qanastek/EMEA-V3 huggingface dataset:
Other serious ocular events observed among Lucentis-treated patients included intraocular inflammation and increased intraocular pressure (see section 4.4).
4 Effetti oħra serji fl- għajn li dehru f’ pazjenti fuq Lucentis kienu jinkludu infjammazzjoni ta ’ ġo l- għajn u żieda fil- pressjoni ta ’ ġo l- għajn (ara sezzjoni 4. 4).
The adverse events listed below occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with Lucentis 0.5 mg than in those receiving control treatment (sham or verteporfin PDT) in the three controlled phase III studies FVF2598g (MARINA), FVF2587g
L- effetti avversi elenkati hawn taħt seħħew b’ rata ogħla (mill- anqas 2 punti perċentwali) f’ pazjenti li kienu qed jirċievu kura b’ Lucentis 0. 5 mg minn dawk li kienu qed jirċievu kura bil- kontroll (sham jew verteporfin PDT) fit- tliet studji ta ’ fażi III bil- kontroll FVF2598g (MARINA), FVF2587g (ANCHOR) u FVF3192g (PIER).
These were therefore considered potential adverse drug reactions.
Għaldaqstant dawn kienu meqjusa bħala reazzjonijiet avversi ta ’ potenzjal għal mediċina.
The safety data described below also include all adverse events (in at least 0.5 percentage points of patients) suspected to be at least potentially related to the injection procedure or medicinal product in the 440 patients of the combined 0.5 mg treatment groups.
It- tgħarif dwar is- sigurtà deskritt hawn taħt jinkludi wkoll l- effetti avversi kollha (f’ mill - inqas 0. 5 punti ta ’ perċentwal ta ’ pazjenti) li hemm suspett li jistgħu jkunu għalmenu potenzjalment relatati mal- proċedura ta ’ l- injezzjoni jew mal- prodott mediċinali fl- 440 pazjent tal- gruppi tal- kura b’ 0. 5 mg kombinati.
The adverse events are listed by system organ class and frequency using the following convention: 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), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
L- effetti avversi huma elenkati skond il- klassi ta ’ l- organu tas- sistema u l- frekwenza billi intużat il - konvenzjoni li ġejja: komuni ħafna (≥1/ 10), komuni (≥1/ 100 to < 1/ 10), mhux komuni (≥1/ 1, 000 to < 1/ 100), rari (≥1/ 10, 000 to < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistgħax jiġi stmat mit- tagħrif disponibbli).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu f’ ordni skond is- serjetà tagħhom.
Investigations Very common
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
Intraocular pressure increased
Investigazzjonijiet Komuni ħafna
Blood and lymphatic system disorders
Żieda fil- pressjoni ta ’ ġo l- għajn
Nervous system disorders
Disturbi tad- demm u tas- sistema limfatika Anemija Komuni
Eye disorders Very common
Disturbi fis- sistema nervuża Uġigħ ta ’ ras Komuni ħafna
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.
Disturbi fl- għajnejn Vitrite, qlugħ tal- vitriju, emorraġija tar- retina, disturbi tal- vista, Komuni ħafna uġigħ fl- għajn, ħjut fil- vitriju, emorraġija tal- konġunktiva, irritazzjoni fl- għajn, sensazzjoni li daħlet xi ħaġa fl- għajnejn, żieda fid- dmugħ, blefarite, għajn xotta, iperimja fl- għajn, ħakk fl- għajn.
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.
Deġenerazzjoni tar- retina, disturbi fir- retina, qlugħ tar- retina, tiċrit Komuni tar- retina, qlugħ ta ’ l- epitilju pigmentat tar- retina, tiċrit ta ’ l- epitilju 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 ta ’ l- injezzjoni, emorraġija ta ’ l- għajn, konġunktivite, konġunktivite allerġika, taħmiġ ta’ l- għajn, fotopsja, fotofobja, skomfort fl- għajn, edima ta ’ tebqet l- għajn, uġigħ ta ’ tebqet l- għajn, iperimja fil- konġunktiva.
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.
Telf tad- dawl, endoftalmite, hypopyon, hyphaema, keratopatija, Mhux komuni adeżjoni ta ’ l- iris, depożiti fil- korneja, edima tal- korneja, striae fil - korneja, uġigħ fis- sit ta ’ l- injezzjoni, irritazzjoni fis- sit ta ’ l - injezzjoni, sensazzjoni mhux normali fl- għajn, irritazzjoni ta ’ tebqet l- għajn.
Respiratory, thoracic and mediastinal disorders Common
Disturbi respiratorji, toraċiċi u medjastinali Sogħla Komuni
Gastrointestinal disorders
Disturbi gastro- intestinali Tqalligħ Komuni
Hypersensitivity 5
5 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Reazzjonijiet allerġiċi (raxx, urtikarja, ħakk, eritema) Komuni
Common
Disturbi fis- sistema immuni Sensittività eċċessiva Komuni
Anxiety
Disturbi psikjatriċi Ansjetà Komuni
Product-class-related adverse reactions:
Reazzjonijiet avversi relatati mal- prodott u l- klassi:
In the phase III studies, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in ranibizumab-treated patients.
Fl- istudji tal- fażi III, il- frekwenza globali ta ’ emorraġiji mhux okulari, każ avvers li jista ’ jkun li għandu x’ jaqsam mal- impediment ta ’ VEGF (fattur ta ’ tkabbir tal- endotelju vaskulari) sistemiku, żdiedet kemmxejn fil- pazjenti kkurati b’ ranibizumab.
However, there was no consistent pattern among the different haemorrhages.
Madankollu, ma kienx hemm mudell konsistenti fost l- emorraġiji differenti.
There is a theoretical risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Hemm riskju teoretiku ta ’ każijiet tromboemboliċi ta ’ l- arterji wara l- użu ġol- vitriju ta ’ impedituri VEGF.
A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials and there were no major differences between the treatment groups.
Rata ta ’ inċidenza baxxa ta ’ każijiet tromboemboliċi ta ’ l- arterji kienet osservata fil- provi kliniċi ta ’ Lucentis u ma kien hemm l- ebda differenzi kbar bejn il- gruppi ta ’ kura.
