FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with mildly impaired renal function (creatinine clearance 50-80 ml/min) no dose adjustment is required.
Maltese: F'pazjenti b'funzjoni renali indebolita b'mod ħafif (tneħħija tal-kreatinina 50-80 ml/min) m'hemmx bżonn li tinbidel id-doża.
English: FREQUENCY ADVERSE REACTION Common
Maltese: FREKWENZA EFFETTI MHUX MIXTIEQA
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhoea).
Maltese: F'każ ta' sinjali u sintomi ta' simulazzjoni eċċessiva tas- Sistema Nervuża Ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas-sintomi bir-reqqa.
English: Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Maltese: Ħu pillola miksija b'rita waħda kuljum ta' 15 mg (oranġjo-griża, ovali-oblong) għal 7 t'ijiem.
English: - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Axura tablets (listed in section 6).
Maltese: - jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal memantine hydrochloride jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Maltese: • Fl-esperjenza wara t-tqegħid fis-suq, każijiet iżolati b'żidiet fil-proporzjon internazzjonali normalizzat (INR) kienu rrappurtati f'pazjenti li kienu qed jingħataw fl-istess waqt warfarin.
English: Package leaflet: Information for the user Axura 20 mg film-coated tablets
Maltese: Informazzjoni għall utent Axura 20 mg pilloli miksijin b'rita
English: Axura 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Maltese: Il-pilloli miksijin b'rita ta' 10 mg huma sofor ċari għal sofor, miksijin b'rita u b'forma ovali, b'xaqq minn fejn tista' taqsam il-pillola u mnaqqxin b' “1-0” fuq naħa waħda u b' “M M” fuq in-naħa l-oħra.
English: EMEA Number Invented Name Strength Pharmaceutical Form
Maltese: Qawwa Għamla Farmaċewtika
English: Packaging Content Package size Withdraw al period
Maltese: Kontenut Daqs talpakkett
English: AstraZeneca A/S Arne Jacobsens Allé 13 2300 København S Denmark
Maltese: AstraZeneca A/S Arne Jacobsens Allé 13 2300
English: Palazzo Galileo, Via F. Sforza, 20080 Basiglio (MI), Italy
Maltese: Palazzo Galileo, Via F. Sforza, 20080
English: AstraZeneca Kft., 1113 Budapest, Bocskai út 134-146., Hungary
Maltese: Bocskai út 134-146., Hungary
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi, Athens Greece
Maltese: Theotokopoulou & Astronafton str 151 25
English: AstraZeneca GmbH, 22876 Wedel, Germany
Maltese: Il-Ġermanja AstraZeneca GmbH, 22876 Wedel,
English: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom
Maltese: Ir-Renju Unit AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU,
English: Radnička cesta 80 10000 Zagreb Croatia
Maltese: AstraZeneca d.o.o. Radnička cesta 80 10000
English: 1, Place Renault 92844 Rueil-Malmaison Cedex, France
Maltese: Rueil-Malmaison Cedex, France
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien,
Maltese: L-Awstrija AstraZeneca Österreich GmbH, Schwarzenbergplatz 7,
English: AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway
Maltese: In-Norveġja AstraZeneca AS Postboks 6050,
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl
English: C/ Serrano Galvache 56, 28033 Madrid,
Maltese: AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, 28033 Madrid,
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110
English: AstraZeneca Pharmaceuticals AB, S-151 85 Södertälje, Sweden
Maltese: Il-Bulgarija AstraZeneca Pharmaceuticals AB, S-151 85 Södertälje, Sweden
English: AstraZeneca UK Ltd. 2 Kingdom Street, London W2 6BD, United Kingdom
Maltese: AstraZeneca UK Limited, 2 Kingdom Street, London W2 6BD, United Kingdom
English: CRESTOR 40 mg 40mg
Maltese: CRESTOR 40 mg
English: Denmark
Maltese: København S Denmark
English: Control, N = 10
Maltese: Kontroll, N = 10
English: System organ class / Frequency
Maltese: Sistema tal-Klassifika tal-Organi / Frekwenza
English: Spark Therapeutics Inc. 3737 Market Street, Suite 1300 Philadelphia
Maltese: 3737 Market Street, Suite 1300 Philadelphia
English: Difference (95% CI) (Intervention-Control) -2.33 (-3.44, -1.22), p<0.001
Maltese: Differenza (95 % CI) (Kontroll tal-Intervent) -2.33 (-3.44, -1.22), p<0.001
English: N Mean (SE)
Maltese: N Medjan (SE)
English: After receiving Luxturna:
Maltese: Wara li tingħata Luxturna:
English: XBL XD30 XD90 XD180
Maltese: XBL XJ30 XJ90 XJ180
English: vg voretigene neparvovec in a total volume of 300 μL.
