FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: • Samtidig anvendelse af andre anti-VEGF-lægemidler (vaskulære endoteliale vækstfaktorer) Der er ingen tilgængelige data om samtidig anvendelse af Eylea og andre anti-VEGFlægemidler (systemiske eller okulære)
English: Eylea is a solution which is injected into the eye to treat eye conditions in adults called
Danish: Eylea er en opløsning, der indsprøjtes i øjet for at behandle øjensygdomme hos voksne, som kaldes
English: At week 24, patients initially randomised to sham were eligible to receive the first dose of Eylea.
Danish: Ved uge 24 kunne patienter, der først var randomiseret til sham, få deres første dosis Eylea.
English: A 13.3 mean letter gain with 42% of patients gaining at least 15 letters in vision from baseline was observed in Protocol T. Ocular and systemic safety profiles (including ATEs) were similar to VIVIDDME and VISTADME.
Danish: Der sås en gennemsnitlig bedring på 13,3 bogstaver, hvor 42 % af patienterne fik en bedring af synet på mindst 15 bogstaver fra baseline i Protocol T. De okulære og systemiske sikkerhedsprofiler (herunder ATEer) var de samme som i VIVIDDME og VISTADME.
English: When initiating Eylea therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Danish: Når behandlingen med Eylea indledes, bør der udvises forsigtighed hos patienter med disse risikofaktorer for rifter i det retinale pigmentepitel.
English: Eylea is for intravitreal injection only.
Danish: Eylea er kun til intravitreal injektion.
English: VEGF acts via two receptor tyrosine kinases; VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Danish: VEGF virker via to receptor-tyrosinkinaser, VEGFR-1 og VEGFR-2, der findes på endotelcellernes overflade.
English: The macula is the portion of retina responsible for fine vision.
Danish: Makula er den del af nethinden, der er ansvarlig for det skarpe syn.
English: • Treatment should be withheld in patients with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Danish: • Behandling bør seponeres hos patienter med rhegmatogen nethindeløsning eller huller i makula, stadie 3 eller 4.
English: In CRVO and BRVO, retinal ischaemia occurs and signals the release of VEGF which in turn destabilises the tight junctions, and promotes endothelial cell proliferation.
Danish: Ved CRVO og BRVO optræder retinal iskæmi som signalerer frigivelse af VEGF hvilket igen destabiliserer de tætte cellebindinger og fremmer endothelcelleproliferation.
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Danish: Patienten skal informeres om øjeblikkeligt at rapportere alle symptomer på endoftalmitis eller andre af ovennævnte bivirkninger.
English: The maximal improvement in visual acuity was achieved at month 3 with subsequent stabilisation of visual acuity and CRT until month 6.
Danish: Den maksimale bedring i visus blev opnået den 3. måned med efterfølgende stabilisering af visus og CRT indtil måned 6.
English: If any of these apply to you, Eylea will be given with caution.
Danish: Hvis noget af dette gælder for dig, vil du med stor forsigtighed blive behandlet med Eylea.
English: At total of 67 subjects in this group received Eylea rescue treatment.
Danish: I alt 67 patienter i denne gruppe fik erstatningsbehandling med Eylea.
English: Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Danish: Monitorering af sygdomsaktivitet kan omfatte klinisk undersøgelse, funktionstest eller billeddiagnostik (f.eks. optisk kohærenstomografi (OCT) eller fluoresceinangiografi).
English: Active Control (laser)/Eylea
Danish: Aktiv kontrol (laser) /Eylea
English: PlGF can synergize with VEGFA in these processes, and is also known to promote leucocyte infiltration and vascular inflammation.
Danish: P1GF kan virke synergistisk med VEGF-A i disse processer og vides også at fremme leukocytinfiltration og vaskulær inflammation.
English: Final study report submission: 30
Danish: Indsendelse af endelig studierapport: 30. november
English: Intravitreal injections must be carried out according to medical standards and applicable guidelines by a qualified physician experienced in administering intravitreal injections.
Danish: Intravitreale injektioner skal udføres i overensstemmelse med medicinske standarder og gældende retningslinjer af en øjenlæge med erfaring i administration af intravitreale injektioner.
