FrancophonIA/ELRC3.0 huggingface dataset:
English: Intravitreal injections, including those with Eylea, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8).
Danish: Reaktioner i forbindelse med intravitreale injektioner Intravitreale injektioner, herunder injektioner med Eylea, er blevet forbundet med endoftalmitis, intraokulær inflammation, rhegmatogen nethindeløsning, nethinderuptur og iatrogen traumatisk katarakt (se pkt.
English: How to store Eylea
Danish: Sådan vil du få Eylea
English: Using aseptic technique, firmly twist a 30 G x ½ inch injection needle onto the Luer-lock syringe tip.
Danish: Med en aseptisk teknik drejes 30 G x ½”-kanylen godt fast på spidsen af Luer-lockinjektionssprøjten.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 November 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: In the VIEW2 study, at week 52, 95.6% of patients in the Eylea 2Q8 group maintained vision compared to 94.4% patients in the ranibizumab 0.5Q4 group.
Danish: I VIEW2studiet bevarede 95,6 % af patienterne i behandlingsgruppen med Eylea 2Q8 visus sammenlignet med 94,4 % af patienterne i gruppen med 0,5Q4 ranibizumab ved uge 52.
English: Patient ages ranged from 22 to 89 years with a mean of 64 years.
Danish: Patienternes alder var fra 22-89 år med et gennemsnit på 64 år.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 behandlede):
English: • visual impairment due to diabetic macular oedema (DME) (see section 5.1),
Danish: • nedsat syn på grund af diabetisk makulaødem (DME) (se pkt.
English: Injecting the entire volume of the vial could result in overdose.
Danish: Injektion af hele mængden fra hætteglasset kan medføre overdosering.
English: Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger to align the cylindrical base of the dome plunger with the black dosing line on the syringe (equivalent to 50 microlitres).
Danish: Fjern alle bobler og sprøjt overskydende lægemiddel ud ved langsomt at trykke stemplet ned, så den cylindriske base på stemplet med afrundet top er på linje med den sorte doseringslinje på injektionssprøjten (svarer til 50 mikroliter).
English: Renal impairment No special studies in patients with renal impairment have been conducted with Eylea.
Danish: Nedsat nyrefunktion Der er ikke udført specifikke studier med Eylea hos patienter med nedsat nyrefunktion.
English: Using aseptic technique withdraw all of the Eylea vial contents into the syringe, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
Danish: Med en aseptisk teknik trækkes hele indholdet af hætteglasset med Eylea ind i injektionssprøjten, mens hætteglasset holdes lodret og en smule på skrå, så alt indholdet trækkes op. For at undgå, at der komme luft med, skal du sikre dig, at nålens skråspids er neddyppet i væsken.
English: These proportions were maintained at week 76, with 84.3% (n=75) in the Eylea group and 84.0% (n=42) in the sham group.
Danish: Disse forhold blev bibeholdt ved uge 76 med 84,3 % (n = 75) i Eylea-gruppen og 84,0 % (n = 42) i sham-gruppen.
English: In the BRVO study, approximately 58% (53/91) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 23% (21/91) were 75 years of age or older.
Danish: I BRVO-studiet var ca. 58 % (53/91) af de patienter, der var randomiseret til behandling med Eylea, 65 år eller ældre, og ca. 23 % (21/91) var 75 år eller ældre.
English: In combined data analysis of VIEW1 and VIEW2, Eylea demonstrated clinically meaningful changes from baseline in pre-specified secondary efficacy endpoint National Eye Institute Visual Function Questionnaire (NEI VFQ-25) without clinically meaningful differences to ranibizumab.
Danish: I den kombinerede dataanalyse af VIEW1 og VIEW2 viste Eylea klinisk betydningsfulde ændringer fra baseline i spørgeskemaet National Eye Institute Visual Function Questionnaire (NEI VFQ-25) uden klinisk betydningsfulde forskelle i forhold til ranibizumab.
English: The solution is a clear, colourless to pale yellow and iso-osmotic solution.
