FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: Medja ta' least squares derivata minn ANCOVA D) Differenza medja ta' LS u intervall ta' kunfidenza bbażati fuq mudell ANCOVA bi grupp ta' trattament ta' fatturi, reġjun (l-Amerika kontra l-bqija tad-dinja għal COPERNICUS
English: Proportion of patients with < 15 letters loss from baseline ( PPS A))
Maltese: Proporzjon ta' pazjenti b'telf ta' < 15-il ittra mil-linja bażi (PPS
English: Efficacy outcomes at week 24 (primary analysis) and week 48 in MYRROR study (Full Analysis Set with LOCFA))
Maltese: Tabella 6: Riżultati tal-effikaċja f'ġimgħa 24 (analiżi primarja) u ġimgħa 48 fl-istudju MYRROR (Sett ta' Analiżi Sħiħa b'LOCFA))
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.
Maltese: F'pazjenti kkurati b'Eylea, li l-maġġoranza tagħhom kienu kklassifikati bħala li għandhom dijabete tat-Tip II, kien osservat rispons rapidu u robust fil-morfoloġija (CRT, livell DRSS).
English: The safety and efficacy of Eylea were assessed in a randomised, multi-centre, double-masked, activecontrolled study in patients with macular oedema secondary to BRVO (VIBRANT) which included Hemi-Retinal Vein Occlusion.
Maltese: Is-sigurtà u l-effikaċja ta' Eylea kienu evalwati fi studju randomised, b'aktar minn ċentru wieħed, double-masked u kkontrollat b'mod attiv f'pazjenti b'edima makulari sekondarja għal BRVO (VIBRANT) li kienet tinkludi Okklużjoni tal-Vina Hemi tar-Retina.
English: Efficacy outcomes at week 52 and week 100 (Full Analysis Set with LOCF) in VIVIDDME and VISTADME studies
Maltese: Riżultati tal-effikaċja f'ġimgħa 52 u ġimgħa 100 (Sett ta' Analiżi Sħiħa b'LOCF) fl-istudji VIVIDDME u VISTADME
English: Mean Change in Visual Acuity from Baseline to Week 96 for the Combined Data from the View1 and View2 Studies
Maltese: Bażi sa Ġimgħa 96 għad-Dejta Kombinata mill-Istudji View1 u View2
English: At the last visit up to week 52, 56.
Maltese: Fl-istudju VIEW1, f'ġimgħa 52, 95.
English: Prior to launch and during the product's lifecycle in each Member State the Marketing Authorisation Holder (MAH) will agree the final educational material with the National Competent Authority.
Maltese: Qabel jitqiegħed fis-suq u matul iċċiklu tal-ħajja tal-prodott f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH - Marketing Authorisation Holder) se jaqbel dwar il-materjal edukattiv finali mal-Awtorità Kompetenti Nazzjonali.
English: - neovascular (wet) age-related macular degeneration (wet AMD), - impaired vision due to macular oedema secondary to retinal vein occlusion (branch RVO (BRVO)
Maltese: - deġenerazzjoni makulari relatata mal-età neovaskulari (imxarrba) (AMD imxarrba - wet agerelated macular degeneration), - indeboliment fil-vista kkawżat minn edima makulari sekondarja għall-okklużjoni tal-vina tarretina (RVO ta' vini sekondarji (BRVO - branch retinal vein occlusion) jew RVO tal-vina ċentrali (CRVO - central retinal vein occlusion), - indeboliment fil-vista kkawżat minn edima makulari dijabetika (DME - diabetic macular oedema). - indeboliment fil-vista kkawżat minn neovaskularizzazzjoni korojdali mijopika (CNV mijopikamyopic choroidal neovascularisation)
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).
Maltese: • Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt it-trattament u għal millinqas 3 xhur wara l-aħħar injezzjoni ġol-vitriju ta' aflibercept (ara sezzjoni 4.6).
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.
