FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vsaki državi članici, v kateri bodo tržili zdravilo LUXTURNA, distribucija zdravila potekala v terapevtskih centrih, v katerih deluje kvalificirano osebje (kar pomeni vitroretinalni kirurgi in farmacevti), ki je opravilo obvezen izobraževalni program o uporabi zdravila in farmacevtsko usposabljanje za zagotavljanje pravilne uporabe zdravila LUXTURNA in zmanjševanje tveganj, ki so povezana z apliciranjem zdravila in/ali s samim postopkom apliciranja (za zvišanje intraokularnega tlaka, raztrganine mrežnice, okvare makule, katarakte, intraokularnega vnetja in/ali okužbe zaradi postopka apliciranja ter odstopa mrežnice in prenosa na druge osebe).
English: A rapid increase in altitude while the air bubble is still present can cause a rise in eye pressure and irreversible vision loss.
Slovenian: Hiter dvig na višjo nadmorsko višino v času, ko je zračni mehurček še prisoten v očesu, lahko povzroči zvišanje intraokularnega tlaka in trajno izgubo vida.
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.
Slovenian: Po posegu na vsakem očesu boste še nekaj ur ostali na opazovanju, da bodo lahko spremljali vaše okrevanje in vas opazovali glede morebitnih neželenih učinkov, do katerih bi lahko prišlo zaradi posega ali anestezije.
English: These mutations prevent the body from producing a protein needed for vision and so lead to loss of sight and eventual blindness.
Slovenian: Zaradi teh mutacij v telesu ne nastaja protein, ki je potreben za vidno zaznavanje, zato pride do poslabšanja vida in sčasoma do slepote.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women.
Slovenian: Podatkov o uporabi voretigen neparvoveka pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
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.
Slovenian: Dokler mehurček ni povsem absorbiran, bi potovanje z letalom ali v kraje z visoko nadmorsko višino lahko povzročilo, da bi se mehurček v očesu povečal in povzročil poškodbo očesa, vključno z izgubo vida.
English: • You may have temporary visual disturbances, such as light sensitivity, and blurred vision.
Slovenian: • lahko pride do prehodnih motenj vida, kot sta pretirana občutljivost za svetlobo in zamegljen vid.
English: Y1, Y2, Y3: one, two and three years after start of study;
Slovenian: L1, L2, L3: eno leto, dve leti oziroma tri leta po začetku študije;
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.
Slovenian: Histološki pregled oči psov in nečloveških primatov, ki so jih izpostavili voretigen neparvoveku, je pokazal le manjše spremembe, ki so bile večinoma povezane s celjenjem poškodbe po kirurškem posegu.
English: Patients should not drive or use heavy machines until visual function has recovered sufficiently, as advised by their ophthalmologist.
Slovenian: Bolniki ne smejo voziti in upravljati težkih strojev, dokler se jim vidna funkcija ne povrne v zadostni meri in jim tega ne dovoli njihov oftalmolog.
English: Luxturna will be given to you in an operating room by surgeons experienced in performing eye surgery.
Slovenian: Zdravilo Luxturna vam bodo v operacijski sobi dali kirurgi, ki imajo izkušnje z izvajanjem operacij na očeh.
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.
Slovenian: V serumu so našli segmente vektorske DNA pri 3 (10 %) od 29 preiskovancev, kar vključuje dva s pozitivnim vzorcem solza, in sicer samo do 3. dne po vsaki od injekcij.
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.
Slovenian: Skupno so prehodne in nizke koncentracije vektorske DNA v vzorcih solza in v nekaj primerih v vzorcih seruma našli pri 14 (48 %) od 29 preiskovancev v študiji faze 3.
English: Follow these precautions for 14 days after the treatment.
Slovenian: Ta previdnostni ukrep morate upoštevati 14 dni po zdravljenju.
English: 1.7 mL extractable volume
Slovenian: 1,7 ml ekstraktabilnega volumna
English: Each eye was administered a single subretinal injection of 1.5 x 10
Slovenian: V vsako oko so aplicirali eno samo subretinalno injekcijo z 1,5 x 10
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.
Slovenian: Po pričakovanjih poteka privzem voretigen neparvoveka v celice s pomočjo heparin sulfat proteoglikanskih receptorjev, razgradnja pa s procesi katabolizma endogenih proteinov in DNA.
English: All subjects had a diagnosis of Leber's congenital amaurosis owing to RPE65 mutations confirmed by genetic analysis in a certified laboratory.
Slovenian: Vsi preiskovanci so imeli diagnozo Leberjeve kongenitalne amavroze zaradi mutacij gena RPE65, potrjenih z genetsko analizo v certificiranem laboratoriju.
English: • You will not be able to donate blood, organs, tissues and cells for transplantation after you have been treated with Luxturna.
