FrancophonIA/ELRC3.0 huggingface dataset:
English: In study TG-MV-014, retinal tear was reported in 1.4% of patients injected with JETREA and 6.8% of sham recipients; the incidence of retinal detachment was 1.4% in both arms.
Maltese: Fi studju TG-MV-014, tiċrita tar-retina kienet irrappurtata f'1.4% tal-pazjenti injettati b'JETREA u f'6.8% ta' dawk li rċevew injezzjoni mingħajr is-sustanza attiva; l-inċidenza ta' distakk tar-retina kien ta' 1.4% fiż-żewġ gruppi.
English: JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted' formulation, no further dilution is required.
Maltese: JETREA 0.375 mg/0.3 mL soluzzjoni għall-injezzjoni huwa formulazzjoni ‘dilwita lesta', mhux meħtieġa akter dilwizzjoni.
English: The safety and efficacy of ocriplasmin in paediatric subjects scheduled for vitrectomy was investigated in study TG-MV-009.
Maltese: Is-sigurtà u l-effikaċja ta' ocriplasmin f'individwi pedjatriċi skedati għal vitrektomija ġew investigati fi studju TG-MV-009.
English: This is generally reversible and will usually disappear without treatment.
Maltese: Ġeneralment dan huwa riversibbli u normalment jgħaddi mingħajr trattament.
English: In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), retinal breaks (tears and detachment) were reported in 1.9% of patients injected with JETREA vs. 4.3% injected with placebo.
Maltese: III ikkontrollati bi plaċebo (TG-MV-006 u TG-MV-007), il-qsim fir-retina (tiċrit u stakkar) kien irrappurtat f'1.9% tal-pazjenti injettati b'JETREA meta mqabbla ma' 4.3% injettati bil-plaċebo.
English: After dilution with 0.2 mL of sodium chloride solution, 0.1 mL of the diluted solution contains 0.125 mg of ocriplasmin.
Maltese: Wara d-dilwizzjoni b'soluzzjoni ta' 0.2 mL ta' sodium chloride, 0.1 mL tas-soluzzjoni dilwita fiha 0.125 mg ta' ocriplasmin.
English: 0.3 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and a blue polypropylene flip-off cap.
Maltese: Soluzzjoni ta' 0.3 mL f'kunjett (ħġieġ tat-tip I) magħluq b'tapp tal-lastiku tal-chlorobutyl u għatu flip off blu tal-polypropylene.
English: Each vial contains 0.375 mg of ocriplasmin* in 0.3 mL solution (1.25 mg/mL).
Maltese: Kull kunjett fih 0.375 mg ta' ocriplasmin* f'0.3 mL soluzzjoni (1.25 mg/mL).
English: Ready-diluted
Maltese: TAL-PRODOTT
English: 0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap.
Maltese: Soluzzjoni ta' 0.2 mL f'kunjett (ħġieġ tat-tip I) magħluq b'tapp tal-lastiku tal-chlorobutyl u għatu flip off oranġjo tal-polypropylene.
English: In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), events of macular hole (including both progression and new onset) were reported for 6.7% of all patients injected with JETREA vs. 9.6% injected with placebo at Month 6.
Maltese: III (TG-MV-006 u TG-MV-007), avvenimenti ta' toqba fil-makula (inklużi progressjoni kif ukoll bidu ġdid) ġew irrappurtati għal 6.7% tal-pazjenti kollha injettati b'JETREA meta mqabbla ma' 9.6% injettati bil-plaċebo f'Xahar 6.
English: The intravitreal toxicity of ocriplasmin has been evaluated in rabbits, monkeys and minipigs.
Maltese: It-tossiċità ġol-vitriju ta' ocriplasmin ġiet evalwata fil-fniek, ix-xadini u l-minipigs.
English: Chromatopsia (including dyschromatopsia and colour vision test abnormal) Colour vision alterations (including yellowish vision and abnormal Roth 28-hue colour vision test) have been reported as a very common adverse reaction in patients injected with JETREA.
Maltese: Bidliet fil-vista tal-kuluri (inkluż vista safranija u test tal-vista tal-kuluri Roth 28-hue mhux normali) kienu irrappurtata bħala reazzjoni avversa komuni ħafna f'pazjenti injettati b'JETREA.
