FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C) unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma tintużax immedjatament, il-ħinijiet u l-kondizzjonijiet ta' ħażna waqt l-użu u qabel l-użu huma r-responsabbiltà tal-utent u normalment ma jkunux ta' aktar minn 24 siegħa f'temperatura ta' 2 °C sa 8 °C jew 8 sigħat f'temperatura ambjentali (≤ 25 °C), sakemm id-dilwizzjoni ma tkunx saret f'kondizzjonijiet asettiċi kkontrollati u vvalidati.
English: Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy and locally advanced unresectable or metastatic TNBC were treated with atezolizumab until disease progression.
Maltese: Pazjenti b'UC avvanzata lokalment jew metastatika li mhumiex eliġibbli għal terapija b'cisplatin kienu ttrattati b'atezolizumab sal-progressjoni tal-marda.
English: ǂStratified by PD-L1 expression in tumour infiltrating immune cells, the number of prior chemotherapy regimens, and histology ** Based on the stratified log-rank test *** Based on Kaplan-Meier estimates
Maltese: *Il-popolazzjoni tal-analiżi primarja tikkonsisti mill-ewwel 850 pazjent randomised ǂStratifikat skont l-espressjoni ta' PD-L1 f'ċelluli immuni li jinfiltraw it-tumur, in-numru ta' korsijiet ta' kimoterapija preċedenti, u l-istoloġija ** Abbażi ta' test log-rank stratifikat *** Abbażi ta' stimi Kaplan-Meier
English: Patients with NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging, were excluded from the pivotal clinical study
Maltese: Il-pazjenti kienu ttrattati sat-telf tal-benefiċċju kliniku kif stmat mill-investigatur jew sa tossiċità mhux aċċettabbli.
English: Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Maltese: Ittrattament b'atezolizumab jista' jinbeda mill-ġdid jekk l-avveniment jitjieb għal ≤ Grad 1 fi żmien 12-il ġimgħa u l-kortikosterojdi jkunu tnaqqsu għal ≤ 10 mg prednisone jew ekwivalenti kuljum.
English: Hypersensitivity***
Maltese: Sensittività eċċessiva***
English: Absorption / Distribution
Maltese: Assorbiment / Distribuzzjoni
English: B) BCVA: Best Corrected Visual Acuity
Maltese: A) BCVA - Best Corrected Visual Acuity:
English: Myopic CNV
Maltese: CNV mijopika
English: Uveitis,
Maltese: Uveite,
English: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥ 1/10,000 to < 1/1,000)
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000).
English: (97.5% CI)
Maltese: (CI ta' 97.5%)
English: (95% CI) p-value p<0.0001
Maltese: (CI ta' 95%) valur p p < 0.0001
English: The statistically significant difference was maintained through week 52.
Maltese: Id-differenza statistikament sinifikanti nżammet sa ġimgħa 52.
English: DifferenceC) (95% CI)D)
Maltese: DifferenzaĊ) (CI ta' 95%)D)
English: Figure 4:
Maltese: Figura 4:
English: Populations with limited data
Maltese: Popolazzjonijiet b'dejta limitata
English: Endophthalmitis**, Retinal detachment, Retinal tear, Iritis,
Maltese: Endoftalmite**, Qtugħ tar-retina, Tiċrita fir-retina, Irite,
English: STATEMENT OF ACTIVE SUBSTANCE Aflibercept
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Aflibercept
English: At week 100, the respective percentages were 32.6% and 37.1% of the Eylea 2Q8 groups and 8.2% and 15.6% of the control groups.
Maltese: F'ġimgħa 100, il-perċentwali rispettivi kienu ta' 32.6% u 37.1% tal-gruppi ta' Eylea 2Q8, u ta' 8.2% u 15.6% tal-gruppi tal-kontroll.
English: What Eylea contains - The active substance is: aflibercept.
Maltese: X'fih Eylea - Is-sustanza attiva hi: aflibercept.
English: Bayer AG Müllerstraße 178 13353 Berlin Germany
Maltese: Bayer AG Müllerstraße 178 13353 Berlin Il-Ġermanja
English: Active severe intraocular inflammation.
Maltese: Infjammazzjoni severa attiva fl-għajn.
