FrancophonIA/ELRC3.0 huggingface dataset:
English: • Key signs and symptoms of serious adverse events including endophthalmitis, intraocular pressure increased, retinal pigment epithelial tear and cataract
Maltese: • Sinjali u sintomi ewlenin ta' avvenimenti avversi serji inkluż edoftalmite, pressjoni ġewwa l-għajn miżjuda, tiċrita tal-epitelju tal-pigment tar-retina u katarretta
English: 100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle.
Maltese: 100 mikrolitru ta' soluzzjoni f'kunjett (ħġieġ tat-tip I) b'tapp (lasktu elastomeriku) u labra 18 G biex tiffiltra.
English: VEGF acts via two receptor tyrosine kinases; VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Maltese: VEGF jaġixxi permezz ta' tyrosine kinases b'żewġ riċetturi; VEGFR-1 u VEGFR-2, li huma preżenti fuq is-superfiċje ta' ċelluli tal-endotelju.
English: Macular oedema secondary to CRVO and BRVO
Maltese: Edima makulari sekondarja għal CRVO u BRVO
English: Using aseptic technique, firmly twist a 30 G x ½ inch injection needle onto the Luer-lock syringe tip.
Maltese: Bl-użu ta' teknika asettika, ilwi b'mod sod illabra 30 G x ½ pulzier tal-injezzjoni fuq il-ponta Luer-lock tas-siringa
English: Pharmacodynamic effects wet AMD
Maltese: Effetti farmakodinamiċi
English: One pre-filled syringe contains 90 microlitres, equivalent to 3.6 mg aflibercept.
Maltese: Siringa mimlija għal-lest waħda fiha 90 mikrolitru, ekwivalenti għal 3.6 mg aflibercept.
English: In patients treated with Eylea in the MYRROR study (one injection given at start of therapy, with additional injections given in case of disease persistence or recurrence), CRT decreased soon after treatment initiation favouring Eylea at week 24 (-79 microns and -4 microns for the Eylea 2 mg treatment group and the control group, respectively), which was maintained through week 48.
Maltese: F'pazjenti kkurati Eylea fl-istudju MYRROR (injezzjoni waħda mogħtija fil-bidu tat-terapija, b'injezzjonijiet addizzjonali mogħtija f'każ ta' persistenza jew rikorrenza tal-marda), CRT naqset hekk kif inbeda t-trattament favur Eylea f'ġimgħa 24 (-79 mikroni u -4 mikroni għall-grupp ta' trattament ta' Eylea 2 mg u l-grupp ta' kontroll, rispettivament), li nżammet matul ġimgħa 48.
English: BCVA as covariate.
Maltese: TA' EĊĊIPJENTI
English: Pharmacokinetic analysis of patients in the VIEW2 study, of which 40% had renal impairment (24% mild, 15% moderate, and 1% severe), revealed no differences with respect to plasma concentrations of active drug after intravitreal administration every 4 or 8 weeks.
Maltese: Analiżi farmakokinetika ta' pazjenti fl-istudju VIEW2, li minnhom 40% kellhom indeboliment renali (24% ħafif, 15% moderat, u 1% sever), ma wriet l-ebda differenza rigward konċentrazzjonijiet filplażma tal-mediċina attiva wara għoti ġol-vitriju kull 4 jew 8 ġimgħat.
English: (laser) (N = 132)
Maltese: (N = 132)
English: At week 52, 27.7% and 29.1% of the Eylea 2Q8 groups, and 7.5% and 14.3% of the control groups experienced a ≥2 step improvement in the DRSS.
Maltese: F'ġimgħa 52, 27.7% u 29.1% tal-gruppi ta' Eylea 2Q8, u 7.5% u 14.
English: • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),
Maltese: • indeboliment tal-vista kkawżat minn edima makulari sekondarja għall-okklużjoni tal-vina tarretina (RVO [retinal vein occlusion] ta' vini sekondarji jew RVO ċentrali) (ara sezzjoni 5.1),
English: Myopic choroidal neovascularisation (myopic CNV) is a frequent cause of vision loss in adults with pathologic myopia.
