FrancophonIA/ELRC3.0 huggingface dataset:
English: It remains unclear if this haemorrhage is related to the injection procedure itself or administration of ocriplasmin.
Croatian: Nije jasno je li to krvarenje bilo povezano sa samim postupkom davanja injekcije ili s primjenom okriplazmina.
English: Tell your doctor/ophthalmologist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika/oftalmologa ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Do not use this needle for the intravitreal injection.
Croatian: Nemojte koristiti ovu iglu za intravitrealnu injekciju.
English: The intravitreal injection of JETREA may have a moderate influence on the ability to drive and use machines due to possible temporary visual disturbances (see section 4.8).
Croatian: Intravitrealna injekcija JETREE može imati umjereni utjecaj na sposobnost upravljanja vozilima i rada sa strojevima zbog privremenog poremećaja vida (vidjeti dio 4.8).
English: The recommended dose is 0.125 mg.
Croatian: Preporučena doza je 0,125 mg.
English: During the studies, vitrectomy could be performed at the discretion of the Investigator.
Croatian: Tijekom ispitivanja vitrektomija se mogla obavljati prema odluci istraživača.
English: Disinfect the top of the vial with an alcohol wipe.
Croatian: Dezinficirajte vrh bočice alkoholnim tupferom.
English: Any persistence or progression of macular hole should be treated according to usual practice.
Croatian: Perzistentnu ili progresivnu makularnu rupu treba liječiti sukladno uobičajenoj praksi.
English: Repeated administration in the same eye is not recommended (see section 4.4).
Croatian: Opetovana primjena u isto oko se ne preporučuje (vidjeti dio 4.4).
English: The diluted solution should be used immediately.
Croatian: Razrijeđena se otopina mora uporabiti odmah.
English: Out of the 4 JETREA patients with acute visual acuity decrease, 3 recovered following vitrectomy.
Croatian: Od 4 bolesnika s akutnim smanjenjem vidne oštrine, koji su primali JETREU, 3 su se oporavila nakon vitrektomije.
English: No carcinogenicity, mutagenicity or reproductive and developmental toxicity data are available.
Croatian: Nema dostupnih podataka o kancerogenosti, mutagenosti, reprodukcijskoj toksičnosti ni razvojnoj toksičnosti.
English: The clinical efficacy and safety of JETREA for the treatment of vitreomacular traction (VMT) was assessed in 3 double-masked studies.
Croatian: Klinička djelotvornost i sigurnost JETREE u liječenju vitreomakularne trakcije (VMT) procijenjena je u 3 dvostruko maskirana ispitivanja.
English: Do not refreeze a vial once it has been thawed.
Croatian: Bočicu ne ponovno zamrzavati nakon što je jednom odmrznuta.
English: At the end of this period the product must be used or discarded.
Croatian: Nakon isteka ovog perioda lijek se mora iskoristiti ili baciti.
English: Beyond the central area, abnormal aspects of the IS/OS band attributed to JETREA have been observed in up to 10% of patients.
Croatian: Izvan središnjeg područja, abnormali aspekti IS/OS sloja koji su pripisani primjeni JETREE zabilježeni su u do 10 % bolesnika.
English: The concentrate is clear and colourless.
Croatian: Koncentrat je bistar i bezbojan.
English: Each vial should only be used once and for the treatment of a single eye.
Croatian: Svaka se bočica smije koristiti samo jedanput i za liječenje jednog oka.
English: No reproductive toxicology studies have been performed.
Croatian: Ispitivanja reprodukcijske toksičnosti nisu provedena.
English: This effect appeared to be dose-related and was observed in all animals administered intravitreal ocriplasmin more than once.
Croatian: Čini se da je taj učinak bio ovisan o dozi, a zamijećen je u svih životinja koje su okriplazmin primile više od jedanput.
English: There is no experience of using Jetrea in pregnant women or during breast-feeding.
Croatian: Nema iskustva s primjenom Jetree trudnicama ili tijekom dojenja.
English: What Jetrea is and what it is used for What you need to know before you are given Jetrea How Jetrea is given
Croatian: Što je Jetrea i za što se koristi Što morate znati prije nego primite Jetreu
English: Your doctor/ophthalmologist will decide if treatment with Jetrea is right for you.
Croatian: Liječnik/oftalmolog će odlučiti je li liječenje Jetreom prikladno za Vas.
English: There is limited experience in patients with non-proliferative diabetic retinopathy or history of uveitis (including active severe inflammation) or significant eye trauma.
Croatian: Postoji ograničeno iskustvo u bolesnika s neproliferativnom dijabetičkom retinopatijom ili s uveitisom u anamnezi (uključujući aktivnu jaku upalu) ili sa značajnom traumom oka.
