FrancophonIA/ELRC3.0 huggingface dataset:
English: JETREA should be used during breast-feeding only if the clinical benefit outweighs the potential risks.
Croatian: JETREA se smije davati tijekom dojenja samo ako se ocijeni da klinička korist nadmašuje moguće rizike.
English: Ocriplasmin levels in the vitreous decrease rapidly after intravitreal administration.
Croatian: Razine okriplazmina u staklovini naglo se snižavaju nakon intravitrealne primjene.
English: Early progression rates of full-thickness macular hole (until Day 7 post-injection) at RPE (retinal pigment epithelium) level were higher in the JETREA treated patients compared to sham or placebo.
Croatian: Stope rane progresije makularne rupe pune debljine (do 7. dana nakon injekcije) na razini retinalnog pigmentnog epitela (RPE) bile su veće kod bolesnika liječenih JETREOM nego u bolesnika koji su primali placebo.
English: Fertility There are no data on the effect of JETREA on fertility.
Croatian: Nema podataka o učinku JETREE na plodnost.
English: Tell your doctor/ophthalmologist if you have or have had any eye conditions or eye treatments.
Croatian: Obavijestite liječnika/oftalmologa ako imate ili ste imali bilo koji poremećaj oka ili ako ste liječili oko.
English: In rabbits and monkeys, the incidence of vitreous cell infiltrates tended to resolve over time.
Croatian: U kunića i majmuna je stanični infiltrat u staklovini pokazivao tendenciju povlačenja s vremenom.
English: ERG changes were not predictive of negative outcomes in terms of visual acuity; visual acuity improved or was maintained in 15 out of 16 patients compared to baseline.
Croatian: Promjene ERG-a nisu bile prediktivne za negativni ishod s obzirom na vidnu oštrinu; vidna oštrina poboljšala se ili je zadržana kod 15 od 16 bolesnika u usporedbi sa početnom.
English: Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji nakon oznake EXP ili „Rok valjanosti“.
English: FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED Belasis Avenue
Croatian: UK LIMITED Belasis Avenue
English: Therefore administration to both eyes concurrently is not recommended.
Croatian: Stoga se za sada primjena u oba oka istodobno ne preporučuje.
English: JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted' formulation, no further dilution is required.
Croatian: JETREA 0,375 mg/0,3 ml otopina za injekciju je pripremljena razrijeđena formulacija; nije potrebno daljnje razrijeđivanje.
English: The most common reason for performing vitrectomy was FTMH (in 24.8% JETREA treated patients and 23.3 % sham patients).
Croatian: Najčešći razlog za obavljanje vitrektomije bila je FTMH (u 24,8 % bolesnika liječenih JETREOM i 23,3 % onih koji su primali placebo).
English: Because of the small dose administered (0.125 mg), detectable levels of ocriplasmin in systemic circulation are not expected after intravitreal injection.
Croatian: Zbog male primijenjene doze (0,125 mg), ne očekuju se mjerljive razine okriplazmina u sistemskoj cirkulaciji nakon intravitrealne injekcije.
English: After thawing, unopened vial may be stored for up to 1 week in a refrigerator.
Croatian: Neotvorena bočica može se čuvati u hladnjaku najviše tjedan dana nakon odmrzavanja.
English: 3 years when stored in a freezer (-20 °C ± 5 °C).
Croatian: 3 godine kada se čuva u zamrzivaču (-20 °C ± 5°C)
English: Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea administration.
Croatian: Neki testovi i snimke stražnjeg dijela oka (mrežnice) bili su neoubičajeni nakon primjene Jetree.
English: Figure 1: Proportion of patients with VMA resolution up to Day 180 (Month 6) (TG-MV-006, TG-MV-007 and integrated data)
Croatian: Udio bolesnika u kojih se VMA povukla do 180. dana (6 mjeseci) (TG-MV-006, TG-MV-007 i integrirani podaci)
English: The remaining sodium chloride 9 mg/mL (0.9%) solution for injection should be discarded.