Maltese: Avvenimenti avversi sistemiċi li jinkludu emorraġiji mhux okulari u avvenimenti trombo-emboliċi arterjali kienu rrappurtati wara injezzjoni ġol-vitriju ta' inibituri ta' VEGF u hemm riskju teoretiku li dawn jistgħu jkunu konnessi ma' inibizzjoni ta' VEGF.
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.
Maltese: Fiż-żewġ studji, ilpazjenti kienu assenjati b'mod randomised fi proporzjon ta' 3:2 biex jirċievu 2 mg Eylea kull 4 ġimgħat (2Q4), jew għall-grupp ta' kontroll biex jirċievu injezzjonijiet mingħajr mediċina kull 4 ġimgħat għal total ta' 6 injezzjonijiet.
English: A secondary efficacy endpoint was change in visual acuity at week 24 compared to baseline, which was statistically significant in favour of Eylea in the VIBRANT study.
Maltese: Punt finali sekondarju tal-effikaċja kien bidla fl-akutezza viżiva f'ġimgħa 24 meta mqabbel mal-linja bażi, li kienet statistikament sinifikanti favur Eylea fl-istudju VIBRANT.
English: Also at the 52 week time point, in the VIEW2 study there were mean decreases in CRT on OCT (-149 and -139 microns for the Eylea 2 mg every two months and ranibizumab 0.5 mg every month study groups, respectively).
Maltese: Barra dan fil-punt ta' żmien ta' 52 ġimgħa, fl-istudju VIEW2 kien hemm tnaqqis medju f'CRT fuq OCT (-149 u -139 mikroni għall-gruppi ta' studju ta' Eylea 2 mg kull xahrejn, u ranibizumab 0.5 mg kull xahar, rispettivament).
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe.
Maltese: Il-labra tal-injezzjoni għandha tiddaħħal 3.5-4.0 mm wara l-limbus fil-ħofra tal-vitriju, waqt li wieħed jevita il-meridjan orizzontali u jimmira lejn iċ-ċentru tal-globu.
English: Adjunctive use of verteporfin photodynamic therapy (PDT) and Eylea has not been studied, therefore, a safety profile is not established.
Maltese: L-użu flimkien ta' terapija fotodinamika (PDT - photodynamic therapy) b'verteporfin u Eylea ma ġiex studjat, għalhekk ma ġiex stabbilit profil tas-sigurtà.
English: The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, sham-controlled studies in patients with macular oedema secondary to CRVO (COPERNICUS and GALILEO) with a total of 358 patients treated and evaluable for efficacy (217 with Eylea).
Maltese: Is-sigurtà u l-effikaċja ta' Eylea kienu evalwati f'żewġ studji randomised, b'aktar minn ċentru wieħed, double-masked u kkontrollati b'kura mingħajr mediċina f'pazjenti b'edima makulari sekondarja għal CRVO (COPERNICUS u GALILEO) b'total ta' 358 pazjent ikkurati u li setgħu jiġu evalwati għalleffikaċja (217 b'Eylea).
English: Iridocyclitis, Lenticular opacities, Corneal epithelium defect,
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI
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.
Maltese: Osservat (NOAEL - No Observed Adverse Effect Level) ta' 0.5 mg/għajn fix-xadini l-esponiment sistemiku kien 42 u 56 darba ogħla bbażat fuq Cmax u lAUC, rispettivament.
English: At week 52, patients in the treat-and-extend arm with 2-week adjustments gained a mean of 9.0 letters from baseline as compared to 8.4 letters for those in the 4-week adjustment group [LS mean difference in letters (95% CI): -0.4 (-3.8,3.0), ANCOVA].
Maltese: [differenza medja ta' LS f'ittri (CI ta' 95%): -0.4 (-3.8,3.0), ANCOVA].
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.
Maltese: Dan it-tnaqqis f'CRT mil-linja bażi inżamm sal-aħħar ta' kull studju, sa ġimgħa 100 f'COPERNICUS, ġimgħa 76 f'GALILEO, u ġimgħa 52 f'VIBRANT.
