FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you have an active infection which your doctor thinks is important.
Maltese: • Jekk inti għandek infezzjoni attiva li t-tabib tiegħek jikkunsidraha importanti.
English: Paediatric patients 6 years and older with plaque psoriasis The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate to severe plaque psoriasis.
Maltese: Pazjenti pedjatriċi ta' 6 snin u aktar bi psorijasi tal-plakka
English: p = 0.012 for ustekinumab 45 mg in comparison with etanercept.
Maltese: 012 għal ustekinumab 45 mg meta mqabbel ma' etanercept.
English: ACR 50 response, N (%) ACR 70 response, N (%) Number of patients with ≥ 3% BSA PASI 75 response, N (%) PASI 90 response, N (%) Combined PASI 75 and ACR 20 response, N (%)
Maltese: Fil-pazjenti randomised mill-ġdid għall-plaċebo u li reġgħu bdew il-kura b'ustekinumab li kellhom oriġinarjament wara telf ta' ≥ 50% ta' titjib PASI, 85% reġgħu kisbu rispons PASI 75 fi żmien 12-il ġimgħa wara li reġgħu bdew il-kura.
English: a 220 (86%) a 228 (91%) 234 (96%)
Maltese: L-Istudju tal-Psorijasi 1 Numru ta' pazjenti randomised Rispons PASI 50 N (%) 26 (10%) 213 (84%) a 220 (86%) a 228 (91%) 234 (96%)
English: STELARA 45 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
Maltese: STELARA 45 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 45 mg ustekinumab f'0.5 mL.
English: In Crohn's disease, dose adjustment from 90 mg every 12 weeks to 90 mg every 8 weeks was associated with an increase in trough serum ustekinumab concentrations and an accompanying increase in efficacy.
Maltese: Crohn, aġġustament fid-doża minn 90 mg kull 12-il ġimgħa għal 90 mg kull 8 ġimgħat ġie assoċjat ma' żieda fl-inqas konċentrazzjonijiet ta' ustekinumab fis-serum u żieda fl-effikaċja.
English: The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis (see section 4.4).
Maltese: L-iktar reazzjonijiet avversi serji li ġew irrappurtati għal STELARA kienu reazzjonijiet serji ta' sensittività eċċessiva li jinkludu anafilassi (ara sezzjoni 4.4).
English: Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.
Maltese: Riżultati serji kienu jinkludu insuffiċjenza respiratorja u rikoverar fit-tul l-isptar.
English: • If you ever had an allergic reaction to Stelara.
Maltese: • Jekk qatt kellek xi reazzjoni allerġika għal Stelara.
English: In Psoriasis Study 1, improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in each ustekinumab treatment group compared with placebo.
Maltese: Fl-Istudju tal-Psorijasi 1, titjib fil-psorijasi tad-difer (l-Indiċi tal-Qawwa tal-Psorijasi fid-Difer), titjib fil-punteġġi tas-sommarju tal-komponenti fiżiċi u mentali tal-SF-36 u titjib fl-iSkala Analoga Viżwali (VAS) tal-Ħakk kienu wkoll sinifikanti f'kull grupp ta' kura b'ustekinumab meta mqabbel ma' plaċebo.
English: Tel.: + 48 22 237 60 00
Maltese: Janssen-Cilag Polska Sp. z o.o. Tel.: + 48 22 237 60 00
English: In patients with Crohn's disease and ulcerative colitis, variability in ustekinumab clearance was affected by body weight, serum albumin level, sex, and antibody to ustekinumab status while body weight was the main covariate affecting the volume of distribution.
Maltese: F'pazjenti bil-marda ta' Crohn u kolite ulċerattiva, varjabilità fit-tneħħija ta' ustekinumab kienet affettwata mill-piż tal-ġisem, mil-livell tal-albumina fis-serum, CRP, stat ta' falliment tal-antagonist ta' TNF, sess, razza (Asjatika kontra mhux Asjatika), u stat ta' antikorp għall-ustekinumab waqt li lpiż tal-ġisem kien il-ko-varjant ewlieni li jaffettwa l-volum ta' distribuzzjoni.