Slovenian: • ne boste smeli darovati krvi, organov, tkiv ali celic za presaditev, ker je zdravilo Luxturna zdravilo za gensko zdravljenje.
English: As a precaution, you should not receive Luxturna while you are pregnant.
Slovenian: Iz previdnostih razlogov zdravila Luxturna ne smete prejeti v času nosečnosti.
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).
Slovenian: Tri dni pred apliciranjem zdravila Luxturna v prvo oko je priporočeno začeti z imunomodulatornim režimom zdravljenja po spodaj navedenem razporedu (preglednica 1).
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'.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Luxturna Zdravilo Luxturna vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: This enables the retina to produce the proteins needed for vision.
Slovenian: Injiciranje zdravila omogoči mrežnici, da izdeluje proteine, ki so potrebni za vidno zaznavanje.
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.
Slovenian: Pri vseh treh navedenih dogodkih je šlo za prehodno pojavljanje asimptomatskih subretinalnih precipitatov pod mestom injiciranja na mrežnici, pojavili so se 1-6 dni po injiciranju in izzveneli brez posledic.
English: As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi voretigen neparvoveka bolje izogibati.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
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.
Slovenian: • povejte zdravniku, če imate znake očesne okužbe ali vnetja v očesu, na primer če je vaše oko pordelo, pretirano občutljivo za svetlobo ali otečeno ali če imate bolečine v očesu.
English: The administration of voretigene neparvovec should be carried out in the surgical suite under controlled aseptic conditions.
Slovenian: Apliciranje voretigen neparvoveka je treba izvajati v operacijski sobi v nadzorovanih aseptičnih pogojih.
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.
Slovenian: Testiranje MLMT je namenjeno merjenju sprememb vidne funkcije, zlasti sposobnosti osebe, da ob različnih stopnjah osvetlitve v prostoru z razumno hitrostjo poišče pravo pot mimo ovir.
English: Other medicines and Luxturna Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The diluted solution should be clear to slightly opalescent.
Slovenian: Razredčena raztopina mora biti bistra do rahlo opalescentna.
English: • Patient Information Leaflet (PIL), which should also be available in alternative formats (including large print and as audio file);
Slovenian: • Navodilo za uporabo (PIL), ki naj bo pripravljeno tudi v drugačnih oblikah (med drugim v povečanem formatu in v obliki avdio datoteke);
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).
Slovenian: AAV2-hRPE65v2-LTFU-01: Za dodatno opredelitev dolgoročne učinkovitosti in varnosti uporabe zdravila Luxturna pri odraslih in pediatričnih bolnikih z izgubo vida zaradi dedne mrežnične distrofije, ki je posledica potrjene bialelne mutacije gena RPE65, mora predlagatelj predložiti rezultate dolgoročnega spremljanja učinkovitosti in varnosti pri bolnikih, ki so prejeli zdravilo Luxturna v okviru kliničnega programa (15-letno spremljanje).
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.
Slovenian: Poleg tega so ocenjevali še tri sekundarne cilje opazovanja: test praga občutljivosti celotnega vidnega polja (full-field light sensitivity threshold, FST) na belo svetlobo, spremembo ocene pri testu MLMT za prvo zdravljeno oko pri posamezniku, in določanje vidne ostrine.
English: • Some people develop cataracts.
Slovenian: • se pri nekaterih osebah razvije katarakta (siva mrena).
English: Luxturna is given under anaesthesia.
Slovenian: Zdravilo Luxturna vam bodo dali v anesteziji.
English: Biodistribution of Luxturna was evaluated at three months following subretinal administration in non-human primates.
Slovenian: Biološko porazdelitev zdravila Luxturna so ovrednotili tri mesece po subretinalni aplikaciji zdravila nečloveškim primatom.
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.
Slovenian: • se takoj obrnite po zdravniško pomoč, če vaše oko ali obe očesi postaneta pordeli, boleči, pretirano občutljivi za svetlobo, če zaznavate bliske ali motnjave v vidnem polju ali opažate kakršno koli poslabšanje vida ali zamegljen vid.
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.
Slovenian: SPKRPE-EUPASS: neintervencijska študija PASS: Za nadaljnjo opredelitev varnosti zdravila Luxturna, vključno z dolgoročno varnostjo, mora predlagatelj izvesti študijo in predložiti rezultate na osnovi podatkov iz registra bolezni pri bolnikih z izgubo vida zaradi dedne mrežnične distrofije, ki je posledica potrjene bialelne mutacije gena RPE65.
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity (see section 4.4).
Slovenian: Zdravila se ne sme aplicirati v neposredno bližino centralne fovee, da fovee ne bi kakorkoli poškodovali (glejte poglavje 4.4).
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.
Slovenian: Pripravo zdravila Luxturna je treba izvesti v roku 4 ur pred začetkom postopka apliciranja, in sicer v aseptičnih pogojih po naslednjem priporočenem postopku.