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.
Maltese: Hemm biss esperjenza limitata fit-trattament ta' individwi b'DME ikkawżata minn dijabete tat-tip I jew f'pazjenti dijabetiċi b'HbA1c ta' aktar minn 12% jew b'retinopatija dijabetika proliferattiva.
English: In the VIEW1 study, at week 52, 95.1% of patients in the Eylea 2Q8 group maintained vision compared to 94.4% patients in the ranibizumab 0.5Q4 group.
Maltese: 1% tal-pazjenti fil-grupp ta' Eylea 2Q8 żammew il-vista meta mqabbel ma' 94.4% tal-pazjenti fil-grupp ta' ranibizumab 0.5Q4. Fl-istudju VIEW2, f'ġimgħa 52, 95.
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.
Maltese: 6% tal-pazjenti żammew il-vista fil-grupp ta' Eylea 2Q8 meta mqabbel ma' 94.4% tal-pazjenti filgrupp ta' ranibizumab 0.5Q4. Fiż-żewġ studji Eylea intweriet li mhux inferjuri u li hija klinikament ekwivalenti għall-grupp ta' ranibizumab 0.5Q4.
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.
Maltese: - qtugħ tas-sustanza qisgħa ġel ta' ġol-għajn minn mar-retina (qtugħ tal-vitriju, li jwassal għal leħħ ta' dawl flimkien ma tikek) - sensazzjoni ta' xi ħaġa barranija fl-għajn - żieda fid-dmugħ - nefħa tal-kappell tal-għajn - fsada fis-sit tal-injezzjoni - ħmura fl-għajn * Kondizzjonijiet magħrufa li huma assoċjati ma' AMD imxarrba; osservati biss f'pazjenti b'AMD imxarrba.
English: Difference in LS
Maltese: U L-UŻU
English: A total of 121 patients were treated and evaluable for efficacy (90 with Eylea).
Maltese: Total ta' 121 pazjent kienu ttrattati u setgħu jiġu evalwati għalleffikaċja (90 b'Eylea).
English: Diabetic macular oedema
Maltese: Edima makulari dijabetika
English: Aflibercept is slowly absorbed from the eye into the systemic circulation after intravitreal administration and is predominately observed in the systemic circulation as an inactive, stable complex with VEGF; however only “free aflibercept” is able to bind endogenous VEGF.
Maltese: Wara għoti ġol-vitriju Aflibercept jiġi assorbit bil-mod mill-għajn fiċ-ċirkolazzjoni sistemika u filbiċċa l-kbira huwa osservat fiċ-ċirkolazzjoni sistemika bħala kumpless inattiv u stabbli ma' VEGF; madankollu “aflibercept ħieles” biss huwa kapaċi jeħel ma' VEGF endoġenu.
English: The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, active-controlled studies in patients with DME (VIVIDDME and VISTADME).
Maltese: Is-sigurtà u l-effikaċja ta' Eylea kienu evalwati f'żewġ studji randomised, b'aktar minn ċentru wieħed, double-masked u kkontrollati b'mod attiv f'pazjenti b'DME (VIVIDDME u VISTADME).
English: • Patient monitoring after intravitreal injection including monitoring for visual acuity and increase of intraocular pressure post-injection
Maltese: • Monitoraġġ tal-pazjent wara injezzjoni ġol-vitriju inkluż monitoraġġ għall-akutezza viżiva u żieda tal-pressjoni fl-għajn wara l-injezzjoni
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.
Maltese: Osservazzjoni Trasferita 'l Quddiem (LOCF - Last Observation Carried Forward) għall-analiżi kollha minbarra l-proporzjon ta' pazjenti li żammew l-akutezza viżiva f'ġimgħa 52 li huwa PPS Ċ) Id-differenza hija l-valur tal-grupp ta' Eylea nieqes il-valur tal-grupp ta' ranibizumab.