English: Lens subluxation was observed in the 3 species at ocriplasmin concentrations at or above 41 µg/mL vitreous, a concentration above the intended clinical concentration of 29 µg/mL.
Maltese: Iċ-ċaqliq fil-lenti kien osservat fit-3 speċijiet f'konċentrazzjonijiet ta' ocriplasmin ta' 41 µg/mL ta' vitriju jew aktar, konċentrazzjoni ogħla mill-konċentrazzjoni klinika maħsuba ta' 29 µg/mL.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: A total of 220 patients (JETREA 146, sham 74) were randomised in this study.
Maltese: F'dan l-istudju kienu randomised total ta' 220 pazjent (JETREA 146, injezzjoni mingħajr is-sustanza attiva 74).
English: In monkeys, after administration of 125 µg/eye (68 µg/mL vitreous) the ERG was fully recovered by Day 55.
Maltese: Fix-xadini, wara l-għoti ta' 125 µg/għajn (68 µg/mL ta' vitriju) l-ERG kien irkuprat għal kollox sal-55 Jum.
English: Pack containing 1 vial.
Maltese: Kull pakkett fih kunjett wieħed.
English: Lens subluxation was observed in 3 animal species at ocriplasmin concentrations above the intended clinical concentration (see section 5.3).
Maltese: Ċaqliq tal-lenti kien osservat fi tliet speċijiet ta' annimali f'konċentrazzjonijiet ta' ocriplasmin ogħla mill-konċentrazzjoni klinika maħsuba (ara sezzjoni 5.3).
English: Sodium hydroxide (NaOH) (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (NaOH) (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: In the placebo-controlled pivotal phase III studies (TG-MV-006 and TG-MV-007), 7.7% of JETREA patients and 1.6% of placebo patients had acute ≥ 2-line (≥ 10 ETDRS letters) loss in best-corrected visual acuity (BCVA) during the first week after injection with no alternative explanation for the change.
Maltese: III (TG-MV-006 u TG-MV-007), 7.7% tal-pazjenti fuq JETREA u 1.6% tal-pazjenti fuq plaċebo kellhom telf akut ta' ≥ 2-linji (≥ 10 ittri ETDRS) fl-aħjar akutezza viżiva kkoreġuta (BCVA - best corrected visual acuity) waqt l-ewwel ġimgħa wara l injezzjoni bl-ebda spjegazzjoni alternattiva għall-bidla.
English: Using aseptic technique, dilute by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (sterile, preservative-free, non-buffered) into the Jetrea vial (Figure 3) and gently swirl the vial until the solutions are mixed (Figure 4).
Maltese: Permezz ta' teknika asettika, iddilwixxi billi żżid 0.2 mL ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni (sterili, mingħajr preservattivi, mhux newtralizzat) fil-kunjett tal- Jetrea (Figura 3) u dawwar il-kunjett bil-mod sakemm jitħalltu s-soluzzjonijiet (Figura 4).
English: All had done so by Month 3.
Maltese: meta mqabbla ma' 10.
English: The most clinically relevant adverse reactions included blindness transient, retinal tear, retinal detachment, lens subluxation and macular hole progression.
Maltese: L-aktar reazzjonijiet avversi klinikament rilevanti kienu jinkludu għama temporanja, tiċrita fir-retina, distakk tar-retina, ċaqliq tal-lenti u progressjoni tat-toqba fil-makula.
English: Any persistence or progression of macular hole should be treated according to usual practice.
Maltese: Kull persistenza jew progressjoni ta' toqba fil-makula għandha tiġi ttrattata skont il-prattika normali.
English: Patients with a smaller VMA diameter at baseline (≤ 1500 microns) were more likely to achieve VMA resolution at Day 28 compared with those who had a diameter > 1500 microns.
Maltese: Pazjenti b'dijametru iżgħar tal-VMA fil-linja bażi (≤ 1500 mikron) kienu aktar probabbli li jilħqu fejqan tal-VMA f'Jum 28 meta mqabbla ma' dawk li kellhom dijametru ta' > 1500 mikron.
English: JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 5.1).
Maltese: JETREA hu indikat għall-uzu fl-adulti għall-kura ta' ġbid vitreomakulari (VMT), inkluż meta jkun assoċjat ma' toqba fil-makula ta' dijametru inqas minn jew daqs 400 mikron (ara sezzjoni 5.1).