Croatian: Preostalu 0,9 %-tnu (9 mg/ml) otopinu natrijeva kloridna za injekciju treba baciti.
English: Treatment with ocriplasmin did not demonstrate an effect on posterior vitreous detachment rate, vitreous liquefaction grade, immediate postoperative retinal reattachment rate, development of proliferative vitreoretinopathy, or stage of retinopathy of prematurity.
Croatian: Liječenje okriplazminom nije pokazalo utjecaj na stopu ablacije stražnje staklovine, stupanj likvefakcije staklovine, stopu prilijeganja mrežnice neposredno nakon operacije, razvoj proliferativne vitreoretinopatije ili stadij retinopatije kod nedonoščadi.
English: Transient increases in IOP including transient blindness and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA.
Croatian: Prolazna povišenja IOT-a, uključujući prolaznu sljepoću i izostanak perfuzije vidnog živca, zamijećeni su unutar 60 minuta nakon injekcije JETREE.
English: However, after treatment, a higher proportion of patients in the JETREA group had a change from an intact IS/OS band at baseline to an incomplete IS/OS band in the central area at a later time point compared with the sham group (7.7% and 2.8%, respectively at Day 28).
Croatian: Ipak, nakon liječenja, veći udio bolesnika u JETREA skupini imao je promjenu od netaknutog IS/OS sloja na početku mjerenja do nepotpunog IS/OS sloja u središnjem području u kasnijoj vremenskoj točki u odnosu na placebo skupinu (7,7% odnosno 2,8% u 28. danu).
English: Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Croatian: Izvadite bočicu iz zamrzivača i ostavite da se sadržaj odmrzne pri sobnoj temperaturi (potrebno je oko 2 minute).
English: Of these, 30% of JETREA treated patients and 15.4% of patients in the sham group experienced non-surgical FTMH closure at Month 24.
Croatian: Od njih, 30 % bolesnika liječenih JETREOM i 15,4 % bolesnika u placebo skupini imali su nekirurško zatvaranje FTMH-a u 24. mjesecu.
English: For storage conditions after thawing and opening/dilution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon odmrzavanja i otvaranja/razrjeđivanja lijeka vidjeti dio 6.3.
English: • Patient information leaflet
Croatian: • Informativna pakiranja za bolesnike
English: A total of 220 patients (JETREA 146, sham 74) were randomised in this study.
Croatian: Ukupno 220 bolesnika (JETREA 146, placebo 74) randomizirano je u ovom ispitivanju.
English: The proportion of patients who underwent vitrectomy was smaller in the JETREA group than in the sham group at all visits.
Croatian: Udio bolesnika koji su imali vitrektomiju bio je manji u JETREA skupini u odnosu na placebo skupinu kod svih posjeta.
English: Intravitreal use after dilution
Croatian: Intravitrealna primjena nakon razrjeđivanja
English: Intravenous administration of 10 mg/kg was generally well tolerated in both rat and dog whether administered as single dose or as repeated dose.
Croatian: Dozu od 10 mg/ml, primijenjenu intravenski, općenito su dobro podnosili i štakori i psi, bez obzira je li primijenjena jednokratno ili opetovano.
English: The European Medicines Agency has waived the obligation to submit the results of studies with JETREA in all subsets of the paediatric population in the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja JETREE u svim podskupinama pedijatrijske populacije pri liječenju vitreomakularne trakcije (VMT), uključujući kada je ona povezana s makularnom rupom promjera manjeg ili jednakog 400 mikrona (vidjeti dio 4.2 informacije o pedijatrijskoj primjeni).
English: The difference continued to be statistically significant through Month 6 in each study (p≤0.024).
Croatian: Razlika je u oba ispitivanja ostala statistički značajna do kraja 6. mjeseca (p≤0,024).
English: There are no data for the use of JETREA in pregnant women.
