FrancophonIA/ELRC3.0 huggingface dataset:
English: Vitreous haemorrhage was reported in a higher proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared with those not receiving anticoagulant therapy (6%).
Croatian: Krvarenja u staklovinu zabilježena su u većoj mjeri u bolesnika liječenih lijekom OZURDEX koji su primali antikoagulantnu terapiju (11%) u usporedbi s onima koji takvu terapiju nisu primali (6%).
English: • Key signs and symptoms of serious adverse events including: worsening of vision after the injection; pain or discomfort in or around the eye, redness of the eye which continues to get worse; increase in floaters or spots in the vision; discharge from the eye
Croatian: • Glavne znakove i simptome ozbiljnih štetnih događaja, uključujući: pogoršanje vida nakon injekcije; bol ili nelagodu u oku ili oko oka; crvenilo oka koje se i dalje pogoršava; povećan broj opaciteta ili točkica u vidnom polju; iscjedak iz oka.
English: The rise in IOP is normally manageable with IOP lowering medication (see section 4.8).
Croatian: Porast IOT-a obično se može kontrolirati lijekovima za snižavanje IOT (vidjeti dio 4.8).
English: Patients who experience and retain improved vision should not be retreated.
Croatian: Bolesnicima kod kojih se poboljšanje vida pojavi i zadrži, ne bi trebalo ponavljati tretman.
English: The reduction in vitreous haze was accompanied by an improvement in visual acuity.
Croatian: Smanjenje zamućenosti staklastog tijela popraćeno je poboljšanom oštrinom vida.
English: Sham N = 261 P-value
Croatian: Placebo N = 261 P-vrijednost
English: Remove the foil pouch from the carton and examine for damage (see section 6.6).
Croatian: Izvadite vrećicu iz kartonske kutije te provjerite postoje li oštećenja (vidjeti dio 6.6).
English: Mean IOP in the study eye at baseline was the same in both treatment groups (15.3 mmHg).
Croatian: Srednji IOT u ispitivanom oku na početku ispitivanja bio je jednak u obje ispitivane skupine (15,3 mmHg).
English: Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections.
Croatian: Uporaba kortikosteroida, uključujući OZURDEX, može inducirati nastanak katarakte (uključujući stražnju supkapsularnu kataraktu), povišeni IOT, steroidima inducirani glaukom i može prouzročiti sekundarne infekcije oka.
English: If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
Croatian: Ako dođe do predoziranja, potrebno je pratiti očni tlak te ga liječiti, ako prisutan liječnik smatra da je to potrebno.
English: Patients who experience deterioration in vision, which is not slowed by OZURDEX, should not be retreated.
Croatian: Bolesnicima kod kojih se javi pogoršanje vida koje nije usporeno lijekom OZURDEX, ne bi trebalo ponavljati tretman.
English: Implant migration to the anterior chamber may lead to corneal oedema.
Croatian: Migracija implantata u prednju očnu sobicu može dovesti do edema rožnice.
English: 4) Depress the actuator button slowly until you hear a click.
Croatian: 4) Polako pritišćite gumb za aktivaciju dok ne čujete „klik”.
English: Of the patients experiencing an increase of IOP of ≥10 mmHg from baseline, the greatest proportion showed this IOP increase between 45 and 60 days following an injection.
Croatian: Od bolesnika kod kojih se pojavio porast IOT od ≥10 mmHg u odnosu na početnu vrijednost, u većini slučajeva taj se porast pojavio između 45 i 60 dana nakon injiciranja.
English: Table 1 Adverse reactions System organ class
Croatian: Tablica 1 Nuspojave Klasifikacija organskih sustava
English: In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no reports of haemorrhagic adverse events in these patients.
Croatian: Kod RVO, antikoagulantna terapija korištena je u 2% bolesnika koji su primili OZURDEX; nije bilo prijava hemoragijskih štetnih događaja kod tih bolesnika.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS APPLICATOR LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA APLIKATORU
English: Dexamethasone remained detectable in the vitreous at 6 months post-injection.
Croatian: Deksametazon je i dalje bilo moguće pronaći u staklastom tijelu 6 mjeseci nakon ubrizgavanja.
English: The efficacy of OZURDEX was assessed in two 3 year, multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,048 patients (studies 206207-010 and 206207-011).
Croatian: Djelotvornost lijeka OZURDEX ocjenjivana je dvama trogodišnjim, multicentričnim, dvostruko maskiranim, randomiziranim, placebom kontroliranim paralelnim ispitivanjima identičnima po dizajnu, tijekom kojih je uspoređivano 1048 bolesnika (ispitivanja 206207-010 i 206207-011).