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.
Slovenian: Pri osebah z mrežnično distrofijo zaradi bialelne mutacije gena RPE65 pride do izgube vida, vključno s poslabšanjem parametrov vidne funkcije, kot sta vidna ostrina in vidno polje, pogosto že v otroštvu ali v mladosti in to slabšanje vida v končni fazi napreduje do popolne slepote.
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.
Slovenian: Postopek apliciranja v vsako od obeh očes je treba izvesti v dveh različnih dneh (ne na isti dan) s kratkim časovnim intervalom, ki pa ne sme biti krajši od 6 dni.
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.
Slovenian: Mutacije gena RPE65 povzročijo zmanjšanje ali odsotnost aktivnosti encima RPE65 vse-trans-retinil izomeraze, kar zavre potek vidnega cikla in povzroči izgubo vida.
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.
Slovenian: Slika 2 prikazuje učinek zdravila v obdobju treh let v skupini preiskovancev, zdravljenih z voretigen neparvovekom, in učinek v kontrolni skupini preiskovancev po prehodu na prejem subretinalne injekcije voretigen neparvoveka.
English: For instructions for preparation, accidental exposure to and disposal of Luxturna, see section 6.6.
Slovenian: Za navodila za pripravljanje zdravila, ravnanje v primeru nenamerne izpostavljenosti zdravilu in za odstranjevanje zdravila Luxturna glejte poglavje 6.6.
English: • Problems associated with the placement of a breathing tube in the windpipe
Slovenian: • težave pri vstavljanju dihalne cevke v sapnik
English: Vector DNA sequences were not detected in gonads.
Slovenian: V spolnih žlezah sekvenc vektorske DNA niso našli.
English: In one animal administered with Luxturna at 7.5 x 10
Slovenian: Pri eni živali, ki so ji aplicirali zdravilo Luxturna v odmerku 7,5 x 10
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).
Slovenian: Priporočeno mesto injiciranja je treba izbrati vzdolž zgornjega žilnega loka, najmanj 2 mm distalno od središča fovee (slika 1B).
English: Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3.
Slovenian: Po odmrznitvi sta tako koncentrat kot vehikel bistri in brezbarvni tekočini z vrednostjo pH 7,3.
English: There is no information on the effect of Luxturna on male or female fertility.
Slovenian: Na voljo ni nobenih podatkov o vplivu zdravila Luxturna na plodnost pri moških in ženskah.
English: Luxturna will be given to you only if genetic testing shows that your vision loss is caused by mutations in the RPE65 gene.
Slovenian: Zdravilo Luxturna boste prejeli samo v primeru, da bo z genetskim testiranjem dokazano, da je izguba vida pri vas povzročeno z mutacijami gena RPE65.
English: It is unknown whether voretigene neparvovec is excreted in human milk.
Slovenian: Ni znano, ali se voretigen neparvovek izloča v materino mleko.
English: Repeat the same procedure to prepare a backup syringe.
Slovenian: Za pripravo rezervne brizge ponovite isti postopek.
English: The primary endpoint of the Phase 3 study measured the mean change from baseline to one year in binocular multi-luminance mobility testing (MLMT) between the intervention and control groups.
Slovenian: V okviru primarnega cilja opazovanja v študiji faze 3 so po enem letu merili povprečno spremembo ocene pri binokularnem testiranju MLMT (multi-luminance mobility testing) od izhodišča in jo primerjali med intervencijsko in kontrolno skupino.
English: Label the 10 mL glass vial containing the diluted concentrate as follows: ‘Diluted Luxturna'.
Slovenian: 10-mililitrsko stekleno vialo, ki vsebuje razredčen koncentrat, označite z naslednjo oznako: "Razredčeno zdravilo Luxturna".
English: Intraocular pressure should be monitored prior to and following administration of the medicinal product and managed appropriately.
Slovenian: Intraokularni tlak je treba spremljati pred apliciranjem zdravila in po njem ter ga ustrezno uravnati.
English: 1 vial concentrate 2 vials solvent
Slovenian: 1 viala s koncentratom 2 viali z vehiklom
English: Instructions for preparation, accidental exposure and disposal of Luxturna
Slovenian: Navodila za pripravljanje zdravila, ravnanje v primeru nenamerne izpostavljenosti zdravilu in odstranjevanje zdravila Luxturna
English: Each single-dose 2 mL vial of Luxturna contains 0.5 extractable mL of concentrate which requires a 1:10 dilution prior to administration, see section 6.6.
Slovenian: Ena 2-mililitrska viala za enkratno odmerjanje z zdravilom Luxturna vsebuje 0,5 ml ekstraktabilnega volumna koncentrata, ki ga je treba pred odmerjanjem razredčiti v razmerju 1:10, glejte poglavje 6.6.