English: EMA/764285/2015 EMEA/H/C/000697
Maltese: EMA/770217/2015 EMA/H/C/000697
English: Suboxone buprenorphine / naloxone
Maltese: Suboxone buprenorfina / naloxone
English: It is available as sublingual tablets containing 2 mg buprenorphine and 0.5 mg naloxone, 8 mg buprenorphine and 2 mg naloxone, or 16 mg buprenorphine and 4 mg naloxone.
Maltese: Jiġi f'pilloli bojod sublingwali li jkun fihom 2mg buprenorfina u 0.5 mg naloxone, 8 mg buprenorfina u 2 mg naloxone, jew 16 mg buprenorfina u 4 mg naloxone. ‘Sublingwali' tfisser li l-pilloli jitpoġġew taħt l-ilsien imbagħad jinħallu.
English: The recommended starting dose is one or two tablets of Suboxone 2 mg/0.5 mg.
Maltese: Id-doża inizjali rrakkomnadata hija pillola waħda jew tnejn ta' Suboxone 2 mg/0.5 mg.
English: This document is a summary of the European public assessment report (EPAR) for Suboxone.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Suboxone.
English: Suboxone contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs).
Maltese: Suboxone fih żewġ sustanzi attivi: il-buprenorfina, li hija agonista tal-oppjojdi parzjali (jiġifieri taġixxi bħal oppjojdi) u n-naloxone, antagonista tal-oppjojdi (sustanza li tiġġieled l-effetti tal-oppjojdi).
English: What is Suboxone?
Maltese: X'inhu Suboxone?
English: Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with 5.8% of the patients receiving placebo.
Maltese: Suboxone kien effettiv daqs il-buprenorfina waħedha u iktar effettiv mill-plaċebo: 17.8% tal-pazjenti li ngħataw Suboxone kellhom kampjuni ta' awrina li rriżultaw fin-negattiv fit-tmiem tal-istudju, meta mqabbla ma' perċentwal ta' 5.8% għall-pazjenti ttrattati bil-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone on 26 September 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Suboxone fis-26 ta' Settembru 2006.
English: In patients who have mild to moderately reduced liver function lower starting doses are recommended.
Maltese: Pazjenti li jbatu minn funzjoni tal-fwied moderatament imnaqqsa huwa rrakkomandat li jingħataw dażi inizjali iktar baxxi.
English: The most common side effects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome.
Maltese: L-effetti sekondarji l-aktar komuni b'Suboxone (li dehru f'aktar minn pazjent 1 minn 10) huma insonnja (diffikultà biex torqod), stitikezza, nawżea (dardir), għaraq, uġigħ ta' ras u sintomi ta' astinenza.
English: The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo.
Maltese: L-iskor tax-xenqiet li kien bejn 62.4 u 65.6 qabel bdiet il-kura, niżel għal 29.8 fi tmiem tal-istudju ta' Suboxone, meta mqabbla ma' 55.1 ta' dawk li ħadu l-plaċebo.
English: What is the risk associated with Suboxone?
Maltese: X'riskji huma assoċjati ma' Suboxone?
English: Why has Suboxone been approved?
Maltese: Għaliex ġie approvat Suboxone?
English: The full EPAR for Suboxone can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports For more information about treatment with Suboxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Maltese: L-EPAR sħiħ ta' Suboxone jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Għal aktar tagħrif rigward il-kura bi Glustin, aqra lfuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: A risk management plan has been developed to ensure that Suboxone is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Suboxone jintuża bl-aktar mod sigur possibbli.
English: The CHMP noted that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuse of the medicine.
Maltese: Is-CHMP nnota li l-kombinazzjoni ta' oppjojde analogu ma' oppjojde antagonista hija strateġija stabbilita għat-tnaqqis tal-użu ħażin potenzjali tal-mediċina.
English: Suboxone is a medicine that contains two active substances, buprenorphine and naloxone.
Maltese: Suboxone huwa mediċina li fiha żewġ sustanzi attivi, buprenorfina u naloxone.
