FrancophonIA/ELRC3.0 huggingface dataset:
English: PlGF can synergize with VEGFA in these processes, and is also known to promote leucocyte infiltration and vascular inflammation.
Slovenian: PlGF lahko v teh procesih deluje sinergično z VEGF-A, znano pa je tudi, da pospešuje infiltracijo levkocitov in vnetje žil.
English: Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Slovenian: Prekomerna aktivacija teh receptorjev z VEGF-A lahko povzroči patološko neovaskularizacijo in prekomerno žilno prepustnost.
English: Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino aflibercept ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: • Confirmation that the vial is for single use only
Slovenian: • poudarek, da je viala samo za enkratno uporabo
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.
Slovenian: Dodatno je bila vključena regija (Evropa/Avstralija v primerjavi z Japonsko) kot dejavnik za študijo VIVIDDME in anamneza MI in/ali CVA kot dejavnik za študijo VISTADME.
English: For handling of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede ravnanja z zdravilom pred uporabo glejte poglavje 6.6.
English: Special precaution is needed in patients with poorly controlled glaucoma (do not inject Eylea while the intraocular pressure is ≥ 30 mmHg).
Slovenian: Posebna previdnost je potrebna pri bolnikih z neustrezno zdravljenim glavkomom (zdravila Eylea ne injicirajte, če je intraokularni tlak ≥ 30 mmHg).
English: The reduction of CNV size and reduction in CRT were generally maintained in the second year of the studies.
Slovenian: Zmanjšana CNV in zmanjšana CRT sta bili običajno ohranjeni tudi v drugem letu študij.
English: A total of 3,102 patients constituted the safety population in the eight phase III studies.
Slovenian: V osmih študijah III. faze je bilo v populacijo za oceno varnosti zdravila vključenih skupaj 3.102 bolnikov.
English: Active or suspected ocular or periocular infection.
Slovenian: Aktivna okužba očesa ali periokularna okužba ali sum nanjo.
English: Across indications no notable difference between the groups treated with aflibercept and the respective comparator groups were observed.
Slovenian: Pri indikacijah niso opazili razlik med skupinami, zdravljenimi z afliberceptom in primerjalno skupino.
English: At total of 67 subjects in this group received Eylea rescue treatment.
Slovenian: Skupno 67 bolnikov v tej skupini je prejelo rešilno zdravljenje z zdravilom Eylea.
English: The monitoring and treatment schedule should be determined by the treating physician based on the individual patient's response.
Slovenian: Načrt spremljanja in zdravljenja bolnika mora določiti lečeči zdravnik in sicer glede na odziv posameznega bolnika na zdravljenje.
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Slovenian: Bolnike je treba poučiti, da takoj poročajo o vseh simptomih, ki bi lahko kazali na endoftalmitis ali če se pojavi kateri koli od zgoraj omenjenih dogodkov.
English: Such effects are not expected after ocular administration with very low systemic exposure.
Slovenian: Taki učinki niso pričakovani po okularni uporabi, kjer je sistemska izpostavljenost zelo majhna.
English: Available data do not suggest a need for a dose adjustment with Eylea in these patients (see section 5.2).
Slovenian: Glede na razpoložljive podatke odmerka zdravila Eylea pri teh bolnikih ni treba prilagajati (glejte poglavje 5.2).
English: The difference between treatment groups was statistically significant in favour of Eylea in both studies.
Slovenian: Razlika med zdravljenima skupinama je bila v obeh študijah statistično značilna v korist zdravila Eylea.
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.
Slovenian: Bolniki v kontrolni skupini z laserskim zdravljenjem so bili lahko dodatno zdravljeni z lasersko fotokoagulacijo (imenovano »rešilno lasersko zdravljenje«), ki se je začelo v 12. tednu, z najkrajšim intervalom 12 tednov.
English: Decreases in mean CNV area were evident in all dose groups in both studies.
Slovenian: Zmanjšanje povprečne velikosti CNV lezije je bilo očitno pri vseh skupinah odmerkov v obeh študijah.
English: • Concomitant use of other anti-VEGF (vascular endothelial growth factor) There is no data available on the concomitant use of Eylea with other anti-VEGF medicinal products (systemic or ocular).