English: Remove the needle in the same direction as used to enter the vitreous.
Croatian: Izvucite iglu u istom smjeru koji je korišten za ulazak u staklasto tijelo.
English: Increased pressure in the eye, clouding of the lens (cataract), bleeding on the surface of the eye*
Croatian: Porast tlaka u oku, zamućenje leće (mrena), krvarenje na površini oka*
English: The safety and efficacy of OZURDEX in uveitis in the paediatric population have not been established.
Croatian: Sigurnost i djelotvornost lijeka OZURDEX u slučaju uveitisa u pedijatrijskoj populaciji nisu ustanovljene.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL NAME OF THE MEDICINAL PRODUCT
Croatian: PODACI ZA ZDRAVSTVENOG RADNIKA NAZIV LIJEKA
English: Patients treated with OZURDEX who have experienced an initial response and in the physician's opinion may benefit from retreatment without being exposed to significant risk should be considered for retreatment.
Croatian: DME U bolesnika liječenih lijekom OZURDEX koji su imali prvotni odgovor na primjenu, a po mišljenju liječnika mogli bi imati koristi od ponovne primjene bez da budu izloženi značajnom riziku, potrebno je razmotriti ponovnu primjenu.
English: • Inflammation of the back of the eye.
Croatian: • upalom stražnjeg dijela oka.
English: Dexamethasone is ultimately metabolised to lipid and water soluble metabolites that can be excreted in bile and urine.
Croatian: Deksametazon se u konačnici metabolizira u lipide i metabolite koji su topivi u vodi i koji mogu biti izlučeni putem žuči i mokraće.
English: All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or without a history of vitrectomy, are at risk of implant migration into the anterior chamber.
Croatian: Kod svih bolesnika s rupturom stražnje kapsule leće, poput onih sa stražnjom lećom (npr. zbog operacije katarakte) i/ili onih koji imaju otvor na šarenici koji dopire do očne jabučice (npr. zbog iridektomije) sa ili bez vitrektomije u anamnezi, postoji opasnost od migracije implantata u prednju očnu sobicu.
English: Diabetic macular oedema is a swelling of the light-sensitive layer at the back of the eye called the macula.
Croatian: Dijabetički makularni edem je zadebljanje na svjetlo osjetljivog sloja u stražnjem dijelu oka koji se naziva makula.
English: Once the foil pouch is opened the applicator should be used immediately.
Croatian: Kada otvorite vrećicu potrebno je odmah upotrijebiti aplikator.
English: Before the injection, the periocular skin, eyelid and ocular surface should be disinfected (using for example drops of povidone iodine 5% solution on the conjunctiva as it was done in the clinical trials for the approval of OZURDEX) and adequate local anaesthesia should be administered.
Croatian: Prije injiciranja treba dezinficirati kožu oko oka, vjeđu i površinu oka (korištenjem na primjer kapi 5% otopine povidon-joda u spojnicu (konjunktivu) kako je činjeno u kliničkim ispitivanjima za odobrenje lijeka OZURDEX) te primijeniti odgovarajuću lokalnu anesteziju.
English: Vascular Endothelial Growth Factor (VEGF) is a cytokine which is expressed at increased concentrations in the setting of macular oedema.
Croatian: Vascular Endothelial Growth Factor) je citokin koji je eksprimiran u povišenim koncentracijama u okolnostima makularnog edema.
English: For instructions on the administration of the intravitreal implant, see section 6.6
Croatian: Za upute za primjenu intravitrealnog implantata vidjeti dio 6.6.
English: OZURDEX was numerically superior to sham in preventing vision loss as shown by a lower of proportion of patients experiencing deterioration of vision of ≥ 15 letters in the OZURDEX group throughout the 6-month assessment period.
Croatian: OZURDEX je brojčano bio superioran placebo postupku u sprječavanju gubitka vida što se pokazuje manjim udjelom bolesnika kod kojih se javilo pogoršanje vida od ≥ 15 slova u skupini liječenoj lijekom OZURDEX tijekom razdoblja procjene od 6 mjeseci.
English: Push the tip about 1 mm into the sclera, keeping it parallel to the limbus.
Croatian: Gurnite vršak igle otprilike 1 mm u bjeloočnicu tako da ulazi paralelno u odnosu na limbus.
English: The most frequently reported adverse reactions across the entire study period in the study eye of patients who received OZURDEX were cataract and elevated IOP (see below).
