FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast-feeding:
Maltese: Data tal-ewwel awtorizzazzjoni:
English: per 0.5 ml dose
Maltese: Doża waħda ta' 0.5 mL
English: Children 9 to less than 18 years of age received a single dose of Flucelvax Tetra.
Maltese: Tfal minn 9 snin sa inqas minn 18-il sena rċevew doża waħda ta' Flucelvax
English: Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02
Maltese: Tilqima tal-influwenza, Kodiċi ATC:
English: • Numbness and tingling sensation
Maltese: • Tmewwit u sensazzjoni ta' tnemnim
English: Table 4: GMTs and seroconversion rates (with 95% CI) in subjects 9 to <18 years of age, 3 weeks after vaccination with Flucelvax Tetra or TIV1c/TIV2c - Per Protocol Set (V130_03)
Maltese: <18-il sena, 3 ġimgħat wara t-tilqima bi Flucelvax Tetra jew TIV1c/TIV2c - Għal Kull Sett ta' Protokoll (V130_03)
English: Mild side effects
Maltese: Effetti sekondarji serji
English: The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Maltese: Is-sustanzi attivi huma antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase),
English: • Tiredness
Maltese: • Tbenġil
English: Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities.
Maltese: Id-dejta tossikoloġika dwar ir-riproduzzjoni u l-iżvilupp minn tilqima trivalenti tal-influwenza bbażata fuq iċċelluli (TIVc) ma tipprevedix żieda fir-riskju ta' anormalitajiet fl-iżvilupp.
English: The percentage of subjects with seroconversion or significant increase in HI antibody titre is >40%, the percentage of subjects achieving an HI titre ≥1:40 is >70%.
Maltese: ≥1:40 huwa ta' >70%.
English: Other medicines and Flucelvax Tetra
Maltese: Mediċini oħra u Flucelvax Tetra
English: Posology Adults and children from 9 years of age:
Maltese: Adulti u tfal minn 9 snin 'il fuq:
English: The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2019/2020 season.
Maltese: It-tilqima għandha fil-mira tagħha erba' razez tal-virus tal-influwenza skont ir-rakkomandazzjonijiet mill-Organizzazzjoni Dinjija tas-Saħħa għall-istaġun 2019/2020.
English: Compared to adults 18 years of age and older, paediatric subjects generally reported higher rates of local and systemic adverse reactions.
Maltese: Meta mqabbla mal-adulti ta' 18-il sena 'l fuq, il-pazjenti pedjatriċi rrappurtaw b'mod ġenerali rati ogħla ta' reazzjonijiet avversi sistemiċi u lokali.
English: b Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
Maltese: b Rata ta' serokonverżjoni = perċentwal ta' individwi b'titru tal-HI ta' qabel l-immunizzazzjoni <1:10 u b'titru tal-HI ta' wara l-immunizzazzjoni ta' ≥1:40 jew b'titru tal-HI ta' qabel l-immunizzazzjoni ta' ≥1:10 u żieda minima ta' 4 darbiet fit-titru tal-HI tal-antikorpi ta' wara l-immunizzazzjoni.
English: Flucelvax Tetra is used to prevent flu in adults and children from 9 years of age.
Maltese: Flucelvax Tetra jintuża għall-prevenzjoni tal-influwenza fl-adulti u fit-tfal minn 9 snin 'il fuq.
English: After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.
Maltese: Wara li tħawwad, id-dehra normali tat-tilqima tkun ta' suspensjoni ċara sa ftit opalexxenti.
English: The immunogenicity endpoints were GMTs of HI antibodies response and percentage of subjects who achieved seroconversions (seroconversion rate), defined as a pre-vaccination HI titre of <1:10 with a post-vaccination titre ≥1:40 or with a pre-vaccination HI titre ≥ 1:10 and a minimum 4-fold increase in serum HI antibody titre.
Maltese: individwi li rċevew serokonverżjonijiet (rata ta' serokonverżjoni), definiti bħala titru tal-HI ta' qabel it-tilqim ta' <1:10 u titru ta' wara t-tilqim ta' ≥1:40 jew titru tal-HI ta' qabel it-tilqim ≥1:10 u żieda minima ta' 4 darbiet fit-titru tal-antikorpi tal-HI fis-serum.