Slovenian: • Sočasna uporaba drugih zaviralcev VEGF (žilni endotelijski rastni dejavnik) Na voljo ni podatkov glede sočasne uporabe zdravila Eylea z drugimi zaviralci VEGF (sistemski ali okularni).
English: • Use of povidone iodine or equivalent
Slovenian: • uporaba povidon jodida ali drugega ustreznega sredstva
English: After 6 consecutive monthly injections, patients received treatment only if they met pre-specified retreatment criteria, except for patients in the control group in the GALILEO study who continued to receive sham (control to control) until week 52.
Slovenian: Po šestih zaporednih mesečnih injekcijah so bolniki prejeli zdravilo le, če so izpolnjevali vnaprej določene kriterije za ponovno zdravljenje, razen bolniki v kontrolni skupini v študiji GALILEO, ki so še naprej prejemali placebo (kontrola kontrolne skupine) do 52. tedna.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom zagotavlja, da bo po dogovoru s pristojnim nacionalnim organom v vsaki državi članici, kjer je zdravilo Eylea na trgu, vse očesne klinike, kjer se pričakuje, da bodo zdravilo Eylea uporabljali, prejele posodobljen paket izobraževalnih gradiv za zdravnike, ki bo vseboval naslednje:
English: In patients treated with Eylea, the majority of whom were classified as having Type II diabetes, a rapid and robust response in morphology (CRT, DRSS level) was observed.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Eylea, od katerih jih je bila večina razvrščenih med bolnike s sladkorno boleznijo tipa II, je bil opažen hiter in robusten morfološki odgovor (CRT, DRSS nivo).
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.
Slovenian: Če se vam vid nenadoma poslabša ali se po injekciji povečata bolečina in pordelost očesa, se takoj posvetujte z zdravnikom.
English: Push the filter needle into the centre of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.
Slovenian: Filtrirno iglo potisnite v sredino zamaška viale, dokler ni cela igla v viali in se konica dotakne dna ali spodnjega roba viale.
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.
Slovenian: Zdravnik bo spremljal vaš odziv na zdravljenje in za vzdrževanje stabilnega stanja morda nadaljeval zdravljenje s postopnim podaljševanjem intervala med injekcijami.
English: Eylea is indicated for adults for the treatment of
Slovenian: Zdravilo Eylea je indicirano pri odraslih za zdravljenje
English: If your condition starts to worsen with a longer treatment interval, your doctor will shorten the interval accordingly.
Slovenian: Če se bo pri podaljšanem intervalu zdravljenja vaše stanje začelo slabšati, bo zdravnik interval ustrezno skrajšal.
English: In all cases, both the intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Slovenian: V vseh primerih je treba zato ustrezno spremljati intraokularni tlak in perfuzijo glave vidnega živca in ustrezno ukrepati.
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.
Slovenian: Aflibercept deluje kot topen vabni receptor, ki veže VEGF-A in PlGF z večjo afiniteto kot njihovi naravni receptorji, zato lahko zavira vezavo in aktivacijo sorodnih receptorjev VEGF.
English: Increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Eylea (see section 4.8).
Slovenian: Povišanje intraokularnega tlaka so opažali v 60 minutah po intravitrealni injekciji, tudi po injiciranju zdravila Eylea (glejte poglavje 4.8).
English: Eylea has been shown to stop the growth of new abnormal blood vessels in the eye which often leak fluid or bleed.
Slovenian: Dokazano je, da zdravilo Eylea ustavi rast novih nenormalnih krvnih žil v očesu, iz katerih pogosto izteka tekočina ali kri.
English: Note: Filter needle is not to be used for intravitreal injection.
Slovenian: Opozorilo: Filtrirne igle ne uporabite za intravitrealno injiciranje.
English: Results from animal studies with high systemic exposure indicate that aflibercept can impair male and female fertility (see section 5.3).
Slovenian: Izsledki študij na živalih, pri katerih je bila sistemska izpostavljenost velika, kažejo, da ima lahko aflibercept škodljiv vpliv na plodnost pri moških in ženskah (glejte poglavje 5.3).
English: The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke.
