FrancophonIA/ELRC3.0 huggingface dataset:
English: A secondary efficacy variable was change in visual acuity at week 24 compared to baseline.
Danish: En sekundær virkningsvariabel var ændring i visus ved uge 24 sammenlignet med baseline.
English: There are limited data on safety in treating patients with CRVO, BRVO, DME and myopic CNV who have had a stroke or a mini-stroke (transient ischaemic attack) or a heart attack within the last 6 months.
Danish: Der er begrænsede data for sikkerhed ved behandling af patienter med CRVO, BRVO, DME og myopisk CNV med tidligere slagtilfælde eller mini-slagtilfælde (transitorisk iskæmisk anfald) eller hjerteanfald inden for de sidste 6 måneder.
English: If any of the above applies to you, your doctor will consider this lack of information when treating you with Eylea.
Danish: Hvis noget af det ovenstående gælder for dig, kan øjenlægen overveje behandling med Eylea på trods af den manglende erfaring.
English: In both studies, patients were randomly assigned in a 3:2 ratio to either 2 mg Eylea administered every 4 weeks (2Q4), or the control group receiving sham injections every 4 weeks for a total of 6 injections.
Danish: I begge studier blev patienterne fordelt tilfældigt i forholdet 3:2 til enten 2 mg Eylea administreret hver 4. uge (2Q4) eller til kontrolgruppen, der fik sham-injektion hver 4. uge med i alt 6 injektioner.
English: In the study, patients were randomly assigned in a 1:1 ratio to either 2 mg Eylea administered every 8 weeks following 6 initial monthly injections or laser photocoagulation administered at baseline (laser control group).
Danish: I studiet blev patienterne randomiseret i forholdet 1:1 enten til 2 mg Eylea administreret hver 8. uge efter indledende månedlige injektioner i 6 måneder eller laserfotokoagulation administreret ved baseline (laser-kontrolgruppe).
English: The secondary efficacy endpoints were the proportion of patients who did not lose ≥15 letters and the proportion of patients who gained at least 15 letters of BCVA from baseline to week 52.
Danish: Det sekundære endepunkt for virkning var andelen af patienter, der ikke mistede ≥15 bogstaver, og andelen af patienter, der fik en forbedring på mindst 15 bogstaver i BCVA fra baseline til uge 52.
English: In patients with CRVO, a blockage occurs in the main blood vessel that transports blood away from the retina.
Danish: Hos patienter med CRVO sker der en blokering i det største blodkar, som transporterer blod væk fra nethinden.
English: The systemic exposure based on Cmax and AUC for free aflibercept were approximately 200and 700-fold higher, respectively, when compared to corresponding values observed in humans after an intravitreal dose of 2 mg. At the No Observed Adverse Effect Level (NOAEL) of 0.5 mg/eye in monkeys the systemic exposure was 42- and 56-fold higher based on Cmax and AUC, respectively.
Danish: Den systemiske eksponering baseret på Cmax og AUC for frit aflibercept var hhv. ca. 200- og 700-gange højere ved sammenligning med tilsvarende værdier observeret hos mennesker efter en intravitreal dosis på 2 mg. Ved niveauet for No Observed Adverse Effect Level (NOAEL) på 0,5 mg/øje hos aber var den systemiske eksponering hhv. 42- og 56-gange højere baseret på Cmax og AUC.
English: 100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle.
Danish: 100 mikroliter opløsning i et hætteglas (type I-glas) med en prop (elastomergummi) og en 18 G filterkanyle.
English: Do not open the sterile pre-filled blister outside the clean administration room.
Danish: Den sterile fyldte blister må ikke åbnes uden for det rene administrationsrum.
English: At the 0.1 mg/kg dose, the systemic exposures based on Cmax and cumulative AUC for free aflibercept were approximately 17- and 10-fold higher, respectively, when compared to corresponding values observed in humans after an intravitreal dose of 2 mg.