English: The safety of Flucelvax Tetra in adults 18 years and older was evaluated in a randomised, controlled study (V130_01), in which 1334 subjects received Flucelvax Tetra.
Maltese: Sommarju tal-profil tas-sigurtà Is-sigurtà ta' Flucelvax Tetra f'adulti ta' età minn 18-il sena jew aktar kienet evalwata fi studju kkontrollat (V130_01), fejn il-pazjenti ntgħażlu b'mod każwali, u li fih 1334 individwu rċevew
English: GMT
Maltese: UŻU
English: Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Maltese: Flucelvax Tetra hu suspensjoni għall-injezzjoni f'siringa mimlija għal-lest (siringa li tkun lesta għallużu).
English: Arthralgia
Maltese: Artralġija
English: Non-inferiority was established for all 4 influenza strains included in Flucelvax Tetra, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination.
Maltese: In-nuqqas ta' inferjorità ġie stabbilit għall-4 razez tal-influwenza inklużi f'Flucelvax Tetra, kif imkejla mill-proporzjon ta' GMTs u d-differenzi fil-perċentwali ta' individwi li kisbu serokonverżjoni fi 3 ġimgħat wara l-immunizzazzjoni.
English: Flucelvax Tetra is a clear to slightly opalescent suspension.
Maltese: Flucelvax Tetra hu suspensjoni minn ċara sa ftit opalexxenti.
English: In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.
Maltese: F'xi wħud mill-istudji fil-bnedmin, titri tal-antikorpi ta' 1:40 jew akbar ġew assoċjati mal-protezzjoni mill-marda tal-influwenza f'sa 50% tal-individwi.
English: The incidence of some adverse reactions were considerably lower among subjects ≥ 65 years of age when compared to subjects 18 to < 65 years of age (see table below).
Maltese: L-inċidenza ta' xi reazzjonijiet avversi kienet konsiderevolment aktar baxxa fost individwi ≥ 65 sena meta mqabbla ma' individwi li għandhom minn 18 sa < 65 sena (ara t-tabella hawn taħt).
English: Children less than 9 years of age reported similar rates of adverse reactions compared to older children.
Maltese: Tfal li kellhom inqas minn 9 snin irrappurtaw rati simili ta' reazzjonijiet avversi meta mqabbla ma' tfal akbar fl-età.
English: In children who received a second dose of Flucelvax Tetra or cell-based trivalent influenza vaccine, the incidence of adverse reactions following the second dose of vaccine was similar to that observed with the first dose in this clinical trial.
Maltese: Fit-tfal li rċevew it-tieni doża ta' Flucelvax Tetra jew tilqima trivalenti tal-influwenza bbażata fuq iċċelluli, l-inċidenza tar-reazzjonijiet avversi wara t-tieni doża tat-tilqima kienu simili għal dawk osservati fl-ewwel doża f'din il-prova klinika.
English: Vaccine Efficacy*
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Suspension for injection in pre-filled syringe 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle
Maltese: 10 siringi mimlijin għal-lest (0.5 mL) mingħajr labra
English: • Shivering
Maltese: Plaċebo
English: Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Tetra can be given at the same time as other vaccines.
Maltese: Abbażi tal-esperjenza klinka b'tilqima trivalenti tal influwenza bbażata fuq iċ-ċelluli (trivalent influenza vaccine, TIVc), Flucelvax Tetra jista' jingħata flistess ħin ma' tilqim ieħor.
English: Extensive swelling of injected limb
Maltese: Ilma għall-injezzjonijiet
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Maltese: Jista' jseħħ sinkope (ħass ħażin) wara, jew anke qabel, kull tilqima bħala rispons psikoġeniku għall injezzjoni bil-labra.
English: • Joint pain
Maltese: Komuni ħafna
English: How Flucelvax Tetra is given 4.
Maltese: Kif jingħata Flucelvax Tetra 4.
English: • You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).
Maltese: • Għandek tgħid lit-tabib tiegħek jekk is-sistema immuni tiegħek hi indebolita, jew jekk qed tieħu kura li taffettwa s-sistema immuni, eż. b'mediċina kontra l-kanċer (kimoterapija) jew mediċini li fihom il-kortikosterojdi (ara s-sezzjoni “Mediċini oħra u Flucelvax Tetra”).
