FrancophonIA/ELRC3.0 huggingface dataset:
English: At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound.
Maltese: (FKBP12) li hi responsabbli għall-akkumulazzjoni intraċellulari tal-kompost.
English: Gelatin capsules imprinted with “TR” on the white capsule cap and “1 mg” on the light orange capsule body.
Maltese: Kapsuli ibsin tal-ġelatina stampati b'“TR” fuq l-għatu abjad tal-kapsula u b“1 mg” fuq il-parti prinċipali oranġjo ċara tal-kapsula.
English: fall, ulcer, chest tightness, thirst very rare:
Maltese: waqgħa, ulċera, tagħfis fis-sider, għatx rari ħafna:
English: Tacforius 0.5 mg / 1 mg / 3 mg prolonged-release hard capsules: red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.
Maltese: (E172), iron oxide isfar E172), titanium dioxide (E171), gelatin
English: Gelatin capsules imprinted with “TR” on the light yellow capsule cap and “0.5 mg” on the light orange capsule body.
Maltese: Kapsuli tal-ġelatina, stampati b'“TR” fuq l-għatu isfar ċar tal-kapsula u “0.5 mg” fuq il-parti prinċipali oranġjo ċara tal-kapsula.
English: Hepatic impairment
Maltese: alluċinazzjonijiet, disturbi mentali
English: Human data show that tacrolimus crosses the placenta.
Maltese: Data mill-bniedem turi li tacrolimus jaqsam il-plaċenta.
English: 6.3 Shelf life
Maltese: Linka stampata Shellac
English: When tacrolimus is administered intravenously as rapid infusion/bolus injection at a dose of 0.1 to 1.0 mg/kg, QTc prolongation has been observed in some animal species.
Maltese: Meta tacrolimus jingħata ġol-vina bħala infużjoni/injezzjoni bolus rapida b'doża ta 0.1 sa 1.0 mg/kg,
English: abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver - Itching, rash, hair loss, acne, increased sweating - Pain in joints, limbs, back and feet, muscle spasms - Insufficient function of the kidneys, reduced production of urine, impaired or painful urination - General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed - Insufficient function of your transplanted organ
Maltese: - Funzjoni tal-kliewi insuffiċjenti, tnaqqis fil-produzzjoni tal-awrina, urinazzjoni batuta jew bl uġigħ - Debbulizza ġenerali, deni, ġabra ta' fluwidu fil-ġisem, uġigħ u skonfort, żieda tal-enzima alkaline phosphatase fid-demm tiegħek, żieda fil-piż, ħass ta' disturbi fit-temperatura
English: Tacforius 0.5 mg / 3 mg / 5 mg prolonged-release hard capsules Pack sizes: 30, 50 and 100 prolonged-release hard capsules in blisters or 30x1, 50x1 and 100x1 prolonged-release hard capsules in perforated unit-dose blisters.
Maltese: Daqsijiet tal-pakkett: 30, 50 u 100 kapsula iebsa li terћi l-mediċina bil-mod f'folji jew 30x1, 50x1, u
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Maltese: Huwa ferm rakkomandat li jiġu mmonitorjati b'attenzjoni l-livelli ta' tacrolimus fid-demm kif ukoll ittitwil ta' QT (bl-ECG), il-funzjoni renali u effetti sekondarji oħra, kull meta tacrolimus jintuża flimkien ma' sustanzi li jista' jkollhom il-potenzjal li jibdlu l-metaboliżmu ta' CYP3A4, jew li b'xi mod ieħor jaffettwaw il-livelli ta' tacrolimus fid-demm, u biex tiġi nterrotta jew aġġustata d-doża ta' tacrolimus kif jixraq ħalli tinżamm espożizzjoni għal tacrolimus simili (ara sezzjonijiet 4.2 u 4.4).
English: Tacforius 0.5 mg prolonged-release hard capsules Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).
Maltese: Kull kapsula iebsa li terћi l-mediċina bil-mod fiha 0.5 mg tacrolimus (bћala monohydrate).
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 ng/ml in liver transplant recipients and 10 - 20 ng/ml in kidney and heart transplant patients in the early post-transplant period.
Maltese: Fil-prattika klinika, il-livelli minimi fid-demm sħiħ kienu ġeneralment fil-medda ta' 5 - 20 ng/ml f'dawk li rċevew trapjant tal-fwied u 1020 ng/ml f'dawk li rċevew trapjant tal-kliewi u tal-qalb kmieni fl-ewwel żmien wara li jkun sar it trapjant.
