FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase 2 study in healthy Indian toddlers aged ≥1 year to <3 years, 24 children were vaccinated with 0.25 ml of IXIARO (the licensed dose for this age group) and 24 children received the adult 0.5 ml dose.
Maltese: Fi studju ta' fażi 2 fi tfal Indjani f'saħħithom li kienu għadhom kif bdew jimxu b'età ta' >1 sena sa <3 snin, 24 tifel u tifla ġew imlaqqma b'0.25 ml ta' IXIARO (id-doża liċenzjata għal dan il-grupp ta' etàjiet) u 24
English: Antibody persistence was evaluated in an uncontrolled Phase 3 follow up clinical trial, enrolling subjects who had completed two pivotal studies, and who received at least one dose of IXIARO.
Maltese: Il-persistenza tal-antikorpi ġiet ivvalutata fi prova klinika ta' segwitu mhux ikkontrollata ta' Fażi 3, li rreġistrat individwi li kienu lestew żewġ studji pivotali, u li rċevew mill-inqas doża waħda ta' IXIARO.
English: Metabolism and Nutrition Disorders
Maltese: Disturbi fil-Metaboliżmu u n
English: Safety and tolerability was evaluated in the entire study population.
Maltese: Is-sigurtà u t-tollerabilità kienu evalwati fil-popolazzjoni kollha tal-istudju.
English: vaccination.
Maltese: KLINIKU
English: Tell your doctor:
Maltese: TA' EĊĊIPJENTI Eċċipjenti :
English: Month 7
Maltese: Xahar 7
English: The booster dose led to a pronounced increase in GMTs and seroprotection rate remained at 100% two years after the booster.
Maltese: Id-doża booster wasslet għal żieda qawwija fil-GMTs u r-rata ta' seroprotezzjoni baqgħet 100% sentejn wara l-booster.
English: Antibody persistence was evaluated for three years after the primary vaccination with IXIARO in an uncontrolled, open-label follow-up clinical trial conducted in the United States, Europe and Australia.
Maltese: Il-persistenza tal-antikorpi kienet evalwata għal tliet snin wara t-tilqim primarju b'IXIARO fi prova klinika mhux ikkontrollata, open-label u ta' segwitu mwettqa fl-Istati Uniti, l-Ewropa u l-Awstralja.
English: See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to <3 years.
Maltese: tifel u tifla rċevew id-doża tal-adulti ta' 0.5 ml.
English: Age Group ≥2 months to <3 years
Maltese: Grupp t'Età ta' ≥2 xahrejn sa <3
English: The recommended dosage for babies and children aged 2 months to < 3 years is a total of 2 injections of 0.25 ml each: The first injection on Day 0 The second injection 28 days after the first injection (Day 28).
Maltese: Id-doża rakkomandata għal trabi u tfal b'età minn xahrejn sa < 3 snin hija total ta' 2 injezzjonijiet ta' 0.25 ml kull waħda:
English: Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension.
Maltese: Qabel l-għoti, ħawwad is-siringa sew sabiex tikseb suspensjoni bajda, opaka u omoġenja.
English: Seroconversion rates and geometric mean titers of IXIARO and JE VAX in the Per Protocol Population.
Maltese: Ir-rati ta' serokonverżjoni (SCRs) u t-titers ġeometriċi medji (GMTs) huma murija f'Tabella 12.
English: Challenge studies were performed in mice that were treated with human IXIARO antisera.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: By Day 56, the proportion of subjects who had seroconverted was similar for both treatment groups (96.4% vs. 93.8% for IXIARO and JE VAX, respectively).
Maltese: Jum 56, il-proporzjon ta' individwi li kienu għaddew minn serokonverżjoni kien simili għaż-żewġ gruppi ta' kura (96.4% vs.