English: Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
Maltese: Tużax din it-tilqima wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara EXP.
English: Antigenically Matched Strains Overall
Maltese: Influwenza Kkonfermata mill-Kolturi Kollha Totali
English: The safety of Flucelvax Tetra in children 4 to less than 18 years of age was evaluated in a randomised, controlled study (V130_03).
Maltese: Is-sigurtà ta' Flucelvax Tetra fit-tfal minn 4 snin sa inqas minn 18-il sena ġiet evalwata fi studju kkontrollat fejn il-pazjenti ntgħażlu b'mod każwali (V130_03).
English: There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Maltese: Ma kien hemm l-ebda evidenza li ż-żieda tat-tieni razza ta' influwenza B irriżultat f'interferenza tal-immunità għal razez oħra inklużi fit-tilqima.
English: Seroconversion Rateb (95% CI)
Maltese: Proporzjon talGrupp tatTilqim (95% CI)
English: Block-7, City North Business Campus Stamullen, Co. Meath, Ireland
Maltese: Block-7, City North Business Campus Stamullen, Co.
English: - The active substance is vestronidase alfa.
Maltese: - Is-sustanza attiva hi vestronidase alfa.
English: (mL/h)
Maltese: (mL/s)
English: Key Secondary Endpoint: Multi-Domain Clinical Responder Index (MDRI)
Maltese: Punt tat-Tmiem Sekondarju Ewlieni: Multi-Domain Clinical Responder Index (MDRI)
English: Febrile convulsion*
Maltese: Konvulżjoni febrili*
English: Each vial contains 17.8 mg sodium.
Maltese: Kull kunjett fih 17.8 mg ta' sodium.
English: Ultragenyx Netherlands B. V. Evert van de Beekstraat 1, Unit 104 1118 CL Schiphol The Netherlands
Maltese: Evert van de Beekstraat 1, Unit 104 1118 CL Schiphol L-Olanda
English: Date of first authorisation: 23 August 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 23 Awissu 2018
English: Studies 301 and 202
Maltese: L-istudji 301 u 202
English: MedDRA Preferred Term
Maltese: Terminu Ppreferut MedDRA
English: - Store in a refrigerator (2°C to 8°C).
Maltese: - Aħżen fi friġġ (2°C sa 8°C).
English: Febrile Convulsion
Maltese: Konvulżjoni febrili
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Maltese: (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), u rari ħafna (< 1/10,000).
English: The pharmacokinetics of vestronidase alfa were evaluated in a total of 19 MPS VII patients including 15 paediatric patients and 4 adults from 3 clinical trials.
Maltese: Il-propjetajiet farmakokinetiċi ta' vestronidase alfa kienu evalwati f'total ta 19-il pazjent b' MPS VII inkluż 15-il pazjent pedjatriku u 4 adulti minn 3 provi kliniċi.
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa (10 mg/ 5 mL).
Maltese: 10 mg ta' vestronidase alfa (10 mg/5 mL) .
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB18
Maltese: Prodotti oħra tal-passaġġ alimentari u tal-metaboliżmu, enzimi, Kodiċi ATC:
English: Nineteen patients were younger than 18 years of age.
Maltese: Disa' pazjenti kienu iżgħar minn 18-il sena.
English: After 24 weeks of treatment with vestronidase alfa, a rapid and sustained, highly significant reduction in uGAG (DS) excretion was achieved with a LS mean (±SE) percentage change of -64.82% (±2.468%) (p<0.0001).
Maltese: Wara 24 ġimgħa ta' trattament b'vestronidase alfa, tnaqqis rapidu u sostnut, sinifikat ħafna fit-tneħħija ta' uGAG (DS) kien milħuq b'bidla perċentwali medja f'LS(±SE) ta' -64.82% (±2.468%) (p<0.0001).
English: Do not flush the line containing vestronidase alfa to avoid a rapid bolus of infused enzyme.
Maltese: Tlaħlaħx il-pajp li fih vestronidase alfa sabiex jiġi evitat bolus rapidu ta' infużjoni ta' enzima.