Croatian: Najčešće prijavljene nuspojave na ispitivanom oku tijekom čitavog razdoblja ispitivanja u bolesnika koji su primili OZURDEX bile su katarakta i povišeni IOT (vidjeti u nastavku).
English: In the non-infectious uveitis study, 1 patient out of the 62 phakic patients underwent cataract surgery after a single injection.
Croatian: U kliničkim studijama neinfektivnog uveitisa, 1 bolesnik od 62 bolesnika s fakičnim lećama podvrgnut je operaciji katarakte nakon jednog ubrizgavanja.
English: However OZURDEX is not recommended during breast feeding unless clearly necessary.
Croatian: Međutim, OZURDEX se ne preporučuje tijekom dojenja osim u slučaju da je to izričito potrebno.
English: ** in a 24-month real world observational study in the treatment of macular oedema following RVO and noninfectious uveitis affecting the posterior segment of the eye these adverse events were reported more frequently among patients who received >2 injections vs patients who received ≤2 injections; cataract formation (24.7% vs 17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP (24.0% vs 16.6%).
Croatian: ** u 24-mjesečnom opservacijskom ispitivanju, u stvarnom životu, liječenja makularnog edema nakon RVO i neinfektivnog uveitisa stražnjeg segmenta oka, ove su nuspojave prijavljivane češće u bolesnika koji su primili >2 injekcije u usporedbi s bolesnicima koji su primili ≤2 injekcije; formiranje katarakte (24,7% naspram 17,7%), progresija katarakte (32,0% naspram 13,1%), vitrelno krvarenje (6,0% naspram 2,0%) i povišeni IOP (24,0% naspram 16,6%).
English: A limited number of subjects with Type 1 diabetes were investigated in the Phase 3 studies, and the response to OZURDEX in these subjects was not significantly different to those subjects with Type 2 diabetes.
Croatian: Ograničeni broj ispitanika s dijabetesom tipa 1 ispitivan je u ispitivanjima faze 3, a odgovor tih ispitanika na OZURDEX nije bio značajno različit od odgovora ispitanika s dijabetesom tipa 2.
English: In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humour, and sclera tissues for 18 hours, no metabolites were observed.
Croatian: U in vitro studiji metabolizma, nakon inkubacije [14C]-deksametazona u rožnici, šarenici-zrakastom tijelu, žilnici, mrežnici, staklastom tijelu i tkivu bjeloočnice ljudi, tijekom 18 sati nisu primijećeni metaboliti.
English: Day 180 a Proportion significantly higher with OZURDEX compared to sham (p < 0.001)
Croatian: Dan 180 a Udio značajno viši kod lijeka OZURDEX u usporedbi s placebo postupkom (p < 0,001)
English: With the exception of headache and migraine, no systemic adverse drug reactions were identified with the use of OZURDEX.
Croatian: Uz izuzetak glavobolje i migrene, kod primjene lijeka OZURDEX nisu identificirane sistemske nuspojave lijeka.
English: Date of first authorisation: 27/07/2010 Date of latest renewal: 23/03/2015
Croatian: Datum posljednje obnove odobrenja: 23. ožujka 2015.
English: • Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The maximum treatment effect was observed at day 60 and the difference in the incidence of responders was statistically significant favouring OZURDEX compared with sham at all time points to day 90 following injection.
Croatian: Maksimalni učinak liječenja primijećen je 60. dana te je razlika u incidenciji bolesnika s odgovorom bila statistički značajna u korist lijeka OZURDEX u usporedbi s placebo postupkom u svim terminima do 90. dana nakon ubrizgavanja.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit:risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: The most frequently reported adverse reactions in the study eye of patients who received OZURDEX were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%).
Croatian: Najčešće prijavljene nuspojave u ispitivanom oku kod bolesnika koji su primili OZURDEX bile su krvarenje iz konjunktive (30,3%), povišeni očni tlak (25,0%) i katarakta (11,8%).
English: Pooled Studies 206207-010 and
Croatian: Objedinjena ispitivanja 206207-010 i
English: A total of 36% of OZURDEX treated patients discontinued study participation for any reason during the study compared with 57% of sham patients.
Croatian: Ukupno 36% bolesnika koji su primili OZURDEX isključeno je iz ispitivanja zbog bilo kojeg razloga, u usporedbi s 57% bolesnika iz placebo skupine.
English: Other than those patients contraindicated (see section 4.3) where OZURDEX should not be used, OZURDEX should be used with caution and only following a careful risk benefit assessment.
Croatian: Kod svih bolesnika, osim onih kod kojih se OZURDEX ne smije koristiti jer je to kontraindicirano (vidjeti dio 4.3), OZURDEX treba koristiti s oprezom i to samo nakon pažljive procjene koristi i rizika.