Danish: Injektionsvæske, opløsning (injektion) Opløsningen er en klar, farveløs til bleggul og iso-osmotisk opløsning.
English: Based on the physician's judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at two months or further extended using a treat-and-extend dosing regimen, where injection intervals are increased in 2- or 4-weekly increments to maintain stable visual and/or anatomic outcomes.
Danish: Baseret på øjenlægens vurdering af visuelle og/eller anatomiske undersøgelser, kan behandlingsintervallet fastholdes på to måneder eller yderligere forlænges ved gradvis forlængelse af behandlingsintervallet (treat and extend regimen), hvor injektionsintervallerne forlænges med 2- eller 4-ugers tillægsperioder for at opnå stabile visuelle og/eller anatomiske undersøgelser.
English: Mean change in BCVA B) as measured by ETDRS letter score from baseline (SD) B) Difference in LS mean C,D,E) (95% CI) Proportion of patients with ≥15 letters gain from baseline Weighted difference D, F) (95% CI)
Danish: Gennemsnitlig ændring i BCVA B) målt ved ETDRS-bogstavsscore fra baseline (SD) B) Forskel i LS-gennemsnit C,D,E) (95 % CI) Andel af patienter med en forbedring på ≥ 15 bogstaver fra baseline Vægtet forskel D,F) (95 % CI)
English: • Intravitreal injection procedure pictogram
Danish: • Piktogram over intravitreal injektionsprocedure
English: Control G) (N = 68)
Danish: Kontrol G) (N = 68)
English: To expel the air bubble along with excess medicinal product, slowly depress the plunger to align the cylindrical base of the dome plunger with the black dosing line on the syringe (equivalent to 50 microlitres i.e. 2 mg aflibercept).
Danish: Fjern alle bobler, og sprøjt overskydende lægemiddel ud ved langsomt at trykke stemplet ned, så den cylindriske base på stemplet med afrundet top er på linje med den sorte doseringslinje på injektionssprøjten (svarer til 50 mikroliter, dvs. 2 mg aflibercept).
English: Detailed results from the analysis of the VIVIDDME and VISTADME studies are shown in Table 5 and Figure 4 below.
Danish: Detaljerede resultater fra analysen af VIVIDDME- og VISTADME-studierne vises i nedenstående tabel 5 og figur 4.
English: At week 24, this was 87.4% (n = 90) in the Eylea group and 58.6% (n = 34) in the sham group.
Danish: Ved uge 24 var dette 87,4 % (n = 90) i Eylea-gruppen og 58,6 % (n = 34) i sham-gruppen.
English: Using aseptic technique, firmly twist the injection needle onto the Luer-lock syringe tip.
Danish: Med en aseptisk teknik drejes kanylen godt fast på spidsen af Luer-lock-injektionssprøjten.
English: After the first 12 months of treatment with Eylea, and based on visual and/or anatomic outcomes, the treatment interval may be extended, such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased to maintain stable visual and/or anatomic outcomes; however there are insufficient data to conclude on the length of these intervals.
Danish: Efter de første 12 måneders behandling med Eylea og baseret på visuelle og/eller anatomiske undersøgelser, kan behandlingsintervallet forlænges f.eks. ved gradvis forlængelse af behandlingsintervallet (treat and extend regimen), hvor behandlingsintervallerne gradvist forlænges for at opnå stabile visuelle og/eller anatomiske undersøgelser.
English: A) Difference is Eylea 2 mg Q4 weeks minus Laser Control B) Difference and 95% CI are calculated using Mantel-Haenszel weighting scheme adjusted for region (North America vs. Japan) and baseline BCVA category (> 20/200 and ≤ 20/200) C) LS mean difference and 95% CI based on an ANCOVA model with treatment group, baseline BCVA category (> 20/200 and ≤ 20/200) and region (North America vs. Japan) as fixed effects, and baseline BCVA as covariate.
