FrancophonIA/ELRC3.0 huggingface dataset:
English: CGM substudy: 2-hr PPG and time in range
Maltese: Sottostudju CGM: PPG wara sagħtejn u ħin fil-medda
English: Following administration of multiple doses (400 and 800 mg dose), the median Tmax values ranged from 2.5 to 4 hours.
Maltese: Wara għoti ta' ħafna dożi (doża ta' 400 u 800 mg), il-valuri tal-medjan tat-Tmax kienu jvarjaw minn 2.5 sa 4 sigħat.
English: • DKA may occur in patients treated with sotagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl), i.e. an explanation of the concept of euglycaemic DKA.
Maltese: • DKA tista' sseħħ f'pazjenti ttrattati b'sotagliflozin anke jekk il-livelli tal-glucose huma taħt l14-il mmol/l (250 mg/dl), i.e. spjegazzjoni tal-kunċett ta' DKA b'livell normali ta' glucose fiddemm.
English: How to store Zynquista
Maltese: Jekk tieqaf tieħu Zynquista
English: Patient Alert Card Patient Alert Card
Maltese: Valutazzjonijiet tal-awrina fil-laboratorju
English: Bolus insulin dose (units/day) Baseline, mean % Change from baseline,
Maltese: Differenza mill-insulna waħedha, medja ta' LS % (valur p)
English: 14 mmol/l (250 mg/dl).
Maltese: 32 mmol/l) f'ġimgħa 24.
English: Hypoglycaemia
Maltese: Doża maqbuża
English: Table 4: Results at 24-week trial with sotagliflozin in patients with type 1 diabetes mellitus inadequately controlled on insulin (Study 1 - Study 2)
Maltese: Tabella 4: Riżultati ta' prova ta' 24 ġimgħa b'sotagliflozin f'pazjenti b'dijabete mellitus tat-tip 1 li mhijiex ikkontrollata b'mod xieraq bl-insulina (Studju 1 - Studju 2)
English: An increase in total exposure and Cmax of rosuvastatin of ca 1.2- and 1.4-fold, respectively, was demonstrated when co-administered with sotagliflozin and is not deemed clinically relevant.
Maltese: Intweriet żieda ta' madwar 1.2 u 1.4 drabi, rispettivament, fl-esponiment totali u fis-Cmax ta'
English: Exposure at the rat no-observedeffect level was 40-times the exposure at the MRHD.
Maltese: 40 darba aktar mill-esponimiment bl-MRHD.
English: • If addition of sotagliflozin leads to marked reduction of insulin need, discontinuation of sotagliflozin should be considered to avoid high risk of DKA.
Maltese: • Jekk iż-żieda ta' sotagliflozin twassal għal tnaqqis kbir fil-ħtieġa tal-insulina, għandu jitqies it twaqqif ta' sotagliflozin biex jiġi evitat ir-riskju ta' DKA.
English: In study 1, a total of 793 patients entered the study.
Maltese: Fi studju 1, ġew irreġistrati total ta' 793 pazjent fl-istudju.
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet jkollha jkunu fis-suq.
English: - Correction of volume depletion prior to initiation of sotagliflozin is recommended in patients with this condition (see section 4.4).
Maltese: - Il-korrezzjoni ta' tnaqqis fil-volum qabel il-bidu ta' sotagliflozin huwa rrakkomandat f'pazjenti b'din il-kondizzjoni (ara sezzjoni 4.4).
English: • How to measure ketones, how to interpret the results and what to do in case of hyperketonaemia/DKA (contact HCP immediately if BHB > 0.6 mmol/L with symptoms or if BHB > 1.5 mmol/L with or without symptoms).
Maltese: (ikuntattja Professjonist fil-Qasam tal-Kura tas-Saħħa immedjatament jekk BHB > 0.6 mmol/L bis-sintomi jew jekk BHB > 1.5 mmol/L bis-sintomi jew mingħajrhom).
English: After starting therapy, the frequency of ketone level testing (either blood or urine) should be individualized, according to the patient's lifestyle and/or risk factors (see section 4.4).
Maltese: Wara li tibda t-terapija, il-frekwenza tal-ittestjar tal-livell tal-keton (fiddemm jew fl-awrina) għandha jiġi individwalizzata, skont l-istil ta' ħajja tal-pazjent u/jew il-fatturi ta' riskju (ara sezzjoni 4.4).