Cases of accidental overdose have been reported from the clinical studies and post-marketing data.
Każijiet ta ’ doża eċċessiva mogħtija bi żball kienu rrappurtati minn studji kliniċi u tagħrif ta ’ wara t - tqegħid fis- suq.
Adverse reactions associated with these reported cases were intraocular pressure increased, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain.
Reazzjonijiet avversi assoċjati ma ’ dawn il- każijiet irrappurtati kienu żieda fil - pressjoni ta ’ ġo l- għajn, telf ta ’ dawl għaddieni, tnaqqis fl- akutezza tal- vista, edima fil- kornea, uġigħ fil- kornea u uġigħ fl- għajn.
If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
Jekk tingħata doża eċċessiva, il- pressjoni ta ’ ġo l- għajn għandha tinżamm taħt osservazzjoni u tiġi kkurata, jekk jitqies meħtieġ mit- tabib li jkun hemm.
Antineovascularisation agents, ATC code:
Aġenti kontra neo- vaskularizzazzjoni, Kodiċi ATC:
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A).
Ranizumab huwa framment ta ’ antikorp rikombinat għall- bniedem immirat kontra l- fattur A (VEGF- A) ta ’ tkabbir endotiljali vaskulari tal- bniedem.
It binds with high affinity to the VEGF-A isoforms (e. g.
Teħel b’ affinità kbira ma ’ l- iżoformi VEGF- A (e. ż.
VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
VEGF110, VEGF121 u VEGF165), u b’ hekk ma tħallix VEGF- A jeħel mar- riċetturi tiegħuVEGFR- 1 u VEGFR- 2.
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.
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.
The clinical safety and efficacy of Lucentis have been assessed in three randomised, double-masked, sham- or active-controlled studies in patients with neovascular AMD.
Is- sigurtà klinika u l- effikaċja ta ’ Lucentis kienu evalwati fi tliet studji kontrollati b’ sham jew b’ mod attiv, double masked, randomized f’ pazjenti b’ AMD neovaskulari.
A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Total ta ’ 1, 323 pazjent (879 attivi u 444 kontroll) kienu reklutati f’ dawn l- istudji.
In study FVF2598g (MARINA), patients with minimally classic or occult with no classic choroidal neovascularisation (CNV) received monthly intravitreal injections of Lucentis 0.3 mg or 0.5 mg or sham injections.
Fl- istudju FVF2598g (MARINA), pazjenti bi ġrieħi ta ’ neovaskularizzazzjoni korojdali (CNV) minimament klassika jew okkulta mingħajr komponent klassiku ingħataw injezzjonijiet fil- vitriju ta ’ Lucentis 0. 3 mg jew 0. 5 mg injezzjonijiet sham.
A total of 716 patients were enrolled in this study (sham, 238; Lucentis 0.3 mg, 238; Lucentis 0.5 mg, 240).
Total ta ’ 716 pazjent kienu reklutati f’ dan l- istudju (sham, 238; Lucentis 0. 3 mg, 238; Lucentis 0. 5 mg, 240).
Data are available up to the end of month 24.
Dejta huwa disponibbli sa l- aħħar ta ’ xahar 24.
1) monthly intravitreal injections of Lucentis 0.3 mg and sham PDT; 2) monthly intravitreal injections of Lucentis 0.5 mg and sham PDT; or 3) sham intravitreal injections and active verteporfin PDT.
6 Fi studju FVF2587g (ANCHOR), pazjenti bi ġrieħi fil- parti l- kbira CNV klassiċi rċevew jew 1) kull xahar injezzjonijiet fil- vitriju ta ’ Lucentis 0. 3 mg u sham PDT; 2) kull xahar injezzjonijiet fil- vitriju ta ’ Lucentis 0. 5 mg u sham PDT; jew 3) injezzjonijiet fil- vitriju sham u verteporfin attiv PDT.
Sham or active verteporfin PDT was given with the initial Lucentis injection and every 3 months thereafter if fluorescein angiography showed persistence or recurrence of vascular leakage.
Sham jew verteporfin attiv PDT ingħata ma ’ l- ewwel injezzjoni ta ’ Lucentis u kull 3 xhur minn hemm ‘ l quddiem jekk anġjografija bil- fluorescein kienet turi tnixxija vaskulari persistenti jew rikurrenti.
A total of 423 patients were enrolled in this study (sham, 143; Lucentis 0.3 mg, 140; Lucentis 0.5 mg, 140).
Total ta ’ 423 pazjent kienu reklutati f’ dan l- istudju (sham, 143; Lucentis 0. 3 mg, 140; Lucentis 0. 5 mg, 140).
In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at 12 months compared with baseline.
Fiż- żewġ studji, l- endpoint ta ’ l- effikaċja ewlieni kien il- proporzjon ta ’ pazjenti li żammew il- vista, definit mit- telf ta ’ anqas minn 15- il ittra ta ’ l- akutezza tal- vista mat- 12- il xahar imqabbel mal- linja bażi.
Almost all Lucentis-treated patients (approximately 95%) maintained their visual acuity.
Kważi l- pazjenti kollha kkurati b’ Lucentis (madwar 95%) żammew l- akutezza tal- vista tagħhom.
34-40% of Lucentis- treated patients experienced a clinically significant improvement in vision, defined as gaining 15 or more letters at 12 months.
34- 40% tal- pazjenti kkurati b’ Lucentis kellhom titjib klinikament sinifikanti fil- vista, definit bħala l - kisba ta ’ 15- il ittra jew aktar mat- 12- il xahar.
The size of the lesion did not significantly affect the results.
Id- daqs tal- ġerħa ma effettwatx b’ mod sinifikanti r - riżultati.
In general, patients with poor visual acuity (< 20/ 200) at the onset of treatment experienced a benefit of treatment.
B’ mod ġenerali, pazjenti b’ akutezza tal- vista baxxa (< 20/ 200) fil- bidu tal- kura kellhom benefiċċju mill- kura.
