FrancophonIA/ELRC3.0 huggingface dataset:
English: Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
Croatian: Stoga treba pratiti intraokularni tlak i perfuziju glave optičkog živca i primjereno intervenirati.
English: Table 9 Outcomes at Months 6 and 24 (BRIGHTER and CRYSTAL)
Croatian: Tablica 9 Ishodi u 6. i 24. mjesecu (BRIGHTER i CRYSTAL)
English: However, there was no consistent pattern among the different haemorrhages.
Croatian: Nije, međutim, bilo dosljednog uzorka u različitim krvarenjima.
English: The nature and timing of the posterior segment inflammation is suggestive of an immune-mediated antibody response, which may be clinically irrelevant.
Croatian: Priroda i trenutak pojave upale u stražnjem segmentu upućuju na imunološki posredovan odgovor antitijelima, no to ne mora biti klinički značajno.
English: Please also refer to section 3 “How Lucentis is given”.
Croatian: Molimo vidjeti i dio 3 „Kako primjenjivati Lucentis“.
English: Intraocular pressure increases
Croatian: Povišeni intraokularni tlak
English: Overall, ranibizumab treatment was well tolerated.
Croatian: Općenito se terapija ranibizumabom dobro podnosila.
English: You must not receive Lucentis - If you are allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primati Lucentis - Ako ste alergični na ranibizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
Croatian: Prilikom pražnjenja bočice osigurajte da se klip štrcaljke povuče dovoljno unazad kako bi se potpuno ispraznila igla s filterom.
English: Each prefilled syringe should only be used for the treatment of a single eye.
Croatian: Svaka napunjena štrcaljka mora se koristiti samo za primjenu na jednom oku.
English: • a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity;
Croatian: • da se najbolje korigirana vidna oštrina (BCVA) smanjila za ≥30 slova u odnosu na prethodnu kontrolu;
English: For the treatment of babies born prematurely with retinopathy of prematurity (ROP) please see the other side of this leaflet.
Croatian: Za liječenje prijevremeno rođene dojenčadi s retinopatijom nedonoščadi (ROP) pogledajte drugu stranu ove upute.
English: Patients should also be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
Croatian: Bolesnike također treba uputiti da prijave pogoršanje intraokularne infekcije, što može biti klinički znak pripisiv intraokularnom stvaranju antitijela.
English: In DME studies, the improvement in BCVA was accompanied by a reduction over time in mean CSFT in all the treatment groups.
Croatian: U ispitivanjima DME-a, poboljšanje BCVA bilo je popraćeno smanjenjem tijekom vremena u srednjem CSFT-u u svim terapijskim skupinama.
English: What Lucentis is and what it is used for
Croatian: Što je Lucentis i za što se koristi
English: • At request of the European Medicines Agency;
Croatian: Ažurirani RMP treba dostaviti: na zahtjev Europske agencije za lijekove;
English: The effect in terms of visual improvement was observed in all patients treated with 0.5 mg ranibizumab monotherapy regardless of their disease duration in both BRIGHTER and CRYSTAL.
Croatian: Učinak u smislu poboljšavanja vida bio je opažen u svih bolesnika liječenih monoterapijom s 0,5 mg ranibizumaba bez obzira na trajanje njihove bolesti u oba ispitivanja, BRIGHTER i CRYSTAL.
English: The primary endpoint was the mean visual acuity change at year 2.
Croatian: Primarni ishod bio je promjena u srednjoj vidnoj oštrini nakon 2 godine.
English: Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects.
Croatian: Obostrana intravitrealna primjena ranibizumaba cinomolgus majmunima u dozama od 0,25 mg/oku do 2,0 mg/oku jednom svaka 2 tjedna do 26 tjedana rezultirala je oftalmičkim učincima ovisnim o dozi.
English: Table 2 Outcomes at Month 3 and 12 (RADIANCE)
Croatian: Tablica 2 Ishodi nakon 3. i 12. mjeseca (RADIANCE)
English: The doctor will monitor the condition of your baby's eye(s) and, depending on how your baby responds to the treatment, will decide if and when further treatment is needed.