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Maltese: Għall-immaniġjar ta' reazzjonijiet avversi, ara s-sezzjonijiet 4.4 u 4.8.
English: Patient Weight Range (kg)
Maltese: Piż talPazjent (kg)
English: Table 1 lists the adverse reactions reported from 4 clinical trials in 23 patients treated with Mepsevii.
Maltese: Tabella 1 telenka r-reazzjonijiet avversi rrappurtati minn 4 provi kliniċi fi 23 pazjent ittrattati b'Mepsevii.
English: Minimal important differences (MIDs) were pre-specified for the six MDRI domains plus fatigue, which are: 6MWT (≥23 meters and ≥10% change from baseline), FVC (5% absolute change or 10% relative change from baseline in FVC%pred), shoulder flexion (20 degree change of both shoulder range of motion), visual acuity (3 lines (corrected, both eyes), BOT-2 fine motor (fine motor precision: change of 0.72, and manual dexterity: change of 1.47), BOT-2 gross motor (balance: 0.57, and running speed and agility: 0.59), and fatigue (10 points of total score).
Maltese: MDRI kif ukoll lgħeja, li huma: 6MWT (≥23 metru ≥10% bidla mil-linja bażi), FVC (5% bidla assoluta jew 10% bidla relattiva mil-linja bażi f'FVC%pred), flessjoni tal-ispalla (bidla ta' 20 grad fil-firxa ta' moviment tażżewġt ispalel), akutezza viżwali, (3 linji (ikkoreġut, iż-żewġt għajnejn, BOT-2 fine motor (preċiżjoni fine motor: bidla ta' 0.72, u desterità manwali: bidla ta' 1.47), BOT-2 gross motor (bilanċ: 0.57, u l veloċità u l-aġilità fil-ġiri: 0.59), u għeja (10 punti mill-iskor totali).
English: The most common adverse reactions from 4 clinical trials in 23 patients treated with vestronidase alfa were anaphylactoid reaction (13%), urticaria (13%), infusion site swelling (13%), infusion site extravasation (8.7%), pruritus (8.7%), diarrhoea (8.7%) and rash (8.7%).
Maltese: Ir-reazzjonijiet avversi l-iktar komuni minn 4 provi kliniċi f'pazjenti ttrattati b'vestronidase alfa kienu reazzjoni anafilattojda (13%), urtikarja (13%), nefħa fis-sit tal-infużjoni* (13%), ħruġ ta' likwidu mis sit tal-infużjoni (8.7%), ħakk (8.7%), dijarea (8.7%) u raxx (8.7%).
English: a. Total dose (mg) = Patient's weight (kg) x 4 mg/kg (recommended dose)
Maltese: Id-doża totali (mg) = il-piż tal-Pazjent (kg) x 4 mg/kg (id-doża rrakkomandata) b.
English: Patients should be observed for a minimum of 60 minutes after completing the infusion of vestronidase alfa.
Maltese: Il-pazjenti għandhom ikunu osservati għal mill-inqas 60 minuta wara li tintemm l-infużjoni ta' vestronidase alfa.
English: What is MPS VII
Maltese: X'inhi MPS VII
English: *Vestronidase alfa is a recombinant form of human beta-glucuronidase (rhGUS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
Maltese: *Vestronidase alfa hu forma rikombinanti ta' beta-glucuronidase uman (rhGUS) u hu magħmul fil kultura ta' ċelloli tal-Ovarji tal-Ħamster Ċiniż permezz tat-teknoloġija tad-DNA rikombinanti.
English: Urticaria Rash Pruritus
Maltese: Urtikarja Raxx Prurite
English: Table 1 Adverse reactions reported in patients treated with Mepsevii MedDRA System Organ Class
Maltese: Reazzjonijiet avversi rrapurtati f'pazjenti ttrattati b'Mepsevii Sistema tal-Klassifika tal-Organi
English: Vestronidase alfa is a recombinant human enzyme and is therefore eliminated by proteolytic degradation into small peptides and amino acids.
Maltese: Vestronidase alfa huwa enzim uman rikombinanti u għalhekk hu eliminat b'degradazzjoni proteolitika f'peptidi żgħar u aċidi amminiċi.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara ‘EXP'.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Propjetajiet farmakokinetiċi
English: The infusion was stopped, the patient received anticonvulsants, antipyretics and antibiotics, and the febrile convulsion resolved.