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.
Slovenian: Če ni uporabljena takoj, čas shranjevanja raztopine pri sobni temperaturi (do 25 °C) ne sme biti daljši od 4 ur.
English: • Retinal disorder (foveal thinning, loss of foveal function), macular hole, maculopathy (epiretinal membrane, macular pucker) and eye disorder (foveal dehiscence).
Slovenian: • okvare mrežnice (tanjšanje mrežnice v predelu fovee, izguba fovealne funkcije), foramen makule, makulopatija (epiretinalna membrana, gubanje epiretinalne membrane v makuli ("macular pucker")) in okvare očesa (dehiscenca fovee).
English: Ask your doctor whether you should stop breast-feeding after receiving Luxturna.
Slovenian: Z zdravnikom se posvetujte, ali bi morali po prejemu zdravila Luxturna prekiniti z dojenjem.
English: After injection it delivers this gene into the cells of the retina, the layer at the back of the eye that detects light.
Slovenian: Po injiciranju omogoči vstop tega gena v celice mrežnice, to je plast, ki leži na zadajšnjem delu očesa in zaznava svetlobo.
English: At baseline, subjects achieved pass marks on the mobility test at between 4 and 400 ambient lux.
Slovenian: Ob izhodišču so preiskovanci zadovoljivo opravili test mobilnosti pri osvetlitvi v prostoru od 4 do 400 luksov.
English: The control group was administered voretigene neparvovec after 1 year of observation.
Slovenian: Preiskovanci v kontrolni skupini so prejeli voretigen neparvovek po 1 letu opazovanja.
English: - All materials that may have come in contact with Luxturna (e.g. vial, syringe, needle, cotton gauze, gloves, masks or dressings) must be disposed of in accordance with local biosafety guidelines.
Slovenian: - Ves material, ki je bil lahko v stiku z zdravilom Luxturna (kot so na primer 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: These handling precautions should be followed for 14 days after administration of voretigene neparvovec.
Slovenian: Te previdnostne ukrepe za rokovanje z odpadki je treba upoštevati 14 dni po tem, ko bolnik prejme voretigen neparvovek.
English: Table 3 Adverse reactions related to administration procedure
Slovenian: Preglednica 3 Neželeni učinki, povezani s postopkom apliciranja
English: 21 subjects were randomised to receive subretinal injection of voretigene neparvovec.
Slovenian: 21 preiskovancev je bilo randomiziranih na prejem subretinalne injekcije voretigen neparvoveka.
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.
Slovenian: Eno leto po izpostavljenosti voretigen neparvoveku je v intervencijski skupini prišlo do izboljšanja vidne ostrine za najmanj 0,3 logMAR pri 11 od 20 (55 %) prvih izbranih zdravljenih oči in pri 4 od 20 (20 %) drugih izbranih zdravljenih oči.
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.
Slovenian: - V primeru stika zdravila s poškodovano kožo ali pri poškodbi z vbodom igle prizadeti predel temeljito očistite z milom, vodo in/ali razkužilom.
English: One subject discontinued from the study prior to treatment.
Slovenian: En preiskovanec je prekinil sodelovanje v študiji, preden je prejel zdravilo.
English: • At the completion of the injection, the subretinal injection cannula is removed from the eye.
Slovenian: • Po zaključenem injiciranju je treba kanilo za subretinalno injiciranje odstraniti iz očesa.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Slovenian: Neuporabljeno zdravilo je treba zavreči v skladu z lokalno sprejetimi predpisi za zagotavljanje biološke varnosti.
English: o Patient card will be available in alternative formats including large print and as an audio file.
Slovenian: o Vsebina bolnikove kartice bo na voljo tudi v drugačnih oblikah, med drugim v povečanem formatu in v obliki avdio datoteke.
English: Voretigene neparvovec is derived from naturally occurring AAV using recombinant DNA techniques.
Slovenian: Voretigen neparvovek je pridobljen iz naravno nastalih adenoasociacijskih (AAC) virusov s tehnologijo rekombinantne DNA.
English: Inspect for any visual particulates.
Slovenian: Raztopino preglejte glede vsebnosti vidnih delcev.
English: Any anomalies or appearance of visual particulates should be reported to the Marketing Authorisation Holder and product should not be used.
Slovenian: Katero koli nepravilnost ali prisotnost vidnih delcev morate prijaviti imetniku dovoljenja za promet z zdravilom, zdravila pa v tem primeru ne smete uporabiti.
English: • Diluted Luxturna should be inspected visually prior to administration.
Slovenian: • Razredčeno zdravilo Luxturna je treba pred odmerjanjem vizualno pregledati.
English: Effects on male and female fertility have not been evaluated in animal studies.
Slovenian: V študijah na živalih vpliva zdravila na plodnost pri moških in ženskah niso ocenjevali.