natgillin/translations-raw huggingface dataset:
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.
Če za vas velja karkoli od zgoraj navedenega ali če o tem niste prepričani, se pogovorite z zdravnikom, preden prejmete zdravilo Luxturna.
Luxturna will be stored by the healthcare professionals at your healthcare facility.
Za shranjevanje zdravila Luxturna poskrbijo zdravstveni delavci v zdravstveni ustanovi.
Warnings and precautions Before receiving treatment with Luxturna:
Opozorila in previdnostni ukrepi Pred prejemom zdravila Luxturna:
Improvement in full-field light sensitivity was maintained for up to 3 years after exposure to voretigene neparvovec.
Izboljšana občutljivost celotnega vidnega polja na svetlobo se je ohranila do 3 leta po izpostavljenosti voretigen neparvoveku.
VIAL LABEL (CONCENTRATE)
NALEPKA NA VIALI (KONCENTRAT)
Adequate anaesthesia should be given to the patient prior to the procedure.
Pred izvedbo postopka je treba bolniku dati ustrezno anestezijo.
• Increase in intraocular pressure.
• zvišanje intraokularnega tlaka.
During treatment with this medicine, the doctor inserts an air bubble in the eye, which is slowly absorbed by your body.
V okviru zdravljenja s tem zdravilom vam zdravnik v oko vbrizga zračni mehurček, ki ga telo nato počasi absorbira.
Results of full-field light sensitivity testing at the first study year: white light [Log10(cd.s/m2)] are shown in Table 5 below.
Rezultati pri testiranju občutljivosti celotnega vidnega polja na belo svetlobo [log10 (cd.s/m 2)] v prvem študijskem letu so prikazani v preglednici 5 spodaj.
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.
Dolgoročno varnost in učinkovitost zdravila Luxturna so ocenjevali v študiji faze 1 za oceno varnosti s stopnjevanjem odmerka (študiji 101), v kateri je 12 preiskovancev enostransko (v eno oko) prejelo subretinalne injekcije voretigen neparvoveka, v nadaljevalni študiji (študiji 102), v kateri so 11 od 12 preiskovancev, ki so sodelovali v študiji s stopnjevanjem odmerka, aplicirali voretigen neparvovek v kontralateralno oko, v enoletni odprti kontrolirani študiji faze 3 (študiji 301), v kateri so v dveh študijskih centrih randomizirali 31 preiskovancev, in v nadaljevanju študije faze 3, v katerem je 9 kontrolnih preiskovancev prešlo v drugo študijsko skupino in prejemalo intervencijsko zdravljenje.
• Breakdown of the surgical wound
• razprtje kirurške rane
Transient and low-level vector shedding may occur in patient tears (see section 5.2).
Vektor prehodno in v majhnih količinah lahko prehaja v bolnikove solze (glejte poglavje 5.2).
It is not known whether it passes into breast milk.
Ni znano, ali zdravilo lahko prehaja v materino mleko.
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).
Za zmanjševanje možnosti za imunogenost morajo bolniki pred in po subretinalnem injiciranju voretigen neparvoveka v vsako oko prejeti sistemske kortikosteroide (glejte poglavje 4.2).
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
Zdravila Luxturna ne boste prejeli: če ste alergični na voretigen neparvovek ali katero koli sestavino tega zdravila (navedeno v poglavju 6), če imate očesno okužbo, če imate vnetje v očesu.
• You should avoid strenuous physical activity because of an increased risk of injury to the eye.
• se morate izogibati napornim telesnim dejavnostim zaradi povečanega tveganja za poškodbo očesa.
Active intraocular inflammation.
Aktivno intraokularno vnetje.
For single administration by subretinal injection into one (1) eye.
Za enkratno odmerjanje s subretinalno injekcijo v eno (1) oko.
Change in MLMT score
Sprememba ocene pri testu MLMT
vector genomes (vg).
vektorskih genomov (vg).
If it does occur, your doctor will treat the symptoms as necessary.
Če bi do tega kljub vsemu prišlo, vas bi zdravnik ustrezno zdravil glede na simptome, ki bi jih imeli.
No adjustment in dosage is necessary for paediatric patients.
Prilagajanje odmerjanja pri pediatričnih bolnikih ni potrebno.
Store at ≤-65 ºC.
Shranjujte pri temperaturi ≤ -65 ºC.
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).
Pred prihodom zdravila LUXTURNA na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, kar vključuje izbiro medijev za komuniciranje in načine distribucije vsebin ter vse druge vidike programa.