English: hallucination, mental disorders - Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - Blurred vision, increased sensitivity to light, eye disorders - Ringing sound in your ears - Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms - Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
Maltese: - Aċċessjonijiet, disturbi fil-koxjenza, tagħrix u tnemnim (nuqqas ta' ħass) (kultant li jweġġa') fl idejn u s-saqajn, sturdamenti, nuqqas ta' ħila biex tikteb, disturbi fis-sistema nervuża - Vista mċajpra, sensittività akbar għad-dawl, disturbi fl-għajnejn - Ħsejjes ta' żarżir fil-widnejn
English: confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare uncommon:
Maltese: konfużjoni u diżorjentament, depressjoni, sintomi ta' ansjetà, alluċinazzjonijiet,
English: Special populations
Maltese: organi primarji
English: Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Maltese: Tacrolimus hu inibitur magħruf ta' CYP3A4; għaldaqstant l-użu ta' tacrolimus flimkien ma' prodotti mediċinali magħrufa li jiġu metabolizzati permezz ta' CYP3A4 jista' jaffettwa l-metaboliżmu ta'
English: A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin - 2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time.
Maltese: Kien hemm varjetà ta' innovazzjonijiet, bħalma hi t-teknika li tinduna kmieni bl-infezzjonijiet Epstein-Barr (EBV) u CMV, żieda fil-mudullun tal-għadam, iż-żieda fl-użu tal-antagonist ta' interleukin-2 daclizumab fl-istess waqt, dożi aktar baxxi fil-bidu ta' tacrolimus biex jintlaħqu l-livelli minimi ta' 10 sa 15 ng/ml, u aktar reċenti l-irradjazzjoni tal-allograft li nħass li għenu biex ikun hemm riżultati aħjar f'din indikazzjoni aktar ma jgħaddi żżmien.
English: Prophylaxis of kidney transplant rejection
Maltese: Profilassi kontra r-rifjut ta' trapjant tal-kliewi
English: The use of Tacforius is not recommended in children and adolescents under 18 years.
Maltese: L-użu ta' Tacforius mhux rakkomandat fit-tfal u adolexxenti taћt it-18-il sena.
English: Mogilska 80
Maltese: U L-UŻU
English: Limited data are available but no recommendation on a posology can be made.
Maltese: Data limitata hija disponibbli iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Maltese: kuljum; tibdil fil-formulazzjoni jew fil-kors ta' dożaġġ irid iseћћ biss taћt superviżjoni mill-qrib tal ispeċjalista tat-trapjanti (ara sezzjonijiet 4.4 u 4.8).
English: Printing Ink
Maltese: indeboliment fis-smigħ
English: Tacforius 0.5 mg prolonged-release hard capsules
Maltese: Tacforius 0.5 mg kapsuli li jerћu l-mediċina bil-mod
English: Certain combinations of tacrolimus with substances known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Maltese: Ċerti taħlitiet ta' tacrolimus ma' sustanzi magħrufa li għandhom effetti nefrotossiċi u newrotossiċi jistgħu jżidu r-riskju ta' dawn l-effetti (ara sezzjoni 4.5).
English: This can lead to graft rejection or increased incidence of adverse reactions, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Maltese: Dan jista' jwassal gћal rifjut tat-trapjant jew gћal żieda fl-inċidenza tar-reazzjonijiet avversi, inklużi nuqqas jew żieda fl-immunosoppressjoni, minћabba differenzi klinikament rilevanti fl-espożizzjoni sistemika gћal tacrolimus.
English: It is not recommended that Tacforius is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Maltese: Mhux rakkomandat li tieћu Tacforius flimkien ma' ciclosporin (mediċina oħra li tintuża biex tevita rifjut tal-organu trapjantat).
English: Caution should be exercised when switching combination therapy from ciclosporin, which interferes with enterohepatic recirculation of mycophenolic acid, to tacrolimus, which is devoid of this effect, as this might result in changes of mycophenolic acid exposure.
Maltese: Wieħed għandu joqgħod attent meta jaqleb it-terapija kombinata minn ciclosporin, li jinterferixxi maċ-ċirkolazzjoni enterepatika ta' mycophenolic acid, għal tacrolimus, li huwa nieqes minn dan l-effett, għax dan jista' jirriżulta f'bidliet fl-esponiment għal mycophenolic acid.
English: Shellac
Maltese: Sess
English: Packs of 30, 50 and 100 prolonged-release hard capsules are available in blisters and packs of 30x1, 50x1 and 100x1 prolonged-release capsules are available in perforated unit-dose blisters.
Maltese: Pakketti ta' 30, 50 u 100 kapsula iebsa li terħi l-mediċina bilmod huma disponibbli f'folji u pakketti ta' 30x1, 50x1 u 100x1 kapsula li terħi l-mediċina bil-mod huma disponibbli mifrudin minn xulxin fuq l-istess folja.
