natgillin/translations-raw huggingface dataset:
Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).
Zdravilo Jetrea se uporablja za zdravljenje odraslih z očesno boleznijo, imenovano vitreomakularna trakcija (VMT), tudi v primeru, ko je povezana z majhno odprtino v makuli (osrednjem delu na svetlobo občutljive plasti v ozadju očesa).
Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Vialo vzemite iz zamrzovalnika in pustite, da se odtaja pri sobni temperaturi (kar traja približno
The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs.
Intravitrealno toksičnost okriplazmina so ocenili pri kuncih, opicah in pritlikavih prašičih.
One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) has been reported.
Poročali so o enem primeru nenamernega prevelikega odmerka 0,250 mg okriplazmina (dvakratni priporočeni odmerek).
• Summary of Product Characteristics (SmPC) • Information packs for the patients
• povzetkom glavnih značilnosti zdravila (SmPC)
- The active substance is ocriplasmin.
- Zdravilna učinkovina je okriplazmin.
• How to prepare for Jetrea treatment
• Kako se pripravite na zdravljenje z zdravilom Jetrea
Study TG-MV-014
Študija TG-MV-014
5) events occurring pre-vitrectomy † using the Roth 28-hue colour vision test. See also section 4.4.
5) dogodki pred vitrektomijo † z uporabo Rothovega testa barvnega vida z 28 barvami.
The incidence of retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the placebo group, while the incidence of retinal tears (without detachment) that occurred pre-vitrectomy was 0.2% in the JETREA group and 0.5% in the placebo group.
Incidenca odstopa mrežnice, ki se je pojavila pred vitrektomijo, je bila 0,4 % za skupino z zdravilom JETREA in nič za skupino s placebom, medtem ko je bila incidenca raztrganja mrežnice (brez odstopa), ki se je pojavila pred vitrektomijo, 0,2 % za skupino z zdravilom JETREA in 0,5 % za skupino s placebom.
If any of the above events occur the patient should be treated according to standard medical practice.
Če se pojavi kar koli od zgoraj navedenega, je treba bolnika zdraviti v skladu s standardno zdravstveno prakso.
This effect was maintained over time and VMA resolution was consistently greater in the JETREA group at each post-injection study visit compared with the sham group.
Ta učinek se je tudi ohranjal skozi čas in odprava VMA v skupini, zdravljeni z zdravilom JETREA, je bila pri vsakem obisku po injiciranju zdravila v študiji večja kot pri skupini z navideznim zdravljenjem.
The difference for improvement in the general vision sub-scale score was statistically significant (6.1 JETREA vs. 2.1 placebo, p=0.024).
Statistično značilno razliko so opazili za izboljšanje podseštevka za splošni vid (6,1 za zdravilo JETREA v primerjavi z 2,1 za placebo, p = 0,024).
The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice.
Pred injiciranjem morajo biti koža okrog oči, veke ter površina očesa dezinficirani in bolnik mora dobiti ustrezno anestezijo in topikalni širokospektralni mikrobiocid v skladu s standardno zdravstveno prakso.
The difference was maintained from Day 7 through Month 6
Razlika se je ohranila od 7. dne do 6. meseca (slika 1).
Once removed from the freezer or refrigerator, the medicinal product may be kept below 25 °C for up to 8 hours.
Ko zdravilo vzamete iz zamrzovalnika ali hladilnika, ga lahko shranjujete pri temperaturi do 25 °C do
Beyond the central area, abnormal aspects of the IS/OS band attributed to JETREA have been observed in up to 10% of patients.
Zunaj centralnega dela so pri do 10 % bolnikov opazili nenormalne značilnosti traka IS/OS, ki so jih pripisali zdravilu JETREA.
VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula.
Vitreomakularno trakcijo povzroči vlek, ki nastane zaradi dolgotrajne povezanosti steklovine (gelu podobne snovi v ozadju očesa) z makulo.
The main reasons for vitrectomy were retinal detachment and retinopathy of prematurity.
Glavna razloga za vitrektomijo sta bila odstop mrežnice in retinopatija nedonošenčkov.
Patients with a smaller VMA diameter at baseline (≤ 1500 microns) were more likely to achieve VMA resolution at Day 28 compared with those who had a diameter > 1500 microns.