Maltese: vg ta' voretigene neparvovec f'volum totali ta' 300 μL.
English: Followed by 5 days
Maltese: Segwit minn 5 ijiem
English: Store at ≤-65 ºC.
Maltese: Aħżen f'temperatura ta' ≤ -65 ºC.
English: The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Maltese: L-età medja kienet 15-il sena (firxa ta' bejn 4 u 44 sena) inklużi 64 % tal-individwi pedjatriċi (n=20, età minn 4 sa 17-il sena) u 36 % adulti (n=11).
English: Difference (95% CI) (Intervention-Control) -1.89 (-3.03, -0.75), p=0.002 Full-field light sensitivity testing - Averaged across both eyes (ITT) Difference (95% CI) (Intervention-Control): -2.11 (-3.19, -1.04), p<0.001
Maltese: Differenza (95 % CI) (Kontroll tal-Intervent) -1.89 (-3.03, -0.75), p=0.002 Medja tal-ittestjar għal sensittività għad-dawl f'kamp sħiħ fiż-żewġ għajnejn (ITT) Differenza (95 % CI) (Intervent-Kontroll): -2.11 (-3.19, -1.04), p<0.001
English: • Summary of Product Characteristics (SmPC);
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SmPC);
English: 30 June 2030
Maltese: 30 ta' Ġunju 2030
English: vector genomes (vg).
Maltese: vettur tal-ġenomi (vg).
English: BL: baseline;
Maltese: BL (Baseline) = BL (Linja Bażi)
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common ≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi permezz talkonvenzjoni li ġejja: 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: vector genomes of voretigene neparvovec.
Maltese: vettur tal-ġenomi ta' voretigene neparvovec.
English: BL D30 D90 D180
Maltese: BL J30 J90 J180
English: Table 2 Adverse reactions related to voretigene neparvovec
Maltese: Tabella 2 Reazzjonijiet avversi relatati ma' voretigene neparvovec
English: Figure 1A Subretinal injection cannula introduced via pars plana
Maltese: Figura 1A Kannula ta' injezzjoni taħt ir-retina introdotta mill-pars plana
English: Table 4 Changes in MLMT score: year 1, compared to baseline (ITT population: n=21 intervention, n=10 control)
Maltese: Tabella 4 Bidliet fil-punteġġ MLMT: meta mqabbel mal-linja bażi (popolazzjoni ITT: n=21 intervent, n=10 kontroll)
English: Prednisone (or equivalent) 1 mg/kg/day (maximum of 40 mg/day)
Maltese: Prednisone (jew ekwivalenti) 1 mg/kg/kuljum (massimu ta' 40 mg/kuljum)
English: 1 vial concentrate 2 vials solvent
Maltese: 2 kunjetti ta' solvent
English: Active intraocular inflammation.
Maltese: Infjammazzjoni attiva ġol-għajn.
English: XBL; XD30; XD90; XD180: baseline, 30, 90 and 180 days after start of study for control crossover group; XY1; XY2: one and two years after start of study for control crossover group.
Maltese: XJ30; XJ90; XJ180: linja bażi, 30, 90 u 180 jum wara l-bidu tal-istudju għall-grupp ta' kontroll b'bidla fittrattament waqt l-istudju;
English: • Retinal disorder (foveal thinning, loss of foveal function), macular hole, maculopathy (epiretinal membrane, macular pucker) and eye disorder (foveal dehiscence).