English: There was no interference with the immune response to Japanese encephalitis virus (JEV) or to hepatitis A or rabies virus vaccines (see section
Maltese: Ma kien hemm ebda interferenza mar-rispons immuni għallvirus tal-enċefalite Ġappuniża (JEV) jew għall-vaċċini kontra l-virus tal-epatite A jew tar-rabbja (ara sezzjoni 5.1).
English: 1 year< 3 years
Maltese: Sena< 3 snin
English: Pregnancy
Maltese: Irritabilità
English: The primary vaccination series consists of two separate doses of 0.25 ml according to the following schedule:
Maltese: Is-serje primarja ta' tilqim tikkonsisti f'żewġ dożi separati ta' 0.25 ml skont l-iskeda li ġejja:
English: First dose at Day 0.
Maltese: L-ewwel doża f'Jum 0.
English: Vaccination scheme IXIARO Day 0,7 Rabipur Day 0,3,7
Maltese: Skema ta' tilqim IXIARO Jum 0,7 Rabipur Jum
English: Neutralising antibody titers against JEV were measured against the JEV strain SA14
Maltese: It-tajters ta' antikorpi newtralizzanti kontra JEV ġew imkejla kontra r-razza ta' JEV SA14-14-2.
English: DK - 3400 Hillerød Denmark
Maltese: DK - 3400 Hillerød
English: 1171 LP Badhoevedorp The Netherlands
Maltese: 1171 LP Badhoevedorp
English: 6Nominal p value
Maltese: 6Valur p nominali
English: MedDRA preferred term Spinraza frequency category, n=84
Maltese: kategorija ta' frekwenza ta' Spinraza, n=84
English: Nusinersen is not a substrate or inhibitor of human BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, or BSEP transporters.
Maltese: Nusinersen mhuwiex substrat jew inibitur ta' BCRP uman, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, jew trasportaturi ta' BSEP.
English: Biogen Hungary Kft. Tel.: +36 (1) 899 9883
Maltese: Magyarország Biogen Hungary Kft. Tel.: +36 (1) 899 9883
English: HFMSE score
Maltese: Punteġġ HFMSE
English: Biogen Austria GmbH Tel: +43 1 484 46 13
Maltese: Österreich Biogen Austria GmbH Tel: +43 1 484 46 13
English: Overall survival2
Maltese: Sopravivenza totali2
English: Biogen GmbH Tel: +49 (0) 89 99 6170
Maltese: Deutschland Biogen GmbH Tel: +49 (0) 89 99 6170
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate Sodium chloride
Maltese: Sodium dihydrogen phosphate dihydrate Disodium phosphateSodium chloride Potassium chloride
English: Symptomatic patients
Maltese: Pazjenti sintomatiċi
English: April 2023.
Maltese: Q2 2024.
English: Nusinersen is an antisense oligonucleotide (ASO) which increases the proportion of exon 7 inclusion in survival motor neuron 2 (SMN2) messenger ribonucleic acid (mRNA) transcripts by binding to an intronic splice silencing site (ISS-N1) found in intron 7 of the SMN2 pre-messenger ribonucleic acid (pre-mRNA).
Maltese: Nusinersen hu antisense oligonucleotide (ASO) li jżid il-proporzjon tal-inklużjoni ta' exon 7 fissurvival motor neuron 2 (SMN2) messenger ribonucleic acid (mRNA) transcripts billi jeħel ma' intronic splice silencing site (ISS-N1) li tinsab f'intron 7 tal-SMN2 pre-messenger ribonucleic acid (pre-mRNA).
English: The 6MWT (six-minute walk test) was conducted for ambulatory patients only.
Maltese: Is-6MWT (test tal-mixi ta' 6 minuti) twettaq għal pazjenti ambulatorji biss.
English: Motor function Motor milestones3
Maltese: Funzjoni tal-moviment Milestones tal-moviment3
English: Biogen Belgium N.V./S.A.
Maltese: België/Belgique/Belgien Biogen Belgium N.V./S.A.
English: The mean terminal elimination half-life in CSF is estimated at 135 to 177 days.