Croatian: Liječnik će kontrolirati stanje oka (očiju) Vašeg djeteta te, ovisno o tome kako dijete reagira na terapiju, odlučiti treba li i kada nastaviti s liječenjem.
English: All components are sterile.
Croatian: Sve su komponente sterilne.
English: Eye disorders Very common
Croatian: Poremećaji oka Vrlo često
English: 9.5 letters
Croatian: 9,5 slova
English: BCVA improved from baseline to Month 12 in all five patients, ranging from 5 to 38 letters (mean of 16.6 letters).
Croatian: BCVA se poboljšao od početne vrijednosti do 12. mjeseca u svih pet bolesnika, a kretala se od 5 do 38 slova (srednja vrijednost 16,6 slova).
English: All components are sterile and for single use only.
Croatian: Sve su komponente sterilne i samo za jednokratnu uporabu.
English: What you need to know before you are given Lucentis
Croatian: Što morate znati prije nego primite Lucentis
English: In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, DME, PDR, RVO, PM and CNV.
Croatian: Ako ga ima previše, VEGF-A uzrokuje abnormalan rast krvnih žila i oticanje u oku koje može dovesti do oštećenja vida u bolestima kao što su AMD, DME, PDR, RVO, PM i CNV.
English: Unfavourable structural outcomes were less frequently reported for ranibizumab 0.2 mg (1 patient, 1.4%) compared with laser therapy (7 patients, 10.1%).
Croatian: Nepovoljni strukturalni ishodi bili su rjeđe prijavljivani za ranibizumab 0,2 mg (1 bolesnik, 1,4%) u usporedbi s laserskom terapijom (7 bolesnika, 10,1%).
English: The safety and efficacy of ranibizumab have not yet been established in paediatric patients.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost ranibizumaba u pedijatrijskoj populaciji još nije ustanovljena.
English: Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD and potentially also other forms of CNV, include a large and/or high pigment epithelial retinal detachment.
Croatian: Čimbenici rizika povezani s razderotinom pigmentnog epitela mrežnice nastalom nakon primjene antiVEGF lijekova u svrhu liječenja vlažnog AMD-a a potencijalno i drugih oblika CNV-a, uključuju opsežnu i/ili visoku ablaciju pigmentnog epitela mrežnice.
English: Table 7 DRSS improvement or worsening of ≥2 or ≥3 steps at year 1 in Protocol S (LOCF Method)
Croatian: Tablica 7 Poboljšanje ili pogoršanje u DRSS-u za ≥2 ili ≥3 koraka nakon 1 godine u Protokolu
English: Before stopping Lucentis treatment
Croatian: Prije prestanka liječenja Lucentisom
English: It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
Croatian: Također može biti povezan s neovaskularizacijom žilnice (CNV) nastalom kao posljedica patološke miopije (PM), angioidnim prugama, centralnom seroznom korioretinopatijom ili upalnim CNV-om.
English: Note: The dose must be set to 0.05 ml.
Croatian: Napomena: Doza mora biti podešena na 0,05 ml.
English: For the adjunctive use of laser photocoagulation and Lucentis in DME and BRVO, see sections 4.2 and 5.1.
Croatian: Za zajedničku primjenu laserske fotokoagulacije i Lucentisa kod DME-a i BRVO-a, vidjeti dijelove 4.2 i 5.1.
English: These side effects may also occur in babies born prematurely.
Croatian: Ove nuspojave također se mogu javiti u prijevremeno rođene dojenčadi.
English: In this study 178 adult patients were randomised in a 2:1 ratio to receive:
Croatian: U tom ispitivanju 178 odraslih bolesnika bilo je randomizirano u omjeru 2:1 da primaju:
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Croatian: Injekcije treba primjenjivati u aseptičnim uvjetima, što uključuje kiruršku dezinfekciju ruku, sterilne rukavice, sterilni prekrivač, sterilni spekulum za očni kapak (ili ekvivalentni instrument) i raspoloživost sterilne paracenteze (ako bude potrebno).
