FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial dosed is therefore equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Kull kunjett mgħoti huwa għalhekk ekwivalenti għal 1.8% tal-konsum massimu ta' sodium fid-dieta ta' kuljum irrakkomandat għal adult.
English: The presence of ADA (non-NAb and NAb) does not appear to affect reduction in the pharmacodynamic marker, urinary glycosaminoglycans (uGAGs).
Maltese: (mhux-NAb u NAb) ma jidhirx li għandha effett fuq tnaqqis tal-marker farmakodinamiku, glycosaminoglycans awrinarji(uGAGs).
English: Spinal/Cervical cord compression
Maltese: Kompressjoni tas-Sinsla tad-dahar/Ċervikali
English: a. Volume (mL) of calculated dose = Total dose (mg) divided by the 2 mg/mL concentration
Maltese: a. Volum (mL) tad-doża kkalkulata = Id-doża totali (mg) diviża mill-konċentrazzjoni ta'
English: The safety and efficacy of vestronidase alfa in patients older than 65 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' vestronidase alfa f'pazjenti b'età 'l fuq minn 65 sena ma ġewx stabbiliti.
English: After repeated dosing of 4 mg/kg every other week, the maximal serum concentration (Cmax) was 20.0 ± 8.1 µg/mL (mean ± s.d.; range: 6.6 to 34.9 µg/mL) and the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) was 57.4 ± 23.9 µg*h/mL (mean ± s.d.; range: 18.8 to 97.0 µg*h/mL).
Maltese: żero sal-aħħar konċentrazzjoni li tista' titkejjel (AUC0-t) kienet 57.4 ± 23.9 µg*h/mL (medja ± s.d.; firxa: 18.8 sa 97.0 µg*h/mL).
English: The clinical program for vestronidase alfa included 23 treatment naïve patients with MPS VII from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Maltese: Il-program kliniku ta' vestronidase alfa kien jinkludi 23 pazjent b'MPS VII li qatt ma kienu ħadu trattament qabel, minn 4 provi kliniċi, b'etajiet bejn 5 xhur sa 25 sena, li rċevew vestronidase alfa f'dożi ta' mhux aktar minn 4 mg/kg darba kull ġimagħtejn għal mhux aktar minn 132 ġimgħa.
English: The pharmacokinetics of vestronidase alfa are time independent with repeat dosing.
Maltese: Il-propjetajiet farmakokinetiċi ta' vestronidase alfa huma dipendenti fuq il-ħin b'dożi repetuti.
English: Currently available data are described in section 4.8 and section 5.1.
Maltese: Dejta attwalment disponibbli hija deskritta f'sezzjoni 4.8 u sezzjoni 5
English: This medicine has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali ġie awtorizzata taħt ‘ċirkustanzi eċċezzjonali'.
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation the total volume of distribution (Vss) was 0.26 ± 0.13 L/kg (range: 0.10 to 0.60 L/kg).
Maltese: Wara dożaġġ repetut ta' 4 mg/kg, ġimgħa iva u ġimgħa le, f'pazjenti b'MPS VII, il-medja ± standard deviation tal-volum totali tad-distribuzzjoni (Vss) kien 0.26 ± 0.13 L/kg (firxa: 0.10 sa 0.60
English: Serious hypersensitivity reactions, including anaphylaxis, have been reported with vestronidase alfa; therefore, appropriate medical support should be readily available when vestronidase alfa is administered.
Maltese: Reazzjonijiet ta'sensittività eċċessiva inkluż l-anafilassi Reazzjonijiet serji ta' sensittività eċċessiva, inkluż l-anafilassi, ġew irrappurtati b'vestronidase alfa; għaldaqstant, kura medika adegwata għandha tkun disponibbli meta jingħata vestronidase alfa.
English: Patients who were enrolled in Study 301 were eligible to roll over to Study UX003-CL202 (referred to as Study 202), an open-label extension trial in which patients received additional doses of vestronidase alfa at 4 mg/kg intravenously every other week for up to 144 weeks.
Maltese: UX003-CL202 (magħruf bħala Studju 202), li huwa prova ta' estensjoni open-label li fih il-pazjenti rċevew dożi addizzjonali ta' 4 mg/kg ta' vestronidase alfa fil-vina, ġimgħa iva u ġimgħa le, għal mhux aktar minn 144 ġimgħa.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Propjetajiet farmakodinamiċi
English: Unopened vials:
Maltese: Wara d-dilwizzjoni:
English: Do not infuse Mepsevii with other medicinal products in the infusion tubing.
Maltese: Mepsevii m'għandux ikun infuż ma' prodotti mediċinali oħra fil-pajp tal-infużjoni.
English: Study UX003-CL203 (referred to as Study 203) is an ongoing open-label, uncontrolled single arm study that enrolled eight patients less than 5 years of age at a dose of 4 mg/kg vestronidase alfa every two weeks for 48 weeks of treatment period and additional weeks during optional continuation period to evaluate reduction of urinary GAG excretion, growth velocity and hepatosplenomegaly.