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
Kaj je zdravilo Luxturna in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Luxturna Kako prejmete zdravilo Luxturna Možni neželeni učinki
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.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z voretigen neparvovekom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The vector shedding and biodistribution were evaluated in tears from both eyes, serum and whole blood of subjects in the Phase 3 clinical study.
Izločanje vektorja v solze in njegovo biološko porazdelitev so ocenjevali v solzah iz obeh očes, serumu in polni krvi preiskovancev v klinični študiji faze 3.
Over time, accumulation of toxic precursors leads to the death of retinal pigment epithelial cells, and subsequently to progressive photoreceptor cell death.
Kopičenje toksičnih predstopenj sčasoma povzroči smrt celic pigmentnega epitelija mrežnice in nato progresivno smrt fotoreceptorskih celic.
What you need to know before you are given Luxturna
Kaj morate vedeti, preden boste prejeli zdravilo Luxturna
Unopened frozen vials
Zaprte zamrznjene viale
This leaflet is available as an audio file and in a large print from the web site: http://www.voretigeneneparvovec.support
To navodilo za uporabo je na voljo v obliki avdio datoteke, v povečanem formatu pa ga je mogoče tudi natisniti s spletne strani: http://www.voretigeneneparvovec.support
Proper aseptic techniques should always be used for the preparation and administration of Luxturna.
Pri pripravljanju in apliciranju zdravila Luxturna je treba vedno uporabljati ustrezne aseptične tehnike.
The development or worsening of cataracts is a known complication of the eye surgery that will be required before you receive Luxturna.
Razvoj ali poslabšanje katarakte je znan zaplet pri očesnem posegu, ki ga je treba izvesti, preden prejmete zdravilo Luxturna.
Nonclinical biodistribution
Neklinična biološka porazdelitev
Patients should be instructed to contact their healthcare professional if visual disturbances persist.
Bolnikom je treba naročiti, naj obvestijo zdravstvenega delavca, če motnje vida ne izzvenijo.
Table 5 Full-field light sensitivity testing
Preglednica 5 Testiranje občutljivosti celotnega vidnega polja na svetlobo
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).
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).
A rapid increase in altitude while the air bubble is still present can cause a rise in eye pressure and irreversible vision loss.
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.
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.
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.
These mutations prevent the body from producing a protein needed for vision and so lead to loss of sight and eventual blindness.
Zaradi teh mutacij v telesu ne nastaja protein, ki je potreben za vidno zaznavanje, zato pride do poslabšanja vida in sčasoma do slepote.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women.
Podatkov o uporabi voretigen neparvoveka pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
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.
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.
• You may have temporary visual disturbances, such as light sensitivity, and blurred vision.
• lahko pride do prehodnih motenj vida, kot sta pretirana občutljivost za svetlobo in zamegljen vid.
Y1, Y2, Y3: one, two and three years after start of study;
L1, L2, L3: eno leto, dve leti oziroma tri leta po začetku študije;
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.
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.
Patients should not drive or use heavy machines until visual function has recovered sufficiently, as advised by their ophthalmologist.
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.
Luxturna will be given to you in an operating room by surgeons experienced in performing eye surgery.
Zdravilo Luxturna vam bodo v operacijski sobi dali kirurgi, ki imajo izkušnje z izvajanjem operacij na očeh.
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.
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.
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.
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.
Follow these precautions for 14 days after the treatment.
Ta previdnostni ukrep morate upoštevati 14 dni po zdravljenju.
1.7 mL extractable volume
1,7 ml ekstraktabilnega volumna
Each eye was administered a single subretinal injection of 1.5 x 10
V vsako oko so aplicirali eno samo subretinalno injekcijo z 1,5 x 10
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.
Po pričakovanjih poteka privzem voretigen neparvoveka v celice s pomočjo heparin sulfat proteoglikanskih receptorjev, razgradnja pa s procesi katabolizma endogenih proteinov in DNA.
All subjects had a diagnosis of Leber's congenital amaurosis owing to RPE65 mutations confirmed by genetic analysis in a certified laboratory.
Vsi preiskovanci so imeli diagnozo Leberjeve kongenitalne amavroze zaradi mutacij gena RPE65, potrjenih z genetsko analizo v certificiranem laboratoriju.
• You will not be able to donate blood, organs, tissues and cells for transplantation after you have been treated with Luxturna.