English: The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA 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) and not known (cannot be estimated from the available data).
Croatian: Nuspojave s osnovanom mogućnošću da su uzrokovane postupkom injiciranja ili JETREOM su navedene prema MedDRA klasifikaciji organskih sustava, a prema učestalosti su razvrstane na sljedeći način: vrlo česte (≥ 1/10), česte (≥ 1/100 i < 1/10), manje česte (≥ 1/1000 i < 1/100), rijetke (≥ 1/10 000 i < 1/1000), vrlo rijetke (< 1/10 000) i nepoznato (procjena iz dostupnih podataka nije moguća).
English: There are no clinical data on concomitant use of ocriplasmin with VEGF-inhibitors (vascular endothelial growth factor) and therefore it is not recommended.
Croatian: Nema kliničkih podataka o istovremenoj primjeni okriplazmina s inhibitorima VEGF-a (vaskularni endotelni faktor rasta) i stoga se ne preporučuje.
English: Disinfect the top of the vial with an alcohol wipe (Figure 2).
Croatian: Dezinficirajte vrh bočice alkoholnim tupferom (Slika 2).
English: However, chemical and physical in-use stability of unopened product in the original carton protected from light has been demonstrated for up to 8 hours when stored below 25 °C.
Croatian: Međutim, dokazana kemijska i fizikalna stabilnost neotvorenog lijeka u originalnoj kutiji, zaštićenog od svjetlosti, iznosi do 8 sati kada se čuva na temperaturi ispod 25°C.
English: In a paediatric study evaluating JETREA as an adjunct to vitrectomy, one case of subluxation was reported in a premature infant who received a single intravitreal injection of JETREA 0.175 mg.
Croatian: U pedijatrijskoj studiji koja je evaluirala JETREU kao dopunu vitrektomiji jedan je slučaj subluksacije prijavljen u prijevremeno rođenog djeteta koje je primilo jednokratnu intravitrealnu injekciju JETREE 0,175 mg.
English: Your doctor/ophthalmologist may ask you to use antibiotic eye drops before and after the injection in order to prevent any possible eye infection.
Croatian: Vaš liječnik/oftalmolog može od Vas tražiti da koristite antibiotske kapi za oko prije i poslije injekcije kako bi se spriječila moguća infekcija oka.
English: The tight binding of the protein components within the macular area of the VRI contribute to vitreomacular traction (VMT), leading to visual impairment and/or macular holes.
Croatian: Čvrsto vezanje proteinskih komponenata vitreoretinalnih sveza unutar makularnog područja doprinosi vitreomakularnoj trakciji (VMT) što dovodi do poremećaja vida i/ili pojave makularnih rupa.
English: Based on the proteolytic activity of ocriplasmin, preclinical and clinical findings, the potential for lens subluxation or phacodonesis cannot be ruled out.
Croatian: Na temelju proteolitičke aktivnosti okriplazmina, pretkliničkih i kliničkih nalaza mogućnost subluksacije leće ili fakodoneze ne može se isključiti.
English: Your doctor/ophthalmologist will monitor you in case you develop an infection or any complications after the injection.
Croatian: Liječnik/oftalmolog će Vas motriti u slučaju da razvijete infekciju ili bilo koju komplikaciju nakon injekcije.
English: The median time to resolution was 22 days.
Croatian: Medijan vremena do povlačenja simptoma bio je 22 dana.
English: On the day of the injection, your doctor/ophthalmologist will use antimicrobial eye drops and clean your eye and eyelid carefully to prevent infection.
Croatian: Na dan injekcije liječnik/oftalmolog će Vam ukapati antimikrobne kapi za oči te oko i vjeđu pažljivo očistiti da spriječi infekciju.
English: Patients should be instructed to report symptoms suggestive of intraocular inflammation/infection or any other visual or ocular symptoms without delay.
Croatian: Bolesnike treba uputiti da bez odlaganja prijave simptome koji upućuju na intraokularnu upalu/infekciju, kao i bilo koji drugi vidni ili očni simptom.
English: After Jetrea treatment you may experience some decrease in vision for a limited amount of time.
Croatian: Nakon primjene Jetree može Vam oslabiti vid na ograničeno vrijeme.
English: The medicinal product should be diluted and used immediately.
Croatian: Lijek se mora razrijediti i primijeniti odmah.
English: From a microbiological point of view, the medicinal product must be used immediately after opening/dilution.
Croatian: S mikrobiološkog stajališta, lijek se mora primijeniti odmah nakon otvaranja/razrjeđivanja.
