FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon side effects (may affect up to 1 in 100 patients): - transient severe decreased vision - difficulty in seeing well at night or in dim light - disturbance in your eye's reaction to the light that may increase your sensitivity to light (pupillary reflex impaired) - double vision - accumulation of blood in the front part of the eye - abnormal constriction of the pupil (black part in the centre of the eye) - different sized pupils - a scratch or scrape of the cornea (transparent layer that covers the front of the eye)
Croatian: - oslabljeni vid noću ili kod slabijeg osvjetljenja - poremećaj u reakciji Vašeg oka na svjetlost koji može pojačati osjetljivost na svjetlo (oštećenje refleksa zjenice) - dvostruki vid - nakupljanje krvi u prednjem dijelu oka - abnormalno sužavanje zjenice (crni dio u središtu oka)
English: Only 0.1 mL of the total 0.3 mL solution in the vial should be administered.
Croatian: Potrebno je primijeniti samo 0,1 ml od ukupno 0,3 ml otopine u bočici.
English: 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.
Croatian: Ispitivanje TG-MV-014 Djelotvornost JETREE dalje je potvrđena u randomiziranom, dvostruko maskiranom, placebom kontroliranom ispitivanju u trajanju od 24 mjeseca u bolesnika sa VMT, završenom nakon inicijalnog odobrenja za stavljanje lijeka u promet.
English: 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.
Croatian: U ispitivanju TG-MV-014, ruptura mrežnice bila je prijavljena u 1,4 % bolesnika koji su primali injekciju JETREE i 6,8 % bolesnika koji su primali placebo, incidencija odignuća mrežnice bila je 1,4 % u obje skupine.
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.
Croatian: Nakon intravitrealne injekcije bolesnike treba pratiti radi mogućih nuspojava, uključujući (ali ne ograničeno na)
English: 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.
Croatian: Alteracije kolornog vida (uključujući žućkasti vid i abnormalan rezultat testa kolornog vida Roth 28nijansi) su prijavljene kao vrlo česte nuspojave u bolesnika koji su primili injekciju JETREE.
English: See section 4.4 for monitoring recommendations.
Croatian: Vidjeti dio 4.4. za preporuke o praćenju bolesnika.
English: 4) including subretinal fluid
Croatian: 3uključujući cistoidni edem makule 4) uključujući subretinalnu tekućinu
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).
Croatian: VMA do 28. dana bila veća u bolesnika liječenih JETREOM nego u onih koji su primili placebo, i to i u podskupini bez ERM-a (37,4% nasuprot 14,3%, p<0,001) i u podskupini s ERM-om (8,7% nasuprot 1,5%, p=0,046).
English: Inject 0.1 mL of the diluted solution immediately into the mid-vitreous as it contains no preservatives.
Croatian: 8. Odmah injicirajte 0,1 ml razrijeđene otopine u središte staklovine jer otopina ne sadrži nikakve konzervanse.
English: Jetrea contains the active substance ocriplasmin.
Croatian: Jetrea sadržava djelatnu tvar okriplazmin.
English: 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).
Croatian: Od njih, udio bolesnika u kojih je do 28. dana postignuto zatvaranje FTMH-a bez vitrektomije bio je veći u skupini koja je primila JETREU nego u onoj koja je primila placebo (40,6% nasuprot 10,6%, p<0,001).
English: Progression rates after Month 6, however, were higher in sham or placebo than in those treated with JETREA.
Croatian: Stope progresije nakon 6. mjeseca bile su veće kod bolesnika liječenih placebom nego u onih liječenih JETREOM.
English: No formal studies have been conducted with JETREA in patients with hepatic impairment.
Croatian: Formalna ispitivanja JETREE u bolesnika s oštećenjem bubrega nisu provedena.
English: The median time to resolution was 6 months.
Croatian: Medijan vremena do povlačenja simptoma iznosio je 6 mjeseci.
English: Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, water for injections.
Croatian: Natrijev klorid, manitol, citratna kiselina, natrijev hidroksid, kloridna kiselina, voda za injekcije.
