FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical safety and efficacy of Lucentis in patients with PDR have been assessed in Protocol S which evaluated the treatment with ranibizumab 0.5 mg intravitreal injections compared with panretinal photocoagulation (PRP).
Maltese: Is-sigurtà u l-effikaċja klinika ta' Lucentis f'pazjenti b'PDR kienu evalwati bi Protocol S li evalwa ttrattament b'ranibizumab 0.5 mg permezz ta' injezzjonijiet fil-vitriju mqabbel ma' fotokoagulazzjoni panretinali (PRP).
English: ≥2-step improvement n (%)
Maltese: aggravazzjoni b'≥2 livelli n (%)
English: In patients with PM, there are limited data on the effect of Lucentis in patients who have previously undergone unsuccessful verteporfin photodynamic therapy (vPDT) treatment.
Maltese: Fost pazjenti b'PM, hemm dejta limitata dwar l-effett ta' Lucentis f'pazjenti li fl-imgħoddi ngħataw bla suċċess kura ta' terapija fotodinamika b'verteporfin (vPDT).
English: One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Maltese: Kunjett wieħed (ħġieġ tip I) b'tapp (lasktu chlorobutyl) li fih 0.23 ml ta' soluzzjoni sterili.
English: Upon monthly intravitreal administration of Lucentis 0.5 mg/eye, serum ranibizumab Cmax, attained approximately 1 day after dosing, is predicted to generally range between 0.79 and 2.90 ng/ml, and Cmin is predicted to generally range between 0.07 and 0.49 ng/ml.
Maltese: Wara l-għotja fil-vitriju ta' Lucentis 0.5 mg/għajn darba f'xahar, is-Cmax ta' ranibizumab, li jinkiseb madwar jum 1 wara d-doża, huwa mbassar li jkun ġeneralment fil-medda ta' bejn 0.79 u 0.49 ng/m, u Cmin huwa mbassar li jvarja ġeneralment bejn 0.07 u 0.49 ng/ml.
English: Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A).
Maltese: Lucentis jagħraf u jintrabat b'mod selettiv mal-proteina msejħa fattur A ta' tkabbir tal-endotelju vaskulari tal-bniedem (VEGF-A) misjuba fl-għajn.
English: This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes).
Maltese: Dan jidher f'mard bħala deġenerazjoni makulari minħabba l-età (AMD) u retinopatija dijabetika proliferattiva (PDR, marda kkawżata mid-dijabete).
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' immaġini (eż. tomografija ta' koerenza ottika jew anġjografija bi fluorescein).
English: Proportion of patients who gained: ≥15 letters, or reached ≥84 letters in BCVA 38.1% Month 12
Maltese: Proporzjoni ta' pazjenti li kisbu: ≥15-il ittra, jew laħqu ≥84 ittra fil-BCVA 38.1% Xahar 12
English: *Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Maltese: *Ranibizumab huwa framment ta' antikorp monoklonali mgħamul għal bniedem f''ċelluli ta' Escherichia coli bit-teknoloġija ta' DNA rikombinat.
English: Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper and one blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents.
Maltese: Pakkett li fih kunjett wieħed tal-ħġieġ b'ranibizumab b'tapp tal-lastku chlorobutyl u labra waħda spuntata b'filtru (18G x 1½″, 1.2 mm x 40 mm, 5 mikrometri) sabiex jinġibed il-kontenut mill-kunjett.
English: Based on analysis of population pharmacokinetics and disappearance of ranibizumab from serum for patients with neovascular AMD treated with the 0.5 mg dose, the average vitreous elimination half-life of ranibizumab is approximately 9 days.
Maltese: Minn analiżi tal-farmakokinetiċi tal-popolazzjoni u l-għejbien ta' ranibizumab mis-serum għal pazjenti b'AMD neovaskulari kkurati bid-doża ta' 0.5 mg, il-medja tal-half-life tal-eliminazzjoni ta' ranibizumab fil-vitriju hija madwar 9 ijiem.
English: TE ranibizumab 0.5 mg + laser n=117
Maltese: Ranibizumab 0.5 mg + lejżer TE n=117
English: The recommended dose for Lucentis in preterm infants is 0.2 mg given as an intravitreal injection.