English: At week 52, there were mean decreases in central retinal thickness (CRT) on OCT of -134.4 and -126.1 microns for the 2-week adjustment group and the 4-week adjustment group, respectively.
Maltese: Fil-ġimgħa 52, kien hemm tnaqqis medju fil-ħxuna tar-retina ċentrali (CRT - central retinal thickness) fuq OCT ta' -134.4 u126.1 mikroni għall-grupp ta' aġġustament ta' ġimagħtejn u l-grupp ta' aġġustament ta' 4 ġimgħat, rispettivament.
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.
Maltese: Il-fattur tat-tkabbir tal-endotelju vaskulari A (VEGF-A - vascular endothelial growth factor-A) u lfattur tat-tkabbir tal-plaċenta (PlGF - placental growth factor) huma membri tal-familja ta' VEGF ta' fatturi anġjoġeniċi li jistgħu jaġixxu bħala fatturi ta' permeabilità vaskulari, mitoġeniċi u kimotatiċi potenti għaċ-ċelluli tal-endotelju.
English: Among those, 2,501 patients were treated with the recommended dose of 2 mg.
Maltese: III. Fost dawn, 2,501 pazjent kienu kkurati bid-doża rakkomandata ta' 2 mg.
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).
Maltese: Fl-istudju, il-pazjenti kienu assenjati b'mod każwali fi proporzjon ta' 1:1 għal 2 mg Eylea mogħti kull 8 ġimgħat wara 6 injezzjonijiet inizjali ta' darba kull xahar jew għal fotokoagulazzjoni billejżer mogħtija fil-linja bażi (grupp ta' kontroll li fih il-pazjenti rċevew il-lejżer).
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
Maltese: D) Intervall ta' kunfidenza (CI - confidence interval) ikkalkulat b'approssimazzjoni normali E) Wara l-bidu tat-trattament bi tliet dożi ta' darba fix-xahar F) Intervall ta' kunfidenza li qiegħed sew 'l fuq minn -10% jindika nuqqas ta' inferjorità ta' Eylea għal ranibizumab
English: Caution should be exercised when treating such patients.
Maltese: Kellem lit-tabib tiegħek qabel twaqqaf it-trattament.
English: * Conditions known to be associated with wet AMD.
Maltese: * Kondizzjonijiet magħrufa li huma assoċjati ma' AMD imxarrba.
English: (N= 73)
Maltese: Kontroll (N= 73)
English: For handling of the medicinal product before administration, see section 6.6.
Maltese: Għall-immaniġġjar tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
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.
Maltese: B'mod ġenerali, għandhom jiġu żgurati anestesija u asepsi adegwati, inkluż mikrobiċida topiku bi spettru wiesa' (eż. povidone iodine applikat fuq il-ġilda ta' madwar l-għajn, il-kappell tal-għajn u s-superfiċje tal-għajn).
English: NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection in pre-filled syringe.
Maltese: IL-PRODOTT MEDIĊINALI Eylea 40 mg/ml soluzzjoni għall-injezzjoni f'kunjett.
English: 100 Weeks
Maltese: Ġimgħa 100
English: Eylea can help to stabilise, and in many cases, improve the vision loss related to wet AMD, CRVO, BRVO, DME and myopic CNV.
Maltese: Eylea jista' jgħin jistabbilizza, u f'ħafna każijiet, itejjeb it-telf tal-vista relatat ma' AMD imxarrba, CRVO, BRVO, DME u CNV mijopika.
English: The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, active-controlled studies in patients with wet AMD (VIEW1 and VIEW2) with a. total of 2,412 patients treated and evaluable for efficacy (1,817 with Eylea).