Croatian: Nema podataka o primjeni JETREE trudnicama.
English: To prepare Jetrea for intravitreal injection, adhere to the following instructions: 1.
Croatian: Za pripravu JETREE za intravitrealnu injekciju pridržavajte se niže navedenih uputa:
English: JETREA is administered by intravitreal injection only.
Croatian: JETREA se primjenjuje samo intravitrealnom injekcijom.
English: 0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap.
Croatian: 0,2 ml otopine u bočici (staklo tipa I) zatvorenoj čepom od klorbutilne gume i sa narančastom polipropilenskom flip-off kapicom.
English: The ≥ 2 or ≥ 3 lines gain in BCVA without vitrectomy favoured JETREA over sham both at Month 6 (26.8%, 14.0%, vs. 15.62%, 6.2%, respectively) and Month 24 (31.9%, 16.8%, vs. 11,7%, 4.1%, respectively).
Croatian: Poboljšanje ≥ 2 ili ≥ 3 reda BCVA bez vitrektomije bilo je veće u JETREA skupini nego u placebo skupini i u 6. mjesecu (26,8%, 14,0%, naspram 15,62%, 6,2%) i u 24. mjesecu (31,9%, 16,8%, naspram 11,7%, 4,1%).
English: At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001
Croatian: U sv im danima nakon injekcije p≤0.024 u TG-MV-006, p≤0.009 u TG-MV-007, p<0.001 u integriranim podacima
English: Store in a freezer (-20 °C ± 5 °C).
Croatian: Čuvati u zamrzivaču (-20 °C ± 5 °C).
English: Lens subluxation was observed in 3 animal species at ocriplasmin concentrations above the intended clinical concentration (see section 5.3).
Croatian: Subluksacija leće zamijećena je u tri životinjske vrste pri koncentracijama okriplazmina većima od one za kliničku primjenu (vidjeti dio
English: If any of the above events occur the patient should be treated according to standard medical practice.
Croatian: Dogodi li se bilo što od gore navedenog, bolesnika treba liječiti u skladu sa standardnom medicinskom praksom.
English: The incidence of retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the placebo group, while the incidence of retinal tears (without detachment) that occurred pre-vitrectomy was 0.2% in the JETREA group and 0.5% in the placebo group.
Croatian: Incidencija odignuća mrežnice, koje su se dogodile prije vitrektomije, iznosila je 0,4% u skupini koja je primila injekciju JETREE i nula u onoj koja je primila injekciju placeba, dok je incidencija ruptura mrežnice (bez odignuća), koje su se dogodile prije vitrektomije, iznosila 0,2% u skupini koja je primila injekciju JETREE i 0,5% u onoj koja je primila placebo.
English: Jetrea is given as an injection into the eye.
Croatian: Jetrea se daje injekcijom u oko.
English: This effect was maintained over time and VMA resolution was consistently greater in the JETREA group at each post-injection study visit compared with the sham group.
Croatian: Ovaj se učinak održao tijekom vremena i povlačenje VMA bilo je dosljedno veće u JETREA skupini kod svakog posjeta nakon injekcije u ispitivanju, u usporedbi sa placebo skupinom.
English: 2) including scotoma
Croatian: 1) uključujući zamagljeni vid 2) uključujući skotome
English: Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.
Croatian: Preoperativno se mogu primjeniti antibiotske kapi prema odluci oftalmologa zaduženog za liječenje.
English: The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice.
Croatian: Površinu kože oko oka kao i površinu vjeđe i oka treba prije injekcije dezinficirati, te dati prikladnu anesteziju i površinski mikrobicid širokog spektra u skladu sa standardnom medicinskom praksom.
English: In this study, FTMH was present at baseline in 50/145 (34.5%) and 26/73 (35.6%) patients in the JETREA and sham groups, respectively.