Maltese: Neovaskularizzazzjoni korojdali mijopika (CNV [choroidal neovascularisation] mijopika) hija kawża frekwenti ta' telf tal-vista f'adulti b'mijopija patoloġika.
English: 1) Eylea administered at 2 mg every 8 weeks following 3 initial monthly doses (Eylea 2Q8); 2) Eylea administered at 2 mg every 4 weeks (Eylea 2Q4);
Maltese: 1) Eylea mogħti b'doża ta' 2 mg kull 8 ġimgħat wara 3 dożi inizjali ta' darba kull xahar (Eylea 2Q8); 2) Eylea mogħti b'doża ta' 2 mg kull 4 ġimgħat (Eylea 2Q4);
English: Pharmacotherapeutic group: Ophthalmologicals / Antineovascularisation agents ATC code: S01LA05
Maltese: Oftalmoloġiċi / Sustanzi kontra n-neovaskularizzazzjoni Kodiċi ATC:
English: Attach the 18 G, 5-micron filter needle supplied in the carton to a 1 ml sterile Luer-lock syringe.
Maltese: Waħħal il-labra 18 G biex tiffiltra ta' 5 mikroni fornuta fil-kartuna mas-siringa Luer lock sterili ta' 1 ml.
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.
Maltese: Fl-istudju dwar BRVO, madwar 58% (53/91) tal-pazjenti randomised għal trattament b'Eylea kellhom età ta' 65 sena jew aktar, u madwar 23% (21/91) kellhom età ta' 75 sena jew aktar.
English: One vial contains 4 mg aflibercept in 100 microlitres (40 mg/ml) in iso-osmotic solution.
Maltese: Kunjett wieħed fih 4 mg aflibercept f'100 mikrolitru (40 mg/ml) f'soluzzjoni iso-osmotika.
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.
Maltese: E) Differenza medja ta' LS u CI ta' 95% bbażati fuq mudell ANCOVA bi grupp ta' trattament u pajjiż (country designations) bħala effetti fissi, u BCVA fil-linja bażi bħala kovarjant.
English: These proportions were maintained at week 100 with 76.8 % (n = 76) in the Eylea group and 78% (n = 39) in the sham group.
Maltese: Dawn il-proporzjonijiet kienu miżmuma f'ġimgħa 100 b'76.8% (n = 76) fil-grupp ta' Eylea u 78% (n = 39) fil-grupp mingħajr mediċina.
English: • Intravitreal injection procedure pictogram
Maltese: • Piktogramma tal-proċedura ta' injezzjoni ġol-vitriju
English: (country designations)
Maltese: (lejżer)
English: Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Maltese: Attivazzjoni eċċessiva ta' dawn ir-riċetturi minn VEGF-A tista' tirriżulta f'neovaskularizzazzjoni patoloġika u permeabilità vaskulari eċċessiva.
English: Control G) (N = 68)
Maltese: Kontroll Ġ) (N = 68)
English: PHARMACEUTICAL FORM AND CONTENTS One pre-filled syringe contains 3.6 mg/90 microlitres (40 mg/ml) in iso-osmotic solution.
Maltese: U KONTENUT Siringa mimlija għal-lest waħda fiha 3.6 mg/90 mikrolitru (40 mg/ml) f'soluzzjoni iso-osmotika.
English: Table 3: Efficacy outcomes at week 24, week 52 and week 76/100 (Full Analysis Set with LOCFC)) in COPERNICUS and GALILEO studies Efficacy Outcomes
Maltese: Tabella 3: Riżultati tal-effikaċja f'ġimgħa 24, ġimgħa 52 u ġimgħa 76/100 (Sett ta' Analiżi Sħiħa b'LOCFĊ)) fl-istudji COPERNICUS u GALILEO Riżultati tal-Effikaċja
English: Macular oedema secondary to BRVO
Maltese: Edima makulari sekondarja għal BRVO
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.