English: Sodium dihydrogen phosphate, monohydrate (for pH adjustment) Disodium hydrogen phosphate, heptahydrate (for pH adjustment) Sodium chloride
Maltese: Sodium dihydrogen phosphate, monohydrate (għall-aġġustament tal-pH) Disodium hydrogen phosphate, heptahydrate (għall-aġġustament tal-pH) Sodium chloride
English: • Use of povidone iodine or equivalent
Maltese: • Użu ta' povidone iodine jew ekwivalenti
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 November 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Novembru 2012
English: Manufacturer Bayer AG Müllerstraße 178 13353 Berlin Germany
Maltese: Manifattur Bayer AG Müllerstraße 178 13353 Berlin Il-Ġermanja
English: Hepatic and/or renal impairment
Maltese: Indeboliment epatiku u/jew renali
English: Adjusted Difference D,C,E
Maltese: Differenza Aġġustatta D,Ċ,E
English: Date of latest renewal: 13 July 2017
Maltese: Data tal-aħħar tiġdid: 13 ta' Lulju 2017
English: Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition.
Maltese: Avvenimenti tromboemboliċi fl-arterji (ATEs - arterial thromboembolic events) huma avvenimenti avversi potenzjalment relatati mal-inibizzjoni sistemika ta' VEGF.
English: Active Control
Maltese: Kontroll Attiv
English: Ranibizumab 0.5Q4 (ranibizumab 0.5 mg every 4 weeks)
Maltese: Ranibizumab 0.5Q4 (ranibizumab 0.5 mg kull 4 ġimgħat)
English: The maternal NOAEL was at the dose of 3 mg/kg or 1 mg/kg, respectively.
Maltese: NOAEL fl-omm kien bid-doża ta' 3 mg/kg jew 1 mg/kg, rispettivament.
English: • There is limited experience with treatment of patients with ischaemic CRVO and BRVO.
Maltese: • Hemm esperjenza limitata ta' trattament ta' pazjenti b'CRVO iskemika u BRVO.
English: The DRSS score was gradable in 73.7% of the patients in VIVIDDME and 98.3% of the patients in VISTADME.
Maltese: Ilpunteġġ DRSS seta' jiġi ggradat fi 73.7% tal-pazjenti f'VIVIDDME u 98.3% tal-pazjenti f'VISTADME.
English: At week 24 these proportions were 80% and 67%, respectively.
Maltese: F'ġimgħa 24 dawn il-proporzjonijiet kienu ta' 80% u 67%, rispettivament.
English: Mean number of injections from baseline Mean number of injections from Week 52 to 96
Maltese: Numru medju ta' injezzjonijiet minn Ġimgħa 52 sa 96
English: Control E,F) (N=73)
Maltese: Kontroll E,F) (N=73)
English: Store in refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2°C sa 8°C).
English: An independent comparative trial (DRCR.net Protocol T) utilised a dosing regimen based on strict OCT and vision re-treatment criteria.
Maltese: Prova indipendenti ta' paragun (DRCR.net Protokoll T) utilizzat kors ta' dożaġġ ibbażat fuq kriterji stretti ta' OCT u ta' trattament mill-ġdid tal-vista.
English: Blindness, Cataract traumatic, Vitritis, Hypopyon
Maltese: Telf tal-vista, Katarretta trawmatika, Vitrite, Ipopijon
English: Active Control (laser)/Eylea
Maltese: (lejżer)/Eylea
English: 4 weeks.
Maltese: 4 injezzjonijiet.
English: Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
Maltese: Aflibercept huwa magħmul fiċ-ċelluli K1 tal-ovarju tal-ħamster Ċiniż (CHO - Chinese hamster ovary) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: As this is a therapeutic protein, there is a potential for immunogenicity with Eylea (see section 4.8).
Maltese: Peress li din hija proteina terapewtika, hemm potenzjal ta' immunoġeniċità b'Eylea (ara sezzjoni 4.8).
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Maltese: Hemm riskju teoretiku ta' avvenimenti tromboemboliċi fl-arterji, inklużi puplesija u infart mijokardijaku, wara l-użu ta' inibituri ta' VEGF ġol-vitriju.
English: The most frequently observed adverse reactions (in at least 5% of patients treated with Eylea) were conjunctival haemorrhage (25%), visual acuity reduced (11%), eye pain (10%), cataract (8%), intraocular pressure increased (8%), vitreous detachment (7%), and vitreous floaters (7%).
