will be stored by the healthcare professionals at your healthcare facility.
Croatian: Luxturnu će čuvati zdravstveni radnici u zdravstvenoj ustanovi.
English: Other medicines and Luxturna Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: These mutations prevent the body from producing a protein needed for vision and so lead to loss of sight and eventual blindness.
Croatian: Te mutacije sprječavaju tijelo da proizvodi protein koji je potreban za vid pa time dovode to gubitka vida i s vremenom do sljepoće.
English: Warnings and precautions Before receiving treatment with Luxturna:
Croatian: Upozorenja i mjere opreza Prije nego primite liječenje Luxternom:
English: The MLMT was designed to measure changes in functional vision, specifically the ability of a subject to navigate a course accurately and at a reasonable pace at different levels of environmental illumination.
Croatian: MLMT je bio osmišljen da izmjeri promjene u funkcionalnom vidu, posebno sposobnost ispitanika da se kreće određenim smjerom točno i razumnom brzinom pri različitim razinama osvjetljenja okoline.
English: These steps are critical in the biological conversion of a photon of light into an electrical signal within the retina.
Croatian: Ti su koraci ključni u biološkoj konverziji fotona svjetlosti u električni signal unutar mrežnice.
English: One subject discontinued from the study prior to treatment.
Croatian: Jedan je ispitanik prekinuo ispitivanje prije liječenja.
English: All participants had a clinical diagnosis of Leber congenital amaurosis, and some may have also had prior or additional clinical diagnoses, including retinitis pigmentosa.
Croatian: Svi sudionici imali su kliničku dijagnozu Leberove kongenitalne amauroze, a neki su moguće imali i prethodne ili dodatne kliničke dijagnoze, uključujući pigmentozni retinitis.
English: 3 days prior to Luxturna administration
Croatian: 3 dana prije primjene Luxturne
English: • Increase in intraocular pressure.
Croatian: • Povećanje intraokularnog tlaka.
English: Store at ≤-65 ºC.
Croatian: Čuvati na ≤ -65 ºC.
English: Precaution to be taken before manipulating or administering the medicinal product This medicinal product contains genetically modified organisms.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Ovaj lijek sadrži genetski modificirane organizme.
English: No clinical data on the effect of the medicinal product on fertility are available.
Croatian: Nisu dostupni klinički podaci o učinku lijeka na plodnost.
English: Proper aseptic techniques should always be used for the preparation and administration of Luxturna.
Croatian: Potrebno je uvijek koristiti odgovarajuće aseptične tehnike za pripremu i primjenu Luxturne.
English: • You should avoid air travel or other travel to high elevations until advised by your doctor.
Croatian: • Trebate izbjegavati putovanje avionom ili druge oblike putovanja na velikim visinama dok Vam liječnik ne kaže drukčije.
English: The back-up syringe may not be retained.
Croatian: Rezervna štrcaljka ne smije se zadržati.
English: This is because Luxturna is a gene therapy product.
Croatian: Razlog tome je što je Luxturna proizvod za gensku terapiju.
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.
Croatian: Pozitivan rezultat za promjenu odražava prolaženje MLMT-a pri nižim razinama svjetlosti, a rezultat od 6 odražava najveće moguće poboljšanje MLMT-a.
English: Difference (95% CI) Intervention-Control p-value using binocular vision using assigned first eye only using assigned second eye only
Croatian: Razlika (95% CI) intervencijska-kontrolna p-vrijednost koristeći binokularni vid koristeći samo prvo oko koristeći samo drugo oko
English: Before Luxturna treatment is started, your doctor may prescribe a medicine that will suppress your immune system (the body's natural defences) so that it will not try to fight the Luxturna when it is given.
Croatian: Prije nego se započne liječenje Luxturnom, liječnik Vam može propisati lijek koji će potisnuti imunološki sustav (prirodnu obranu tijela) kako se ne bi pokušalo boriti protiv Luxturne nakon što je primijenjena.
English: A rapid increase in altitude while the air bubble is still present can cause a rise in eye pressure and irreversible vision loss.
Croatian: Naglo povećanje nadmorske visine dok je mjehurić zraka još uvijek prisutan može uzrokovati povećanje očnog tlaka i nepovratan gubitak vida.
