FrancophonIA/ELRC3.0 huggingface dataset:
English: In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humour, and sclera tissues for 18 hours, no metabolites were observed.
Maltese: Fi studju in vitro dwar il-metaboliżmu, wara l-inkubazzjoni ta' [14C]-dexamethasone b'kornea tal-bniedem, korp ċiljari tal-ħabba tal-għajn, korojd, retina, vitreous humour, u tessut tal-isklera għal 18-il siegħa, l-ebda metaboliti ma kienu osservati.
English: RVO and uveitis
Maltese: RVO u uveite
English: The proportion of patients with at least 15 letters improvement from baseline BCVA in the study eye at week 8 was more than 6-fold higher with OZURDEX (42.9%) compared to Sham (6.6%), p < 0.001.
Maltese: BCVA fil-għajn li ġiet studjata f'ġimgħa 8 kien iktar minn 6 darbiet ogħla b'OZURDEX (42.9%) meta mqabbel mal-plaċebo (6.6%), p < 0.001.
English: The adverse reaction profile of 341 patients analysed following a second injection of OZURDEX, was similar to that following the first injection.
Maltese: Il-profil tar-reazzjonijiet avversi ta' 341 pazjent analizzati wara t-tieni injezzjoni ta' OZURDEX, kien simili għal dak ta' wara l-ewwel injezzjoni.
English: Allergan Baltics UAB Tel: +37052 072 777
Maltese: Tel: +37052 072 777
English: The primary and key secondary endpoints for studies 206207-010 and 011 are presented in Table 2.
Maltese: Il-punti aħħarin primarji u dawk sekondarji ewlenin għal studji 206207-010 u 011 huma ppreżentati f'Tabella 2.
English: • inflammation of the posterior segment of the eye presenting as non-infectious uveitis
Maltese: • infjammazzjoni tas-segment ta' wara tal-għajnejn li tidher bħala uveite mhux infettiva
English: There is only very limited information on repeat dosing intervals less than 6 months (see section 5.1).
Maltese: Hemm tagħrif ristrett ħafna dwar intervalli ta' dożaġġ ripetut ta' inqas minn 6 xhur (ara sezzjoni 5.1).
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Maltese: kortikosterojdi sistemiċi u topiċi.
English: Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting oedema, fibrin deposition, capillary leakage, and phagocytic migration of the inflammatory response.
Maltese: Intwera li dexamethasone, kortikosterojd qawwi, irażżan l-infjammazzjoni billi jinibixxi edema, depożitu ta' fibrin, tnixxija kapillari, u migrazzjoni fagoċitika tar-rispons infjammatorju.
English: In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no reports of haemorrhagic adverse events in these patients.
Maltese: F'RVO, terapija kontra l-koagulazzjoni ntużat fi 2% tal-pazjenti li kienu qed jirċievu OZURDEX; ma kien hemm l-ebda rapporti ta' avvenimenti emorraġiċi avversi f'dawn il-pazjenti.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: metodoloġija AUC (ittri)
English: The plunger is controlled by a lever on the side of the applicator body.
Maltese: Il-planġer hu kkontrollat minn liver fuq in-naħa tal-korp tal-applikatur.
English: Among patients who used anti-coagulant therapy, the frequency of haemorrhagic adverse events was similar in the OZURDEX and sham groups (29% vs 32%).
Maltese: Fost il-pazjenti li użaw terapija antikoagulanti, il frekwenza ta' avvenimenti avversi emorraġiċi kienet simili fil-gruppi ta' OZURDEX u plaċebo (29%
English: In a 6-month monkey study following a single intravitreal injection of OZURDEX the dexamethasone vitreous humour Cmax was 100 ng/mL at day 42 post-injection and 5.57 ng/mL at day 91.
Maltese: Fi studju fuq ix-xadini li dam 6 xhur wara injezzjoni waħda ta' OZURDEX ġol-vitriju, is-Cmax ta' dexamethasone fil-vitreous humour kien ta' 100 ng/mL f'jum 42 wara l-injezzjoni u 5.57 ng/mL f'jum 91.
English: The highest plasma concentration value of 0.102 ng/mL was observed in 1 subject from the 700 µg group.