Maltese: Il-medja tal-half-life tal-eliminazzjoni terminali fis-CSF hi stmata li hi 135 sa 177 jum.
English: A cumulative search of postmarketing data identified 37 possible hypersensitivity events; 20 medically confirmed.
Maltese: Tiftixa kumulattiva fid-dejta ta' wara t-tqegħid fis-suq identifikat 37 avveniment ta' sensittività eċċessiva possibbli; 20 kienu kkonfermati medikament.
English: Figure 3: Change in HINE Motor Milestones versus Study days for Study CS3B (treated and sham-control), CS3A, CS5 and CS11
Maltese: Figura 3: Bidla fil-HINE Motor Milestones kontra Jiem tal-istudju għal Studju CS3B (ikkurati u bi proċedura falza), CS3A, CS5 u CS11
English: • Then around day 14, day 28 and day 63
Maltese: • Imbagħad bejn wieħed u ieħor f'jum 14, jum 28 u jum 63
English: Number of patients who died Hazard Ratio (95% CI) p-value6
Maltese: Numru ta' pazjenti li mietu Proporzjon ta' Periklu (95% CI) valur-p6
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, water for injections.
Maltese: Sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet.
English: The mean CHOP INTEND score at last assessment was 61.0 (46 - 64) amongst patients with 2 SMN2 copies and 62.6 (58 - 64) amongst those with 3 SMN2 copies.
Maltese: Il-medja tal-punteġġ CHOP INTEND fl-aħħar evalwazzjoni kienet 61.0 (46 - 64) fost pazjenti b'2 kopji ta' SMN2, u 62.6 (58 - 64) fost dawk bi 3 kopji ta' SMN2.
English: 1 out of 28 patients had 2 SMN2 gene copies, 21 had 3 copies, and 6 had 4 copies.
Maltese: 1 minn 28 pazjent kellu 2 kopji tal-ġene SMN2, 21 kellhom 3 kopji, u 6 kellhom 4 kopji.
English: Date of first authorisation: 30 May 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 30 Mejju, 2017
English: Other medicines and Spinraza
Maltese: Mediċini oħra u Spinraza
English: The mean total score was13.8 (SD 3.09) at Day 253 and 15.7 (SD 1.92) at Day 1050.
Maltese: Il-punteġġ totali medju kien 13.8 (SD 3.09) f'Jum 253 u 15.7 (SD 1.92) f'Jum 1050.
English: Each dose of Spinraza contains less than 1 mmol (23 mg) sodium.
Maltese: Kull doża ta' Spinraza fiha anqas minn 1 mmol (23 mg) sodium.
English: 6Based on log-rank test stratified by disease duration
Maltese: 6Ibbażat fuq test log-rank stratifikat skont it-tul tal-marda
English: Lumbar puncture procedure
Maltese: Proċedura tat-titqiba lumbari
English: The length of treatment ranged from 74 to 474 days (median 250 days) at the time of the interim analysis.
Maltese: It-tul tat-trattament varja minn 74 sa 474 jum (medjan ta' 250 jum) fil-ħin tal-analiżi interim.
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen (2.4 mg/ml).
Maltese: Kull kunjett ta' 5 ml fih nusinersen sodium, ekwivalenti għal 12 mg ta' nusinersen (2.4 mg/ml)
English: Further improvement in mean total motor milestone (HINE-Section 2) (2.1; SD 4.36; n=22) and CHOP INTEND (4.68; SD 3.993, n=22) scores were observed from baseline to Study Day 304 in Study CS11.
Maltese: Titjib addizzjonali filmedja tal-punteġġi tal-milestones totali tal-moviment (HINE-Sezzjoni 2) (2.1; SD 4.36; n=22) u CHOP INTEND (4.68; SD 3.993, n=22) ġie osservat mil-linja bażi sa Jum tal-Istudju 304 fi Studju CS11.