Danish: Ved en dosis på 0,1 mg/kg var de systemiske eksponeringer baseret på Cmax og kumulativ AUC for frit aflibercept hhv. ca. 17- og 10-gange højere ved sammenligning med tilsvarende værdier observeret hos mennesker efter en intravitreal dosis på 2 mg.
English: The excess volume should be expelled before injecting.
Danish: Overskydende volumen skal fjernes før injektion.
English: DifferenceC) (95% CI)D)
Danish: ForskelC) (95 % CI)D)
English: Based on pre-specified criteria, patients in the laser group could receive rescue treatment with Eylea 2mg from week 24, administered every 4 weeks for 3 months followed by every 8 weeks.
Danish: På basis af præpecificerede kriterier kunne patienterne i laser-gruppen få erstatningsbehandling med Eylea 2 mg fra uge 24, administreret hver 4. uge i 3 måneder og derefter hver 8. uge.
English: • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),
Danish: • neovaskulær (våd) aldersrelateret makulær degeneration (AMD) (se pkt.
English: Based on Cmax and AUC for free aflibercept observed at the 3 mg/kg intravenous dose, the systemic exposures were approximately 4,900-fold and 1,500-fold higher, respectively, than the exposure observed in humans after an intravitreal dose of 2 mg. All changes were reversible.
Danish: Baseret på Cmax og AUC for frit aflibercept observeret ved den intravenøse dosis på 3 mg/kg var de systemiske eksponeringer hhv. ca. 4.900- og 1.500-gange højere end eksponeringen observeret hos mennesker efter en intravitreal dosis på 2 mg. Alle ændringer var reversible.
English: There are limited data on safety in the treatment of patients with CRVO, BRVO, DME or myopic CNV with a history of stroke or transient ischaemic attacks or myocardial infarction within the last 6 months.
Danish: Der er begrænsede data for sikkerhed ved behandling af patienter med CRVO, BRVO, DME eller myopisk CNV med tidligere slagtilfælde eller transitoriske iskæmiske anfald eller myokardieinfarkt inden for de sidste 6 måneder.
English: Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
Danish: Systemiske bivirkninger, herunder ikke-okulære blødninger og arterielle tromboemboliske hændelser, er set efter intravitreal injektion med VEGF-hæmmere, og der er en teoretisk risiko for, at disse kan have forbindelse med VEGF-hæmning.
English: Post-authorisation efficacy study (PAES) To perform a post-authorisation randomised study in patients with neovascular (wet) AMD with the primary objective of comparing the standard regime of injections every 8 weeks with a reactive regimen based on visual and anatomic outcomes, based on a CHMP approved protocol.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES) Udføre et randomiseret studie med patienter med neovaskulær (våd) AMD efter udstedelse af markedsføringstilladelsen med det primære formål at sammenligne standardbehandlingen med injektioner hver 8. uge med en reaktiv behandling baseret på visuelle og anatomiske resultater, på basis af en CHMP-godkendt protokol.
English: Table 1: All treatment-emergent adverse drug reactions reported in patients in phase III studies (pooled data of the phase III studies for the indications wet AMD, CRVO, BRVO, DME and myopic CNV) or during post-marketing surveillance
Danish: Tabel 1: Alle bivirkninger, der opstod under behandlingen, og blev indberettet hos patienter i fase III-studier (samlede data fra fase III-studier for indikationerne våd AMD, CRVO, BRVO, DME og myopisk CNV) eller i forbindelse med overvågning efter markedsføringen.
English: What you need to know before you are given Eylea
Danish: Det skal du vide, før du begynder at få Eylea
English: Diabetic macular oedema (DME)
Danish: Diabetisk makulaødem (DME)
English: In COPERNICUS, 67.5% (n = 77) of the Eylea group and 68.5% (n = 50) of the sham group had perfused CRVO at baseline.
