FrancophonIA/ELRC3.0 huggingface dataset:
English: In the laser group 67 patients received rescue treatment with Eylea beginning at week 24 (Active Control/ Eylea 2mg group), which resulted in improvement of visual acuity by about 5 letters from week 24 to 52.
Slovenian: V kontrolni skupini z laserskim zdravljenjem je 67 bolnikov v začetku 24. tedna prejelo rešilno zdravljenje z zdravilom Eylea (aktivna kontrola/zdravilo Eylea 2 mg), kar se je kazalo v izboljšanju ostrine vida za 5 črk od 24. do 52. tedna.
English: At week 24, the reduction in CRT was statistically superior versus control in all three studies (COPERNICUS in CRVO: -457 vs. -145 microns; GALILEO in CRVO: -449 vs. -169 microns; VIBRANT in BRVO:280 vs. -128 microns).
Slovenian: V 24. tednu je bilo zmanjšanje CRT superiorno v primerjavi s kontrolno skupino v vseh treh študijah (COPERNICUS pri CRVO: -457 oziroma -145 mikronov; GALILEO pri CRVO: -449 oziroma -169 mikronov; VIBRANT pri BRVO: -280 oziroma -128 mikronov).
English: There is only limited experience in the treatment of subjects with DME due to type I diabetes or in diabetic patients with an HbA1c over 12% or with proliferative diabetic retinopathy.
Slovenian: Izkušnje z zdravljenjem bolnikov z diabetičnim makularnim edemom zaradi sladkorne bolezni tipa I ali bolnikov s sladkorno boleznijo, pri katerih je HbA1c več kot 12 % ali s proliferativno diabetično retinopatijo, so omejene.
English: Thereafter, plasma concentrations of free aflibercept declined to values below or close to the lower limit of quantitation generally within one week; undetectable concentrations were reached before the next administration after 4 weeks in all patients.
Slovenian: Plazemske koncentracije prostega aflibercepta so se znižale do vrednosti pod ali blizu spodnje meje običajno v enem tednu; pred naslednjim injiciranjem po 4 tednih so bile koncentracije pri vseh bolnikih nezaznavne.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Eylea in all subsets of the paediatric population in wet AMD, CRVO, BRVO, DME and myopic CNV populations (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Eylea za vse podskupine pediatrične populacije z vlažno AMD, CRVO, BRVO, DME in miopično CNV (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In patients treated with 6 consecutive monthly injections of Eylea 2mg, there was a consistent, rapid and robust morphologic response (as measured by improvements in mean CRT) observed.
Slovenian: Pri bolnikih, zdravljenih s 6 zaporednimi mesečnimi injekcijami zdravila Eylea 2 mg je bil opažen dosleden, hiter in robusten morfološki odgovor (na podlagi meritev izboljšanj povprečne CRT).
English: Aflibercept, the active substance in Eylea, blocks the activity of a group of factors, known as Vascular Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor (PlGF).
Slovenian: Aflibercept, učinkovina v zdravilu Eylea, zavira delovanje skupine dejavnikov, znanih kot VEGF-A (žilni endotelijski rastni dejavnik A) in PlGF (placentni rastni dejavnik).
English: In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Slovenian: V tednu po prejemu injekcije je treba bolnike dodatno spremljati, da se, v primeru okužbe, lahko začne zgodnje zdravljenje.
English: Leakage of blood and fluid from CNV may cause retinal thickening or oedema and/or sub-/intra-retinal haemorrhage, resulting in loss of visual acuity.
Slovenian: Iztekanje krvi in tekočin iz CNV lahko povzroči zadebelitev ali edem mrežnice in/ali sub-/intraretinalno krvavitev ter posledično izgubo ostrine vida.
English: The adverse reactions are listed by system organ class and frequency using the following convention:
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti kot sledi:
English: Bayer AG Müllerstraße 178 13353 Berlin Germany
Slovenian: Bayer AG Müllerstraße 178 13353 Berlin Nemčija
English: In the wet AMD phase III studies, there was an increased incidence of conjunctival haemorrhage in patients receiving anti-thrombotic agents.
Slovenian: V študijah III. faze pri bolnikih z vlažno AMD je bila povečana incidenca krvavitev pod očesno veznico pri bolnikih, ki so prejemali antitrombotike.
English: • The need to expel excess volume of the syringe before injecting Eylea to avoid overdose
Slovenian: • iztis odvečnega volumna iz injekcijske brizge pred injiciranjem zdravila Eylea v izogib prevelikemu odmerjanju
English: - if you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may have eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, and increased sensitivity to light.