Maltese: Ir-reazzjonijiet avversi osservati bl-aktar mod frekwenti (f'mill-inqas 5% tal-pazjenti kkurati b'Eylea) kienu emorraġija fil-konġuntiva (25%), akutezza viżiva mnaqqsa (11%), uġigħ fl-għajn (10%), katarretta (8%), żieda fil-pressjoni ta' ġol-għajn (8%), qtugħ tal-vitriju (7%), u materjal fil-vitriju
English: Clinical efficacy and safety wet AMD
Maltese: Effikaċja u sigurtà klinika
English: Diabetic macular oedema (DME)
Maltese: Edima makulari dijabetika (DME - diabetic macular oedema)
English: The recommended dose is 2 mg aflibercept (50 microlitres).
Maltese: Id-doża rakkomandata hija 2 mg aflibercept (50 mikrolitru).
English: A positive value favours Eylea.
Maltese: Valur pożittiv jiffavorixxi Eylea.
English: - The other ingredients are: polysorbate 20, sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injection.
Maltese: - Is-sustanzi l-oħra huma: polysorbate 20, sodium dihydrogen phosphate monohydrate (għallaġġustament tal-pH), disodium hydrogen phosphate heptahydrate (għall-aġġustament tal-pH), sodium chloride, sucrose, ilma għall-injezzjoni.
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.
Maltese: F'COPERNICUS, 67.5% (n = 77) mill-grupp ta' Eylea u 68.5% (n = 50) mill-grupp mingħajr mediċina kellhom CRVO perfuża fil-linja bażi.
English: wet AMD
Maltese: AMD imxarrba
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.
Maltese: F'GALILEO, 86.4% (n=89) mill-grupp ta' Eylea u 79.4% (n=54) mill-grupp mingħajr mediċina kellhom CRVO perfuża fil-linja bażi.
English: • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).
Maltese: • indeboliment fil-vista kkawżat minn neovaskularizzazzjoni korojdali mijopika (CNV mijopika - myopic choroidal neovascularisation) (ara sezzjoni 5.1).
English: mean B,C,E
Maltese: LSB,Ċ,E
English: This benefit was maintained through week 100.
Maltese: Dan il-benefiċċju nżamm tul ġimgħa 100.
English: Eylea 2Q8 E) (Eylea 2 mg every 8 weeks following 3 initial monthly doses) (N = 607)
Maltese: Eylea 2Q8 E) (Eylea 2 mg kull 8 ġimgħat segwit minn 3 dożi inizjali ta' darba fix-xahar) (N = 607)
English: Rensselaer, New York 12144
Maltese: Regeneron Pharmaceuticals, Inc. 81 Columbia Turnpike Rensselaer, New York 12144
English: Ocular and systemic safety profiles were similar to the safety observed in the pivotal studies VIEW1 and VIEW2.
Maltese: Il-profili ta' sigurtà okulari u sistemiċi kienu simili għas-sigurtà osservata fl-istudji pivotali VIEW1 u VIEW2.
English: In the VIVIDDME and VISTADME studies, 36 (9%) and 197 (43%) patients received prior anti-VEGF therapy, respectively, with a 3-month or longer washout period.
Maltese: Fl-istudji VIVIDDME u VISTADME, 36 (9%) u 197 (43%) pazjent irċevew terapija kontra VEGF qabel, rispettivament, b'perjodu ta' 3 xhur jew aktar fejn il-pazjenti ma ħadux mediċina.
English: A,C)
Maltese: NUMRU(I)
English: • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),
Maltese: • deġenerazzjoni makulari relatata mal-età (AMD - age-related macular degeneration) neovaskulari (imxarrba) (ara sezzjoni 5.1),
English: List of side effects reported
Maltese: Lista ta' effetti sekondarji rrappurtati
English: Macular oedema secondary to RVO (branch RVO or central RVO)
Maltese: Edima makulari sekondarja għal RVO (RVO tal-vini sekondarji jew RVO ċentrali)
English: (laser) (N = 154)
Maltese: (N = 154)
English: Table 2: Efficacy outcomes at week 52 (primary analysis) and week 96; combined data from the VIEW1 and VIEW2 studiesB)
Maltese: Tabella 2: Riżultati tal-effikaċja f'ġimgħa 52 (analiżi primarja) u ġimgħa 96; dejta kkombinata millistudji VIEW1 u VIEW2B)
English: In these clinical studies, approximately 89% (1,616/1,817) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 63% (1,139/1,817) were 75 years of age or older.
