FrancophonIA/ELRC3.0 huggingface dataset:
English: ≥ 3 lines in BCVA without vitrectomy favoured JETREA at Month 6 (23.7% vs. 11.2%, p<0.001 for a gain ≥ 2 lines and 9.7% vs. 3.7%, p=0.008 for a gain ≥ 3 lines).
Slovenian: ≥ 3 vrstice pri BCVA brez vitrektomije, je bil v 6. mesecu v korist skupine, zdravljene z zdravilom JETREA (23,7 % v primerjavi z 11,2 %, p <0,001 za pridobitev ≥ 2 vrstici in 9,7 % v primerjavi s 3,7 %, p = 0,008 za pridobitev ≥ 3 vrstice).
English: The systemic exposure of JETREA is expected to be very low after intravitreal injection.
Slovenian: Pričakovana sistemska izpostavljenost zdravilu JETREA po intravitrealnem injiciranju je zelo majhna.
English: Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia*
Slovenian: Očesne bolezni Zelo pogosti delci v steklovini, bolečina v očesu, krvavitev očesne veznice, kromatopsija*
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.
Slovenian: večja občutljivost na svetlobo ali večje število temnih lebdečih pik v vidnem polju (lebdečih delcev) so tudi opazili pri največ 1 od 10 bolnikov in so lahko znaki okužbe, krvavitve, odstopa ali raztrganja mrežnice ali povišanja tlaka v zdravljenem očesu.
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.
Slovenian: Delež bolnikov z izboljšanjem za ≥ 3 vrstice od izhodišča v skupini, zdravljeni z zdravilom JETREA (23,4 % v primerjavi z 12,8 %), je bil večji samo v podskupini, ki ni imela FTMH v izhodišču.
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.
Slovenian: Študij za preučitev farmakokinetike okriplazmina pri bolnikih z okvaro jeter niso izvedli, saj je pričakovana sistemska izpostavljenost po intravitrealni uporabi zdravila nizka.
English: Single use vial for intravitreal use only.
Slovenian: Viala za enkratno uporabo samo za intravitrealno uporabo.
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.
Slovenian: Učinek na odstotek posteriornega odstopa steklovine, stopnjo utekočinjenosti steklovine, odstotek takojšnje postoperativne ponovne povezanosti mrežnice, razvoj proliferativne vitreoretinopatije ali stadij retinopatije nedonošenčkov pri zdravljenju z okriplazminom ni bil dokazan.
English: - Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.
Slovenian: - O simptomih, kot so fluktuacija vida, dvojni vid, glavobol, kolobar okoli svetlobe, slabost in bruhanje, so poročali pri največ 1 od 100 bolnikov.
English: Following the intravitreal injection, patients should be monitored for any side effects such as (but not limited to) intraocular inflammation/infection and elevation in IOP.
Slovenian: Po intravitrealnem injiciranju je treba bolnika spremljati glede morebitnih neželenih učinkov, ki med drugim vključujejo intraokularno vnetje/okužbo in zvišan očesni tlak.
English: Your doctor/ophthalmologist will monitor you in case you develop an infection or any complications after the injection.
Slovenian: Vaš zdravnik/oftalmolog vas bo spremljal, da ugotovi morebitno okužbo ali zaplete po injiciranju zdravila.
English: Do not refreeze a vial once it has been thawed.
Slovenian: Že odmrznjene viale ne smete ponovno zamrzniti.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Jetrea Vsebina pakiranja in dodatne informacije
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).
Slovenian: ali ≥ 3 vrstice pri BCVA brez vitrektomije so govorile v prid skupini, zdravljeni z zdravilom JETREA, pred skupino z navideznim zdravljenjem, tako v 6. mesecu (26,8 % , 14,0 % v primerjavi s 15,62 %, 6,2 %) kot v 24. mesecu (31,9 %, 16,8 % v primerjavi z 11,7 %, 4,1 %).
English: The median time to resolution was 6 months.
Slovenian: Mediani čas do izginotja sprememb je bil 6 mesecev.
English: There is limited experience in patients with non-proliferative diabetic retinopathy or history of uveitis (including active severe inflammation) or significant eye trauma.
Slovenian: Izkušnje pri bolnikih z neproliferativno diabetično retinopatijo ali uveitisom (vključno z aktivnim hudim vnetjem) oz. večjo poškodbo očesa v anamnezi so omejene.