Slovenian: - Če imate okužbo ali vnetje v očesu (endoftalmitis) ali druge zaplete, se vam lahko pojavijo bolečine v očesu ali poslabša neprijeten občutek v očesu, poveča pordelost očesa, pojavi zamegljen vid ali poslabša ostrina vida in poveča občutljivost za svetlobo.
English: When ready to administer Eylea, open the carton and remove the sterilized blister.
Slovenian: Ko ste pripravljeni za aplikacijo zdravila Eylea, odprite škatlo in odstranite steriliziran pretisni omot.
English: Diabetic macular oedema is a consequence of diabetic retinopathy and is characterised by increased vasopermeability and damage to the retinal capillaries which may result in loss of visual acuity.
Slovenian: Diabetični makularni edem je posledica diabetične retinopatije in zanj sta značilna povečana žilna prepustnost in poškodbe mrežničnih kapilar, kar lahko povzroči izgubo ostrine vida.
English: In the laser group, where patients were eligible for rescue treatment with Eylea from week 24, the proportion of perfused patients increased to 78% by week 52.
Slovenian: V kontrolni skupini z laserskim zdravljenjem, kjer so bili od 24. tedna bolniki primerni za rešilno zdravljenje z zdravilom Eylea, se je delež perfundiranih bolnikov do 52. tedna povečal na 78 %.
English: • Eylea should not be used in pregnancy unless the potential benefit outweighs the potential risk to the foetus (see section 4.6).
Slovenian: • Zdravila Eylea se ne sme uporabljati med nosečnostjo, razen če so možne koristi večje od možnega tveganja za plod (glejte poglavje 4.6).
English: There is only limited experience in the treatment of - patients with DME due to type I diabetes.
Slovenian: Izkušnje so omejene pri zdravljenju - bolnikov z DME zaradi sladkorne bolezni tipa I,
English: Wet AMD is characterised by pathological choroidal neovascularisation (CNV).
Slovenian: Za vlažno AMD je značilna patološka horoidalna neovaskularizacija (CNV).
English: • The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: o a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; o a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50%, of the total lesion area.
Slovenian: • Z zdravljenjem je treba prenehati in se ga ne sme ponovno začeti prej kot ob naslednjem načrtovanem odmerku v naslednjih primerih: zmanjšana najboljša korigirana ostrina vida (BCVA) > 30 črk v primerjavi z zadnjo oceno ostrine vida, krvavitev pod mrežnico, tudi v vidni jamici (fovea centralis), ali če je velikost krvavitve > 50 % celotne lezije.
English: It develops as a wound healing mechanism consequent to Bruch's membrane ruptures and represents the most vision-threatening event in pathologic myopia.
Slovenian: Razvije se kot mehanizem za celjenje ran, ki so posledice ruptur Bruchove membrane in najbolj ogrožajo vid pri patološki kratkovidnosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/797/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/797/001
English: In the clinical trials, there was an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage) in patients with wet AMD receiving blood thinners.
Slovenian: V kliničnih preskušanjih je bila povečana pogostnost krvavitve iz manjših krvnih žil v zunanje plasti očesa (krvavitev pod veznico) pri bolnikih z vlažno starostno degeneracijo makule, ki so prejemali zdravila za redčenje krvi.
English: An effect of aflibercept on intrauterine development was shown in embryo-foetal development studies in pregnant rabbits with intravenous (3 to 60 mg/kg) as well as subcutaneous (0.1 to 1 mg/kg) administration.
Slovenian: Učinek aflibercepta na intrauterini razvoj se je pokazal v študiji razvoja zarodka/ploda pri brejih kunčjih samicah po intravenski (3 do 60 mg/kg) in po subkutani uporabi (0,1 do 1 mg/kg).
English: As this is a therapeutic protein, there is a potential for immunogenicity with Eylea (see section 4.8).
Slovenian: Ker je aflibercept terapevtski protein, obstaja možnost za imunogenost zdravila Eylea (glejte poglavje 4.8).
English: The maximal improvement in visual acuity was achieved at month 3 with subsequent stabilisation of visual acuity and CRT until month 6.
Slovenian: V obeh ključnih študijah je bilo največje izboljšanje ostrine vida doseženo v tretjem mesecu, ki mu je sledila stabilizacija ostrine vida in CRT do šestega meseca.
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Slovenian: Teoretično obstaja tveganje za arterijske trombembolične dogodke, tudi možgansko kap in miokardni infarkt, po intravitrealni uporabi zaviralcev VEGF.
English: Active Control (laser)
Slovenian: aktivna kontrola (lasersko zdravljenje
English: A total of 121 patients were treated and evaluable for efficacy (90 with Eylea).