Bolniki z manjšim premerom VMA v izhodišču študije (≤ 1500 mikronov) so z večjo verjetnostjo dosegli odpravo VMA ob 28. dnevu v primerjavi s tistimi, ki so imeli premer > 1500 mikronov.
At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001
Pri v seh dneh po injiciranju, p ≤0,024 za študijo TG-MV-006, p ≤0,009 za študijo TG-MV-007, p <0,001 za integrirane podatke
The patient also developed mild conjunctival hyperaemia, eye inflammation and miosis which resolved with corticosteroid eye drops.
Pri bolniku so se pojavili tudi blaga hiperemija očesne veznice, vnetje očesa in mioza, ki so po uporabi kortikosteroidnih kapljic za oko izzveneli.
Because of the small dose administered (0.125 mg), detectable levels of ocriplasmin in systemic circulation are not expected after intravitreal injection.
Zaradi majhnega uporabljenega odmerka (0,125 mg) ni pričakovati, da bi bile po intravitrealnem injiciranju v sistemskem obtoku zaznavne ravni okriplazmina.
Very common side effects (may affect more than 1 in 10 patients): - dark floating spots in the field of vision (floaters) - eye pain - bleeding on the surface of the eye - colour vision changes
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - temne plavajoče lise v vidnem polju (lebdeči delci) - očesna bolečina - krvavitev na površini očesa
Tell your doctor/ophthalmologist if you have or have had any eye conditions or eye treatments.
Obvestite svojega zdravnika/oftalmologa, če imate ali ste imeli katero koli očesno bolezen ali so vam zdravili oko.
After opening/dilution
Po odprtju/redčenju
Only 0.1 mL of the total 0.3 mL solution in the vial should be administered.
Dati morate le 0,1 ml od skupno 0,3 ml raztopine v viali.
The efficacy of JETREA has been further confirmed in a randomised, double-masked, shamcontrolled, 24-month study in patients with VMT finalised since the initial marketing authorisation approval.
Učinkovitost zdravila JETREA je bila dodatno potrjena v randomizirani, dvojno slepi, z navideznim zdravljenjem kontrolirani, 24-mesečni študiji pri bolnikih z VMT, ki je bila zaključena v času po pridobitvi dovoljenja za promet z zdravilom.
Studies TG-MV-006 and TG MV-007
Študiji TG-MV-006 in TG MV-007
Intravitreal injections have been associated with intraocular inflammation/infection, intraocular haemorrhage and increased intraocular pressure (IOP).
Intravitrealno injiciranje je lahko povezano z intraokularnim vnetjem/okužbo, intraokularno krvavitvijo in zvišanim očesnim tlakom.
The proportion of patients who underwent vitrectomy for an event of VMA/VMT was 8.3% in the JETREA group compared to 19.2% in the sham group.
Delež bolnikov, pri katerih je bila opravljena vitrektomija zaradi dogodka VMA/VMT, je bil 8,3 % v skupini, zdravljeni z zdravilom JETREA, v primerjavi z 19,2 % v skupini z navideznim zdravljenjem.
In both pivotal studies, the proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was significantly (p≤0.003) higher in the JETREA group compared with the placebo group.
V obeh osrednjih študijah je bil delež bolnikov, pri katerih je bila ob 28. dnevu dosežena odprava VMA (primarni cilj študije), pomembno višji (p ≤0,003) v skupini z zdravilom JETREA v primerjavi s skupino s placebom.
Of these, 30% of JETREA treated patients and 15.4% of patients in the sham group experienced non-surgical FTMH closure at Month 24.
Od teh je imelo 30 % bolnikov, zdravljenih z zdravilom JETREA, in 15,4 % bolnikov iz skupine z navideznim zdravljenjem nekirurško zaprtje FTMH v 24. mesecu, pri vseh pa se je to zgodilo do 3. meseca.
0.3 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and a blue polypropylene flip-off cap.
0,3 ml raztopine v viali (steklo tipa I), zaprti s klorobutilnim gumijastim zamaškom in modro polipropilensko odmično zaporko.
Treatment with JETREA in the other eye is not recommended concurrently or within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye.
