FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from both trials indicated that continued ranibizumab treatment may also be of benefit in patients who lost ≥15 letters of best-corrected visual acuity (BCVA) in the first year of treatment.
Croatian: Rezultati iz oba ispitivanja ukazuju da kontinuirano liječenje ranibizumabom može koristiti i bolesnicima koji su izgubili ≥15 slova najbolje korigirane vidne oštrine (BCVA) u prvoj godini liječenja.
English: Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus.
Croatian: Stoga se ranibizumab ne smije koristiti tijekom trudnoće, osim ako očekivana korist ne nadmašuje mogući rizik za plod.
English: CI = confidence interval, M = total number of patients with non-missing value on primary efficacy outcome (including imputed values), n = number of patients with absence of active ROP and absence of unfavourable structural outcome in both eyes 24 weeks after the first study treatment (including imputed values).
Croatian: CI = interval pouzdanosti, M = ukupni broj bolesnika kojima nije nedostajala vrijednost za primarni ishod djelotvornosti (uključujući imputirane vrijednosti), n = broj bolesnika bez aktivnog ROP-a i bez nepovoljnog strukturalnog ishoda u oba oka 24 tjedna nakon prvog liječenja u sklopu ispitivanja (uključujući imputirane vrijednosti).
English: - Lucentis is not recommended during breast-feeding because it is not known whether Lucentis passes into human milk.
Croatian: - Lucentis se ne preporučuje tijekom dojenja, jer nije poznato da li Lucentis prelazi u majčino mlijeko.
English: The injection procedure should be carried out under aseptic conditions.
Croatian: Injiciranje se mora obaviti u aseptičnim uvjetima.
English: The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME.
Croatian: Interval liječenja smije se produžiti za najviše dva tjedna u jednom koraku za vlažni AMD te za najviše jedan mjesec u jednom koraku za DME.
English: Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection.
Croatian: Nekim bolesnicima će možda biti potrebna samo jedna injekcija tijekom prvih 12 mjeseci; drugima će možda trebati učestalija primjena, uključujući i primjenu injekcije jednom mjesečno.
English: Adverse reactions established for adult indications are considered applicable to preterm infants with ROP, though not all were observed in the RAINBOW trial.
Croatian: Nuspojave ustanovljene kod indikacija za odrasle smatraju se primjenjivima i na prijevremeno rođenu dojenčad s ROP-om, iako nisu sve opažene u ispitivanju RAINBOW.
English: Injecting the entire volume of the pre-filled syringe could result in overdose.
Croatian: Injiciranje cjelokupnog volumena napunjene štrcaljke može dovesti do predoziranja.
English: Excess volume to be expelled.
Croatian: Suvišak volumena treba izbaciti.
English: Lucentis should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).
Croatian: Lucentis se ne smije primjenjivati istodobno s drugim anti-VEGF lijekovima (sistemskim ili okularnim).
English: This is something you may not notice, therefore your doctor may monitor this after each injection.
Croatian: To je nešto što možda nećete zamijetiti; stoga će liječnik nakon svake injekcije provjeravati očni tlak.
English: Do not use the product if the packaging is damaged.
Croatian: Nemojte koristiti lijek ako je pakiranje oštećeno.
English: Odds ratio is calculated by using Cochran-Mantel-Haenszel test with ROP zone at baseline (zone I and II; per CRF) as stratum factor.
Croatian: Omjer izgleda izračunava se korištenjem Cochran-Mantel-Haenszelovog testa sa zonom ROP-a na početku (zona I i II; prema CRF-u) kao stratifikacijskim čimbenikom.
English: Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Croatian: Lucentis se ne smije primjenjivati tijekom trudnoće, osim ako je moguća korist veća od mogućeg rizika za nerođeno dijete.
English: Gain of ≥15 letters or
Croatian: Dobiveno ≥15 slova ili
English: b p<0.0001for null hypothesis in CRYSTAL that the mean change at Month 24 from baseline is zero.
Croatian: b p<0,0001 za nultu hipotezu u ispitivanju CRYSTAL da srednja promjena u 24. mjesecu od početne vrijednosti iznosi nula.
English: The absence of ranibizumab-mediated effects on embryo-foetal development is plausibly related mainly to the inability of the Fab fragment to cross the placenta.
Croatian: Odsutnost ranibizumabom-posredovanih učinaka na embrio-fetalni razvoj vjerojatno je povezana uglavnom s nemogućnošću da Fab fragment prođe kroz posteljicu.
English: The pre-filled syringe contains more than the recommended dose of 0.5 mg.
Croatian: Napunjena štrcaljka sadrži više od preporučene doze od 0,5 mg.