English: What Lucentis looks like and contents of the pack Lucentis is a solution for injection in a vial (0.23 ml).
Croatian: Kako Lucentis izgleda i sadržaj pakiranja Lucentis je otopina za injekciju u bočici (0,23 ml).
English: The opening of the sealed tray and all subsequent steps should be done under aseptic conditions.
Croatian: Otvaranje zatvorene kasete, kao i sve naknadne korake primjene lijeka treba obaviti u aseptičnim uvjetima.
English: Carefully remove the needle cap by pulling it straight off (see Figure 5).
Croatian: 8. Pažljivo uklonite poklopac igle povlačeći ga ravno prema gore (vidjeti Sliku 5).
English: Introduction Read all the instructions carefully before using the pre-filled syringe.
Croatian: Pažljivo pročitajte sve upute prije primjene napunjene štrcaljke.
English: Limited data on bilateral use of Lucentis (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.
Croatian: Podaci o primjeni Lucentisa u oba oka (uključujući primjenu u istom danu) su ograničeni i ne ukazuju na povećani rizik od sistemskih štetnih događaja u usporedbi s primjenom u jedno oko.
English: The number of scheduled treatment visits after the initial 3 injections, was 13 and 20 for the TE and PRN regimens, respectively.
Croatian: Broj planiranih posjeta za primjenu terapije nakon početne 3 injekcije za LIP režim bio je 13, odnosno 20 za p.p. režim.
English: Most patients (78%) in the conducted clinical study received one injection per eye.
Croatian: Većina bolesnika (78%) u provedenom kliničkom ispitivanju primila je jednu injekciju po oku.
English: In patients with <3 months disease duration an increase in visual acuity of 13.3 and 10.0 letters was seen at Month 1; and 17.7 and 13.2 letters at Month 24 in BRIGHTER and CRYSTAL, respectively.
Croatian: U bolesnika s trajanjem bolesti od <3 mjeseca u 1. mjesecu uočeno je povećanje vidne oštrine od 13,3 odnosno 10,0 slova; te od 17,7 odnosno 13,2 slova u 24. mjesecu u ispitivanjima BRIGHTER i CRYSTAL.
English: Post-authorisation efficacy study (PAES): CRFB002H2301E1
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (engl. post-authorisation efficacy study, PAES): CRFB002H2301E1
English: In both studies, the improvement of vision was accompanied by a continuous and significant reduction in the macular oedema as measured by central retinal thickness.
Croatian: U oba ispitivanja, poboljšanje vida bilo je popraćeno stalnim i značajnim smanjenjem makularnoga edema na koje su ukazivali rezultati mjerenja centralne debljine mrežnice.
English: Your baby's doctor may monitor this after each injection.
Croatian: Liječnik Vašeg djeteta će provjeravati očni tlak nakon svake injekcije.
English: Nevertheless, a case was described with high maternal ranibizumab serum levels and presence of ranibizumab in foetal serum, suggesting that the anti-ranibizumab antibody acted as (Fc region containing) carrier protein for ranibizumab, thereby decreasing its maternal serum clearance and enabling its placental transfer.
Croatian: Ipak, opisan je slučaj s visokim razinama ranibizumaba u serumu majke i prisutnošću ranibizumaba u serumu fetusa, što navodi na zaključak da je anti-ranibizumab protutijelo djelovalo kao proteinski nosač (koji sadrži Fc regiju) za ranibizumab, čime se smanjuje njegov klirens iz seruma majke i omogućuje njegov prijenos kroz posteljicu.
English: Additional side effects that have been observed with Lucentis in adults are listed below.
Croatian: Dodatne nuspojave koje su opažene kada je Lucentis primjenjivan u odraslih su navedene ispod.