English: • Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA, sotagliflozin should be discontinued.
Maltese: • Pazjenti b'DKA b'livell normali ta' glucose fid-demm għandhom jirċievu glucose, insulina u fluwidi għal DKA, sotagliflozin għandu jitwaqqaf.
English: This treatment is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with T1DM with a BMI ≥27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Maltese: Dan it-trattament huwa indikat biex jiżdied mat-terapija tal-insulina sabiex itejjeb il-kontroll gliċemiku f'adulti b'T1DM li għandhom BMI ≥27 kg/m2, li ma kisbux kontroll gliċemiku xieraq minkejja l-aħjar terapija bl-insulina.
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi tad-dijabete għandu jitqies f'każ ta' sintomi mhux speċifiċi bħal nawsja, rimettar, anoreksja, uġigħ fl-addome, għatx eċċessiv, diffikultà biex tieħu n-nifs, konfużjoni, għeja jew ngħas mhux tas-soltu.
English: In study 2, a total of 782 patients entered the study.
Maltese: Fl-istudju 2, ġew irreġistrati total ta' 782 pazjent fl-istudju.
English: Percent Time in range 3.9-10.0 mmol/L Baseline (after 6-week insulin optimisation) , LS mean Change from baseline, LS mean Difference from insulin alone, LS mean % (p-value)
Maltese: Bidla mil-linja bażi, medja ta' LS Differenza mill-insulna waħedha, medja ta' LS % (valur p)
English: Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure.
Maltese: Pazjenti li jużaw pompa għall-infużjoni tal-insulina għandhom riskju akbar ta' DKA u għandu jkollhom esperjenza fl-użu tal-pompa, fl-strateġiji biex isolvu problemi komuni li jistgħu jinaqalgħu meta jseħħ waqfien temporanju fl-għoti tal-insulina permezz tal-pompa (problemi bil-post fejn tidħol, pajpijiet miżduda, reservoir vojt, eċċ.) u fl-użu ta' injezzjonijiet supplimentari tal-insulina b'pinna jew siringa kif meħtieġ f'każ li l-pompa ma taħdimx.
English: Insulin may increase the risk of hypoglycaemia.
Maltese: L-insulina tista' żżid ir-riskju ta' ipogliċemija.
English: The doctor may decide to temporarily stop the treatment with Zynquista.
Maltese: It-tabib jista' jiddeċiedi li jwaqqaf it-trattament b'Zynquista b'mod temporanju.
English: • Contact details of the sotagliflozin ‘prescriber' and ‘Name of patient'.
Maltese: • Dettalji biex tikkuntattja ‘min ordna' sotagliflozin u ‘L-isem tal-pazjent'.
English: Hypotension/ volume depletion
Maltese: Pazjenti b'indeboliment tal-kliewi
English: If ketones are elevated (blood beta-hydroxybutyrate (BHB) reading is greater than 0.6 mmol/L or urine ketones one plus (+)) treatment with sotagliflozin should not be initiated nor the dose should be increased to sotagliflozin 400 mg until the ketone levels are normal (see sections 4.4).
Maltese: Jekk il-ketoni jkunu għoljin (qari ta' BHB jkun aktar minn 0.6 mmol/L), ittrattament b'sotagliflozin m'għandux jinbeda sakemm il-livelli tal-keton jkunu normali (ara sezzjoni 4.2).
English: For the first meal on Day 1, patients were instructed to decrease their calculated (or usual) mealtime carbohydrate bolus insulin by 30%.
Maltese: Għall-ewwel ikla f'Jum 1 il-pazjenti ngħataw istruzzjonijiet biex inaqqsu bi 30% l-insulina kalkulata
English: FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED Belasis Avenue
Maltese: DIOSYNTH BIOTECHNOLOGIES UK LIMITED Belasis Avenue
English: (Figure 1).
Maltese: (Figura 1).
English: 2) including scotoma
Maltese: 2) inkluż skotoma
English: Use thawed solution by: ----- / ----- / ----
Maltese: Uża s-soluzzjoni maħlula sa: ----- / ----- / ----
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 December 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Marzu 2013 Data tal-aħħar tiġdid: 8 ta' Diċembru 2017
English: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven Belgium
Maltese: Oxurion NV Gaston Geenslaan 1 B-3001 Leuven
English: Sodium chloride (NaCl) Mannitol
Maltese: Sodium chloride (NaCl)
English: • Key signs and symptoms of serious adverse events
Maltese: • Sinjali u sintomi ewlenin ta' avvenimenti avversi serji
English: - The active substance is ocriplasmin.