English: When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation.
Croatian: Primjenjuje li ih se istoga dana, Lucentis je potrebno dati najmanje 30 minuta nakon laserske fotokoagulacije.
English: The warnings and precautions for adults also apply to preterm infants with ROP.
Croatian: Upozorenja i mjere opreza za odrasle vrijede i za prijevremeno rođenu dojenčad s ROP-om.
English: Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.
Croatian: Podaci iz dvaju ispitivanja (MONT BLANC, BPD952A2308 i DENALI, BPD952A2309) provedenih nakon dobivanja odobrenja potvrdili su djelotvornost Lucentisa, ali nisu pokazali dodatni učinak kombinirane primjene verteporfina (Visudyne PDT) i Lucentisa u usporedbi s monoterapijom Lucentisom.
English: This information will be taken into account to evaluate if Lucentis is the appropriate treatment for you.
Croatian: Ovaj podatak uzet će se u obzir pri razmatranju je li Lucentis za Vas primjeren lijek ili ne.
English: • The treatment of proliferative diabetic retinopathy (PDR)
Croatian: • Liječenje proliferativne dijabetičke retinopatije (PDR)
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Croatian: Bolesnike treba uputiti da bez odgađanja prijave bilo koji simptom koji ukazuje na endoftalmitis ili na bilo koje drugo gore navedeno stanje.
English: Before the injection, your doctor will wash your eye carefully to prevent infection.
Croatian: Prije injekcije, liječnik će Vam pažljivo isprati oko, da spriječi infekciju.
English: *Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Croatian: * Ranibizumab je fragment humaniziranog monoklonskog antitijela proizvedenog na stanicama Escherichia coli tehnologijom rekombinantne DNA.
English: Luer lock
Croatian: Luer zatvarač
English: a p<0.0001for both comparisons in BRIGHTER at Month 6: Lucentis 0.5 mg vs Laser and Lucentis 0.5 mg + Laser vs Laser.
Croatian: a p<0,0001 za obje usporedbe u ispitivanju BRIGHTER u 6. mjesecu: Lucentis 0,5 mg naspram laser i Lucentis 0,5 mg + laser naspram laser.
English: Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Croatian: Praćenje aktivnosti bolesti može uključivati klinički pregled, funkcionalno testiranje ili tehnike slikovne dijagnostike (npr. optičku koherentnu tomografiju ili fluoresceinsku angiografiju).
English: Lucentis specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye.
Croatian: Lucentis specifično prepoznaje i veže se za protein koji se naziva ljudski čimbenik rasta vaskularnog endotela A (VEGF-A) i prisutan je u oku.
English: As the embryofoetal development investigations were performed in healthy pregnant animals and disease (such as diabetes) may modify the permeability of the placenta towards a Fab fragment, the study should be interpreted with caution.
Croatian: Budući da su istraživanja embrio-fetalnog razvoja provedena u zdravih gravidnih ženki, a bolesti (poput šećerne bolesti) mogu modificirati propusnost posteljice za Fab fragment, rezultate ispitivanja treba tumačiti s oprezom.
English: A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Croatian: U ta ispitivanja je bilo uključeno ukupno 1323 bolesnika (879 u aktivnoj, a 444 u kontrolnoj skupini).
English: In Group II, which is the recommended posology (see section 4.2), 50.9% of patients required 1 or 2 injections, 34.5% required 3 to 5 injections and 14.7% required 6 to 12 injections over the 12-month study period.
Croatian: U II. skupini, koja je primala preporučeno doziranje (vidjeti dio 4.2), 50,9% bolesnika trebalo je 1 ili 2 injekcije, 34,5% trebalo je 3 do 5 injekcija, a 14,7% trebalo je 6 do 12 injekcija tijekom 12-mjesečnog razdoblja ispitivanja.
English: The MAH shall ensure that, following discussions and agreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date patient information pack.
Croatian: Nositelj odobrenja dužan je osigurati da nakon razgovora i usuglašavanja s nadležnim nacionalnim tijelima u svakoj državi članici u kojoj se Lucentis nalazi na tržištu, prilikom stavljanja i nakon stavljanja lijeka u promet svim oftalmološkim klinikama u kojima se očekuje da će se primjenjivati Lucentis bude dostavljen ažurirani informacijski paket za bolesnike.
English: Package leaflet: Information for the adult patient
Croatian: Uputa o lijeku: Informacije za odraslog bolesnika
English: The difference in least square means was 3.5 letters (95% CI: [0.2 to 6.7]).