Maltese: Id-doża rrakkomandata ta' Lucentis fit-trabi mwielda qabel iż-żmien hi ta' 0.2 mg mogħtija bħala injezzjoni intravitreali.
English: Mean change in visual acuity (letters) (SD)
Maltese: Xahar (ittri) (SD)
English: Prior to launch in each Member State the MAH shall agree the final educational material with the National Competent Authority.
Maltese: Qabel it-tnedija f'kull Stat Membru l-MAH għandu jaqbel dwar il-materjal edukattiv aħħari malAwtorità Kompetenti Nazzjonali.
English: The nature and timing of the posterior segment inflammation is suggestive of an immune-mediated antibody response, which may be clinically irrelevant.
Maltese: In-natura u l-ħin meta ħarġet l-infjammazzjoni fis-segment posterjuri tindika rispons ta' antikorp medjat bis-sistema immuni, li jista' jkun kilinikament irrilevanti.
English: Serum and vitreous antibodies to ranibizumab were found in a subset of treated animals.
Maltese: Antikorpi fis-serum u fil-vitriju għal ranibizumab instabu f'subset ta' annimali trattati.
English: Please also refer to section 3 “How Lucentis is given”.
Maltese: Jekk jogħġbok irreferi wkoll għal sezzjoni 3 “Kif għandu jingħata Lucentis”.
English: The estimated difference between ranibizumab and laser was 29.9% (95% CI: [20.0, 39.7]).
Maltese: Id-differenza stmata bejn ranibizumab u l-lejżer kienet ta' 29.9% (95% CI: [20
English: • Group I (ranibizumab 0.5 mg, dosing regimen driven by “stability” criteria defined as no change in BCVA compared to two preceding monthly evaluations).
Maltese: • Grupp I (ranibizumab 0.5 mg, reġim tad-doża mfassal skont il-kriterji ta' “stabbiltà” definiti bħala ebda bidla fil-BCVA mqabbel maż-żewġ evalwazzjonijiet fix-xahar li saru qabel).
English: Each ml contains 10 mg ranibizumab.
Maltese: Kull ml fih 10 mg ranibizumab.
English: Vial + filter needle pack
Maltese: Pakkett b'kunjett + labra b'filtru
English: PRE-FILLED SYRINGE
Maltese: Fl-istudju pivotali
English: Lucentis 10 mg/ml solution for injection ranibizumab
Maltese: Lucentis 10 mg/ml soluzzjoni għall-injezzjoni ranibizumab
English: Table 4 Treatment effect overall and across baseline aetiology subgroups
Maltese: Tabella 4 L-effett ġenerali b'mod ġenerali u fis-sottogruppi fl-aetijoloġija fil-linja bażi
English: The long-term safety profile of ranibizumab observed in the 24-month studies is consistent with the known Lucentis safety profile.
Maltese: Il-profil tas-sigurtà fit-tul ta' ranibizumab osservat fl-istudju ta' estensjoni ta' 24 xahar huwa konsistenti mal-profil tas-sigurtà magħruf ta' Lucentis.
English: Table 9 Outcomes at Months 6 and 24 (BRIGHTER and CRYSTAL)
Maltese: Xahar (BRIGHTER u CRYSTAL)
English: ≥3-step worsening n (%)
Maltese: aggravazzjoni bi ≥3 livelli n (%)
English: Sustained IOP increases have also been identified (see section 4.8).
Maltese: Żidiet sostenibbli fl-IOP dehru wkoll (ara sezzjoni 4.8).
English: During the 24 weeks of the study, fewer patients in the ranibizumab 0.2 mg group switched to another treatment modality due to lack of response compared with the laser group (14.9% vs. 24.3%).
Maltese: Matul l-24 ġimgħa tal-istudju, anqas pazjenti fil-grupp mogħti ranibizumab 0.2 mg għaddew għal modalità oħra ta' trattament minħabba n-nuqqas ta' rispons imqabbel mal-grupp mogħti trattament billejżer (14.9% vs. 24.3%).
English: Additionally, change in diabetic retinopathy (DR) severity was assessed based on fundus photographs using the DR severity score (DRSS).
Maltese: Barra minn hekk, it-tibdil fil-gravità tar-retinopatija dijabetika (DR) kien evalwat skont ritratti tal-parti fonda tal-għajn billi ntuża l-punteġġ tal-gravità tad-DR (DRSS).