However, neovascular AMD that has evolved into lesions characterised by subretinal fibrosis and
Madankollu, AMD neovaskulari li żviluppat f’ feriti karatterizzati minn fibrożi taħt ir- retina u atrofija ġeografika avvanzata mhux probabbli li turi rispons għal Lucentis.
Detailed results are shown in the tables below.
Riżultati dettaljati jidhru fit- tabelli hawn taħt.
Outcomes at month 12 and month 24 in study FVF2598g (MARINA)
Kisbiet ma ’ xahar 12 u xahar 24 fl- istudju FVF2598g (MARINA)
Lucentis 0.5 mg
Kejl tal- kisba
(n=238)
Xahar Sham (n=238)
(n=240)
Lucentis 0. 5 mg (n=240)
Loss of < 15 letters in visual acuity (%)a (maintenance of vision)
Telf ta ’ < 15 ittri fl- akutezza tal- vista (%) a (żamma tal- vista)
Month 12 Month 24
Xahar 12 Xahar 24
Gain of ≥ 15 letters in visual acuity (%)a
Żieda ta ’ ≥15 ittri fl- akutezza tal- vista (%) a
Mean change in visual acuity (letters) (SD)a a p < 0.01
Bidla medja fl- akutezza talvista (ittri) (SD) a a p < 0. 01
-10.5 (16.6) -14.9 (18.7)
- 10. 5 (16. 6) - 14. 9 (18. 7)
+7.2 (14.4) +6.6 (16.5)
+7. 2 (14. 4) +6. 6 (16. 5)
Outcomes at month 12 and month 24 in study FVF2587g (ANCHOR)
Kisbiet ma ’ xahar 12 u xahar 24 fl- istudju FVF2587g (ANCHOR)
Outcome measure
Kejl tal- kisba
Month
Xahar
Lucentis 0.5 mg (n=140)
Lucentis 0. 5 mg (n=140)
Mean change in visual acuity (letters) (SD)a a p < 0.01
Il- medja tal- bidla fl- akutezza tal- vista (ittri) (SD) a a p < 0. 01
-9.5 (16.4) -9.8 (17.6)
- 9. 5 (16. 4) - 9. 8 (17. 6)
+11.3 (14.6) +10.7 (16.5)
+11. 3 (14. 6) +10. 7 (16. 5)
Mean change in visual acuity from baseline to month 24 in study FVF2598g (MARINA) and study FVF2587g (ANCHOR)
Medja tal- bidla fl- akutezza tal- vista mill- linja bażi sa 24 xahar fl- istudju FVF2598g (MARINA) u fl- istudju FVF2587g (ANCHOR)
Study FVF2598g (MARINA) Mean change in visual acuity ± SE
Medja tal- bidla fl- akutezza tal- vista
15 10 +6.6 5 (letters)
(littri)
0 + 21.5 -5 -10
5 0
-15
Studju FVF2598g (MARINA) +6. 6
-14.9
+ 21. 5 - 5 - 10 - 14. 9 - 15
12 14 16 18 20 22 24 Month
12 14 16 18 20 22 24 Xahar
Study FVF2587g (ANCHOR) 15 Mean change in visual acuity ± SE
Studju FVF2587g (ANCHOR) Medja tal- bidla fl- akutezza tal- vista ±SE
+10.7 10 5 (letters)
15 +10. 7 10 5 +20. 5 0 (littri)
+20.5
- 5 - 9. 8 - 10 - 15
MARINA LUCENTIS 0.5 mg (n=240) Sham (n=238)
MARINA LUCENTIS 0. 5 mg (n=240) Sham (n=238)
ANCHOR LUCENTIS 0.5 mg (n=140) Verteporfin PDT (n=143)
ANCHOR LUCENTIS 0. 5 mg (n=140) Verteporfin PDT (n=143)
Patients in the group treated with Lucentis had minimal observable CNV lesion growth, on average.
Pazjenti fil- grupp ikkurati b’ Lucentis dehrilhom tkabbir fil- ġerħa CNV minimu, bħala medja.
At month 12, the mean change in the total area of the CNV lesion was 0.1-0.3 DA for Lucentis versus 2.3-2.6 DA for the control arms.
Ma ’ xahar 12, il- medja tal- bidla ta ’ l- erja totali tal- ġerħa CNV kien 0. 1- 0. 3 DA għal Lucentis kontra 2. 3- 2. 6 DA għall- fergħat tal- kontroll.
Results from both trials indicated that continued ranibizumab-treatment may also be of benefit in patients who lost ≥ 15 letters of best-corrected visual acuity (BCVA) in the first year of treatment.
Riżultati miż- żewġ provi indikaw li kura b’ ranibizumab li titkompla tista ’ tkun ukoll ta ’ benefiċċju f’ pazjenti li tilfu ≥15- il ittra fl- akutezza tal- vista bl- aħjar mod li tista ’ tkun korretta (BCVA) fl- ewwel sena ta ’ kura.
The use of Lucentis beyond 24 months has not been studied.
L- użu ta ’ Lucentis għal aktar minn 24 xahar ma ġiex studjat.
Study FVF3192g (PIER) was a randomised, double-masked, sham-controlled, two-year study designed to assess the safety and efficacy of Lucentis in patients with neovascular AMD (79% of the patients had minimally classic or occult AMD, 21% had a predominantly classic CNV component).
Studju FVF3192g (PIER) kien randomised, double masked, kontrollat b’ sham, li dam sentejn u mfassal sabiex jevalwa is- sigurtà u l- effikaċja ta ’ Lucentis f’ pazjenti b’ AMD neovaskulari (79% tal - pazjenti kellhom AMD minimament klassiku jew okkult, 21% kellhom komponent CNV li kien fil - parti l- kbira klassiku).
Patients received Lucentis 0.3 mg or 0.5 mg intravitreal injections or sham injections once a month for 3 consecutive doses, followed by a dose administered once every 3 months.
Il- pazjenti irċevew injezzjonijiet ta ’ Lucentis 0. 3 mg jew 0. 5 mg fil- vitreja jew
A total of 184 patients were enrolled in this study (Lucentis 0.3 mg, 60; Lucentis 0.5 mg, 61; sham, 63); 107 (88%) of
Total ta ’ 184 pazjent kienu reklutati f’ dan l- istudju (Lucentis 0. 3 mg, 60; Lucentis 0. 5 mg, 61; sham, 63); 107 (88%) tal- pazjenti kkurati b’ ranibizumab temmew 24 xahar minn dan l- istudju.
