FrancophonIA/ELRC3.0 huggingface dataset:
English: Retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous haemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, vision blurred, injection site haemorrhage, eye haemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid oedema, eyelid pain, conjunctival hyperaemia.
Maltese: Deġenerazzjoni tar-retina, disturbi fir-retina, qlugħ tar-retina, tiċrit tar-retina, qlugħ tal-epitilju pigmentat tar-retina, tiċrit talepitilju pigmentat tar-retina, akutezza mnaqqsa tal-vista, emorraġija tal-vitriju, disturbi tal-vitriju, uvejite, irite, iridoċiklite, katarretta, katarretta sottokapsulari, il-kapsula posterjuri ssir opaka, keratite punctuate, brix tal-kornea, vampa tal-kavità anterjuri, vista mċajpra, emorraġija fis-sit talinjezzjoni, emorraġija tal-għajn, konġunktivite, konġunktivite allerġika, taħmiġ ta'l-għajn, fotopsja, fotofobja, skomfort flgħajn, edima ta' tebqet l-għajn, uġigħ ta' tebqet l-għajn, iperimja fil-konġunktiva.
English: Lucentis 0.5 mg + Laser N=178
Maltese: Lucentis 0.5 mg + Lejżer N=178
English: * The proportion of patients who did not require any ranibizumab treatment during the extension phase was 19%, 25% and 20% in the prior ranibizumab, prior ranibizumab + laser and prior laser groups, respectively.
Maltese: * Il-proporzjon ta' pazjenti li ma kellhom bżonn ebda kura b'ranibizumab matul il-fażi ta' estensjoni kien ta' 19%, 25% u 20% fil-gruppi ta' qabel ranibizumab, qabel ranibizumab + lejżer u qabel illejżer, rispettivament.
English: Also contains: α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.
Maltese: Fih ukoll: α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; ilma għall-injezzjonijiet.
English: Dispose of the syringe cap (see Figure 3).
Maltese: Armi l-għatu tas-siringa (ara Figura 3).
English: Other medicines and Lucentis
Maltese: Mediċini oħra u Lucentis
English: The safety of Lucentis 0.2 mg was studied in a 6-month clinical trial (RAINBOW), which included 73 preterm infants with ROP treated with ranibizumab 0.2 mg (see section 5.1).
Maltese: Is-sigurtà ta' Lucentis 0.2 mg ġiet studjata waqt prova klinika li damet 6 xhur (RAINBOW), li kienet tinkludi 73 tarbija mwielda qabel iż-żmien b'ROP ittrattati b'ranibizumab 0.2 mg (ara sezzjoni 5.1).
English: Single dose of 0.5 mg/0.05 ml.
Maltese: Doża waħda ta' 0.5 mg/0.05 ml.
English: • ranibizumab 0.5 mg monotherapy on a PRN regimen.
Maltese: • monoterapija ta' ranibizumab 0.5 mg fuq kors PRN.
English: Table 7 DRSS improvement or worsening of ≥2 or ≥3 steps at year 1 in Protocol S (LOCF Method)
Maltese: Tabella 7 DRSS imtejjeb jew li mar għall-agħar b' ≥2 jew ≥3 livelli fl-1 sena fil-Protocol S (Metodu LOCF)
English: It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
Maltese: Dan jista' wkoll ikun assoċjat ma' neovaskularizzazzjoni korojdali (CNV) minħabba mijopija patoloġika (PM), strixxi anġijojdi, korijoretinopatija seroża ċentrali jew CNV infjammatorja.
English: Blindness, endophthalmitis, hypopyon, hyphaema, keratopathy, iris adhesion, corneal deposits, corneal oedema, corneal striae, injection site pain, injection site irritation, abnormal sensation in eye, eyelid irritation.