Maltese: Aflibercept huwa proteina rikombinanti magħmula permezz ta' fużjoni li tikkonsisti minn porzjonijiet ta' dominji ekstraċellulari tar-riċetturi ta' VEGF 1 u 2 umani magħquda mal-porzjon Fc ta' IgG1 uman.
English: Sham/ Eylea 2mg (N = 31)
Maltese: Trattament mingħajr mediċina/ Eylea 2mg (N = 31)
English: As with other intravitreal anti-VEGF treatments for AMD, CRVO, BRVO, DME and myopic CNV the following also applies:
Maltese: Bħal ma bi trattamenti oħra ġol-vitriju kontra VEGF għal AMD, CRVO, BRVO, DME u CNV mijopika dan li ġej japplika wkoll:
English: In the CRVO studies, approximately 52% (112/217) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 18% (38/217) were 75 years of age or older.
Maltese: Fl-istudji dwar CRVO, madwar 52% (112/217) tal-pazjenti randomised għal trattament b'Eylea kellhom età ta' 65 sena jew aktar, u madwar 18% (38/217) kellhom età ta' 75 sena jew aktar.
English: • Techniques for the intravitreal injection
Maltese: • Tekniki għall-injezzjoni ġol-vitriju
English: At the last visit up to week 52, 56.8% and 57.8% 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 vista sa ġimgħa 52, 56.8% u 57.8% tal-pazjenti fil-gruppi ta' aġġustament ta' ġimagħtejn u ta' 4 ġimgħat, rispettivament kellhom l-injezzjoni li jmiss tagħhom skedata wara intervall ta' 12-il ġimgħa jew aktar.
English: The proportion of patients who did not lose ≥15 letters in the two treatment arms was similar (96.7% in the 2-week and 95.9% in the 4-week adjustment groups).
Maltese: Il-proporzjon ta' pazjenti li ma' tilfux ≥15-il ittri fiż-żewġ gruppi ta' trattament kien simili (96.7% fil-grupp ta' aġġustament ta' ġimagħtejn u 95.9% f'dak ta' 4 ġimgħat).
English: NAME OF THE MEDICINAL PRODUCT Eylea 40 mg/ml solution for injection Aflibercept
Maltese: TAL-PRODOTT MEDIĊINALI Eylea 40 mg/ml soluzzjoni għall-injezzjoni Aflibercept
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.
Maltese: Kienet osservata rata baxxa ta' inċidenza ta' avvenimenti tromboemboliċi fl-arterji fil-provi kliniċi b'Eylea f'pazjenti b'AMD, DME, RVO u CNV mijopika.
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.
Maltese: Huwa stmat li wara għoti ġol-vitriju ta' 2 mg lill-pazjenti, il-konċentrazzjoni massima medja fil-plażma ta' aflibercept ħieles hija aktar minn 100 darba inqas mill-konċentrazzjoni ta' aflibercept li hija meħtieġa biex jeħel b'mod massimu ma' nofs VEGF sistemiku (2.91 mikrogramma/ml) fi studju ta' voluntiera f'saħħithom.
English: Therefore, its use in this age group is not relevant.
Maltese: Għalhekk, l-użu tiegħu f'dan il-grupp ta' età mhux rilevanti.
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.
Maltese: Fil-grupp ta' trattament ta' aflibercept (n = 224) f'ġimgħa 52, dan il-kors ta' trattament irriżulta f'pazjenti li rċevew medja ta' 9.2 injezzjonijiet, li huwa simili għan-numru ta' dożi mogħtija fil-grupp ta' Eylea 2Q8 f'VIVIDDME u VISTADME, filwaqt li leffikaċja globali tal-grupp ta' trattament ta' aflibercept fi Protokoll T kien komparabbli mal-grupp ta'
English: A) Difference is Eylea 2 mg Q4 weeks minus Laser Control
Maltese: Id-differenza hi Eylea 2 mg Q4 ġimgħat mingħajr il-kontroll
English: Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200) C) BCVA: Best Corrected Visual Acuity
Maltese: u l-Ewropa kontra l-Asja/Paċifiku għal GALILEO) u għall-kategorija ta' BCVA fil-linja bażi (> 20/200 u ≤ 20/200)
English: Across indications no notable difference between the groups treated with aflibercept and the respective comparator groups were observed.