Danish: I COPERNICUS havde 67,5 % (n = 77) i Eylea-gruppen og 68,5 % (n = 50) i sham-gruppen perfunderet CRVO ved baseline.
English: In both studies, patients were randomly assigned in a 1:1:1 ratio to 1 of 3 dosing regimens: 1) Eylea administered 2 mg every 8 weeks following 5 initial monthly injections (Eylea 2Q8); 2) Eylea administered 2 mg every 4 weeks (Eylea 2Q4); and 3) macular laser photocoagulation (active control).
Danish: I begge studier blev patienterne i forholdet 1:1:1 tilfældigt tildelt ét ud af tre doseringsskemaer: 1) Eylea administreret 2 mg hver 8. uge efter 5 indledende månedlige injektioner (Eylea 2Q8); 2) Eylea administreret 2 mg hver 4. uge (Eylea 2Q4), og 3) makulær laser-fotokoagulation (aktiv kontrol).
English: Ask your pharmacist how to throw away any medicines you no longer use.
Danish: • Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: A total of 121 patients were treated and evaluable for efficacy (90 with Eylea).
Danish: I alt 121 patienter blev behandlet og evalueret for virkning (90 med Eylea).
English: Final study report submission:
Danish: Indsendelse af endelig studierapport: november
English: There is no relevant use of Eylea in the paediatric population for the indications of wet AMD, CRVO, BRVO, DME and myopic CNV.
Danish: Det er ikke relevant at bruge Eylea til den pædiatriske population på indikationerne våd AMD, CRVO, BRVO, DME og myopisk CNV.
English: • Women of childbearing potential have to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept (see section 4.6).
Danish: • Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 3 måneder efter den sidste intravitreale injektion af aflibercept (se pkt.
English: • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).
Danish: • nedsat syn på grund af myopisk koroidal neovaskularisering (myopisk CNV) (se pkt.
English: Hepatic and/or renal impairment
Danish: Nedsat lever- og/eller nyrefunktion
English: C Difference is Eylea group minus active control (laser) group D Difference with confidence interval (CI) and statistical test is calculated using Mantel-Haenszel weighting scheme adjusted by region (Europe/Australia vs. Japan) for VIVIDDME and medical history of MI or CVA for VISTADME E BCVA: Best Corrected Visual Acuity ETDRS: Early Treatment Diabetic Retinopathy Study LOCF: Last Observation Carried Forward LS: Least square means derived from ANCOVA CI: Confidence interval
Danish: C Forskel er Eylea-gruppen minus aktiv kontrolgruppe (laser) D Forskel med konfidensinterval (CI) og statistisk test beregnes via Mantel-Haenszels vægtningsskema, justeret for region (Europa/Australien vs. Japan) for VIVIDDME, og tidligere MI eller CVA for VISTADME E BCVA: Bedste korrigerede visus (Best Corrected Visual Acuity) ETDRS: Diabetisk retinopatistudie med tidlig behandling (Early Treatment Diabetic Retinopathy Study) LOCF: Sidste observation ført fremad (Last Observation Carried Forward) LS: Gennemsnit beregnet fra mindste kvadraters metode (Least Square Means) afledt fra ANCOVA CI: Konfidensinterval
English: Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.
Danish: Ekstraktion af flere doser fra ét hætteglas kan øge risikoen for kontaminering og efterfølgende infektion.
English: In the VIBRANT study, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in BCVA at week 24 compared to baseline and the Eylea group was superior to laser control.
Danish: I VIBRANT-studiet var det primære virkningsendepunkt for den andel af patienterne, der opnåede forbedring på mindst 15 bogstaver i BCVA i uge 24 sammenlignet med baseline, og Eylea-gruppen var overlegen i forhold til laser-kontrolgruppen.
English: wet AMD
Danish: Våd AMD
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg øjenlægen, hvis der er noget, du er i tvivl om, om anvendelsen af dette lægemiddel.
