FrancophonIA/ELRC3.0 huggingface dataset:
English: These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical studies.
Croatian: Ove ozbiljne nuspojave koje zahvaćaju oko javile su se u manje od 1 na svakih 1900 injekcija u kliničkim ispitivanjima.
English: PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes.
Croatian: PlGF se veže samo za VEGFR-1, koji se također nalazi na površini leukocita.
English: If any of the above applies to you, your doctor will consider this lack of information when treating you with Eylea.
Croatian: Ako se nešto od gore navedenog odnosi na Vas, liječnik će uzeti u obzir ovaj nedostatak informacija kad će Vas liječiti lijekom Eylea.
English: If your condition starts to worsen with a longer treatment interval, your doctor will shorten the interval accordingly.
Croatian: Ako se Vaše stanje počne pogoršavati u duljim intervalima liječenja, Vaš će liječnik skratiti intervale sukladno tome.
English: Active or suspected ocular or periocular infection.
Croatian: Aktivna očna ili periokularna infekcija ili sumnja na takvu infekciju.
English: Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity.
Croatian: Liječenje se nastavlja u mjesečnim intervalima sve dok se ne postigne maksimalna oštrina vida i/ili dok nema znakova aktivnosti bolesti.
English: Your doctor will monitor your response to treatment and may continue your treatment by gradually increasing the interval between your injections to maintain a stable condition.
Croatian: Vaš liječnik će pratiti Vaš odgovor na liječenje te može nastaviti Vaše liječenje postepenim produljenjem intervala između injekcija kako bi se održalo stabilno stanje.
English: - if you have a severe form of CRVO or BRVO (ischaemic CRVO or BRVO), treatment with Eylea is not recommended.
Croatian: - ako imate težak oblik CRVO-a ili BRVO-a (ishemijski CRVO ili BRVO) liječenje lijekom Eylea se ne preporučuje.
English: In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Croatian: Dodatno, bolesnike treba pratiti u tjednu nakon primanja injekcije kako bi se u slučaju infekcije omogućilo rano liječenje.
English: Differences for both endpoints were maintained through week 48.
Croatian: Razlika u oba ishoda održala se do 48. tjedna.
English: Clinical efficacy and safety wet AMD
Croatian: Klinička djelotvornost i sigurnost
English: • The dose should be withheld within the previous or next 28 days in the event of a performed or planned intraocular surgery.
Croatian: • Doza se ne smije dati unutar 28 dana prije ili nakon provedene ili planirane intraokularne operacije.
English: No studies have been conducted on the mutagenic or carcinogenic potential of aflibercept.
Croatian: Nisu provedena ispitivanja mutagenosti i kancerogenosti aflibercepta.
English: Make a new appointment for an examination and injection.
Croatian: Dogovorite novi posjet liječniku zbog pregleda i injekcije.
English: Special precaution is needed in patients with poorly controlled glaucoma (do not inject Eylea while the intraocular pressure is ≥ 30 mmHg).
Croatian: Potrebne su posebne mjere opreza u bolesnika sa slabo kontroliranim glaukomom (ne injicirajte lijek Eylea dok je intraokularni tlak ≥ 30 mmHg).
English: Keep the syringe in the sterile tray until you are ready for assembly.
Croatian: Štrcaljku odložite na sterilnu pliticu dok ne budete spremni sastaviti je.
English: The difference between treatment groups was statistically significant in favour of Eylea in both studies.
Croatian: Razlika između terapijskih skupina bila je statistički značajna u korist lijeka Eylea u oba ispitivanja.
English: Free aflibercept binds VEGF to form a stable, inert complex.
Croatian: Slobodni aflibercept veže VEGF s kojim stvara stabilan, inertni kompleks.
English: Absent or irregular menses associated with alterations in female reproductive hormone levels and changes in sperm morphology and motility were observed at all dose levels.
Croatian: Izostanak ili nepravilni menstrualni ciklusi povezani s promjenama razina ženskih spolnih hormona i promjene u morfologiji i pokretljivosti spermija bili su opaženi pri svim razinama doza.
English: • Use of povidone iodine or equivalent
Croatian: • Primjenu jodiranog povidona ili ekvivalenta
English: The MAH has agreed to provide EU Educational Material for Eylea.
Croatian: Nositelj odobrenja složio se da će dostaviti edukacijski materijal za područje EU za lijek Eylea.
English: Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Croatian: Praćenje aktivnosti bolesti može uključivati klinički pregled, testiranje funkcionalnosti ili tehnike oslikavanja (npr. optičku koherentnu tomografiju ili fluorescentnu angiografiju).
