natgillin/translations-raw huggingface dataset:
In the Eylea group the proportion of perfused patients was maintained through week 52.
V skupini, ki je prejemala zdravilo Eylea se je delež perfundiranih bolnikov ohranil do 52. tedna.
The extractable volume of the vial (100 microlitres) is not to be used in total.
Vsebina viale (100 mikrolitrov) se ne porabi v celoti.
1 ml solution for injection contains 40 mg aflibercept*.
1 ml raztopine za injiciranje vsebuje 40 mg aflibercepta*.
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.
Pri CRVO in BRVO se pojavi ishemija mrežnice in spodbuja sproščanje VEGF, ki nato destabilizira tesne stike med endotelijskimi celicami in spodbuja njihovo proliferacijo.
24 Weeks
24 tednov
Instructions for use of vial:
Navodilo za uporabo viale
Manufacturer Bayer AG Müllerstraße 178 13353 Berlin Germany
Izdelovalec Bayer AG Müllerstraße 178 13353 Berlin Nemčija
After the initial injection, treatment is given monthly.
Po začetni injekciji se zdravilo aplicira enkrat na mesec.
(95% CI) p-value p<0.0001
(95 % IZ) vrednost p p < 0,0001
A total of 181 patients were treated and evaluable for efficacy (91 with Eylea).
V študiji so zdravili skupno 181 bolnikov in pri njih je bila ocenjena učinkovitost (91 bolnikov je bilo zdravljenih z zdravilom Eylea).
Eylea is a solution for injection (injection) in a vial (4 mg/100 microlitres).
Zdravilo Eylea je raztopina za injiciranje (injekcija) v viali (4 mg/100 mikrolitrov).
Patients with bilateral disease were eligible to receive anti-VEGF treatment in their fellow eye if assessed necessary by the physician.
Bolnike, pri katerih sta bili prizadeti obe očesi, so zdravili z zaviralci VEGF na drugem očesu, če je zdravnik presodil, da je to potrebno.
Eylea is a solution which is injected into the eye to treat eye conditions in adults called
Zdravilo Eylea je raztopina, ki se injicira v oko za zdravljenje očesnih bolezni pri odraslih, imenovanih
MARKETING AUTHORISATION NUMBER(S) EU/1/12/797/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/797/002
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.
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.
If any of the above applies to you, your doctor will consider this lack of information when treating you with Eylea.
Če kar koli od zgoraj navedenega velja za vas, bo zdravnik pri zdravljenju z zdravilom Eylea upošteval sicer maloštevilne informacije o teh stanjih.
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.
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.
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.
Aflibercept je rekombinantni fuzijski protein, sestavljen iz delov ekstracelularnih domen receptorjev 1 in 2 humanega VEGF, vezanega na Fc del humanega IgG1.
Eylea must only be administered by a qualified physician experienced in administering intravitreal injections.
Zdravilo Eylea sme aplicirati samo usposobljen zdravnik, ki ima izkušnje z dajanjem intravitrealnih injekcij.
The following is a list of the side effects reported to be possibly related to the injection procedure or to the medicine.
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.
• How to prepare for Eylea treatment
• kako se pripraviti na zdravljenje z zdravilom Eylea
Pharmacotherapeutic group: Ophthalmologicals / Antineovascularisation agents ATC code: S01LA05
Farmakoterapevtska skupina: zdravila za očesne bolezni/učinkovine za preprečevanje neovaskularizacije, oznaka ATC: S01LA05
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.
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).
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.
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.
When initiating Eylea therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Pri uvajanju zdravila Eylea je pri bolnikih s prisotnima navedenima dejavnikoma tveganja za zatrganje pigmentnega epitelija mrežnice potrebna previdnost.
52 Weeks
52 tednov
Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
Odstranite plastični pokrov in razkužite zunanji del gumijastega zamaška viale.
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.
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).
In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred.
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.
Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na razvoj zarodka/ploda (glejte poglavje 5.3).
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).
Velikost teh sprememb je bila podobna tistim, o katerih so poročali v objavljenih študijah, kar ustreza pridobitvi 15 črk BCVA (Best Corrected Visual Acuity).
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.
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.
Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.
To je možno z ugotavljanjem perfuzije glave vidnega živca ali s tonometrijo.
Proper aseptic injection techniques must always be used when administering Eylea.
Pri uporabi zdravila Eylea je treba vedno upoštevati ustrezne aseptične tehnike injiciranja.
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.
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.
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.
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)
Eylea is administered directly into the vitreous to exert local effects in the eye.