English: In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup with VMA ≤ 1500 microns at baseline (34.7% vs. 14.6%, p<0.001) and with VMA > 1500 microns at baseline (5.9% vs. 0%, p=0.113).
Maltese: Fid-dejta integrata, ir-rata ta' riżoluzzjoni tal-VMA f'Jum 28 kienet ogħla f'pazjenti kkurati b'JETREA meta mqabbla mal-plaċebo kemm fis-sottogrupp b'VMA ≤ 1500 mikron fil-linja bażi (34.7% kontra 14.6%,
English: The proportion of patients who gained ≥ 2 or ≥ 3 lines in BCVA at Month 6, irrespective of vitrectomy, was slightly higher in the JETREA group (36.2%, 18.6%) than in the sham group (28.6%, 13.1%).
Maltese: Il-proporzjon ta' pazjenti li kisbu ≥ 2 jew ≥ 3 linji f'BCVA f'Xahar 6, irrispettivament minn vitrektomija, kien ftit ogħla fil-grupp ta' JETREA (36.2%, 18.6%) milli fil-grupp ta' injezzjoni mingħajr is-sustanza attiva (28.6%, 13.1%).
English: Precautions to be taken before handling or administering the medicinal product The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Maltese: Il-proċedura tal-injezzjoni fil-vitriju għandha ssir taħt kundizzjonijiet asettiċi kkontrollati, li jinkludu l-użu ta' diżinfezzjoni tal-idejn permezz ta' teknika użata waqt kirurġija, ingwanti sterili, drapp sterili, spekulu sterili għall-kappell tal-għajn (jew simili) u d-disponibilità ta' paraċentesi sterili (jekk meħtieġ).
English: In study TG-MV-014, 2.8% of JETREA patients and 1.4% of sham patients had acute ≥ 2-line loss in BCVA during the first week after injection.
Maltese: TG-MV-014, 2.8% tal-pazjenti fuq JETREA u 1.4% tal-pazjenti fuq injezzjoni mingħajr is-sustanza attiva kellhom telf akut ta' ≥ 2 linji f'BCVA matul l-ewwel ġimgħa wara l-injezzjoni.
English: The proportion of patients who achieved VMA resolution at Day 28 (primary endpoint) was 41.7% in the JETREA group compared with 6.2% in the sham group (p<0.001).
Maltese: Il-proporzjon ta' pazjenti li kisbu għejbien ta' VMA f'Jum 28 (punt finali primarju) kien ta' 41.7% filgrupp ta' JETREA meta mqabbel ma' 6.2% fil-grupp ta' injezzjoni mingħajr is-sustanza attiva (p<0.001).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, other than sterile, preservative-free, non-buffered diluent sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Fin-nuqqas ta' studji ta' kompatibbiltà, dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn, minbarra dilwent sterili, mingħajr preservattivi, mhux newtralizzat ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: 4) including subretinal fluid
Maltese: 1) inkluż vista mċajpra
English: In the integrated analysis of the National Eye Institute Visual Function Questionnaire-25 (VFQ-25), a numerical difference in favour of JETREA over placebo was shown in each sub-scale score, as well as the composite score.
Maltese: Fl-analiżi integrata ta' Kwestjonarju-25 tal-Funzjoni tal-Vista (VFQ-25 - Visual Function Questionnaire-25) tal-Istitut Nazzjonali tal-Għajnejn intweriet differenza numerika favur JETREA fuq il-plaċebo f'kull punteġġ sottoskala, kif ukoll il-punteġġ kompost.
English: Out of the 4 JETREA patients with acute visual acuity decrease, 3 recovered following vitrectomy.
Maltese: Mill-4 pazjenti fuq JETREA bi tnaqqis akut fl-akutezza viżiva, 3 irkupraw wara vitrektomija.
English: Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).
Maltese: Oħroġ il-kunjett minn ġol-friża u ħallih jinħall f'temperatura ambjentali (madwar 2 minuti).
English: In 3 clinical studies with follow-up from 6 months (TG-MV-006 and TG-MV-007) to 24 months (TG-MV-014), the most commonly reported adverse reactions were vitreous floaters, eye pain, photopsia and chromatopsia as well as conjunctival haemorrhage resulting from the injection procedure.