• ne boste smeli darovati krvi, organov, tkiv ali celic za presaditev, ker je zdravilo Luxturna zdravilo za gensko zdravljenje.
As a precaution, you should not receive Luxturna while you are pregnant.
Iz previdnostih razlogov zdravila Luxturna ne smete prejeti v času nosečnosti.
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).
Tri dni pred apliciranjem zdravila Luxturna v prvo oko je priporočeno začeti z imunomodulatornim režimom zdravljenja po spodaj navedenem razporedu (preglednica 1).
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'.
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'.
This enables the retina to produce the proteins needed for vision.
Injiciranje zdravila omogoči mrežnici, da izdeluje proteine, ki so potrebni za vidno zaznavanje.
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.
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.
As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi voretigen neparvoveka bolje izogibati.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
• 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.
• 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.
The administration of voretigene neparvovec should be carried out in the surgical suite under controlled aseptic conditions.
Apliciranje voretigen neparvoveka je treba izvajati v operacijski sobi v nadzorovanih aseptičnih pogojih.
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.
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.
Other medicines and Luxturna Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The diluted solution should be clear to slightly opalescent.
Razredčena raztopina mora biti bistra do rahlo opalescentna.
• Patient Information Leaflet (PIL), which should also be available in alternative formats (including large print and as audio file);
• Navodilo za uporabo (PIL), ki naj bo pripravljeno tudi v drugačnih oblikah (med drugim v povečanem formatu in v obliki avdio datoteke);
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).
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).
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.
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.
• Some people develop cataracts.
• se pri nekaterih osebah razvije katarakta (siva mrena).
Luxturna is given under anaesthesia.
Zdravilo Luxturna vam bodo dali v anesteziji.
Biodistribution of Luxturna was evaluated at three months following subretinal administration in non-human primates.
Biološko porazdelitev zdravila Luxturna so ovrednotili tri mesece po subretinalni aplikaciji zdravila nečloveškim primatom.
• 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.
• 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.
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.
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.
It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity (see section 4.4).
Zdravila se ne sme aplicirati v neposredno bližino centralne fovee, da fovee ne bi kakorkoli poškodovali (glejte poglavje 4.4).
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.
Pripravo zdravila Luxturna je treba izvesti v roku 4 ur pred začetkom postopka apliciranja, in sicer v aseptičnih pogojih po naslednjem priporočenem postopku.
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.
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.
The individual administration procedure to each eye should be performed on separate days within a close interval, but no fewer than 6 days apart.
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.
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.
Mutacije gena RPE65 povzročijo zmanjšanje ali odsotnost aktivnosti encima RPE65 vse-trans-retinil izomeraze, kar zavre potek vidnega cikla in povzroči izgubo vida.
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.
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.
For instructions for preparation, accidental exposure to and disposal of Luxturna, see section 6.6.
Za navodila za pripravljanje zdravila, ravnanje v primeru nenamerne izpostavljenosti zdravilu in za odstranjevanje zdravila Luxturna glejte poglavje 6.6.
• Problems associated with the placement of a breathing tube in the windpipe
• težave pri vstavljanju dihalne cevke v sapnik
Vector DNA sequences were not detected in gonads.
V spolnih žlezah sekvenc vektorske DNA niso našli.
In one animal administered with Luxturna at 7.5 x 10
Pri eni živali, ki so ji aplicirali zdravilo Luxturna v odmerku 7,5 x 10
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).
Priporočeno mesto injiciranja je treba izbrati vzdolž zgornjega žilnega loka, najmanj 2 mm distalno od središča fovee (slika 1B).
Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3.
Po odmrznitvi sta tako koncentrat kot vehikel bistri in brezbarvni tekočini z vrednostjo pH 7,3.
There is no information on the effect of Luxturna on male or female fertility.
Na voljo ni nobenih podatkov o vplivu zdravila Luxturna na plodnost pri moških in ženskah.
Luxturna will be given to you only if genetic testing shows that your vision loss is caused by mutations in the RPE65 gene.
Zdravilo Luxturna boste prejeli samo v primeru, da bo z genetskim testiranjem dokazano, da je izguba vida pri vas povzročeno z mutacijami gena RPE65.
It is unknown whether voretigene neparvovec is excreted in human milk.
Ni znano, ali se voretigen neparvovek izloča v materino mleko.
Repeat the same procedure to prepare a backup syringe.
Za pripravo rezervne brizge ponovite isti postopek.