English: When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
Slovenian: Pri napredovanju trakcije lahko nastane tudi odprtina v makuli (imenovana foramen makule).
English: Read the package leaflet before use.
Slovenian: za enkratno uporabo Pred uporabo preberite priloženo navodilo!
English: The median time to resolution was 3 months.
Slovenian: Mediani čas do izginotja sprememb je bil 3 mesece.
English: For single use only Read the package leaflet before use.
Slovenian: že razredčena oblika samo za enkratno uporabo Pred uporabo preberite priloženo navodilo!
English: You should contact your doctor/ophthalmologist immediately if you develop any of the eye symptoms described in section 4, after an injection of Jetrea.
Slovenian: Takoj se obrnite na svojega zdravnika/oftalmologa, če opazite po injiciranju zdravila Jetrea kakršne koli očesne simptome, opisane v poglavju 4.
English: Ellipsoid Zone disruption within and outside the central area has been reported in non-interventional studies and post-marketing reports.
Slovenian: V neintervencijskih študijah in v obdobju trženja zdravila so poročali o prekinitvah elipsoidne cone znotraj in zunaj centralnega dela.
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).
Slovenian: Značilno višji odstotek bolnikov, zdravljenih z zdravilom JETREA, je doživel popoln posteriorni odstop steklovine na 28. dan v primerjavi z bolniki, zdravljenimi s placebom (integrirani podatki: 13,4 % v primerjavi s 3,7 %; p <0,001).
English: Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present, which may decrease the symptoms caused by VMT.
Slovenian: Zdravilo Jetrea deluje tako, da loči steklovino od makule in pomaga zapreti odprtino v makuli, če je ta prisotna.
English: • Patient information leaflet
Slovenian: • informativnim paketom za bolnike.
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.
Slovenian: V tej študiji je bil foramen makule, ki je segal čez vse plasti mrežnice (FTMH), navzoč ob izhodišču pri 50/145 (34,5 %) bolnikov, zdravljenih z zdravilom JETREA, in pri 26/73 (35,6 %) bolnikov z navideznim zdravljenjem.
English: If you get any side effects, talk to your doctor/ophthalmologist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom/oftalmologom.
English: In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup with VMA ≤ 1500 microns at baseline (34.7% vs. 14.6%, p<0.001) and with VMA > 1500 microns at baseline (5.9% vs. 0%, p=0.113).
Slovenian: V integriranih podatkih je bil odstotek odprav VMA na 28. dan višji pri bolnikih, zdravljenih z zdravilom JETREA, v primerjavi s placebom v obeh podskupinah, z VMA ≤ 1500 mikronov v izhodišču (34,7 % v primerjavi s 14,6 %, p <0,001) in z VMA > 1500 mikronov v izhodišču (5,9 % v primerjavi z 0 %, p=0,113).
English: No formal studies have been conducted with JETREA in patients with renal impairment.
Slovenian: Formalnih študij z zdravilom JETREA pri bolnikih z okvaro ledvic niso izvedli.
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).
Slovenian: Pri bolnikih, zdravljenih z zdravilom JETREA, je bila potreba po vitrektomiji ob koncu študije (6. mesec) manjša v primerjavi z bolniki, zdravljenimi s placebom (integrirani podatki: 17,7 % v primerjavi s 26,6 %; p = 0,016).
English: Subretinal fluid and signs and symptoms of impaired photoreceptor function including decreased visual acuity (in some cases severe) were reported in association with these events.
Slovenian: V povezavi s temi dogodki so poročali o kopičenju tekočine pod mrežnico ter o znakih in simptomih slabšega delovanja fotoreceptorjev, vključno z zmanjšanjem ostrine vida (v nekaterih primerih hudo zmanjšanje).
English: The proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was 41.7% in the JETREA group compared with 6.2% in the sham group (p<0.001).
Slovenian: Delež bolnikov, pri katerih je bila na 28. dan dosežena odprava VMA (primarni cilj študije), je znašal 41,7 % v skupini, zdravljeni z zdravilom JETREA, v primerjavi s 6,2 % v skupini z navideznim zdravljenjem (p<0,001).
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).
Slovenian: Z aseptično tehniko vsebini viale z zdravilom Jetrea dodajte 0,2 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje (sterilno, brez konzervansov in pufrov), da jo razredčite (slika 3) in vialo nežno obračajte, dokler ni raztopina premešana (slika 4).