English: Based on the physician's judgement the schedule of monitoring visits may be more frequent than the injection visits.
Danish: Baseret på øjenlægens vurdering kan planen for overvågning godt indeholde flere besøg end planen for injektionerne.
English: B LS mean and CI based on an ANCOVA model with baseline BCVA measurement as a covariate and a factor for treatment group.
Danish: A Efter påbegyndelse af behandlingen med 5 månedlige injektioner B LS-gennemsnit og CI baseret på en ANCOVA-model med baseline BCVA-måling som en kovariat, og en faktor for behandlingsgruppe.
English: Some of these may be serious and include blindness, a serious infection or inflammation inside the eye (endophthalmitis), detachment, tear or bleeding of the light-sensitive layer at the back of the eye (retinal detachment or tear), clouding of the lens (cataract), bleeding in the eye (vitreous haemorrhage), detachment of the gel-like substance inside the eye from the retina (vitreous detachment) and increase of pressure inside the eye, see section 2.
Danish: Nogle af disse kan være alvorlige, herunder blindhed, en alvorlig infektion eller betændelse i øjet (endoftalmitis), løsning af nethinden eller rift eller blødning i nethinden (det lysfølsomme lag bag i øjet (nethindeløsning eller rift i nethinden)), uklarhed i linsen (katarakt), blødning i øjet (blødning i glaslegemet), løsning af den geléagtige substans i øjet fra nethinden (glaslegemeløsning) og stigning i trykket i øjet, se punkt 2.
English: Women of childbearing potential have to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept (see section 4.4).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 3 måneder efter den sidste intravitreale injektion af aflibercept (se pkt.
English: G) In GALILEO study, both control group and Eylea 2mg patients received Eylea 2 mg on an as-needed basis every 8 weeks starting from week 52 to week 68; patients had mandatory visits every 8 weeks.
Danish: G) I GALILEO-studiet fik både kontrolgruppen og Eylea 2 mg-patienterne Eylea 2 mg efter behov hver 8. uge med start fra uge 52 til uge 68.
English: Carefully peel open the blister ensuring the sterility of its contents.
Danish: Blisteren åbnes forsigtigt, så indholdet forbliver sterilt.
English: C) LS mean: Least square means derived from ANCOVA model D) CI: Confidence Interval
Danish: C) LS-gennemsnit: Gennemsnit afledt fra ANCOVA-modellen ved mindste kvadraters metode D) CI: Konfidensinterval
English: At week 24, the reduction in CRT was statistically superior versus control in all three studies (COPERNICUS in CRVO: -457 vs. -145 microns; GALILEO in CRVO: -449 vs. -169 microns; VIBRANT in BRVO:280 vs. -128 microns).
Danish: I uge 24 var reduktionen i CRT statistiskt større sammenlignet med kontrolgruppen i alle tre studier (COPERNICUS med CRVO: -457 sammenlignet med -145 mikrometer; GALILEO med CRVO:440) sammenlignet med -169mikrometer; VIBRANT med BRVO: -280 sammenlignet med128 mikrometer).
English: When the macula swells with fluid, central vision becomes blurry.
Danish: Når makula hæver på grund af væske, bliver det centrale syn sløret.
English: A decision must be made whether to discontinue breast-feeding or to abstain from Eylea therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Eylea seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Efficacy outcomes at week 52 and week 100 (Full Analysis Set with LOCF) in VIVIDDME and VISTADME studies
Danish: Resultater for virkning ved uge 52 og uge 100 (fuldt analysesæt med LOCF) i VIVIDDME- og VISTADME-studierne
English: Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof aflibercept eller over for et eller flere af hjælpestofferne anført i pkt.
English: In both studies, the primary efficacy endpoint was the proportion of patients in the Per Protocol Set who maintained vision, i.e. losing fewer than 15 letters of visual acuity at week 52 from baseline.