From month 14 of the study, sham- treated patients were allowed to cross over to receive ranibizumab and from month 19, more frequent treatments were possible.
Mix- xahar 14 ta ’ l - istudju, pazjenti kkurati sham tħallew jaqilbu għal - ranibizumab u mid- 19- il xahar, kura aktar frekwenti saret possibbli.
Patients treated with Lucentis in PIER received a mean of 10 total treatments out of possible 13 from day 0 to month 24.
Il- pazjenti li kienu kkurati b’ Lucentis f’ PIER irċevew medja ta’ 10 kuri sħaħ mit- 13 possibbli minn jum 0 sa xahar 24.
In PIER, the primary efficacy endpoint was mean change in visual acuity at 12 months compared with baseline.
F’ PIER, l- endpoint ewlieni ta ’ l- effikaċja kien il- medja tal- bidla fl- akutezza tal- vista mat- 12- il xahar imqabbel mal- linja bażi.
After an initial increase in visual acuity (following monthly dosing), on average, patients dosed once every three months with Lucentis lost visual acuity, returning to baseline at month 12.
Wara żieda inizzjali fl- akutezza tal- vista (wara dożaġġi mogħtija darba f’ xahar), bħala medja, il- pazjenti li ngħataw doża waħda ta ’ Lucentis kull tliet xhur tilfu l- akutezza fil - vista, u marru lura għal- linja bażi mat- 12- il xahar.
This effect was essentially maintained at month 24 (see Figure 2).
Dan l- effett kien essenzjalment miżmum fix - xahar 24 (ara Figura 2).
In PIER, most Lucentis-treated patients (82%) maintained their visual acuity at month 24.
F’ PIER il- biċċa l- kbira tal- pazjenti (82%) li ngħataw Lucentis żammew l - akutezza tal- vista tagħhom fl- 24 xahar.
Data from a limited number of subjects that crossed over to receive ranibizumab after more than a year of sham-treatment suggested that early initiation of treatment may be associated with a better preservation of visual acuity than if treatment was initiated when the disease had reached a more advanced stage.
Dejta min- numru limitat ta ’ individwi li qalbu għal - ranibizumab wara aktar minn sena ta ’ kura sham issuġġeriet li kura li tinbeda kmieni tista ’ tkun assoċjata ma ’ l- ppriservar aħjar ta ’ l- akutezza tal- vista milli jekk il- kura inbdiet meta l- marda laħqet stat aktar avvanzat.
Mean change in visual acuity from baseline to month 24 in study FVF3192g (PIER)
Medja tal- bidla fl- akutezza tal- vista mill- linja bażi għall- 24 xahar fl- istudju FVF3192g (PIER)
Mean change from baseline in visual acuity ± SE (letters)
Il- bidla medja mill linja bażi fl- akutezza tal- vista ± SE (Ittri)
Study FVF3192g (PIER)
Studju FVF3192g (PIER)
0 -2.3 -4
0 - 2. 3 - 4
19.1
19. 1 - 12
-20 -21.4 -24
- 20 - 21. 4 - 24 20
LUCENTIS 0.5 mg (n=61)
LUCENTIS 0. 5 mg (n=61)
Data from an open label study (PROTECT) in 32 patients followed for 9 months in which the safety of same-day administration of verteporfin PDT and Lucentis 0.5 mg was evaluated showed that the incidence of intraocular inflammation following the initial treatment was 6.3% (2 of 32 patients).
Tagħrif minn- open label study (PROTECT) f’ 32 pazjent segwiti ghal 9 xhur li fih kienet evalwata s - sigurtà fl- istess jum li ingħataw verteporfin PDT u Lucentis 0. 5 mg wera li l- frekwenza ta ’ infjammazzjoni fl- għajn wara li l- kura fil- bidu kienet 6. 3% (2 minn 32 pazjenti).
In both the MARINA and ANCHOR studies, the improvement in visual acuity seen with Lucentis 0.5 mg at 12 months translated into patient-reported benefits as measured on the three subscales of the National Eye Institute Visual Function Questionnaire (VFQ-25) which were pre-specified secondary efficacy endpoints (near activities, distance activities, and vision-specific dependency).
Fl- istudju MARINA, id- differenzi versus il- kura sham kienu kibru aktar fl -
In study MARINA, the differences versus sham treatment had further increased at 24 months (p < 0.0001 for all three subscales).
9 24 xahar (p < 0. 0001għat- tlitt sottoskali kollha).
In the ANCHOR study, the treatment effect of ranibizumab over verteporfin PDT was essentially maintained for the three VFQ-25 scores after 24 months.
Fl- istudju ANCHOR, l- effet tal- kura b’ ranibizumab fuq verteporfin PDT kien essenzjalment miżmum għat- tliet punteġġi VFQ- 25 wara 24 xahar.
All differences between Lucentis 0.5 mg and the two control groups were statistically significant and clinically meaningful, with p-values ranging from 0.009 to < 0.0001.
Id - differenzi kolha bejn Lucentis 0. 5 mg u ż- żewġ gruppi ta ’ kontroll kienu statistikament sinifikanti u kellhom tifsira klinika, b’ valuri- p li varjaw bejn 0. 009 sa < 0. 0001.
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).
Wara l- għotja ta ’ Lucentis fil- vitriju darba f’ xahar lill- pazjenti b’ AMD neovaskulari, il - konċentrazzjonijiet 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).
Cmax was dose proportional over the dose range of 0.05 to 1.0 mg/ eye.
Cmax kien proporzjonali mad- doża fil- medda tad- doża minn 0. 05 sa 1. 0 mg/ għajn.
Based on analysis of population pharmacokinetics and disappearance of ranibizumab from serum for patients treated with the 0.5 mg dose, the average vitreous elimination half-life of ranibizumab is approximately 9 days.