Slovenian: Zdravili so skupno 121 bolnikov in pri njih je bila ocenjena učinkovitost (90 bolnikov je bilo zdravljenih z zdravilom Eylea).
English: As with all therapeutic proteins, there is a possibility for an immune reaction (formation of antibodies) with Eylea.
Slovenian: Kot pri vseh terapevtskih beljakovinah obstaja možnost imunske reakcije (nastanka protiteles) z zdravilom Eylea.
English: Eylea is for intravitreal injection only.
Slovenian: Zdravilo Eylea je samo za intravitrealno injiciranje.
English: In the Eylea group the proportion of perfused patients was maintained through week 52.
Slovenian: V skupini, ki je prejemala zdravilo Eylea se je delež perfundiranih bolnikov ohranil do 52. tedna.
English: The extractable volume of the vial (100 microlitres) is not to be used in total.
Slovenian: Vsebina viale (100 mikrolitrov) se ne porabi v celoti.
English: 1 ml solution for injection contains 40 mg aflibercept*.
Slovenian: 1 ml raztopine za injiciranje vsebuje 40 mg aflibercepta*.
English: In CRVO and BRVO, retinal ischaemia occurs and signals the release of VEGF which in turn destabilises the tight junctions, and promotes endothelial cell proliferation.
Slovenian: Pri CRVO in BRVO se pojavi ishemija mrežnice in spodbuja sproščanje VEGF, ki nato destabilizira tesne stike med endotelijskimi celicami in spodbuja njihovo proliferacijo.
English: 24 Weeks
Slovenian: 24 tednov
English: Instructions for use of vial:
Slovenian: Navodilo za uporabo viale
English: Manufacturer Bayer AG Müllerstraße 178 13353 Berlin Germany
Slovenian: Izdelovalec Bayer AG Müllerstraße 178 13353 Berlin Nemčija
English: After the initial injection, treatment is given monthly.
Slovenian: Po začetni injekciji se zdravilo aplicira enkrat na mesec.
English: (95% CI) p-value p<0.0001
Slovenian: (95 % IZ) vrednost p p < 0,0001
English: A total of 181 patients were treated and evaluable for efficacy (91 with Eylea).
Slovenian: V študiji so zdravili skupno 181 bolnikov in pri njih je bila ocenjena učinkovitost (91 bolnikov je bilo zdravljenih z zdravilom Eylea).
English: Eylea is a solution for injection (injection) in a vial (4 mg/100 microlitres).
Slovenian: Zdravilo Eylea je raztopina za injiciranje (injekcija) v viali (4 mg/100 mikrolitrov).
English: Patients with bilateral disease were eligible to receive anti-VEGF treatment in their fellow eye if assessed necessary by the physician.
Slovenian: Bolnike, pri katerih sta bili prizadeti obe očesi, so zdravili z zaviralci VEGF na drugem očesu, če je zdravnik presodil, da je to potrebno.
English: Eylea is a solution which is injected into the eye to treat eye conditions in adults called
Slovenian: Zdravilo Eylea je raztopina, ki se injicira v oko za zdravljenje očesnih bolezni pri odraslih, imenovanih
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/797/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/797/002
English: Figure 5:
Slovenian: Slika 5:
English: E) Beginning at week 24 subjects in the Laser Group could receive rescue treatment with Eylea, if they met at least one pre-specified eligibility criterion.
Slovenian: V začetku 24. tedna so bolniki v kontrolni skupini z laserskim zdravljenjem lahko prejeli rešilno zdravljenje z zdravilom Eylea, če je bil izpolnjen vsaj en vnaprej določen kriterij ustreznosti.
English: If any of the above applies to you, your doctor will consider this lack of information when treating you with Eylea.
Slovenian: Če kar koli od zgoraj navedenega velja za vas, bo zdravnik pri zdravljenju z zdravilom Eylea upošteval sicer maloštevilne informacije o teh stanjih.
English: A decision must be made whether to discontinue breast-feeding or to abstain from Eylea therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Eylea, pri čemer je treba pretehtati koristi dojenja za otroka in koristi zdravljenja za mater.
English: Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
Slovenian: Aflibercept je rekombinantni fuzijski protein, sestavljen iz delov ekstracelularnih domen receptorjev 1 in 2 humanega VEGF, vezanega na Fc del humanega IgG1.
English: Eylea must only be administered by a qualified physician experienced in administering intravitreal injections.
Slovenian: Zdravilo Eylea sme aplicirati samo usposobljen zdravnik, ki ima izkušnje z dajanjem intravitrealnih injekcij.
English: The following is a list of the side effects reported to be possibly related to the injection procedure or to the medicine.