Maltese: F'dawn l-istudji kliniċi, madwar 89% (1,616/1,817) tal-pazjenti randomised għal trattament b'Eylea kellhom età ta' 65 sena jew aktar, u madwar 63% (1,139/1,817) kellhom età ta' 75 sena jew aktar.
English: 3) Eylea administered at 0.5 mg every 4 weeks (Eylea 0.5Q4); and 4) ranibizumab administered at 0.5 mg every 4 weeks (ranibizumab 0.5Q4).
Maltese: 3) Eylea mogħti b'doża ta' 0.5 mg kull 4 ġimgħat (Eylea 0.5Q4), u 4) ranibizumab mogħti b'doża ta' 0.5 mg kull 4 ġimgħat (ranibizumab 0.5Q4).
English: At baseline, the proportion of perfused patients in the Eylea and laser groups was 60% and 68%, respectively.
Maltese: Fil-linja bażi, il-proporzjon ta' pazjenti li kellhom perfużjoni fil-gruppi ta' Eylea u tal-lejżer kien ta' 60% and 68%, rispettivament.
English: 1 ml solution for injection contains 40 mg aflibercept*.
Maltese: 1 ml ta' soluzzjoni għall-injezzjoni fih 40 mg aflibercept*.
English: At week 100 the decrease was maintained with -195.8 and -191.1 microns for the 2Q8 Eylea groups and -85.7 and -83.9 microns for the control groups, in the VIVIDDME and VISTADME studies, respectively.
Maltese: F'ġimgħa 100, it-tnaqqis inżamm b'-195.8 u -191.1 mikroni għall gruppi ta' Eylea 2Q8, u -85.7 u -83.9 mikroni għall-gruppi tal-kontroll, fl-istudji VIVIDDME uVISTADME, rispettivament.
English: In the VIEW1 study there were mean decreases in CRT on optical coherence tomography (OCT) (-130 and -129 microns at week 52 for the Eylea 2 mg every two months and ranibizumab 0.5 mg every month study groups, respectively).
Maltese: Fl-istudju VIEW1 kien hemm tnaqqis medju f'CRT fuq tomografija ta' koerenza ottika (OCT - optical coherence tomography) (-130 u -129 mikroni f'ġimgħa 52 għall-gruppi ta' studju ta' Eylea 2 mg kull xahrejn u ranibizumab 0.5 mg kull xahar, rispettivament).
English: The difference between treatment groups was statistically significant in favour of Eylea in both studies.
Maltese: Id-differenza bejn il-gruppi ta' trattament kienet statistikament sinifikanti favur Eylea fiż-żewġ studji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/797/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/797/002
English: Proportion of patients with ≥15 letters gain from Baseline (%) Weighted Difference A,B) (95% CI) p-value p=0.0003
Maltese: Proporzjon ta' pazjenti b'żieda ta' ≥15-il ittra mil-Linja bażi Differenza miżuna A,B) (%) (CI ta' 95%) valur p p=0.0003
English: F) Difference and 95% CI are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for country
Maltese: F) Differenza u CI ta' 95% huma kkalkulati permezz tat-test Cochran-Mantel-Haenszel (CMH) aġġustat għall pajjiż (country designations)
English: Cataract cortical, Cataract nuclear, Cataract subcapsular, Corneal erosion, Corneal abrasion, Intraocular pressure increased, Vision blurred,
Maltese: Katarretta kortikali, Katarretta nukleari, Katarretta subkapsulari, Taħfir tal-kornea, Barxa fil-kornea, Żieda fil-pressjoni ta' ġol-għajn,
English: The MAH has agreed to provide EU Educational Material for Eylea.
Maltese: Il-MAH qabel li jipprovdi Materjal Edukattiv tal-UE għal Eylea.
English: In the DME studies, approximately 47% (268/576) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 9% (52/576) were 75 years of age or older.
Maltese: Fl-istudji dwar DME, madwar 47% (268/576) talpazjenti randomised għal trattament b'Eylea kellhom età ta' 65 sena jew aktar, u madwar 9% (52/576) kellhom età ta' 75 sena jew aktar.