Minn analiżi tal- farmakokinetiċi tal- popolazzjoni u l- għejbien ta ’ ranibizumab mis- serum għal pazjenti kkurati bid- doża ta ’ 0. 5 mg, il- medja tal- half- life ta ’ l- eliminazzjoni ta ’ ranibizumab fil- vitriju hija madwar 9 ijiem.
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.
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.
Serum ranibizumab concentrations are predicted to be approximately 90,000-fold lower than vitreal ranibizumab concentrations.
Il - konċentrazzjonijiet ta ’ ranibizumab fis- serum huma mbassra li jkunu madwar 90, 000- darba aktar baxxi mill- konċentrazzjonijiet ta ’ ranibizumab fil- vitriju.
No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with renal impairment.
Ma sarux studji formali sabiex jiġu eżaminati l- farmakokinetiċi ta ’ Lucentis f’ pazjenti b’ indeboliment renali.
Sixty-eight percent (136 of 200) of patients in a population pharmacokinetic analysis had renal impairment (46.5% mild [50-80 ml/ min], 20% moderate [30-50 ml/ min], and 1.5% severe [< 30 ml/ min]).
Tmienja u sittin fil- mija (136 minn 200) tal- pazjenti f’ analiżi tal- farmakokinetiċi tal- popolazzjoni kellhom indeboliment renali (46. 5% ħafif [50- 80 ml/ min], 20% moderat [30- 50 ml/ min] u 1. 5% sever [< 30 ml/ min]).
Systemic clearance was slightly lower, but this was not clinically significant.
It- tneħħija sistemika kienet ħarira aktar baxxa, iżda din ma kienetx klinikament sinifikanti.
No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with hepatic impairment.
Ma sarux studji formali sabiex jiġu eżaminati il- farmakokinetiċi ta ’ Lucentis f’ pazjenti b’ indeboliment tal- fwied.
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.
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.
Intraocularly, there were dose-dependent increases in anterior chamber flare and cells with a peak 2 days after injection.
Ġol- għajn, kien hemm żiediet fil- vampa tal- kavità anterjuri u ċ- ċelluli li kienu jiddependu mid- doża, u laħqu l- quċċata jumejn wara ngħatat l- injezzjoni.
The severity of the inflammatory response generally diminished with subsequent injections or during recovery.
Is- severità tar- rispons infjammatorju ġeneralment naqset ma ’ l- injezzjonijiet li ngħataw wara jew waqt l- irkupru.
In the posterior segment, there were vitreal cell infiltration and floaters, which also tended to be dose-dependent and generally persisted to the end of the treatment period.
Fis- segment posterjuri, kien hemm infiltrazzjoni ta ’ ċelluli fil- vitriju u ħjut, li wkoll kellhom tendenza li jkunu jiddependu mid- doża u li ġeneralment baqgħu sa ’ tmiem il- perijodu tal- kura.
In the 26-week study, the severity of the vitreous inflammation increased with the number of injections.
Fl- istudju ta ’ 26- ġimgħa, is- severità ta ’ l - infjammazzjoni fil- vitriju żdiedet man- numru ta ’ injezzjonijiet.
However, evidence of reversibility was observed after recovery.
Madankollu, kien hemm evidenza li dawn kienu riversibbli wara l- irkupru.
The nature and timing of the posterior segment inflammation is suggestive of an immune-mediated antibody response, which may be clinically irrelevant.
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.
Cataract formation was observed in some animals after a relatively long period of intense inflammation, suggesting that the lens changes were secondary to severe inflammation.
Il- formazzjoni ta ’ katarretti dehret f’ xi annimali wara perijodi relattivament twal ta ’ infjammazzjoni qawwija, li tindika li bidliet fil- lenti kienu sekondarji għall- infjammazzjoni severa.
A transient increase in post-dose intraocular pressure was observed following intravitreal injections, irrespective of dose.
Żieda mumentanja fil- pressjoni ta ’ ġol- għajn wara li ngħatat id- doża seħħet wara injezzjonijiet ġol- vitriju, irrispettivament mid- doża.
Microscopic ocular changes were related to inflammation and did not indicate degenerative processes.
Bidliet mikroskopiċi okulari kienu relatati ma ’ infjammazzjoni u ma kienux jindikaw proċessi diġenerattivi.
Granulomatous inflammatory changes were noted in the optic disc of some eyes.
Bidliet infjammatorji granulomatużi dehru fid- disk ottiku ta ’ xi għajnejn ta ’ pazjenti.
These posterior segment changes diminished, and in some instances resolved, during the recovery period.
Dawn il- bidliet fis- segment posterjuri naqsu, u f’ xi każijiet għaddew, waqt il- perijodu ta ’ rkupru.
Following intravitreal administration, no signs of systemic toxicity were detected.
Wara l- għotja ġol- vitriju ma kienx hemm sinjali ta ’ tossiċità sistemika.
Serum and vitreous antibodies to ranibizumab were found in a subset of treated animals.
Antikorpi fis- serum u fil- vitriju għal ranibizumab instabu f’ subset ta ’ annimali trattati.
No carcinogenicity, mutagenicity or reproductive and developmental toxicity data are available.
10 M’ hemmx dejta dwar il- kanċeroġeniċità, mutaġeniċità u tossiċità ta ’ l- iżvilupp.
α ,α -trehalose dihydrate Histidine hydrochloride, monohydrate Histidine Polysorbate 20 Water for injections
α, α- trehalose dihydrate Histidine hydrochloride, monohydrate Histidine Polysorbate 20 Ilma għall- injezzjonijiet
0.23 ml solution in a vial (type I glass) with a stopper (chlorobutyl rubber), with 1 filter needle, 1 injection needle and 1 syringe (polypropylene).
0. 23 ml ta ’ soluzzjoni f’ kunjett (ħġieġ tip I) b’ tapp (lasktu chlorobutyl), f’ labra 1 b’ filtru, labra 1 għall- injezzjoni u siringa 1 (polyproylene).
Pack containing 1 vial.
Pakkett li fih kunjett 1.
Vials are for single use only.
Il- kunjetti qegħdin għal użu ta ’ darba biss.