English: After dilution, 0.1 mL contains 0.125 mg ocriplasmin.
Croatian: Nakon razrjeđivanja, 0,1 ml sadržava 0,125 mg okriplazmina.
English: For handling of the medicinal product, see section 6.6.
Croatian: Za upute o rukovanju lijekom, vidjeti dio 6.6.
English: Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia*
Croatian: Zamućenja u vidnom polju, bol u oku, krvarenje u spojnicu, kromatopsija*
English: 0.3 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and a blue polypropylene flip-off cap.
Croatian: 0,3 ml otopine u bočici (staklo tipa I) zatvorenoj čepom od klorbutilne gume i sa plavom polipropilenskom flip-off kapicom . Pakiranje sadržava 1 bočicu.
English: No systemic toxicity was observed after intravitreal administration of ocriplasmin.
Croatian: Nakon intravitrealne primjene okriplazmina nije primijećena sistemska toksičnost.
English: No studies have been conducted to examine the pharmacokinetics of ocriplasmin in patients with hepatic impairment since the systemic exposure is expected to be very low after intravitreal administration.
Croatian: Ispitivanja farmakokinetike okriplazmina u bolesnika s oštećenjem funkcije jetre nisu provedena jer se očekuje da sistemska izloženost bude vrlo mala nakon intravitrealne primjene.
English: This provides a usable amount to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin.
Croatian: To osigurava iskoristivu količinu za primjenu jedne doze od 0,1 ml koja sadržava 0,125 mg okriplazmina.
English: Any excess volume should be expelled prior to injection in order to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin.
Croatian: Suvišni volumen treba istisnuti prije davanja injekcije kako bi se primijenila jedna doza od 0,1 ml koja sadrži 0,125 mg okriplazmina.
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.
Croatian: - Ostali sastojci su natrijev klorid (NaCl), manitol, citratna kiselina, natrijev hidroksid (NaOH) (za podešavanje pH), kloridna kiselina (HCl) (za podešavanje pH) i voda za injekcije.
English: Electroretinographic (ERG) changes (a- and b-wave amplitude decrease) have been reported as a very common adverse reaction in patients injected with JETREA; in the majority of cases visual impairment and chromatopsia were also reported.
Croatian: Elektroretinografske (ERG) promjene (smanjenje amplituda a- i b-valova) prijavljene su kao vrlo česta nuspojava u bolesnika koji su primili injekciju JETREE.
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.
Croatian: TG-MV-007) do 24 mjeseca (TG-MV-014) najčešće prijavljivane nuspojave bile su zamućenja u vidnom polju, bol u oku, fotopsija i kromatopsija, kao i krvarenje u spojnicu uzrokovano postupkom davanja injekcije.
English: 5) events occurring pre-vitrectomy † using the Roth 28-hue colour vision test. See also section 4.4.
Croatian: † koristeći test kolornog vida Roth 28-nijansi.
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).
Croatian: Udio bolesnika kod kojih je do 28. dana (primarna mjera ishoda) postignuto povlačenje VMA bio je 41,7% u JETREA skupini u odnosu na 6,2% u skupini liječenoj placebom (p<0,001).
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.
Croatian: U ispitivanju TG-MV-014, 2,8% bolesnika koji su primali JETREU i 1,4 % bolesnika koji su primali placebo imalo je akutno smanjenje BCVA ≥ 2 reda tijekom prvog tjedna nakon injekcije.
English: If you get any side effects, talk to your doctor/ophthalmologist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika/oftalmologa.
English: 1 vial contains 0.375 mg ocriplasmin in 0.3 mL solution (1.25 mg/mL).
Croatian: 1 bočica sadržava 0,375 mg okriplazmina u 0,3 ml otopine (1,25 mg/ml).
English: The median time to resolution was 3 months.
Croatian: Medijan vremena do povlačenja simptoma iznosio je 3 mjeseca.
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
Croatian: Prolazna sljepoća, subluksacija leće*, ruptura mrežnice *5), odignuće mrežnice *5), noćno sljepilo, oštećenje refleksa zjenice, diplopija, hifema, mioza, nejednake zjenice, abrazija rožnice, upala u prednjoj očnoj sobici, upala oka, nadražaj konjunktive.