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.
Danish: • Risikofaktorer forbundet med udviklingen af en rift i det retinale pigmentepitel efter antiVEGF-behandling for våd AMD inkluderer en stor og/eller høj løsning af det retinale pigmentepitel.
English: Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Danish: Dyreforsøg har påvist embryo-/fostertoksicitet (se pkt.
English: Keep the syringe in the sterile tray until you are ready for assembly.
Danish: Opbevar injektionssprøjten på den sterile bakke, indtil du er klar til at samle den.
English: Systemic effects
Danish: Systemisk virkning
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.
Danish: Efter injektion hver måned i 6 måneder fik patienterne kun behandling, hvis de opfyldte visse forudspecificerede genbehandlingskriterier, bortset fra patienter i kontrolgruppen i GALILEO-studiet, som fortsat fik sham-injektioner (kontrol til kontrol) indtil uge 52.
English: 100 Weeks
Danish: 100 uger
English: In the second year of the study, efficacy was generally maintained up to and including the last assessment at week 96, with a mean gain from baseline of 7.6 letters for the 2-week adjustment group and 6.1 letters for the 4-week adjustment group.
Danish: I det andet studieår, blev virkningen generelt opretholdt til og med den sidste vurdering i uge 96, med en gennemsnitlig øgning fra baseline på 7,6 bogstaver for gruppen med justeringer på 2 uger og 6,1 bogstaver for gruppen med justeringer på 4 uger.
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.
Danish: I VIVIDDME- og VISTADME-studierne havde hhv. 36 (9 %) og 197 (43 %) af patienterne fået tidligere anti-VEGF-behandling, med en 3-måneders udvaskningsperiode eller længere.
English: Erosions and ulcerations of the respiratory epithelium in nasal turbinates in monkeys treated with aflibercept intravitreally were observed at systemic exposures in excess of the maximum human exposure.
Danish: Erosioner og ulcerationer af det respiratoriske epitel i concha nasalis hos aber behandlet med aflibercept intravitrealt blev observeret ved systemiske eksponeringer, som er væsentlig over den maksimale humane eksponering.
English: As with all therapeutic proteins, there is a potential for immunogenicity with Eylea.
Danish: Som ved alle terapeutiske proteiner er der potentiale for immunogenicitet med Eylea.
English: Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
Danish: Aflibercept er et rekombinant fusionsprotein, der består af dele af human VEGF-receptor 1 og 2 ekstracellulære domæner fusioneret til Fc-delen af human IgG1.
English: - non-Asian patients with myopic CNV.
Danish: - ikke-asiatiske patienter med myopisk CNV.
English: 76 Weeks
Danish: 76 uger
English: Although the systemic exposure after ocular administration is very low, Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Danish: Selvom den systemiske eksponering efter okulær administration er meget lav, bør Eylea ikke anvendes under graviditeten, medmindre de potentielle fordele for moderen opvejer den potentielle risiko for fosteret.
English: The mean maximum plasma concentration of free aflibercept is approximately 50 to 500 times below the aflibercept concentration required to inhibit the biologic activity of systemic VEGF by 50% in animal models, in which blood pressure changes were observed after circulating levels of free aflibercept attained approximately 10 microgram/ml and returned to baseline when levels fell below approximately 1 microgram/ml.
Danish: Middelværdien for den maksimale plasmakoncentration af frit aflibercept er ca. 50 til 500 gange under den koncentration af aflibercept, som er nødvendig for at hæmme den biologiske aktivitet af systemisk VEFG med 50 % i dyremodeller, hvor ændringer i blodtryk blev observeret efter cirkulerende niveauer af frit aflibercept nåede ca. 10 mikrogram/ml og vendte tilbage til baseline, når niveauerne faldt under ca. 1 mikrogram/ml.
English: Based on your response to treatment your doctor will decide on the schedule for follow up examinations and treatments.
Danish: Afhængigt af hvordan du reagerer på behandlingen, fastlægger din øjenlæge en plan for efterfølgende undersøgelser og behandlinger.