Before withdrawal, the outer part of the rubber stopper of the vial should be disinfected.
Qabel jinġibed, il- parti ta ’ barra tat- tapp tal- lasktu tal- kunjett għandu jiġi diżinfettat.
Assemble the 5 µm filter needle (provided) onto the 1 ml syringe (provided) using aseptic technique.
Waħħal il- labra b’ filtru ta ’ 5 µm (ipprovduta) fuq siringa ta ’ ml 1.
Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
Imbotta l- ponta tal- labra b’ filtru li ma taqtax fiċ- ċentru tat- tapp tal- kunjett sakemm il- labra tmiss it- tarf tal- qiegħ tal - kunjett.
Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
Iġbed il- likwidu kollu mill- kunjett, fil- waqt li żżomm il- kunjett f’ pożizzjoni dritta, mejjel ftit sabiex ikun eħfef biex tiġbdu kollu.
Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
Aċċerta ruħek li l- bastun tal- planġer ikun lura biżżejjed meta tkun qed tbattal il- kunjett sabiex tkun tista ’ tbattal għall- kollox il- labra b’ filtru.
Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle.
Ħalli l- labra b’ filtru li ma taqtax fil- kunjett u aqla ’ s- siringa mill- labra b’ filtru li ma taqtax.
The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
Il - labra b’ filtru ghandha timtrema wara li jkunu nġibdu l- kontenuti tal- kunjett u m’ għandhomx jintużaw għall- injezzjoni fil- vitriju.
Aseptically and firmly assemble the injection needle (provided) onto the syringe.
B’ mod asettiku u sod, arma l- labra ta ’ l- injezzjoni (ipprovduta) fuq is- siringa.
Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe.
B’ attenzjoni neħħi l- għatu mil- labra ta ’ l- injezzjoni mingħajr ma taqla l- labra minn mas- siringa.
Grip at the yellow hub of the injection needle while removing the cap.
Aqbad il- parti s- safra tan- nofs tal- labra ta ’ l- injezzjoni waqt li tkun qed tneħħi l- għatu.
Carefully expel the air from the syringe and adjust the dose to the 0.05 ml mark on the syringe.
B’ attenzjoni, neħħi l- arja mis- siringa u irregola d- doża sal- marka 0. 05 ml fuq is- siringa.
The syringe is ready for injection.
Is - siringa lesta għall- injezzjoni.
Do not wipe the injection needle.
Timsaħx il- labra ta ’ l- injezzjoni.
Do not pull back on the plunger.
Timbuttax il- planġer lura.
Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue France
Centre de Biotechnologie 8, rue de l' Industrie F- 68330 Huningue Franza
(See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
The Marketing Authorisation Holder (MAH) shall ensure, at launch, all physicians who are expected to prescribe/ use Lucentis are provided with a physician information pack containing the following: • Physician information • Intravitreal injection procedure video • Intravitreal injection procedure pictogram • Patient information pack
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) sejjer jaċċerta, ma ’ l- ewwel ħruġ, li t- tobba kollha li huma mistennija li jordnaw/ jużaw Lucentis jingħataw pakkett ta ’ tagħrif għat- tobba li jkun fih dan li ġej: • Tgħarif għat- tabib • Filmat tal- proċedura kif tingħata injezzjoni ġol- vitriju • Piktogramma dwar il- proċedura kif tingħata injezzjoni ġol- vitriju • Pakkett ta ’ tgħarif għall- pazjent
The physician information should contain the following key elements: • The Summary of Product Characteristics • Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection • Use of antibiotics • Use of povidone iodine or equivalent • Techniques for the intravitreal injection • Key signs and symptoms of IVT injection related adverse events • Management of IVT injection related adverse events
It- Tagħrig għat- tabib għandu jkoll dawn l- elementi kruċjali: • Is- Sommarju tal- Karatteristiċi tal- Prodott • Proċeduri tekniċi sterili, inkluż kif tidiżinfetta d- dawra ta ’ l- għajnejn u l- għajnejn, sabiex ikun minimizzat ir- riskju ta ’ infezzjoni • L- użu ta ’ antibijotiċi • L- użu ta ’ povidone iodine jew ekwivalenti • Proċeduri tekniċi għall- injezzjoni fil- vitriju • Sinjali u sintomi kruċjali ta ’ effetti avversi relatati ma ’ l- injezzjoni IVT • Maniġġjar ta ’ effetti avversi relatati ma ’ l- injezzjoni
The patient information pack should be provided in both a form of patient information booklet and audio-CD that contain following key elements: • Patient information leaflet • How to prepare for Lucentis treatment • Which are the steps following treatment with Lucentis • Key signs and symptoms of serious adverse events • When to seek urgent attention from the health care provider
Il- pakkett ta ’ tagħrif tal- pazjent għandu jkun provdut kemm bħala ktejjeb ta ’ tagħrif għall - pazjent kif ukoll CD bl- awdjo li jkun fih dawn l- elementi kruċjali: • Fuljett ta ’ tagħrif għall- pazjent • Kif tipprepara għall- kura ta ’ Lucentis • Liema huma il- passi ta ’ wara l- kura b’ Lucentis • Sinjali u sintomi kruċjali ta ’ effetti avversi serji
14 The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States.
14 • Meta għandek tfittex attenzjoni urġenti minn min ikun qed jieħu ħsieb ta ’ saħħtek.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 5.0 dated 25 June 2008 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Il- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 5. 0 b’ data 25 ta ’ Ġunju 2008 ppreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun f’ lokha u taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 dated 25 February 2008, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġar tar- Riskju Il- MAH jintrabat li jwettaq l- istudji u l- attivitajiet l- oħra dwar il- farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza, hekk kif miftiehem fil- verżjoni 2 datata l- 25 ta ’ Frar 2008 tal- Pjan ta ’ l - Immaniġġjar tar- Riskju (RMP) ippreżentat f’ modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti ta ’ l- RMP sussegwenti kif miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar Is- Sistemi ta ’ l- Immaniġġar tar- Riskju għall- prodotti mediċinali għall- użu fil- bniedem, kull RMP aġġornat għandu jiġi sottomess fl- istess ħin mar- Rapport Perjodiku dwar is- Sigurtà Aġġornat (PSUR) sussegwenti.