Maltese: • Disturb fir-retina (traqqiq tal-fovea, telf tal-funzjoni tal-fovea), toqba makulari, makulopatija (membrana epiretinali, macular pucker), u disturb fl-għajnejn (feriti miftuħa fil-fovea).
English: Endotracheal intubation complication, wound dehiscence
Maltese: Komplikazzjoni ta' intubazzjoni endotrakeali, qsim tal-ġrieħi
English: o Contact information for adverse event reporting.
Maltese: o Informazzjoni ta' kuntatt għal rapportar ta' avvenimenti avversi.
English: • Periodic Safety Update Reports
Maltese: • Rapporti Perjodiċi Aġġornati dwaris-Sigurtà
English: Prednisone (or equivalent) 0.5 mg/kg/day (maximum of 20 mg/day)
Maltese: Prednisone (jew ekwivalenti) 0.5 mg/kg/kuljum (massimu ta' 20 mg/kuljum)
English: The long-term safety and efficacy of Luxturna were assessed in a Phase 1 safety and dose escalation study (101), in which 12 subjects received unilateral subretinal injections of voretigene neparvovec; a follow-on study (102) in which voretigene neparvovec was administered to the contralateral eye in 11 of the 12 subjects who participated in the dose escalation study; a one-year, open-label Phase 3 controlled study (301) in which 31 subjects were randomised at two sites; and the continuation of the Phase 3 study, in which the 9 control subjects crossed over and received the intervention.
Maltese: Is-sigurtà u l-effikaċja fit-tul ta' Luxturna kienu vvalutati fi studju ta' sigurtà u żieda fid-doża ta' Fażi 1 (101), fejn 12-il individwu ngħataw injezzjonijiet unilaterali taħt ir-retina ta' voretigene neparvovec; studju ta' segwitu (102) li fih voretigene neparvovec ingħata fl-għajn kontrolaterali fi 11 mit-12-il individwu li pparteċipaw fl-istudju b'żieda fid-doża; studju kkontrollat ta' Fażi 3, b'tikketta miftuħa, ta' sena (301) li fih 31 individwu kienu randomizzati f'żewġ siti; u l-kontinwazzjoni talistudju ta' Fażi 3, li fih 9 individwi ta' kontroll biddlu u ngħataw l-intervent.
English: D30, D90, D180: 30, 90 and 180 days after start of study;
Maltese: J30, J90, J180: 30, 90 u 190 wara l-bidu tal-istudju;
English: XY1
Maltese: XS1
English: The retinal pigment epithelium-specific 65 kilodalton protein (RPE65) is located in the retinal pigment epithelial cells and converts all-trans-retinol to 11-cis-retinol, which subsequently forms the chromophore, 11-cis-retinal, during the visual (retinoid) cycle.
Maltese: Il-proteina 65 kilodalton speċifika għall-epitelju tal-pigmenti tar-retina (RPE65) tinsab fiċ-ċelloli epiteljali tal-pigmenti tar-retina u tikkonverti l-all-trans-retinol għal 11-cis-retinol, li sussegwentement tifforma l-kromofor, 11-cis-retinal, matul iċ-ċiklu (retinojde) viżiv.
English: XY2
Maltese: XS2
English: • Eye inflammation (including endophthalmitis), retinal tear and retinal detachment.
Maltese: • Infjammazzjoni fl-għajn (inkluża endoftalmite), tiċrita tar-retina u qlugħ tar-retina.
English: Each mL of concentrate contains 5 x 10
Maltese: Kull mL ta' konċentrat fih 5 x 10
English: Study 301 was an open-label, randomised, controlled study.
Maltese: Studju 301 kien studju kkontrollat, randomizzat u b'tikketta miftuħa.
English: Shedding
Maltese: Treddigħ
English: Solvent for Luxturna
Maltese: Solvent għal Luxturna
English: Immunomodulatory regimen
Maltese: Reġim immunomodulatorju
English: You may have temporary visual disturbances after receiving Luxturna.
Maltese: Jaf ikollok disturbi fil-vista temporanji wara li tirċievi Luxturna.
English: Accidental exposure must be avoided.
Maltese: Għandu jiġi evitat esponiment aċċidentali.