English: Each vial contains 2.3 mg ranibizumab in 0.23 ml solution.
Maltese: Kull kunjett fih 2.3 mg ranibizumab f'soluzzjoni ta' 0.23 ml.
English: • Group II (ranibizumab 0.5 mg, dosing regimen driven by “disease activity” criteria defined as vision impairment attributable to intra- or subretinal fluid or active leakage due to the CNV
Maltese: • Grupp II (ranibizumab 0.5 mg, reġim tad-doża mfassal skont il-kriterji ta' “attività tal-marda”
English: In a meta-analysis of these studies, 48.4% of the 315 patients with gradable DRSS scores in the subgroup of patients with moderately severe non-proliferative DR (NPDR) or worse at baseline experienced a ≥2-step improvement in the DRSS at Month 12 when treated with ranibizumab (n=192) vs 14.6% of patients treated with laser (n=123).
Maltese: F'meta-analiżi ta' dawn l-istudji, 48.4% tat-315-il pazjent b'punteġġi DRSS gradabbli fis-sottogrupp ta' pazjenti b'DR mhux proliferattiva moderatament severa (NPDR) jew agħar fil-linja bażi esperjenzaw titjib ≥2 stadji fid-DRSS wara 12-il Xahar meta kkurati b'ranibizumab (n=192) meta mqabbla ma' 14.6% tal-pazjenti kkurati bil-lejżer (n=123).
English: In this study 277 patients were randomised in a 2:2:1 ratio to the following arms:
Maltese: F'dan l-istudju 277 pazjent kienu randomizzati fil-proporzjon ta' 2:2:1 filgruppi li ġejjin:
English: Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, all of which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, pathologic myopia and CNV or to visual impairment caused by either diabetic macular oedema or macular oedema secondary to RVO in adults and retinopathy of prematurity in preterm infants.
Maltese: Meta VEGF-A jeħel mar-riċetturi tiegħu, ikun hemm proliferazzjoni taċ-ċelluli endotiljali u neovaskularizzazzjoni kif ukoll tnixxija vaskulari, li kollha kemm huma hu maħsub li jikkontribwixxu għall-avvanz tal-forma neovaskulari tad-deġenerazzjoni makulari relatata ma' l-età, mijopija patoloġika u CNV jew ma' indeboliment tal-vista kkawżat jew minn,edima makulari dijabetika jew minn edima makulari sekondarja għal RVO fl-adulti u retinopatija minħabba prematurità fi trabi mwielda qabel iż-żmien.
English: Snap off (do not turn or twist) the syringe cap (see Figure 2).
Maltese: Iftaħ (iddawwarx jew tgħawweġ) l-għatu tas-siringa (ara Figura 2).
English: Vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus.
Maltese: Vitrite, qlugħ tal-vitriju, emorraġija tar-retina, disturbi tal-vista, uġigħ fl-għajn, ħjut fil-vitriju, emorraġija tal-konġunktiva, irritazzjoni fl-għajn, sensazzjoni ta' korpi barranin fl-għajn, żieda fid-dmugħ, blefarite, għajn xotta, iperimja fl-għajn, ħakk fl-għajn.
English: Prior ranibizumab 0.5 mg + laser n=83
Maltese: Ranibizumab 0.5 mg + lejżer minn qabel n=83
English: There are limited data on safety in the treatment of DME, macular oedema due to RVO and CNV secondary to PM patients with prior history of stroke or transient ischaemic attacks.
Maltese: Hemm dejta limitata dwar is-sigurtà fil-kura ta' pazjenti b'DME, b'edima makulari dovuta għal RVO u b'CNV sekondarja għal PM li jkollhom storja medika ta' puplesija jew attakki iskemiċi temporanji fil-passat.
English: CI = confidence interval, M = total number of patients with non-missing value on primary efficacy outcome (including imputed values), n = number of patients with absence of active ROP and absence of unfavourable structural outcome in both eyes 24 weeks after the first study treatment (including imputed values).
Maltese: CI = l-intervall ta' kunfidenza, M = l-għadd totali ta' pazjenti b'valur mhux disponibbli tar-riżultat tal-effikaċja primarja (li jinkludi valuri imputati), n = l-għadd ta' pazjenti b'nuqqas ta' ROP attiva u nuqqas ta' riżultat strutturali mhux favorevoli fl-għajnejn 24 ġimgħa wara l-ewwel studju mittrattament (li jinkludi valuri imputati).
