FrancophonIA/ELRC3.0 huggingface dataset:
English: vg (5 times the recommended per eye dose), vector DNA sequences were detected in colon, duodenum and trachea.
Maltese: vg (5 darbiet id-doża rrakkomandata għal kull għajn), sekwenzi tad-DNA tal-vettur instabu fil-kolon, fidduwodenu u t-trakea.
English: The concentrate (0.5 mL extractable volume in a single-dose 2 mL vial) requires a 1:10 dilution prior to administration.
Maltese: Il-konċentrat (0.5 mL ta' volum li jista' jiġi estratt f'kunjett ta' doża waħda ta' 2 mL) jeħtieġ dilwizzjoni 1:10 qabel l-għoti.
English: One of 41 (2%) subjects reported a serious event of retinal detachment that was assessed as related to the administration procedure.
Maltese: Wieħed minn 41 (2 %) individwu rrapporta avveniment serju ta' qlugħ tar-retina li ġie vvalutat bħala relatat mal-proċedura tal-għoti.
English: • Surgical education for LUXTURNA administration, including description of materials and procedures needed to perform LUXTURNA subretinal injection or • Pharmacy training manual, including information on LUXTURNA preparation and storage;
Maltese: • Edukazzjoni kirurġika għall-għoti ta' LUXTURNA, inkluża deskrizzjoni tal-materjali u l proċeduri meħtieġa biex titwettaq l-injezzjoni taħt ir-retina ta' LUXTURNA
English: Each single-dose 2 mL vial of Luxturna contains 0.5 extractable mL of concentrate which requires a 1:10 dilution prior to administration, see section 6.6.
Maltese: Kull kunjett ta' 2 mL ta' doża waħda ta' Luxturna fih 0.5 mL li jista' jiġi estratt ta' konċentrat li għandu bżonn dilwizzjoni ta' 1:10 qabel l-għoti, ara sezzjoni 6.6.
English: At baseline, subjects achieved pass marks on the mobility test at between 4 and 400 ambient lux.
Maltese: Fil-linja bażi, l-individwi kisbu l-marki minimi meħtieġa fit-test tal-mobbiltà f'bejn 4 u 400 lux ambjentali.
English: Full-field light sensitivity testing - Second assigned eye (ITT) Intervention, N = 21
Maltese: Ittestjar għal sensittività għad-dawl f'kamp sħiħ - It-tieni għajn assenjata (ITT) Intervent, N = 21
English: The MAH shall ensure that in each Member State (MS) where LUXTURNA is marketed, the product is distributed through treatment centres where qualified staff (i.e. vitreoretinal surgeons and pharmacists) have participated in the mandatory educational program about use of the product and pharmacy training, in order to ensure LUXTURNA correct use so as to minimise the risks associated with its administration and/or the administration procedure (increased intraocular pressure, retinal tear, macular disorders, cataract, intraocular inflammation and/or infection related to the procedure and retinal detachment, third party transmission).
Maltese: L-MAH għandu jiżgura li f'kull Stat Membru fejn LUXTURNA jitqiegħed fis-suq, il-prodott jitqassam permezz ta' ċentri ta' kura fejn persunal ikkwalifikat (jiġifieri kirurgi u spiżjara vetreoretinali) ikunu pparteċipaw fil-programm edukattiv obbligatorju dwar l-użu tal-prodott u t-taħriġ lill-ispiżjara, sabiex jiġi żgurat l-użu korrett ta' LUXTURNA sabiex jitnaqqsu kemm jista' jkun irriskji assoċjati mal-għoti u/jew il-proċedura tal-għoti (pressjoni akbar ġol-għajn, tiċrita tar-retina, disturbi makulari, katarretti, infjammazzjoni ġol-għajn u/jew infezzjoni relatata mal-proċedura u lqlugħ tar-retina, trażmissjoni minn parti terza).
English: vector genomes/mL concentrate for solution for injection voretigene neparvovec
Maltese: vettur tal-ġenomi/mL konċentrat għal soluzzjoni għal injezzjoni voretigene neparvovec
English: Luxturna is a sterile concentrate solution for subretinal injection that requires thawing and dilution prior to administration (see section 6.6).
Maltese: Luxturna huwa soluzzjoni ta' konċentrat sterili għal injezzjoni taħt ir-retina li jeħtieġ dewbien u dilwizzjoni qabel l-għoti (ara sezzjoni 6.6).