Danish: I begge studier var det primære endepunkt for virkning andelen af patienter i per-protokol-sættet, som bevarede visus, dvs. mistede færre end 15 bogstaver i visus ved uge 52 fra baseline.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Eylea in all subsets of the paediatric population in wet AMD, CRVO, BRVO, DME and myopic CNV populations (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Eylea i alle undergrupper af den pædiatriske population med våd AMD, CRVO, BRVO, DME og myopiske CNV-populationer (se pkt.
English: In patients with BRVO, one or more branches of the main blood vessel that transports blood away from the retina is blocked.
Danish: Hos patienter med BRVO er en eller flere grene af det store blodkar, der transporterer blod væk fra nethinden, blokeret.
English: ALTAIR was a 96 week multicentre, randomised, open-label study in 247 Japanese patients with treatment naïve wet AMD, designed to assess the efficacy and safety of Eylea following two different adjustment intervals (2- weeks and 4- weeks) of a treat-and-extend dosing regimen.
Danish: ALTAIR var et 96-ugers multicenter, randomiseret, åbent studie med 247 japanske patienter med behandlingsnaiv våd AMD designet til at undersøge effekten og sikkerheden af Eylea ved gradvis forlængelse af behandlingsintervallet (treat and extend regimen) med to forskellige justeringsintervaller (2 uger og 4 uger).
English: Mean number of injections from baseline Mean number of injections from Week 52 to 96
Danish: Gennemsnitligt antal injektioner fra uge 52-96
English: Macular oedema secondary to CRVO
Danish: Makulaødem sekundært til CRVO
English: With administration of Eylea, there may be some side effects affecting the eyes which are due to the injection procedure.
Danish: I forbindelse med injektion af Eylea kan der på grund af injektionsproceduren optræde nogle bivirkninger, der påvirker øjnene.
English: Mean Change from Baseline to Week 48 in Visual Acuity by Treatment Group for the MYRROR Study (Full Analysis Set, LOCF)
Danish: Den gennemsnitlige ændring af synsskarphed fra baseline til uge 48 pr. behandlingsgruppe for MYRROR-studiet (fuldt analysesæt, LOCF)
English: In patients presenting with clinical signs of irreversible ischaemic visual function loss, the treatment is not recommended.
Danish: Behandlingen anbefales ikke hos patienter med kliniske tegn på irreversibelt iskæmisk visuelt funktionstab.
English: In the aflibercept treatment group (n = 224) at week 52, this treatment regimen resulted in patients receiving a mean of 9.2 injections, which is similar to the administered number of doses in the Eylea 2Q8 group in VIVIDDME and VISTADME, while overall efficacy of the aflibercept treatment group in Protocol T was comparable to the Eylea 2Q8 group in VIVIDDME and VISTADME.
Danish: I aflibercept-behandlingsgruppen (n = 224) ved uge 52 havde dette behandlingsregimen som resultat, at patienterne fik gennemsnitligt 9,2 injektioner, hvilket svarer til antallet af administrerede doser i Eylea-2Q8-gruppen i VIVIDDME og
English: Eylea is not recommended during breast-feeding.
Danish: Eylea anbefales ikke under amning.
English: In GALILEO, 86.4% (n=89) of the Eylea group and 79.4% (n=54) of the sham group had perfused CRVO at baseline.
Danish: I GALILEO havde 86,4 % (n = 89) i Eylea-gruppen and 79,4 % (n = 54) i sham-gruppen perfunderet CRVO ved baseline.
English: A low incidence rate of arterial thromboembolic events was observed in the Eylea clinical trials in patients with AMD, DME, RVO and myopic CNV.
Danish: I kliniske studier med Eylea sås der en lav forekomst af arterielle tromboemboliske hændelser hos patienter med AMD, DME, RVO og myopatisk CNV.
English: • Eylea should not be used in pregnancy unless the potential benefit outweighs the potential risk to the foetus (see section 4.6).