Maltese: Tul l-indikazzjonijiet ma kienet osservata lebda differenza notevoli bejn il-gruppi ttrattati b'aflibercept u l-gruppi rispettivi ta' paragun.
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
Maltese: D Differenza b'intervall ta' kunfidenza (CI - confidence interval) u test statistiku huma kkalkulati permezz tal-iskema ta' kejl Mantel-Haenszel aġġustata skont ir-reġjun (Ewropa/Awstralja vs. il-Ġappun) għal VIVIDDME u storja medika ta' MI jew CVA għal VISTADME E BCVA - Best Corrected Visual Acuity:
English: • What are the steps following treatment with Eylea
Maltese: • X'inhuma l-passi wara trattament b'Eylea
English: Detailed results from the analysis of the MYRROR study are shown in Table 6 and Figure 5 below.
Maltese: Riżultati dettaljati mill-analiżi tal-istudju MYRROR huma murija fit-Tabella 6 u Figura 5 taħt.
English: There is no experience in the treatment of - patients with acute infections.
Maltese: M'hemmx esperjenza fit-trattament ta' - pazjenti b'infezzjonijiet akuti.
English: As with all therapeutic proteins, there is a potential for immunogenicity with Eylea.
Maltese: Bħal ma bil-proteini terapewtiċi kollha, hemm potenzjal ta' immunoġeniċità b'Eylea.
English: In a pharmacokinetic sub-study in 6 neovascular wet AMD patients with frequent sampling, maximum plasma concentrations of free aflibercept (systemic Cmax) were low, with a mean of approximately 0.02 microgram/ml (range 0 to 0.054) within 1 to 3 days after a 2 mg intravitreal injection, and were undetectable two weeks following dosage in almost all patients.
Maltese: F'sottostudju dwar il-farmakokinetika f'6 pazjenti b'AMD neovaskulari imxarrba b'teħid frekwenti ta' kampjuni, il-konċentrazzjonijiet massimi fil-plażma ta' aflibercept ħieles (Cmax sistemika) kienu baxxi, b'medja ta' madwar 0.02 mikrogrammi/ml (firxa 0 sa 0.054) fi żmien 1 sa 3 ijiem wara injezzjoni ġolvitriju ta' 2 mg, u ma setgħux jiġu osservati ġimagħtejn wara d-dożaġġ fi kważi l-pazjenti kollha.
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.
Maltese: Fiddoża ta' 0.1 mg/kg, l-esponimenti sistemiċi għal aflibercept ħieles ibbażati fuq Cmax u l-AUC kumulattiv kienu madwar 17 u 10 darbiet ogħla, rispettivament, meta mqabbla ma' valuri korrispondenti osservati fil-bnedmin wara doża ġol-vitriju ta' 2 mg.
English: Table 4: Efficacy outcomes at week 24 and week 52 (Full Analysis Set with LOCF) in VIBRANT study
Maltese: Tabella 4: Riżultati tal-Effikaċja f'ġimgħa 24 u ġimgħa 52 (Sett ta' Analiżi Sħiħa b'LOCF) flIstudju VIBRANT
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.
Maltese: Ibbażat fuq Cmax u l-AUC għalaflibercept ħieles osservati bid-doża ta' 3 mg/kg fil-vini, l-esponimenti sistemiċi kienu madwar 4,900 darba u 1,500 darba ogħla, rispettivament, mill-esponiment osservat fil-bnedmin wara doża ġolvitriju ta' 2 mg.
English: Corneal oedema
Maltese: Kif taħżen Eylea
English: Pre-filled syringe
Maltese: Edima fil-kornea
English: The macula is the portion of retina responsible for fine vision.