Maltese: L-ogħla valur tal-konċentrazzjoni fil-plażma ta' 0.102 ng/mL ġie osservat f'individwu 1 mill-grupp li kien qed jieħu doża ta' 700 µg.
English: - The other ingredients are: Ester terminated 50:50 poly D,L-lactide-co-glycolide and
Maltese: - Is-sustanzi l-oħra huma: Ester terminated 50:50 poly D,L-lactide-co-glycolide u
English: This will create a shelved scleral path.
Maltese: Dan se joħloq rotta sklerali bi xkaffa.
English: The needle is protected by a cap and the lever by a safety tab.
Maltese: Il-labra hi protetta minn għatu, u l-lever minn tab tas-sigurtà.
English: Patients were eligible for retreatment based upon central subfield retinal thickness >175 microns by optical coherence tomography (OCT) or upon investigators interpretation of the OCT for any evidence of residual retinal edema consisting of intraretinal cysts or any regions of increased retinal thickening within or outside of the central subfield.
Maltese: 175 mikroni permezz ta' tomografija ta' koerenza ottika (OCT - optical coherence tomography) jew meta saret l-interpretazzjoni tal-investigaturi tal-OCT għal kwalunkwe evidenza ta' edima residwa tar retina li tkun tikkonsisti minn ċisti intraretinali jew kwalunkwe reġjuni ta' żieda fil-ħxuna tar-retina ġo jew 'il barra mis-subfield ċentrali.
English: Plasma concentrations were obtained from a subgroup of patients in the two DME pivotal studies prior to dosing and on days 1, 7, and 21, and months 1.5 and 3 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone.
Maltese: Il-konċentrazzjonijiet fil-plażma nkisbu minn sottogrupp ta' pazjenti fiż-żewġ studji importanti ħafna dwar DME qabel id-dożaġġ u f'jiem 1, 7, u 21, u xhur 1.5 u 3 wara l-injezzjoni ġol-vitriju ta' impjant wieħed ġol-vitriju li fih 350 µg jew 700 µg ta' dexamethasone.
English: A total of 401 patients (94 %) randomised and treated with OZURDEX completed the initial treatment period (up to day 180).
Maltese: Total ta' 401 pazjent (94%) li ntgħażlu b'mod każwali u kienu kkurati b'OZURDEX, temmew il-perjodu ta' kura inizjali (sa jum 180).
English: Vitreous haemorrhage was reported in a higher proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared with those not receiving anticoagulant therapy (6%).
Maltese: Emorraġija fil-vitriju ġiet irrappurtata fi proporzjon ogħla ta' pazjenti kkurati b'OZURDEX li rċivew terapija antikoagulanti (11%) meta mqabbla ma' dawk li kinux qed jirċievu terapija antikoagulanti (6%).
English: OZURDEX is indicated for the treatment of adult patients with:
Maltese: OZURDEX hu indikat għall-kura ta' pazjenti adulti b':
English: Of these, a total of 77 were randomised to receive OZURDEX, 76 to dexamethasone 350 µg and 76 to sham.
Maltese: Minn dawn, total ta' 77 intgħażlu b'mod każwali biex jirċievu OZURDEX, 76 biex jirċievu dexamethasone 350 µg u 76 pazjent biex jirċievu Plaċebo.
English: • Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: The most frequently reported adverse reactions in the study eye of patients who received OZURDEX were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti fil-pazjenti li l-għajn tagħhom ġiet studjata, li rċivew OZURDEX, kienu emorraġija tal-konġuntiva (30.3%), żieda fil-pressjoni ġolgħajnejn (25.0%) u katarretti (11.8%).
English: Among patients who did not use anti-coagulant therapy, 27% of OZURDEX treated patients reported haemorrhagic adverse events compared to 20% in the sham group.
Maltese: Fost il-pazjenti li ma użawx terapija antikoagulanti, 27% tal-pazjenti kkurati b'OZURDEX irrappurtaw avvenimenti avversi emorraġiċi meta mqabbla ma' 20% fil-grupp tal-plaċebo.
English: The maximum treatment effect was observed at day 60 and the difference in the incidence of responders was statistically significant favouring OZURDEX compared with sham at all time points to day 90 following injection.