English: Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present, which may decrease the symptoms caused by VMT.
Croatian: Jetrea djeluje tako da odvaja staklovinu od makule i pomaže u zatvaranju makularne rupe ako je ona prisutna čime se mogu ublažiti simptomi prouzročeni VMT-om.
English: Monitoring for increases in IOP may consist of a check for perfusion of the optic nerve head immediately after the injection and tonometry within 30 minutes following the injection.
Croatian: Praćenje zbog mogućeg povišenja IOT-a može se sastojati od provjere perfuzije vidnog živca neposredno nakon injekcije i tonometrije unutar 30 minuta nakon injekcije.
English: - A severe decrease in vision has been reported in up to 1 in 10 patients within one week after Jetrea treatment.
Croatian: - Jako oslabljen vid prijavljivan je u do 1 na 10 bolesnika unutar tjedan dana nakon primjene
English: The safety and efficacy of ocriplasmin in paediatric subjects scheduled for vitrectomy was investigated in study TG-MV-009.
Croatian: Sigurnost i djelotvornost okriplazmina kod pedijatrijskih bolesnika predviđenih za vitrektomiju bila je ispitivana u TG-MV-009 ispitivanju.
English: Administration in close temporal association with other medicinal products in the same eye may affect the activity of both medicinal products and is therefore not recommended.
Croatian: Njegova primjena kratko vrijeme prije ili nakon primjene drugog lijeka u isto oko može utjecati na aktivnost obaju lijekova te se stoga ne preporučuje.
English: • What are the steps following treatment with Jetrea
Croatian: • Koji su koraci nakon postupka liječenja Jetreom
English: The following table summarises the adverse reactions reported in the treated eye in clinical studies and/or from post-marketing experience.
Croatian: U sljedećoj tablici zbirno su prikazane nuspojave u liječenom oku zabilježene u kliničkim ispitivanjima i/ili nakon stavljanja lijeka u promet.
English: From a microbiological point of view, the medicinal product must be used immediately after opening.
Croatian: S mikrobiološkog stajališta, lijek se mora primijeniti odmah nakon otvaranja.
English: A difference was maintained through the end of the studies (Month 6).
Croatian: Razlika se zadržala do kraja ispitivanja (6. mjesec).
English: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgium
Croatian: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgija
English: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven BELGIUM
Croatian: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven BELGIJA
English: Your doctor/ophthalmologist will also give you a local anaesthetic to prevent any pain from the injection.
Croatian: Liječnik/oftalmolog će Vam dati i lokalni anestetik da spriječi bol pri davanju injekcije.
English: One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) has been reported.
Croatian: Prijavljen je jedan slučaj slučajnog predoziranja dozom od 0,250 mg okriplazmina (dvaput više od preporučene doze).
English: The use of Jetrea is therefore not recommended in this patient group.
Croatian: Stoga se primjena Jetree ne preporučuje za ovu dobnu skupinu bolesnika.
English: Patients should be monitored appropriately (see section 4.8).
Croatian: Bolesnike treba prikladno motriti (vidjeti dio 4.8).
English: - The active substance is ocriplasmin.
Croatian: - Djelatna tvar je okriplazmin.
English: The safety and efficacy of JETREA administered to both eyes concurrently has not been studied.
Croatian: Sigurnost i djelotvornost primjene JETREE u oba oka istodobno nije ispitana.
English: The efficacy of JETREA was demonstrated in 2 pivotal multicentre, randomised, double-masked, placebo-controlled, 6-month studies in patients with VMT.
Croatian: Djelotvornost JETREE dokazana je u dva pivotalna multicentrična, randomizirana, dvostruko maskirana, placebom kontrolirana, 6-mjesečna ispitivanja u bolesnika s VMT-om.
English: Lens subluxation/phacodonesis
Croatian: Subluksacija leće/fakodoneza
English: Concentrate for solution for injection (sterile concentrate).
Croatian: Koncentrat za otopinu za injekciju (sterilni koncentrat).
English: The potential for lens subluxation or phacodonesis cannot be ruled out.
Croatian: Mogućnost subluksacije leće ili fakodoneze ne može se isključiti.
English: Days Post-Injection
Croatian: Dani nakon injekcije
English: A single intravitreal injection of 0.175 mg (above the recommended dose), or placebo, was injected in the mid-vitreous of 24 eyes of children aged 0 to 16 years, 30 to 60 minutes prior to the planned start of vitrectomy.
Croatian: Jednokratna intravitrealna injekcija od 0,175 mg (iznad preporučene doze), ili placebo, je injicirana u sredinu staklovine u 24 oka djece u dobi od 0 do 16 godina, 30 do 60 minuta prije planiranog početka vitrektomije.