Maltese: L-infużjoni ġiet imwaqqfa, il-pazjent irċieva antikonvulsanti, antipiretiċi u antibijotiċi, u lkonvulżjoni febrili sfat riżolta.
English: Study UX003-CL201 (referred to as Study 201) was a single arm, open-label, dose exploration trial that enrolled three MPS VII patients, ranging in age from 5 years to 25 years.
Maltese: Studju UX003-CL201 (magħruf bħala Studju 201) kien prova esploratorja tad-doża, single-arm, open label, li rreġistra tliet pazjenti b'MPS VII, b'firxa ta' etajiet minn 5 snin sa 25 sena.
English: Sodium restricted diet
Maltese: Dieta ristretta fis-sodium
English: Dilution preparation should be done at room temperature.
Maltese: Il-preparazzjoni tad-dilwizzjoni għandha ssir fit temperatura tal-kamra.
English: Most adverse reactions were mild to moderate in severity.
Maltese: Il-maġġoranza tar-reazzjonijiet avversi kienu ta' severità baxxa jew moderata.
English: Pack size: 1 vial of 5 mL
Maltese: Kunjett 1 ta' 5 mL
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad dati ta'referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The infusion rate may be slowed, temporarily interrupted or discontinued in the event of hypersensitivity reactions (see section 4.4).
Maltese: Ir-rata tal-infużjoni tista' titnaqqas, tkun interrotta temporanjament jew imwaqqfa f'każ ta' reazzjonijiet ta' sensittività eċċessiva (ara sezzjoni 4.4.).
English: Infusion Rate for 1st Hour
Maltese: Infużjoni għall-1el
English: After dilution: Chemical and physical in-use stability of the diluted medicinal product has been demonstrated for up to 36 hours under refrigeration at 2°C - 8°C followed by up to 6 hours at room temperature up to a maximum of 25°C.
Maltese: Stabbiltà kimika u fiżika waqt l-użu tal-prodott mediċinali dilwit kienu murija sa 36 siegħa f'temperatura tal-friġġ ta' 2°C - 8°C segwit minn massimu ta' 6 sigħat f'temperatura tal kamra sa temperatura massima ta' 25°C.
English: In a multi-centre, randomized, placebo-controlled, Blind-Start, single-crossover Phase 3 trial (Study UX003-CL301, referred to as Study 301), 12 patients with MPS VII received vestronidase alfa 4 mg/kg every two weeks for 24 to 48 weeks.
Maltese: Fi prova każwali, multiċentrika, Blind-Start, single-crossover ta' Fażi 3, bi plaċebo bħala kontroll (Studju UX003-CL301, magħruf bħala Studju 301), 12 il pazjent b'MPS VII irċevew vestronidase alfa 4 mg/kg kull ġimagħtejn għal 24 sa 48 ġimgħa.
English: - This medicine has been prescribed for you only.
Maltese: - Il-mediċina trid tkun dilwita qabel ma tingħata.
English: The limited pharmacokinetic data at steady state suggest dose proportional increase in exposure of vestronidase alfa over the dose range of 1 - 4 mg/kg every other week.
Maltese: Id-dejta farmakokinetika limitata fi stat konstanti tissuġġerixxi żieda proporzjonali tad-doża fl-esponiment għall-vestronidase alfa fuq il-firxa tad-doża ta' 1 - 4 mg/kg ġimgħa iva u ġimgħa le.
English: The patients were randomized in a blinded manner into 4 groups: 3 patients received vestronidase alfa immediately for 48 weeks (Group A), 3 patients received placebo for 8 weeks then vestronidase alfa for 40 weeks (Group B), 3 patients received placebo for 16 weeks then vestronidase alfa for 32 weeks (Group C), and 3 patients received placebo for 24 weeks then vestronidase alfa for 24 weeks (Group D).