Sočasno zdravljenje drugega očesa z zdravilom JETREA ali zdravljenje drugega očesa v 7 dneh po začetni injekciji ni priporočljivo, zato da lahko spremljamo potek po injiciranju, vključno z možnim poslabšanjem vida injiciranega očesa.
For handling of the medicinal product, see section 6.6.
Za navodila glede ravnanja z zdravilom glejte poglavje 6.6.
The remaining sodium chloride 9 mg/mL (0.9%) solution for injection should be discarded.
Preostalo raztopino 0,9-odstotnega natrijevega klorida (9 mg/ml) za injiciranje zavrzite.
In the JETREA group, 1 patient (0.7%) developed retinal tear and retinal detachment between Day 0 and Day 7 post-injection.
V skupini z zdravilom JETREA pa sta se pri enem bolniku (0,7 %) pojavila raztrganje mrežnice in odstop mrežnice med dnevom 0 in 7. dnevom po injiciranju.
However, after treatment, a higher proportion of patients in the JETREA group had a change from an intact IS/OS band at baseline to an incomplete IS/OS band in the central area at a later time point compared with the sham group (7.7% and 2.8%, respectively at Day 28).
Vendar se je po zdravljenju pri večjem odstotku bolnikov iz skupine, ki je prejemala zdravilo JETREA, v izhodišču popoln trak IS/OS v centralnem delu v poznejši časovni točki spremenil v nepopolnega, v primerjavi s skupino, ki je prejemala navidezno zdravljenje (7,7 % oziroma 2,8 % na 28. dan).
Early progression rates of full-thickness macular hole (until Day 7 post-injection) at RPE (retinal pigment epithelium) level were higher in the JETREA treated patients compared to sham or placebo.
Pogostnosti zgodnjega napredovanja foramna makule, ki je zajemal vse plasti mrežnice (do 7. dne po injiciranju) do ravni RPE (retinalnega pigmentnega epitelija) so bile višje v skupini bolnikov, zdravljenih z zdravilom JETREA, kot pri bolnikih, zdravljenih navidezno ali s placebom.
Inject 0.1 mL of the diluted solution immediately into the mid-vitreous as it contains no preservatives.
Takoj injicirajte 0,1 ml razredčene raztopine v sredino steklovine, saj ne vsebuje konzervansov.
3) including cystoid macular oedema
3) vključno s cistoidnim makularnim edemom
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, other than sterile, preservative-free, non-buffered diluent sodium chloride 9 mg/mL (0.9%) solution for injection.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s sterilno raztopino 0,9-odstotnega natrijevega klorida (9 mg/ml) za injiciranje brez konzervansov in pufrov.
0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap.
0,2 ml raztopine v viali (steklo tipa I), zaprti s klorobutilnim gumijastim zamaškom in oranžno polipropilensko odmično zaporko.
No dose adjustment or special considerations are anticipated for patients with hepatic impairment (see section 5.2).
Prilagajanje odmerka ali posebni ukrepi za bolnike z okvaro ledvic niso potrebni (glejte poglavje 5.2).
- A severe decrease in vision has been reported in up to 1 in 10 patients within one week after Jetrea treatment.
- Pri največ 1 od 10 bolnikov so v enem tednu po zdravljenju z zdravilom Jetrea opazili hudo poslabšanje vida.
The diluent should be withdrawn from an unopened container which should be used only once.
Vehikel izvlecite iz zaprtega vsebnika, ki ga uporabite le enkrat.
Treatment is not recommended in such patients.
Pri teh bolnikih se zdravljenje odsvetuje.
The new in-use expiry date should be calculated and noted on the carton before it is placed in the refrigerator.
Preden date zdravilo v hladilnik, morate izračunati nov datum roka uporabnosti in ga zabeležiti na škatli.
Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea administration.
Izvidi nekaterih preiskav in slikanja očesnega ozadja (mrežnice) so bili po dajanju zdravila Jetrea nenormalni.
After Jetrea treatment you may experience some decrease in vision for a limited amount of time.
Po zdravljenju z zdravilom Jetrea bo vaš vid morda nekaj časa slabši.