Maltese: Is-sigurtà u l-effikaċja ta' Eylea kienu evalwati f'żewġ studji randomised, b'aktar minn ċentru wieħed, double-masked u kkontrollati b'mod attiv f'pazjenti b'AMD imxarrba (VIEW1 u VIEW2) b'total ta' 2,412-il pazjent ikkurati u li setgħu jiġu evalwati għall-effikaċja (1,817 b'Eylea).
English: One pre-filled syringe contains 3.6 mg aflibercept in 90 microlitres (40 mg/ml) in iso-osmotic solution.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa mimlija għal-lest waħda fiha 3.6 mg aflibercept f'90 mikrolitru (40 mg/ml) f'soluzzjoni isoosmotika.
English: At the last visit prior to week 96, 64.9% and 61.2% of patients in the 2week and 4-week adjustment groups, respectively had their next injection scheduled at an interval of 12 weeks or beyond.
Maltese: Fl-aħħar żjara qabel ġimgħa 96, 64.9% u 61.2% tal-pazjenti fil-gruppi ta' aġġustament ta' ġimagħtejn u 4 ġimgħat, rispettivament kellhom l-injezzjoni li jmiss skedata f'intervall ta' 12-il ġimgħa jew wara.
English: An effect of aflibercept on intrauterine development was shown in embryo-foetal development studies in pregnant rabbits with intravenous (3 to 60 mg/kg) as well as subcutaneous (0.1 to 1 mg/kg) administration.
Maltese: Effett ta' aflibercept fuq l-iżvilupp ġewwa l-utru intwera fi studji dwar l-iżvilupp tal-embriju u tal-fetu fi fniek tqal b'għoti fil-vini (3 sa 60 mg/kg) kif ukoll taħt il-ġilda (0.1 sa 1 mg/kg).
English: The difference between treatment groups was statistically significant in favour of Eylea for the primary endpoint (change in BCVA) and confirmatory secondary efficacy endpoint (proportion of patients who gained 15 letters in BCVA) at week 24 compared to baseline.
Maltese: Id-differenza bejn il-gruppi ta' trattament kienet statistikament sinifikanti favur Eylea għall-punt finali primarju (bidla f'BCVA) u l-punt finali sekondarju konfermattiv tal-effikaċja (proporzjon ta' pazjenti li żiedu 15-il ittra f'BCVA) f'ġimgħa 24 meta mqabbla mal-linja bażi.
English: Mean Change in BCVA as Measured by ETDRS Letter Score from Baseline to Week 100 in VIVIDDME and VISTADME Studies
Maltese: Jekk xi waħda minn dawn tapplika għalik, it-tabib tiegħek se jikkunsidra dan in-nuqqas ta' informazzjoni meta jikkurak b'Eylea.
English: Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry.
Maltese: Monitoraġġ xieraq jista' jikkonsisti minn iċċekkjar għall-perfużjoni tar-ras tan-nerv ottiku jew tonometrija.
English: Figure 3: Mean Change in BCVA as Measured by ETDRS Letter Score from Baseline to Week 52 in VIBRANT Study
Maltese: Figura 3: Bidla medja f'BCVA kif Imkejjla mill-Punteġġ ta' Ittri minn ETDRS mil-Linja Bażi sa Ġimgħa 52 fl-Istudju VIBRANT
English: Posology wet AMD
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: 76 Weeks
Maltese: Ġimgħa 76
English: • Patient information leaflet
Maltese: • Pakketti ta' informazzjoni għall-pazjent
English: Patient ages ranged from 27 to 83 years with a mean of 58 years.
Maltese: L-etajiet tal-pazjenti varjaw minn 27 sa 83 sena b'medja ta' 58 sena.
English: Extraction of multiple doses from a pre-filled syringe may increase the risk of contamination and subsequent infection.
Maltese: L-estrazzjoni ta' dożi multipli minn siringa mimlija għal lest tista' żżid ir-riskju ta' kontaminazzjoni u ta' infezzjoni sussegwenti.