English: Change in MLMT score
Croatian: Promjena u rezultatu za MLMT
English: Presence of a clinical pharmacy capable of handling and preparing AAV vector-based gene therapy products;
Croatian: Postojanje kliničke ljekarne koja je sposobna za rukovanje i pripremu genske terapije na bazi AAV vektora;
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.
Croatian: Postoji dodatan rizik od mrene ako je leća u oku oštećena iglom koja se koristi za injiciranje lijeka u pozadinu oka.
English: Prior to launch of LUXTURNA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Croatian: Prije stavljanja u promet LUXTURNE u svakoj državi članici nositelj odobrenja mora se usuglasiti s nadležnim nacionalnim tijelom oko sadržaja i formata edukativnog programa, uključujući komunikacijske medije, načine distribucije i bilo koje druge aspekte programa.
English: • You may have temporary visual disturbances, such as light sensitivity, and blurred vision.
Croatian: • Možete imati privremene vidne smetnje, kao što su osjetljivost na svjetlost i zamagljeni vid.
English: Vector DNA sequences were not detected in gonads.
Croatian: Sekvence vektorske DNK nisu bile otkrivene u spolnim žlijezdama.
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.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja voretigen neparvovekom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: • Get immediate care from your doctor if your eye or eyes become red, painful, sensitive to light, you see flashes or floaters in your vision, or if you notice any worsening or blurred vision.
Croatian: • Zatražite odmah pomoć svog liječnika ako Vam oko ili oči postanu crvene, bolne, osjetljive na svjetlost, ako vidite bljeskove ili zamućenje u vidu, ili ako primijetite bilo kakvo pogoršanje ili zamagljeni vid.
English: Talk to your doctor before resuming these activities.
Croatian: Razgovarajte s liječnikom prije nego nastavite s ovim aktivnostima.
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).
Croatian: Da bi se smanjio potencijal za imunogenost, bolesnici trebaju primati sistemske kortikosteroide prije i nakon subretinalne injekcije voretigen neparvoveka u svako oko (vidjeti dio 4.2).
English: There is reduced vision in the days after surgery that usually improves; tell your doctor if vision does not return.
Croatian: U danima nakon zahvata vid je smanjen, ali obično se popravi; obavijestite svog liječnika ako
English: The MAH shall ensure that in each Member State (MS) where LUXTURNA is marketed, the product is distributed through treatment centres where qualified staff (i.e. vitreoretinal surgeons and pharmacists) have participated in the mandatory educational program about use of the product and pharmacy training, in order to ensure LUXTURNA correct use so as to minimise the risks associated with its administration and/or the administration procedure (increased intraocular pressure, retinal tear, macular disorders, cataract, intraocular inflammation and/or infection related to the procedure and retinal detachment, third party transmission).
Croatian: Nositelj odobrenja će osigurati da se u svakoj državi članici u kojoj se LUXTURNA nalazi na tržištu lijek distribuira kroz centre za liječenje gdje je kvalificirano osoblje (tj. vitreoretinalni kirurzi i ljekarnici) sudjelovalo u obaveznom edukacijskom programu o upotrebi lijeka i farmaceutskoj obuci kako bi se osiguralo da se LUXTURNA ispravno koristi te kako bi se minimizirali rizici povezani s njenom primjenom i/ili postupkom primjene (povišeni intraokularni tlak, ruptura mrežnice, poremećaji makule, katarakta, intraokularna upala i/ili infekcija povezana s postupkom i ablacija mrežnice, prijenos na treće osobe).
English: • Some people develop cataracts.
Croatian: • U nekih se ljudi razviju mrene.
English: The individual administration procedure to each eye is performed on separate days within a close interval, but no fewer than 6 days apart.
Croatian: Pojedinačni postupak primjene u svako oko provodi se u zasebne dane u kratkom intervalu, ali u razmaku od najmanje 6 dana.
English: • Increased pressure in the eye
Croatian: • Povišeni tlak u oku
English: The following side effects may happen with the injection procedure:
Croatian: Sljedeće se nuspojave mogu pojaviti uz postupak primjene injekcije:
English: However, no adjustment in dosage is necessary for elderly patients.
Croatian: Međutim, nije potrebna prilagodba doze za starije bolesnike.
English: The monocular MLMT change score significantly improved in the treatment group and was similar to the binocular MLMT results (see Table 4).