Maltese: (TG-MV-006 u TG-MV-007) sa 24 xahar (TG-MV-014), l-aktar reazzjonijiet avversi irrappurtati b'mod komuni kienu depożiti fil-vitriju, uġigħ fl-għajn, fotopsja u kromatopsja kif ukoll emorraġija konġuntivali kkawżata mill-proċedura tal-injezzjoni.
English: One case of lens subluxation/phacodonesis was reported in clinical studies in adults and appears to have been possibly related to treatment with JETREA.
Maltese: Każ wieħed ta' ċaqliq tal-lenti/fakodonesi kien irrappurtat fi studji kliniċi f'adulti u jidher li possibbilment kien relatat ma' kura b'JETREA.
English: Intraocular pressure increased, macular reflex abnormal, optical coherence tomography (OCT) abnormal* * see section ‘Description of selected adverse reactions' 1) including dim vision
Maltese: Żieda tal-pressjoni fl-għajnejn, rifless makulari mhux normali, tomografija ta' koerenza ottika (OCT - optical coherence tomography) mhux normali* * ara sezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula'
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Maltese: Qabel it-tqegħid fis-suq f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiftiehem mal-Awtorità Kompetenti Nazzjonali dwar programm edukattiv.
English: However, chemical and physical in-use stability of unopened product in the original carton protected from light has been demonstrated for up to 8 hours when stored below 25 °C.
Maltese: Madankollu, stabbiltà kimika u fiżika waqt l-użu tal-prodott mhux miftuħ fil-kartuna oriġinali protett mid-dawl intweriet sa 8 sigħat meta jinħażen f'temperatura taħt 25 °C.
English: JETREA 0.375 mg/0.3 mL solution for injection
Maltese: JETREA 0.375 mg/0.3 mL
English: in integrated data
Maltese: U KWANTITATTIVA
English: Blindness transient, lens subluxation*, retinal tear*5), retinal detachment*5), night blindness, pupillary reflex impaired, diplopia, hyphaema, miosis, pupils unequal, corneal abrasion, anterior chamber inflammation, eye inflammation, conjunctival irritation
Maltese: għama matul il-lejl jew f'dawl baxx, indeboliment fir-rifless tal-ħabba tal-għajn, diplopja, ħajfima, mijosi, pupilli mhux indaqs, brix tal-kornea, infjammazzjoni fil-kompartiment anterjuri, infjammazzjoni fl-għajnejn, irritazzjoni konġuntivali Investigazzjonijiet Komuni ħafna
English: Jetrea is a solution for injection in a vial.
Maltese: Soluzzjoni ċara u mingħajr kulur.
English: In a paediatric study evaluating JETREA as an adjunct to vitrectomy, one case of subluxation was reported in a premature infant who received a single intravitreal injection of JETREA 0.175 mg.
Maltese: Fi studju pedjatriku li evalwa JETREA bħala żieda mal-vitrektomija, kien irrappurtat każ wieħed ta' ċaqliq tal-lenti f'tarbija prematura li ngħatat injezzjoni waħda ta' JETREA 0.175 mg ġol-vitriju.
English: A significantly higher percentage of JETREA treated patients experienced total PVD at Day 28 compared to placebo treated patients (integrated data: 13.4% vs. 3.7%, respectively; p<0.001).
Maltese: Perċentwal konsiderevolment ogħla ta' pazjenti kkurati b'JETREA kellhom PVD totali fit-28 Jum meta mqabbla mal-pazjenti li ngħataw plaċebo (dejta integrata: 13.4% meta mqabbla ma' 3.7%, rispettivament;
English: During the studies, vitrectomy could be performed at the discretion of the Investigator.
Maltese: Waqt l-istudji, vitrektomija setgħet issir skont id-diskrezzjoni tal-Investigatur.
English: One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) has been reported.
Maltese: Ġie rrappurtat każ wieħed ta' doża eċċesiva aċċidentali ta' 0.250 mg ocriplasmin (darbtejn id-doża rakkomandata).
English: The most common reason for performing vitrectomy was FTMH (in 24.8% JETREA treated patients and 23.3 % sham patients).
Maltese: Ir-raġuni l-aktar komuni għall-vitrektomija kienet FTMH (f'24.8% tal-pazjenti ttrattati b'JETREA u 23.3% tal-pazjenti ttrattati b'injezzjoni mingħajr is-sustanza attiva).
English: For handling of the medicinal product, see section 6.6.
Maltese: Għall-immaniġġjar tal-prodott mediċinali, ara sezzjoni 6.6.