Danish: B) Forskel og 95 % CI er beregnet med Mantel-Haenszel-vægtningsskema justeret for region (Nordamerika vs. Japan) og BCVA-kategori ved baseline (> 20/200 og ≤ 20/200) C) LS-middelforskel og 95 % CI baseret på en ANCOVA-model med behandlingsgruppe, BCVA-kategori ved baseline (> 20/200 og ≤ 20/200) og region (Nordamerika vs. Japan) som faste virkninger og BCVA
English: retinal detachment/tear) - degeneration of the retina (causing disturbed vision) - bleeding in the eye (vitreous haemorrhage) - certain forms of clouding of the lens (cataract) - damage to the front layer of the eyeball (the cornea) - increase in eye pressure - moving spots in vision (floaters) - detachment of the gel-like substance inside the eye from the retina (vitreous detachment, resulting in flashes of light with floaters) - a feeling of having something in the eye - increased tear production - swelling of the eyelid - bleeding at the injection site - redness of the eye * Conditions known to be associated with wet AMD; observed in wet AMD patients only.
Danish: - løsning af eller rift i et af lagene bag i øjet, hvilket giver lysglimt, der bevæger sig som flyvende fluer og nogen gange udvikler sig til synstab (løsning af eller rift* i nethinden eller nethinde pigment-epitelet) - nedbrydning af nethinden (medfører synsforstyrrelser) - blødning i øjet (blødning i glaslegemet) - visse former for uklarhed af linsen (katarakt) - beskadigelse af øjenæblets yderste lag (hornhinden) - stigning af trykket inden i øjet - små pletter i synsfeltet (”flyvende fluer”) - løsning af den geléagtige substans inde i øjet fra nethinden (glaslegemeløsning, hvilket medfører lysglimt/og eller flyvende fluer) - en følelse af at have noget i øjet - øget tåredannelse - hævelse af øjenlåget - blødning på injektionsstedet - rødt øje
English: Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Danish: Patienterne skal overvåges for stigning i det intraokulære tryk umiddelbart efter den intravitreale injektion.
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 behandlede):
English: The solution should be inspected visually for any foreign particulate matter and/or discolouration or any variation in physical appearance prior to administration.
Danish: Før injektion skal injektionsvæsken inspiceres visuelt for fremmedlegemer, misfarvning eller enhver forandring i det fysiske udseende.
English: Detailed results from the analysis of the MYRROR study are shown in Table 6 and Figure 5 below.
Danish: Detaljerede resultater fra analysen af MYRROR-studier vises i tabel 6 og figur 5 nedenfor.
English: The proportion of patients who extended their treatment interval to 12 weeks or beyond was 42.3% in the 2-week adjustment group and 49.6 % in the 4-week adjustment group.
Danish: Andelen af patienter, der forlængede behandlingsintervallet til 12 uger eller derover var 42,3 % i gruppen med justeringer på 2 uger og 49,6 % i gruppen med justeringer på 4 uger.
English: - allergic reactions (hypersensitivity)** - serious inflammation or infection inside the eye (endophthalmitis) - inflammation in the iris or other parts of the eye (iritis, uveitis, iridocyclitis, anterior chamber flare) - abnormal sensation in the eye - eyelid irritation
Danish: - allergiske reaktioner (overfølsomhed)** - alvorlig inflammation (betændelseslignende reaktion) eller betændelse inden i øjet (endoftalmitis) - betændelse i regnbuehinden eller andre dele af øjet (iritis, uveitis, iridocyklitis, lysglimt i forreste kammer) - unormal fornemmelse i øjet - irritation af øjenlåget - hævelse af øjeæblets yderste lag (hornhinden) **Der blev set allergiske reaktioner såsom udslæt, kløe (pruritus), nældefeber (urticaria) og få tilfælde af alvorlige allergiske reaktioner (anafylaktiske/anafylaktoide reaktioner).
English: In the VISTADME study, 217 (70.7%) of Eylea patients received bilateral Eylea injections until week100; in the VIVIDDME study, 97 (35.8%) of Eylea patients received a different anti-VEGF treatment in their fellow eye.