English: Vomiting*
Maltese: Rimettar*
English: Figure 1: Change in CHOP INTEND from Baseline to Later of Day 183, Day 302, and Day 394 Study Visit - Endear Study /CS3B (Efficacy Set, ES)
Maltese: Viżta talIstudju Jum 183, Jum 302, u Jum 394 - Studju Endear /CS3B (Sett tal-Effikaċja, ES)
English: A second gene SMN2, located near SMN1, is responsible for a small amount of SMN protein production.
Maltese: It-tieni ġene SMN2, li jinsab qrib SMN1, hu responsabbli għal ammont żgħir ta; produzzjoni tal-proteina SMN.
English: Spinraza 12 mg solution for injection nusinersen
Maltese: Spinraza 12 mg soluzzjoni għall-injezzjoni nusinersen
English: Number of patients who died or received permanent ventilation Hazard ratio (95% CI) p-value6
Maltese: Numru ta' pazjenti li mietu jew li rċivew ventilazzjoni permanenti Proporzjon ta' periklu (95% CI) valur-p6
English: Spinraza 12 mg solution for injection
Maltese: Spinraza 12 mg soluzzjoni għall-injezzjoni
English: 3At the final analysis, CHOP INTEND and motor milestone analyses were conducted using the Efficacy Set (Spinraza n=73; Sham-control n=37).
Maltese: 3Fl-analiżi finali, analiżijiet CHOP INTEND u dwar milestone tal-moviment, twettqu bl-użu tas-Sett tal-Effikaċja (Spinraza n=73; pazjenti tal-kontroll ikkurati bi proċedura falza n=37).
English: Median age of onset of clinical signs and symptoms was 56 days and patients had either 2 SMN2 gene copies (n=17) or 3 SMN2 gene copies (n=2) (SMN2 gene copy number unknown for 1 patient).
Maltese: L-età medjana tal-bidu ta' sinjali u sintomi kliniċi kienet 56 jum, u lpazjenti kellhom jew 2 kopji tal-ġene SMN2 (n=17) jew 3 kopji tal-ġene SMN2 (n=2) (in-numru ta' kopji tal-ġene SMN2 ma kienx magħruf għal pazjent wieħed).
English: The majority of patients (88%) have 3 copies of the SMN2 gene (8% have 2 copies, 2% have 4 copies, and 2% have an unknown copy number).
Maltese: Il-maġġoranza tal-pazjenti (88%) għandhom 3 kopji tal-ġene SMN2 (8% għandhom 2 kopji, 2% għandhom 4 kopji, u 2% għandhom numru mhux magħruf ta' kopji).
English: Table 2: Primary and secondary endpoints at final analysis - Study CS3B Efficacy Parameter
Maltese: Tabella 2: Punti ta' l-aħħar primarji u sekondarji fl-analiżi finali - Studju CS3B Parametru ta' Effikaċja
English: Median plasma Tmax values ranged from 1.7 to 6.0 hours.
Maltese: Il-medjan tal-valuri tatTmax fil-plażma varja minn 1.7 sa 6.0 sigħat.
English: Spinraza is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment (see sections 4.5 and 5.2).
Maltese: Spinraza ma jiġix metabolizzat permezz tas-sistema tal-enzimi ta' ċitokrom P450 fil-fwied, u għalhekk aġġustament fid-doża mhux probabbli li jkun meħtieġ f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.5 u 5.2).
English: In vitro studies indicated that nusinersen is not an inducer or inhibitor of CYP450 mediated metabolism.
Maltese: Studji in vitro jindikaw li nusinersen mhuwiex induttur jew inibitur ta' metaboliżmu medjat minn CYP450.
English: The remaining 2 events (rash and eosinophil count increased, both nonserious) were possibly related to nusinersen.
Maltese: Iż-żewġ avvenimenti l-oħra (raxx u żieda fl-għadd ta' eosinofili, it-tnejn li huma mhux serji) kienu possibbilment relatati ma' nusinersen.