In addition, an updated RMP should be submitted − When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached − At the request of the EMEA
Minbarra hekk, RMP aġġornat għandu jkun sottomess − Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni kurrenti dwar is - Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet sabiex ikun imnaqqas għall- minimu r- riskju. − Fi żmien 60 jum minn meta jintlaħaq avveniment importanti (farmakoviġilanza jew tnaqqis tar - riskju għall- minimu). − Fuq talba ta ’ l- EMEA
15 ANNEX III
15 ANNESS III
Lucentis 10 mg/ ml solution for injection Ranibizumab
Lucentis 10 mg/ ml soluzzjoni għall- injezzjoni Ranibizumab
One ml contains 10 mg of ranibizumab.
Millilitru wieħed fih 10 mg ta ’ ranibizumab.
Vial containing 2.3 mg of ranibizumab.
Kunjett fiha 2. 3 mg ta ’ ranibizumab.
Also contains: α ,α -trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.
Fih ukoll: α, α- trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; ilma għall- injezzjonijiet.
1 vial of 0.23 ml solution for injection
Kunjett 1 ta ’ 0. 23 ml soluzzjoni għall- injezzjoni
Vial for single use only.
Għal użu ġol- vitriju Kunjett għal użu ta ’ darba biss.
Lucentis 10 mg/ ml solution for injection Ranibizumab Intravitreal use
Lucentis 10 mg/ ml soluzzjoni għall- injezzjoni Ranibizumab Għal użu ġol- vitriju
1 vial = 2.3 mg ranibizumab.
Kunjett 1 = 2. 3 mg ranibizumab.
Read all of this leaflet carefully before you are given this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tingħata din il- mediċina.
What Lucentis is and what it is used for 2.
X’ inhu Lucentis u għalxiex jintuża 2.
Before you use Lucentis 3.
Qabel ma tuża Lucentis 3.
How to use Lucentis 4.
Kif għandek tuża Lucentis 4.
How to store Lucentis 6.
Kif taħżen Lucentis 6.
WHAT LUCENTIS IS AND WHAT IT IS USED FOR
X’ INHU LUCENTIS U GĦALXIEX JINTUŻA
Lucentis is given as an injection into the eye by your eye doctor under a local anaesthetic.
Lucentis jingħata bħala injezzjoni fl- għajn taħt loppju lokali mit- tabib ta ’ l- għajnejn tiegħek.
It is used to treat damage to the retina (the light-sensitive back part of the eye) when this damage is caused by abnormal blood vessels growing and leaking into the eye.
Jintuża biex jikkura ħsara lir- retina (il- parti ta ’ wara ta ’ l- għajn sensittiva għad- dawl) meta din il- ħsara tkun ġiet ikkawżata minn vini anormali tad- demm li jkunu qed jikbru u jnixxu fl- għajn.
This happens in diseases such as age-related macular degeneration (AMD).
Dan jiġri f’ mard bħall deġenerazzjoni makulari relatata ma ’ l- età (AMD).
Lucentis can help to improve the damaged vision or stop it from getting worse.
Lucentis jista ’ jgħin biex itejjeb il - vista mxekkla jew iwaqqafha milli tmur għall- agħar.
The active substance in Lucentis is ranibizumab.
Is- sustanza attiva f’ Lucentis hija ranibizumab.
Ranibizumab helps to stop the growth and leakage of new blood vessels in the eye, abnormal processes that contribute to the progression of AMD.
Ranibizumab jgħin biex iwaqqaf milli jikbru u jnixxu vini ġodda tad- demm fl- għajn, proċess anormali li jikkontribwixxi għall- avvanz ta ’ AMD.
BEFORE YOU USE LUCENTIS
QABEL MA TUŻA LUCENTIS
You must not receive Lucentis
M’ għandekx tirċievi Lucentis
- if you are allergic (hypersensitive) to ranibizumab or any of the other ingredients of Lucentis
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ranibizumab jew sustanzi oħra ta ’
listed at the end of this leaflet (see section 6).
Lucentis elenkati fl- aħħar ta ’ dan il- fuljett (ara sezzjoni 6).
- if you have an infection in or around your eye.
- jekk għandek infezzjoni f’ għajnejk jew mad- dawra ta ’ għajnejk.
- if you have pain or redness (severe intraocular inflammation) in your eye.
- jekk għandek uġigħ jew ħmura (infjammazzjoni sever ġo l- għajn) f’ għajnejk.
Take special care with Lucentis
Oqgħod attent ħafna b’ Lucentis
- Lucentis is given as an injection into the eye.
- Lucentis jingħata bħala injezzjoni ġol- għajn.
Occasionally, an infection in the internal portion
Xi drabi, jista ’ jkun li jsseħħu infezzjoni tal- parti
of the eye, pain or redness (inflammation), detachment or tear of the layer in the back of the eye (retinal detachment or tear), or clouding of the lens (cataract) may occur after Lucentis treatment.
ta ’ ġewwa ta ’ l- għajn, uġigħ jew ħmura (infjammazzjoni), qlugħ jew tiċrit tas- saff ta ’ wara l - għajn (qlugħ jew tiċrit tar- retina), jew li l- lenti tittappan (katarretti) wara li tingħata kura b’ Lucentis.
It is important to identify and treat such an infection or retinal detachment as soon as possible.
Huwa importanti li tinduna u tikkura din l- infezzjoni jew qlugħ tar- retina kemm jista ’ jkun malajr.
Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.
Jekk jogħġbok għid lit- tabib immedjatament jekk jiżviluppawlek sintomi bħal uġigħ f’ għajnejk jew fastidju f’ għajnejk, għajnejk isiru aktar ħomor, tara mċajpar jew tara inqas, jew żieda fin- numru ta ’ ħjut żgħar li tara f’ għajnejk jew żieda fis- sensitività għad- dawl.
- In some patients the eye pressure may increase for a short period directly after the injection.