Danish: I VISTADME-studiet fik 217 (70,7 %) af Eylea-patienterne bilaterale Eylea-injektioner indtil uge 100.
English: At week 24, this was 91.8% (n=89) in the Eylea group and 85.5% (n=47) in the sham group.
Danish: Ved uge 24 var dette 91,8 % (n = 89) i Eylea-gruppen og 85,5 % (n = 47) i sham-gruppen.
English: The proportion of patients who extended their treatment interval to 12 weeks or beyond was 56.9% in the 2-week adjustment group and 60.2% in the 4-week adjustment group.
Danish: Andelen af patienter som forlængede behandlingsintervallet til 12 uger eller derover, var 56,9 % i gruppen med justeringer på 2 uger og 60,2 % i gruppen med justeringer på 4 uger.
English: ControlE) (N =73)
Danish: KontrolE) (N = 73)
English: Control
Danish: Kontrolgruppe
English: Each pre-filled syringe should only be used for the treatment of a single eye.
Danish: Hver fyldt injektionssprøjte bør kun anvendes til behandling af et enkelt øje.
English: • Management of intravitreal injection related adverse events
Danish: • Håndtering af bivirkninger relateret til intravitreale injektioner
English: For the intravitreal injection, a 30 G x ½ inch injection needle should be used.
Danish: Der skal bruges en 30 G x ½”-kanyle til intravitreal injektion.
English: (laser) (N = 154)
Danish: (N = 154)
English: One vial contains 100 microlitres, equivalent to 4 mg aflibercept.
Danish: Et hætteglas indeholder 100 mikroliter svarende til 4 mg aflibercept.
English: • Keep the pre-filled syringe in its blister and in the outer carton in order to protect from light.
Danish: • Opbevar den fyldte injektionssprøjte i blisteren og i den ydre karton for at beskytte mod lys.
English: Detailed results from the analysis of the VIBRANT study are shown in Table 4 and Figure 3 below.
Danish: Detaljerede resultater fra analysen i VIBRANT-studiet vises i tabel 4 og figur 3 nedenfor.
English: Using aseptic technique, remove the syringe from the sterilized blister.
Danish: Injektionssprøjten fjernes fra den steriliserede blister med aseptisk teknik.
English: Instructions for use of pre-filled syringe:
Danish: Brugsanvisning til fyldt injektionssprøjte:
English: D) From week 24 on the treatment interval in the Eylea treatment group was extended for all subjects from 4 weeks to 8 weeks through week 48.
Danish: ved baseline som kovariat D) Fra uge 24 og frem til uge 48 blev behandlingsintervallet i Eylea-behandlingsgruppen forlænget fra 4 uger til 8 uger for alle patienter.
English: There is only limited experience in the treatment of subjects with DME due to type I diabetes or in diabetic patients with an HbA1c over 12% or with proliferative diabetic retinopathy.
Danish: Der er kun begrænset erfaring med behandling af personer med DME, der skyldes type I-diabetes eller hos diabetespatienter med et HbA1c-niveau over 12 % eller med proliferativ diabetisk retinopati.. Eylea er ikke blevet undersøgt hos patienter med aktive, systemiske infektioner, eller hos patienter med andre øjensygdomme, såsom nethindeløsning eller huller i makula.
English: Store in refrigerator (2°C to 8°C).
Danish: Opbevares i køleskab (2° C - 8 °C).
English: The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
Danish: Herefter indsprøjtes injektionsvolumenet på 0,05 ml.
English: Each vial contains 100 microlitres, equivalent to 4 mg aflibercept.
Danish: Hvert hætteglas indeholder 100 mikroliter svarende til 4 mg aflibercept.