English: This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Maltese: Dan minħabba, li meta jkun injettat, in-naloxone jikkumbatti l-effetti tal-oppjojdi, u jikkawża sintomi ta' astinenza fil-pazjent.
English: Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support.
Maltese: Suboxone jintuża fl-adulti u fiż-żgħażagħ minn 15-il sena 'l fuq li jkunu qed jingħataw ukoll appoġġ mediku, soċjali u psikoloġiku.
English: One main study compared Suboxone with buprenorphine on its own or with placebo (a dummy treatment) in 326 heroin-dependent patients for four weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study.
Maltese: Studju ewlieni qabbel Suboxone mal-buprenorfina waħedha jew flimkien ma' plaċebo (kura finta) fi 326 pazjent dipendenti mill-eroina fuq medda ta' erba' ġimgħat, u kejjel il-persentaġġ ta' pazjenti li ma kellhomx traċċi ta' oppjojdi fl-awrina tagħhom fl-aħħar tal-istudju.
English: The tablets must never be swallowed but should be placed under the tongue and allowed to dissolve, which usually takes five to 10 minutes.
Maltese: Il-pilloli ma għandhom qatt jibelgħu, iżda għandhom jitpopġġew taħt l-ilsien u jinħallu, proċess li normalment jieħu bejn ħames u 10 minuti.
English: How has Suboxone been studied?
Maltese: Kif ġie studjat Suboxone?
English: It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption), delirium tremens (a condition caused by alcohol withdrawal) or together with medicines known as opioid antagonists used for the treatment of alcohol or opioid dependence.
Maltese: Lanqas ma għandu jintuża f pazjenti b'intossikazzjoni qawwija tal-akoħol (konsum eċċessiv tal-alkoħol), delirium tremens (kondizzjoni kkawżata mill-astinenza mill-akoħol) jew flimkien ma' mediċini bħall-oppjojde antagonisti użati fil-kura ta' dipendenza mill-alkoħol jew l-oppjojdi.
English: Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Maltese: Suboxone jintuża fil-kura tad-dipendenza fuq id-drogi oppjojdi (narkotiċi) bħall-eroina jew il-morfina f'persuni li jabbużaw mid-droga (drogati vvizzjati) li qablu li jidħlu għall-kura minħabba d-dipendenza li jkollhom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Suboxone.
Maltese: L-effikaċja tal-kura ta' Suboxone tiddependi minn kemm il-pazjent jingħata appoġġ mediku, soċjali u psikoloġiku.
English: ‘Sublingual' means that the tablet is placed under the tongue where it dissolves.
Maltese: Ladarba l-pazjent ikun stabbli, Id-doża ta' manutenzjoni tkun tista' titnaqqas bil-mod u eventwalment il-kura tkun tista' titwaqqaf.
English: What measures are being taken to ensure the safe and effective use of Suboxone?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Suboxone?
English: Other information about Comtan:
Maltese: Informazzjoni oħra dwar Comtan:
English: The marketing authorisation was renewed on 22 September 2003 and on 22 September 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-22 ta' Settembru 2003 u fit-22 ta' Settembru 2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTAN EPAR summary for the public
Maltese: RAPPORT TAL-VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) COMTAN Sommarju ta' l-EPAR għall-pubbliku
English: Comtan is a medicine that contains the active substance entacapone.
Maltese: Comtan hu mediċina li fiha s-sustanza attiva entacapone.
English: Comtan can only be used with conventional combinations of levodopa.
Maltese: Comtan jista' jintuża biss ma' kombinazzjonjiet konvenzjonali ta' levodopa.
English: Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called catechol-O-methyl transferase (COMT).
Maltese: Entacapone jimblokka enzim li għandu x'jaqsam mat-tkissir ta' levodopa fil-ġisem magħruf bħala catechol-O-methyl transferase (COMT).