English: • a retinal break;
Maltese: Pazjenti b'indeboliment renali:
English: For the intravitreal injection, a 30G x ½″ sterile injection needle should be used.
Maltese: Għall-injezzjoni intravitreali, għandha tintuża labra sterilizzata tat-tip 30G x ½″.
English: Carefully expel the air along with the excess solution from the syringe and adjust the dose to the 0.05 ml mark on the syringe.
Maltese: B'attenzjoni neħħi l-arja flimkien mas-soluzzjoni żejda u rregola d-doża sal-marka 0.05 ml fuq is-siringa.
English: This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)).
Maltese: Din in-nefħa tista' tiġi mid-dijabete (mara msejħal edima tal-makula minħabba d-dijabete (DME)) jew minn vini retinali mblukkati tar-retina (marda msejħa okklużjoni tal-vina retinali (RVO)).
English: The recommended dose for Lucentis in adults is 0.5 mg given as a single intravitreal injection.
Maltese: Id-doża ta' Lucentis rrakkomandata fl-adulti hija ta' 0.5 mg mogħtija bħala injezzjoni singola ġolvitriju.
English: VIAL
Maltese: FOLJA
English: Gain of ≥15 letters or BCVA ≥84 letters at Month 12 (%)
Maltese: Kisba ta' ≥15 letters jew BCVA ta' ≥84 ittra f'Xahar 12 (%) Għadd medju ta' injezzjonijiet (Xhur 0
English: The safety and efficacy of Lucentis in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Lucentis fit-tfal u l-adolexxenti ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: (letters) (SD) (primary endpoint) Mean change in BCVA at Month 12 (letters) (SD) Gain of ≥15 letters in visual acuity at Month 6
Maltese: (ittri) SD (endpoint primarju) Bidla medja f'BCVA f'Xahar 12 (ittri) SD Kisba ta' ≥15-il ittra flakutezza tal-vista f'Xahar 6
English: For preparation and intravitreal injection the following medical devices for single use are needed: - a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided) - a 1 ml sterile syringe (including a 0.05 ml mark, not included within the Lucentis pack) - an injection needle (30G x ½″; not included within the Lucentis pack)
Maltese: Biex wieħed iħejji ruħu u anke għall-injezzjoni fil-vitriju hemm bżonn tat-tagħmir mediku li ġej u li jista' jintuża darba biss: - labra b'filtru ta' 5 µm (18G x 1½″, 1.2 mm x 40 mm, ipprovduta) - siringa sterili ta' 1 ml (li tinkludi l-marka ta' 0.05 ml, mhux inkluża f'dan il-pakkett ta'
English: Gain of ≥15 letters or BCVA ≥84 letters at Month 36 (%) Mean number of injections (Months 12-35)* p<0.0001 for comparisons of ranibizumab arms vs. laser arm. n in D2301-E1 (RESTORE Extension) is the number of patients with a value at both D2301 (RESTORE) baseline (Month 0) and at the Month 36 visit.
Maltese: n f'D2301-E1 (Estensjoni RESTORE) huwa n-numru ta' pazjenti b'valur kemm fil-linja bażi ta' D2301 (RESTORE) (Xahar 0) kif ukoll fil-vista ta' Xahar 36.
English: Allergic reactions (rash, urticaria, pruritus, erythema)
Maltese: Reazzjonijiet allerġiċi (raxx, urtikarja, ħakk, eritema) Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna
English: This provides a suitable amount to deliver a single dose of 0.02 ml containing 0.2 mg ranibizumab.
Maltese: Dan jipprovdi ammont xieraq sabiex tingħata doża singola ta' 0.02 ml li fiha 0.2 mg ranibizumab.
English: Solution for injection in pre-filled syringe Novartis Pharma GmbH Roonstrasse 25
Maltese: Soluzzjoni għall-injezzjoni siringa mimlija għal-lest Novartis Pharma GmbH
English: Attach needle 7.
Maltese: Kontroll komparattiv sat-3 Xahar.
English: This corresponds to an injection volume of 0.02 ml.