English: Optical coherence tomography abnormal
Maltese: Tomografija ta' koerenza ottika mhux normali
English: Electroretinographic (ERG) changes (a- and b-wave amplitude decrease) have been reported as a very common adverse reaction in patients injected with JETREA; in the majority of cases visual impairment and chromatopsia were also reported.
Maltese: Bidliet elettroretinografiċi (ERG) (tnaqqis fl-amplitudni tal-mewġ a- u b-) ġew irrappurtati bħala reazzjoni avversa komuni ħafna f'pazjenti injettati b'JETREA; fil-maġġoranza tal-każijiet ġew irrappurtati wkoll indeboliment fil-vista u kromatopsja.
English: In study TG-MV-014, a sub-set of 40 patients receiving JETREA systematically underwent ERG testing; the ERG changes which had developed in 16 out of 40 patients resolved in the majority of patients (13 out of 16).
Maltese: Fl-istudju TG-MV-014, sub-sett ta' 40 pazjent li kienu qed jirċievu JETREA sistematikament sarilhom ittestjar ERG; il-bidliet fl-ERG li żviluppaw f'16 minn 40 pazjent għaddew fil-maġġoranza tal-pazjenti (13 minn 16).
English: See section 4.4 for monitoring recommendations.
Maltese: Ara sezzjoni 4.4 għar-rakkomandazzjonijiet dwar il-monitoraġġ.
English: - Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.
Maltese: - Sintomi bħal varjazzjoni fil-vista, vista doppja, uġigħ ta' ras, ċrieki madwar id-dawl, dardir u rimettar ġew irrappurtati f'sa 1 minn kull 100 pazjent u jistgħu jkunu sinjali ta' spostament jew ċaqliq tal-lenti tal-għajn mill-pożizzjoni normali tagħha.
English: See section 4.4 of the Summary of Product Characteristics for instructions on post-injection monitoring.
Maltese: Ara sezzjoni 4.4 tas-Sommarju tal-Karatteristiċi tal-Prodott għal istruzzjonijiet dwar il-monitoraġġ ta' wara l-injezzjoni.
English: In the integrated data, the VMA resolution rate at Day 28 was higher in patients treated with JETREA compared to placebo in both the subgroup without ERM (37.4% vs. 14.3%, p<0.001) and with ERM (8.7% vs. 1.5%, p=0.046).
Maltese: 3%, p<0.001) kif ukoll f'dak b'ERM (8.7% kontra 1.5% , p=0.046).
English: Fertility There are no data on the effect of JETREA on fertility.
Maltese: Fertilità M'hemmx tagħrif dwar l-effett ta' JETREA fuq il-fertilità.
English: - The other ingredients are mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma mannitol, citric acid, sodium hydroxide (NaOH) (għall-aġġustament talpH) u ilma għall-injezzjonijiet.
English: Based on the proteolytic activity of ocriplasmin, preclinical and clinical findings, the potential for lens subluxation or phacodonesis cannot be ruled out.
Maltese: Abbażi tal-attività proteolitika ta' ocriplasmin, sejbiet prekliniċi u kliniċi, il-potenzjal ta' ċaqliq tal-lenti jew fakodonesi ma jistax ikun eskluż.
English: The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice.
Maltese: Jekk iseħħ dan l-avveniment, dan għandu jiġi kkurat skont il-prattika medika standard.
English: Uncommon side effects (may affect up to 1 in 100 patients): - transient severe decreased vision - difficulty in seeing well at night or in dim light - disturbance in your eye's reaction to the light that may increase your sensitivity to light (pupillary reflex impaired) - double vision - accumulation of blood in the front part of the eye - abnormal constriction of the pupil (black part in the centre of the eye) - different sized pupils - a scratch or scrape of the cornea (transparent layer that covers the front of the eye)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa pazjent 1 minn kull 100): - tnaqqis sever u temporanju fil-vista - diffikultà biex tara sew bil-lejl jew f'dawl baxx - disturb fir-reazzjoni ta' għajnek għad-dawl li jista' jżid is-sensittività tiegħek għad-dawl
English: Oxurion NV
Maltese: TAGĦRIF
English: Ethnicity Experience is limited in groups other than Caucasians.
Maltese: Etniċità L-esperjenza fi gruppi oħrajn minbarra l-Kawkasi hija limitata.