Zdravilo Eylea se daje neposredno v steklovino, da lokalno učinkuje v očesu.
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.
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.
The maternal NOAEL was at the dose of 3 mg/kg or 1 mg/kg, respectively.
Za mater je bil odmerek brez vidnega neželenega učinka (NOAEL) 3 mg/kg oziroma 1 mg/kg.
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.
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.
• Sterile techniques, including periocular and ocular disinfection to minimise the risk of infection
• opis sterilnih postopkov, vključno z razkuževanjem očesa in kože okoli njega, za zmanjšanje tveganja za okužbo
** 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.
** endoftalmitis s pozitivno in negativno kulturo *** Poročila o preobčutljivostnih reakcijah iz obdobja trženja vključujejo osip, pruritus, urtikarijo in posamezne primere hudih anafilaktičnih/anafilaktoidnih reakcij.
Treatment intervals greater than four months between injections have not been studied (see Section
Intervala med injekcijami, daljšega od štirih mesecev, niso preučevali.
• Who should be treated with Eylea
• koga je treba zdraviti z zdravilom Eylea
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).
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).
The solution should be inspected visually for any foreign particulate matter and/or discolouration or any variation in physical appearance prior to administration.
Pred uporabo je treba raztopino vizualno pregledati, če so prisotni tuji delci in/ali ima spremenjeno barvo ali je kakor koli fizikalno spremenjena.
The DRSS score was gradable in 73.7% of the patients in VIVIDDME and 98.3% of the patients in VISTADME.
Ocena po lestvici resnosti diabetične retinopatije je bila možna pri 73,7 % bolnikov v študiji VIVIDDME in 98,3 % bolnikov v študiji VISTADME.
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).
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).
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.
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.
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.
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.
In patients treated with Eylea in the MYRROR study (one injection given at start of therapy, with additional injections given in case of disease persistence or recurrence), CRT decreased soon after treatment initiation favouring Eylea at week 24 (-79 microns and -4 microns for the Eylea 2 mg treatment group and the control group, respectively), which was maintained through week 48.
Pri bolnikih, zdravljenih z zdravilom Eylea, v študiji MYRROR (ena injekcija na začetku zdravljenja, dodatne injekcije pa v primeru vztrajanja bolezni ali ponovitvi), se je kmalu po začetku zmanjšala CRT, v korist zdravljenja z zdravilom Eylea v 24. tednu (-79 mikronov v skupini, zdravljeni z zdravilom Eylea 2 mg oziroma -4 mikrone v kontrolni skupini), ki se je ohranila do 48. tedna.
Keep the syringe in the sterile tray until you are ready for assembly.
Brizgo shranjujte na sterilnem pladnju, dokler je ni potrebno sestaviti.
• Risk factors associated with the development of a retinal pigment epithelial tear after antiVEGF therapy for wet AMD, include a large and/or high pigment epithelial retinal detachment.
• Dejavniki tveganja za zatrganje pigmentnega epitelija mrežnice pri zdravljenju vlažne starostne degeneracije makule z zaviralci VEGF sta obsežen in/ali visok odstop pigmentnega epitelija mrežnice.
Myopic CNV
CNV.
The excess volume should be expelled before injecting.
Presežni volumen je treba odstraniti pred injiciranjem.
In each study, patients were randomly assigned in a 1:1:1:1 ratio to 1 of 4 dosing regimens:
V obeh študijah so bolnike naključno razporedili v enega od treh režimov odmerjanja v razmerju 1:1:1:
F) Difference and 95% CI are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for country
Razlika in 95 % interval zaupanja (IZ) se izračunata s pomočjo Cochran-Mantel-Haenszelovega (CMH) testa, prilagojenega za državo (country designations).
The extractable volume of the syringe (90 microlitres) is not to be used in total.
Vsebina brizge (90 mikrolitrov) se ne porabi v celoti.
At week 100, the respective percentages were 32.6% and 37.1% of the Eylea 2Q8 groups and 8.2% and 15.6% of the control groups.
V 100. tednu je bil odstotek 32,6 % oziroma 37,1 % v skupinah, ki sta prejemali zdravilo Eylea 2Q8, ter 8,2 % oziroma 15,6 % v kontrolnih skupinah.
• Eylea is not recommended during breast-feeding.
• Uporabe zdravila Eylea se ne priporoča med dojenjem.
Eylea is given as an injection into your eye (intravitreal injection).
Zdravilo Eylea se injicira v oko (intravitrealna injekcija).