Croatian: Razlika u srednjoj vrijednosti dobivenoj metodom najmanjih kvadrata bila je 3,5 slova (95% CI: [0,2 do 6,7]).
English: In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive:
Croatian: U ispitivanju faze IIIb D2304 (RETAIN), 372 bolesnika bilo je randomizirano u omjeru 1:1:1 na primanje:
English: • Zone I, stage 1+, 2+, 3 or 3+ disease, or
Croatian: • Bolest zone I, stadij 1+, 2+, 3 ili 3+, ili
English: Since there is a potential for an increased systemic exposure in subjects with DME, an increased risk for developing hypersensitivity in this patient population cannot be excluded.
Croatian: Budući da postoji mogućnost povećane sistemske izloženosti u bolesnika s DME-om, kod ove populacije bolesnika ne može se isključiti povećani rizik za razvoj preosjetljivosti.
English: The syringe is ready for injection.
Croatian: Štrcaljka je spremna za injiciranje.
English: Caution should be exercised when treating such patients (see section 4.8).
Croatian: Pri liječenju ovakvih bolesnika potrebno je biti oprezan (vidjeti dio 4.8).
English: Serum concentrations in a limited number of DME patients indicate that a slightly higher systemic exposure cannot be excluded compared to those observed in neovascular AMD patients.
Croatian: Koncentracije u serumu kod ograničenog broja bolesnika s DME-om ukazuju na to da se ne može isključiti malo viša sustavna izloženost u usporedbi s onima zabilježenim u bolesnika s neovaskularnim AMD-om.
English: Do not pull back on the plunger.
Croatian: Klip štrcaljke nemojte potezati unazad.
English: The pre-filled syringe is sterile.
Croatian: Napunjena štrcaljka je sterilna.
English: * Starting at Month 6 ranibizumab 0.5 mg treatment was allowed (24 patients were treated with laser only).
Croatian: * Počevši od 6. mjeseca bilo je dopušteno liječenje s 0,5 mg ranibizumaba (24 bolesnika bilo je liječeno samo laserom).
English: Month
Croatian: Mjesec
English: Snap off (do not turn or twist) the syringe cap (see Figure 2).
Croatian: Otkinite (nemojte vrtiti ili okretati) zatvarač štrcaljke (vidjeti Sliku 2).
English: The filter needle is not for injection.
Croatian: Igla s filterom nije namijenjena za injekciju.
English: Before the injection, your baby's doctor will wash your baby's eyes carefully to prevent infection.
Croatian: Prije injekcije, liječnik Vašeg djeteta će pažljivo djetetu isprati oči, da spriječi infekciju.
English: • the syringe cap is not detached from the Luer lock.
Croatian: • se zatvarač štrcaljke nije odvojio od Luer zatvarača.
English: 240 patients, who had previously completed the 12-month RESTORE study, were enrolled in the open-label, multicentre 24-month extension (RESTORE Extension) study.
Croatian: 240 bolesnika koji su prethodno dovršili 12-mjesečno ispitivanje RESTORE uključeno je u otvoreni, multicentrični, 24-mjesečni produžetak ispitivanja (RESTORE Produžetak).
English: • the solution looks clear, colourless to pale yellow and does not contain any particles.
Croatian: • otopina izgleda bistro, bezbojna je do blijedožuta i ne sadrži nikakve čestice.
English: Table 4 Treatment effect overall and across baseline aetiology subgroups
Croatian: Tablica 4 Učinak liječenja ukupno i u podskupinama prema početnoj etiologiji
English: The adverse reactions are listed by 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), not known (cannot be estimated from the available data).
Croatian: Nuspojave su podijeljene prema organskim sustavima i učestalosti koja se definira kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
Croatian: Iz bočice izvucite svu tekućinu, držeći ju u uspravnom položaju, lagano nagnutu kako bi se olakšalo potpuno izvlačenje.
English: Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters.
Croatian: Nakon toga, liječnik utvrđuje intervale praćenja i liječenja koji se trebaju temeljiti na aktivnosti bolesti, procijenjenim parametrima vidne oštrine i/ili anatomskim parametrima.
English: The extractable volume of the pre-filled syringe (0.1 ml) is not to be used in total.
Croatian: Ukupni volumen koji je moguće izvući iz napunjene štrcaljke (0,1 ml) ne smije se u cijelosti primijeniti.
English: In addition the European Medicines Agency has waived the obligation to submit the results of studies with Lucentis in the following subsets of the paediatric population for ROP: term newborn infants, infants, children and adolescents.
Croatian: Osim toga, Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Lucentis u sljedećim podskupinama pedijatrijske populacije za ROP: novorođenčad rođena u terminu, dojenčad, djeca i adolescenti.