English: Cataract cortical, Cataract nuclear, Cataract subcapsular, Corneal erosion, Corneal abrasion, Intraocular pressure increased, Vision blurred,
Danish: Kortikal katarakt, Nukleær katarakt, Cataracta subcapsularis, Corneaerosion, Cornea-abrasion, Forhøjet intraokulært tryk, Sløret syn, Flyvende fluer, Løsning af glaslegemet, Smerte på injektionsstedet, Følelse af fremmedlegeme i øjet,
English: The pre-filled syringe is for single use in one eye only.
Danish: Den fyldte injektionssprøjte er kun til engangsbrug og kun til ét øje.
English: Detailed results from the analysis of both studies are shown in Table 3 and Figure 2 below.
Danish: Detaljerede resultater fra analysen af begge studier vises i nedenstående tabel 3 og figur 2.
English: Table 2: Efficacy outcomes at week 52 (primary analysis) and week 96; combined data from the VIEW1 and VIEW2 studiesB)
Danish: Tabel 2: Resultater for virkning ved uge 52 (primær analyse) og uge 96.
English: Each vial should only be used for the treatment of a single eye.
Danish: Hvert hætteglas bør kun anvendes til behandling af et enkelt øje.
English: Very common
Danish: Ikke almindelig Sjælden
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.
Danish: Patienterne i Eylea-grupperne kunne få laser, og patienterne i kontrolgruppen kunne få Eylea.
English: Control (N = 68)
Danish: Kontrol (N = 68)
English: NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection Aflibercept
Danish: LÆGEMIDLETS NAVN Eylea 40 mg/ml injektionsvæske, opløsning aflibercept
English: Mean change in BCVA as measured by ETDRSA) letter score from baseline Difference in LS A) mean change (ETDRS letters)C) (95% CI)D)
Danish: Gennemsnitlig ændring i BCVA målt med ETDRSA)bogstavs-score fra baseline Forskel i LS A) gennemsnitsændring (ETDRS-bogstaver)C) (95 % CI)D)
English: Organ
Danish: Administration
English: Pre-filled syringe
Danish: Flad stempelkant
English: (laser) (N = 132)
Danish: (N = 132)
English: • Keep the vial in its outer carton in order to protect from light.
Danish: • Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: The vial is for single use in one eye only.
Danish: Hætteglasset er kun til engangsbrug og kun til ét øje.
English: A) Difference is Eylea 2 mg Q4 weeks minus control B) Difference and confidence interval (CI) are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200) C) BCVA: Best Corrected Visual Acuity ETDRS: Early Treatment Diabetic Retinopathy Study LOCF: Last Observation Carried Forward SD: Standard deviation LS: Least square means derived from ANCOVA D) LS mean difference and confidence interval based on an ANCOVA model with factors treatment group, region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200) E) In COPERNICUS study, control group patients could receive Eylea on an as-needed basis as frequently as every 4 weeks during week 24 to week 52; patients had visits every 4 weeks.
Danish: A) Forskellen er Eylea 2 mg Q4 uger minus laserkontrol B) Forskel og 95 % CI er beregnet med Mantel-Haenszel-vægtningsskema justeret for region (Nordamerika vs. Japan) og BCVA-kategori ved baseline (> 20/200 og ≤ 20/200) C) LS-middelforskel og 95 % CI baseret på en ANCOVA-model med behandlingsgruppe, BCVA-kategori ved baseline (> 20/200 og ≤ 20/200) og region (Nordamerika vs. Japan) som faste virkninger og BCVA ved baseline som kovariat D) Fra uge 24 og frem til uge 48 blev behandlingsintervallet i Eylea-behandlingsgruppen forlænget fra 4 uger til 8 uger for alle patienter.
English: Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes, however there are insufficient data to conclude on the length of these intervals.
Danish: Behandlingen kan derefter fortsættes med gradvis forlængelse af behandlingsintervallet (treat and extend regimen) for at bibeholde stabile visuelle og/eller anatomiske resultater.
English: E) LS mean difference and 95% CI based on an ANCOVA model with treatment group and country (country designations) as fixed effects, and baseline BCVA as covariant.