Croatian: Rezultat za promjenu u monokularnom MLMT-u značajno se poboljšao u terapijskoj skupini i bio je sličan rezultatima za binokularni MLMT (vidjeti Tablicu 4).
English: The testing of each subject was videotaped and assessed by independent graders.
Croatian: Testiranje svakog ispitanika snimano je video kamerom, a snimke su ocjenjivali neovisni ocjenjivači.
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity (see section 4.4).
Croatian: Ne smije se primijeniti u neposrednoj blizini fovee kako bi se očuvala cjelovitost fovee (vidjeti dio 4.4).
English: Label the 10 mL glass vial containing the diluted concentrate as follows: ‘Diluted Luxturna'.
Croatian: Označite staklenu bočicu od 10 ml koja sadrži razrijeđeni koncentrat sa: ‘Razrijeđena Luxturna'.
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.
Croatian: Nakon razrjeđivanja u aseptičnim uvjetima, otopina se mora odmah upotrijebiti; ako se ne upotrijebi odmah, vrijeme čuvanja na sobnoj temperaturi (ispod 25 °C) ne smije biti dulje od 4 sata.
English: Table 1 Pre- and post-operative immunomodulatory regimen for each eye
Croatian: Tablica 1 Imunomodulacijski režim prije i poslije operacije za svako oko
English: The product is administered as a subretinal injection after vitrectomy in each eye.
Croatian: Lijek se primjenjuje kao subretinalna injekcija nakon vitrektomije u svako oko.
English: For single administration by subretinal injection into one (1) eye.
Croatian: Za jednokratnu primjenu subretinalnom injekcijom u jedno (1) oko.
English: Biodistribution of Luxturna was evaluated at three months following subretinal administration in non-human primates.
Croatian: Biodistribucija Luxturne ocijenjena je tri mjeseca nakon subretinalne primjene u ne-ljudskih primata.
English: Ask your doctor whether you should stop breast-feeding after receiving Luxturna.
Croatian: Pitajte svog liječnika trebate li prekinuti dojenje nakon što ste primili Luxturnu.
English: At one year after exposure to voretigene neparvovec, improvement in visual acuity of at least 0.3 LogMAR occurred in 11/20 (55%) of the first-treated eyes and 4/20 (20%) of the second-treated eyes in the intervention group; no one in the control group displayed such an improvement of visual acuity in either the first or second eye.
Croatian: Godinu dana nakon izloženosti voretigen neparvoveku, do poboljšanja vidne oštrine od najmanje 0,3 LogMAR došlo je u 11/20 (55%) očiju koja su prva liječena te u 4/20 (20%) očiju koja su druga liječena u intervencijskoj skupini; nitko u kontrolnoj skupini nije imao takva poboljšanja vidne oštrine ni u prvom ni u drugom oku.
English: Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3.
Croatian: Nakon odmrzavanja iz zamrznutog stanja, i koncentrat i otapalo su bistre, bezbojne tekućine koje imaju pH 7,3.
English: Voretigene neparvovec is derived from naturally occurring AAV using recombinant DNA techniques.
Croatian: Voretigen neparvovek dobiva se iz prirodnog AAV-a koristeći tehnike rekombinantne DNK.
English: Table 4 Changes in MLMT score: year 1, compared to baseline (ITT population: n=21 intervention, n=10 control)
Croatian: Tablica 4 Promjene u rezultatu za MLMT: 1. godina, u usporedbi s početnim vrijednostima (ITT populacija: n=21 intervencijska skupina, n=10 kontrolna skupina)
English: All three of these events were a transient appearance of asymptomatic subretinal precipitates inferior to the retinal injection site, 1-6 days after injection and resolved without sequelae.
Croatian: Sva tri događaja bila su prolazna pojava asimptomatskih subretinalnih precipitata ispod mjesta primjene retinalne injekcije, 1-6 dana nakon injekcije, i povukli su se bez posljedica.
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.
Croatian: Priprema Luxturne mora se obaviti u roku od 4 sata od početka postupka primjene, u skladu sa sljedećim preporučenim postupkom koji se provodi u aseptičnim uvjetima.
English: The horizontal bar within each box represents the median.
Croatian: Vodoravna crta unutar svakog pravokutnika predstavlja medijan.