English: The patient information pack of the educational material includes a patient information booklet and an audio-CD that contain following key elements:
Croatian: Paket informacija za bolesnike u edukacijskom materijalu uključuje knjižicu s informacijama za bolesnike i audio-CD-a koji sadrže sljedeće ključne elemente:
English: Results from animal studies with high systemic exposure indicate that aflibercept can impair male and female fertility (see section 5.3).
Croatian: Rezultati ispitivanja na životinjama kod visoke sistemske izloženosti pokazuju da aflibercept može narušiti plodnost mužjaka i ženki (vidjeti dio 5.3).
English: What Eylea is and what it is used for What you need to know before you are given Eylea How you will be given Eylea Possible side effects
Croatian: Što je Eylea i za što se koristi Što morate znati prije nego počnete primati lijek Eylea Kako ćete primati lijek Eylea Moguće nuspojave
English: For handling of the medicinal product before administration, see section 6.6.
Croatian: Za rukovanje lijekom prije primjene, vidjeti dio 6.6.
English: This lack of information should be considered by the physician when treating such patients.
Croatian: Liječnik treba uzeti u obzir ovaj nedostatak informacija kod liječenja takvih bolesnika.
English: Patients with bilateral disease were eligible to receive anti-VEGF treatment in their fellow eye if assessed necessary by the physician.
Croatian: Bolesnici s bilateralnom bolešću bili su pogodni za primanje anti-VEGF terapije za drugo oko, ako je liječnik procijenio da je to potrebno.
English: Over the 2 year treatment period patients received an average of 10.4 injections.
Croatian: Tijekom 2 godine liječenja bolesnici su primili u prosjeku 10,4 injekcija.
English: Note: Filter needle is not to be used for intravitreal injection.
Croatian: Napomena: Filtar-igla se ne koristi za intravitrealnu injekciju.
English: Patients in the laser control group could receive additional laser photocoagulation (called ‘rescue laser treatment') beginning at week 12 with a minimum interval of 12 weeks.
Croatian: Bolesnici u kontrolnoj skupini s laserom mogli su primiti dodatnu lasersku fotokoagulaciju (zvanu „spasonosno lasersko liječenje“) s početkom u 12. tjednu, s najmanjim intervalom od 12 tjedana.
English: Ranibizumab 0.5Q4 (ranibizumab 0.5 mg every 4 weeks) (N = 595) Week 52 Week 96 Week 52 Week 96
Croatian: Ranibizumab 0,5Q4 (ranibizumab 0,5 mg svaka 4 tjedna) (N = 595) 52. tjedan 96. tjedan 52. tjedan 96. tjedan
English: • The need to expel excess volume of the syringe before injecting Eylea to avoid overdose
Croatian: • Potrebu da se istisne suvišan volumen lijeka iz štrcaljke prije injiciranja lijeka Eylea kako bi se izbjeglo predoziranje
English: Important information about some of the ingredients of Eylea This medicine contains less than 1 mmol (23 mg) of sodium per dose which means it is essentially “sodium-free”.
Croatian: Važne informacije o nekim sastojcima lijeka Eylea Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, što znači da u osnovi ne sadrži natrij.
English: In patients presenting with clinical signs of irreversible ischaemic visual function loss, the treatment is not recommended.
Croatian: U bolesnika koji pokazuju kliničke znakove ireverzibilnog ishemijskog gubitka funkcije vida liječenje se ne preporučuje.
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Croatian: Iglu za injekciju treba uvesti 3,5 do 4,0 mm posteriorno u odnosu na limbus u šupljinu staklovine, pri čemu treba izbjegavati horizontalni meridijan i ciljati prema središtu očne jabučice.
English: If bilateral treatment is performed at the same time this could lead to an increased systemic exposure, which could increase the risk of systemic adverse events.
Croatian: Ako se lijek istodobno primjenjuje u oba oka, to može dovesti do povišenog sistemskog izlaganja, što može povisiti rizik od nastanka sistemskih štetnih događaja.
English: If your condition worsens, the interval between injections can be shortened, but to not less than every two months in the first year of treatment.
Croatian: Ako Vam se stanje pogorša, intervali između injekcija mogu se smanjiti, ali ne na kraće od svaka dva mjeseca u prvoj godini liječenja.
English: Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.
Croatian: Odgovarajući nadzor može se sastojati od provjere perfuzije glave vidnog živca ili tonometrije.
English: Based on your response to treatment your doctor will decide on the schedule for follow up examinations and treatments.