Croatian: U ovom ispitivanju, FTMH je bio prisutan na početku ispitivanja kod 50/145 (34,5%) bolesnika u JETREA skupini i 26/73 (35,6%) u placebo skupini.
English: Using aseptic technique, dilute by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (sterile, preservative-free, non-buffered) into the Jetrea vial (Figure 3) and gently swirl the vial until the solutions are mixed (Figure 4).
Croatian: Primjenom aseptičke tehnike, razrijedite dodavanjem 0,2 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (sterilna, bez konzervansa, nepuferirana) u bočicu s Jetreom (Slika 3) i pažljivo vrtite bočicu dok se tekućine ne izmiješaju (Slika 4).
English: The difference was maintained from Day 7 through Month 6
Croatian: Razlika se održavala od 7. dana do kraja 6. mjeseca (Slika 1).
English: Studies TG-MV-006 and TG MV-007
Croatian: Ispitivanja TG-MV-006 i TG MV-007
English: No dose adjustment or special considerations are anticipated for patients with hepatic impairment (see section 5.2).
Croatian: Ne predviđaju se prilagođavanje doze ni posebna upozorenja za bolesnike s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: The unopened vial in the original carton protected from light may be stored in a refrigerator (2 °C to 8 °C) for up to 1 week.
Croatian: Neotvorena bočica u originalnoj kutiji, zaštićena od svjetlosti, može se čuvati u hladnjaku (2 °C do
English: - Symptoms such as eye pain, worsening eye redness, severely blurred or decreased vision, increased sensitivity to light or increased number of dark floating spots in the field of vision (floaters) are also seen in up to 1 in 10 patients and may be the signs of an infection, bleeding, separation or tear of the retina or an increase in the pressure inside the treated eye.
Croatian: - Simptomi kao što su bol, crvenilo oka koje se pogoršava, jako zamućen vid ili slabiji vid, pojačana osjetljivost na svjetlo ili veći broj tamnih lebdećih mrlja u vidnom polju („mušice“) također su primjećeni u do 1 na 10 bolesnika i mogu biti znaci infekcije, krvarenja, razderotine mrežnice ili porasta tlaka u liječenom oku.
English: The proportion of patients who underwent vitrectomy for an event of VMA/VMT was 8.3% in the JETREA group compared to 19.2% in the sham group.
Croatian: Udio bolesnika koji su imali vitrektomiju zbog VMA/VMT bio je 8,3 % u JETREA skupini u odnosu na 19,2 % u placebo skupini.
English: Lens subluxation was observed in the 3 species at ocriplasmin concentrations at or above 41 µg/mL vitreous, a concentration above the intended clinical concentration of 29 µg/mL.
Croatian: životinjske vrste pri koncentracijama okriplazmina od 41 µg/ml staklovine i većima, što je više od predviđene kliničke koncentracije od 29 µg/ml.
English: Mannitol, citric acid, sodium hydroxide, water for injections.
Croatian: Manitol, citratna kiselina, natrijev hidroksid, voda za injekcije.
English: In the JETREA group, 1 patient (0.7%) developed retinal tear and retinal detachment between Day 0 and Day 7 post-injection.
Croatian: JETREOM, 1 bolesnik (0,7%) razvio je rupturu mrežnice i odignuće mrežnice u periodu između 0. i 7. dana nakon injekcije.
English: Treatment with JETREA in the other eye is not recommended concurrently or within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye.
Croatian: Ne preporučuje se istodobna primjena JETREE u drugo oko, a ni unutar 7 dana od prve injekcije, kako bi se mogao pratiti tijek nakon davanja injekcije, uključujući mogućnost slabijeg vida na oko u koje je injekcija primijenjena.
English: How Jetrea is given
Croatian: Kako se Jetrea daje
English: Vials are for single use only.
Croatian: Bočice su samo za jednokratnu primjenu.
English: The proportion of patients who gained ≥ 2 or ≥ 3 lines in BCVA at Month 6, irrespective of vitrectomy, was slightly higher in the JETREA group (36.2%, 18.6%) than in the sham group (28.6%, 13.1%).