Danish: E) Forskel i LS-gennemsnit og 95 % CI baseret på en ANCOVA-model med behandlingsgruppe og land
English: Package Leaflet: Information for the patient Eylea 40 mg/ml solution for injection in a pre-filled syringe Aflibercept
Danish: Indlægsseddel: Information til patienten Eylea 40 mg/ml injektionsvæske, opløsning, i et hætteglas aflibercept
English: Proportion of patients with ≥15 letters gain from Baseline (%) Weighted Difference A,B) (95% CI) p-value p=0.0003
Danish: Andel af patienter med en forbedring på ≥ 15 bogstaver fra baseline Vægtet forskel D,F) (95 % CI)
English: D) Confidence interval (CI) calculated by normal approximation E) After treatment initiation with three monthly doses F) A confidence interval lying entirely above -10% indicates a non-inferiority of Eylea to ranibizumab
Danish: Et konfidensinterval, der er fuldstændigt over -10 %, indikerer Eyleas non-inferioritet sammenlignet med ranibizumab
English: Efficacy Outcome
Danish: Resultat for virkning
English: Efficacy Outcomes
Danish: Resultater for virkning
English: One vial delivers a dose of 2 mg aflibercept in 50 microlitres.
Danish: Et hætteglas giver en dosis på 2 mg aflibercept i 50 mikroliter.
English: One pre-filled syringe delivers a dose of 2 mg aflibercept in 50 microlitres.
Danish: En fyldt injektionssprøjte giver en dosis på 2 mg aflibercept i 50 mikroliter.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Eylea 40 mg/ml solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Eylea 40 mg/ml injektionsvæske aflibercept
English: Consult your doctor before stopping the treatment.
Danish: Hvis du holder op med Eylea-behandlingen Kontakt øjenlægen, før du holder op med behandlingen.
English: Pregnancy and breast-feeding - 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: Graviditet og amning - Kvinder i den fertile alder skal anvende sikker prævention under behandlingen og i mindst
English: Mean change in BCVA as measured by ETDRS letter score from Baseline (SD)
Danish: Middelændring i BCVA målt ved ETDRS (bogstaver) fra baseline (SD)
English: The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres.
Danish: Den anbefalede dosis for Eylea er 2 mg aflibercept svarende til 50 mikroliter.
English: Keep the pre-filled syringe in its blister in the outer carton to protect from light.
Danish: Opbevar den fyldte injektionssprøjte i blisteren i den ydre karton for at beskytte mod lys.
English: The recommended dose for Eylea is 2 mg aflibercept, equivalent to 50 microlitres.
Danish: Den anbefalede dosis af Eylea er 2 mg aflibercept svarende til 50 mikroliter.
English: A) BCVA: Best Corrected Visual Acuity ETDRS: Early Treatment Diabetic Retinopathy Study LS: Least square means derived from ANCOVA PPS: Per Protocol Set B) Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) for all analyses except proportion of patients with maintained visual acuity at week 52 which is PPS C) The difference is the value of the Eylea group minus the value of the ranibizumab group.
Danish: BCVA: Best Corrected Visual Acuity ETDRS: Early Treatment Diabetic Retinopathy Study LS: Mindste kvadrat middeltal afledt fra ANCOVA PPS: Per-protokol-sæt
English: Mean change in BCVA C) as measured by ETDRSC) letter score from baseline (SD)
Danish: Gennemsnitlig ændring i BCVA B) målt ved ETDRS-bogstavsscore fra baseline (SD) B)
English: Based on the physician's judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at two months or further extended using a treat-and-extend dosing regimen, where injection intervals are increased in 2- or 4-weekly increments to maintain stable visual and/or anatomic outcomes..
Danish: Baseret på øjenlægens vurdering af visuelle og/eller anatomiske undersøgelser, kan behandlingsintervallet fastholdes på to måneder eller yderligere forlænges ved gradvis forlængelse af behandlingsintervallet (treat and extend regimen), hvor injektionsintervallerne forlænges med 2- eller