English: • Group III (vPDT - patients were allowed to receive ranibizumab treatment as of Month 3).
Croatian: • III. skupina (vPDT - bolesnici su smjeli primati terapiju ranibizumabom od 3. mjeseca).
English: In patients with PM, there are limited data on the effect of Lucentis in patients who have previously undergone unsuccessful verteporfin photodynamic therapy (vPDT) treatment.
Croatian: U bolesnika s PM-om postoje ograničeni podaci o učinku Lucentisa u bolesnika koji su se prethodno neuspješno podvrgnuli verteporfin fotodinamskoj terapiji (vPDT) terapiji.
English: However, subjects with a baseline BCVA >73 letters and macular oedema with central retinal thickness <300 µm did not appear to benefit from treatment with ranibizumab compared to laser photocoagulation.
Croatian: Međutim, ispitanici s početnim BCVA-om >73 slova i makularnim edemom s centralnom retinalnom debljinom <300 µm čini se da nisu imali koristi od liječenja ranibizumabom u usporedbi s laserskom fotokoagulacijom.
English: This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes).
Croatian: To se uočava u bolestima kao što su senilna makularna degeneracija (AMD) i proliferativna dijabetička retinopatija (PDR, bolest koju uzrokuje šećerna bolest).
English: In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity.
Croatian: Ukupno se smiju primijeniti do tri injekcije po oku unutar šest mjeseci od početka liječenja ako postoje znakovi aktivnosti bolesti.
English: There is limited experience of treatment with Lucentis in diabetic patients with an HbA1c over 108 mmol/mol (12%) and no experience in patients with uncontrolled hypertension.
Croatian: Postoji ograničeno iskustvo vezano uz terapiju Lucentisom u dijabetičara s HbA1c vrijednosti višom od 108 mmol/mol (12%), a nema iskustva u bolesnika s hipertenzijom koja nije primjereno kontrolirana.
English: - Lucentis is given as an injection into the eye.
Croatian: - Lucentis se daje injekcijom u oko.
English: a p<0.00001 comparison with vPDT control b
Croatian: a p<0,00001 usporedba s vPDT kontrolom b
English: Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment.
Croatian: Liječnik će kontrolirati stanje Vašeg oka te, ovisno o tome kako reagirate na terapiju, odlučiti trebate li i kada nastaviti s liječenjem.
English: Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml for adults and 0.02 ml for preterm infants), a portion of the volume contained in the vial must be discarded prior to administration.
Croatian: Budući da je volumen sadržan u bočici (0,23 ml) veći od preporučene doze (0,05 ml za odrasle i 0,02 ml za nedonoščad), dio volumena sadržanog u bočici mora se baciti prije primjene.
English: In both studies, a rapid and statistically significant decrease from baseline in central retinal subfield thickness was observed at Month 1.
Croatian: U oba ispitivanja bilo je opaženo brzo i statistički značajno smanjenje od početne vrijednosti u centralnoj retinalnoj debljini u 1. mjesecu.
English: A total of 868 patients (708 active and 160 control) were enrolled in these studies.
Croatian: Ukupno je 868 bolesnika uključeno u ova ispitivanja (708 u ispitivanoj skupini, a 160 u kontrolnoj).
English: • Zone II, stage 3+ disease, or
Croatian: • Bolest zone II, stadij 3+, ili
English: Patients with active or suspected ocular or periocular infections.
Croatian: Bolesnici s aktivnim infekcijama oka ili periokularnog područja ili sa sumnjom na te infekcije.
English: The corresponding visual acuity gain in patients with ≥12 months disease duration was 8.6 and 8.4 letters in the respective studies.
Croatian: Odgovarajući porast vidne oštrine u bolesnika s trajanjem bolesti od ≥12 mjeseci bio je 8,6 odnosno 8,4 slova u predmetnim ispitivanjima.
English: Protocol S was a multicentre, randomised, active-controlled, parallel-assignment, non-inferiority phase III study in which 305 patients (394 study eyes) with PDR with or without DME at baseline were enrolled.
Croatian: S bio je multicentrično, randomizirano, aktivno kontrolirano ispitivanje neinferiornosti s paralelnim skupinama faze III u koje je bilo uključeno 305 bolesnika (394 ispitivanih očiju) s PDR-om sa ili bez DME-a na početku.
English: The majority of patients treated with ranibizumab 0.2 mg (78.1%) received a single injection per eye.
Croatian: Većina bolesnika liječenih ranibizumabom 0,2 mg (78,1%) primila je jednu injekciju po oku.