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus aiming towards the centre of the vitreous cavity avoiding the horizontal meridian.
Croatian: Injekcijsku iglu treba uvesti 3,5-4,0 mm iza limbusa, usmjerivši ju prema središtu vitrealne šupljine i izbjegavajući horizontalni meridijan.
English: In study TG-MV-014, a sub-set of 40 patients receiving JETREA systematically underwent ERG testing; the ERG changes which had developed in 16 out of 40 patients resolved in the majority of patients (13 out of 16).
Croatian: U ispitivanju TG-MV-014, podskupina od 40 bolesnika koji su primali JETREU, sistematično je bila podvrgnuta ERG testu; promjene ERG-a koje su se razvile kod 16 od 40 bolesnika povukle su se kod većine bolesnika (13 od 16).
English: The new in-use expiry date should be calculated and noted on the carton before it is placed in the refrigerator.
Croatian: Novi rok valjanosti lijeka nakon odmrzavanja treba se izračunati i zapisati na kutiji prije stavljanja u hladnjak.
English: Visual symptoms perceived in the contralateral eye or bilaterally have also been reported.
Croatian: Prijavljeni su i simptomi koji zahvaćaju vid, primjećeni u kontralateralnom oku ili bilateralno.
English: Visual acuity reduced
Croatian: Smanjena vidna oštrina
English: Information on resolution of specific events such as chromatopsia and ERG changes can be found in the relevant paragraph of the ‘description of selected adverse reactions' section.
Croatian: Informacije o povlačenju posebnih događaja poput kromatopsije i promjena ERG-a mogu se pronaći u poglavlju „opis odabranih nuspojava“.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, other than sterile, preservative-free, non-buffered diluent sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim sa sterilnom, bez konzervansa, nepuferiranom 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekcije.
English: The difference for improvement in the general vision sub-scale score was statistically significant (6.1 JETREA vs. 2.1 placebo, p=0.024).
Croatian: Razlika u poboljšanju rezultata dobivenog podljestvicom za ocjenu općeg vida bila je statistički značajna. (6,1 JETREA nasuprot 2,1 placebo, p=0,024).
English: JETREA should be used during pregnancy only if the clinical benefit outweighs the potential risks.
Croatian: JETREA se smije davati u trudnoći samo ako se ocijeni da klinička korist nadmašuje moguće rizike.
English: A total of 652 patients (JETREA 464, placebo 188) were randomised in these 2 studies.
Croatian: Ukupno 652 bolesnika (JETREA 464, placebo 188) su randomizirana u ta 2 ispitivanja.
English: Inform your doctor/ophthalmologist if you have had an injection of a medicine into the eye recently.
Croatian: Obavijestite liječnika/oftalmologa ako ste nedavno dobili injekciju u oko.
English: Information about storage
Croatian: Informacije o čuvanju
English: Repeated administration in the same eye is not recommended.
Croatian: Ponovljena primjena u isto oko se ne preporučuje.
English: Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.
Croatian: Neke nuspojave (poput bljeskova, lebdećih mrlja u vidnom polju) mogu se u nekim slučajevima opaziti na drugom oku.
English: In monkeys, after administration of 125 µg/eye (68 µg/mL vitreous) the ERG was fully recovered by Day 55.
Croatian: U majmuna se, nakon primjene 125 µg po oku (68 µg/ml staklovine) ERG posve normalizirao do 55. dana.
English: Only a clear, colourless solution without visible particles should be used.
Croatian: Smije se primijeniti samo bistra, bezbojna otopina bez vidljivih čestica.
English: Very common Retinogram abnormal*, colour vision test abnormal†
Croatian: Abnormalni retinogram*, abnormalni nalaz testa kolornog vida†
English: VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula.
Croatian: VMT uzrokuje trakcija koja je posljedica stalne pripijenosti staklovine (materijal u stražnjem dijelu oka, nalik na želatinu) uz makulu.
English: The majority of these reactions were non-serious, mild to moderate in intensity and resolved within 2 to 3 weeks.
Croatian: Nuspojave većinom nisu bile ozbiljne, po svojoj naravi bile su blage do umjerene i prolazile su unutar 2 do 3 tjedna.
English: Intravitreal injections have been associated with intraocular inflammation/infection, intraocular haemorrhage and increased intraocular pressure (IOP).
Croatian: Intravitrealne su injekcije povezane s intraokularnom upalom/infekcijom, intraokularnim krvarenjem i povišenim intraokularnim tlakom IOT).
English: Pack containing 1 vial.
Croatian: Pakiranje sadržava 1 bočicu.