English: Patients randomised to vPDT were allowed to receive ranibizumab treatment as of Month 3 (in Group III, 38 patients received ranibizumab as of Month 3)
Croatian: Bolesnici randomizirani na vPDT smjeli su primati terapiju ranibizumabom od 3. mjeseca (u III. skupini 38 bolesnika primalo je ranibizumab od 3. mjeseca)
English: Most patients (78%) in the clinical study received one injection per eye.
Croatian: Većina bolesnika (78%) u kliničkom ispitivanju primila je jednu injekciju po oku.
English: Lucentis can be administered in patients who have received previous laser photocoagulation.
Croatian: Lucentis se može primijeniti u bolesnika koji su ranije podvrgavani laserskoj fotokoagulaciji.
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Croatian: Postoji teoretski rizik za arterijske tromboembolijske događaje koji uključuju moždani udar i infarkt miokarda, nakon intravitrealne primjene VEGF inhibitora.
English: If, in the physician's opinion, visual and anatomical parameters indicate that the patient is not benefiting from continued treatment, Lucentis should be discontinued.
Croatian: Ako po liječnikovom mišljenju parametri vidne oštrine i anatomski parametri upućuju na to da bolesnik nema koristi od nastavka liječenja, primjenu Lucentisom potrebno je prekinuti.
English: Key outcome measures from BRAVO and CRUISE are summarised in Table 8 and Figures 5 and 6.
Croatian: Ključni pokazatelji ishoda iz ispitivanja BRAVO i CRUISE sažeto su prikazani u Tablici 8 te na Slikama 5 i 6.
English: Your baby must not receive Lucentis - If your baby is allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Vaše dijete ne smije primati Lucentis - Ako je Vaše dijete alergično na ranibizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Lucentis is indicated in preterm infants for:
Croatian: Lucentis je indiciran u prijevremeno rođene dojenčadi za:
English: Laser therapy (N=74)
Croatian: Laserska terapija (N=74)
English: Additionally, change in diabetic retinopathy (DR) severity was assessed based on fundus photographs using the DR severity score (DRSS).
Croatian: Dodatno, promjena u težini dijabetičke retinopatije (DR) procijenjena je na temelju fotografija očne pozadine koristeći ocjenu težine dijabetičke retinopatije (engl. diabetic retinopathy severity score, DRSS).
English: Patient numbers [n] (treatment +sham)
Croatian: Broj bolesnika [n] (terapija + placebo postupak)
English: It is important to identify and treat serious side effects such as infection of the eyeball or retinal detachment as soon as possible.
Croatian: Važno je što prije otkriti i liječiti ozbiljne nuspojave kao što su infekcija očne jabučice ili odignuće mrežnice.
English: 1x 0.23 ml vial, 1 filter needle.
Croatian: 1x 0,23 ml bočica, 1 igla s filterom.
English: There are insufficient data to conclude on the effect of Lucentis in patients with RVO presenting irreversible ischaemic visual function loss.
Croatian: Nema dovoljno podataka da bi se donio zaključak o učinku Lucentisa u bolesnika s RVO-om u kojih je došlo do ireverzibilnog gubitka vidne funkcije zbog ishemije.
English: Granulomatous inflammatory changes were noted in the optic disc of some eyes.
Croatian: U optičkom disku nekih očiju uočene su granulomatozne upalne promjene.
English: The pre-filled syringe has a plunger rod and a finger grip, and is packed in a sealed tray.
Croatian: Napunjena štrcaljka sadrži potisni klip i hvatište za prst, a pakirana je u zatvorenoj kaseti.
English: Table 6 Outcomes in study D2304 (RETAIN)
Croatian: Tablica 6 Ishodi u ispitivanju D2304 (RETAIN)
English: Lucentis is used in babies born prematurely to treat retinopathy of prematurity (ROP), a disease causing vision impairment due to damage to the back of the eye (the retina) caused by abnormal growth of blood vessels.