Maltese: Telf tad-dawl, endoftalmite, hypopyon, hyphaema, keratopatija, adeżjoni tal-iris, depożiti fil-korneja, edima tal-korneja, striae fil-korneja, uġigħ fis-sit tal-injezzjoni, irritazzjoni fis-sit talinjezzjoni, sensazzjoni mhux normali fl-għajn, irritazzjoni ta' tebqet l-għajn.
English: In this study, 225 patients were randomised in a 1:1:1 ratio to receive intravitreal ranibizumab 0.2 mg (n=74), 0.1 mg (n=77), or laser therapy (n=74).
Maltese: F'dan l-istudju, 225 pazjent kienu magħżul għall-għarrieda fi proporzjon ta' 1:1:1 biex jingħataw ranibizumab 0.2 mg intravitreali (n=74), 0.1 mg (n=77), jew terapija bil-lejżer (n=74).
English: At year 1, 41.8% of eyes experienced a ≥2-step improvement in the DRSS when treated with ranibizumab (n=189) compared to 14.6% of eyes treated with PRP (n=199).
Maltese: Fl-ewwel sena, 41.8% tal-għajnejn esperjenzaw titjib ta' ≥2 livelli fid-DRSS meta ttrattati b'ranibizumab (n=189) imqabbel ma' 14.6% tal-għajnejn ittrattati b'PRP (n=199).
English: Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents, ATC code: S01LA04
Maltese: Oftalmoloġiċi, aġenti kontra neo-vaskularizzazzjoni, Kodiċi ATC:
English: Lucentis and laser photocoagulation in DME and in macular oedema secondary to BRVO There is some experience of Lucentis administered concomitantly with laser photocoagulation (see section 5.1).
Maltese: Lucentis u fotokoagulazzjoni bil-lejżer f'DME jew edima makulari sekondarja għal BRVO Hemm ftit tal-esperjenza dwar l-għoti ta' Lucentis flimkien ma' fotokoagulazzjoni bil-lejżer (ara sezzjoni 5.1).
English: Each pre-filled syringe of 0.165 ml solution contains 1.65 mg of ranibizumab (10 mg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 0.165 ml soluzzjoni li fiha 1.65 mg ranibizumab (10 mg/ml).
English: Prior ranibizumab 0.5 mg n=83
Maltese: Ranibizumab minn qabel 0.5 mg n=83
English: Intravitreous injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.8).
Maltese: Injezzjonijiet fil-vitriju, inklużi dawk b'Lucentis, kienu assoċjati ma' endoftalmite, infjammazzjoni flgħajn, qlugħ tar-retina regmatoġenuż, tiċrit tar-retina u katarretti trawmatiċi jatroġeniċi (ara sezzjoni 4.8).
English: At year 1 in the ranibizumab-treated group in Protocol S, ≥2-step improvement in DRSS was consistent in eyes without DME (39.9%) and with baseline DME (48.8%).
Maltese: Fl-ewwel sena fil-grupp ittrattat b'ranibizumab f'Protocol S, it-titjib ta' ≥2 livelli fid-DRSS kien konsistenti f'għajnejn mingħajr DME (39.9%) u b'DME fil-linja bażi (48.8%).
English: Treatment of visual impairment due to macular oedema secondary to RVO The clinical safety and efficacy of Lucentis in patients with visual impairment due to macular oedema secondary to RVO have been assessed in the randomised, double-masked, controlled studies BRAVO and CRUISE that recruited subjects with BRVO (n=397) and CRVO (n=392), respectively.
Maltese: Kura ta' indeboliment tal-vista minħabba edima makulari sekondarja għal RVO Is-sigurtà u l-effikaċja klinika ta' Lucentis f'pazjenti b'indeboliment tal-vista minħabba edima makulari sekondarja għal RVO ġew ivvalutati fi studji kkontrollati, double-masked, randomizzati BRAVO u CRUISE li ingaġġaw pazjenti b'BRVO (n=397) u b'CRVO (n=392), rispettivament.