English: The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.5).
Maltese: Għoti flimkien ta' ciclosporin u tacrolimus għandu jiġi evitat u għandha tingħata attenzjoni meta tacrolimus jingħata lill-pazjenti li qabel kienu jieħdu ciclosporin (ara sezzjonijiet 4.2 u 4.5).
English: - the corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - nefazodone, used to treat depression - Herbal preparations containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
Maltese: - mycophenolic acid, użat għas-soppressjoni tas-sistema immuni biex jipprevjeni r-rifjut tat trapjant - mediċini gћall-ulċeri fl-istonku u rifluss tal-aċidu (eż. omeprazole, lansoprazole jew cimetidine)
English: Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Maltese: infezzjonijiet, urtikarja, letarġija u żiediet fil-urea nitrogen tad-demm, fil-kreatinina fis-serum u fillivelli ta' alanine aminotransferase.
English: Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.
Maltese: Tacrolimus jista' jikkaġuna diffikultajiet newroloġiċi u fil-vista.
English: As gastrointestinal perforation is a medically important event that may lead to a life-threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.
Maltese: Billi perforazzjoni gastro-intestinali hija avveniment mediku importanti li jista jwassal għal kondizzjoni li tista tipperikola l-ħajja jew kondizzjoni serja trattamenti adegwati għandhom jiġu kkunsidrati immedjatament wara li jiġru sintomi jew sinjali suspettuzi.
English: Westport, Co Mayo Ireland
Maltese: Westport, Co Mayo L-Irlanda
English: 1 implant
Maltese: 1 impjant
English: NAME OF THE MEDICINAL PRODUCT
Maltese: MEDIKU ISEM
English: - The active substance is dexamethasone.
Maltese: - Is-sustanza attiva hi dexamethasone.
English: 17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP (24.0% vs 16.6%).
Maltese: kataretti (24.7% kontra 17.7%), progressjoni tal-kataretti (32.0% kontra 13.1%), emorraġija fil-vitriju (6.0% kontra 2.0%), u żieda fl-IOP (24.0% kontra 16.6%).
English: Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari
English: It is a potent promoter of vascular permeability.
Maltese: Hu promotur qawwi ta' permeabilità vaskulari.
English: By Day 180 the mean retinal thickness reduction (-119.3 microns) compared with sham was not significant.
Maltese: Sa Jum 180, il-medja ta' tnaqqis fil-ħxuna tar-retina (-119.3 mikrons) meta mqabbla ma' plaċebo, ma kinitx sinifikanti.
English: The implant is approximately 0.46 mm in diameter and 6 mm in length.
Maltese: L-impjant fih dijametru ta' madwar 0.46 mm u tul ta' 6 mm.
English: Day 60
Maltese: Jum 60
English: to <1/1,000); very rare (<1/10,000).
Maltese: (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Efficacy in studies 206207-010 and 206207-011 (ITT population)
Maltese: Effikaċja fi studji 206207-010 u 206207-011 (popolazzjoni ITT)
English: Statistical superiority was maintained up to and including week 26 (p ≤ 0.014) as shown in Table 6.
Maltese: Is-superjorità statistika nżammet sa, u inkluża, ġimgħa 26 (p ≤ 0.014) kif muri f'Tabella 6.
English: 1) Hold the long axis of the applicator parallel to the limbus.
Maltese: 1) Żomm l-assi t-twila tal-applikatur b'mod parallel mal-limbus.
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 17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP (24.0% vs 16.6%).
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' kataretti (24.7% kontra 17.7%), progressjoni tal-kataretti (32.0% kontra 13.1%), emorraġija fil-vitriju (6.0% kontra 2.0%), u żieda fl-IOP (24.0% kontra 16.6%).
English: Date of first authorisation: 27/07/2010 Date of latest renewal: 23/03/2015
Maltese: Data tal-aħħar tiġdid: 23/03/2015
English: The active substance in OZURDEX is dexamethasone.
Maltese: Is-sustanza attiva f'OZURDEX hi dexamethasone.
English: In DME, anti-coagulant therapy was used in 8% of patients.
Maltese: F'DME, intużat terapija b'antikoagulanti fi 8% tal-pazjenti.
English: Day 30
Maltese: Jum 30
English: Day 180 a Proportion significantly higher with OZURDEX compared to sham (p < 0.001)
Maltese: Jum 180 a Proporzjon sinifikanti ogħla b'OZURDEX meta mqabbel ma' plaċebo (p < 0.001)
English: A total of 54 % of patients experienced at least one adverse reaction.