English: Voretigene neparvovec is expected to be taken up by cells through heparin sulphate proteoglycan receptors and be degraded by endogenous proteins and DNA catabolic pathways.
Maltese: Voretigene neparvovec huwa mistenni li jittieħed miċ-ċelloli permezz tar-riċetturi ta' heparin sulphate proteoglycan u jiġi ddegradat minn proteini endoġeni u l-passaġġi kataboliċi tad-DNA.
English: vector genomes/mL concentrate and solvent for solution for injection voretigene neparvovec
Maltese: vettur tal-ġenomi/mL konċentrat u solvent għal soluzzjoni għal injezzjoni voretigene neparvovec
English: Figure 1B Tip of the subretinal injection cannula placed within the recommended site of injection (surgeon's view)
Maltese: Figura 1B Ponta tal-kannula tal-injezzjoni taħt ir-retina mqiegħda fis-sit irrakkomandat talinjezzjoni (dak li jara l-kirurgu)
English: Each dose of diluted solution contains 1.5 x 10
Maltese: Kull doża ta' soluzzjoni dilwita fiha 1.5 x 10
English: Prepare the syringes for injection by drawing 0.8 mL of the diluted solution into each sterile 1 mL syringe.
Maltese: Ipprepara s-siringi għall-injezzjoni billi tiġbed 0.8 mL mis-soluzzjoni dilwita f'kull siringa sterili ta' 1 mL.
English: At one year after exposure to voretigene neparvovec, improvement in visual acuity of at least 0.3 LogMAR occurred in 11/20 (55%) of the first-treated eyes and 4/20 (20%) of the second-treated eyes in the intervention group; no one in the control group displayed such an improvement of visual acuity in either the first or second eye.
Maltese: Sena wara l-esponiment għal voretigene neparvovec, titjib fl-akutezza viżiva ta' mill-inqas 0.3 LogMAR seħħ fi 11/20 (55 %) tal-għajnejn ikkurati l-ewwel u 4/20 (20 %) tal-għajnejn ikkurati ttieni fil-grupp ta' intervent; l-ebda wieħed fil-grupp ta' kontroll ma wera dak it-titjib fl-akutezza viżiva la fl-ewwel u lanqas fit-tieni għajn.
English: Elderly
Maltese: Inferjuri
English: Presence of a specialist ophthalmologist with expertise in care and treatment of patients with inherited retinal dystrophy (IRD);
Maltese: Preżenza ta' oftalmologu speċjalizzat b'kompetenza fil-kura u t-trattament ta' pazjenti b'distrofija tar-retina li tintiret (IRD);
English: 31 subjects were enrolled, 13 males and 18 females.
Maltese: Wieħed u tletin individwu kienu rreġistrati, 13-il raġel u 18-il mara.
English: The highest levels of vector DNA sequences were detected in intraocular fluids (anterior chamber fluid and vitreous) of vector-injected eyes.
Maltese: L-ogħla livelli tas-sekwenzi tad-DNA tal-vettur instabu fil-fluwidi ġol-għajn (il-fluwidu talkompartiment anterjuri u l-vitriju) tal-għajnejn injettati bil-vettur.
English: Each box represents the middle 50% of distribution of MLMT score change.
Maltese: Kull kaxxa tirrappreżenta in-nofs tal-50 % tad-distribuzzjoni tal-bidla fil-punteġġ MLMT.
English: Luxturna is injected directly into the eye. Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of the product.
Maltese: Il-funzjoni tal-fwied u l-kliewi, il-polimorfiżmi taċċitokromu P450 u t-tixjiħ mhumiex mistennija li jinfluwenzaw l-effikaċja klinika jew is-sigurtà talprodott.
English: Mutations in the RPE65 gene lead to reduced or absent RPE65 all-trans-retinyl isomerase activity, blocking the visual cycle and resulting in vision loss.
Maltese: Il-mutazzjonijiet fil-ġene RPE65 iwasslu għal tnaqqis fl-attività RPE65 all-trans-retinyl isomerase jew l-ebda attività, u dan jimblokka ċ-ċiklu viżiv u jirriżulta f'telf tal-vista.
