FrancophonIA/ELRC3.0 huggingface dataset:
English: 28% of patients treated with OZURDEX had a ≥ 10 mm Hg IOP increase from baseline at one or more visits during the study.
Croatian: 28% bolesnika liječenih lijekom OZURDEX imalo je porast IOT-a ≥ 10 mm Hg u odnosu na početne vrijednosti na jednom ili više pregleda tijekom ispitivanja.
English: OZURDEX has not been studied in patients with macular oedema secondary to RVO with significant retinal ischemia.
Croatian: OZURDEX nije ispitivan kod bolesnika s makularnim edemom sekundarno okluziji mrežnične vene sa značajnom retinalnom ishemijom.
English: Ninety-five percent of the plasma dexamethasone concentration values for the 350 µg dose group and 86% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL).
Croatian: Devedeset i pet postotaka vrijednosti koncentracije deksametazona u plazmi u skupini koja je primila dozu od 350 µg i 86% u skupini koja je primila dozu od 700 µg bile su ispod donje granice mjerljivosti (0,05 ng/ml).
English: Efficacy in studies 206207-010 and 206207-011 (ITT population)
Croatian: Tablica 2. Djelotvornost u ispitivanju 206207-010 i ispitivanju 206207-011 (Populacija ITT)
English: The applicator containing the implant is packaged in a sealed foil pouch containing desiccant.
Croatian: Aplikator koji sadrži implantat upakiran je u hermetički zatvorenu vrećicu koja sadrži sredstvo za sušenje.
English: Discontinuation due to lack of efficacy was lower in the OZURDEX group compared to sham (7% vs 24%).
Croatian: Stopa prekida sudjelovanja u ispitivanju zbog izostanka učinka bila je niža u skupini lijeka OZURDEX u usporedbi s placebom (7% naspram 24%).
English: Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay, e.g. eye pain, blurred vision etc. (see section 4.8).
Croatian: Bolesnike je potrebno uputiti da bez odgode prijave sve simptome koji upućuju na endoftalmitis ili bilo koji od gore navedenih događaja, npr. bol u oku, zamućen vid itd. (vidjeti dio 4.8).
English: Plasma concentrations were obtained from a subgroup of patients in the two DME pivotal studies prior to dosing and on days 1, 7, and 21, and months 1.5 and 3 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone.
Croatian: Koncentracija u plazmi mjerena je u uzorcima podskupine bolesnika u dva ključna ispitivanja DME, i to prije primjene doze te 1., 7. i 21. dan i 1,5 i 3 mjeseca nakon intravitrealne injekcije jednog intravitrealnog implantata koji sadrži 350 µg odnosno 700 µg deksametazona.
English: The applicator consists of a plunger (stainless steel) within a needle where the implant is held in place by a sleeve (silicone).
Croatian: Aplikator se sastoji od klipa (od nehrđajućeg čelika) u igli, gdje implantat na mjestu drži cjevčica
English: • inflammation of the posterior segment of the eye presenting as non-infectious uveitis
Croatian: • upalom stražnjeg očnog segmenta u vidu neinfektivnog uveitisa
English: The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials (DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ class in the table below using the following convention:
Croatian: Nuspojave za koje se smatra da su povezane s primjenom lijeka OZURDEX prijavljene tijekom faze III kliničkog ispitivanja (DME, BRVO/CRVO i uveitis) kao i spontane prijave navedene su prema MedDRA klasi organskih sustava u tablici u nastavku koristeći sljedeće načelo:
English: Persistent severe corneal oedema could progress to the need for corneal transplantation.
Croatian: Uporni teški edem rožnice može s vremenom imati za posljedicu potrebu za transplantacijom rožnice.
English: These patients should be closely monitored to allow for early diagnosis and management of device migration.
Croatian: Potrebno je te bolesnike pažljivo pratiti kako bi se omogućila rana dijagnoza i intervencija u slučaju migracije implantata.
English: The cumulative response rate curves (time to vitreous haze score of 0) were significantly different for the OZURDEX group compared to the Sham group (p < 0.001), with patients receiving dexamethasone showing an earlier onset and greater treatment response.
Croatian: Krivulje kumulativne stope odgovora (vrijeme do nultog stupnja zamućenja staklastog tijela) bile su značajno drukčije u skupini lijeka OZURDEX u usporedbi sa skupinom s placebo postupkom (p < 0,001), a bolesnici koji su primali deksametazon pokazali su raniji početak i veći odgovor na liječenje.
English: A total of 427 patients were randomised to receive OZURDEX and 426 to receive sham in the two Phase III studies.