English: 1x 0.23 ml vial
Maltese: Kunjett ta' 0.23 ml x1
English: In the 405 DRSS gradable patients with moderate NPDR or better, a ≥2-step DRSS improvement was observed in 1.4% and 0.9% of the ranibizumab and laser groups, respectively.
Maltese: Fl-405 pazjenti gradabbli ta' DRSS b'NPDR moderata jew aħjar, ġie osservat titjib fid-DRSS ta' ≥2 stadji f'1.4% u 0.9% tal-gruppi ta' ranibizumab u lejżer, rispettivament.
English: The long-term (24 months) clinical safety and efficacy of Lucentis in patients with visual impairment due to macular oedema secondary to RVO were assessed in the BRIGHTER (BRVO) and CRYSTAL (CRVO) studies.
Maltese: Is-sigurtà u l-effikaċja klinika fit-tul (24 xahar) ta' Lucentis f'pazjenti b'indeboliment tal-vista minħabba edima makulari sekondarja għal RVO kienu evalwati fl-istudji BRIGHTER (BRVO) u CRYSTAL (CRVO).
English: - Store in a refrigerator (2°C - 8°C).
Maltese: - Aħżen fi friġġ (2C - 8C).
English: The mean average change in BCVA from Month 1 to Month 12 compared to baseline was +7.8 (±7.72) letters in the pooled ranibizumab-treated patients (n=102), compared to -0.1 (±9.77) letters for sham-treated patients; and the mean change in BCVA at Month 12 from baseline was 10.3 (±9.1) letters compared to -1.4 (±14.2) letters, respectively (p<0.0001 for the treatment difference).
Maltese: Ilmedja tal-bidla medja f'BCVA minn Xahar 1 sa Xahar 12 meta mqabbel mal-linja bażi kienet ta' +7.8 (±7.72) ittri fil-pazjenti miġbura kkurati b'ranibizumab (n=102) meta mqabbel ma' -0.1 (±9.77) ittri għal pazjenti fuq kura falza; u l-bidla medja fil-BCVA f'Xahar 12 mil-linja bażi kienet ta' 10.3 (±9.1) ittri mqabbel ma' 1.4 (±14.2) ittri, b'mod rispettiv (p<0.0001 għad-differenza fil-kura).
English: TE ranibizumab 0.5 mg alone n=125
Maltese: Ranibizumab 0.5 mg TE waħdu n=125
English: • Group III (vPDT - patients were allowed to receive ranibizumab treatment as of Month 3).
Maltese: • Grupp III (vPDT - il-pazjenti tħallew jingħataw trattament b'ranibizumab mit-3 Xahar).
English: Proportion of patients who gained: ≥15 letters, or reached ≥84 letters in BCVA 53.3%
Maltese: Proporzjoni ta' pazjenti li kisbu: ≥15-il ittra, jew laħqu ≥84 ittra fil-BCVA 53.3%
English: Unfavourable structural outcomes were less frequently reported for ranibizumab 0.2 mg (1 patient, 1.4%) compared with laser therapy (7 patients, 10.1%).
Maltese: Ir-riżultati strutturali mhux favorevoli kienu rrappurtati b'anqas frekwenza għal ranibizumab 0.2 mg (pazjent 1, 1.4%) imqabbel mat-terapija bil-lejżer (7 pazjenti, 10.
English: - The other ingredients are α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.
Maltese: - Is-sustanzi l-oħra huma α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; ilma għall-injezzjonijiet.
English: Mean change in BCVA at Month 12 (SD)
Maltese: Bidla medja f'BCVA f'Xahar 12 (SD)
English: Treatment success, as measured by the absence of active ROP and absence of unfavourable structural outcomes in both eyes 24 weeks after the first study treatment, was highest with ranibizumab 0.2 mg (80%) compared to laser therapy (66.2%) (see Table 10).