Maltese: Il-makula hija l-parti tar-retina responsabbli għall-vista dettaljata.
English: 1 vial (4 mg/0.1 ml) 18G filter needle Single dose: 2 mg/0.05 ml Excess volume to be expelled.
Maltese: Kunjett wieħed (4 mg/0.1 ml) Labra 18G biex tiffiltra Doża waħda:
English: Eylea is a solution for injection (injection) in a vial (4 mg/100 microlitres).
Maltese: Eylea huwa soluzzjoni għall-injezzjoni (injezzjoni) f'kunjett (4 mg/100 mikrolitru).
English: As with all therapeutic proteins, there is a possibility for an immune reaction (formation of antibodies) with Eylea.
Maltese: Bħal bil-proteini terapewtiċi kollha, hemm possibbiltà ta' reazzjoni immuni (formazzjoni ta' antikorpi) b'Eylea.
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.
Maltese: B) Differenza u intervall ta' kunfidenza (CI - confidence interval) huma kkalkulati permezz tat-test Cochran-Mantel-Haenszel (CMH) aġġustat għar-reġjun (l-Amerika kontra l-bqija tad-dinja għal COPERNICUS u l-Ewropa kontra l-Asja/Paċifiku għal GALILEO) u għall-kategorija ta' BCVA fil-linja bażi (> 20/200 u ≤ 20/200) C) BCVA - Best Corrected Visual Acuity:
English: At week 24, this was 91.8% (n=89) in the Eylea group and 85.5% (n=47) in the sham group.
Maltese: F'ġimgħa 24, dan kien 91.8% (n=89) fil-grupp ta' Eylea u 85.
English: The proportion of patients who gained ≥15 letters at week 52 was 32.5% in the 2-week adjustment group and 30.9% in the 4-week adjustment group.
Maltese: Il-proporzjon ta' pazjenti li kisbu ≥15-il ittra f'ġimgħa 52 kien ta' 32.5% fil-grupp ta' aġġustament ta' ġimagħtejn u 30.9% fil-grupp ta' aġġustament ta' 4 ġimgħat.
English: Ranibizumab 0.5Q4 (ranibizumab 0.5 mg every 4 weeks) (N = 595) Week 52 Week 96 Week 52 Week 96
Maltese: (N = 595) Ġimgħa 52 Ġimgħa 96 Ġimgħa 52 Ġimgħa 96
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.
Maltese: 7%) tal-pazjenti ta' Eylea rċevew injezzjonijiet ta' Eylea fiż-żewġ għajnejn sa ġimgħa 100; fl-istudju VIVIDDME, 97 (35.8%) talpazjenti ta' Eylea rċevew trattament kontra VEGF differenti fl-għajn l-oħra.
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.
Maltese: F'pazjenti kkurati b'injezzjoni kull xahar ta' Eylea 2mg għal sitt xhur konsekuttivi, kien osservat rispons morfoloġiku konsistenti, rapidu u robust (kif imkejjel permezz ta' titjib f'CRT medja).
English: Elimination As Eylea is a protein-based therapeutic, no metabolism studies have been conducted.
Maltese: Eliminazzjoni Peress li Eylea huwa terapewtiku fuq bażi ta' proteina, ma sarux studji dwar il-metaboliżmu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose = 2 mg/50 microlitres 3.6 mg/90 microlitres
Maltese: Doża waħda = 2 mg/50 mikrolitru
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.
Maltese: Differenza medja ta' LS u CI ta' 95% ibbażati fuq mudell ANCOVA bil-grupp ta' trattament, kategorija ta' BCVA fil-linja bażi (> 20/200 u ≤ 20/200) u r-reġjun (Amerika ta' Fuq vs. il-Ġappun) bħala effetti fissi, u BCVA fil-linja bażi bħala kovarjabbli.
English: • Management of intravitreal injection related adverse events
Maltese: • Immaniġġar ta' avvenimenti avversi relatati ma' injezzjoni ġol-vitriju
English: Difference in LS mean
Maltese: Differenza fil-medja ta'
English: 90 microlitres of solution in pre-filled syringe (type I glass) marked with a black dosing line, with a plunger stopper (elastomeric rubber) and a Luer lock adaptor with a tip cap (elastomeric rubber).