English: With the bevel of the needle up away from the sclera, advance the needle about 1 mm into the sclera then redirect toward the centre of the eye into the vitreous cavity until the silicone sleeve is against the conjunctiva.
Croatian: S kosim rubom igle okrenutim prema gore, gurnite iglu otprilike 1 mm u bjeloočnicu te je onda preusmjerite prema središtu oka u vitrealnu šupljinu dok silikonski omotač ne dodirne konjunktivu.
English: Patients of less than 45 years of age with macular oedema following Retinal Vein Occlusion or inflammation of the posterior segment of the eye presenting as non-infectious uveitis are more likely to experience increases in IOP.
Croatian: Kod bolesnika mlađih od 45 godina s makularnim edemom nakon okluzije mrežnične vene (RVO) ili upalom stražnjeg očnog segmenta koji se javlja kao neinfektivni uveitis postoji veća vjerojatnost da će se pojaviti porast očnog tlaka.
English: One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator.
Croatian: Jedan sterilni implantat produženog učinka u obliku štapića, koji sadrži 700 mikrograma deksametazona, a nalazi se u igli (od nehrđajućeg čelika) jednokratnog aplikatora.
English: In each of the phase III studies and the pooled analysis, mean retinal thickness was significantly less, and the mean reduction from baseline was significantly greater, with OZURDEX (-207.9 microns) compared to sham (-95.0 microns) at day 90 (p < 0.001, pooled data).
Croatian: U svakoj studiji faze III i u analizi objedinjenih podataka, prosječna debljina mrežnice bila je značajno manja, a prosječno smanjenje u odnosu na početne vrijednosti bilo je značajno veće s lijekom OZURDEX (-207,9 mikrona) u usporedbi s placebo postupkom (-95,0 mikrona) na 90. dan (p < 0,001, objedinjeni podaci).
English: OZURDEX is a single-use intravitreal implant in applicator for intravitreal use only.
Croatian: OZURDEX je jednokratni intravitrealni implantat u aplikatoru samo za intravitrealnu uporabu.
English: The incidence of all observed cataract types (i.e. cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract lenticular, cataract) was 68% in OZURDEX treated patients with a phakic study eye across the 3 year studies.
Croatian: Incidencija svih oblika primijećenih katarakti tijekom 3 godina ispitivanja (npr. kortikalna katarakta, dijabetička katarakta, nuklearna katarakta, subkapsularna katarakta, lentikularna katarakta) iznosila je 68% u bolesnika u kojih je fakično ispitivano oko liječeno lijekom OZURDEX.
English: Day 90
Croatian: Dan 90
English: Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment.
Croatian: Intravitrealne injekcije, uključujući i one koje sadrže OZURDEX, mogu biti povezane s endoftalmitisom, intraokularnom upalom, povišenim očnim tlakom i ablacijom mrežnice (retine).
English: As for the initial treatment, peak response was seen at Day 60 in the open label phase.
Croatian: Kao i kod početnog liječenja, najviša točka odgovora na terapiju primijećena je na 60. dan otvorene faze ispitivanja.
English: The primary and key secondary endpoints for the pooled analysis for pseudophakic patients are presented in Table 3.
Croatian: Rezultati praćenja primarnih i ključnih sekundarnih ishoda u objedinjenoj analizi bolesnika s pseudofakijom prikazani su u tablici 3.
English: Sham N = 101 P-value
Croatian: Placebo N = 101 P-vrijednost
English: The most commonly-reported adverse events reported following treatment with OZURDEX are those frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract formation and conjunctival or vitreal haemorrhage respectively).
Croatian: Najčešće zabilježene nuspojave prijavljene nakon liječenja lijekom OZURDEX su one koje su često primijećene kod oftalmičke primjene steroidnih lijekova ili intravitrealnih injekcija (povišen IOT, nastanak katarakte i konjunktivalno odnosno vitrealno krvarenje).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine, učestalosti nuspojave su prikazane prema opadajućoj ozbiljnosti.
English: OZURDEX is a rod-shaped implant which is stored inside the needle of an applicator.
Croatian: OZURDEX je implantat u obliku štapića koji se čuva unutar igle aplikatora.
English: Therefore, regular monitoring of IOP, irrespective of baseline IOP, is required and any elevation should be managed appropriately post-injection as needed.
Croatian: Stoga je potrebno redovito praćenje očnog tlaka, bez obzira na početnu vrijednost IOT-a, i svaki porast tlaka nakon injiciranja potrebno je liječiti prema potrebi na primjeren način.