Maltese: Is-suċċess tat-trattament, kif imkejjel bin-nuqqas ta' ROP attiva u n-nuqqas ta' riżultati strutturali mhux favorevoli fl-għajnejn 24 ġimgħa wara l-ewwel studju mit-trattament, kien l-ogħla meta ngħataw ranibizumab 0.2 mg (80%) imqabbel mat-terapija bil-lejżer (66.2%) (ara Tabella 10).
English: Patients were treated with ranibizumab 0.5 mg pro re nata (PRN) in the same eye as the core study (D2301 RESTORE).
Maltese: Il-pazjenti kienu kkurati b'ranibizumab 0.5 mg pro re nata (PRN) fl-istess għajn bħala l-istudju ewlieni (D2301 RESTORE).
English: Retinal pigment epithelial tear
Maltese: Tiċrita fl-epitelju pigmentat tar-retina
English: Luer lock
Maltese: Lokk tat-tip Luer
English: The clinical safety and efficacy of Lucentis 0.2 mg for the treatment of ROP in preterm infants have been assessed based on the 6-month data of the randomised, open-label, 3-arm, parallel-group superiority study H2301 (RAINBOW), which was designed to evaluate ranibizumab 0.2 mg and 0.1 mg given as intravitreal injections in comparison to laser therapy.
Maltese: Trattament ta' ROP fi trabi mwielda qabel iż-żmien Is-sigurtà u l-effikaċja klinika ta' Lucentis 0.2 mg għat-trattament ta' ROP fi trabi mwielda qabel iżżmien ġew evalwati skont data miġbura fuq medda ta' 6 xhur waqt studju ta' superjorità H2301 (RAINBOW) randomizzat, open-label, fost 3 gruppi, bi gruppi paralleli, li tfassal sabiex jevalwa ranibizumab 0.2 mg u 0.1 mg mogħtija bħala injezzjonijiet intravitreali mqabbel ma' terapija billejżer.
English: Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors.
Maltese: Kienu rrappurtati episodji avversi sistemiċi li jinkludu emorraġiji mhux okulari u episodji ta' tromboemboliċi tal-arterji wara injezzjoni intravitreali b'inibituri ta' VEGF.
English: Assemble a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm) onto a 1 ml syringe using aseptic technique.
Maltese: Waħħal labra b'filtru ta' 5 µm (18G x 1½″, 1.2 mm x 40 mm, 5 µm) fuq siringa ta' ml 1.
English: Treatment of PDR
Maltese: Kura tal-PDR
English: When comparing ranibizumab versus sham control at Month 2, a consistent treatment effect both overall and across baseline aetiology subgroups was observed:
Maltese: Meta ranibizumab jitqabbel kontra l-kontroll b'sham fit-2 Xahar, kien osservat effett konsistenti fittrattament kemm b'mod ġenerali u anke fost is-sottogruppi fl-aetijoloġija fil-linja bażi.
English: • Zone II, stage 3+ disease, or
Maltese: • Marda f'żona II, stadju 3+, jew
English: PRN ranibizumab 0.5 mg n=117
Maltese: Ranibizumab 0.5 mg PRN n=117
English: Renal impairment Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Maltese: M'hemmx bżonn li tinbidel id-doża f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: In study FVF2587g (ANCHOR), 423 patients with predominantly classic CNV lesions were randomised in a 1:1:1 ratio to receive Lucentis 0.3 mg monthly, Lucentis 0.5 mg monthly or verteporfin PDT (at baseline and every 3 months thereafter if fluorescein angiography showed persistence or recurrence of vascular leakage).
Maltese: Fi studju FVF2587g (ANCHOR), 423 pazjent bi ġrieħi fil-parti l-kbira CNV klassiċi kienu rrandomizzati skont proporzjon ta' 1:1:1 biex jirċievu Lucentis 0.3 mg kull xahar, Lucentis 0.5 mg kull xahar jew verteporfin PDT (fil-linja bażi u kull 3 xhur minn hemm ‘l quddiem jekk anġjografija bil-fluorescein kienet turi tnixxija vaskulari persistentijew rikurrenti).