Maltese: - Is-sustanza attiva hi ocriplasmin.
English: At Month 24, the proportions were 48/145 (33.3%) and 32/73 (43%), respectively.
Maltese: F'Xahar 24, il-proporzjonijiet kienu 48/145 (33.3%) u 32/73 (43%), rispettivament.
English: Store in a freezer.
Maltese: Aħżen fil-friża.
English: No systemic interactions are anticipated.
Maltese: Mhumiex previsti interazzjonijiet sistemiċi.
English: Retinogram abnormal
Maltese: Retinogramma mhux normali
English: The difference for improvement in the general vision sub-scale score was statistically significant (6.1 JETREA vs. 2.1 placebo, p=0.024).
Maltese: Id-differenza għat-titjib fil-punteġġ sottoskala ġenerali tal-vista kienet statistikament sinifikanti (6.1 JETREA kontra 2.1 plaċebo, p=0.024).
English: *Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system.
Maltese: *Ocriplasmin huwa forma maqtugħa ta' plażmin tal-bniedem magħmul permezz ta' teknoloġija rikombinanti tad-DNA f'sistema ta' espressjoni Pichia pastoris.
English: Figure 1: Proportion of patients with VMA resolution up to Day 180 (Month 6) (TG-MV-006, TG-MV-007 and integrated data)
Maltese: Figura 1: Proporzjon ta' pazjenti b'fejqan tal-VMA sal-180 Jum (is-6 Xahar) (TG-MV-006, TG-MV-007 u dejta integrata)
English: These include optical coherence tomography (OCT), ophthalmoscopy (foveal reflex), colour vision test (Roth 28-hue) and full-field ERG.
Maltese: Dawn jinkludu tomografija ta' koerenza ottika (OCT - optical coherence tomography), oftalmoskopija (rifless foveal), test tal-vista tal-kuluri (Roth 28-hue) u full-field ERG.
English: Study TG-MV-014
Maltese: Studju TG-MV-014
English: Jetrea contains the active substance ocriplasmin.
Maltese: Jetrea fih is-sustanza attiva ocriplasmin.
English: At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001
Maltese: Il-ġranet kollha ta' wara l-injezzjoni, p≤0.024 f'TG-MV-006, p≤0.009 f'TG-MV-007, p≤0.001 f'dejta integrata
English: The clinical efficacy and safety of JETREA for the treatment of vitreomacular traction (VMT) was assessed in 3 double-masked studies.
Maltese: L-effikaċja klinika u s-sigurtà ta' JETREA għat-trattament ta' ġbid vitreomakulari (VMTvitreomacular traction) kienu evalwati fi 3 studji double-masked.
English: The safety findings observed in study TG-MV-009 were consistent with the known safety profile for JETREA.
Maltese: Is-sejbiet ta' sigurtà osservati fl-istudju TG-MV-009 kienu konsistenti mal-profil tas-sigurtà magħruf għal JETREA.
English: When administered intravenously, ocriplasmin enters the endogenous protein catabolism pathway through which it is rapidly inactivated via its interactions with protease inhibitor α2-antiplasmin or α2-macroglobulin.
Maltese: Meta jingħata ġol-vini, ocriplasmin jidħol fil-passaġġ tal-kataboliżmu tal-proteini endoġeni li permezz tiegħu jiġi inattivat b'mod rapidu permezz tal-interazzjonijiet tiegħu mal-inibitur protease α2-antiplasmin jew α2-macroglobulin.
English: Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, water for injections.
Maltese: Sodium chloride, mannitol, citric acid, sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet.
English: (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Studies TG-MV-006 and TG MV-007
Maltese: TG-MV-006 u TG MV-007
English: 1 vial contains 0.375 mg ocriplasmin in 0.3 mL solution (1.25 mg/mL).
Maltese: 1 kunjett fih 0.375 mg ta' ocriplasmin f'0.3 mL ta' soluzzjoni (1.25 mg/mL).
English: A total of 652 patients (JETREA 464, placebo 188) were randomised in these 2 studies.
Maltese: Total ta' 652 pazjent (JETREA 464, plaċebo 188) intgħażlu b'mod każwali f'dawn iż-żewġ studji.