English: Aflibercept, the active substance in Eylea, blocks the activity of a group of factors, known as Vascular Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor (PlGF).
Maltese: Aflibercept, is-sustanza attiva f'Eylea, twaqqaf l-attività ta' grupp ta' fatturi, magħrufa bħala Fattur tat-Tkabbir tal-Endotelju Vaskulari A (VEGF-A - Vascular Endothelial Growth Factor A) u Fattur tatTkabbir tal-Plaċenta (PlGF - Placental Growth Factor).
English: One vial contains 100 microlitres, equivalent to 4 mg aflibercept.
Maltese: Kunjett wieħed fih 100 mikrolitru, ekwivalenti għal 4 mg aflibercept.
English: The safety and efficacy of Eylea have not been established in children and adolescents.
Maltese: Is-sigurtà u l-effikaċja ta' Eylea ma ġewx determinati fi tfal u adolexxenti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/797/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/797/001
English: Delivers a single dose of 2 mg/0.05 ml.
Maltese: Tipprovdi doża waħda ta' 2 mg/0.05 ml.
English: *Fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
Maltese: *Proteina magħmula permezz ta' fużjoni li tikkonsisti minn porzjonijiet ta' dominji ekstraċellulari tarriċetturi ta' VEGF (Fattur tat-Tkabbir tal-Endotelju Vaskulari) 1 u 2 umani magħquda mal-porzjon Fc ta' IgG1 uman u magħmula fiċ-ċelluli K1 tal-ovarju tal-ħamster Ċiniż (CHO - Chinese hamster ovary) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: Difference in LS meanA,C,D,E)
Maltese: Differenza fil-medja ta' LS Ċ,D,E)
English: • visual impairment due to diabetic macular oedema (DME) (see section 5.1),
Maltese: • indeboliment fil-vista kkawżat minn edima makulari dijabetika (DME - diabetic macular oedema) (ara sezzjoni 5.1),
English: At week 24, this was 87.4% (n = 90) in the Eylea group and 58.6% (n = 34) in the sham group.
Maltese: F'ġimgħa 24, dan kien 87.4% (n = 90) fil-grupp ta' Eylea u 58.6% (n = 34) fil-grupp mingħajr mediċina.
English: ControlE) (N =73)
Maltese: KontrollE) (N =73)
English: Increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including those with Eylea (see section 4.8).
Maltese: Żidiet tal-pressjoni fl-għajn dehru fi żmien 60 minuta wara injezzjoni ġol-vitriju, inkluż wara injezzjoni b'Eylea (ara sezzjoni 4.8).
English: In the VIVIDDME and the VISTADME studies, a statistically significant greater mean decrease in CRT from baseline to week 52 was observed in patients treated with Eylea than with the laser control,192.4 and -183.1 microns for the 2Q8 Eylea groups and -66.2 and -73.3 microns for the control groups, respectively.
Maltese: Fl-istudji VIVIDDME u VISTADME, kien osservat tnaqqis medju statistikament sinifikanti akbar f'CRT mil-linja bażi sa ġimgħa 52 f'pazjenti ttrattati b'Eylea milli fil-grupp ta' kontroll li fih il-pazjenti rċevew il-lejżer, -192.4 u -183.1 mikroni għall-gruppi ta' Eylea 2Q8 u -66.2 u -73.3 mikroni għallgruppi tal-kontroll, rispettivament.
English: Final study report submission: 30
Maltese: Sottomissjoni tarrapport finali talistudju: Novembru
English: Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva aflibercept jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Wet AMD is characterised by pathological choroidal neovascularisation (CNV).
Maltese: AMD imxarrba hija kkaratterizzata minn neovaskularizzazzjoni korojdali patoloġika (CNVchoroidal neovascularisation).
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).
Maltese: Reazzjonijiet avversi serji fl-għajnejn fl-għajn taħt studju relatati mal-proċedura tal-injezzjoni seħħew f'inqas minn injezzjoni waħda minn 1,900 injezzjoni ta' Eylea fil-vitriju u kienu jinkludu telf tal-vista, endoftalmite, qtugħ tar-retina, katarretta trawmatika, katarretta, emorraġija fil-vitriju, qtugħ tal-vitriju, u żieda fil-pressjoni ta' ġol-għajn (ara sezzjoni 4.4).