English: A total of 191 eyes (48.5%) were randomised to ranibizumab 0.5 mg and 203 eyes (51.5%) eyes were randomised to PRP.
Maltese: Total ta' 191 għajn (48.5%) kienu randomizzati għal ranibizumab 0.5 mg u 203 għajnejn (51.5%) kienu randomizzati għal PRP. Total ta' 88 għajn (22.3%) kellhom DME fil-linja bażi:
English: Ranibizumab 0.5 mg + Laser n=118
Maltese: Ranibizumab 0.5 mg + Lejżer n=118
English: Following monthly intravitreal administration of Lucentis to patients with neovascular AMD, serum concentrations of ranibizumab were generally low, with maximum levels (Cmax) generally below the ranibizumab concentration necessary to inhibit the biological activity of VEGF by 50% (11-27 ng/ml, as assessed in an in vitro cellular proliferation assay).
Maltese: Wara l-għotja ta' Lucentis fil-vitriju darba f'xahar lill-pazjenti b'AMD neovaskulari, ilkonċentrazzjonijiet fis-serum ta' ranibizumab kienu ġeneralment baxxi, b'livelli massimi (Cmax) ġeneralment taħt il-konċentrazzjoni ta' ranibizumab meħtieġa sabiex tiġi impedita l-attività bioloġika ta' VEGF b'50% (11-27 ng/ml kif stmat minn assay in vitro ta' proliferazzjoni ċellulari).
English: A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
Maltese: Rata ta' inċidenza baxxa ta' każijiet tromboemboliċi tal-arterji kienet osservata fil-provi kliniċi ta' Lucentis f'pazjenti b'AMD, DME, PDR, RVO u CNV u ma kien hemm l-ebda differenzi kbar bejn il-gruppi kkurati b'ranibizumab meta mqabbla ma' dawk ikkontrollati.
English: BLISTER FOIL
Maltese: Iċċekkja ssiringa
English: Table 5 Outcomes at Month 12 in study D2301 (RESTORE) and at Month 36 in study D2301-E1 (RESTORE Extension)
Maltese: Riżultati f'Xahar 12 fl-istudju D2301 (RESTORE) u f'Xahar 36 fl-istudju D2301-E1 (Estensjoni RESTORE)
English: Anxiety
Maltese: Injetta
English: In the phase III study D2301 (RESTORE), 345 patients were randomised in a 1:1:1 ratio to receive ranibizumab 0.5 mg monotherapy and sham laser photocoagulation, combined ranibizumab 0.5 mg and laser photocoagulation or sham injection and laser photocoagulation.
Maltese: Fl-istudju ta' fażi III D2301 (RESTORE), 345 pazjent kienu rrandomizzati skont proporzjon ta' 1:1:1 biex jirċievu ranibizumab 0.5 mg bħala monoterapija u fotokoagulazzjoni bil-lejżer sham, ranibizumab 0.5 mg flimkien ma' fotokoagulazzjoni bil-lejżer jew injezzjoni sham u fotokoagulazzjoni bil-lejżer Mitejn u erbgħin pazjent, li qabel kienu temmew l-istudju ta' 12-il xahar RESTORE, kienu rreġistrati fl-istudju ta' estensjoni open-label, b'aktar minn ċentru wieħed ta' 24 xahar (Estensjoni RESTORE).
English: For the adjunctive use of laser photocoagulation and Lucentis in DME and BRVO, see sections 4.2 and 5.1.
Maltese: Għall-użu ta' fotokoagulazzjoni bil-lejżer flimkien ma' Lucentis f'DME u BRVO, ara sezzjonijiet 4.2 u 5
English: Treatment of visual impairment due to CNV (other than secondary to PM and wet AMD) The clinical safety and efficacy of Lucentis in patients with visual impairment due to CNV have been assessed based on the 12-month data of the double-masked, sham-controlled pivotal study G2301 (MINERVA).