Croatian: Ovisno o Vašem odgovoru na liječenje Vaš liječnik će odlučiti o rasporedu kontrolnih pregleda i liječenju.
English: The MAH ensures that, following discussions and agreement with the National Competent Authorities in each Member State where Eylea is marketed, ophthalmological clinics where Eylea is expected to be used are provided with an updated physician information pack containing the following elements:
Croatian: Nositelj odobrenja jamči da će, nakon rasprave i dogovora s nadležnim tijelom u pojedinoj zemlji članici u kojoj se Eylea stavlja u promet, oftalmološke klinike u kojima se očekuje primjena lijeka Eylea dobiti nadopunjeni paket s informacijama za liječnike koji će sadržavati sljedeće elemente:
English: A doctor experienced in giving eye injections will inject Eylea into your eye under aseptic (clean and sterile) conditions.
Croatian: Liječnik s iskustvom u davanju injekcija u oko ubrizgat će Vam lijek Eylea u oko u aseptičkim (čistim i sterilnim) uvjetima.
English: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥ 1/10,000 to < 1/1,000)
Croatian: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000 bolesnika).
English: To avoid compromising the sterility of the product, do not pull back on the plunger.
Croatian: Da biste izbjegli narušavanje sterilnosti lijeka, nemojte izvlačiti klip.
English: Such effects are not expected after ocular administration with very low systemic exposure.
Croatian: Takvi se učinci ne očekuju nakon primjene u oko, kod koje je sistemska izloženost vrlo niska.
English: Across indications no notable difference between the groups treated with aflibercept and the respective comparator groups were observed.
Croatian: U svim indikacijama nije opažena značajna razlika između skupina liječenih afliberceptom i odgovarajućih skupina liječenih komparatorom.
English: Talk to your doctor before you are given Eylea:
Croatian: Obratite se svom liječniku prije nego Vam daju lijek Eylea:
English: There is limited experience in patients older than 75 years with DME.
Croatian: Iskustvo u bolesnika s DME-om starijih od 75 godina je ograničeno.
English: Patients with myopic CNV will be treated with one single injection.
Croatian: Bolesnici s miopijskim CNV-om liječit će se jednom injekcijom.
English: VEGF acts via two receptor tyrosine kinases; VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Croatian: VEGF djeluje putem dvije receptorske tirozin kinaze: VEGFR-1 i VEGFR-2, koje se nalaze na površini endotelnih stanica.
English: Adjusted Difference D,C,E
Croatian: Prilagođena razlika D,C,E
English: Additionally, region (Europe/Australia vs. Japan) had been included as factor for VIVIDDME, and history of MI and/or CVA as a factor for VISTADME.
Croatian: Osim toga, regija (Europa/Australija naspram Japana) je bila uključena kao čimbenik u VIVIDDME, a MI i/ili CVA u povijesti bolesti kao čimbenik u VISTADME.
English: Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar aflibercept ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Eylea should be discontinued.
Croatian: Ako vizualni i anatomski ishodi ukazuju da bolesnik nema koristi od nastavka liječenja, liječenje lijekom Eylea treba prekinuti.
English: Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
Croatian: Dodatna primjena fotodinamske terapije (PDT) verteporfinom uz lijek Eylea nije ispitana pa stoga sigurnosni profil nije ustanovljen.
English: Eylea is given as an injection into your eye (intravitreal injection).
Croatian: Eylea se primjenjuje kao injekcija u oko (intravitrealna injekcija).
English: The course of visual improvement was rapid and peaked at 3 months with maintenance of the effect until month 12.
Croatian: Poboljšanje vida bilo je brzo, s vršnim poboljšanjem u 3. mjesecu i održavanjem tog učinka do 12. mjeseca.
English: If you experience a sudden decrease in vision, or an increase in pain and redness in your eye after your injection, contact your doctor immediately.
Croatian: Ako primjetite iznenadno pogoršanje vida ili pojačanje boli i crvenila u oku nakon injekcije, odmah se obratite liječniku.
English: Therefore, its use in this age group is not relevant.
Croatian: Stoga, primjena lijeka Eylea u ovoj dobnoj skupini nije relevantna.
English: After your injection with Eylea, you may experience some temporary visual disturbances.
Croatian: Nakon injekcije lijeka Eylea možete osjetiti neke privremene poremećaje vida.
English: In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred.
Croatian: U kliničkim ispitivanjima primjenjivane su doze do 4 mg u mjesečnim intervalima, a u izoliranim slučajevima došlo je do predoziranja s dozom od 8 mg.