English: Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, while no inflammation or ERG changes were observed in minipigs.
Croatian: Okriplazmin je izazvao upalni odgovor i prolazne promjene ERG-a u kunića i majmuna, no u patuljastih svinja nisu zamijećene ni upala ni promjene ERG-a.
English: At Month 24, 51.4% of JETREA patients had a ≥ 5 points improvement in VFQ-25 composite score compared to 30.1% in the sham group.
Croatian: U 24. mjesecu, 51,4% bolesnika u JETREA skupini imalo je poboljšanje ≥ 5 bodova u VFQ-25 kompozitnom rezultatu u odnosu na 30,1% u placebo skupini.
English: The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including patient history, clinical examination and investigation using currently accepted diagnostic tools, such as optical coherence tomography (OCT).
Croatian: Dijagnoza vitreokmakularne trakcije (VMT) se mora sastojati od kompletne kliničke slike, uključujući bolesnikovu anamnezu, klinički pregled i ispitivanje korištenjem trenutno prihvaćenih dijegnostičkih sredstava, kao što je optička koherentna tomografija (OCT).
English: Pathological changes related to intraocular haemorrhage were observed in rabbits and monkeys.
Croatian: Patološke promjene povezane s intraokularnim krvarenjem zamijećene su u kunića i majmuna.
English: The visual acuity decrease had resolved by the end of the studies for the majority of JETREA patients (80.6%) but there were some patients who had not recovered despite vitrectomy.
Croatian: Smanjenje vidne oštrine povuklo se do kraja ispitivanja kod većine bolesnika koji su primali JETREU (80,6%) , ali je bilo i nekih bolesnika koji se nisu oporavili unatoč vitrektomiji.
English: If you have any further questions on the use of this medicine, ask your doctor/ophthalmologist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku/oftalmologu.
English: The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA > 1500 microns (see section 5.1).
Croatian: Učinak okriplazmina (osobito u indukciji uklanjanja vitreomakularne adhezije ili uzrokovanju potpunog stražnjeg odvajanja staklovine smanjen je u osoba s epiretinalnom membranom (ERM) ili s VMA promjera > 1500 mikrona (vidjeti dio 5.1).
English: Information about storage and the time to use Jetrea once it has been thawed and diluted are described in the section intended for healthcare professionals only.
Croatian: Informacije o čuvanju i vremenu u kojem se Jetrea treba primijeniti nakon odmrzavanja i razrjeđivanja opisane su u poglavlju namijenjenom samo za zdravstvene radnike.
English: The systemic toxicity of ocriplasmin has been evaluated in both rat and dog.
Croatian: Sistemska toksičnost okriplazmina ispitana je u štakora i pasa.
English: What you need to know before you are given Jetrea 3.
Croatian: Što morate znati prije nego primite Jetreu
English: The systemic exposure of JETREA is expected to be very low after intravitreal injection.
Croatian: Očekuje se da je sistemska izloženost JETREI nakon intravitrealne injekcije vrlo niska.
English: The main reasons for vitrectomy were retinal detachment and retinopathy of prematurity.
Croatian: Osnovni razlozi za vitrektomiju bili su ablacija mrežnice i retinopatija nedonoščadi.
English: The patient also developed mild conjunctival hyperaemia, eye inflammation and miosis which resolved with corticosteroid eye drops.
Croatian: Bolesnik je razvio i blagu hiperemiju konjunktive, upalu oka i miozu koje su prošle nakon primjene kortikosteroidnih kapi za oči.
English: See section 4.4 for instructions on post-injection monitoring.
Croatian: Vidjeti dio 4.4 za upute o praćenju nakon davanja injekcije.
English: Talk to your doctor/ophthalmologist before you are given Jetrea.
Croatian: Posavjetujte se s liječnikom/oftalmologom prije nego što primite Jetreu.
English: Repeated administration of JETREA in the same eye has not been adequately studied and is therefore not recommended.
Croatian: Ponovna primjena JETREE u isto oko nije primjereno ispitana te se stoga ne preporučuje.
English: There is no relevant use of JETREA in children aged under 18 years for the indication of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Croatian: Nema relevantne primjene JETREE u u djece u dobi ispod 18 godina za indikaciju vitreomakularne trakcije (VMT), uključujući kada je povezana s makularnom rupom promjera manjeg ili jednakog 400 mikrona.
English: - Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.
Croatian: - Simptomi poput promjenjivog vida, dvoslike, glavobolje, krugova oko svjetla u vidnom polju, mučnine i povraćanja prijavljivani su u do 1 na 100 bolesnika i mogu biti znaci pomaka ili nestabilnosti leće u oku s njena normalnog položaja.