Maltese: Is-sigurtà u l-effikaċja klinika ta' Lucentis f'pazjenti b'indeboliment tal-vista minħabba CNV ġew evalwati skont dejta miksuba tul 12-il xahar waqt studju pivotali kkontrollat bix-sham, double-masked G2301 (MINERVA).
English: Treatment of visual impairment due to CNV secondary to PM The clinical safety and efficacy of Lucentis in patients with visual impairment due to CNV in PM have been assessed based on the 12-month data of the double-masked, controlled pivotal study F2301 (RADIANCE).
Maltese: Is-sigurtà u l-effikaċja klinika ta' Lucentis f'pazjenti b'indeboliment tal-vista minħabba CNV għallPM ġew evalwati skont dejta miksuba tul 12-il xahar waqt studju pivotali kkontrollat, double-masked F2301 (RADIANCE).
English: In wet AMD, in CNV, in PDR and in visual impairment due to DME or to macular oedema secondary to RVO the recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.
Maltese: F'AMD mxarrba, f'CNV, f'PDR u f'indeboliment tal-vista minħabba DME jew edima makulari sekondarja għal RVO id-doża rrakkomandata ta' Lucentis hija 0.5 mg mogħtija bħala injezzjoni singola ġol-vitriju.
English: Please see section 4 (“Possible side effects”) for more detailed information on side effects that could occur during Lucentis therapy.
Maltese: Jekk jogħġbok ara sezzjoni 4 (“Effetti sekondarji possibbli”) għal tagħrif iddetaljat dwar l-effetti sekondarji li jistgħu jseħħu waqt it-terapija b'Lucentis.
English: Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects.
Maltese: L-għotja bilaterali ġol-vitriju ta' ranibizumab lix-xadini cynomolgus b'dożi bejn 0.25 mg/għajn u 2.0 mg/għajn darba kull 2 ġimgħat għal mhux aktar minn 26 ġimgħa kkawżat effetti fl-għajnejn li kienu jiddependu mid-doża.
English: Less frequently reported, but more serious, adverse reactions include endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4).
Maltese: Reazzjonijiet avversi li ġew irrappurtati b'mod anqas frekwenti, iżda li kienu aktar serji, jinkludu endoftalmite, telf tad-dawl, qlugħ tar-retina, tiċrita fir-retina u katarretta trawmatika jatroġenika (ara sezzjoni 4.4).
English: DRSS was also assessed in three separate active-controlled phase III DME studies (ranibizumab 0.5 mg PRN vs laser) that included a total of 875 patients, of whom approximately 75% were of Asian origin.
Maltese: III kkontrollati b'mod attiv (ranibizumab 0.5 mg PRN vs lejżer) li inkludew total ta' 875 pazjent, li madwar 75% minnhom kienu ta' oriġini Asjatika.
English: Lucentis 10 mg/ml solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Lucentis 10 mg/ml soluzzjoni għall-injezzjoni
English: Post-inflammatory retinochoroidopathy 6.5 Central serous chorioretinopathy Idiopathic chorioretinopathy Miscellaneous aetiologies a a encompasses different aetiologies of low frequency of occurrence not included in the other subgroups
Maltese: Retinokorojdopatija postinfjammatorja Korijoretinopatija seroża ċentrali Korijoretinopatija idjopatika Aetijoloġiji mħallta a a tinkludi aetijoloġiji differenti li jseħħu bi frekwenza baxxa mhux inklużi f'sottogruppi oħrajn
English: * Starting at Month 6 ranibizumab 0.5 mg treatment was allowed (24 patients were treated with laser only).
Maltese: * Imniedi fis-6 Xahar bi trattament ta' 0.5 mg ranibizumab permissibbli (24 pazjent kienu ttrattati b'lejżer biss).
English: In adults transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis.