Danish: • Eylea bør ikke anvendes under graviditeten, medmindre den potentielle fordel for moderen opvejer den potentielle risiko for fosteret (se pkt.
English: Macular oedema secondary to CRVO and BRVO
Danish: Makulaødem sekundært til CRVO og BRVO
English: In patients treated with Eylea (one injection per month for three consecutive months, followed by one injection every 2 months), central retinal thickness [CRT] decreased soon after treatment initiation, and the mean CNV lesion size was reduced, consistent with the results seen with ranibizumab 0.5 mg every month.
Danish: Hos patienter, der blev behandlet med Eylea (én injektion én gang om måneden i tre på hinanden følgende måneder efterfulgt af én injektion hver anden måned), faldt den centrale nethindetykkelse (CRT) hurtigt efter behandlingsstart, og den gennemsnitlige CNV-læsionsstørrelse blev reduceret, hvilket var overensstemmende med de resultater, der blevet set med ranibizumab 0,5 mg om måneden.
English: One vial contains 4 mg aflibercept in 100 microlitres (40 mg/ml) in iso-osmotic solution.
Danish: Ét hætteglas indeholder 4 mg aflibercept i 100 mikroliter (40 mg/ml) i en isosmotisk opløsning.
English: Eylea is a solution for injection (injection) in a vial (4 mg/100 microlitres).
Danish: Eylea er en injektionsvæske, opløsning (injektion) i et hætteglas (4 mg/100 mikroliter).
English: Serious ocular adverse reactions in the study eye related to the injection procedure have occurred in less than 1 in 1,900 intravitreal injections with Eylea and included blindness, endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous haemorrhage, vitreous detachment, and intraocular pressure increased (see section 4.4).
Danish: Alvorlige okulære bivirkninger i det undersøgte øje i forbindelse med injektionsproceduren opstod ved færre end 1 ud af 1.900 intravitreale injektioner med Eylea og inkluderede blindhed, endoftalmitis, nethindeløsning, traumatisk katarakt, katarakt, vitreal blødning, løsning af glaslegemet og forhøjet intraokulært tryk (se pkt.
English: Eylea is a solution for injection (injection) in a pre-filled syringe (3.6 mg/90 microlitres).
Danish: Eylea er en injektionsvæske, opløsning (injektion) i en fyldt injektionssprøjte (3,6 mg/90 mikroliter).
English: In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in BCVA at week 24 compared to baseline.
Danish: I begge studier var det primære virkningsendepunkt andelen af patienter, som fik en forbedring på mindst 15 bogstaver i BCVA ved uge 24 sammenlignet med baseline.
English: Patient ages ranged from 42 to 94 years with a mean of 65 years.
Danish: Patienterne var fra 42 til 94 år gamle med et gennemsnit på 65 år.
English: No specific studies in patients with hepatic and/or renal impairment have been conducted with Eylea.
Danish: Der er ikke udført specifikke studier med Eylea hos patienter med nedsat lever- og/eller nyrefunktion.
English: B) BCVA: Best Corrected Visual Acuity
Danish: A) LOCF: Last Observation Carried Forward B) BCVA: Best Corrected Visual Acuity
English: Post-authorisation efficacy study (PAES) To perform an interventional post-authorisation efficacy study in patients with diabetic macular oedema with the primary objective of comparing, after the first initial year of Eylea treatment, the standard regime of injections every 8 weeks with alternative treatment regimens, i.e. extended treatment intervals based on visual and anatomic outcomes (PRN and treat-and-extend).
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS) Udføre et interventionsstudie over virkning efter udstedelse af markedsføringstilladelsen hos patienter med diabetisk makulaødem med det primære formål efter det første års behandling med Eylea at sammenligne standardbehandlingen med injektioner hver 8. uge med alternativ behandling, f.eks. forlængede behandlingsintervaller baseret på visuelle og anatomiske resultater (PRN og behandl-og-forlæng).