English: There were three non-serious adverse reactions of retinal deposits in three of 41 (7%) subjects that were considered to be related to voretigene neparvovec.
Maltese: Kien hemm tliet reazzjonijiet avversi mhux serji ta' depożiti retinali fi tlieta mill-41 (7 %) individwu li kienu kkunsidrati bħala relatati ma' voretigene neparvovec.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodju (23 mg) f'kull doża, jiġifieri essenzjalment huwa “mingħajr sodju”.
English: Individuals with biallelic RPE65 mutation-associated retinal dystrophy exhibit vision loss, including impaired visual function parameters such as visual acuity and visual fields often during childhood or adolescence; this loss of vision ultimately progresses to complete blindness.
Maltese: L-individwi b'distrofija retinali assoċjata ma' mutazzjoni RPE65 bijallelika juru telf fil-vista, inkluż indeboliment tal-parametri tal-funzjoni viżiva bħalma huma l-akutezza viżiva u l-kampi viżivi ħafna drabi waqt it-tfulija jew l-adoloxxenza; dan it-telf tal-vista finalment javvanza sakemm il-pazjent ma jibqax jara għal kollox.
English: Confirmed biallelic RPE65 mutations and the presence of sufficient viable retinal cells (an area of retina within the posterior pole of >100 micron thickness, as estimated by optical coherence tomography [OCT]) were established for all participants.
Maltese: Mutazzjonijiet PRE65 bijalleliċi kkonfermati u l-preżenza ta' biżżejjed ċelloli retinali vijabbli (parti mir-retina fil-punt ta' wara bi ħxuna ta' > 100 micron, kif stmat mit-tomografija ta' koerenza ottika [OCT]), kienu stabbiliti għall-parteċipanti kollha.
English: Y1, Y2, Y3: one, two and three years after start of study;
Maltese: S1, S2, S3: sena, sentejn u tliet snin wara l-bidu tal-istudju;
English: • Connect the syringe containing the diluted product to the tubing and microcannula.
Maltese: • Qabbad is-siringa li fiha l-prodott dilwit mat-tubu u l-mikrokannula.
English: • Detachment of the retina
Maltese: • Depożiti taħt ir-retina
English: Presence of or affiliation with a retinal surgeon experienced in sub-retinal surgery and capable of administrating LUXTURNA;
Maltese: Preżenza ta' jew affiljazzjoni ma' kirurgu tar-retina esperjenzat fil-kirurġija taħt ir-retina u li kapaċi jagħti LUXTURNA;
English: 1.7 mL extractable volume
Maltese: 1.7 mL volum li jista' jiġi estratt
English: Electrocardiogram T wave inversion Injury, poisoning and procedural complications Common
Maltese: Inverżjoni tal-mewġa elettrokardjogramma T Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Komuni
English: It should not be administered in the immediate vicinity of the fovea to maintain foveal integrity (see section 4.4).
Maltese: Dan għandu jingħata qrib eżatt tal-fovea biex tinżamm l-integrità tal-fovea (ara sezzjoni 4.4).
English: Change in MLMT score
Maltese: .8 Effetti mhux mixtieqa
English: Figure 1 Tip of the subretinal injection cannula placed within recommended injection site (surgeon's view)
Maltese: Figura 1 Ponta tal-kannula tal-injezzjoni taħt ir-retina mqiegħda fis-sit tal-injezzjoni rrakkomandat (dak li jara l-kirurgu)
English: Nonclinical biodistribution
Maltese: Trocar talvitrektomija
English: Each single dose of 1.5 x 10
Maltese: Kull doża waħda ta' 1.5 x 10
English: Transfer 2.7 mL of solvent taken from the two thawed vials and dispense into a sterile 10 mL empty glass vial using a 3 mL syringe.
Maltese: Ittrasferixxi 2.7 mL mis-solvent meħud miż-żewġ kunjetti maħlula u ferrgħu f'kunjett tal-ħġieġ sterili ta' 10 mL permezz ta' siringa ta' 3 mL.
English: The solvent contains sodium chloride (see end of section 2), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate dihydrate (for pH adjustment), poloxamer 188 and water for injections.
Maltese: Is-solvent fih sodium chloride (ara tmiem is-sezzjoni 2), sodium dihydrogen phosphate monohydrate (għall-aġġustament tal-pH), disodium hydrogen phosphate dihydrate (għallaġġustament tal-pH), poloxamer 188 u ilma għall-injezzjonijiet.