English: The mean total score was 49.8 (SD 12.46) at Day 253 and 52.6 (SD 12.78) at 1050 days.
Maltese: Ilpunteġġ totali medju kien ta' 49.8 (SD 12.46) f'Jum 253 u ta' 52.6 (SD 12.78) f'Jum 1050.
English: Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Intrathecal injection of nusinersen into the CSF allows nusinersen to be fully available for distribution from the CSF to the target central nervous system (CNS) tissues.
Maltese: Injezzjoni ġot-teka ta' nusinersen ġos-CSF, tippermetti li nusinersen jkun kompletament disponibbli għad-distribuzzjoni mis-CSF għat-tessut tas-sistema nervuża ċentrali (CNS, central nervous system) fil-mira.
English: Each ml contains 2.4 mg of nusinersen.
Maltese: Kull ml fih 2.4 mg ta' nusinersen.
English: - Each ml contains 2.4 mg of nusinersen.
Maltese: - Kull ml fih 2.4 mg ta' nusinersen.
English: Improvement in mean total motor milestone (HINE-Section 2) (1.2; SD 1.8; n=12) and CHOP INTEND (3.58; SD 7.051, n=12) scores were observed from baseline to Study Day 304 in Study CS11.
Maltese: Titjib fil-medja tal-punteġġi tal-milestones totali tal-moviment (HINE-Sezzjoni 2) (1.2; SD 1.8; n=12) u CHOP INTEND (3.58; SD 7.051, n=12) ġie osservat mil-linja bażi sa Jum tal-Istudju 304 fi Studju CS11.
English: At the interim analysis, all 25 patients (2 SMN2 gene copies, n=15; 3 SMN2 gene copies, n=10) were alive without permanent ventilation..
Maltese: Fl-analiżi interim, il25 pazjent kollha (2 kopji tal-ġene SMN2, n=15; 3 kopji tal-ġene SMN2, n=10) kienu ħajjin mingħajr ventilazzjoni permanenti.
English: As of 19 October 2018, 100 AEs of hypersensitivity due to the administration of nusinersen were identified from the clinical trial database.
Maltese: Mid-19 ta' Ottubru 2018, kienu identifikati 100 Avveniment Avvers (AEs - Adverse Events) ta' sensittività eċċessiva minħabba l-għoti ta' nusinersen fid-database tal-prova klinika.
English: Of the 346 patients who received Spinraza up to a maximum of 5 years, 258 patients received treatment for at least 1 year.
Maltese: Mit-346 pazjent li rċivew Spinraza sa massimu ta' 5 snin, 258 pazjent irċivew kura għal mill-inqas sena.
English: SMA is a progressive neuromuscular disease resulting from mutations in chromosome 5q in the SMN1 gene.
Maltese: SMA hi marda newromuskolari progressiva li tirriżulta minn mutazzjonijiet fi kromożom 5q filġene SMN1.
English: Adverse reactions have been identified during post-approval use of Spinraza.
Maltese: Reazzjonijiet avversi ġew identifikati waqt l-użu wara l-approvazzjoni ta' Spinraza.
English: Communicating hydrocephalus, aseptic meningitis and hypersensitivity (e.g. angioedema, urticaria and rash) have also been reported.
Maltese: Ġew irrappurtati ukoll idroċefalu komunikabbli, meningite asettika u sensittività eċċessiva (eż. anġjoedema, urtikarja u raxx).
English: To allow for long term follow up of these patients, at the end of Study CS3B, 89 patients (Spinraza: n=65; sham-control: n=24) enrolled in Study CS11 (SHINE).
Maltese: Biex tippermetti għal segwitu fit-tul ta' dawn il-pazjenti, fit-tmiem ta' Studju CS3B, 89 pazjent (Spinraza: n=65; kontroll bi plaċebo: n=24) irreġistraw fi Studju CS11 (SHINE).