English: Because of the small dose administered (0.125 mg), detectable levels of ocriplasmin in systemic circulation are not expected after intravitreal injection.
Maltese: Minħabba d-doża żgħira mogħtija (0.125 mg), mhumiex mistennija livelli li jistgħu jiġu osservati ta' ocriplasmin fiċ-ċirkolazzjoni sistemika wara l-injezzjoni ġol-vitriju.
English: However, after treatment, a higher proportion of patients in the JETREA group had a change from an intact IS/OS band at baseline to an incomplete IS/OS band in the central area at a later time point compared with the sham group (7.7% and 2.8%, respectively at Day 28).
Maltese: Madankollu, wara t-trattament, proporzjon ogħla ta' pazjenti fil-grupp ta' JETREA kellhom bidla minn strixxa IS/OS intatta fil-linja bażi għal strixxa IS/OS mhux kompluta fl-erja ċentrali f'punt ta' żmien aktar tard meta mqabbel mal-grupp ta' injezzjoni mingħajr is-sustanza attiva (7.7% u 2.8%,
English: The proportion of patients who underwent vitrectomy for an event of VMA/VMT was 8.3% in the JETREA group compared to 19.2% in the sham group.
Maltese: Il-proporzjon ta' pazjenti li kellhom vitrektomija minħabba avveniment ta' VMA/VMT kien ta' 8.3% fil-grupp ta' JETREA meta mqabbel ma' 19.2% fil-grupp ta' injezzjoni mingħajr is-sustanza attiva.
English: In the JETREA group, 1 patient (0.7%) developed retinal tear and retinal detachment between Day 0 and Day 7 post-injection.
Maltese: Fil-grupp ta' JETREA, pazjent wieħed (0.7%) żviluppa tiċrita fir retina u distakk tar-retina bejn Jum 0 u Jum 7 wara l-injezzjoni.
English: Information on resolution of specific events such as chromatopsia and ERG changes can be found in the relevant paragraph of the ‘description of selected adverse reactions' section.
Maltese: Informazzjoni dwar lgħejbien ta' avvenimenti speċifiċi bħal kromatopsja u bidliet fl-ERG jistgħu jinstabu fil-paragrafu rilevanti tas-sezzjoni ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula'.
English: At Month 24, the proportion of patients with ≥ 2 lines improvement from baseline in BCVA was greater in the JETREA group than in the sham group (50.5% vs. 39.1%).
Maltese: F'Xahar 24, il-proporzjon ta' pazjenti b'titjib ta' ≥ 2 linji mil-linja bażi f'BCVA kien akbar fil-grupp ta' JETREA milli fil-grupp ta' injezzjoni mingħajr is sustanza attiva (50.5% vs.
English: The remaining sodium chloride 9 mg/mL (0.9%) solution for injection should be discarded.
Maltese: Il-bqija tas-soluzzjoni tal-sodium chloride 9 mg/mL (0.9%) għall-injezzjoni għandha tintrema.
English: Using aseptic technique, dilute by adding 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (sterile, preservative-free, non-buffered) into the JETREA vial and gently swirl the vial until the solutions are mixed.
Maltese: soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride (sterili, mingħajr preservattivi, mhux newtralizzata) fil-kunjett ta' JETREA u dawwar il-kunjett bil-mod sakemm jitħalltu s-soluzzjonijiet.
English: Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, while no inflammation or ERG changes were observed in minipigs.
Maltese: Ocriplasmin ikkawża rispons infjammatorju u bidliet ERG temporanji fil-fniek u x-xadini, filwaqt li ma ġiet osservata l-ebda infjammazzjoni jew bidla ERG fil-minipigs.
English: The intravitreal injection of JETREA may have a moderate influence on the ability to drive and use machines due to possible temporary visual disturbances (see section 4.8).
Maltese: L-injezzjoni ta' JETREA ġol-vitriju tista' jkollha effett moderat fuq il-ħila biex issuq u tħaddem magni minħabba l-possibbiltà ta'disturbi temporanji fil-vista (ara sezzjoni 4.8).
English: JETREA 0.375 mg/0.3 mL solution for injection ocriplasmin
Maltese: JETREA 0.375 mg/0.3 mL soluzzjoni għall-injezzjoni
English: EXP
Maltese: JETREA
English: Macular hole
Maltese: Mħallat