Croatian: Udio bolesnika koji su dobili ≥ 2 ili ≥ 3 reda BCVA u 6. mjesecu, neovisno o vitrektomiji, bio je malo veći u JETREA skupini (36,2%, 18,6%) u odnosu na placebo skupinu (28,6%, 13,1%).
English: It is unknown whether JETREA is excreted in human milk.
Croatian: Nije poznato izlučuje li se JETREA u majčino mlijeko.
English: The patient had a decrease in BCVA of 21 ETDRS letters from baseline that returned to within 9 letters of baseline at the end of the study.
Croatian: BCVA se u bolesnika smanjila za 21 slovo na ETDRS tabelici u usporedbi s početnom, no do kraja ispitivanja vratila se na 9 slova u odnosu na onu početnu.
English: JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 5.1).
Croatian: JETREA je indicirana u odraslih za liječenje vitreomakularne trakcije (VMT), uključujući kada je povezana s makularnom rupom promjera manjeg ili jednakog 400 mikrona (vidjeti dio 5.1).
English: Intraocular pressure increased, macular reflex abnormal, optical coherence tomography (OCT) abnormal* * see section ‘Description of selected adverse reactions' 1) including dim vision
Croatian: Povišeni intraokularni tlak, abnormalni makularni refleks, abnormalni nalaz optičke koherentne tomografije (OCT)*.
English: JETREA has not been studied in patients with large diameter macular holes (> 400 microns), high myopia (> 8 dioptre spherical correction or axial length > 28 mm), aphakia, history of rhegmatogenous retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including laser therapy), proliferative diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions, exudative age-related macular degeneration (AMD) and vitreous haemorrhage.
Croatian: Populacije o kojima nema podataka ili su podaci ograničeni JETREA nije ispitana u bolesnika s makularnom rupom velikog promjera (> 400 mikrona), visokom miopijom (> 8 dioptrija sferne korekcije ili aksijalne dužine > 28 mm), afakijom, regmatogenom ablacijom mrežnice u anamnezi, zonularnom nestabilnošću, nedavnom operacijom oka ili intraokularnom injekcijom (uključujući liječenje laserom), proliferativnom dijabetičkom retinopatijom, ishemijskim retinopatijama, okluzijama mrežnične vene, eksudativnom senilnom makularnom degeneracijom (SMD) i vitrealnim krvarenjem.
English: After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.
Croatian: Nakon razrjeđivanja s 0,2 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju, 0,1 ml razrijeđene otopine sadržava 0,125 mg okriplazmina.
English: • How to prepare for Jetrea treatment
Croatian: • Kako se pripremiti za liječenje s Jetreom • Kako se provodi liječenje Jetreom
English: To prepare JETREA for intravitreal injection, adhere to the following instructions: Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Croatian: Za pripravu Jetree za intravitrealnu injekciju pridržavajte se niže navedenih uputa: 1. Izvadite bočicu iz zamrzivača i ostavite da se sadržaj odmrzne pri sobnoj temperaturi (traje oko 2
English: Ophthalmological examinations may be abnormal following the administration of JETREA.
Croatian: Nalazi oftalmoloških pretraga nakon primjene JETREE mogu biti abnormalni.
English: Intravitreal use after dilution.
Croatian: Intravitrealna primjena nakon razrjeđivanja.
English: The proportion of patients with ≥3 lines improvement from baseline was only greater in the JETREA group (23.4% vs. 12.8%, respectively) in the subgroup who had no FTMH at baseline.
Croatian: Udio bolesnika sa ≥ 3 reda poboljšanja u odnosu na početno mjerenje bio je veći samo u JETREA skupini (23,4% naspram 12,8%), u podskupini koja nije imala FTMH na početku ispitivanja.
English: Patients with a smaller VMA diameter at baseline (≤ 1500 microns) were more likely to achieve VMA resolution at Day 28 compared with those who had a diameter > 1500 microns.