Maltese: Dan jikkorrispondi għal injezzjoni b'volum ta' 0.02 ml.
English: Syringe cap 0.05 ml dose mark Finger grip
Maltese: Linja tad-doża 0.05 ml Manku
English: The most frequently reported ocular adverse reactions following injection of Lucentis are: eye pain, ocular hyperaemia, increased intraocular pressure, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye and eye pruritus.
Maltese: L-aktar reazzjonijiet avversi okulari li ġew irrappurtati b'mod frekwenti wara injezzjoni ta' Lucentis huma: uġigħ fl-għajn, iperimja okulari, żieda fil-pressjoni ta' ġol-għajn, vitrite, qlugħ tal-vitriju, emorraġija mir-retina, disturb fil-vista, ħjut fil-vitriju, emorraġija mill-konġuntiva, irritazzjoni flgħajn, sensazzjoni ta' korpi barranin fl-għajn, żieda fid-dmugħ, blefarite, għajn xotta u ħakk fl-għajn.
English: Breast-feeding is not recommended during the use of Lucentis.
Maltese: Kellem lit-tabib tiegħek qabel ma inti tingħata Lucentis.
English: In adults 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 fuq wara tal-limbus filkavità vitreali, filwaqt li tevita l-meridjan orizzjontali u tersaq lejn iċ-ċentru tal-globu.
English: The pre-filled syringe is sterile.
Maltese: Il-komponenti kollha huma sterili.
English: Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis.
Maltese: Żiediet temporanji fil-pressjoni ta' ġo l-għajn (IOP) dehru fi żmien 60 minuta minn meta tkun ingħatat injezzjoni b'Lucentis.
English: Patients randomised to vPDT were allowed to receive ranibizumab treatment as of Month 3 (in Group III, 38 patients received ranibizumab as of Month 3)
Maltese: Pazjenti randomizzati għall-vPDT tħallew jirċievu trattament b'ranibizumab sa mit-3 Xahar (fi Grupp III, 38 pazjent irċevew ranibizumab sa mit-3 Xahar)
English: When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation.
Maltese: Meta jingħataw fl-istess ġurnata, Lucentis għandu jingħata għall-anqas 30 minuta wara l-fotokoagulazzjoni bil-lejżer.
English: Do not use the product if the packaging is damaged.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab.
Maltese: Dan jipprovdi ammont xieraq sabiex tingħata doża singola ta' 0.05 ml li fiha 0.5 mg ranibizumab.
English: Lucentis 10 mg/ml solution for injection in pre-filled syringe ranibizumab
Maltese: Lucentis 10 mg/ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest ranibizumab
English: Non-ocular adverse reactions reported in more than one patient treated with ranibizumab 0.2 mg were nasopharyngitis, anaemia, cough, urinary tract infection and allergic reactions.
Maltese: Ir-reazzjonijiet avversi mhux okulari rrappurtati f'aktar minn pazjent wieħed ittrattati b'ranibizumab 0.2 mg kienu nażofariniġite, anemija, sogħla, infezzjoni fil-passaġġ tal-awrina u reazzjonijiet allerġiċi.
English: A PK/PD analysis showed no clear relationship between systemic ranibizumab concentrations and systemic VEGF concentrations.
Maltese: Analiżi PK/PD ma wrietx relazzjoni ċara bejn il-konċentrazzjonijiet sistemiċi ta' ranibizumab u lkonċentrazzjonijiet sistemiċi ta' VEGF.
English: On TE, ranibizumab was administered at treatment intervals of 2-3 months.
Maltese: Fuq TE, ranibizumab ingħata bħala trattament f'intervalli ta' 2-3 xhur.
English: 0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter.
Maltese: Soluzzjoni sterili ta' 0.165 ml f'siringa mimlija għal-lest (ħġieġ tat-tip I) bl-istoper tal-planġer magħmul mil-lastku bromobutyl u t-tokka tas-siringa li fiha siġill iebes abjad li jindika jekk ġietx imbgħabsa jew le bil-wiċċ tal-għatu tal-lastku bromobutyl li fih adattur tat-tip Luerli jillokkja.