English: A total of 191 eyes (48.5%) were randomised to ranibizumab 0.5 mg and 203 eyes (51.5%) eyes were randomised to PRP.
Croatian: Ukupno je 191 oko (48,5%) bilo randomizirano na ranibizumab 0,5 mg, a 203 oka (51,5%) bila su randomizirana na PRP.
English: The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/foetotoxic.
Croatian: Sustavna izloženost ranibizumabu pri oftalmičkoj primjeni je niska, no zbog mehanizma njegova djelovanja, ranibizumab se mora smatrati kao potencijalno teratogen i embriotoksičan/fetotoksičan.
English: In pregnant monkeys, intravitreal ranibizumab treatment resulting in maximal systemic exposures 0.9-7-fold a worst case clinical exposure did not elicit developmental toxicity or teratogenicity, and had no effect on weight or structure of the placenta, although, based on its pharmacological effect ranibizumab should be regarded as potentially teratogenic and embryo-/foetotoxic.
Croatian: U gravidnih ženki majmuna, intravitrealna primjena ranibizumaba koja je rezultirala maksimalnom sustavnom izloženošću 0,9-7 puta većom od one u najgorem slučaju kliničke izloženosti nije izazvala razvojnu toksičnost niti teratogenost, te nije imala utjecaja na težinu ili strukturu posteljice, iako bi se, na temelju njegovog farmakološkog učinka, ranibizumab trebao smatrati potencijalno teratogenim i embrio-/fetotoksičnim.
English: If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 6).
Croatian: Ako ima mjehurića zraka, prstom nježno kucnite štrcaljku dok se mjehurići zraka ne podignu na vrh štrcaljke (vidjeti Sliku 6).
English: Table 3 Outcomes at Month 2 (MINERVA)
Croatian: Tablica 3 Ishodi nakon 2. mjeseca (MINERVA)
English: In the posterior segment, there were vitreal cell infiltration and floaters, which also tended to be dose-dependent and generally persisted to the end of the treatment period.
Croatian: U stražnjem segmentu uočene su leteće mutnine i infiltracija vitreusa stanicama, također s tendencijom ovisnosti o dozi, i općenito su se zadržavali sve do kraja razdoblja liječenja.
English: Key outcome measures from BRIGHTER and CRYSTAL are shown in Table 9.
Croatian: Ključne mjere ishoda iz ispitivanja BRIGHTER i CRYSTAL prikazane su u Tablici 9.
English: The mean number of ranibizumab injections given in the study eye over 12 months was 3 (ranged from 2 to 5).
Croatian: Srednji broj injekcija ranibizumaba primijenjenih u ispitivano oko tijekom 12 mjeseci bio je 3 (u rasponu od 2 do 5).
English: Overall and per baseline aetiology
Croatian: Ukupno i prema početnoj etiologiji
English: Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents, ATC code: S01LA04
Croatian: Farmakoterapijska skupina: oftalmici, lijekovi za liječenje neovaskularizacije; ATK oznaka: S01LA04 Mehanizam djelovanja
English: -0.4 letters
Croatian: -0,4 slova
English: Concomitant use of other anti-VEGF (vascular endothelial growth factor)
Croatian: Istodobna primjena s drugim anti-VEGF-om (vaskularni endotelni faktor rasta)
English: Treatment of wet AMD
Croatian: Liječenje vlažnog AMD-a
English: Treatment success, as measured by the absence of active ROP and absence of unfavourable structural outcomes in both eyes 24 weeks after the first study treatment, was highest with ranibizumab 0.2 mg (80%) compared to laser therapy (66.2%) (see Table 10).
Croatian: Uspješnost liječenja, mjerena odsutnošću aktivnog ROP-a i odsutnošću nepovoljnih strukturalnih ishoda u oba oka 24 tjedna nakon prvog liječenja u sklopu ispitivanja, bila je najveća uz ranibizumab 0,2 mg (80%) u usporedbi s laserskom terapijom (66,2%) (vidjeti Tablicu 10).
English: • What are the steps following treatment with Lucentis
Croatian: • Koji su koraci nakon liječenja Lucentisom
English: DRSS was also assessed in three separate active-controlled phase III DME studies (ranibizumab 0.5 mg PRN vs laser) that included a total of 875 patients, of whom approximately 75% were of Asian origin.
Croatian: DRSS je također procijenjena u tri odvojena aktivno kontrolirana ispitivanja DME faze III (ranibizumab 0,5 mg prema potrebi u odnosu na laser) koja su uključivala ukupno 875 bolesnika, od kojih je otprilike 75% bilo azijskog porijekla.