English: Eylea is a solution which is injected into the eye to treat eye conditions in adults called
Croatian: Eylea je otopina koja se ubrizgava u oko zbog liječenja stanja oka u odraslih koja se zovu
English: Additional doses may be administered if visual and/or anatomic outcomes indicate that the disease persists.
Croatian: Mogu se primijeniti dodatne doze ako vidni i/ili anatomski ishodi pokazuju da je bolest i dalje prisutna.
English: In the second year of the studies, efficacy was generally maintained through the last assessment at week 96, and 2-4% of patients required all injections on a monthly basis, and a third of patients required at least one injection with a treatment interval of only one month.
Croatian: U drugoj godini ispitivanja, djelotvornost se općenito održavala kroz zadnju procjenu u 96. tjednu, i za 2-4% bolesnika bile su potrebne sve injekcije na mjesečnoj osnovi, dok je za trećinu bolesnika bila potrebna najmanje jedna injekcija s intervalom liječenja od samo jednog mjeseca.
English: Your doctor will then decide whether the treatment interval between injections may be kept at every two months or be gradually extended in 2- or 4-weekly intervals if your condition has been stable.
Croatian: Vaš će liječnik tada odlučiti može li se razmak između injekcija zadržati na svaka dva mjeseca ili se može postepeno produljivati za 2 ili 4 tjedna, ako Vam je stanje postalo stabilno.
English: Myopic CNV
Croatian: Miopijski CNV
English: Observed in the wet AMD studies only.
Croatian: Opaženo samo u ispitivanjima vlažnog AMD-a.
English: 24 hours.
Croatian: 24 sata.
English: • The safety and efficacy of Eylea therapy administered to both eyes concurrently have not been systematically studied (see section 5.1).
Croatian: • Sigurnost i djelotvornost primjene lijeka Eylea istodobno u oba oka nije sustavno ispitana (vidjeti dio 5.1).
English: Thereafter, plasma concentrations of free aflibercept declined to values below or close to the lower limit of quantitation generally within one week; undetectable concentrations were reached before the next administration after 4 weeks in all patients.
Croatian: Nakon toga, koncentracije slobodnog aflibercepta u plazmi su obično unutar tjedan dana pale do vrijednosti koje su bile blizu ili niže od donje granice kvantifikacije; koncentracije koje nije moguće odrediti dostignute su prije iduće primjene nakon 4 tjedna u svih bolesnika.
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Croatian: Bolesnike treba uputiti da bez odgađanja prijave sve simptome koji bi mogli ukazivati na endoftalmitis ili na bilo koji od gore navedenih događaja.
English: Ocular and systemic safety profiles were similar to the safety observed in the pivotal studies VIEW1 and VIEW2.
Croatian: Okularni i sistemski sigurnosni profili bili su slični onima opaženim u pivotalnim ispitivanjima VIEW1 i VIEW2.
English: The monitoring and treatment schedule should be determined by the treating physician based on the individual patient's response.
Croatian: Nadležni liječnik treba odrediti praćenje i režim liječenja na temelju pojedinačnog odgovora bolesnika.
English: Patients should be instructed to report any signs or symptoms of intraocular inflammation, e.g. pain, photophobia, or redness, which may be a clinical sign attributable to hypersensitivity.
Croatian: Bolesnicima treba dati uputu da prijave svaki znak ili simptom intraokularne upale, npr. bol, fotofobiju ili crvenilo, što mogu biti klinički znakovi koji se mogu pripisati preosjetljivosti.
English: Extension or shortening of the treatment interval was decided based on visual and/or anatomic criteria defined by protocol with a maximum treatment interval of 16 weeks for both groups.
Croatian: Za produljenje ili skraćenje intervala liječenja odlučilo se na temelju vizualnih i/ili anatomskih kriterija, definiranih protokolom, s intervalom liječenja od najviše 16 tjedana za obje skupine.
English: It develops as a wound healing mechanism consequent to Bruch's membrane ruptures and represents the most vision-threatening event in pathologic myopia.
Croatian: Odvija se kao mehanizam cijeljenja ozljede nakon rupture Bruchove membrane i predstavlja događaj koji najviše ugrožava vid kod patološke kratkovidnosti.
English: Blindness, Cataract traumatic, Vitritis, Hypopyon
Croatian: sljepoća, traumatska katarakta, vitritis, hipopion.
English: Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Croatian: Pretjerana aktivacija ovih receptora koju uzrokuje VEGF-A može dovesti do patološke neovaskularizacije i pojačane vaskularne permeabilnosti.
English: There is a theoretical risk of such events following injection of Eylea into the eye.