English: ≥ 3 lines in BCVA without vitrectomy favoured JETREA at Month 6 (23.7% vs. 11.2%, p<0.001 for a gain ≥ 2 lines and 9.7% vs. 3.7%, p=0.008 for a gain ≥ 3 lines).
Maltese: Barra dan il-proporzjon ta' pazjenti li ggwadanjaw ≥ 2 jew ≥ 3 linji fil-BCVA mingħajr vitrektomija iffavorixxa JETREA f'Xahar 6 (23.7% kontra 11.2%, p<0.001 għal gwadann ta' ≥ 2 linji u 9.7% kontra 3.7%, p=0.008 għal gwadann ta' ≥ 3
English: 1 vial contains 0.5 mg ocriplasmin.
Maltese: 1 kunjett fih 0.5 mg ta' ocriplasmin.
English: JETREA 0.5 mg/0.2 mL sterile concentrate ocriplasmin
Maltese: JETREA 0.5 mg/0.2 mL konċentrat sterili ocriplasmin
English: Very common Retinogram abnormal*, colour vision test abnormal†
Maltese: Retinogramma mhux normali*, test tal-vista tal-kuluri mhux normali†
English: Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein matrix responsible for the abnormal vitreomacular adhesion (VMA).
Maltese: Ocriplasmin għandu attività proteolitika kontra l-komponenti tal-proteina tal-materja tal-vitriju u s-superfiċje vitreoretinali (VRI) (eż. laminin, fibronectin u collagen) u jimmira li jħoll il-matriċi tal-proteina responsabbli għat-twaħħil vitreomakulari mhux normali (VMA).
English: In the integrated data, full-thickness macular hole (FTMH) was present at baseline in 106/464 (22.8%) patients and 47/188 (25%) patients in the JETREA and placebo groups, respectively.
Maltese: Fid-dejta integrata, toqba fil-makula ta' ħxuna sħiħa (FTMH - full-thickness macular hole) kienet preżenti fil-linja bażi f'106/464 (22.8%) pazjent u f'47/188 (25%) pazjent fil-gruppi ta' JETREA u tal-plaċebo, rispettivament.
English: The recommended dose is 0.125 mg.
Maltese: Id-doża rrakkomandata hija 0.125 mg.
English: Combined Placebo
Maltese: Plaċebo
English: Lens subluxation/phacodonesis
Maltese: Ċaqliq tal-lenti/fakodonesi
English: Mannitol, citric acid, sodium hydroxide, water for injections.
Maltese: Mannitol, citric acid, sodium hydroxide, ilma għall-injezzjonijiet.
English: In a clinical study in patients scheduled for vitrectomy receiving 0.125 mg JETREA (corresponding to a theoretical start concentration of 29 µg/mL vitreous), mean ocriplasmin activity was 9% of theoretical start concentration 2-4 hours after injection and below the lower level of quantification at 7 days.
Maltese: Fi studju kliniku f'pazjenti skedati għal vitrektomija li ngħataw 0.125 mg JETREA (li jikkorrispondi għal konċentrazzjoni teoretika inizjali ta' 29 µg/mL vitriju), l-attività medja ta' ocriplasmin kienet ta' 9%
English: The inactive ocriplasmin/α2-antiplasmin complex is cleared from the circulation with a half-life (t1/2) of several hours.
Maltese: Il-kumpless ocriplasmin/α2-antiplasmin inattiv jiġi eliminat miċ-ċirkolazzjoni b'half-life (t1/2) ta' diversi sigħat.
English: JETREA has not been studied in patients with large diameter macular holes (> 400 microns), high myopia (> 8 dioptre spherical correction or axial length > 28 mm), aphakia, history of rhegmatogenous retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including laser therapy), proliferative diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions, exudative age-related macular degeneration (AMD) and vitreous haemorrhage.
Maltese: JETREA ma ġiex studjat f'pazjenti b'toqob ta' dijametru kbir fil-makula (>400 mikron), mijopija għolja (korrezzjoni sferika ta' >8 dioptre jew tul assjali >28 mm), afakja, storja ta' stakkar regmatoġenus tar-retina, nuqqas ta' stabilità taz-zonule tal-lenti, kirurġija jew injezzjoni reċenti fl-għajnejn (inkluża t-terapija bil-lejżer), retinopatija dijabetika proliferattiva, retinopatiji iskemiċi, okklużjonijiet tal-vini tar-retina, deġenerazzjoni makulari eżudattiva marbuta mal-età (AMD) u emorraġija fil-vitriju.