Slovenian: Seznam neželenih učinkov, o katerih so poročali V nadaljevanju so navedeni drugi neželeni učinki, o katerih so poročali, da so morda povezani s postopkom injiciranja ali z zdravilom.
English: • How to prepare for Eylea treatment
Slovenian: • kako se pripraviti na zdravljenje z zdravilom Eylea
English: Pharmacotherapeutic group: Ophthalmologicals / Antineovascularisation agents ATC code: S01LA05
Slovenian: Farmakoterapevtska skupina: zdravila za očesne bolezni/učinkovine za preprečevanje neovaskularizacije, oznaka ATC: S01LA05
English: Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
Slovenian: Bolnike je treba poučiti, da po intravitrealni injekciji takoj poročajo o vseh simptomih, ki bi lahko kazali na endoftalmitis (npr. bolečina v očesu, pordelost očesa, fotofobija, zamegljen vid).
English: The mean maximum plasma concentration of free aflibercept is approximately 50 to 500 times below the aflibercept concentration required to inhibit the biologic activity of systemic VEGF by 50% in animal models, in which blood pressure changes were observed after circulating levels of free aflibercept attained approximately 10 microgram/ml and returned to baseline when levels fell below approximately 1 microgram/ml.
Slovenian: Povprečna največja koncentracija prostega aflibercepta v plazmi je približno 50- do 500-krat manjša od tiste koncentracije aflibercepta, ki je potrebna za 50-odstotno zaviranje biološke aktivnosti sistemskega VEGF v živalskih modelih; pri njih so opazili spremembe krvnega tlaka, ko so vrednosti prostega aflibercepta v krvnem obtoku dosegle približno 10 mikrogramov/ml.
English: When initiating Eylea therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Slovenian: Pri uvajanju zdravila Eylea je pri bolnikih s prisotnima navedenima dejavnikoma tveganja za zatrganje pigmentnega epitelija mrežnice potrebna previdnost.
English: 52 Weeks
Slovenian: 52 tednov
English: Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
Slovenian: Odstranite plastični pokrov in razkužite zunanji del gumijastega zamaška viale.
English: In general, adequate anaesthesia and asepsis, including topical broad spectrum microbicide (e.g. povidone iodine applied to the periocular skin, eyelid and ocular surface), have to be ensured.
Slovenian: Potrebno je zagotoviti ustrezno anestezijo in aseptične pogoje, vključno z uporabo lokalnega mikrobiocida širokega spektra (npr. nanos povidon joda na kožo okoli očesa, veko in površino očesa).
English: In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred.
Slovenian: V kliničnih preskušanjih so uporabljali enkrat na mesec odmerke do 4 mg; v posameznih primerih pa je prišlo do prekomernega odmerjanja z odmerki po 8 mg.
English: Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na razvoj zarodka/ploda (glejte poglavje 5.3).
English: The magnitude of these changes was similar to that seen in published studies, which corresponded to a 15letter gain in Best Corrected Visual Acuity (BCVA).
Slovenian: Velikost teh sprememb je bila podobna tistim, o katerih so poročali v objavljenih študijah, kar ustreza pridobitvi 15 črk BCVA (Best Corrected Visual Acuity).
English: In the VISTADME study, 217 (70.7%) of Eylea patients received bilateral Eylea injections until week100; in the VIVIDDME study, 97 (35.8%) of Eylea patients received a different anti-VEGF treatment in their fellow eye.
Slovenian: V študiji VISTADME je 217 (70,7 %) bolnikov v skupini, zdravljeni z zdravilom Eylea prejemalo injekcije zdravila Eylea v obe očesi do 100. tedna; v študiji VIVIDDME pa je 97 (35,8 %) bolnikov v skupini, zdravljeni z zdravilom Eylea, v drugo oko prejemalo drug zaviralec VEGF.
English: Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.
Slovenian: To je možno z ugotavljanjem perfuzije glave vidnega živca ali s tonometrijo.
English: Proper aseptic injection techniques must always be used when administering Eylea.
Slovenian: Pri uporabi zdravila Eylea je treba vedno upoštevati ustrezne aseptične tehnike injiciranja.
English: Although the systemic exposure after ocular administration is very low, Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Slovenian: Čeprav je sistemska izpostavljenost po intraokularni uporabi zdravila Eylea zelo majhna, se zdravila Eylea ne sme uporabljati med nosečnostjo, razen če možne koristi pretehtajo možna tveganja za plod.
English: D) From week 24 on the treatment interval in the Eylea treatment group was extended for all subjects from 4 weeks to 8 weeks through week 48.