Maltese: L-effett massimu tal-kura kien osservat f'jum 60 u d-differenza fl-inċidenza ta' dawk li rrispondew kienet tiffavorixxi b'mod statistikament sinifikanti lil OZURDEX meta mqabbel ma' plaċebo fil-punti kollha taż-żmien sa jum 90 wara l-injezzjoni.
English: Plasma concentrations were obtained from a subset of 21 patients in the two RVO, 6-month efficacy studies prior to dosing and on days 7, 30, 60 and 90 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone.
Maltese: RVO dwar leffikaċja li damu 6 xhur, qabel id-dożaġġ u f'jiem 7, 30, 60, u 90 wara injezzjoni ġol-vitriju ta' impjant wieħed għal ġol-vitriju li kien fih 350 µg jew 700 µg ta' dexamethasone.
English: A total of 229 patients were randomised to receive dexamethasone 350 µg or 700 µg implants or sham.
Maltese: Total ta' 229 pazjent intgħażlu b'mod każwali biex jirċievu impjanti ta' dexamethasone 350 µg jew 700 µg jew Plaċebo.
English: No treatment is required since spontaneous resolution occurs.
Maltese: L-ebda kura mhi meħtieġa, għax iseħħ fejqan spontanju.
English: • Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Maltese: • Infezzjoni okulari jew periokulari attiva jew issuspettata, li tinkludi l-biċċa l-kbira tal-mard virali tal-kornea u konġuntiva, li jinkludi keratite b'herpes simplex epiteljali (keratite dendritika), vaċċinja, ġidri r-riħ, infezzjonijiet mikobatterjali, u mard fungali.
English: The incidence of increased IOP (24.9 %) was similar to that seen following the first injection and likewise returned to baseline by open-label day 180.
Maltese: L-inċidenza ta' żieda fl-IOP (24.9%) kienet simili għal dak li ġie osservat wara lewwel injezzjoni, u bl-istess mod, din reġgħet lura għal-linja bażi sa jum 180 bit-tikketta tidher.
English: Systemic absorption is minimal and no interactions are anticipated.
Maltese: L-assorbiment sistemiku hu minimu u l-ebda interazzjonijiet mhuma antiċipati.
English: The most frequently reported adverse reactions in patients who received OZURDEX were increased intraocular pressure (24.0 %) and conjunctival haemorrhage (14.7 %).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti f'pazjenti li rċivew OZURDEX kienu żieda fil-pressjoni ġol għajnejn (24.0%) u emorraġija tal-konġuntiva (14.7%).
English: For information concerning the current safety experience of repeat administrations beyond 2 implants in posterior segment non-infectious uveitis and Retinal Vein Occlusion, see section 4.8.
Maltese: Għal informazzjoni dwar l-esperjenza kurrenti dwar is-sigurtà ta' għoti ripetut ta' aktar minn 2 impjanti f'pazjenti b'uveite mhux infettiva fis-segment ta' wara tal-għajnejn u Okklużjoni tal-Vina tar-Retina, ara sezzjoni 4.8.
English: Device dislocation* (migration of implant) with or without corneal oedema (see also section 4.4), complication of device insertion resulting in ocular tissue injury* (implant misplacement)
Maltese: Ċaqliq tal-impjant (migrazzjoni tal-impjant) bi jew mingħajr edima tal-kornea (ara wkoll sezzjoni 4.4), komplikazzjoni fl-inserzjoni tat-tagħmir li tirriżulta fi ħsara fit-tessut okulari* (tqegħid ħażin tal impjant)
English: Increased intraocular pressure (IOP) with OZURDEX peaked at day 60 and returned to baseline levels by day 180.
Maltese: Żieda fil-pressjoni ġol-għajnejn (IOP) b'OZURDEX laħqet il-massimu f'jum 60 u reġgħet lura għallivelli tal-linja bażi sa jum 180.
English: Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotizing retinitis, retinal detachment and retinal tear.
Maltese: Reazzjonijiet avversi rrappurtati b'mod inqas frekwenti, iżda aktar serji, jinkludu endoftalmite, retinite nekrotizzanti, qlugħ tar-retina u tiċrita tar-retina.
English: CARTON AND POUCH EXTENDED LABEL
Maltese: TIKKETTA ESTIŻA TAL-KARTUNA U TAL-BORŻA
English: The most common haemorrhagic adverse event reported was conjunctival haemorrhage (up to 24%).