English: Injection of voretigene neparvovec into the subretinal space results in transduction of retinal pigment epithelial cells with a cDNA encoding normal human RPE65 protein (gene augmentation therapy), providing the potential to restore the visual cycle.
Maltese: L-injezzjoni ta' voretigene neparvovec fl-ispazju taħt ir-retina tirriżulta fit-trasduzzjoni taċ-ċelloli epiteljali tal-pigmenti tar-retina bi proteina RPE65 normali tal-bniedem li tikkodifika s-cDNA (terapija ta' awmentazzjoni tal-ġeni), li tipprovdi l-potenzjal biex jitreġġa' lura ċ-ċiklu viżiv.
English: The recommended site of injection should be located along the superior vascular arcade, at least 2 mm distal to the centre of the fovea (Figure 1B).
Maltese: Is-sit irrakkomandat tal-injezzjoni għandu jinsab tul l-arkata vaskulari superjuri, tal-inqas 2 mm mix-xifer taċ-ċentru tal-fovea (Figura 1B).
English: This leaflet is available as an audio file and in a large print from the web site: http://www.voretigeneneparvovec.support
Maltese: Dan il-fuljett huwa disponibbli fuq fajl tal-awdjo u b'tipa kbira mis-sit elettroniku: http://www.voretigeneneparvovec.support
English: • Change of the electrical activity of the heart
Maltese: • Bidla fl-attività elettrika tal-qalb
English: • Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec.
Maltese: • Tagħmir protettiv personali (li għandu jinkludi ġigaga tal-laboratorju, nuċċalijiet tas-sigurtà, u ingwanti) għandu jintlibes waqt il-preparazzjoni jew l-għoti ta' voretigene neparvovec.
English: For dilution, transfer 0.3 mL of thawed concentrate into a 1 mL syringe and add it to the 10 mL sterile vial containing the solvent.
Maltese: Għad-dilwizzjoni, ittrasferixxi 0.3 mL ta' konċentrat maħlul f'siringa ta' 1 mL u żidu ma' kunjett sterili ta' 10 mL li fih is-solvent.
English: For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara t-tidwib u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme.
Maltese: Reazzjonijiet avversi serji relatati mal-proċedura ta' għoti kienu rrappurtati fi tliet individwi matul ilprogramm kliniku.
English: 1.7 mL extractable volume of solvent in a 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.
Maltese: 1.7 mL ta' volum li jista' jiġi estratt ta' solvent f'2 mL ta' kunjett ta' polimeru ta' olefin ċikliku b'tapp tal-lasktu tal-chlorobutyl imwaħħal f'postu b'siġill tal-aluminju li jista' jinqala'.
English: Concentrate and solvent must be stored and transported frozen at ≤-65 ºC.
Maltese: Il-konċentrat u s-solvent għandhom jinħażnu u jiġu ttrasportati ffriżati f'temperatura ta' ≤ -65 ºC.
English: Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
Maltese: Luxturna jintuża għall-kura ta' adulti u tfal b'telf tal-vista minħabba distrofija retinali ereditarja kkawżata mill-mutazzjonijiet fil-ġene RPE65.
English: Transient and low-level vector shedding may occur in patient tears (see section 5.2).
Maltese: L-ebda aġġustament fid-doża mhuwa meħtieġ f'dawn il-pazjenti (ara sezzjoni 5.2).
English: The primary endpoint of the Phase 3 study measured the mean change from baseline to one year in binocular multi-luminance mobility testing (MLMT) between the intervention and control groups.
Maltese: Il-punt ta' tmiem primarju tal-istudju ta' Fażi 3 kejjel il-bidla medja mil-linja bażi sa sena f'ittestjar tal-mobbiltà tal-multiluminanza binokulari (MLMT) bejn il-gruppi tal-intervent u tal-kontroll.
English: In one animal administered with Luxturna at 7.5 x 10
Maltese: F'annimal wieħed mogħti Luxturna f'7.5 x 10
English: In an earlier toxicology study, a similar AAV2 vector administered subretinally in dogs at a dose of 10 times the recommended dose resulted in focal retinal toxicity and inflammatory cell infiltrates histologically in regions exposed to the vector.