English: No formal studies have been conducted with JETREA in patients with hepatic impairment.
Slovenian: Formalnih študij z zdravilom JETREA pri bolnikih z okvaro jeter niso izvedli.
English: - The other ingredients are mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment) and water for injections.
Slovenian: - Druge sestavine zdravila so manitol, citronska kislina, natrijev hidroksid (NaOH) (za uravnavanje pH) in voda za injekcije.
English: 4) including subretinal fluid
Slovenian: 4) vključno s kopičenjem tekočine pod mrežnico
English: The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression.
Slovenian: Klinično najpomembnejši neželeni učinki so bili prehodna slepota, raztrganje mrežnice, odstop mrežnice, subluksacija očesne leče in povečevanje foramna makule.
English: Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, water for injections.
Slovenian: natrijev klorid, manitol, citronska kislina, natrijev hidroksid, klorovodikova kislina, voda za injekcije
English: The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal injection to the affected eye once as a single dose.
Slovenian: Priporočeni odmerek je 0,125 mg v 0,1 ml raztopine, uporabljen v obliki intravitrealne injekcije v prizadeto oko kot enkratni odmerek.
English: The recommended dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection to the affected eye once as a single dose.
Slovenian: Priporočeni odmerek je 0,125 mg (0,1 ml razredčene raztopine), uporabljen v obliki intravitrealne injekcije v prizadeto oko kot enkratni odmerek.
English: In the sham group, no events occurred prior to vitrectomy.
Slovenian: V skupini z navideznim zdravljenjem pred vitrektomijo ni bilo nobenih dogodkov.
English: Blindness transient, lens subluxation*, retinal tear*5), retinal detachment*5), night blindness, pupillary reflex impaired, diplopia, hyphaema, miosis, pupils unequal, corneal abrasion, anterior chamber inflammation, eye inflammation, conjunctival irritation
Slovenian: Občasni prehodna slepota, subluksacija leče*, raztrganje mrežnice*5), odstop mrežnice*5), nočna slepota, zmanjšan pupilarni refleks, diplopija, hifema, mioza, neenakomerni zenici, abrazija roženice, vnetje sprednjega očesnega prekata, vnetje očesa, draženje očesne veznice
English: 2) including scotoma
Slovenian: 1) vključno z zamegljenim vidom2) vključno s skotomi
English: Jetrea is a concentrate for solution for injection in a vial.
Slovenian: Zdravilo Jetrea je koncentrat za raztopino za injiciranje v viali.
English: In 3 clinical studies with follow-up from 6 months (TG-MV-006 and TG-MV-007) to 24 months (TG-MV-014), the most commonly reported adverse reactions were vitreous floaters, eye pain, photopsia and chromatopsia as well as conjunctival haemorrhage resulting from the injection procedure.
Slovenian: (TG-MV-006 in TG-MV-007) do 24 mesecev (TG-MV-014) so bili najpogostejši neželeni učinki, o katerih so poročali, delci v steklovini, bolečina v očesu, fotopsija in kromatopsija ter krvavitev očesne veznice zaradi postopka injiciranja.
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).
Slovenian: Zdravilo JETREA je indicirano pri odraslih za zdravljenje vitreomakularne trakcije (VMT), tudi v primeru, ko je povezana s foramnom makule premera 400 mikronov ali manj (glejte poglavje 5.1).
English: Jetrea is given as an injection into the eye.
Slovenian: Zdravilo Jetrea se injicira v oko.
English: If this event occurs, it should be treated according to standard medical practice.
Slovenian: Če se tak dogodek pojavi, je potrebno zdravljenje skladno s standardno zdravstveno prakso.
English: A total of 220 patients (JETREA 146, sham 74) were randomised in this study.
Slovenian: V tej študiji so naključno razvrstili skupaj 220 bolnikov (146 za zdravilo JETREA in 74 za navidezno zdravljenje).
English: - The other ingredients are sodium chloride (NaCl), mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment), hydrochloric acid (HCl) (for pH adjustment) and water for injections.
Slovenian: - Druge sestavine zdravila so natrijev klorid (NaCl), manitol, citronska kislina, natrijev hidroksid (NaOH) (za uravnavanje pH), klorovodikova kislina (HCl) (za uravnavanje pH) in voda za injekcije.