The difference between treatment groups was statistically significant in favour of Eylea for the primary endpoint (change in BCVA) and confirmatory secondary efficacy endpoint (proportion of patients who gained 15 letters in BCVA) at week 24 compared to baseline.
Razlika med zdravljenima skupinama je bila statistično značilna v korist zdravljenja z zdravilom Eylea za primarni cilj učinkovitosti (sprememba BCVA) in potrjena s sekundarnim ciljem učinkovitosti (delež bolnikov, ki so do 24. tedna pridobili 15 črk BCVA glede na izhodiščne vrednosti).
As with all therapeutic proteins, there is a potential for immunogenicity with Eylea.
Kot pri vseh terapevtskih proteinih obstaja tudi pri zdravilu Eylea možnost za razvoj imunogenosti.
Additional doses may be administered if visual and/or anatomic outcomes indicate that the disease persists.
Dodatni odmerki se lahko uporabijo, če ocena ostrine vida in/ali anatomski izgled rumene pege kažeta, da je bolezen še prisotna.
In the second year of the studies, patients continued to receive the initially randomised dosage but on a modified dosing schedule guided by assessment of visual and anatomic outcomes with a protocoldefined maximum dosing interval of 12 weeks.
V drugem letu študij so bolniki še naprej prejemali odmerke v jakostih, v katere so bili randomizirani na začetku, vendar s spremenjenim režimom odmerjanja, glede na oceno ostrine vida in anatomski izgled rumene pege, z največjim intervalom odmerjanja 12 tednov, kar je bilo opredeljeno v protokolu.
In the aflibercept treatment group (n = 224) at week 52, this treatment regimen resulted in patients receiving a mean of 9.2 injections, which is similar to the administered number of doses in the Eylea 2Q8 group in VIVIDDME and VISTADME, while overall efficacy of the aflibercept treatment group in Protocol T was comparable to the Eylea 2Q8 group in VIVIDDME and VISTADME.
tedni tedni afliberceptom (N = 224) v 52. tednu, so bolniki po tem režimu zdravljenja prejeli povprečno 9,2 injekciji, kar je bilo podobno prejetemu številu odmerkov v skupini Eylea 2Q8 v VIVIDDME in VISTADME, medtem ko je bila učinkovitost v skupini, zdravljeni z afliberceptom v protokolu T primerljiva s skupino Eylea 2Q8 v VIVIDDME in VISTADME.
There is no relevant use of Eylea in the paediatric population for the indications of wet AMD, CRVO, BRVO, DME and myopic CNV.
Zdravilo Eylea ni primerno za uporabo pri pediatrični populaciji za indikacije vlažna AMD, CRVO, BRVO, DME in miopična CNV.
Please note: You should snap off (do not turn or twist) the syringe cap.
Opozorilo: zaščitno zaporko morate odlomiti (ne obračajte in ne zvijajte je).
• Physician information
• informacije za zdravnika
Eylea 2Q8 E) (Eylea 2 mg every 8 weeks following 3 initial monthly doses) (N = 607)
Izid učinkovitosti zdravilo Eylea 2Q8 E (zdravilo Eylea 2 mg vsakih 8 tednov po 3 začetnih mesečnih odmerkih) (N = 607)
In pharmacokinetic sub-studies in patients with CRVO, BRVO, DME or myopic CNV mean Cmax of free aflibercept in plasma were similar with values in the range of 0.03 to 0.05 microgram/ml and individual values not exceeding 0.14 microgram/ml.
V farmakokinetični podštudiji pri bolnikih s CRVO, BRVO, DME ali miopično CNV je bila povprečna vrednost Cmax prostega aflibercepta v plazmi podobna, v razponu od 0,03 do 0,05 mikrogramov/ml in posamezne vrednosti niso presegle 0,14 mikrogramov/ml.
Up-regulation of VEGF is associated with the breakdown of the blood retina barrier, increased vascular permeability, retinal oedema, and neovascularisation complications.
Povečano sproščanje VEGF je povezano z razpadanjem krvno-mrežnične pregrade, povečanjem prepustnosti žil, edemom mrežnice in zapleti neovaskularizacije.
In combined data analysis of GALILEO and COPERNICUS, Eylea demonstrated clinically meaningful changes from baseline in pre-specified secondary efficacy endpoint National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
V analizi združenih podatkov iz študij GALILEO in COPERNICUS, je zdravilo Eylea pokazalo klinično pomembne spremembe glede na izhodiščno stanje pri predhodno določenih sekundarnih ciljih učinkovitosti po National Eye institute Visual Function Questionnaire (NEI VFQ-25).