Maltese: Fi studju tossikoloġiku li sar qabel, vettur AAV2 simili mogħti taħt ir-retina fi klieb b'doża 10 darbiet aktar mid-doża rrakkomandata rriżulta f'tossiċità tar-retina fokali u infiltrati taċ-ċelloli infjammatorji istoloġikament f'postijiet esposti għall-vettur.
English: The safety and efficacy of voretigene neparvovec in patients ≥65 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' voretigene neparvovec f'pazjenti ≥ 65 sena ma ġewx determinati s'issa.
English: AAV2-hRPE65v2-LTFU-01: In order to further evaluate the long-term efficacy and safety outcomes of Luxturna in adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations, the applicant should submit the long-term efficacy and safety follow-up of trial participants who received Luxturna in the clinical programme (15-year follow-up).
Maltese: Sabiex tiġi evalwata aktar l-effikaċja fit-tul u r-riżultati tas-sigurtà ta' Luxturna f'pazjenti adulti u pedjatriċi b'telf talvista minħabba distrofija tar-retina li tintiret kkawżata minn mutazzjonijiet RPE65 bijalleliċi kkonfermati, l-applikant għandu jissottometti l-effikaċja fit-tul u s-segwitu għas-sigurtà ta' parteċipanti fil-prova li rċevew Luxturna fil-programm kliniku (segwitu ta' 15-il sena).
English: • You may have temporary visual disturbances, such as light sensitivity, and blurred vision.
Maltese: • Jista' jkollok disturbi temporanji fil-vista, bħal sensittività għad-dawl u vista mċajpra.
English: o Inform healthcare professionals that the patient has received gene therapy, and the importance of reporting adverse events.
Maltese: o Li tinforma lill-professjonisti tal-kura tas-saħħa li l-pazjent irċieva terapija ġenetika, u limportanza li jirrapporta avvenimenti avversi.
English: • Problems associated with the placement of a breathing tube in the windpipe
Maltese: • Problemi assoċjati mat-tqegħid ta' tubu tan-nifs fil-pajp tan-nifs
English: The pupil of the eye to be injected must be dilated and a broad-spectrum microbicide should be topically administered prior to the surgery according to standard medical practice.
Maltese: Il-ħabba tal-għajn li tkun se tiġi injettata trid tkun dilatata, u għandu jingħata b'mod topiku mikrobiċidu bi spettru wiesgħa qabel l-operazzjoni skont il-prattika medika standard.
English: 4 days (including the day of administration)
Maltese: 4 ijiem (inkluż il-jum tal-għoti)
English: To reduce the potential for immunogenicity patients should receive systemic corticosteroids before and after the subretinal injection of voretigene neparvovec to each eye (see section 4.2).
Maltese: Biex jitnaqqas il-potenzjal għall-immunoġeniċità, il-pazjenti għandhom jirċievu kortikosterojdi sistemiċi qabel u wara l-injezzjoni taħt ir-retina ta' voretigene neparvovec f'kull għajn (ara sezzjoni 4.2).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingћata b'riċetta speċjali u ristretta tat-tabib (ara Anness I: Sommarju talKaratteristiċi tal-Prodott, sezzjoni 4.2.
English: Change
Maltese: Manifattur
English: - Personal protective equipment (to include laboratory coat, safety glasses and gloves) should be worn while preparing or administering voretigene neparvovec.
Maltese: - Tagħmir protettiv personali (li jinkludi ġigaga tal-laboratorju, nuċċalijiet tas-sigurtà u ingwanti) għandu jintlibes waqt il-preparazzjoni jew l-għoti ta' voretigene neparvovec.
English: Thaw one single-dose vial of concentrate and two single-use vials of solvent at room temperature.
Maltese: Ħoll kunjett wieħed ta' doża waħda ta' konċentrat u żewġ kunjetti ta' solvent f'temperatura tal-kamra.
English: All participants had a clinical diagnosis of Leber congenital amaurosis, and some may have also had prior or additional clinical diagnoses, including retinitis pigmentosa.
Maltese: Il-parteċipanti kollha kellhom dijanjożi klinika ta' amaurosis konġenitali ta' Leber, u xi wħud jaf kellhom ukoll dijanjożi klinika minn qabel jew addizzjonali, inkluża retinitis pigmentosa.