Croatian: U bolesnika s manjim promjerom VMA na početku ispitivanja (≤ 1500 mikrona) postojala je veća sklonost povlačenja VMA do 28. dana nego u onih s promjerom VMA > 1500 mikrona.
English: The injection volume of 0.1 mL is then delivered into the mid-vitreous.
Croatian: Injekcijski volumen od 0,1 ml potom se aplicira u sredinu staklovine.
English: No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with renal impairment since the systemic exposure is expected to be very low after intravitreal administration.
Croatian: Ispitivanja farmakokinetike okriplazmina u bolesnika s oštećenjem funkcije bubrega nisu provedena jer se očekuje da sistemska izloženost bude vrlo mala nakon intravitrealne primjene.
English: Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving injections into the eye.
Croatian: Jetreu smije davati samo kvalificirani oftalmolog (specijalist za oko) koji ima iskustvo u davanju injekcija u oko.
English: Ethnicity Experience is limited in groups other than Caucasians.
Croatian: Etnička pripadnost Iskustvo s ostalim rasama, osim bijele, je ograničeno.
English: JETREA treated patients were less likely to have had a vitrectomy by the end of the study (Month 6) compared with placebo treated patients (integrated data: 17.7% vs. 26.6%, respectively; p=0.016).
Croatian: JETREOM vitrektomija je do kraja ispitivanja (6. mjesec) bila rjeđe indicirana nego u onih koji su primili placebo (integrirani podaci: 17,7% nasuprot 26,6%; p=0,016).
English: In a clinical study in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical start concentration of 29 µg/mL vitreous), mean ocriplasmin activity was 9% of theoretical start concentration 2-4 hours after injection and below the lower level of quantification at 7 days.
Croatian: U kliničkom ispitivanju bolesnika predviđenih za vitrektomiju koji su primili 0,125 mg JETREE (što odgovara teoretskoj početnoj koncentraciji 29 µg/ml staklovine), srednja vrijednost aktivnosti okriplazmina 2-4
English: In the integrated data, full-thickness macular hole (FTMH) was present at baseline in 106/464 (22.8%) patients and 47/188 (25%) patients in the JETREA and placebo groups, respectively.
Croatian: U integriranim podacima, makularna rupa pune debljine (engl. full-thickness macular hole, FTMH) bila je prisutna na početku ispitivanja kod 106/464 (22,8%) bolesnika u JETREA skupini i 47/188 (25%) bolesnika u placebo skupini.
English: A significantly higher percentage of JETREA treated patients experienced total PVD at Day 28 compared to placebo treated patients (integrated data: 13.4% vs. 3.7%, respectively; p<0.001).
Croatian: Značajno veći postotak bolesnika liječenih JETREOM iskusili su potpuno stražnje odvajanje staklovine 28. dana u usporedbi s placebom liječenim bolesnicima (integrirani podaci: 13,4% nasuprot 3,7%, p<0,001).
English: All adverse reactions were ocular.
Croatian: Sve nuspojave bile su okularne.
English: For storage conditions after thawing/opening of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon odmrzavanja/otvaranja lijeka vidjeti dio 6.3.
English: In both pivotal studies, the proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was significantly (p≤0.003) higher in the JETREA group compared with the placebo group.
Croatian: U oba pivotalna ispitivanja udio bolesnika u kojih se VMA povukla 28. dana (primarni ishod) bio je značajno veći (p≤0,003) u JETREA skupini u usporedbi s placebo skupinom.
English: The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Croatian: Postupak davanja intravitrealne injekcije mora se obaviti u nadziranim aseptičnim uvjetima, koji uključuju kiruršku dezinfekciju ruku, sterilne rukavice, sterilni ogrtač, sterilni spekulum za vjeđe (ili ekvivalent) i dostupnost sterilne paracenteze (u slučaju potrebe).