Croatian: Ukupno 427 bolesnika odabranih slučajnim odabirom primalo je OZURDEX, a 426 primalo je placebo postupak u tim dvjema studijama faze III.
English: Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application.
Croatian: Za deksametazon je dokazano da je teratogen kod miševa i zečeva nakon topikalne oftalmološke primjene.
English: This blockage leads to a build up of fluid causing swelling in the area of the retina (the light-sensitive layer at the back of the eye) called the macula.
Croatian: To začepljenje vodi do nakupljanja tekućine, što uzrokuje oticanje u području mrežnice (sloj u stražnjem dijelu oka osjetljiv na svjetlost) koji se naziva makula ili žuta pjega.
English: For information concerning the current safety experience of repeat administrations beyond 2 implants in posterior segment non-infectious uveitis and Retinal Vein Occlusion, see section 4.8.
Croatian: Za informacije koje se odnose na trenutačna iskustva o sigurnosti u ponovljenoj primjeni u slučaju neinfektivnog uveitisa stražnjeg očnog segmenta s više od 2 implantata i okluzije mrežnične vene,
English: The mean increase from baseline IOP did not exceed 3.2 mmHg across all visits in the OZURDEX group with the mean IOP peaking at the 1.5 month visit post injection, and returning to approximately baseline levels by month 6 following each injection.
Croatian: Srednji porast IOT-a u odnosu na početne vrijednosti nije premašio 3,2 mmHg tijekom svih pregleda u skupini OZURDEX, s time da je najveći porast srednje vrijednosti IOT-a zabilježen na pregledu 1,5 mjeseci nakon injekcije, i vratio se na približno početnu vrijednost 6 mjeseci nakon svake injekcije.
English: Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex and not be used in active ocular herpes simplex.
Croatian: Kortikosteroide treba primjenjivati s oprezom kod bolesnika s očnim herpes simpleksom u anamnezi, a ne bi ih trebalo primijeniti u slučaju aktivnog očnog herpes simpleksa.
English: The percent of patients requiring escape medications from baseline to week 8 was nearly 3-fold less with OZURDEX (7.8%) compared to Sham (22.4%), p = 0.012.
Croatian: Postotak bolesnika kojima je bio potreban dodatni lijek od početne vrijednosti do 8. tjedna bio je skoro 3 put manji s lijekom OZURDEX (7,8%) u usporedbi s placebo postupkom (22,4%), p = 0,012.
English: Discontinuation rates due to adverse events were similar across treatment and sham groups (13% vs 11%).
Croatian: Stopa isključivanja iz ispitivanja zbog nuspojava bila je slična između skupina ispitivanog lijeka i placeba (13% naspram 11%).
English: One patient treated with OZURDEX required incisional surgery (trabeculectomy) to manage the steroid-induced IOP elevation, 1 patient had a trabeculectomy owing to anterior chamber fibrin blocking the aqueous outflow leading to increased IOP, 1 patient had an iridotomy for narrow angle glaucoma and 1 patient had iridectomy due to cataract surgery.
Croatian: U 1 bolesnika liječenog lijekom OZURDEX bila je potrebna kirurška incizija (trabekulektomija) radi kontrole povišenja IOT-a induciranog steroidima, 1 je bolesnik podvrgnut trabekulektomiji zbog fibrinom uzrokovane blokade istjecanja očne vodice iz prednje očne komore koja je dovela do povišenja IOT-a, 1 je bolesnik podvrgnut iridektomiji zbog glaukoma uskog kuta, a 1 je bolesnik podvrgnut iridektomiji zbog operacije katarakte.
English: A total of 229 patients were randomised to receive dexamethasone 350 µg or 700 µg implants or sham.
Croatian: Ukupno 229 bolesnika odabranih slučajnim odabirom primilo je implantate deksametazona od 350 µg ili 700 µg ili placebo postupak.
English: Corticosteroids should be used cautiously in patients with a history of ocular viral (e.g. herpes simplex) infection and not be used in active ocular herpes simplex.
Croatian: Kortikosteroide treba primjenjivati s oprezom kod bolesnika s virusnim infekcijama oka (npr. herpes simpleksom) u anamnezi, a ne bi ih trebalo primijeniti u slučaju aktivnog očnog herpes simpleksa.
English: A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of IOP elevation.
Croatian: Ukupno 4 bolesnika (1%) liječenih lijekom OZURDEX imali su zahvate na ispitivanom oku radi liječenja povišenog IOT-a.
English: The safety and efficacy of OZURDEX administered to both eyes concurrently have not been studied.
Croatian: Sigurnost i djelotvornost lijeka OZURDEX primijenjenog u oba oka istovremeno nisu ispitivane.