English: • Headache, dizziness
Maltese: • Uġigħ ta' ras, sturdament
English: • Break in the retina
Maltese: • Tiċrita tar-retina
English: The product is slowly injected through the tubing and microcannula to eliminate any air bubbles in the system.
Maltese: Il-prodott jiġi injettat bilmod mit-tubu u l-mikrokannula biex tiġi eliminata kwalunkwe bużżieqa tal-arja mis-sistema.
English: Prior to launch of LUXTURNA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Maltese: Qabel ma jniedi LUXTURNA f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) għandu jaqbel dwar il-kontenut u l-format tal-programm edukattiv, inklużi l-mezzi ta' komunikazzjoni, il-modalitajiet ta' distribuzzjoni u kwalunkwe aspett ieħor tal-programm, malAwtorità Nazzjonali Kompetenti (NCA).
English: Table 5 Full-field light sensitivity testing
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Luxturna
English: The interval between injection to the eyes for each subject was from 6 to 18 days.
Maltese: L-intervall bejn linjezzjoni fl-għajnejn għal kull individwu kien ta' bejn 6 u 18-il jum.
English: For single administration by subretinal injection into one (1) eye.
Maltese: Konċentrat u solvent għal soluzzjoni għal injezzjoni kunjett (1) ta' konċentrat
English: Results of full-field light sensitivity testing at the first study year: white light [Log10(cd.s/m2)] are shown in Table 5 below.
Maltese: Ir-riżultati tal-ittestjar għal sensittività għad-dawl f'kamp sħiħ fl-ewwel sena ta' studju: dawl abjad [Log10(cd.s/m2)] huma murija fit-Tabella 5 hawn taħt.
English: Patients will receive a single dose of 1.5 x 10
Maltese: Kull għajn ingħatat injezzjoni waħda taħt irretina ta' 1.5 x 10
English: What Luxturna is and what it is used for What you need to know before you are given Luxturna How Luxturna is given to you Possible side effects
Maltese: X'għandek tkun taf qabel ma tingħata Luxturna Kif għandek tingħata Luxturna Effetti sekondarji possibbli Kif taħżen Luxturna
English: Patients should be instructed to avoid air travel or other travel to high elevations until the air bubble formed as a result of administration of Luxturna has completely dissipated from the eye. A time period of up to one week or more following injection may be required before dissipation of the air bubble; this should be verified on ophthalmic examination.
Maltese: LMLMT kien iddisinjat biex ikejjel il-bidliet fil-viżjoni funzjonali, b'mod speċifiku l-abbiltà ta' individwu li jimxi tul perkors b'mod preċiż u b'pass raġonevoli f'livelli differenti ta' illuminazzjoni ambjentali.
English: Rash, swelling face
Maltese: Raxx, nefħa tal-wiċċ
English: Three secondary endpoints were also tested: full-field light sensitivity threshold (FST) testing using white light; the change in MLMT score for the first assigned eye; and visual acuity (VA) testing.
Maltese: Ġew ittestjati wkoll tliet punti ta' tmiem sekondarji: ittestjar tal-livell limitu għas-sensittività tad-dawl f'kamp sħiħ (FST) bl-użu ta' dawl abjad; il-bidla fil-punteġġ ta' MLMT għall-ewwel għajn assenjata; u ttestjar tal-akutezza viżiva (VA).
English: o Patient card will be available in alternative formats including large print and as an audio file.
Maltese: o Il-kard tal-pazjent tkun disponibbli f'formati alternattivi inkluż stampar b'tipa kbira u bħala fajl awdjo.
English: Phase 3 study
Maltese: Studju ta' Fażi 3
English: • Nausea (feeling sick), vomiting, abdominal (belly) pain, lip pain
Maltese: • Dardir (tħossok ma tiflaħx), rimettar, uġigħ fl-addome (żaqqek), uġigħ fix-xufftejn
English: Children and adolescents Luxturna has not been studied in children under four years of age.
Maltese: Tfal u adolexxenti Luxturna ma ġiex studjat fi tfal li għandhom inqas minn erba' snin.
English: POUCH
Maltese: UŻU
English: Ask your doctor whether you should stop breast-feeding after receiving Luxturna.
Maltese: Bћala prekawzjoni, m'għandekx tirċievi Luxturna waqt li tkun tqila.