Slovenian: Sistemska uporaba zaviralcev VEGF, snovi, podobnih tistim, ki jih vsebuje zdravilo Eylea, je lahko povezana s tveganjem za nastanek krvnih strdkov, ki zamašijo krvne žile (arterijski trombembolični dogodki), kar lahko privede do srčnega napada ali možganske kapi.
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.
Slovenian: Bolnike je treba poučiti, da poročajo o vseh znakih in simptomih vnetja v očesu npr. bolečini, fotofobiji ali pordelosti, ki bi lahko bili klinični znaki preobčutljivosti.
English: VEGF acts via two receptor tyrosine kinases; VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Slovenian: VEGF deluje preko dveh tirozinkinaznih receptorjev, VEGFR-1 in VEGFR-2, ki sta prisotna na površini endotelijskih celic.
English: Free aflibercept binds VEGF to form a stable, inert complex.
Slovenian: Prosti aflibercept se z VEGF veže v stabilni inertni kompleks.
English: (97.5% CI)
Slovenian: (97,5 % IZ)
English: - Eylea is not recommended during breast-feeding as it is not known whether Eylea passes into human milk.
Slovenian: - Uporaba zdravila Eylea se ne priporoča med dojenjem, saj ni znano, ali zdravilo Eylea prehaja v materino mleko.
English: Myopic choroidal neovascularisation (myopic CNV) is a frequent cause of vision loss in adults with pathologic myopia.
Slovenian: Miopična horoidalna neovaskularizacija (miopična CNV) je pogost vzrok izgube vida pri odraslih s patološko kratkovidnostjo.
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%).
Slovenian: Najpogosteje opaženi neželeni učinki (pri vsaj 5 % bolnikov, zdravljenih z zdravilom Eylea) so bili krvavitev pod očesno veznico (25 %), zmanjšana ostrina vida (11 %), bolečina v očesu (10 %), katarakta (8 %), povišan intraokularni tlak (8 %), odstop steklovine (7 %) in motnjave v steklovini
English: This decrease from baseline in CRT was maintained to the end of each study, week 100 in COPERNICUS, week 76 in GALILEO, and week 52 in VIBRANT.
Slovenian: Zmanjšanje CRT glede na izhodiščne vrednosti se je ohranilo do konca vsake študije, do 100. tedna v študiji COPERNICUS, 76. tedna v študiji GALILEO in 52. tedna v študiji VIBRANT.
English: • Female patients of childbearing potential have to use effective contraception and pregnant women should not use Eylea
Slovenian: • bolnice v rodni dobi morajo uporabljati učinkovito kontracepcijo, pri nosečnicah pa se zdravila ne sme uporabljati
English: In the VIVIDDME and VISTADME studies, 36 (9%) and 197 (43%) patients received prior anti-VEGF therapy, respectively, with a 3-month or longer washout period.
Slovenian: V študijah VIVIDDME in VISTADME je 36 (9 %) oziroma 197 (43 %) bolnikov prejemalo predhodno zdravljenje z zaviralci VEGF s 3-mesečnim ali daljšim obdobjem izpiranja.
English: As with other intravitreal anti-VEGF treatments for AMD, CRVO, BRVO, DME and myopic CNV the following also applies:
Slovenian: Kot pri drugih intravitrealnih zaviralcih VEGF za zdravljenje AMD, CRVO, BRVO, DME in miopične CNV je treba upoštevati tudi naslednje:
English: The beneficial effect of Eylea treatment on visual function was similar in the baseline subgroups of perfused and non-perfused patients.
Slovenian: Koristni učinki zdravljenja z zdravilom Eylea na vid so bili na začetku podobni v podskupinah perfundiranih in neperfundiranih bolnikov.
English: If any of these apply to you, Eylea will be given with caution.
Slovenian: Če se kar koli od naštetega nanaša na vas, vam bodo dajali zdravilo Eylea posebno previdno.
English: DifferenceC) (95% CI)D)
Slovenian: RazlikaC (95 % IZ)D
English: What Eylea contains - The active substance is: aflibercept.
Slovenian: Kaj vsebuje zdravilo Eylea - Učinkovina je aflibercept.
English: What you need to know before you are given Eylea
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Eylea
English: The schedule for monitoring should be determined by the treating physician.