English: Please tell your doctor immediately if you develop increased eye pain or increased discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters, partially blocked vision, decreased vision or increased sensitivity to light after your injection.
Croatian: Molimo da odmah obavijestite svog liječnika ako primijetite pojačanu bol u oku ili sve veću nelagodu, crvenilo oka koje se pogoršava, bljeskove i iznenadni porast broja lebdećih čestica
English: OZURDEX is for single use only.
Croatian: OZURDEX je namijenjen samo za jednokratnu uporabu.
English: abnormal feeling in the eye * itchiness of the eyelid, redness of the white of the eye*, migration of the OZURDEX implant from the back to the front of the eye causing blurred or decreased vision and which may or may not cause swelling of the clear part of the eye (cornea)*, accidental incorrect placement of the OZURDEX implant*, migraine
Croatian: svrbež očnog kapka, crvenilo bjeloočnice*, pomak implantata OZURDEX iz stražnjeg dijela oka prema naprijed zbog kojeg je nastupilo zamućenje ili slabljenje vida, a koje može ili ne mora izazvati oteknuće prozirnog dijela oka (rožnice)*, slučajno neispravno postavljanje implantata OZURDEX*, migrena.
English: Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay, e.g. eye pain, blurred vision etc. (see SmPC section 4.8).
Croatian: Bolesnike je potrebno uputiti da bez odgode prijave sve simptome koji upućuju na endoftalmitis ili bilo koji od gore navedenih događaja, npr. bol u oku, zamućen vid itd. (vidjeti dio 4.8 sažetka opisa svojstava lijeka).
English: - The other ingredients are: Ester terminated 50:50 poly D,L-lactide-co-glycolide and
Croatian: - Drugi sastojci su: 50:50 poli(D,L-laktid-ko-glikolid) s terminalnom esterskom skupinom i
English: • Aphakic eyes with ruptured posterior lens capsule.
Croatian: • Afakične oči s rupturom stražnje kapsule leće,
English: Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see section 4.8).
Croatian: Bolesnici mogu iskusiti privremeno smanjenje sposobnosti vida nakon primanja lijeka OZURDEX intravitrealnim ubrizgavanjem (vidjeti dio 4.8).
English: Therefore administration to both eyes concurrently is not recommended.
Croatian: Stoga se ne preporučuje primjena u oba oka istovremeno.
English: Increased intraocular pressure (IOP) with OZURDEX peaked at day 60 and returned to baseline levels by day 180.
Croatian: Povišeni očni tlak pri uporabi lijeka OZURDEX bio je najviši na 60. dan te se vratio na početne vrijednosti do 180. dana.
English: Week 8
Croatian: Tjedan 8
English: One intravitreal implant in applicator.
Croatian: Jedan intravitrealni implantat u aplikatoru.
English: 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: injekcije u usporedbi s bolesnicima koji su primili ≤2 injekcije; formacija 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: One hundred percent of the plasma dexamethasone concentration values for the 350 µg dose group and 90% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL).
Croatian: Sto posto vrijednosti koncentracija deksametazona u plazmi u skupini koja je primila dozu od 350 µg i 90% u skupini koja je primila dozu od 700 µg bilo je ispod donje kvantitativne granice (0,05 ng/ml).
English: In each Phase III study and the pooled analysis, the time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response curves were significantly different with OZURDEX compared to sham (p < 0.001) with OZURDEX treated patients achieving a 3-line improvement in BCVA earlier than sham treated patients.
Croatian: U svakoj studiji faze III i u analizi objedinjenih podataka, kumulativne krivulje odgovora za vrijeme postizanja poboljšanja od ≥ 15 slova (3 retka) u BCVA bile su značajno drugačije kod bolesnika liječenih lijekom OZURDEX u usporedbi s placebo postupkom (p < 0,001), s tim da su bolesnici liječeni lijekom OZURDEX postigli poboljšanje od 3 retka u BCVA ranije nego bolesnici liječeni placebo postupkom.
English: Mean BCVA average change over 3 years, AUC approach (letters) P-value
Croatian: Srednja vrijednost prosječne promjene BCVA kroz 3 godine, AUC pristup (slova) P-vrijednost
English: Day 60
Croatian: Dan 60
English: The highest plasma concentration value of 0.102 ng/mL was observed in 1 subject from the 700 µg group.
Croatian: Najviša vrijednost koncentracije u plazmi od 0,102 ng/ml primijećena je u 1 ispitanika iz skupine koja je primila 700 µg.
English: Week 20
Croatian: Tjedan 20
English: Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotizing retinitis, retinal detachment and retinal tear.