English: In the integrated analysis of the National Eye Institute Visual Function Questionnaire-25 (VFQ-25), a numerical difference in favour of JETREA over placebo was shown in each sub-scale score, as well as the composite score.
Slovenian: Visual Function Questionnaire-25) se je za vsak podseštevek in za skupni seštevek pokazala številčna razlika v korist skupine z zdravilom JETREA pred skupino s placebom.
English: in integrated data
Slovenian: KLINIČNI PODATKI
English: 1 vial contains 0.5 mg ocriplasmin.
Slovenian: 1 viala vsebuje 0,5 mg okriplazmina.
English: Visual acuity reduced*, visual impairment1), visual field defect2), vision blurred, retinal haemorrhage, vitreous haemorrhage, macular hole*, macular degeneration, retinal degeneration, macular oedema3), retinal oedema4), retinal pigment epitheliopathy, metamorphopsia, conjunctival oedema, eyelid oedema, vitritis, anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival hyperaemia, ocular hyperaemia, vitreous detachment, eye irritation, dry eye, foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia, lacrimation increased
Slovenian: krvavitev v mrežnico, krvavitev v steklovino, foramen makule*, degeneracija makule, degeneracija mrežnice, makularni edem3), edem mrežnice4), pigmentna epiteliopatija mrežnice, metamorfopsija, edem veznice, edem veke, vitritis, celice v sprednjem očesnem prekatu, motnjave v sprednjem očesnem prekatu, iritis, fotopsija, hiperemija veznice, očesna hiperemija, odstop steklovine, draženje očesa, suho oko, občutek tujka v očeh, očesni pruritus, neprijeten občutek v očesu, fotofobija, povečano solzenje
English: In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), 7.7% of JETREA patients and 1.6% of placebo patients had acute ≥ 2-line (≥ 10 ETDRS letters) loss in best-corrected visual acuity (BCVA) during the first week after injection with no alternative explanation for the change.
Slovenian: V osrednjih, s placebom kontroliranih študijah faze III (TG-MV-006 in TG-MV-007), je imelo 7,7 % bolnikov, zdravljenih z zdravilom JETREA, in 1,6 % bolnikov, ki so dobili placebo, akutno izgubo najboljše korigirane vidne ostrine (BCVA) za ≥ 2 vrstici (≥ 10 ETDRS črk) v prvem tednu po injiciranju.
English: Jetrea is a solution for injection in a vial.
Slovenian: Zdravilo Jetrea je raztopina za injiciranje v viali.
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).
Slovenian: JETREA za vse podskupine pediatrične populacije za zdravljenje vitreomakularne trakcije, vključno v povezavi s foramnom makule premera 400 mikronov ali manj (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In study TG-MV-014, events of macular hole (including both progression and new onset) were reported in 15.8% JETREA vs. 13.5% sham recipients at Month 24.
Slovenian: V študiji TG-MV-014 so v 24. mesecu poročali o dogodkih v zvezi s foramnom makule (vključno z napredovanjem in novim pojavom) pri 15,8 % bolnikov, ki so bili zdravljeni z zdravilom JETREA, v primerjavi s 13,5 % prejemnikov navideznega zdravljenja.
English: In a paediatric study evaluating JETREA as an adjunct to vitrectomy, one case of subluxation was reported in a premature infant who received a single intravitreal injection of JETREA 0.175 mg.
Slovenian: V pediatrični študiji, v kateri so ocenili zdravilo JETREA kot dodatno zdravljenje poleg vitrektomije, so poročali o enem primeru subluksacije pri nedonošenčku, ki je prejel eno samo intravitrealno injekcijo zdravila JETREA 0,175 mg. Subluksacijo leče so opazili pri 3 živalskih vrstah s koncentracijami okriplazmina nad predvidenimi kliničnimi koncentracijami (glejte poglavje 5.3).
English: No systemic toxicity was observed after intravitreal administration of ocriplasmin.
Slovenian: Po intravitrealnem dajanju okriplazmina niso opazili sistemske toksičnosti.
English: In study TG-MV-014, incomplete Inner Segment/Outer Segment (IS/OS) band, also referred to as Ellipsoid Zone, in the central area was very common at baseline (65.8% in the JETREA group and 62.2% in the sham group).