English: See section 4.4 for instructions on post-injection monitoring.
Maltese: Ara sezzjoni 4.4 għal istruzzjonijiet dwar il-monitoraġġ ta' wara l-injezzjoni.
English: The injection needle should be inserted 3.5-4.0 mm posterior to the limbus aiming towards the centre of the vitreous cavity avoiding the horizontal meridian.
Maltese: Il-labra tal-injezzjoni għandha tiddaħħal 3.5-4.0 mm wara l-limbus f'direzzjoni lejn iċ-ċentru tal-ħofra tal-vitriju filwaqt li jiġi evitat il-meridjan orizzontali.
English: Store in a freezer (-20 °C ± 5 °C).
Maltese: Aħżen fil-friża (-20
English: After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.
Maltese: Wara dilwizzjoni b'0.2 mL ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, 0.1 mL tas-soluzzjoni dilwita jkun fiha 0.125 mg ocriplasmin.
English: The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA 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) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi b'possibbiltà raġonevoli ta' relazzjoni kawżali mal-proċedura tal-injezzjoni jew ma' JETREA huma elenkati skont is-sistema tas-sistema tal-klassifika tal-organi tal-MedDRA u skont il-frekwenza: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: % VMA Resolution
Maltese: % ta' Fejqan tal- VMA
English: No reproductive toxicology studies have been performed.
Maltese: Ma sar l-ebda studju riproduttiv tossikoloġiku.
English: Visual acuity reduced*, visual impairment1), visual field defect2), vision blurred, retinal haemorrhage, vitreous haemorrhage, macular hole*, macular degeneration, retinal degeneration, macular oedema3), retinal oedema4), retinal pigment epitheliopathy, metamorphopsia, conjunctival oedema, eyelid oedema, vitritis, anterior chamber cell, anterior chamber flare, iritis, photopsia, conjunctival hyperaemia, ocular hyperaemia, vitreous detachment, eye irritation, dry eye, foreign body sensation in eyes, eye pruritus, ocular discomfort, photophobia, lacrimation increased
Maltese: Tnaqqis fl-akutezza tal-vista*, indeboliment fil-vista1), difett fil-kamp viżiv2), vista mċajpra, emorraġija fir-retina, emorraġija fil-vitriju, toqba fil-makula*, deġenerazzjoni tal-makula, deġenerazzjoni tar-retina, edima fil-makula3), edima fir-retina4), epiteljopatija tal-kulur tar-retina, metamorfopsja, edima konġuntivali, edima fil-kappell tal-għajn, vitrite, ċelluli kompartimentali anterjuri, tgħammix kompartimentali anterjuri, irite, fotopsja, iperimja konġuntivali, iperimja okulari, il-vitriju jinqala', irritazzjoni fl-għajn, għajn tinħass xotta, sensazzjoni ta' frak fl-għajnejn, ħakk fl-għajnejn, skumdità fl-għajnejn, fotofobija, żieda fid-dmugħ
English: The clinical data on the effects of JETREA overdose are limited.
Maltese: Id-dejta klinika dwar l-effetti ta' doża eċċesiva ta' JETREA hija limitata.
English: In study TG-MV-014, events of macular hole (including both progression and new onset) were reported in 15.8% JETREA vs. 13.5% sham recipients at Month 24.
Maltese: Fi studju TG-MV-014, avvenimenti ta' toqba fil-makula (inklużi progressjoni kif ukoll bidu ġdid) ġew irrappurtati fi 15.8% tal-pazjenti li rċevew JETREA vs. 13.5% tal-pazjenti li rċevew injezzjoni mingħajr is-sustanza attiva f'Xahar 24.
English: In study TG-MV-014, incomplete Inner Segment/Outer Segment (IS/OS) band, also referred to as Ellipsoid Zone, in the central area was very common at baseline (65.8% in the JETREA group and 62.2% in the sham group).
Maltese: Inner Segment/Outer Segment), magħrufa wkoll bħala Żona Ellipsojda, fl-erja ċentrali kienet komuni ħafna fil-linja bażi (65.8% fil-grupp ta' JETREA u 62.2% fil-grupp ta' injezzjoni mingħajr is-sustanza attiva).