Croatian: Rjeđe prijavljene ali ozbiljnije nuspojave uključuju endoftalmitis, nekrotizirajući retinitis, ablaciju retinemrežnice i rupturu mrežnice.
English: Intravitreal implant in applicator.
Croatian: Intravitrealni implantat u aplikatoru.
English: OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Croatian: OZURDEX smije primijeniti samo osposobljen oftalmolog koji ima iskustva s intravitrealnim injiciranjem lijekova.
English: OZURDEX 700 micrograms intravitreal implant in applicator
Croatian: OZURDEX 700 mikrograma intravitrealni implantat u aplikatoru
English: The proportion of patients with at least 15 letters improvement from baseline BCVA in the study eye at week 8 was more than 6-fold higher with OZURDEX (42.9%) compared to Sham (6.6%), p < 0.001.
Croatian: Udio bolesnika s poboljšanjem od barem 15 slova u odnosu na početne vrijednosti BCVA u ispitivanom oku u 8. tjednu bio je više od 6 puta veći s lijekom OZURDEX (42,9%) u usporedbi s placebo postupkom (6,6%), p < 0,001.
English: • visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy
Croatian: OZURDEX je indiciran u liječenju odraslih bolesnika s: • oštećenjem vida zbog dijabetičkog makularnog edema (DME) koji imaju pseudofakiju ili za koje se smatra da nemaju zadovoljavajući odgovor ili nisu prikladni za nekortikosteroidnu terapiju
English: After the first injection the incidence of cataract appears higher in patients with non-infectious uveitis of the posterior segment compared with BRVO/CRVO patients.
Croatian: Nakon prvog injiciranja, incidencija katarakte čini se češća u bolesnika s neinfektivnim uveitisom stražnjeg segmenta nego u bolesnika s BRVO/CRVO.
English: The clinical safety of OZURDEX in patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis, has been assessed in a single, multicentre, masked, randomised study.
Croatian: Klinička sigurnost lijeka OZURDEX kod bolesnika s upalom stražnjeg očnog segmenta koji se javlja kao neinfektivni uveitis procijenjena je u jednoj multicentričnoj, maskiranoj, randomiziranoj studiji.
English: • Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Croatian: • Aktivni slučajevi ili sumnje u infekcije oka ili područja oko oka, uključujući većinu virusnih bolesti rožnice i konjunktive, uključujući aktivni epitelni keratitis uzrokovan virusom herpes simpleks (dendritički keratitis), vakciniju, varičelu-zoster, infekcije mikobakterijama te gljivične bolesti.
English: Very common Intraocular pressure increased**, cataract**, conjunctival haemorrhage*
Croatian: Povišeni intraokularni tlak**, katarakta**, krvarenje iz konjunktive*
English: Remove the foil pouch from the carton and examine for damage (see SmPC section 6.6).
Croatian: Izvadite vrećicu iz kartonske kutije te provjerite postoje li oštećenja (vidjeti dio 6.6 sažetka opisa svojstava lijeka).
English: The efficacy of OZURDEX was assessed in two multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,267 patients who were randomized to receive treatment with dexamethasone 350 µg or 700 µg implants or sham (studies 206207-008 and 206207-009).
Croatian: randomizirane, paralelne studije kontrolirane placebo postupkom, koje su bile zamišljene na identičan način i koje su zajedno obuhvatile 1267 bolesnika koji su liječeni deksametazonom u implantatima od 350 µg ili 700 µg ili placebo postupkom (studije 206207-008 i 206207-009).
English: For patients using concomitant and anti-platelet medication, haemorrhagic adverse events were reported in a slightly higher proportion of patients injected with OZURDEX (up to 29%) compared with the sham group (up to 23%), irrespective of indication or number of treatments.
Croatian: hemoragijski štetni događaji prijavljeni su u nešto većem udjelu kod bolesnika kojima je ubrizgan OZURDEX (do 29%), u usporedbi s placebo skupinom (do 23%), neovisno o indikaciji ili broju tretmana.
English: • diabetic macular oedema
Croatian: • dijabetičkog makularnog edema
English: Week 26
Croatian: Tjedan 26
English: OZURDEX has not been studied in patients with renal impairment however no special considerations are needed in this population.
Croatian: OZURDEX nije ispitivan kod bolesnika s bubrežnim bolestima, no nisu potrebne posebne mjere opreza kod ove populacije bolesnika.
English: The adverse reaction profile for BRVO patients was similar to that observed for CRVO patients although the overall incidence of adverse reactions was higher for the subgroup of patients with CRVO.