English: There is a risk of side effects occuring after Spinraza is given by a lumbar puncture procedure (see section 3).
Maltese: Hemm riskju ta' effetti sekondarji li jseħħu wara li Spinraza jingħata permezz ta' proċedura ta' titqiba fis-sinsla (ara sezzjoni 3).
English: България ТП ЕВОФАРМА
Maltese: ТП ЕВОФАРМА Teл.:
English: Table 3: Primary and secondary endpoints at final analysis - Study CS41 Spinraza treated Patients
Maltese: Tabella 3: Punti aħħarin primarji u sekondarji fl-analiżi finali - Studju CS41 Pazjenti kkurati bi
English: Pack size of one vial per carton.
Maltese: Daqs tal-pakkett ta' kunjett wieħed f'kull kartuna.
English: • Serious infection related to lumbar puncture (e.g. meningitis)
Maltese: • Infezzjoni serja relatata ma' titqiba fis-sinsla (eż. meninġite)
English: Mean change from baseline to month 15 in total RULM score2,3
Maltese: Bidla medja mil-linja bażi sa Xahar 15 fil-punteġġ totali RULM2,3
English: At day 700, 7 out of 11 patients (64%) with 2 SMN2 gene copies and 0 out of 5 patients (0%) with 3 SMN2 copies, met the protocol-defined criteria of clinically manifested SMA, however, these patients were gaining weight and achieving WHO milestones, inconsistent with Type I SMA.
Maltese: F'jum 700, 7 minn 11il pazjent (64%) b'2 kopji ta' ġene SMN2 u 0 minn 5 pazjenti (0%) bi 3 kopji ta' SMN2, kisbu lkriterji definiti mill-protokoll ta' SMA manifestata b'mod kliniku, madankollu, dawn il-pazjenti kienu qed iżidu l-piż u jiksbu milestones tal-WHO, inkonsistenti ma' SMA ta' Tip I.
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX07
Maltese: Mediċini oħra għal disturbi fis- sistema muskoloskeletali, Kodiċi ATC:
English: The exception was an acute, transient deficit in lower spinal reflexes which occurred at the highest dose levels in each study (3 or 4 mg per dose; equivalent to 30 or 40 mg per intrathecal dose in patients).
Maltese: L-eċċezzjoni kien tnaqqis akut u temporanju fir-riflessi talparti t'isfel tas-sinsla, li seħħ fl-ogħla livelli tad-doża f'kull studju (3 jew 4 mg f'kull doża; ekwivalenti għal 30 jew 40 mg għal kull doża minn ġot-teka fil-pazjenti).
English: Spinal muscular atrophy is caused by a shortage of a protein called survival motor neuron (SMN) in the body.
Maltese: Atrofija muskolari tas-sinsla hi kkawżata minn nuqqas ta' proteina imsejħa survival motor neuron (SMN) fil-ġisem.
English: Of the 13 patients with infantile-onset SMA, 7 of out 9 patients (78%; 95%CI: 45, 94) in the Spinraza group and 0 out of 4 patients (0%; 95%CI: 0, 60) in the sham group met the criteria for motor milestone response (according to HINE section 2: ≥2 point increase [or maximal score] in ability to kick OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking and improvement in more categories of motor milestones than worsening) .
Maltese: Mit13-il pazjent b'SMA li bdiet meta kienu trabi, 7 minn 9 pazjenti (78%; 95% CI: 45, 94) fil-grupp ta' Spinraza, u 0 minn 4 pazjenti (0%; 95% CI: 0, 60) fil-grupp tal-plaċebo, issodisfaw il-kriterja għal rispons għal milestones tal-moviment (skont HINE sezzjoni 2: Żieda ta' ≥2 punti [jew fil-punteġġ massimu] fil-kapaċità li tagħti bis-sieq, JEW żieda ta' ≥1 punt f'milestones tal-moviment tal-kontroll tar-ras, li titgerbeb, li togħod bilqiegħda, li titkaxkar, li toqgħod bilwieqfa jew li timxi, u titjib f'aktar kategoriji ta' milestones tal-moviment milli aggravament). Mit-8 pazjenti b'SMA li bdiet aktar tard, 4 minn 5 pazjenti (80%; 95% CI: 38, 96) fil-grupp ta' Spinraza, u 2 minn 3 pazjenti (67%; 95% CI: 21, 94) fil-grupp tal-plaċebo, issodisfaw din id-definizzjoni ta' rispons.