Maltese: L-avveniment avvers emorraġiku l-aktar komuni li ġie irrappurtat kienet emorraġija fil-konġuntiva (sa 24%).
English: Discontinuation due to lack of efficacy was lower in the OZURDEX group compared to sham (7% vs 24%).
Maltese: It-twaqqif minħabba nuqqas ta' effikaċja kien inqas fil-grupp ta' OZURDEX meta mqabbel ma' dak tal-plaċebo (7% vs 24%).
English: In the 3 year DME clinical studies, 59% of patients with a phakic study eye treated with OZURDEX underwent cataract surgery in the study eye (see SmPC section 4.8).
Maltese: Fl-istudji kliniċi dwar DME li damu 3 snin, 59% tal-pazjenti b'għajn fakika li ġiet studjata, ikkurati b'OZURDEX, kellhom operazzjoni tal-katarretti fl-għajn li ġiet studjata (ara sezzjoni 4.8).
English: Ninety-five percent of the plasma dexamethasone concentration values for the 350 µg dose group and 86% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL).
Maltese: Ħamsa u disgħin filmija tal-valuri tal-konċentrazzjoni ta' dexamethasone fil-plażma għall-grupp li kien qed jieħu doża ta' 350 µg u 86% għall-grupp li kien qed jieħu doża ta' 700 µg kienu taħt il-limitu t'isfel ta' kwantifikazzjoni (0.05 ng/mL).
English: The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials (DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ class in the table below using the following convention:
Maltese: III (DME, BRVO/CRVO u uveite) u minn rappurtar spontanju, huma elenkati skont is-Sistema tal klassifika tal-organi MedDRA fit-tabella hawn taħt bl-użu tal-konvenzjoni li ġejja:
English: Tel.: +48 22 256 3700
Maltese: Allergan Sp. z o.o. Tel.: +48 22 256 3700
English: During the initial treatment period, 0.7 % (3/421) of the patients who received OZURDEX required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2 % (1/423) with sham.
Maltese: Matul il-perjodu tal-kura inizjali, 0.7% (3/421) tal-pazjenti li rċivew OZURDEX kienu jeħtieġu proċeduri bil-laser jew kirurġiċi għal immaniġġjar ta' IOP għolja fl-għajn li ġiet studjata meta mqabbla ma' 0.2% (1/423) tal-pazjenti li ngħataw plaċebo.
English: Table 1 Adverse reactions System organ class
Maltese: Sistema tal-klassifika tal-organi
English: Sham N = 185
Maltese: N = 185
English: The European Medicines Agency has waived the obligation to submit the results of studies with OZURDEX in all subsets of the paediatric population for retinal vascular occlusion and also for diabetic macular oedema (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea dwar il-Mediċini iddifferiet l-obbligi li jiġu ppresentati riżultati tal-istudji b'OZURDEX f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika li jbatu b'okklużjoni vaskulari tar-retina u wkoll għal edima makulari dijabetika (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated intraocular lens and ruptured posterior lens capsule.
Maltese: • Għajnejn b'Lenti Intraokulari tal-Kompartiment Anterjuri (ACIOL), ħabba tal-għajn jew lenti intraokulari transklerali fissa u bil-kapsula ta' wara tal-lenti mċarta.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Maltese: Qabel it-tnedija f'kull Stat Membru, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jaqbel dwar il-materjal edukattiv finali mal-Awtorità Kompetenti Nazzjonali.
English: In each Phase III study and the pooled analysis, the time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response curves were significantly different with OZURDEX compared to sham (p < 0.001) with OZURDEX treated patients achieving a 3-line improvement in BCVA earlier than sham treated patients.
Maltese: III u l-analiżi miġbura, iż-żmien biex jinkiseb titjib ta' ≥ 15-il ittra (3 linji) fil-kurvi ta' rispons kumulattiv tal-BCVA, kien differenti b'mod sinifikanti b'OZURDEX meta mqabbel ma' plaċebo (p < 0.001) b'pazjenti kkurati b'OZURDEX li kisbu titjib ta' 3 linji fil-BCVA iktar kmieni minn pazjenti kkurati bi plaċebo.
English: At baseline 3% of patients required IOP-lowering medication(s).