English: The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Maltese: L-iktar effetti sekondarji komuni ma' Comtan (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma d-diskinesja (movimenti inkontrollabbli), id-dardir u tibdil fil-kulur ta' l-awrina li ma jagħmilx ħsara.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Comtan to Novartis Europharm Limited on 22 September 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Comtan lil Novartis Europharm Limited fit-22 ta' Settembru 1998.
English: Comtan has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Maltese: Comtan ġie studjat fi 376 pazjent bil-marda tal-Parkinson, f'żewġ studji li damu sitt xhur li kejlu leffetti taż-żieda ta' Comtan jew plaċebo (mediċina finta) mal-kombinazzjoni ta' levodopa u carbidopa jew levodopa u benserazide.
English: Why has Comtan been approved?
Maltese: Għaliex ġie approvat Comtan?
English: Comtan should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Maltese: Comtan m'għandux jintuża flimkien ma' mediċini oħra li jagħmlu parti mill-grupp ta' ‘inibituri talmonoamino ossidażi' (monoamine oxidase - tip ta' mediċina kontra d-dipressjoni).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Comtan huma akbar mir-riskji tiegħu bħala aġġunt ta' preparazzjonijiet standard ta' levodopa/benserazide jew levodopa/carbidopa għall-użu f'pazjenti bil-marda tal-Parkinson u għal tibdiliet f'daqqa fil-moviment fi tmiem id-doża, li ma jkunux jistgħu jiġu stabbiliti f'dawn ilkombinazzjonijiet.
English: What is Comtan?
Maltese: X'inhu Comtan?
English: How has Comtan been studied?
Maltese: Kif ġie studjat Comtan?
English: What is the risk associated with Comtan?
Maltese: Għal xiex jintuża Comtan?
English: Comtan is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Maltese: Comtan jintuża biss f'kombinazzjoni jew ma' levodopa u benserazide jew ma' levodopa u carbidopa.
English: In the first study, adding Comtan increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
Maltese: Fl-ewwel studju, iż-żieda ta' Comtan żiedet ilħin li jkunu ‘on' b' siegħa u 18-il minuta iktar miż-żieda tal-plaċebo.
English: Comtan is used to treat patients with Parkinson's disease.
Maltese: Comtan jintuża fit-trattament ta' pazjenti bil-marda tal-Parkinson.
English: The active substance in Comtan, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Maltese: Is-sustanza attiva f'Comtan, entacapone, taħdem billi treġġa' għan-normal il-livelli ta' dopamina fil-partijiet tal-moħħ li jikkontrollaw il-moviment u lko-ordinazzjoni.
English: 1 vial
Maltese: 1 kunjeti
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Maltese: U* - Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strejn Ic-02-001) 290-1000
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Maltese: U* - Leptospira interrogans serogroup Australis serovar Bratislava (strejn As-05-073) 500-1700
English: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Maltese: --1 - Leptospira interrogans serogroup Canicola serovar Portland-vere (strejn Ca-12-000) 3550-7100
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Maltese: U* - Leptospira kirschneri serogroup Grippotyphosa serovar Dadas (strejn Gr-01-005) 650-1300 U* *Units Massa antiġenika ELISA.
English: Belgium TEVA Pharma B.V. Computerweg 10,
Maltese: Is-Slovakkja TEVA Pharma B.V. Computerweg 10,
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika (għamliet farmaċewtiċi), qawwa (qawwiet) tal-prodott(i) mediċinali, mnejn jingħata, applikant fl-Istati
English: Immediate Packaging Pack size
Maltese: Daqs tal-pakket t
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata Il-pakkett li jmiss mal-prodott
English: Ocular use vial (glass)
Maltese: Użu għall-għajnejn kunjett (ħġieġ)
English: EMA Number
Maltese: soluzzjoni
English: Eye drops, solution
Maltese: Qtar għall-għajnejn,
English: Other information about Luxturna
Maltese: Informazzjoni oħra dwar Luxturna
English: Further information on Luxturna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/luxturna.
Maltese: ema.europa.eu/medicines/human/EPAR/luxturna.
English: Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012).