For storage conditions after thawing and opening/dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po odmrznitvi in odprtju/redčenju zdravila glejte poglavje 6.3.
The proportion of patients who gained ≥ 2 or ≥ 3 lines in BCVA at Month 6, irrespective of vitrectomy, was slightly higher in the JETREA group (36.2%, 18.6%) than in the sham group (28.6%, 13.1%).
Delež bolnikov, ki so pridobili ≥ 2 ali ≥ 3 vrstice pri BCVA v 6. mesecu ne glede na izvedbo vitrektomije, je bil nekoliko večji v skupini, zdravljeni z zdravilom JETREA (36,2 %, 18,6 %), kot pa v skupini z navideznim zdravljenjem (28,6 %, 13,1 %).
Of these, the proportion of patients who achieved FTMH closure without vitrectomy at Day 28 was higher in the JETREA group than the placebo group (40.6% vs. 10.6%, respectively; p<0.001).
Med njimi je bil delež bolnikov, ki je dosegel zaprtje FTMH brez vitrektomije na 28. dan, višji v skupini z zdravilom JETREA kot v skupini s placebom (40,6 % v primerjavi z 10,6 %; p <0,001).
JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted' formulation, no further dilution is required.
Zdravilo JETREA 0,375 mg/0,3 ml raztopina za injiciranje je že razredčena oblika in ne zahteva nadaljnjega redčenja.
What Jetrea looks like and contents of the pack
Izgled zdravila Jetrea in vsebina pakiranja
Patients with no ERM at baseline were more likely to achieve VMA resolution at Day 28 compared with those who had ERM at baseline.
Bolniki brez ERM v izhodišču študije so z večjo verjetnostjo dosegli odpravo VMA ob 28. dnevu v primerjavi s tistimi z ERM v izhodišču študije.
The injection volume of 0.1 mL is then delivered into the mid-vitreous.
Volumen injekcije 0,1 ml se nato vnese v sredino steklovine.
Ocriplasmin levels in the vitreous decrease rapidly after intravitreal administration.
Ravni okriplazmina v steklovini po intravitrealni uporabi naglo upadejo.
Concentrate for solution for injection 1 vial
koncentrat za raztopino za injiciranje 1 viala
In study TG-MV-014, retinal tear was reported in 1.4% of patients injected with JETREA and 6.8% of sham recipients; the incidence of retinal detachment was 1.4% in both arms.
V študiji TG-MV-014 so o raztrganju mrežnice poročali pri 1,4 % bolnikov, ki so jim injicirali zdravilo JETREA, in pri 6,8 % prejemnikov navideznega zdravljenja; v obeh skupinah je bila incidenca odstopa mrežnice 1,4 %.
See section 4.4 for monitoring recommendations.
Za priporočila o spremljanju glejte poglavje 4.4.
Store in a freezer (-20 °C ± 5 °C).
Shranjujte v zamrzovalniku (-20 °C ± 5 °C).
Active or suspected ocular or periocular infections.
Aktivna okužba očesa ali okolice očesa ali sum nanju.
The patient information pack should be provided in printed and in audio format, and contain the following key elements:
Informativni paket za bolnike mora biti pripravljen v tiskani in avdio obliki.
There is no relevant use of JETREA in children aged under 18 years for the indication of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Zdravilo JETREA ni primerno za uporabo pri otrocih, starih do 18 let, za indikacijo vitreomakularne trakcije (VMT), tudi če je povezana s foramnom makule premera 400 mikronov ali manj.
For storage conditions after thawing/opening of the medicinal product, see section 6.3.
Za pogoje shranjevanja po odmrznitvi/odprtju zdravila glejte poglavje 6.3.
Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving injections into the eye.
Zdravilo Jetrea mora dati usposobljen oftalmolog (specialist za oči), ki ima izkušnje z dajanjem injekcij v oko.
The proportion of patients who underwent vitrectomy was smaller in the JETREA group than in the sham group at all visits.
Delež bolnikov, pri katerih je bila opravljena vitrektomija, je bil ob vseh obiskih manjši v skupini, zdravljeni z zdravilom JETREA, kot v skupini z navideznim zdravljenjem.