English: Proportion achieving a 4-point worsening
Maltese: Proporzjon li kellhom aggravament ta' 4 punti
English: The recommended dosage is 12 mg (5 ml) per administration.
Maltese: Id-dożaġġ rakkomandat hu ta' 12 mg (5 ml) f'kull għoti.
English: There is no accumulation in plasma exposure measures (Cmax and AUC) after multiple doses.
Maltese: M'hemmx akkumulazzjoni fil-kejl tal-esponiment fil-plażma (Cmax u AUC) wara dożi multipli.
English: A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050.
Maltese: Titjib sostnut ġie osservat f'pazjenti b'SMA tat-Tip II li esperjenzaw titjib medju mill-punteġġ HFMSE fil-linja bażi ta' 5.1 (SD 4.05, n=11) f'Jum 253, u 9.1 (SD 6.61, n-9) f'Jum 1050 u ma ġie osservat l-ebda plateau.
English: - Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Maltese: - Kull kunjett ta' 5 ml fih nusinersen sodium, ekwivalenti għal 12 mg ta' nusinersen.
English: Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Maltese: Spinraza huwa indikat għall-kura ta' Atrofija Muskolari tas-Sinsla 5q.
English: Clear and colourless solution with pH of approximately 7.2.
Maltese: Soluzzjoni ċara u bla kulur soluzzjoni b'pH ta' madwar 7.2.
English: In the efficacy set, 18 patients (25%) in the Spinraza group and 12 patients (32%) in the sham-control group required permanent ventilation.
Maltese: Fis-sett tal-effikaċja, 18-il pazjent (25%) fil-grupp ta' Spinraza u 12-il pazjent (32%) fil-grupp talkontroll ikkurati bi plaċebo, kienu jeħtieġu ventilazzjoni permanenti.
English: At the time of a Study CS11 interim analysis, 61 out of 65 patients (94%) were alive.
Maltese: Fil-ħin talanaliżi interim ta' Studju CS11, 61 minn 65 pazjent (94%) kienu ħajjin.
English: Patients with Type III SMA demonstrated a mean improvement from baseline HFMSE score of 1.3 (SD 1.87, n=16) at Day 253 and 1.2 (SD 4.64, n=11) at Day 1050.
Maltese: Pazjenti b'SMA ta' Tip III urew titjib medju mil-punteġġ HFMSE fil-linja bażi ta' 1.3 (SD 1.87, n=16) f'Jum 253 u 1.2 (SD 4.64, n=11) f'Jum 1050.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,
Maltese: - Is-sustanzi mhux attivi l-oħra huma sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet.
English: An interim analysis was conducted when patients had been on study for median of 27.1 months (15.135.5 months) and were of a median age at last visit of 26.0 months (14.0 -34.3 months).
Maltese: 135.5 xhur) u kellhom età medjana fl-aħħar vista ta' 26.
English: Upon completion of Study CS4 (CHERISH) 125 patients enrolled in Study CS11 (SHINE), where all patients received Spinraza.
Maltese: Mat-tmiem ta' Studju CS4 (CHERISH), 125 pazjent irreġistraw fi Studju CS11 (SHINE), fejn ilpazjenti kollha rċivew Spinraza.
English: *Adverse events considered related to the lumbar puncture procedure.
Maltese: *Avvenimenti avversi kkunsidrati li huma relatati mal-proċedura tat-titqiba fis-sinsla.