Slovenian: Nenormalen izvid optične koherentne tomografije V študiji TG-MV-014 je bil v izhodišču v centralnem delu zelo pogosto navzoč nepopoln trak notranjega segmenta/zunanjega segmenta (IS - Inner Segment/OS - Outer Segment), imenovan tudi elipsoidna cona (65,8 % bolnikov iz skupine, ki je prejemala zdravilo JETREA, in 62,2 % iz skupine,
English: If an adverse reaction occurs, it should be treated according to standard medical practice.
Slovenian: Če pride do neželenega učinka, ga zdravite v skladu s standardno zdravstveno prakso.
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.
Slovenian: močno kratkovidnostjo (>8 dioptrij sferične korekcije ali osne dolžine >28 mm), afakijo, regmatogenim odstopom mrežnice v anamnezi, nestabilnostjo zonule leče, nedavno operacijo na očesu ali intraokularno injekcijo (vključno z lasersko terapijo), proliferativno diabetično retinopatijo, ishemičnimi retinopatijami, okluzijo mrežnične vene, eksudativno starostno makularno degeneracijo in krvavitvijo v steklovino.
English: In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup without ERM (37.4% vs. 14.3%, p<0.001) and with ERM (8.7% vs. 1.5%, p=0.046).
Slovenian: 28. dan višji pri bolnikih, zdravljenih z zdravilom JETREA, v primerjavi s placebom v obeh podskupinah, brez ERM (37,4 % v primerjavi s 14,3 %, p <0,001) in z ERM (8,7 % v primerjavi z 1,5 %, p=0,046).
English: In study TG-MV-014, 2.8% of JETREA patients and 1.4% of sham patients had acute ≥ 2-line loss in BCVA during the first week after injection.
Slovenian: V študiji TG-MV-014 je imelo v prvem tednu po injiciranju 2,8 % bolnikov, zdravljenih z zdravilom JETREA, in 1,4 % bolnikov, ki so dobili navidezno zdravljenje, akutno izgubo najboljše korigirane ostrine vida (BCVA) za ≥ 2 vrstici.
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.
Slovenian: V integriranih podatkih je bil pri 106/464 (22,8 %) bolnikih v skupini z zdravilom JETREA oz.
English: TG-MV-007 Placebo
Slovenian: TG-MV-007 placebo kombinirano placebo
English: Eye disorders
Slovenian: - vnetje očesa
English: In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), retinal breaks (tears and detachment) were reported in 1.9% of patients injected with JETREA vs. 4.3% injected with placebo.
Slovenian: V osrednjih, s placebom kontroliranih študijah faze III (TG-MV-006 in TG-MV-007), so o razpoki mrežnice (raztrganje in odstop) poročali pri 1,9 % bolnikov, ki so jim injicirali zdravilo JETREA, v primerjavi s 4,3 %, ki so jim injicirali placebo.
English: Jetrea is given as a single injection into the affected eye.
Slovenian: Zdravilo Jetrea boste prejeli v obliki injekcije v prizadeto oko.
English: Over 1400 patients have been treated with the recommended dose of 0.125 mg of JETREA in interventional clinical studies.
Slovenian: V intervencijskih kliničnih študijah so več kot 1400 bolnikov zdravili s priporočenim odmerkom
English: In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), events of macular hole (including both progression and new onset) were reported for 6.7% of all patients injected with JETREA vs. 9.6% injected with placebo at Month 6.
Slovenian: V osrednjih, s placebom kontroliranih študijah faze III (TG-MV-006 in TG-MV-007), so poročali o dogodkih v zvezi s foramnom makule (vključno z napredovanjem in novim pojavom) pri 6,7 % vseh bolnikov, ki so jim injicirali zdravilo JETREA, v primerjavi z 9,6 % bolnikov, ki so jim injicirali placebo v 6. mesecu.
English: There is a risk for a significant decrease in visual acuity during the first week after the injection.
Slovenian: V prvem tednu po injiciranju obstaja tveganje za pomembno zmanjšanje ostrine vida.
English: Each vial contains 0.5 mg of ocriplasmin* in 0.2 mL solution.
Slovenian: Ena viala vsebuje 0,5 mg okriplazmina* v 0,2 ml raztopine.
English: Intraocular pressure increased, macular reflex abnormal, optical coherence tomography (OCT) abnormal* * see section ‘Description of selected adverse reactions' 1) including dim vision
Slovenian: Pogosti zvišan očesni tlak, nenormalen makularni refleks, nenormalen izvid optične koherentne tomografije (OCT)*