Maltese: Id-distrofija retinali li ntirtet hija rari, u Luxturna ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) għal żewġ forom tal-marda f'diversi dati (retinitis pigmentosa: 28 ta' Lulju 2015; amaurosis konġenitali ta' Leber:
English: RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.
Maltese: RPE65 hija responsabbli mill-produzzjoni ta' enzima msejħa isomerażi tar-retinil all-trans (all-trans retinyl isomerase), li hija meħtieġa għall-funzjonament normali taċ-ċelloli retinali.
English: Luxturna consists of a virus that contains normal copies of the RPE65 gene.
Maltese: Luxturna jikkonsisti minn virus li fih kopji normali tal-ġene RPE65.
English: Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.
Maltese: Il-pazjenti ġew ikkunsidrati li għaddew mit-test jekk spiċċaw ir-rotta fi 3 minuti u laqtu mhux aktar minn 3 ostakli.
English: Luxturna will only be available from centres where the educational programme is in place.
Maltese: Luxturna ser ikun disponibbli biss minn ċentri fejn ikun stabbilit il-programm edukattiv.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini ema.europa.eu/medicines/human/orphan-designations.
English: Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Luxturna fih is-sustanza attiva voretigene neparvovec u huwa tip ta' mediċina terapewtika avvanzata msejħa ‘prodott ta' terapija tal-ġeni'.
English: This overview was last updated in 11-2018.
Maltese: 2 ta' April 2012.
English: What are the risks associated with Luxturna?
Maltese: X'inhuma r-riskji assoċjati ma' Luxturna?
English: Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations.
Maltese: Luxturna kien investigat fi studju ewlieni wieħed li kien jinvolvi 31 pazjent li jbatu minn distrofija retinali li ntirtet minħabba l-mutazzjonijiet RPE65.
English: After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route.
Maltese: Wara sena ta' kura, il-pazjenti kkurati b'Luxturna tejbu l-punteġġi tagħhom b'1.8 punti, filwaqt li lpazjenti li ma ngħatawx Luxturna tejbu l-punteġġi tagħhom b'0.2 punti, u dan ifisser li l-pazjenti kkurati b'Luxturna kienu kapaċi jimxu aħjar tul ir-rotta.
English: Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so.
Maltese: Barra minn hekk, 13 mill-21 pazjent (62 %) ikkurati b'Luxturna għaddew mit-test tal-mobbiltà fil-livell ta' dawl l-aktar baxx ta' 1 lux (simili għallkondizzjonijiet ta' bankina mdawla b'dawl baxx ħafna bil-lejl), filwaqt li l-ebda wieħed mill-pazjenti li ma ngħatawx il-mediċina ma seta' jagħmel dan.
English: This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition.
Maltese: Dan kien ikkunsidrat bħala benefiċċju kliniku importanti, meta jitqies in-nuqqas ta' kuri awtorizzati għal din il-kondizzjoni deġenerattiva u progressiva.
English: Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.
Maltese: Il-pazjenti għandhom jibdew jirċievu mediċini immunosuppressanti (mediċini li jnaqqsu l-attività tas-sistema immunitarja, id-difiżi naturali tal-ġisem) 3 ijiem qabel Luxturna jiġi injettat fl-ewwel għajn, biex jitnaqqas ir-riskju li l-mediċina tkun rifjutata mill-ġisem, u din il-kura għandha titkompla għal 14-il jum wara l-injezzjoni
English: The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.
Maltese: It-tip ta' virus użat f'din il-mediċina (virus assoċjat mal-adeno) ma jikkawżax mard fil-bnedmin.
English: Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).
Maltese: Luxturna huwa mediċina li tintuża għall-kura ta' adulti u tfal b'telf tal-vista minħabba distrofija retinali li ntirtet, disturb ġenetiku rari tar-retina (il-membrana sensittiva għad-dawl fuq wara tal-għajn).
English: How is Luxturna used?
Maltese: Luxturna?
English: Why is Luxturna authorised in the EU?
Maltese: Għaliex Luxturna huwa awtorizzat fl-UE?
English: As for all medicines, data on the use of Luxturna are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Luxturna hija ssorveljata kontinwament.