Croatian: Lucentis se koristi u prijevremeno rođene dojenčadi za liječenje retinopatije nedonoščadi (ROP), bolesti koja uzrokuje oštećenje vida zbog oštećenja stražnjeg dijela oka (mrežnice), a uzrokovana je poremećenim rastom krvnih žila.
English: The safety and efficacy of Lucentis in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost Lucentisa u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Upon opening of the sealed tray, proceed under aseptic conditions.
Croatian: Nakon otvaranja zatvorene kasete, nastavite s postupkom u aseptičnim uvjetima.
English: Do not use the pre-filled syringe if the solution is discoloured, cloudy or contains particles.
Croatian: Nemojte koristiti napunjenu štrcaljku ako je otopina promijenila boju, ako je zamućena ili sadrži vidljive čestice.
English: For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis in wet AMD and PM, see section 5.1.
Croatian: Za zajedničku primjenu fotodinamske terapije (PDT) verteporfinom i Lucentisa kod vlažnog AMD-a i PM-a, vidjeti dio 5.1.
English: BABIES BORN PREMATURELY
Croatian: Prijevremeno rođena dojenčad
English: In RVO patients, 48.2% (253 of 525) had renal impairment (36.4% mild, 9.5% moderate and 2.3% severe).
Croatian: U bolesnika s RVO-om, 48,2% (253 od 525) bolesnika imalo je oštećenje bubrega (36,4% blago, 9,5% umjereno, a 2,3% teško).
English: For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).
Croatian: Za CNV nastao kao posljedica patološke miopije (PM), mnogim bolesnicima će možda biti potrebna samo jedna ili dvije injekcije tijekom prve godine (vidjeti dio 5.1).
English: Single dose for babies born prematurely: 0.2 mg/0.02 ml.
Croatian: Jednokratna doza za prijevremeno rođenu dojenčad: 0,2 mg/0,02 ml.
English: A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
Croatian: Zapažena je niska stopa incidencije arterijskih tromboembolijskih događaja u kliničkim ispitivanjima Lucentisa u bolesnika s AMD-om, DME-om, PDR-om, RVO-om i CNV-om te nije bilo većih razlika među skupinama liječenih ranibizumabom u usporedbi s kontrolnim skupinama.
English: N/A N/A
Croatian: N/P N/P
English: Ranibizumab 0.2 mg vs laser
Croatian: Ranibizumab 0,2 mg naspram lasera
English: Ask your doctor or pharmacist for advice before Lucentis treatment.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete Lucentis.
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 intraokularni tlak i liječiti ga, ako liječnik koji liječi bolesnika ocijeni da je to nužno.
English: Withholding Lucentis in adults
Croatian: Nedavanje Lucentisa u odraslih
English: After 6 months, subjects in the laser arm could receive 0.5 mg ranibizumab.
Croatian: Nakon 6 mjeseci, ispitanici u skupini s laserom mogli su primati 0,5 mg ranibizumaba.
English: In a population pharmacokinetic analysis of neovascular AMD patients, 68% (136 of 200) of patients had renal impairment (46.5% mild [50-80 ml/min], 20% moderate [30-50 ml/min], and 1.5% severe [<30 ml/min]).
Croatian: U analizi populacijske farmakokinetike u bolesnika s neovaskularnim AMD-om, 68% (136 od 200) bolesnika imalo je oštećenje bubrega (46,5% blago [50-80 ml/min], 20% umjereno [30-50 ml/min], a 1,5% teško [<30 ml/min]).
English: Cmax was dose proportional over the dose range of 0.05 to 1.0 mg/eye.
Croatian: Cmax bila je razmjerna dozi u rasponu doza od 0,05 do 1,0 mg/oku.
English: Any component with packaging showing signs of damage or tampering must not be used.
Croatian: Komponente pakiranja na kojem ima znakova oštećenja ili neovlaštenog otvaranja ne smiju se koristiti.
English: After an initial increase in visual acuity (following monthly dosing), on average, patients' visual acuity declined with quarterly dosing, returning to baseline at Month 12 and this effect was maintained in most ranibizumab-treated patients (82%) at Month 24.