English: Excipients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, poloxamer 188, water for injections.
Maltese: Eċċipjenti: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, poloxamer 188, ilma għall-injezzjonijiet.
English: Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec (see section 6.6).
Maltese: Tagħmir personali protettiv (li jinkludi ġigaga tal-laboratorju, nuċċalijiet tas-sigurtà, u ingwanti) għandu jintlibes waqt ilpreparazzjoni jew l-għoti ta' voretigene neparvovec (ara sezzjoni 6.6).
English: Conjunctival hyperaemia, cataract
Maltese: Iperimija konġuntivali, katarretti
English: Retinal tear, dellen, macular hole, eye inflammation, eye irritation, eye pain, maculopathy, choroidal haemorrhage, conjunctival cyst, eye disorder, eye swelling, foreign body sensation in eyes, macular degeneration, endophthalmitis, retinal detachment, retinal disorder, retinal haemorrhage
Maltese: Tiċrita tar-retina, dellen, toqba makulari, infjammazzjoni flgħajn, irritazzjoni fl-għajn, uġigħ fl-għajnejn, makulopatija, emorraġija korojdali, cista konġuntivali, disturbi fl-għajnejn, nefħa fl-għajnejn, sensazzjoni ta' xi frak fl-għajnejn, deġenerazzjoni makulari, endoftalmite, qlugħ tar-retina, disturbi tar-retina, emorraġija tar-retina
English: Store and transport frozen at ≤-65 ºC.
Maltese: Aħżen u ttrasporta ffriżat f'temperatura ta' ≤ -65 ºC.
English: • Rash, facial swelling
Maltese: • Raxx, nefħa fil-wiċċ
English: The control group was administered voretigene neparvovec after 1 year of observation.
Maltese: Il-grupp ta' kontroll ingħata voretigene neparvovec wara sena ta' osservazzjoni.
English: A total of 41 subjects (81 eyes injected [one Phase 1 subject did not meet eligibility criteria for a second injection]) participated in the clinical programme.
Maltese: Total ta' 41 individwu (81 għajn injettati [individwu wieħed ta' Fażi 1 ma ssodisfax il-kriterji ta' eliġibbiltà għal injezzjoni oħra]) ipparteċipaw fil-programm kliniku.
English: - Treat all Luxturna spills with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
Maltese: - Ittratta kull tixrid ta' Luxturna b'aġent viruċidali bħal 1 % ta' sodium chloride u nixxef permezz ta' materjali assorbenti.
English: Y3
Maltese: S3
English: • After vitrectomy is completed, Luxturna is administered by subretinal injection using a subretinal injection cannula introduced via pars plana (Figure 1A).
Maltese: • Wara li titlesta l-vitrektomija, Luxturna jingħata b'injezzjoni taħt ir-retina permezz ta' kannula ta' injezzjoni taħt ir-retina introdotta mill-pars plana (Figura 1A).
English: • Cataract (clouding of the lens)
Maltese: • Kataretti (tidnis tal-lenti)
English: Y1
Maltese: S1
English: Clinical pharmacokinetics and shedding
Maltese: Farmakokinetika klinika u tixrid
English: Pharmacotherapeutic group: {not yet assigned}, ATC code: {not yet assigned}.
Maltese: {mhux assenjat} Kodiċi ATC:
English: Luxturna is a gene therapy product that contains the active substance voretigene neparvovec.
Maltese: Luxturna huwa prodott ta' terapija ġenetika li fih is-sustanza attiva voretigene neparvovec.
English: • Eye swelling
Maltese: L-Ewwel Sena
English: After dilution each dose of Luxturna contains 1.5 x 10
Maltese: Wara d-dilwizzjoni, kull doża ta' Luxturna fiha 1.5 x 10
English: Label the 10 mL glass vial containing the diluted concentrate as follows: ‘Diluted Luxturna'.
Maltese: Waħħal tikketta mal-kunjett tal-ħġieġ ta' 10 mL li fih il-konċentrat dilwit kif ġej: “Luxturna Dilwit”.