Prior to launch and during the product's lifecycle in each Member State the Marketing Authorisation Holder (MAH) will agree the final educational material with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se bo pred prihodom na trg in med življenskim ciklusom zdravila s pristojnim nacionalnim regulatornim organom v vsaki državi članici dogovoril o končni različici izobraževalnega gradiva.
Since the pre-filled syringe contains more volume (90 microlitres) than the recommended dose (50 microlitres), a part of the volume contained in the syringe has to be discarded prior to the administration.
Ker napolnjena injekcijska brizga vsebuje večji volumen (90 mikrolitrov) kot je priporočeni odmerek (50 mikrolitrov), je treba odvečni del raztopine v brizgi zavreči pred uporabo.
- The other ingredients are: polysorbate 20, sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injection.
- Druge sestavine zdravila so: polisorbat 20, natrijev dihidrogenfosfat monohidrat (za uravnavanje pH), dinatrijev hidrogenfosfat heptahidrat (za uravnavanje pH), natrijev klorid, saharoza, voda za injekcije.
Table 1: All treatment-emergent adverse drug reactions reported in patients in phase III studies (pooled data of the phase III studies for the indications wet AMD, CRVO, BRVO, DME and myopic CNV) or during post-marketing surveillance
Preglednica 1: Vsi neželeni učinki zdravila, ki so se pojavili pri bolnikih med zdravljenjem v študijah III. faze (zbrani podatki iz študij III. faze za indikacije vlažna AMD, CRVO, BRVO, DME in miopična CNV) ali v obdobju trženja
Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
Aflibercept je pridobljen z rekombinantno DNK tehnologijo v K1 celicah jajčnika kitajskega hrčka.
Since the vial contains more volume (100 microlitres) than the recommended dose (50 microlitres), a part of the volume contained in the vial has to be discarded prior to the administration.
Ker viala vsebuje večji volumen (100 mikrolitrov) kot je priporočeni odmerek (50 mikrolitrov), je treba odvečni del raztopine v viali zavreči pred uporabo.
In both studies, patients were randomly assigned in a 3:2 ratio to either 2 mg Eylea administered every 4 weeks (2Q4), or the control group receiving sham injections every 4 weeks for a total of 6 injections.
V obeh študijah so bolnike naključno razporedili v razmerju 3:2 v skupino, ki je vsake 4 tedne prejemala 2 mg zdravila Eylea (2Q4) ali v kontrolno skupino, ki je vsake 4 tedne prejemala injekcije placeba, skupno 6 injekcij.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
When the macula swells with fluid, central vision becomes blurry.
Ko rumena pega zaradi tekočine nabrekne, se centralni vid zamegli.
With administration of Eylea, there may be some side effects affecting the eyes which are due to the injection procedure.
Pri injiciranju zdravila Eylea se lahko pojavijo nekateri neželeni učinki, ki prizadenejo oko in so povezani s postopkom injiciranja.
Your doctor will decide on the schedule for follow up examinations.
Zdravnik bo določil načrt nadaljnjih pregledov.
• Intravitreal injection procedure video
• video postopek intravitrealnega injiciranja
Aflibercept is slowly absorbed from the eye into the systemic circulation after intravitreal administration and is predominately observed in the systemic circulation as an inactive, stable complex with VEGF; however only “free aflibercept” is able to bind endogenous VEGF.
V sistemskem obtoku je na voljo predvsem kot neaktiven, stabilen kompleks z VEGF; na endogeni VEGF se lahko veže le "prosti aflibercept".
A secondary efficacy endpoint was change in visual acuity at week 24 compared to baseline, which was statistically significant in favour of Eylea in the VIBRANT study.
Spremenljivka sekundarne učinkovitosti je bila sprememba v ostrini vida v 24. tednu v primerjavi z izhodiščnim stanjem in je bila statistično značilna v korist zdravila Eylea v študiji VIBRANT.
Serious ocular adverse reactions in the study eye related to the injection procedure have occurred in less than 1 in 1,900 intravitreal injections with Eylea and included blindness, endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous haemorrhage, vitreous detachment, and intraocular pressure increased (see section 4.4).
Resni očesni neželeni učinki, povezani s postopkom injiciranja, ki so se pojavili v zdravljenem očesu, pri manj kot 1 od 1.900 intravitrealnih injekcij zdravila Eylea, so vključevali slepoto, endoftalmitis, odstop mrežnice, travmatsko katarakto, katarakto, krvavitev v steklovino, odstop steklovine in povišan intraokularni tlak (glejte poglavje 4.4).