English: - The other ingredients are mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment) and water for injections.
Croatian: - Ostali sastojci su manitol, citratna kiselina, natrijev hidroksid (NaOH) (za podešavanje pH) i voda za injekcije.
English: Concentrate for solution for injection 1 vial
Croatian: Koncentrat za otopinu za injekciju
English: • Summary of Product Characteristics (SmPC) • Information packs for the patients
Croatian: • Uputa o lijeku: Informacija za bolesnika
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.
Croatian: Morate se odmah javiti liječniku/oftalmologu ako nakon injekcije Jetree razvijete bilo koji simptom oka opisan u dijelu 4.
English: How Jetrea is stored
Croatian: Kako čuvati Jetreu
English: Mannitol
Croatian: JETREE
English: Each vial contains 0.375 mg of ocriplasmin* in 0.3 mL solution (1.25 mg/mL).
Croatian: Jedna bočica sadržava 0,375 mg okriplazmina* u 0,3 ml otopine (1,25 mg/ml).
English: Jetrea is given as a single injection into the affected eye.
Croatian: Jetrea se daje u jednoj injekciji u zahvaćeno oko.
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.
Croatian: U placebom kontroliranim pivotalnim ispitivanjima faze III (TG-MV-006 i TG-MV-007), slučajevi makularne rupe (uključujući progresiju i nove slučajeve) prijavljeni su u 6,7% svih ispitanika koji su primili injekciju JETREE i u 9,6% onih koji su primili injekciju placeba u 6. mjesecu.
English: If this event occurs, it should be treated according to standard medical practice.
Croatian: Dogodi li se taj slučaj, treba provesti liječenje u skladu sa standardnom medicinskom praksom.
English: Jetrea is a concentrate for solution for injection in a vial.
Croatian: Jetrea je koncentrat za otopinu za injekciju u bočici.
English: If an adverse reaction occurs, it should be treated according to standard medical practice.
Croatian: Pojavi li se nuspojava, treba ju liječiti u skladu sa standardnom medicinskom praksom.
English: Contact your doctor/ophthalmologist immediately if you develop any of the following symptoms after injection of Jetrea.
Croatian: Odmah se javite svom liječniku/oftalmologu ako nakon injekcije Jetree razvijete bilo koji od niže navedenih simptoma.
English: The vial and any unused portion of the diluted solution must be discarded after single use.
Croatian: Bočica i sva neiskorištena razrijeđena otopina moraju se baciti nakon jednokratne primjene.
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.
Croatian: ispitanika koji su primali JETREU i 1,6% onih koji su primali placebo zamijećeno je akutno smanjenje najbolje korigirane vidne oštrine (BCVA) za ≥ 2 reda (≥ 10 slova na EDTRS tablici) tijekom prvog tjedna nakon injekcije, bez alternativnog objašnjenja te promjene.
English: Over 1400 patients have been treated with the recommended dose of 0.125 mg of JETREA in interventional clinical studies.
Croatian: U intervencijskim kliničkim ispitivanjima preporučenu dozu od 0,125 mg JETREE primilo je više od 1400 bolesnika.
English: Jetrea is a solution for injection in a vial.
Croatian: Jetrea je otopina za injekciju u bočici.
English: Package leaflet: Information for the patient JETREA 0.375 mg/0.3 mL solution for injection
Croatian: Uputa o lijeku: Informacije za bolesnika JETREA 0,375 mg/0,3 ml otopina za injekciju okriplazmin
English: Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein matrix responsible for the abnormal vitreomacular adhesion (VMA).
Croatian: (npr. laminin, fibronektin, kolagen) s ciljem da otopi proteinski matriks odgovoran za nenormalnu vitreomakularnu adheziju (VMA).
English: One vial of Jetrea contains 0.375 mg of ocriplasmin in 0.3 mL solution.
Croatian: Jedna bočica Jetree sadržava 0,375 mg okriplazmina u 0,3 ml otopine.