English: - patients previously treated for myopic CNV.
Danish: - patienter, der tidligere er blevet behandlet for myopisk CNV.
English: - patients with damage outside the central part of the macula (extrafoveal lesions) for myopic CNV.
Danish: - patienter med skader uden for den centrale del af makula (ekstrafoveale læsioner) for myopisk
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.
Danish: Lignende resultater blev set hos patienter med CRVO i GALILEO-studiet, og hos patienter med DME i VIVIDDME-studiet, og hos patienter med myopisk CNV i MYRROR-studiet.
English: A total of 862 patients were treated and evaluable for efficacy, 576 with Eylea.
Danish: I alt 862 patienter blev behandlet og evalueret for virkning, 576 med Eylea.
English: There is only limited experience in the treatment of - patients with DME due to type I diabetes.
Danish: Der er kun begrænset erfaring ved behandling af - patienter med DME, der skyldes type I-sukkersyge.
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.
Danish: Vaskulær endethelial vækstfaktor-A (VEGF-A) og placenta vækstfaktor (P1GF) er medlemmer af VEFG-familien af angiogene faktorer, der kan virke som potente mitogene, kemotaktiske og vaskulære permeabilitetsfaktorer for endotelceller.
English: Eylea 2Q8 E) (Eylea 2 mg every 8 weeks following 3 initial monthly doses) (N = 607)
Danish: Eylea 2Q8 E) (Eylea 2 mg hver 8. uge efter 3 indledende månedlige doser) (N = 607)
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%).
Danish: De hyppigst observerede bivirkninger (hos mindst 5 % af de patienter, der blev behandlet med Eylea) var konjunktivalblødning (25 %), nedsat visus (11 %), øjensmerter (10 %), katarakt (8 %), forhøjet intraokulært tryk (8 %), løsning af glaslegemet (7 %) og glaslegemeflydere (7 %).
English: Overdosing with increased injection volume may increase intraocular pressure.
Danish: Overdosering med øget injektionsvolumen kan øge det intraokulære tryk.
English: The use of Eylea in children or adolescents under 18 has not been studied because wet AMD, CRVO, BRVO, DME and myopic CNV occur mainly in adults.
Danish: Anvendelsen af Eylea til børn eller unge under 18 år er ikke blevet undersøgt, da våd AMD, CRVO, BRVO, DME og myopisk CNV hovedsageligt forekommer hos voksne.
English: In both studies, the primary efficacy endpoint was the mean change from baseline in BCVA at week 52 and both Eylea 2Q8 and Eylea 2Q4 groups demonstrated statistical significance and were superior to the control group.
Danish: I begge studier var det primære endepunkt for virkning den gennemsnitlige ændring fra baseline af BCVA ved uge 52, og både Eylea 2Q8- og Eylea 2Q4-grupperne viste en statistisk signifikans og var bedre end kontrolgruppen.
English: Other medicines and Eylea Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Eylea Fortæl altid øjenlægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver gruppering af hyppighed er bivirkningerne opstillet efter hvor alvorlige de er.
English: Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
Danish: Sørg for, at stempelstangen er trukket tilstrækkeligt tilbage, når hætteglasset tømmes, for at tømme filterkanylen helt.
English: If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, Eylea should be discontinued.
Danish: Hvis resultaterne fra visuelle og anatomiske undersøgelser viser, at patienten ikke har gavn af fortsat behandling, skal Eylea seponeres.
English: A) Difference is Eylea 2 mg Q4 weeks minus Laser Control
Danish: A) Forskellen er Eylea 2 mg Q4 uger minus laserkontrol
English: - if you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may have eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, and increased sensitivity to light.
Danish: - Hvis du får betændelse eller inflammation (betændelseslignende tilstand) inden i øjet (endoftalmitis), eller du får andre komplikationer, kan du få øjensmerter, øget ubehag, forværring af øjenrødme, sløret eller nedsat syn og øget lysfølsomhed.
English: Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
Danish: Aflibercept fremstilles i K1-ovarieceller fra kinesisk hamster (CHO) med rekombinant DNAteknologi.