Croatian: Nakon početnog poboljšanja vidne oštrine (nakon doziranja jednom mjesečno), ona se, u prosjeku, smanjila u bolesnika koji su Lucentis nastavili primati jednom svaka tri mjeseca te se u 12. mjesecu vratila na početnu razinu, a taj se učinak zadržao kod većine bolesnika liječenih ranibizumabom (82%) u 24. mjesecu.
English: The key outcomes from RADIANCE are summarised in Table 2 and Figure 2.
Croatian: Ključni ishodi ispitivanja RADIANCE sažeti su u Tablici 2 i Slici 2.
English: Sustained IOP increases have also been identified (see section 4.8).
Croatian: Također su uočeni slučajevi produljenog porasta intraokularnog tlaka (vidjeti dio 4.8).
English: Uncommon serious side effects (may affect up to 1 in 100 people): Blindness, infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye.
Croatian: Manje česte ozbiljne nuspojave (mogu se javiti u 1 na svakih 100 osoba): sljepoća, infekcija očne jabučice (endoftalmitis) s upalom unutrašnjosti oka.
English: Month 1 to Month 24 (SD)
Croatian: 24. mjeseca 24 (SD)
English: 0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter.
Croatian: 0,165 ml sterilne otopine u napunjenoj štrcaljki (staklo tip I) s brombutilnim gumenim čepom i poklopcem za štrcaljku koji se sastoji od bijelog, čvrstog zaštitnog zatvarača sa sivom brombutilnom gumenom kapicom i adaptera s Luer zatvaračem.
English: Figure 4 Figure 5
Croatian: Slika 4 Slika 5
English: intraocular inflammation, retinal detachment & retinal tear and infectious endophthalmitis
Croatian: intraokularnu upalu, ablaciju mrežnice i razderotinu mrežnice i infektivni endoftalmitis
English: (letters) (SD) Gain of ≥15 letters in BCVA at Month 24 (%) Mean number of injections (SD) (months 0-23)
Croatian: (slova) (SD) Povećanje od ≥15 slova u BCVA-u u 24. mjesecu (%) Srednji broj injekcija (SD) (mjeseci 0-23)
English: Patients treated with Lucentis in PIER received a mean of 10 total treatments.
Croatian: Bolesnici koji su u ispitivanju PIER liječeni Lucentisom primili su prosječno ukupno 10 injekcija.
English: What Lucentis is
Croatian: Što je Lucentis
English: Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Dostupni podaci u bolesnika u dobi od 12 do 17 godina s oštećenjem vida uzrokovanim CNV-om opisani su u dijelu 5.1, ali ne mogu se dati nikakve preporuke za doziranje.
English: Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
Croatian: Iglu s filterom gurajte kroz sredinu čepa bočice sve dok igla ne dotakne dno bočice.
English: Please tell the doctor immediately if your baby develops signs such as eye pain or worsening eye redness.
Croatian: Molimo odmah obavijestite liječnika ako se kod Vašeg djeteta razviju znakovi kao što su bol u oku ili pogoršanje crvenila oka.
English: The safety of Lucentis 0.2 mg was studied in a 6-month clinical trial (RAINBOW), which included 73 preterm infants with ROP treated with ranibizumab 0.2 mg (see section 5.1).
Croatian: Sigurnost Lucentisa 0,2 mg ispitivana je u 6-mjesečnom kliničkom ispitivanju (RAINBOW), koje je uključivalo 73 prijevremeno rođene dojenčadi s ROP-om liječenih ranibizumabom 0,2 mg (vidjeti dio 5.1).
English: Key outcome measures from MINERVA are summarised in Table 3 and Figure 3.
Croatian: Ključne mjere ishoda iz ispitivanja MINERVA sažete su u Tablici 3 i Slici 3.
English: Talk to your doctor before you are given Lucentis.
Croatian: Obratite se svom liječniku prije nego primite Lucentis.