English: Outcome measure at Month 36 compared to D2301 (RESTORE) baseline in study D2301-E1 (RESTORE Extension)
Maltese: Kejl tar-riżultat f'Xahar 36 imqabbel ma' D2301 (RESTORE) fil-linja bażi fl-istudju D2301-E1 (Estensjoni RESTORE)
English: Elderly (age 65 years and over)
Maltese: Pazjenti akbar fl-età (minn 65 sena 'l fuq)
English: Patients with renal impairment: No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with renal impairment.
Maltese: Ma sarux studji formali sabiex jiġu eżaminati l-farmakokinetiċi ta' Lucentis f'pazjenti b'indeboliment renali.
English: Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Id-dejta disponibbli dwar pazjenti adolexxenti li għandhom bejn 12 u 17-il sena b'indeboliment tal-vista minħabba CNV tinsab deskritta fis-sezzjoni 5.1 imma ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: In study FVF3192g (PIER), 184 patients with all forms of neovascular AMD were randomised in a 1:1:1 ratio to receive Lucentis 0.3 mg, Lucentis 0.5 mg or sham injections once a month for 3 consecutive doses, followed by a dose administered once every 3 months.
Maltese: Fi studju FVF3192g (PIER), 184 pazjent bil-forom kollha ta' AMD neovaskulari kienu rrandomizzati skont proporzjon ta' 1:1:1 biex jingħataw Lucentis 0.3 mg, Lucentis 0.5 mg, jew injezzjonijiet foloz darba fix-xahar għal tliet dożi wara xulxin, segwit b'doża kull 3 xhur.
English: Withholding Lucentis in adults
Maltese: Kif tipprepara u tagħti Lucentis lill-adulti
English: In CRYSTAL, patients with ischaemia present (N=53) or absent (N=300) and treated with ranibizumab monotherapy had a mean change from baseline of +15.0 and +11.5 letters, respectively.
Maltese: Waqt CRYSTAL, il-pazjenti b'iskemija (N=53) jew mingħajrha (N=300) u ttrattati b'monoterapija b'ranibizumab kellhom bidla fil-medja mil-linja bażi ta' +15.0
English: Figure 5 Mean change from baseline BCVA over time to Month 6 and Month 12 (BRAVO)
Maltese: Il-bidla medja minn BCVA tal-linja bażi maż-żmien sa Xahar 6 u Xahar 12 (BRAVO)
English: CSFT - central retinal subfield thickness
Maltese: Kif jidher Lucentis u l-kontenut tal-pakkett
English: Rhegmatogenous retinal detachment or macular holes
Maltese: Is-siringa mimlija għal-lest hi sterilizzata.
English: • ranibizumab 0.5 mg monotherapy on a TE regimen,
Maltese: • monoterapija ta' ranibizumab 0.5 mg fuq kors ta' TE,
English: Angioid streaks
Maltese: Strixxi anġijojdi
English: However, there was no consistent pattern among the different haemorrhages.
Maltese: Madankollu, ma kienx hemm mudell konsistenti fost l-emorraġiji differenti.
English: Lucentis has not been studied in patients with hepatic impairment.
Maltese: Lucentis ma ġiex studjat f'pazjenti b'indeboliment tal-fwied.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lucentis in all subsets of the paediatric population in neovascular AMD, visual impairment due to DME, visual impairment due to macular oedema secondary to RVO, visual impairment due to CNV and diabetic retinopathy (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Lucentis f'kull sett tal-popolazzjoni pedjatrika f'AMD neovaskulari, fl-indeboliment tal-vista minħabba DME, indeboliment tal-vista minħabba edima makulari sekondarja għal RVO, indeboliment tal-vista sekonarja għal PM u retinopatija dijabetika (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Single dose for babies born prematurely: 0.2 mg/0.02 ml.
Maltese: Doża singola għal trabi mwielda qabel iż-żmien: 0.2 mg/0.
English: For preparation and intravitreal injection the following medical devices for single use are needed: - a 5 µm filter needle (18G); not included within the Lucentis pack - a low volume high accuracy sterile syringe (supplied separately inside the VISISURE kit) - an injection needle (30G x ½″); (supplied separately inside the VISISURE kit)
Maltese: VISISURE) - labra għall-injezzjoni (30G x ½″); (ipprovduta separatament fuq ġewwa tal-kit VISISURE)
English: ≥3-step improvement n (%)
Maltese: titjib b ≥3 livelli n (%)