Slovenian: Načrt spremljanja bolnika mora določiti lečeči zdravnik.
English: - your doctor will check whether you have other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment or tear), in which case Eylea must be given with caution.
Slovenian: - Zdravnik bo preveril ali pri vas obstajajo drugi dejavniki tveganja, kar lahko poveča možnost za raztrganine ali odstop ene od plasti v zadnjem delu očesa (odstop ali raztrganine mrežnice, in odstop ali zatrganje pigmentnega epitelija mrežnice), ker je treba v teh primerih dati zdravilo Eylea posebno previdno.
English: Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as potent mitogenic, chemotactic, and vascular permeability factors for endothelial cells.
Slovenian: Žilni endotelijski rastni dejavnik-A (VEGF-A) in placentni rastni dejavnik (PlGF) spadata v skupino VEGF angiogenih dejavnikov, ki lahko delujejo kot močni dejavniki mitogene, kemotaktične in žilne prepustnosti za endotelijske celice.
English: Effects on male and female fertility were assessed as part of a 6-month study in monkeys with intravenous administration of aflibercept at doses ranging from 3 to 30 mg/kg.
Slovenian: Učinke na sposobnost razmnoževanja pri moških in ženskah so ocenili kot del 6-mesečne študije pri opicah, ki so jim intravensko aplicirali aflibercept v odmerkih od 3 do 30 mg/kg.
English: • Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • Patient monitoring after intravitreal injection including monitoring for visual acuity and increase of intraocular pressure post-injection
Slovenian: • spremljanje bolnikov po prejemu intravitrealne injekcije vključno s spremljanjem ostrine vida in povišanja intraokularnega tlaka po injiciranju
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.
Slovenian: V drugem letu študij se je učinkovitost v splošnem ohranila do zadnjega ocenjevanja v 96. tednu; pri 2 - 4 % bolnikov so bile potrebne vse injekcije v intervalu enega meseca; pri tretjini bolnikov pa je bila po enem mesecu potrebna vsaj ena injekcija.
English: Effects in non-clinical studies on repeated dose toxicity were observed only at systemic exposures considered substantially in excess of the maximum human exposure after intravitreal administration at the intended clinical dose indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke toksičnosti pri ponavljajočih odmerkih opazili samo pri sistemskih izpostavljenostih, ki so močno presegale največjo izpostavljenost pri ljudeh po intravitrealni aplikaciji izbranega kliničnega odmerka, kar kaže na majhen pomen za klinično uporabo.
English: Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified physician experienced in administering intravitreal injections.
Slovenian: Intravitrealne injekcije mora v skladu s strokovnimi standardi in veljavnimi smernicami aplicirati usposobljen zdravnik, ki ima izkušnje z dajanjem intravitrealnih injekcij.
English: Pharmacokinetic analysis of patients in the VIEW2 study, of which 40% had renal impairment (24% mild, 15% moderate, and 1% severe), revealed no differences with respect to plasma concentrations of active drug after intravitreal administration every 4 or 8 weeks.
Slovenian: Farmakokinetične analize bolnikov v študiji VIEW2, v kateri je imelo 40 % bolnikov ledvično okvaro (24 % blago, 15 % zmerno in 1 % hudo), po intravitrealni aplikaciji vsake 4 ali vsakih 8 tednov, niso pokazale razlik v koncentracijah učinkovine v plazmi.
English: Similar results were seen in patients with CRVO in the GALILEO study, in patients with DME in the VIVIDDME study, and in patients with myopic CNV in the MYRROR study.
Slovenian: Podobne izsledke so opazili pri bolnikih s CRVO v študiji GALILEO, bolnikih z DME v študiji VIVIDDME in bolnikih z miopično CNV v študiji MYRROR.
English: Final study report submission: 30
Slovenian: predložitev končnega poročila o študiji: 30. november
English: Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
Slovenian: Prepričajte se, da je med praznjenjem viale bat potegnjen dovolj nazaj, da filtrirno iglo povsem izpraznite.
English: Elimination As Eylea is a protein-based therapeutic, no metabolism studies have been conducted.
Slovenian: Izločanje Ker je zdravilo Eylea terapevtski protein, študij presnove niso izvedli.