Slovenian: Od 24. tedna je bil interval med injekcijami v skupini, ki je prejemala zdravilo Eylea podaljšan za vse bolnike od 4 tednov na 8 tednov (do 48. tedna)
English: Eylea is administered directly into the vitreous to exert local effects in the eye.
Slovenian: Zdravilo Eylea se daje neposredno v steklovino, da lokalno učinkuje v očesu.
English: The secondary efficacy endpoints were the proportion of patients who did not lose ≥15 letters and the proportion of patients who gained at least 15 letters of BCVA from baseline to week 52.
Slovenian: Sekundarni cilj učinkovitosti je bil delež bolnikov, ki niso izgubili ≥15 črk oziroma delež bolnikov, ki so pridobili vsaj 15 črk BCVA, od izhodiščne vrednosti do 52. tedna.
English: The maternal NOAEL was at the dose of 3 mg/kg or 1 mg/kg, respectively.
Slovenian: Za mater je bil odmerek brez vidnega neželenega učinka (NOAEL) 3 mg/kg oziroma 1 mg/kg.
English: Treatment effects in the subgroup of patients who had previously been treated with a VEGF inhibitor were similar to those seen in patients who were VEGF inhibitor naïve.
Slovenian: Učinki zdravljenja v podskupini bolnikov, ki so se zdravili z zaviralci VEGF, so bili podobni kot pri bolnikih, ki se še niso zdravili z zaviralci VEGF.
English: • Sterile techniques, including periocular and ocular disinfection to minimise the risk of infection
Slovenian: • opis sterilnih postopkov, vključno z razkuževanjem očesa in kože okoli njega, za zmanjšanje tveganja za okužbo
English: ** Culture positive and culture negative endophthalmitis *** During the post-marketing period, reports of hypersensitivity included rash, pruritus, urticaria, and isolated cases of severe anaphylactic/anaphylactoid reactions.
Slovenian: ** endoftalmitis s pozitivno in negativno kulturo *** Poročila o preobčutljivostnih reakcijah iz obdobja trženja vključujejo osip, pruritus, urtikarijo in posamezne primere hudih anafilaktičnih/anafilaktoidnih reakcij.
English: Treatment intervals greater than four months between injections have not been studied (see Section
Slovenian: Intervala med injekcijami, daljšega od štirih mesecev, niso preučevali.
English: • Who should be treated with Eylea
Slovenian: • koga je treba zdraviti z zdravilom Eylea
English: Intravitreal injections, including those with Eylea, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8).
Slovenian: Intravitrealne injekcije, tudi tiste z zdravilom Eylea, so povezovali z endoftalmitisom, intraokularnim vnetjem, regmatogenim odstopom mrežnice, raztrganinami mrežnice in iatrogeno travmatsko katarakto (glejte poglavje 4.8).
English: The solution should be inspected visually for any foreign particulate matter and/or discolouration or any variation in physical appearance prior to administration.
Slovenian: Pred uporabo je treba raztopino vizualno pregledati, če so prisotni tuji delci in/ali ima spremenjeno barvo ali je kakor koli fizikalno spremenjena.
English: The DRSS score was gradable in 73.7% of the patients in VIVIDDME and 98.3% of the patients in VISTADME.
Slovenian: Ocena po lestvici resnosti diabetične retinopatije je bila možna pri 73,7 % bolnikov v študiji VIVIDDME in 98,3 % bolnikov v študiji VISTADME.
English: 90 microlitres of solution in pre-filled syringe (type I glass) marked with a black dosing line, with a plunger stopper (elastomeric rubber) and a Luer lock adaptor with a tip cap (elastomeric rubber).
Slovenian: 90 mikrolitrov raztopine v napolnjeni injekcijski brizgi (steklo tipa I), označeno s črno črto za odmerjanje, z batom (elastomerna guma) in nastavkom Luer Lock z zaščitno zaporko (elastomerna guma).
English: The safety data described below include all adverse reactions from the eight phase III studies in the indications wet AMD, CRVO, BRVO, DME and myopic CNV with a reasonable possibility of causality to the injection procedure or medicinal product.
Slovenian: Spodaj opisani podatki o varnosti vključujejo vse neželene učinke iz osmih študij III. faze za indikacije vlažna AMD, CRVO, BRVO, DME in miopična CNV, ki so zelo verjetno povezani s postopkom injiciranja ali zdravilom.
English: If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly to a minimum of two months during the first 12 months of treatment.
Slovenian: Če se glede na oceno ostrine vida in/ali anatomski izgled rumene pege stanje poslabša, je treba interval med injekcijami ustrezno skrajšati, tj. na najmanj 2 meseca v prvih 12. mesecih zdravljenja.