English: Mean change in BCVA as measured by ETDRSA) letter score from baseline Difference in LS A) mean change (ETDRS letters)C)
Maltese: Least square means derivat minn ANCOVA PPS - Per Protocol Set: Sett Skont il-Protokoll B) Sett ta' Analiżi Sħiħa (FAS - Full Analysis Set), L-Aħħar
English: D) From week 24 on the treatment interval in the Eylea treatment group was extended for all subjects from 4
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: or central RVO (CRVO)), - impaired vision due to diabetic macular oedema (DME), - impaired vision due to myopic choroidal neovascularisation (myopic CNV).
Maltese: • Użu flimkien ma' sustanza oħra kontra VEGF (fattur tat-tkabbir tal-endotelju vaskulari) M'hemm l-ebda dejta disponibbli dwar l-użu ta' Eylea flimkien ma' prodotti mediċinali oħra kontra VEGF (sistemiċi jew fl-għajnejn).
English: • Use of antibiotics according to national guidelines
Maltese: • Użu ta' antibijotiċi skont linji gwida nazzjonali
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).
Maltese: Li jwettaq studju ta' intervent dwar l-effikaċja wara l-awtorizzazzjoni f'pazjenti b'edima makulari dijabetika bil-għan primarju li jqabbel, wara lewwel sena inizjali ta' trattament b'Eylea, il-kors standard ta' injezzjonijiet kull 8 ġimgħat ma' korsijiet ta' trattament alternattiv, jiġifieri intervalli estiżi ta' trattament ibbażati fuq riżultati viżivi u anatomiċi (PRN u ittratta u tawwal).
English: 48 Weeks
Maltese: Ġimgħa 48
English: At total of 67 subjects in this group received Eylea rescue treatment.
Maltese: Total ta' 67 individwu f'dan il-grupp irċevew trattament ta' salvataġġ b'Eylea.
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)
Maltese: Proporzjon ta' pazjenti b'żieda ta' ≥15-il ittra mil-linja bażi Differenza miżunaA,B,E) (CI ta' 95%) valur p p < 0.0001
English: 24 Weeks
Maltese: Ġimgħa 24
English: The ALTAIR study was conducted in Japanese patients with treatment naïve wet AMD, showing similar outcomes to the VIEW studies using 3 initial monthly Eylea 2 mg injections, followed by one injection after a further 2 months, and then continued with a treat-and-extend regimen with variable treatment intervals (2-week or 4-week adjustments) up to a maximum 16 week interval according to pre-specified criteria.
Maltese: L-istudju ALTAIR twettaq fuq pazjenti Ġappuniżi b'AMD imxarrba li qatt ma rċevew trattament qabel, li juri riżultati simili għall-istudji VIEW bl-użu ta' 3 injezzjonijiet inizjali ta' Eylea 2 mg darba fix-xahar, segwiti minn injezzjoni waħda wara xahrejn oħra, u mbagħad komplew b'kors ta' ittratta u estendi b'intervalli bejn it-trattament varjabbli (aġġustamenti ta' ġimagħtejn jew 4 ġimgħat) sa intervall massimu ta' 16-il ġimgħa skont kriterji speċifikati minn qabel.
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)
Maltese: Proporzjon ta' pazjenti b'żieda ta' ≥ 15-il ittra mil-linja bażi DifferenzaĊ) (CI ta' 95%)D)
English: Important information about some of the ingredients of Eylea This medicine contains less than 1 mmol (23 mg) of sodium per dose which means it is essentially “sodium-free”.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Eylea Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg ) f'kull doża, jiġifieri essenzjalment “ħieles mis-sodium”.
English: This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept.
Maltese: Dan jipprovdi ammont li jista' jintuża biex tingħata doża waħda ta' 50 mikrolitru li fiha 2 mg aflibercept.
English: The recommended dose for Eylea is 2 mg aflibercept equivalent to 50 microlitres.
Maltese: Id-doża rakkomandata għal Eylea hija ta' 2 mg aflibercept ekwivalenti għal 50 mikrolitru.