English: Y2
Maltese: S2
English: The corticosteroids may decrease the potential immune reaction to either vector capsid (adeno-associated virus serotype 2 [AAV2] vector) or transgene product (retinal pigment epithelial 65 kDa protein [RPE65]).
Maltese: Il-kortikosterojdi jistgħu jnaqqsu r-reazzjoni immuni potenzjali għal xi waħda millkapsidi tal-vettur (vettur tas-serotip 2 tal-vajrus adeno-assoċjat [AAV2]) jew prodott transġene (proteina tal-epitelju tal-pigmenti tar-retina 65 kDa [RPE65]).
English: 22 November 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 22 Novembru 2018
English: As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Maltese: Bћala prekawzjoni huwa preferribli li voretigene neparvovec ma jintużax waqt it-tqala.
English: Accidental exposure
Maltese: Esponiment aċċidentali
English: For instructions for preparation, accidental exposure to and disposal of Luxturna, see section 6.6.
Maltese: Għall-istruzzjonijiet għall-preparazzjoni, għall-esponiment aċċidentali u r-rimi ta' Luxturna, ara sezzjoni 6.6.
English: • All spills of voretigene neparvovec must be treated with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials.
Maltese: • Kull tixrid ta' voretigene neparvovec għandu jiġi ttrattat b'aġent viruċidali bħal 1 % ta' sodium hypochlorite u jitnixxef permezz ta' materjali assorbenti.
English: Sodium dihydrogen phosphate monohydrate (for pH adjustment) Disodium hydrogen phosphate dihydrate (for pH adjustment) Poloxamer 188
Maltese: Sodium dihydrogen phosphate monohydrate (għall-aġġustament tal-pH) Disodium hydrogen phosphate dihydrate (għall-aġġustament tal-pH) Poloxamer 188
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Retinal deposits
Maltese: Depożiti retinali
English: Treatment should be initiated and administered by a retinal surgeon experienced in performing macular surgery.
Maltese: Il-kura għandha tinbeda u tingħata minn kirurgu retinali esperjenzat fit-twettiq ta' kirurġija makulari.
English: • Breakdown of the surgical wound
Maltese: • Ftuħ mill-ġdid tal-ferità kirurġika
English: Table 3 Adverse reactions related to administration procedure
Maltese: Tabella 3 Reazzjonijiet avversi relatati mal-proċedura ta' għoti
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu ta' voretigene neparvovec f'nisa tqal.
English: The most common adverse reactions (incidence ≥5%) related to the administration procedure were conjunctival hyperaemia, cataract, increased intraocular pressure, retinal tear, dellen, macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain and maculopathy (wrinkling on the surface of the macula).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (inċidenza ta' ≥5 %) relatati mal-proċedura tal-għoti kienu iperimija konġuntivali, katarretti, żieda fil-pressjoni ġol-għajn, tiċrita tar-retina, dellen, toqba makulari, depożiti taħt ir-retina, infjammazzjoni fl-għajn, irritazzjoni fl-għajn, uġigħ fl-għajn, u makulopatija (tikmix fuq il-wiċċ tal-makula).
English: One of 41 (2%) subjects reported a serious event of intraocular pressure increased (secondary to administration of depo-steroid) that was associated with treatment for endophthalmitis related to the administration procedure and resulted in optic atrophy, and one of 41 (2%) subjects reported a serious event of retinal disorder (loss of foveal function) that was assessed as related to the administration procedure.
Maltese: Wieħed minn 41 (2 %) individwu rrappurta avveniment serju ta' pressjoni aktar għolja ġol-għajn (sekondarju għall-għoti ta' depo-sterojde) li kien assoċjat ma' kura għal endoftalmite relatata mal-proċedura tal-għoti u rriżulta f'atrofija ottika, u wieħed minn 41 (2 %) individwu rrappurta avveniment serju ta' disturb fir-retina (telf tal-funzjoni tal-fovea) li kien ivvalutat bħala relatat mal-proċedura tal-għoti.