Croatian: Postoji teoretski rizik od takvih događaja nakon injekcije lijeka Eylea u oko.
English: ETDRS: Early Treatment Diabetic Retinopathy Study
Croatian: ETDRS: Ispitivanje ranog liječenja dijabetičke retinopatije
English: 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.
Croatian: Prije stavljanja lijeka u promet te tijekom životnog ciklusa lijeka u svakoj zemlji članici, nositelj odobrenja će dogovoriti konačni edukacijski materijal s nadležnim tijelom u pojedinoj zemlji.
English: The most frequently observed adverse reactions (in at least 5% of patients treated with Eylea) were conjunctival haemorrhage (25%), visual acuity reduced (11%), eye pain (10%), cataract (8%), intraocular pressure increased (8%), vitreous detachment (7%), and vitreous floaters (7%).
Croatian: Najčešće opažene nuspojave (u najmanje 5% bolesnika liječenih lijekom Eylea) bile su krvarenje spojnice (25%), smanjena oštrina vida (11%), bol u oku (10%), katarakta (8%), povećanje intraokularnog tlaka (8%), odignuće staklovine (7%) i zamućenja u vidnom polju (7%).
English: At total of 67 subjects in this group received Eylea rescue treatment.
Croatian: Ukupno je 67 ispitanika u ovoj skupini primilo spasonosno liječenje lijekom Eylea.
English: Before the injection your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection.
Croatian: Prije davanja injekcije liječnik će uporabiti dezinfekcijsko sredstvo za ispiranje oka kako bi Vam pažljivo očistio oko zbog sprječavanja infekcije.
English: Three or more consecutive, monthly injections may be needed.
Croatian: Možda će biti potrebne 3 ili više uzastopne mjesečne injekcije.
English: F) Difference and 95% CI are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for country
Croatian: F) Razlika i 95% CI izračunati su pomoću Cochran-Mantel-Haenszelovog (CMH) testa prilagođenog za zemlju (oznaku zemlje)
English: Remove the filter needle and properly dispose of it.
Croatian: Izvucite filtar-iglu i zbrinite je na ispravan način.
English: - diabetics with an eye disease caused by diabetes called proliferative diabetic retinopathy.
Croatian: - osoba sa šećernom bolešću koje imaju očnu bolest uzrokovanu šećernom bolešću, koja se zove proliferativna dijabetička retinopatija.
English: - Eylea is not recommended during breast-feeding as it is not known whether Eylea passes into human milk.
Croatian: - Eylea se ne preporučuje tijekom dojenja, jer nije poznato izlučuje li se Eylea u majčino mlijeko.
English: If any of these apply to you, Eylea will be given with caution.
Croatian: Ako se nešto od navedenog odnosi na Vas, lijek Eylea davat će Vam se s oprezom.
English: If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
Croatian: Ako se vizualni i/ili anatomski ishodi pogoršaju, intervale liječenja treba skratiti sukladno tome.
English: Increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Eylea (see section 4.8).
Croatian: Povećanje intraokularnog tlaka opaženo je unutar 60 minuta od primjene intravitrealne injekcije, uključujući injekcije lijeka Eylea (vidjeti dio 4.8).
English: Furthermore, in the 4-week adjustment group 40.7% of patients were extended to 16 week intervals.
Croatian: Nadalje, u skupini s 4-tjednom prilagodbom za 40,7% bolesnika intervali su produljeni na 16 tjedana.
English: • 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.
Croatian: • Čimbenici rizika povezani s nastankom razderotine pigmentnog epitela mrežnice nakon anti-VEGF terapije zbog vlažnog AMD-a, uključuju veliko i/ili visoko odignuće pigmentnog epitela mrežnice.
English: The beneficial effect of Eylea treatment on visual function was similar in the baseline subgroups of perfused and non-perfused patients.
Croatian: Koristan učinak lijeka Eylea na funkciju vida bio je sličan u početnim podskupinama bolesnika sa i bez perfuzije.
English: The reduction in CRT was generally maintained in both treatment arms in the second year of the ALTAIR study.
Croatian: Smanjenje CRT-a se općenito zadržalo u obje liječene skupine u drugoj godini ispitivanja ALTAIR.
English: Aflibercept acts as a soluble decoy receptor that binds VEGF-A and PlGF with higher affinity than their natural receptors, and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Croatian: Aflibercept djeluje kao topljivi lažni receptor koji veže VEGF-A i PlGF većim afinitetom nego njihovi prirodni receptori pa tako može inhibirati vezanje i aktivaciju ovih srodnih VEGF receptora.