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.
Danish: Patienterne bør informeres om, at de skal rapportere ethvert tegn eller symptom på intraokulær inflammation, dvs. smerte, fotofobi eller røde øjne, som kan være et klinisk tegn på overfølsomhed.
English: Increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Eylea (see section 4.8).
Danish: Stigninger i intraokulært tryk er set inden for 60 minutter fra intravitreal injektion, herunder injektioner med Eylea (se pkt.
English: - if you have glaucoma.
Danish: - Hvis du har grøn stær.
English: • The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: o a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; o a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50%, of the total lesion area.
Danish: • Dosis skal seponeres, og behandlingen bør tidligst genoptages ved næste planlagte behandling hvis følgende sker: o Et fald i bedst korrigeret visus (BCVA) af ≥ 30 bogstaver sammenlignet med den sidste bestemmelse af synsstyrken; o En subretinal blødning, som omfatter centret af fovea, eller hvis blødningens størrelse er ≥ 50 % af det samlede læsionsområde.
English: It is estimated that after intravitreal administration of 2 mg to patients, the mean maximum plasma concentration of free aflibercept is more than 100-fold lower than the concentration of aflibercept required to half-maximally bind systemic VEGF (2.91 microgram/ml) in a study of healthy volunteers.
Danish: Det vurderes, at efter intravitreal administration af 2 mg til patienter, er middelværdien for den maksimale plasmakoncentration af frit aflibercept mere end 100 gange lavere end den koncentration af aflibercept, som er nødvendigt til halv-maksimalt at binde systemisk VEGF (2,91 mikrogram/ml) i et studie med raske frivillige.
English: Eylea must only be administered by a qualified physician experienced in administering intravitreal injections.
Danish: Eylea må kun administreres af en øjenlæge med erfaring i administration af intravitreale injektioner.
English: Leakage of blood and fluid from CNV may cause retinal thickening or oedema and/or sub-/intra-retinal haemorrhage, resulting in loss of visual acuity.
Danish: Udsivning af blod og væske fra CNV kan forårsage ødem i eller fortykkelse af retina og/eller sub-/intra-retinal blødning, hvilket resulterer i tab af synsstyrke.
English: In general, adequate anaesthesia and asepsis, including topical broad spectrum microbicide (e.g. povidone iodine applied to the periocular skin, eyelid and ocular surface), have to be ensured.
Danish: Generelt skal tilstrækkelig anæstesi og aseptik sikres, herunder topisk bredspektret mikrobicid (f.eks. povidon-jod påført den periokulære hud, øjenlåget og øjets overflade).
English: In the wet AMD phase III studies, there was an increased incidence of conjunctival haemorrhage in patients receiving anti-thrombotic agents.
Danish: I våd AMD fase III-studierne var der en øget forekomst af konjunktivale blødninger hos patienter, der fik anti-trombotiske midler.
English: • Patient monitoring after intravitreal injection including monitoring for visual acuity and increase of intraocular pressure post-injection
Danish: • Patientovervågning efter den intravitreale injektion, herunder overvågning af synsskarphed og stigning i det intraokulære tryk efter injektion
English: The schedule for monitoring should therefore be determined by the treating physician and may be more frequent than the schedule of injections.
Danish: Planen for monitoreringen skal derfor fastlægges af den behandlende øjenlæge, og den kan foretages hyppigere end injektionerne.
English: In each study, patients were randomly assigned in a 1:1:1:1 ratio to 1 of 4 dosing regimens:
Danish: I hvert studie blev patienterne tilfældigt tildelt 1 af 4 doseringsregimer i forholdet 1:1:1:1:
English: - patients with other eye conditions such as a detachment of the retina or a hole in the macula.
Danish: - patienter med andre øjensygdomme, såsom løsning af nethinden eller et hul i makula.
English: Treatment effects in the subgroup of patients who had previously been treated with a VEGF inhibitor were similar to those seen in patients who were VEGF inhibitor naïve.
Danish: Virkningen af behandlingen i subgruppen af patienter, der tidligere havde fået behandling med en VEGF-hæmmer, var sammenlignelig med den observerede virkning hos patienter, som var naive med hensyn til VEGFhæmmer.