English: The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Maltese: Il-persunal ikkwalifikat (jiġifieri kirurgi vitreoretinali u spiżjara) fiċ-ċentri ta' kura għandu jiġi pprovdut b'materjal edukattiv inkluż:
English: Presence of a clinical pharmacy capable of handling and preparing AAV vector-based gene therapy products;
Maltese: Preżenza ta' spiżerija klinika li tista' timmaniġġa u tipprepara prodotti ta' terapija ġenetika bbażata fuq il-vettur AAV;
English: Important information about some of the ingredients of Luxturna Luxturna contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Informazzjoni importanti dwar xi wħud mill-ingredjenti ta' Luxturna Luxturna fih inqas minn 1 mmol ta' sodju (23 mg) f'kull doża, eż. essenzjalment huwa “mingħajr sodju”.
English: The active substance in Luxturna, voretigene neparvovec, is a modified virus that contains a working copy of the RPE65 gene.
Maltese: Is-sustanza attiva f'Luxturna, voretigene neparvovec, huwa vajrus immodifikat li fih kopja funzjonali tal-ġene RPE65.
English: • You will not be able to donate blood, organs, tissues and cells for transplantation after you have been treated with Luxturna.
Maltese: • Mhux se tkun tista' tagħti d-demm, organi, tessuti, u ċelloli għal trapjant wara li tkun ġejt ikkurat b'Luxturna.
English: In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
Maltese: Fl-istudju ta' Fażi 3, lMLMT uża seba' livelli ta' illuminazzjoni li jvarjaw minn 400 lux sa 1 lux (li jikkorrispondu, pereżempju, għal uffiċċju mdawwal sew sa lejl sajfi mingħajr qamar).
English: Voretigene neparvovec is a gene transfer vector that employs an adeno-associated viral vector serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina.
Maltese: Voretigene neparvovec huwa vettur li jittrasferixxi l-ġeni li juża kapsida ta' serotip 2 ta' vettur virali adeno-assoċjat (AAV2) bħala mezz ta' għoti għas-CDNA tal-proteina tal-epitelju tal-pigmenti tarretina tal-bniedem 65 kDa fir-retina.
English: Visual acuity (LogMAR) of the first eye of these subjects at baseline was 1.29 (0.21), mean (SE).
Maltese: L-akutezza viżiva (LogMAR) tal-ewwel għajn ta' dawn l-individwi fil-linja bażi kienet ta' 1.29 (0.21), medja (SE).
English: Difference (95% CI) Intervention-Control p-value using binocular vision using assigned first eye only using assigned second eye only
Maltese: Differenza (95% CI) Kontroll tal-Intervent valur-p permezz tal-viżjoni binokulari permezz tal-ewwel għajn assenjata biss permezz tat-tieni għajn assenjata biss
English: Overall, transient and low levels of vector DNA were detected in tear and occasional serum samples from 14/29 (48%) of subjects in the Phase 3 study.
Maltese: Kumplessivament, livelli temporanji u baxxi tad-DNA tal-vettur kienu misjuba fil-kampjuni tad-dmugħ u xi drabi fis-serum minn 14/29 (48 %) individwu fl-istudju ta' Fażi 3.
English: Low levels of vector DNA sequences were detected in the optic nerve of the vector-injected eye, optic chiasm, spleen and liver, and sporadically in the stomach and lymph nodes.
Maltese: Livelli baxxi ta' sekwenzi tad-DNA tal-vettur nstabu fin-nerv ottiku tal-għajn injettata bil-vettur, il-chiasm ottiku, il-milsa u l-fwied, u sporadikament fl-istonku u n-noduli limfatiċi.
English: Vector DNA sequences were detected in serum in 3/29 (10%) subjects, including two with positive tear samples, and only up to day 3 following each injection.
Maltese: Sekwenzi tad-DNA tal-vettur kienu misjuba fis-serum fi 3/29 (10 %) individwu, inkluż tnejn b'kampjuni ta' dmugħ pożittivi, u sat-tielet jum biss wara kull injezzjoni.
English: Visual acuity (LogMAR) of the first eye of these subjects at baseline was 1.18 (0.14), mean (SE).
Maltese: L-akutezza viżiva (LogMAR) tal-ewwel għajn ta' dawn l-individwi fil-linja bażi kienet ta' 1.18 (0.14), medja (SE).