Maltese: Fil-linja bażi, 3% tal-pazjenti kellhom bżonn ta' medikazzjoni(jiet) li jbaxxu l-IOP.
English: Of the patients experiencing an increase of IOP of ≥10 mmHg from baseline, the greatest proportion showed this IOP increase between 45 and 60 days following an injection.
Maltese: Mill-pazjenti li jkollhom żieda ta' IOP ta' ≥10 mmHg millinja bażi, l-ikbar proporzjon wera din iż-żieda fl-IOP bejn 45 u 60 jum wara l-injezzjoni.
English: The highest plasma concentration value of 0.094 ng/mL was observed in one subject from the 700 µg group.
Maltese: L-ogħla valur ta' konċentrazzjoni fil-plażma ta' 0.094 ng/mL kien f'persuna waħda mill-grupp li kienet qed tieħu doża ta' 700 µg.
English: ** in a 24-month real world observational study in the treatment of macular oedema following RVO and noninfectious uveitis affecting the posterior segment of the eye these adverse events were reported more frequently among patients who received >2 injections vs patients who received ≤2 injections; cataract formation (24.7% vs
Maltese: ** fi studju ta' osservazzjoni ta' 24 xahar li sar fid-dinja reali dwar il-kura ta' edima makulari wara RVO u uveite mhux infettiva li taffettwa s-segment posterjuri tal-għajn, dawn l-avvenimenti avversi ġew irrappurtati b'mod aktar frekwenti fost pazjenti li rċivew >2 injezzjonijiet kontra pazjenti li rċivew ≤2 injezzjonijiet; formazzjoni ta'
English: Necrotizing retinitis, endophthalmitis*, glaucoma, retinal detachment*, retinal tear*, hypotony of the eye*, anterior chamber inflammation*, anterior chamber cells/ flares*, abnormal sensation in eye*, eyelids pruritus, scleral hyperaemia*
Maltese: qlugħ tar-retina*, tiċrita fir-retina*, ipotonija talgħajn*, infjammazzjoni tal-kompartiment anterjuri*, aggravament taċ-ċelluli tal kompartiment anterjuri*, sensazzjoni anormali fl għajnejn*, ħakk f'tebqet il-għajnejn, iperemija tal isklera*
English: As for the initial treatment, peak response was seen at Day 60 in the open label phase.
Maltese: Fir-rigward tal-kura inizjali, ir-rispons massimu kien osservat f'jum 60 tal-fażi open label.
English: Mean BCVA change from baseline at year 3/final visit (letters) P-value
Maltese: Bidla medja ta' BCVA mil-linja bażi f'sena 3/vista finali (ittri)
English: BCVA ≥ 15-letter improvement from baseline at Year 3/Final visit (%)
Maltese: metodoloġija AUC (ittri) BCVA ≥ titjib ta' 15-il ittra mil-linja bażi f'Sena 3/Vista finali (%)
English: Only 1 patient out of 368 required cataract surgery during the first treatment and 3 patients out of 302 during the second treatment.
Maltese: Pazjent wieħed biss minn 368 kien jeħtieġ operazzjoni talkatarretti matul l-ewwel kura u 3 minn fost 302 matul it-tieni kura.
English: Sham N = 350
Maltese: N = 350
English: The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).
Maltese: Il-proċedura tal-injezzjoni ġol-vitriju għandha ssir taħt kundizzjonijiet asettiċi kkontrollati li jinkludu l-użu ta' ingwanti sterilizzati, drapp sterilizzat u spekulum sterilizzat ta' tebqet il-għajn (jew ekwivalenti).
English: Push the tip about 1 mm into the sclera, keeping it parallel to the limbus.
Maltese: Imbotta l-ponta madwar 1 mm fl-isklera, waqt li żżommha parallela mal-limbus.
English: vaccinia, varicella, mycobacterial infections, and fungal diseases.
Maltese: Retinite nekrotizzanti, endoftalmite*, glawkoma,
English: Intravitreal implant in applicator.
Maltese: Mhux applikabbli.
English: The clinical efficacy of OZURDEX has been assessed in a single, multicentre, masked, randomised study for the treatment of non-infectious ocular inflammation of the posterior segment in patients with uveitis.