English: The cumulative response rates were higher throughout the open label phase in those patients receiving two consecutive OZURDEX injections compared with those patients who had not received an OZURDEX injection in the initial phase.
Croatian: Kumulativne stope odgovora na terapiju bile su veće tijekom cijele otvorene faze kod onih bolesnika koji su primili dvije uzastopne injekcije lijeka OZURDEX u usporedbi s bolesnicima koji nisu primili OZURDEX tijekom početne faze.
English: The clinical efficacy of OZURDEX has been assessed in a single, multicentre, masked, randomised study for the treatment of non-infectious ocular inflammation of the posterior segment in patients with uveitis.
Croatian: Klinička djelotvornost lijeka OZURDEX procijenjena je u jednoj multicentričnoj, maskiranoj, randomiziranoj studiji za liječenje neinfektivne upale stražnjeg očnog segmenta kod bolesnika s uveitisom.
English: In BRVO/CRVO clinical studies, cataract was reported more frequently in patients with phakic lens receiving a second injection (see section 4.8).
Croatian: U kliničkim studijama BRVO/CRVO, katarakta je prijavljena češće kod bolesnika s fakičnim lećama koji su dobili drugu injekciju (vidjeti dio 4.8).
English: In addition, patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs.
Croatian: Uz to, bolesnike treba pratiti nakon injiciranja kako bi se omogućilo rano liječenje ako dođe do infekcije ili povišenog očnog tlaka.
English: Plasma concentrations were obtained from a subset of 21 patients in the two RVO, 6-month efficacy studies prior to dosing and on days 7, 30, 60 and 90 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone.
Croatian: Koncentracije u plazmi uzete su od podskupine od 21 bolesnika u dvije RVO, šestomjesečne studije djelotvornosti prije primjene te na dan 7, 30, 60 i 90 nakon intravitrealne injekcije jednog intravitrealnog implantata koji sadrži 350 µg ili 700 µg deksametazona.
English: Patients were eligible for retreatment based upon central subfield retinal thickness >175 microns by optical coherence tomography (OCT) or upon investigators interpretation of the OCT for any evidence of residual retinal edema consisting of intraretinal cysts or any regions of increased retinal thickening within or outside of the central subfield.
Croatian: >175 mikrona utvrđenog optičkom koherentnom tomografijom (OCT) ili na temelju ispitivačeve interpretacije nalaza OCT-a u smislu postojanja rezidualnog edema retine koji se sastojao od intraretinalnih cista ili bilo kojeg područja retine s povećanim zadebljanjem unutar ili izvan središnjeg polja mrežnice.
English: The mean change from baseline BCVA was significantly greater with OZURDEX compared to sham at all time points.
Croatian: Prosječna promjena od početne vrijednosti BCVA bila je značajno veća kod lijeka OZURDEX u usporedbi s placebo postupkom u svim terminima.
English: Whereas, delaying treatment for 6 months results in a lower proportion of responders at all time points in the open label phase when compared with those receiving a second OZURDEX injection.
Croatian: Međutim, odgoda liječenja za 6 mjeseci rezultira u manjem udjelu bolesnika koji su reagirali na liječenje u svim terminima u otvorenoj fazi u usporedbi s onima koji su primili drugu injekciju lijeka OZURDEX.
English: OZURDEX works by reducing this inflammation.
Croatian: OZURDEX djeluje tako što smanjuje to oticanje žute pjege
English: - if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6) - if you have an infection of any kind in or around your eye (bacterial, viral or fungal) - if you have glaucoma or high pressure inside your eye which is not controlled properly with the medicines you may be using - if the eye to be treated does not have a lens and the back of the lens capsule (“the bag”) has been ruptured
Croatian: - ako imate infekciju bilo koje vrste u oku ili u području oko njega (bakterijsku, virusnu ili gljivičnu infekciju) - ako imate glaukom ili visoki očni tlak koji nije odgovarajuće kontroliran lijekovima koje možda koristite - ako u oku u koje morate primiti lijek nemate leću a stražnja strana kapsule leće je razderana
English: 6) Dispose of the applicator safely immediately after treatment.
Croatian: 6) Odmah nakon postupka zbrinite aplikator na siguran način.
English: A total of 73 patients (95%) randomised and treated with OZURDEX completed the 26-week study.
Croatian: Ukupno 73 bolesnika (95%) odabranih slučajnim odabirom i liječenih lijekom OZURDEX dovršilo je studiju od 26 tjedana.