Din
This is something you may not notice, therefore your doctor may monitor this after each injection.
hija xi ħaga li jista ’ jkun li ma tindunax biha, u għalhekk it- tabib ser jeżaminak wara kull injezzjoni.
22 Children and adolescents (below 18 years of age) The use of Lucentis in children and adolescents has not been studied and is therefore not recommended.
Tfal u adolexxenti (taħt it- 18- il sena) L- użu ta ’ Lucentis fit- tfal u adolexxenti ma ġiex studjat u għalhekk mhux rakkomandat.
Using other medicines Please tell your doctor if you are using or have recently used any other medicines, including medicines bought without a prescription.
22 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tuża jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
- There is no experience of using Lucentis in pregnant women; therefore the potential risks are
- M’ hemmx esperjenza bl- użu ta ’ Lucentis f’ nisa waqt it- tqala, għalhekk ir- riskji potenzjali li
unknown.
jista ’ jkun hemm m’ humhiex magħrufa.
If you are pregnant or planning to become pregnant, please discuss this with your doctor before Lucentis treatment.
Jekk ħriġt tqila jew qed taħseb għat- tqala, jekk jogħġbok iddiskutiha mat- tabib tiegħek qabel tibda l- kura b’ Lucentis.
- Lucentis is not recommended during breast-feeding because it is not known whether Lucentis
- Lucentis mhux rakkomandat waqt it- treddigħ għalhiex mhux mgħaruf jekk Lucentis joħroġx
passes into human milk.
mal- ħalib tal- mara.
Ask your doctor or pharmacist for advice before Lucentis treatment.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel il- kura b’ Lucentis.
Driving and using machines After Lucentis treatment you may experience some temporary vision blurring.
Sewqan u tħaddim ta ’ magni Wara l- kura b’ Lucentis il- vista tista ’ ssir imċajpra għal żmien qasir.
If this happens, do not drive or use machines until this resolves.
Jekk jiġri hekk, issuqx jew tħaddimx magni sakemm jgħaddilek.
HOW TO USE LUCENTIS
KIF GĦANDEK TUŻA LUCENTIS
All Lucentis injections will be administered by your doctor.
L- injezzjonijiet kollha ta ’ Lucentis ser jingħatawlek mit- tabib tiegħek.
Lucentis is administered as a single injection into your eye.
Lucentis jingħata bħala injezzjoni waħda f’ għajnejk.
The injection is given once a month in the first 3 months.
L- injezzjoni tingħata darba f’ xahar għall- ewwel 3 xhur.
Afterwards, your doctor will monitor your vision on a monthly basis.
Wara, it- tabib tiegħek ser jeżaminalek il- vista kull xahar.
If your condition is found to be worsening, your doctor will administer Lucentis to your affected eye again.
Jekk il- kundizzjoni tiegħek tkun sejra għall- agħar, it- tabib tiegħek ser jerġa jgħatik Lucentis fl- għajn effettwata.
The interval between two doses should not be shorter than 1 month.
L- intervall bejn iż- żewġ dożi m’ għandux ikun anqas minn xahar 1.
Before the injection, your doctor will use antibiotic eye drops and wash your eye carefully to prevent infection.
Qabel l- injezzjoni, it- tabib tiegħek ser jużalek taqtir b’ antibijotiċi u jaħsillek għajnejk sew biex jevita infezzjoni.
Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
It- tabib tiegħek ser itik ukoll loppju lokali biex inaqqas jew jevita kull uġigħ li tista ’ tħoss bl- injezzjoni.
Before and after each injection your doctor will ask you to use antimicrobial eye drops four times daily for 3 days before and after each injection in order to prevent any possible eye infection.
Qabel u wara kull injezzjoni t- tabib tiegħek ser isaqsik biex tuża taqtir kontra l- mikrobi erba ’ darbiet kuljum 3 ijiem qabel u wara kull injezzjoni sabiex jevita kull infezzjoni li tista ’ taqbdek f’ għajnejk.
Older people (age 65 years and over) Lucentis can be used for people of 65 years of age and over without dose adjustment.
Pazjenti anzjani (minn 65 sena ’ l fuq) Lucentis jista ’ jintuża f’ pazjenti li għandhom ’ l fuq minn 65 sena mingħajr ma jkun hemm tibdil fid - doża.
If a dose of Lucentis is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Jekk taqbeż doża ta ’ Lucentis Għamel kuntatt mat- tabib tiegħek jew l- isptar kemm jista ’ jkun malajr sabiex tgħamel appuntament ieħor mill- ġdid.
Before stopping Lucentis treatment If you are considering stopping Lucentis treatment, please go to your next appointment and discuss this with your doctor.
Qabel twaqqaf il- kura b’ Lucentis Jekk qed tikkonsidra li twaqqaf il- kura b’ Lucentis, jekk jogħġbok mur għall- appuntament li jmiss u ddiskutiha mat- tabib tiegħek.
Your doctor will advise you and decide how long you should be treated with Lucentis.
It- tabib tiegħek itik parir u jiddeċidi għall- kemm għandek iddum tieħu l - kura b’ Lucentis.
Like all medicines, Lucentis can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Lucentis jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Please do not be alarmed by this list of possible side effects.
Jekk jogħġbok tkunx allarmat b’ din il- lista ta ’ effetti sekondarji.
You may not experience any of them.
Jista ’ jkun li ma tħoss l- ebda wieħed minnhom.
With administration of Lucentis, there may be some side effects, mostly in the eye and due to the
Meta jingħata Lucentis, jista jkun hemm xi effetti sekondarji, l- aktar fl- għajnejn minħabba l- proċedura ta ’ l- injezzjoni.
23 injection procedure.
23 għajn (qlugħ jew tiċrit tar- retina), jew tittappan il- lenti (katarretti) jistgħu jseħħu fil- ġimgħatejn wara l - kura b’ Lucentis.
Occasionally an infection in the internal portion of the eye, detachment or tear of the layer in the back of the eye (retinal detachment or tear), or clouding of the lens (cataract) may occur in the two weeks after Lucentis treatment.
Effetti sekondarji oħra jinkludu uġigħ jew ħmura (infjammazzjoni) u żieda fil - pressjoni ta ’ l- għajn.