English: Sodium hydroxide (NaOH) (for pH adjustment) Hydrochloric acid (HCl) (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (NaOH) (għall-aġġustament tal-pH) Hydrochloric acid (HCl) (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Pharmacotherapeutic group: Ophthalmologicals, Other ophthalmologicals, ATC code: S01XA22
Maltese: Oftalmoloġiċi, Oftalmoloġiċi oħrajn, Kodiċi ATC:
English: (17.1% and 6.4%) (p=0.003 and p=0.024, respectively).
Maltese: 6%, rispettivament; p=0.016).
English: The ≥ 2 or ≥ 3 lines gain in BCVA without vitrectomy favoured JETREA over sham both at Month 6 (26.8%, 14.0%, vs. 15.62%, 6.2%, respectively) and Month 24 (31.9%, 16.8%, vs. 11,7%, 4.1%, respectively).
Maltese: 62%, 6.2%, rispettivament) kif ukoll f'Xahar 24 (31.9%, 16.8%, vs. 11,7%, 4.1%, rispettivament).
English: 3) including cystoid macular oedema
Maltese: 3) inkluż edima makulari ċistojde 4) inkluż fluwidu taħt ir-retina
English: A single intravitreal injection of 0.175 mg (above the recommended dose), or placebo, was injected in the mid-vitreous of 24 eyes of children aged 0 to 16 years, 30 to 60 minutes prior to the planned start of vitrectomy.
Maltese: Injezzjoni waħda ġol-vitriju ta' 0.175 mg (ogħla mid-doża rrakkomandata), jew plaċebo, ġew injettati fil-vitriju tan-nofs ta' 24 għajn ta' tfal b'età minn 0 sa 16-il sena, 30 sa 60 minuta qabel il-bidu ppjanat tal-vitrektomija.
English: After dilution, 0.1 mL contains 0.125 mg ocriplasmin.
Maltese: Wara d-dilwizzjoni, 0.1 mL fih 0.125 mg ta' ocriplasmin.
English: At Month 24, 51.4% of JETREA patients had a ≥ 5 points improvement in VFQ-25 composite score compared to 30.1% in the sham group.
Maltese: 51.4% tal-pazjenti fuq JETREA kellhom titjib ta' ≥ 5 punti fil-punteġġ tal-kompost VFQ-25 meta mqabbel ma' 30.1% fil-grupp ta' injezzjoni mingħajr is-sustanza attiva.
English: Transient increases in IOP including transient blindness and non-perfusion of the optic nerve have been seen within 60 minutes of injection of JETREA.
Maltese: Żidiet temporanji fl-IOP inkluża għama temporanja u nuqqas ta' perfużjoni tan-nerv ottiku ġew osservati fi żmien 60 minuta mill-injezzjoni b'JETREA.
English: The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA > 1500 microns (see section 5.1).
Maltese: [PVD - posterior vitreous detachment]) huwa anqas f'individwi b'membrana epiretinali (ERM) jew b'dijametru tal-VMA ta' >1500 mikron (ara sezzjoni 5.1).
English: In this study, FTMH was present at baseline in 50/145 (34.5%) and 26/73 (35.6%) patients in the JETREA and sham groups, respectively.
Maltese: F'dan l-istudju, FTMH kienet preżenti fil-linja bażi f'50/145 (34.5%) pazjent u f'26/73 (35.
English: Ocriplasmin is a proteolytic enzyme with serine protease activity which could be present in the eye for several days after intravitreal injection (see section 5.2).
Maltese: Ocriplasmin huwa enzima proteolitika b'attività tas-serine protease li tista' tkun preżenti fl-għajn għal bosta ġranet wara l-injezzjoni ġol-vitriju (ara sezzjoni 5.2).
English: Very common Vitreous floaters, eye pain, conjunctival haemorrhage, chromatopsia*
Maltese: Komuni ħafna Depożiti fil-vitriju, uġigħ fl-għajn, emorraġija konġuntivali, kromatopsja*
English: Combined JETREA
Maltese: Jetrea.
English: 5) events occurring pre-vitrectomy † using the Roth 28-hue colour vision test. See also section 4.4.
Maltese: 5) avvenimenti li jseħħu qabel il-vitrektomija † bl-użu tat-test tal-vista tal-kuluri Roth 28-hue.
English: JETREA 0.375 mg/0.3 mL injection ocriplasmin
Maltese: JETREA 0.375 mg/0.3 mL injezzjoni ocriplasmin