Croatian: Profil nuspojava kod bolesnika s okluzijom grane mrežnične vene bio je sličan onom koji je primijećen kod bolesnika s okluzijom središnje mrežnične vene, iako je ukupna incidencija nuspojava bila veća kod podskupine bolesnika s okluzijom središnje mrežnične vene.
English: The active substance in OZURDEX is dexamethasone.
Croatian: Djelatna tvar u lijeku OZURDEX je deksametazon.
English: The most frequently reported adverse reactions in patients who received OZURDEX were increased intraocular pressure (24.0 %) and conjunctival haemorrhage (14.7 %).
Croatian: Najčešće prijavljene nuspojave kod bolesnika koji su primili OZURDEX bile su povišeni očni tlak (24,0%) i krvarenje iz konjunktive
English: Among patients who did not use anti-coagulant therapy, 27% of OZURDEX treated patients reported haemorrhagic adverse events compared to 20% in the sham group.
Croatian: Među bolesnicima koji nisu koristili antikoagulantnu terapiju, u 27% bolesnika koji su primali OZURDEX zabilježeni su hemoragijski štetni događaji u usporedbi s 20% bolesnika u placebo skupini.
English: Package leaflet: information for the user OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone
Croatian: Uputa o lijeku: Informacije za korisnika OZURDEX 700 mikrograma intravitrealni implantat u aplikatoru deksametazon
English: • Hypersensitivity to the active substance or to any of the excipients as listed in SmPC section 6.1.
Croatian: • preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u sažetku opisa svojstava lijeka u dijelu 6.1.
English: • Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated intraocular lens and ruptured posterior lens capsule.
Croatian: • Oči s intraokularnom lećom u prednjoj očnoj sobici (Anterior Chamber Intraocular LensACIOL), intraokularnom lećom pričvršćenom za šarenicu ili transskleralno i rupturom stražnje kapsule leće.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH AND OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see SmPC section 4.8).
Croatian: Bolesnici mogu iskusiti privremeno smanjenje sposobnosti vida nakon primanja lijeka OZURDEX intravitrealnim ubrizgavanjem (vidjeti dio 4.8 sažetka opisa svojstava lijeka).
English: 5) Withdraw the applicator in the same direction that you used to enter the vitreous.
Croatian: 5) Izvucite iglu u istom smjeru koji je korišten za ulazak u staklasto tijelo.
English: Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs (see section 4.4).
Croatian: Potrebno je pratiti bolesnike nakon ubrizgavanja kako bi bilo omogućeno rano liječenje ako dođe do infekcije ili povišenog očnog tlaka (vidjeti dio 4.4).
English: The prevalence of conjunctival haemorrhage in patients with non-infectious uveitis of the posterior segment appears to be higher compared with BRVO/CRVO and DME.
Croatian: Prevalencija krvarenja konjunktive kod bolesnika s neinfektivnim uveitisom stražnjeg segmenta izgleda češća nego u bolesnicima s BRVO/CRVO i DME.
English: The highest plasma concentration value of 0.094 ng/mL was observed in one subject from the 700 µg group.
Croatian: Najveća vrijednost koncentracije u plazmi od 0,094 ng/ml zabilježena je kod jednog ispitanika iz skupine koja je primila dozu od 700 µg.
English: The following information is intended for medical or healthcare professionals only, and includes the numbered sections of the SmPC which provide practical information for use of the medicinal product.
Croatian: [Treba dostaviti unutar kartonske kutije] Sljedeće informacije namijenjene su samo zdravstvenim radnicima i sadrže dijelove sažetka opisa svojstava lijeka označene brojevima koji pružaju praktične informacije za primjenu lijeka; za potpune informacije o lijeku pogledajte sažetak opisa svojstava lijeka.
English: - if the eye to be treated has undergone cataract surgery and has a man-made lens, which was implanted in the front compartment of the eye (anterior chamber intraocular lens) or was fixed to the white portion of the eye (sclera) or to the coloured part of the eye (iris), and the back of the lens capsule (“the bag”) has been ruptured
Croatian: - ako ste na oku u koje morate primiti lijek imali operaciju mrene i imate umjetnu leću koja je ugrađena u prednju očnu sobicu, ili je učvršćena za bjeloočnicu (skleru) ili šarenicu oka (iris), a stražnja kapsula leće je razderana.
English: All OZURDEX injections will be given by an appropriately qualified eye doctor.
Croatian: Svako ubrizgavanje lijeka OZURDEX izvršit će odgovarajuće osposobljen oftalmolog.
English: Week 16
Croatian: Tjedan 16
English: If the dates for submission of a PSUR and the update of the RMP coincide, they can be submitted at the same time.
Croatian: Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: Day 30
Croatian: Dan 30