English: Eylea has not been studied in patients with active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole.
Slovenian: Zdravila Eylea niso preučevali pri bolnikih z aktivno sistemsko okužbo ali pri bolnikih s sočasnimi očesnimi boleznimi, kot sta odstop mrežnice ali makularna luknja.
English: In both studies Eylea was shown to be non-inferior and clinically equivalent to the ranibizumab 0.5Q4 group.
Slovenian: V obeh študijah se je pokazalo, da je zdravljenje z zdravilom Eylea neinferiorno in klinično enakovredno zdravljenju z ranibizumabom 0,5Q4.
English: If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top.
Slovenian: Če so mehurčki, s prsti nežno potrkajte po brizgi, da se mehurčki dvignejo na vrh brizge.
English: 100 Weeks
Slovenian: 100 tednov
English: - injections with Eylea may cause an increase in eye pressure (intraocular pressure) in some patients within 60 minutes of the injection.
Slovenian: - Injiciranje zdravila Eylea lahko pri nekaterih bolnikih v 60 minutah po injiciranju povzroči povišanje očesnega tlaka (intraokularni tlak).
English: To avoid compromising the sterility of the product, do not pull back on the plunger.
Slovenian: Za zagotovitev sterilnosti zdravila, bata ne vlecite nazaj.
English: Therefore, in case of overdose, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
Slovenian: V primeru prevelikega odmerjanja je treba spremljati intraokularni tlak in uvesti ustrezno zdravljenje, če lečeči zdravnik oceni, da je potrebno.
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
Slovenian: Kaj je zdravilo Eylea in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Eylea Kako boste prejeli zdravilo Eylea Možni neželeni učinki
English: It is unknown whether aflibercept is excreted in human milk.
Slovenian: Dojenje Ni znano, ali se aflibercept izloča v materino mleko.
English: Three or more consecutive, monthly injections may be needed.
Slovenian: Morda bo tri ali več zaporednih mesecev potrebna 1 injekcija na mesec.
English: Your doctor may decide to stop treatment with Eylea if it is determined that you are not benefiting from continued treatment.
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Eylea, če bo ugotovil, da vam nadaljnje zdravljenje ne bi koristilo.
English: If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Eylea should be discontinued.
Slovenian: Če ocena ostrine vida in anatomski izgled rumene pege kažeta, da bolnik nima koristi od nadaljevanja zdravljenja, je treba zdravljenje z zdravilom Eylea prenehati.
English: Beginning at week 24, patients meeting a pre-specified threshold of vision loss were eligible to receive additional treatment: patients in the Eylea groups could receive laser and patients in the control group could receive Eylea.
Slovenian: V 24. tednu so začeli bolniki, ki so dosegli vnaprej določen prag izgube vida, prejemati dodatno zdravljenje: bolniki v skupini, ki je prejemala zdravilo Eylea, so se lahko zdravili lasersko in bolniki v kontrolni skupini so lahko prejeli zdravilo Eylea.
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.
Slovenian: Podaljšanje ali skrajšanje intervala med injekcijami je bilo določeno glede na oceno ostrine vida in/ali anatomski izgled rumene pege, določenem po protokolu; največji interval med injekcijami je bil 16 tednov za obe skupini.
English: Overdosing with increased injection volume may increase intraocular pressure.
Slovenian: Prekomerno odmerjanje z injiciranjem večje količine raztopine lahko poviša intraokularni tlak.
English: Clinical efficacy and safety wet AMD
Slovenian: Klinična učinkovitost in varnost
English: - There is no experience of using Eylea in pregnant women.
Slovenian: - Izkušenj z uporabo zdravila Eylea pri nosečnicah ni.
English: What Eylea looks like and contents of the pack
Slovenian: Izgled zdravila Eylea in vsebina pakiranja
English: Ranibizumab 0.5Q4 (ranibizumab 0.5 mg every 4 weeks)
Slovenian: ranibizumab 0,5Q4 (ranibizumab 0,5 mg vsake 4 tedne)
English: There is limited experience in patients older than 75 years with DME.
Slovenian: Izkušnje pri bolnikih z diabetičnim makularnim edemom, starejših od 75 let, so omejene.