English: The mean maximum plasma concentration of free aflibercept is approximately 50 to 500 times below the aflibercept concentration required to inhibit the biologic activity of systemic VEGF by 50% in animal models, in which blood pressure changes were observed after circulating levels of free aflibercept attained approximately 10 microgram/ml and returned to baseline when levels fell below approximately 1 microgram/ml.
Maltese: Il-konċentrazzjoni massima medja fil-plażma ta' aflibercept ħieles hija madwar 50 sa 500 darba inqas mill-konċentrazzjoni ta' aflibercept li hija meħtieġa biex tinibixxi l-attività bijoloġika ta' VEGF sistemiku b'50% f'mudelli ta' annimali, fejn bidliet fil-pressjoni tad-demm kienu osservati wara li il livelli fiċ-ċirkolazzjoni ta' aflibercept ħieles laħqu madwar 10 mikrogrammi/ml u rritornaw għall-linjabażi meta l-livelli naqsu taħt madwar 1 mikrogramma/ml.
English: The proportion of patients without fluid on OCT at week 52 was 68.3% and 69.1% in the 2- and 4-week adjustment groups, respectively.
Maltese: Il-proporzjon ta' pazjenti mingħajr fluwidu fuq OCT fil-ġimgħa 52 kien ta' 68.3% u 69.1% fil-gruppi ta' aġġustament ta' 2 u 4 ġimgħat, rispettivament.
English: The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
Maltese: Wara jingħata volum ta' injezzjoni ta' 0.05 ml; għandha tintuża sit sklerali differenti għall-injezzjonijiet sussegwenti.
English: In the myopic CNV study, approximately 36% (33/91) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 10% (9/91) were 75 years of age or older.
Maltese: Fl-istudju dwar CNV mijopika, madwar 36% (33/91) tal-pazjenti randomised għal trattament b'Eylea kellhom età ta' 65 sena jew aktar, u madwar 10% (9/91) kellhom età ta' 75 sena jew aktar.
English: In patients presenting with clinical signs of irreversible ischaemic visual function loss, the treatment is not recommended.
Maltese: F'pazjenti li jkollhom sinjali kliniċi ta' telf irriversibbli iskemiku tal-funzjoni visiva, it-trattament mhux rakkomandat.
English: Figure 2: Mean Change from Baseline to Week 76/100 in Visual Acuity by Treatment Group for the COPERNICUS and GALILEO Studies (Full Analysis Set)
Maltese: Figura 2: Bidla Medja mil-Linja Bażi sa Ġimgħa 76/100 fl-Akutezza Viżiva skont il-Grupp ta' Trattament għall-Istudji COPERNICUS u GALILEO (Sett ta' Analiżi Sħiħa)
English: Control (N = 68)
Maltese: Kontroll (N = 68)
English: Macular oedema secondary to CRVO
Maltese: Edima makulari sekondarja għal CRVO
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).
Maltese: Injezzjonijiet ġol-vitriju, inkluż dawk b'Eylea, kienu assoċjati ma' endoftalmite, infjammazzjoni ġewwa l-għajn, qtugħ regmatoġenuż tar-retina, tiċrita tar-retina u katarretti trawmatiċi jatroġeniċi (ara sezzjoni 4.8).
English: Differences for both endpoints were maintained through week 48.
Maltese: Differenzi għaż-żewġ punti finali inżammu tul ġimgħa 48.
English: C) LS mean: Least square means derived from ANCOVA model D) CI: Confidence Interval
Maltese: Medja ta' least squares derivata minn ANCOVA CI: Intervall ta' kunfidenza
English: - non-Asian patients with myopic CNV.
Maltese: - pazjenti kkurati minn qabel għal CNV mijopika.
English: In pharmacokinetic sub-studies in patients with CRVO, BRVO, DME or myopic CNV mean Cmax of free aflibercept in plasma were similar with values in the range of 0.03 to 0.05 microgram/ml and individual values not exceeding 0.14 microgram/ml.
Maltese: F'sottostudji farmakokinetiċi f'pazjenti b'CRVO, BRVO, DME jew CNV mijopika Cmax medja ta' aflibercept ħieles fil-plażma kienet simili b'valuri fil-firxa ta' 0.03 sa 0.05 mikrogrammi/ml u valuri individwali li ma qabżux 0.14-il mikrogramma/ml.