The tight binding of the protein components within the macular area of the VRI contribute to vitreomacular traction (VMT), leading to visual impairment and/or macular holes.
Tesna vezava beljakovinskih sestavin z makularnim predelom vitreoretinalne povezave prispeva k vitreomakularni trakciji, kar povzroči okvaro vida in/ali foramen makule.
Chromatopsia (including dyschromatopsia and colour vision test abnormal) Colour vision alterations (including yellowish vision and abnormal Roth 28-hue colour vision test) have been reported as a very common adverse reaction in patients injected with JETREA.
O spremembah barvnega vida (vključno z rumenkastim vidom in nenormalnim izvidom Rothovega testa barvnega vida z 28 barvami) so poročali kot o zelo pogostem neželenem učinku pri bolnikih, ki so jim injicirali zdravilo JETREA.
Mannitol, citric acid, sodium hydroxide, water for injections.
manitol, citronska kislina, natrijev hidroksid, voda za injekcije
The potential for lens subluxation or phacodonesis cannot be ruled out.
Možnosti subluksacije leče ali fakodoneze ne moremo izključiti.
≥ 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).
≥ 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).
The systemic exposure of JETREA is expected to be very low after intravitreal injection.
Pričakovana sistemska izpostavljenost zdravilu JETREA po intravitrealnem injiciranju je zelo majhna.
Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia*
Očesne bolezni Zelo pogosti delci v steklovini, bolečina v očesu, krvavitev očesne veznice, kromatopsija*
- 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.
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.
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.
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.
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.
Študij za preučitev farmakokinetike okriplazmina pri bolnikih z okvaro jeter niso izvedli, saj je pričakovana sistemska izpostavljenost po intravitrealni uporabi zdravila nizka.
Single use vial for intravitreal use only.
Viala za enkratno uporabo samo za intravitrealno uporabo.
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.
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.
- 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.
- O simptomih, kot so fluktuacija vida, dvojni vid, glavobol, kolobar okoli svetlobe, slabost in bruhanje, so poročali pri največ 1 od 100 bolnikov.
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.
Po intravitrealnem injiciranju je treba bolnika spremljati glede morebitnih neželenih učinkov, ki med drugim vključujejo intraokularno vnetje/okužbo in zvišan očesni tlak.
Your doctor/ophthalmologist will monitor you in case you develop an infection or any complications after the injection.
Vaš zdravnik/oftalmolog vas bo spremljal, da ugotovi morebitno okužbo ali zaplete po injiciranju zdravila.
Do not refreeze a vial once it has been thawed.
Že odmrznjene viale ne smete ponovno zamrzniti.
Contents of the pack and other information
Shranjevanje zdravila Jetrea Vsebina pakiranja in dodatne informacije
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).
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 %).
The median time to resolution was 6 months.
Mediani čas do izginotja sprememb je bil 6 mesecev.
There is limited experience in patients with non-proliferative diabetic retinopathy or history of uveitis (including active severe inflammation) or significant eye trauma.
Izkušnje pri bolnikih z neproliferativno diabetično retinopatijo ali uveitisom (vključno z aktivnim hudim vnetjem) oz. večjo poškodbo očesa v anamnezi so omejene.
When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
Pri napredovanju trakcije lahko nastane tudi odprtina v makuli (imenovana foramen makule).
Read the package leaflet before use.
za enkratno uporabo Pred uporabo preberite priloženo navodilo!
The median time to resolution was 3 months.
Mediani čas do izginotja sprememb je bil 3 mesece.
For single use only Read the package leaflet before use.
že razredčena oblika samo za enkratno uporabo Pred uporabo preberite priloženo navodilo!
You should contact your doctor/ophthalmologist immediately if you develop any of the eye symptoms described in section 4, after an injection of Jetrea.
Takoj se obrnite na svojega zdravnika/oftalmologa, če opazite po injiciranju zdravila Jetrea kakršne koli očesne simptome, opisane v poglavju 4.
Ellipsoid Zone disruption within and outside the central area has been reported in non-interventional studies and post-marketing reports.
V neintervencijskih študijah in v obdobju trženja zdravila so poročali o prekinitvah elipsoidne cone znotraj in zunaj centralnega dela.
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).
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).