English: in integrated data
Croatian: KLINIČKI PODACI
English: (17.1% and 6.4%) (p=0.003 and p=0.024, respectively).
Croatian: u 6. mjesecu ( 28,0% i 12,3% redom) u usporedbi s bolesnicima liječenim placebom (17,1% i 6,4%) (redom, p=0,003 i p=0,024).
English: Package leaflet: Information for the patient JETREA 0.5 mg/0.2 mL concentrate for solution for injection
Croatian: Uputa o lijeku: Informacije za bolesnika JETREA 0,5 mg/0,2 ml koncentrat za otopinu za injekciju okriplazmin
English: JETREA 0.5 mg/0.2 mL sterile concentrate ocriplasmin
Croatian: JETREA 0,5 mg/0,2 ml sterilni koncentrat okriplazmin
English: Method of administration Single use vial for intravitreal use only.
Croatian: Bočica za jednokratnu primjenu, samo za intravitrealnu primjenu.
English: Post-injection monitoring
Croatian: Praćenje nakon injekcije
English: After dilution with 0.2 mL of sodium chloride solution, 0.1 mL of the diluted solution contains 0.125 mg of ocriplasmin.
Croatian: Nakon razrjeđivanja s 0,2 ml otopine natrijeva klorida, 0,1 ml razrijeđene otopine sadržava 0,125 mg okriplazmina.
English: Patients with no ERM at baseline were more likely to achieve VMA resolution at Day 28 compared with those who had ERM at baseline.
Croatian: U bolesnika bez ERM-a na početku ispitivanja postojala je veća sklonost povlačenja VMA do 28. dana nego u onih s ERM-om na početku ispitivanja.
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.
Croatian: U integriranoj analizi Upitnika za ocjenu funkcije vida Nacionalnog očnog instituta (VFQ-25),
English: The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Intravitrealna toksičnost okriplazmina ispitana je u kunića, majmuna i patuljastih svinja.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I I PROIZVOĐAČ(I)
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
Croatian: Smanjena vidna oštrina*, poremećaj vida1), poremećaj vidnog polja2), zamagljen vid, krvarenje mrežnice, krvarenje u staklovini, makularna rupa*, makularna degeneracija, degeneracija mrežnice, makularni edem3), edem mrežnice4), mrežnična pigmentna epiteliopatija, metamorfopsija, edem spojnice, edem vjeđe,
English: The vial and any unused portion of the solution must be discarded after single use.
Croatian: Bočica i sva neiskorištena otopina moraju se baciti nakon jednokratne primjene.
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.
Croatian: Preporučena doza je 0,125 mg (0,1 ml razrijeđene otopine) koja se daje intravitrealnom injekcijom u zahvaćeno oko jedanput u jednokratnoj dozi.
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.
Croatian: U placebom kontroliranim pivotalnim ispitivanjima faze III (TG-MV-006 i TG-MV-007), rupture i odignuće mrežnice prijavljeni su u 1,9% bolesnika koji su primili injekciju JETREE i u 4,3% onih koji su primili injekciju placeba.
English: One vial of Jetrea contains 0.5 mg of ocriplasmin in 0.2 mL solution.
Croatian: Jedna bočica Jetree sadržava 0,5 mg okriplazmina u 0,2 ml otopine.
English: In the integrated data, 26.5% in the JETREA group compared with 10.1% in the placebo group achieved VMA resolution at Day 28 (p<0.001).
Croatian: bolesnika u JETREA skupini u usporedbi s 10,1% u skupini placebo VMA se povukla 28. dana (p<0,001).
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).
Croatian: nego u onih koji su primili placebo, i to i u podskupini s VMA ≤ 1500 mikrona na početku ispitivanja (34,7% nasuprot 14,6%, p<0,001) i u onoj s VMA > 1500 mikrona na početku ispitivanja (5,9% nasuprot 0%, p=0,113).
English: 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).
Croatian: uključujući kada je ona povezana s malom rupom u makuli (centralni dio sloja osjetljivog na svjetlost u pozadini oka).
English: Visually inspect the vial for particulate matter.