English: Manufacturer Bayer AG Müllerstraße 178 13353 Berlin Germany
Danish: Fremstiller Bayer AG Müllerstraße 178 13353 Berlin Tyskland
English: You will start your treatment with a series of monthly Eylea injections.
Danish: Din behandling starter med en række månedlige Eylea-injektioner.
English: In myopic CNV there is no experience with Eylea in the treatment of non-Asian patients, patients who have previously undergone treatment for myopic CNV, and patients with extrafoveal lesions.
Danish: Der ingen erfaring med Eylea til behandling af myopisk CNV hos ikke-asiatiske patienter, patienter, der tidligere har gennemgået behandling for myopisk CNV, samt patienter med ekstrafoveale læsioner.
English: In the clinical trials, there was an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage) in patients with wet AMD receiving blood thinners.
Danish: I kliniske studier var der en øget forekomst af blødning fra de små blodkar i de ydre lag af øjet (konjunktival blødning) hos patienter med våd AMD, der fik blodfortyndende medicin.
English: - Eylea should not be used in pregnancy unless the potential benefit outweighs the potential risk to the unborn child. - women of childbearing potential have to use effective contraception during treatment and for at least three further months after the last injection of Eylea.
Danish: - Eylea bør ikke anvendes under graviditeten, medmindre den potentielle fordel opvejer den potentielle risiko for det ufødte barn - Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 3 måneder efter den sidste injektion af Eylea.
English: In the second year of the studies, patients continued to receive the initially randomised dosage but on a modified dosing schedule guided by assessment of visual and anatomic outcomes with a protocoldefined maximum dosing interval of 12 weeks.
Danish: I studiernes andet år modtog patienterne fortsat den dosisstyrke, som de blev randomiseret til indledningsvist, men på en modificeret doseringsplan på basis af resultaterne fra visuelle og anatomiske undersøgelser med et protokoldefineret maksimalt doseringsinterval på 12 uger.
English: In patients treated with 6 consecutive monthly injections of Eylea 2mg, there was a consistent, rapid and robust morphologic response (as measured by improvements in mean CRT) observed.
Danish: Hos patienter, der er behandlet med 6 på hinanden følgende månedlige injektioner med Eylea 2 mg, var der konsekvent, hurtig og solid morfologisk respons (målt ved forbedringer i gennemsnitlig CRT.
English: In patients with wet AMD and myopic CNV, these factors, in excess are involved in the abnormal formation of new blood vessels in the eye.
Danish: Hos patienter med våd AMD og myopisk CNV er disse vækstfaktorer involveret i den unormale dannelse af nye blodkar i øjet, hvis der er overskud af dem.
English: The solution is colourless to pale yellow.
Danish: Opløsningen er farveløs til let gul.
English: Therefore, in case of overdose, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
Danish: Det intraokulære tryk bør derfor overvåges i tilfælde af overdosering og passende behandling bør iværksættes, hvis det skønnes nødvendigt af den behandlende øjenlæge.
English: Unless you experience any problems or are advised differently by your doctor, there is no need for you to see your doctor between the injections.
Danish: Medmindre du oplever problemer eller får anden rådgivning fra øjenlægen, er det ikke nødvendigt at konsultere øjenlægen mellem injektionerne.
English: Wet AMD is characterised by pathological choroidal neovascularisation (CNV).
Danish: Våd AMD karakteriseres af patologisk koroidal neovaskularisation (CNV).
English: An independent comparative trial (DRCR.net Protocol T) utilised a dosing regimen based on strict OCT and vision re-treatment criteria.
Danish: Et sammenlignende studie (DRCR.net Protocol T) anvendte et doseringsregimen, hvor kriterierne for genbehandling var nøje baseret på OCT og ændring i visus.
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.
Danish: Hos patienter, der fik Eylea, hvoraf hovedparten var klassificeret som type II-diabetikere, blev der snart efter behandlingsstart observeret et hurtigt og robust respons i morfologi (CRT, DRSS-niveau).