Maltese: 90 mikrolitru ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tat-tip I) immarkata b'linja sewda taddożaġġ, b'tapp tal-planġer (lasktu elastomeriku) u adattatur Luer lock b'għata għat-tarf (lasktu elastomeriku).
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).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat l-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Eylea f'kull sett tal-popolazzjoni pedjatrika f'AMD imxarrba, CRVO, BRVO, DME u popolazzjonijiet ta' CNV mijopika (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Maltese: Monitoraġġ għall-attività tal-marda jista' jinkludi eżami kliniku, ittestjar funzjonali jew tekniki ta' xbihat (eż. tomografija ta' koerenza ottika jew anġjografija bi fluorescein).
English: Eylea G) 2 mg (N = 103)
Maltese: Eylea Ġ) 2 mg (N = 103)
English: Eylea is a solution for injection (injection) in a pre-filled syringe (3.6 mg/90 microlitres).
Maltese: Eylea huwa soluzzjoni għall-injezzjoni (injezzjoni) f'siringa mimlija għal-lest (3.6 mg/90 mikrolitru).
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.
Maltese: F'analiżi ta' dejta kkombinata ta' VIEW1 u VIEW2, Eylea wriet bibliet ta' sinifikanza klinika millinja bażi fil-punt finali sekondarju speċifikat minn qabel tal-effikaċja tal-Kwestjonarju dwar ilFunzjoni viżiva tal-Istitut Nazzjonali tal-Għajnejn (NEI VFQ-25 - National Eye Institute Visual Function Questionnaire) mingħajr differenzi ta' sinifikanza klinika minn ranibizumab.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose = 2 mg/50 microlitres Extractable content = 4 mg/100microlitres
Maltese: Kontenut li jista' jiġi estratt = 4 mg/100 mikrolitru
English: Treatment effects in evaluable subgroups (e.g., age, gender, race, baseline HbA1c, baseline visual acuity, prior anti-VEGF therapy) in each study and in the combined analysis were generally consistent with the results in the overall populations.
Maltese: Effetti tat-trattament fis-sottogruppi li setgħu jiġu evalwati (eż., età, sess, razza, HbA1c fil-linja bażi, akutezza viżiva fil-linja bażi, terapija preċedenti kontra VEGF) f'kull studju u fl-analiżi kkombinata ġeneralment kienu konsistenti mar-riżultati fil-popolazzjonijiet totali.
English: At week 16, patients were randomised 1:1 into two treatment groups: 1) Eylea treat-and-extend with 2-week adjustments and 2) Eylea treat-and-extend with 4-week adjustments.
Maltese: F'ġimgħa 16, il-pazjenti kienu randomised 1:1 f'żewġ gruppi ta' trattament: 1) Eylea ittratta u estendi b'aġġustamenti ta' ġimagħtejn u 2) Eylea ittratta u estendi b'aġġustamenti ta' 4 ġimgħat.
English: • Key signs and symptoms of intravitreal injection related adverse events including endophthalmitis, increased intraocular pressure, retinal pigment epithelial tear and cataract
Maltese: • Sinjali u sintomi ewlenin ta' avvenimenti avversi relatati ma' injezzjoni ġol-vitriju li jinkludu edoftalmite, żieda fil-pressjoni ġewwa l-għajn, tiċrita tal-epitelju tal-pigment tar-retina u katarretta
English: In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred.
Maltese: Fi provi kliniċi ġew użati dożi sa 4 mg f'intervalli ta' xahar u seħħew każijiet iżolati ta' doża eċċessiva bi 8 mg.
English: A total of 862 patients were treated and evaluable for efficacy, 576 with Eylea.
Maltese: Total ta' 862 pazjent kienu kkurati u setgħu jiġu evalwati għall-effikaċja, 576 b'Eylea.