Maltese: Fl-adulti żiediet temporanji fil-pressjoni ta' ġo l-għajn (IOP) dehru fi żmien 60 minuta minn meta tkun ingħatat injezzjoni b'Lucentis.
English: In this study 178 adult patients were randomised in a 2:1 ratio to receive:
Maltese: F'dan l-istudju 178 pazjent adult kienu randomizzati fil-proporzjon ta' 2:1 biex jingħataw:
English: An analysis of year 2 data from Protocol S demonstrated that 42.3% (n=80) of eyes in the ranibizumab-treated group had ≥2-step improvement in DRSS from baseline compared with 23.1% (n=46) of eyes in the PRP group.
Maltese: Analżi tad-data tat-tieni sena minn Protocol S uriet li 42.3% (n=80) tal-għajnejn fil-grupp ittrattat b' ranibizumab kien hemm titjib ta' ≥2 livelli fid-DRSS mil-linja bażi mqabbel mat-23.1% (n=46) talgħajnejn fil-grupp b'PRP.
English: Assemble a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm) onto a 1 ml syringe using aseptic technique.
Maltese: Waħħal labra b'filtru ta' 5 µm (18G x 1½″, 1.2 mm x 40 mm) fuq siringa ta' ml 1.
English: There is limited experience in patients older than 75 years with DME.
Maltese: Hemm esperjenza limitata f'pazjenti b'DME li għandhom aktar minn 75 sena.
English: • ranibizumab 0.5 mg at baseline, followed by an individualised dosing regimen driven by disease activity as assessed by visual acuity and/or anatomical parameters (e.g. VA impairment, intra/sub-retinal fluid, haemorrhage or leakage);
Maltese: • ranibizumab 0.5 mg fil-linja bażi, segwiti b'reġim ta' trattament individwalizzat skont l-attività tal-marda kif ġie evalwat bl-akutezza tal-vista' u/ jew parametri anatomiċi (eżempju indeboliment VA, intr- jew sottoretinali, emorraġiji jew tnixxija;
English: Lucentis and laser photocoagulation in DME and macular oedema secondary to BRVO There is some experience of Lucentis administered concomitantly with laser photocoagulation.
Maltese: Lucentis u fotokoagulazzjoni bil-lejżer f'DME u edima makulari sekondarja għal BRVO Hemm ftit tal-esperjenza dwar l-għoti ta' Lucentis flimkien ma' fotokoagulazzjoni bil-lejżer.
English: Check syringe 3.
Maltese: Ipprepara 1.
English: However, subjects with a baseline BCVA >73 letters and macular oedema with central retinal thickness <300 µm did not appear to benefit from treatment with ranibizumab compared to laser photocoagulation.
Maltese: Madankollu, individwi b'BCVA fil-linja bażi >73 ittra u edima makulari bi ħxuna ċentrali tar-retina <300 µm ma deherx li bbenefikaw minn kura b'ranibizumab meta mqabbel ma' fotokoagulazzjoni bil-lejżer.
English: For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis in wet AMD and PM, see section 5.1.
Maltese: Għall-użu ta' terapija fotodinamika b'verteporfin (PDT) flimkien ma' Lucentis f'AMD mxarrba u f'PM, ara sezzjoni 5
English: In Group II, which is the recommended posology (see section 4.2), 50.9% of patients required 1 or 2 injections, 34.5% required 3 to 5 injections and 14.7% required 6 to 12 injections over the 12-month study period.
Maltese: Fi Grupp II, li hu l-pożoloġija rrakkomandata (ara sezzjoni 4.2), 50.9% tal-pazjenti kellhom bżonn injezzjoni waħda jew tnejn, 34.5% kellhom bżonn bejn 3 u 4 injezzjonijiet u 14.7% kellhom bżonn bejn 6 u 12-il injezzjoni tul il-perjodu ta' studju ta' 12-il xahar. 62.9% tal-pazjenti fi Grupp II ma kellhomx bżonn injezzjonijiet fit-tieni 6 xhur tal-istudju.