Maltese: Total ta' 54% ta' pazjenti kellhom mill-inqas reazzjoni avversa waħda.
English: Pooled Studies 206207-010 and
Maltese: 206207-010 u
English: Ocular hypertension, cataract subcapsular, vitreous haemorrhage**, visual acuity reduced*, visual impairment/ disturbance, vitreous detachment*, vitreous floaters*, vitreous opacities*, blepharitis, eye pain*, photopsia*, conjunctival oedema* conjunctival hyperaemia*
Maltese: Pressjoni għolja fl-għajnejn, katarretti subkapsulari, emorraġija vitreuża**, tnaqqis fiċ-ċarezza tal vista*, indeboliment/disturb tal-vista, qlugħ vitreuż*, floaters vitreużi*, opaċitajiet vitreużi*, blefarite, uġigħ fl-għajn*, fotopsija*, edima talkonġuntiva* iperemija tal-konġuntiva*
English: Pharmacotherapeutic group: Ophthalmologicals, antiinflammatory agents, ATC code: S01BA01
Maltese: Mediċini oftalmoloġiċi, sustanzi antiinfjammatorji; Kodiċi ATC:
English: In each of the phase III studies and the pooled analysis, mean retinal thickness was significantly less, and the mean reduction from baseline was significantly greater, with OZURDEX (-207.9 microns) compared to sham (-95.0 microns) at day 90 (p < 0.001, pooled data).
Maltese: III u l-analiżi miġbura, il-medja tal-ħxuna tar-retina kienet inqas b'mod sinifikanti, u l-medja ta' tnaqqis mil-linja bażi kienet akbar b'mod sinifikanti, b'OZURDEX (-207.9 mikrons) meta mqabbla ma' plaċebo (-95.0 mikron) f'jum 90 (p < 0.001, dejta miġbura).
English: • Hypersensitivity to the active substance or to any of the excipients as listed in SmPC section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fl-SmPC sezzjoni 6.1.
English: A total of 427 were randomised to OZURDEX, 414 to dexamethasone 350 µg and 426 patients to sham.
Maltese: Total ta' 427 intgħażlu b'mod każwali għal OZURDEX, 414 ingħataw dexamethasone 350 µg u 426 pazjenti ngħataw plaċebo.
English: The rank order of dexamethasone concentration was retina > iris > ciliary body > vitreous humour > aqueous humour > plasma.
Maltese: L-ordni ta' klassifikazzjoni tal-konċentrazzjoni ta' dexamethasone kienet retina > ħabba tal-għajn > korp ċiljari > vitreous humour > aqueous humour > plażma.
English: Efficacy in pseudophakic patients (pooled studies 206207-010 and 206207-011)
Maltese: Tabella 3. Effikaċja f'pazjenti psewdofakiċi (studji miġbura 206207-010 u 206207-011)
English: Dexamethasone belongs to a group of medicines called corticosteroids.
Maltese: Dexamethasone jappartjeni għal grupp ta' mediċini msejħa kortikosterojdi.
English: Statistical superiority was achieved at week 3 and maintained up to and including week 26 (p < 0.001) as shown in Table 6.
Maltese: Superjorità statistika nkisbet f'ġimgħa 3 u nżammet sa, u inkluża, ġimgħa 26 (p < 0.001) kif muri f'Tabella 6.
English: The efficacy of OZURDEX was assessed in two 3 year, multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,048 patients (studies 206207-010 and 206207-011).
Maltese: L-effikaċja ta' OZURDEX ġiet evalwata f'żewġ studji paralleli ta' disinn identiku li damu 3 snin, multiċentriċi, double-masked, li fihom il-parteċipani ntgħażlu b'mod każwali, ikkontrollati bi plaċebo, li flimkien kienu jinkludu 1,048 pazjent (studji 206207-010 u 206207-011).
English: DME
Maltese: Fih
English: The efficacy of OZURDEX was assessed in two multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,267 patients who were randomized to receive treatment with dexamethasone 350 µg or 700 µg implants or sham (studies 206207-008 and 206207-009).
Maltese: L-effikaċja ta' OZURDEX kienet evalwata f'żewġ studji multiċentriċi u paralleli, double-masked, li fihom il-parteċipanti ntgħażlu b'mod każwali, ikkontrollati bi plaċebo, li kienu ddisinjati b'mod identiku li flimkien kienu jinkludu 1,267 pazjent li ntgħażlu b'mod każwali biex jirċievu il-kura b'impjanti ta' dexamethasone ta' 350 µg jew ta' 700 µg, jew inkella plaċebo (studji 206207-008 u 206207-009).