Croatian: Vizualno provjerite da u bočici nema vidljivih čestica.
English: Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin) (Figure 4).
Croatian: Iglu zamijenite drugom prikladnom sterilnom iglom, iz štrcaljke pažljivo istisnite suvišan volumen lagano potiskujući klip tako da se vrh klipa poravna s oznakom za 0,1 ml na štrcaljki (odgovara količini od 0,125 mg okriplazmina) (Slika 4).
English: Inject 0.1 mL of the diluted solution immediately into the mid-vitreous.
Croatian: Odmah injicirajte 0,1 ml razrijeđene otopine u središte staklovine.
English: JETREA must be administered by a qualified ophthalmologist experienced in intravitreal injections.
Croatian: JETREU mora primjenjivati kvalificirani oftalmolog s iskustvom u davanju intravitrealnih injekcija.
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.
Croatian: Preporučena doza je 0,125 mg u 0,1 ml otopine koja se daje intravitrealnom injekcijom u zahvaćeno oko jedanput u jednokratnoj dozi.
English: Sodium hydroxide (NaOH) (for pH adjustment) Hydrochloric acid (HCl) (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid (NaCl) manitol citratna kiselina natrijev hidroksid (NaOH)(za podešavanje pH) kloridna kiselina (HCl) (za podešavanje pH) voda za injekcije
English: Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin).
Croatian: Iglu zamijenite drugom prikladnom sterilnom iglom, iz štrcaljke pažljivo istisnite suvišak volumena, lagano potiskujući klip tako da se vrh klipa poravna s oznakom za 0,1 ml na štrcaljki (odgovara količini od 0,125 mg okriplazmina).
English: The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression.
Croatian: Klinički najrelevantnije nuspojave uključuju prolaznu sljepoću, rupturu mrežnice, odignuće mrežnice,
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).
Croatian: ≥ 2 reda i 9,7 % nasuprot 3,7 %, p=0,008 za poboljšanje 3 reda).
English: JETREA must be prepared and administered by a qualified ophthalmologist experienced in intravitreal injections.
Croatian: JETREU mora pripravljati i davati kvalificirani oftalmolog s iskustvom u davanju intravitrealnih injekcija.
English: JETREA 0.5 mg/0.2 mL concentrate for solution for injection ocriplasmin
Croatian: JETREA 0,5 mg/0,2 ml koncentrat za otopinu za injekciju okriplazmin
English: JETREA 0.5 mg/0.2 mL concentrate for solution for injection
Croatian: JETREA 0,5 mg/0,2 mL koncentrat za otopinu za injekciju
English: Common side effects (may affect up to 1 in 10 patients): - decreased vision which may be severe - visual disturbances - decreased vision or blind spots in parts of the field of view - blurred vision - bleeding inside the eye - blind spot or blind area in the centre of the vision - distorted vision - swelling of the surface of the eye - swelling of the eyelid - inflammation of the eye - flashes of light in the eye - eye redness - irritation on the surface of the eye - dry eye - a feeling of having something in the eye - itching of the eye - eye discomfort - sensitivity to light - increased tear production
Croatian: - oteklina površine oka - oteklina vjeđe - upala oka - bljeskovi svjetla u oku - crvenilo oka - nadražaj površine oka - suho oko - osjećaj stranog tijela u oku - svrbež oka
English: Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial
Croatian: Nakon potpunog odmrzavanja skinite zaštitnu plavu polipropilensku flip-off kapicu s bočice
English: A greater proportion of patients in the JETREA group had a ≥ 5 points improvement in VFQ-25
Croatian: Veći udio bolesnika u JETREA skupini imao je poboljšanje ≥5 bodova u VFQ-25 kompozitnom rezultatu i u rezultatima podljestvica, bez obzira na vitrektomiju, u svim posjetima.
English: 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
Croatian: - bol u oku - krvarenje na površini oka - promjene u raspoznavanju boja
English: Inject 0.1 mL of the solution immediately into the mid-vitreous.
Croatian: Odmah injicirajte 0,1 ml otopine u središte staklovine.