Maltese: L-effikaċja klinika ta' OZURDEX ġiet evalwata fi studju wieħed, multiċentriku, masked, li fih il-parteċipanti ntgħażlu b'mod każwali għall-kura ta' infjammazzjoni okulari tas-segment posterjuri f'pazjenti b'uveite.
English: Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see SmPC section 4.8).
Maltese: Il-pazjenti jista' jkollhom tnaqqis temporanju fil-vista wara li jirċievu OZURDEX permezz ta' injezzjoni ġol-vitriju (ara l-SmPC sezzjoni 4.8).
English: No mutagenicity, carcinogenicity, reproductive or developmental toxicity data are available for OZURDEX.
Maltese: M'hemm l-ebda dejta disponibbli dwar il-mutaġeniċità, karċinoġeneċità, tossiċità riproduttiva jew waqt l-iżvilupp għal OZURDEX.
English: Very common Intraocular pressure increased**, cataract**, conjunctival haemorrhage*
Maltese: Żieda fil-pressjoni ġol-għajnejn**, katarretti**, emorraġija tal-konġuntiva*
English: One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator.
Maltese: Impjant wieħed sterilizzat b'forma ta' lasta tat-tip li jintreħa b'mod sostnut, li jista' jiġi impjantat, li fih 700 mikrogramma ta' dexamethasone, li jinsab gol-labra (magħmula minn azzar li ma jsaddadx) ta' applikatur li jintrema wara li jintuża.
English: For instructions on the administration of the intravitreal implant, see section 6.6
Maltese: Għal istruzzjonijiet dwar l-għoti tal-impjant għal ġol-vitriju, ara sezzjoni 6.6
English: With the exception of headache and migraine, no systemic adverse drug reactions were identified with the use of OZURDEX.
Maltese: Bl-eċċezzjoni ta' wġigħ ta' ras u emigranja, ma ġew identifikati l-ebda reazzjonijiet avversi sistemiċi tal-mediċina bl-użu ta' OZURDEX.
English: A total of 77 patients were randomised to receive OZURDEX and 76 to receive Sham.
Maltese: Total ta' 77 pazjent intgħażlu b'mod każwali biex jirċievu OZURDEX u 76 biex jirċievu Plaċebo.
English: * indicates adverse reactions considered to be related to the intravitreal injection procedure (the frequency of these adverse reactions is proportional to the number of treatments given).
Maltese: * jindika reazzjonijiet avversi li huma kkunsidrati bħala relatati mal-proċedura tal-injezzjoni ġol-vitriju (ilfrekwenza ta' dawn ir-reazzjonijiet avversi hi proporzjonali għan-numru ta' kuri mogħtija)
English: abnormal feeling in the eye * itchiness of the eyelid, redness of the white of the eye*, migration of the OZURDEX implant from the back to the front of the eye causing blurred or decreased vision and which may or may not cause swelling of the clear part of the eye (cornea)*, accidental incorrect placement of the OZURDEX implant*, migraine
Maltese: tqegħid mhux korrett bi żball tal-impjant OZURDEX*, emigranja *Dawn l-effetti sekondarji jistgħu jiġu kkawżati mill-proċedura tal-injezzjoni u mhux mill-impjant ta' OZURDEX innifsu.
English: Sham N = 165
Maltese: N = 165
English: A total of 36% of OZURDEX treated patients discontinued study participation for any reason during the study compared with 57% of sham patients.
Maltese: Total ta' 36% tal-pazjenti kkurati b'OZURDEX waqqfu l-parteċipazzjoni tagħhom fl-istudju għal kwalunkwe raġuni matul l-istudju meta mqabbla ma' 57% tal-pazjenti li kienu kkurati bi plaċebo.
English: Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, intraocular inflammation, increased intraocular pressure and retinal detachment.
Maltese: Injezzjonijiet ġol-vitriju, inkluż dawk b'OZURDEX, jistgħu jkunu assoċjati ma' endoftalmite,
English: A total of 427 patients were randomised to receive OZURDEX and 426 to receive sham in the two Phase III studies.
Maltese: Total ta' 427 pazjent intgħażlu b'mod każwali biex jirċievu OZURDEX u 426 biex jirċievu plaċebo fiż-żewġ studji ta' Fażi
English: Week 20
Maltese: Ġimgħa 20