English: The percent of patients requiring escape medications from baseline to week 8 was nearly 3-fold less with OZURDEX (7.8%) compared to Sham (22.4%), p = 0.012.
Maltese: Il-perċentwali ta' pazjenti li kienu jeħtieġu mediċini ‘escape' mil-linja bażi sa ġimgħa 8 kien kważi 3 darbiet inqas b'OZURDEX (7.8%) meta mqabbel mal-Plaċebo (22.4%), p = 0.012.
English: Of the patients who were treated in the open label phase, 98% received an OZURDEX injection between 5 and 7 months after the initial treatment.
Maltese: Millpazjenti li kienu kkurati fil-fażi open label, 98% irċivew injezzjoni b'OZURDEX bejn 5 u 7 xhur wara l-kura inizjali.
English: • diabetic macular oedema
Maltese: • edima makulari kemm wara
English: OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone
Maltese: OZURDEX 700 mikrogramma impjant għal ġol-vitriju f'applikatur dexamethasone
English: 6) Dispose of the applicator safely immediately after treatment.
Maltese: 6) Armi l-applikatur b'mod sigur immedjatament wara ttrattament.
English: Sham N = 101 P-value
Maltese: N = 101 Valur p
English: The OZURDEX matrix slowly degrades to lactic acid and glycolic acid through simple hydrolysis, then further degrades into carbon dioxide and water.
Maltese: Il-matriċi ta' OZURDEX tiddegrada bil-mod għal lactic acid u glycolic acid permezz ta' idrolisi sempliċi, imbagħad tiddegrada b'mod ulterjuri għal carbon dioxide u ilma.
English: [To be provided in the carton]
Maltese: [Biex jiġi pprovdut fil-kaxxa tal-kartun]
English: BCVA ≥ 15-letter improvement from baseline at Year 3/Final (%) P-value
Maltese: BCVA ≥ titjib ta' 15-il ittra mil linja bażi f'Sena 3/Vista finali (%) Valur P
English: Patients who had a BCVA score of <84 OR retinal thickness > 250 microns by optical coherence tomography OCT and in the investigator's opinion treatment would not put the patient at risk; were eligible to receive an OZURDEX treatment in an open label extension.
Maltese: Pazjenti li kellhom punteġġ BCVA ta' < 84 JEW ħxuna tar-retina ta' > 250 mikron kif imkejjel minn optical coherence tomography (OCT) li fl-opinjoni tal-investigatur, il-kura ma kinitx ser tpoġġi l-pazjent f'riskju; kienu eliġibbli biex jirċievu kura b'OZURDEX f'estensjoni open label.
English: A total of 351 were randomised to OZURDEX, 347 to dexamethasone 350 µg and 350 patients to sham.
Maltese: intgħażlu b'mod każwali għal OZURDEX, 347 għal dexamethasone 350 µg u 350 pazjent għal plaċebo.
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see SmPC section 5.1)
Maltese: • edima makulari wara jew Okklużjoni ta' Vina Sekondarja tar-Retina (BRVO - Branch Retinal Vein Occlusion) jew Okklużjoni ta' Vina Ċentrali tar-Retina (CRVO - Central Retinal Vein Occlusion) (ara l-SmPC sezzjoni 5.1)
English: OZURDEX 700 micrograms intravitreal implant in applicator
Maltese: OZURDEX 700 mikrogramma impjant għal ġol-vitriju f'applikatur
English: • macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) (see section 5.1)
Maltese: • edima makulari wara jew Okklużjoni ta' Vina Sekondarja tar-Retina (BRVO - Branch Retinal Vein Occlusion) jew Okklużjoni ta' Vina Ċentrali tar-Retina (CRVO - Central Retinal Vein Occlusion) (ara sezzjoni 5.1)
English: The proportion of patients with vitreous haze score of 0 in the study eye at week 8 (primary endpoint) was 4-fold higher with OZURDEX (46.8%) compared to Sham (11.8%), p < 0.001.
Maltese: Il-proporzjon ta' pazjenti b'punteġġ ta' ċpar vitreuż ta' 0 fil-għajn li ġiet studjata f'ġimgħa 8 (punt aħħari primarju) kien ta' 4 darbiet ogħla b'OZURDEX (46.8%) meta mqabbel mal-plaċebo (11.8%), p < 0.001.
English: You may hear a ‘click' during the injection of OZURDEX; this is normal.
Maltese: Tista' tisma' ‘klikk' waqt l-injezzjoni ta' OZURDEX; dan hu normali.
English: Other medicines and OZURDEX
Maltese: Mediċini oħra u OZURDEX