Maltese: Il-pazjenti kienu magħżula każwalment b'mod għami f'4 gruppi: 3 pazjenti rċevew vestronidase alfa immedjatament għal 48 ġimgħa (Grupp A), 3 pazjenti rċevew plaċebo għal 8 ġimgħat imbagħad vestronidase alfa għal 40 ġimgħa (Grupp B), 3 pazjenti rċevew plaċebo għal 16-il ġimgħa imbagħad vestronidase alfa għal 32 ġimgħa (Grupp Ċ), u 3 pazjenti rċevew plaċebo għal 24 ġimgħa imbagħad vestronidase alfa għal 24 ġimgħa (Grupp D).
English: Mucopolysaccharidosis VII is a lysosomal storage disorder characterized by the deficiency of betaglucuronidase (GUS) that results in glycosaminoglycans (GAGs) accumulation in cells throughout the body leading to multisystem tissue and organ damage.
Maltese: Il-mukopolisakkaridożi VII hija disturb fil-ħażna ta' liżożomi kkaratterizzata minn nuqqas ta' betaglucuronidase (GUS) li tirriżulta f'akkumulazzjoni ta' glycosaminoglycans (GAGs) f'ċelloli fil-ġisem kollu li twassal għal dannu f' diversi sistemi ta' tessuti u organi.
English: Mepsevii 2 mg/mL sterile concentrate vestronidase alfa
Maltese: IL-PRODOTT MEDIĊINALI Mepsevii 2 mg/mL konċentrat għal soluzzjoni għall-infużjoni vestronidase alfa
English: Sixteen out of 23 patients (70%) from 4 clinical trials developed anti-recombinant human betaglucuronidase (rhGUS) antibodies (ADA), nine of whom further developed neutralizing antibodies (NAb) on at least one occasion, but not consistently over time.
Maltese: Sittax minn 23 pazjent (70%) minn 4 provi kliniċi żviluppaw antikorpi (ADA), kontra betaglucuronidase uman rikombinanti (rhGUS), u disgħa minnhom komplew żviluppaw antikorpi newtralizzanti (NAb) almenu f'okkażjoni waħda, imma mhux b'mod konsistenti maż-żmien.
English: Mepsevii contains an enzyme called vestronidase alfa.
Maltese: Mepsevii fih enżima li jisimha vestronidase alfa.
English: There was a single adverse reaction of febrile convulsion observed in one patient (4.3%); the patient recovered without sequelae.
Maltese: Kien hemm reazzjoni avversa waħda ta' konvulżjoni febrili osservata f'pazjent wieħed (4.3%); il-pazjent irkupra mingħajr konsegwenzi oħra.
English: Very common Common
Maltese: Komuni Komuni
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrapurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Common *Refer to description of selected adverse reactions for details on the febrile convulsion reported in 1 of 23 trial patients.
Maltese: *Irreferi għad-deskrizzjoni tar-reazzjonijiet avversi magħżula għal dettalji dwar il-konvulżjoni febrili rraportata f'1 minn 23 pazjent fil-prova.
English: The key secondary endpoint was the multi-domain clinical responder index (MDRI) score consisting of six domains [six-minute walk test (6MWT), forced vital capacity (FVC), shoulder flexion, visual acuity, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) fine motor and gross motor function] after 24 weeks of treatment and fatigue total score as measured by the Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL).
Maltese: FVC), flessjoni tal-ispalla (shoulder flexion), l-akutezza viżwali, il-Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) għall-fine motor u gross motor function] wara 24 ġimgħa ta' trattament u l-punteġġ totali tal-għeja kif inhu mkejjel mill-Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL).
English: b. Total number of vials = Total dose (mg) divided by 10 mg/vial
Maltese: In-numru totali ta' kunjetti = Id-doża totali (mg) diviża b'10 mg/kunjett
English: A sufficiently large needle (18 gauge) should be used to minimise bubbles in the solution.
Maltese: (18 gauge) biex tnaqqas il-bżieżaq fis-soluzzjoni.
English: This medicinal product contains 17.8 mg sodium per vial and is administered in sodium chloride 9 mg/mL (0.9%) solution for infusion (see section 6.6).
Maltese: Dan il-prodott mediċinali fih 17.8 mg ta' sodium f'kull kunjett u jingħata f'soluzzjoni għall-infużjoni ta' sodium chloride ta' 9 mg/mL (0.9%) (ara sezzjoni 6.6.).