Maltese: Studju UX003-CL203 (magħruf bħala Studju 203) huwa studju għaddej, open-label, single arm mhux ikontrollat li rreġistra tmien pazjenti ta' inqas minn 5 snin b'doża ta' 4 mg/kg vestronidase alfa kull ġimagħtejn għal perjodu ta' trattament ta' 48 ġimgħa u ġimgħat addizjonali matul perjodu ta' kontinwazzjoni mhux obbligatorju biex jiġi evalwat it-tnaqqis fl-eliminazzjoni tal-GAG awrinarju, il veloċità tat-tkabbir u l-epatosplenomegalija.
English: After 24 weeks of vestronidase alfa treatment, the overall MDRI results, both pre-specified and post-hoc (6 MDRI domains plus fatigue domain) analyses, were positive with an increase of +0.5 domains (p=0.0527) and +0.8 domains (p=0.0433) including fatigue, respectively (t-test).
Maltese: Wara 24 ġimgħa ta' trattament b'vestronidase alfa, ir-riżultati ġenerali tal-MDRI, kemm l-analiżi speċifikati minn qabel kif ukoll dawk post-hoc (6 dominji MDRI flimkien mad dominju tal-għeja), kienu pożittivi, b'żieda ta' +0.5 dominji (p=0.0527) u +0.8 dominji (p= 0.
English: This medicine contains 17.8 mg sodium (main component of cooking/table salt) in each 5-mL vial, and is administered with sodium chloride 9 mg/mL as a diluent.
Maltese: Din il-mediċina fiha 17.8 mg ta' sodium (il-komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'kull kunjett ta' 5 mL, u hi mogħtija bis-sodium chloride 9 mg/mL bħala dilwent.
English: Mepsevii contains sodium
Maltese: Mepsevii għandu s-sodium
English: The assessment of adverse reactions was based on the exposure of 23 patients from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Maltese: L-assessjar ta' reazzjonijiet avversi kien ibbażat fuq l-użu fi 23 pazjent minn 4 provi kliniċi, b'etajiet bejn 5 xhur u 25 sena, li rċevew vestronidase alfa f'dożi ta' mhux aktar minn 4 mg/kg darba kull ġimagħtejn għal mhux aktar minn 132 ġimgħa.
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rrapurtati reazzjonijiet avversi.
English: Dilute the calculated dose 1:1 using equal volume of sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous infusion.
Maltese: Id-doża kkalkulata hawn fuq dilwita 1:1 f'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%) għandha tkun miżjuda ġo borża tal-infużjoni vojta u ġdida.
English: Based on mechanism of action, rhGUS is not expected to be tumorigenic.
Maltese: Fuq bażi tal-mekkaniżmu tal-azzjoni, rhGUS mhux mistenni li jkun tumorġeniku.
English: After 120 weeks of exposure to vestronidase alfa, one patient demonstrated a 21% improvement over baseline in forced vital capacity (FVC% predicted) on pulmonary function testing in addition to a 105 meter improvement in the 6MWT.
Maltese: Wara esponiment ta' 120 ġimgħa għal vestronidase alfa, pazjent wieħed wera titjib ta' 21% fuq il-linja bażi fil-kapaċità vitali furzata (forced vital capacity FVC% prevista) waqt ittestjar tal-funzjoni pulmonari flimkien ma'
English: As a precautionary measure, it is preferable to avoid the use of vestronidase alfa during pregnancy, unless the potential benefit to the mother outweighs the potential theoretical risks to the foetus.
Maltese: Bħala prekawzjoni, hu preferibbli li vestronidase alfa ma jintuzax waqt it-tqala, ħlief meta l-benefiċċju potenzjali għall-omm jisboq ir-riskji teoretiċi potenzjali għall-fetu.
English: In most patients, a pattern of attenuated immunogenicity with chronic exposure was suggested by declining antibody titres over time on continuous treatment.
Maltese: Fil maġġoranza tal-pazjenti, tendenza ta' immunoġeniċità attenwata ma' esponiment kroniku kienet issuġġerita minn tnaqqis fit-titri ta' antikorpi maż-żmien fuq trattament kontinwu.
English: One patient receiving a vestronidase alfa dose of 4 mg/kg experienced a febrile convulsion during treatment at the week 66, within 3 days of diphtheria, tetanus, pertussis vaccination.
Maltese: Pazjent wieħed li kien qed jirċievi doża ta' 4 mg/kg ta' vestronidase alfa esperjenza konvulżjoni febrili waqt it-trattament f'ġimgħa numru 66, fi żmien 3 ijiem ta' tilqim kontra d-difterite, it-tetnu u l pertussi.
English: Type I) with a rubber stopper with fluoro-resin coating, and an aluminium over seal with a plastic flip-off cap.
Maltese: Tip I) b'tapp tal-lastku b'kisja ta' fluoro-resin, u mgħotti b'siġill tal-aluminju b' tapp tal-plastik li jista' jinqala'.
English: 36 months
Maltese: 36 xahar
English: To minimise the risk of hypersensitivity reactions, a non-sedating antihistamine with or without an antipyretic medicinal product should be administered 30-60 minutes prior to the start of the infusion (see section 4.4).
Maltese: Biex jitnaqqas ir-riskju ta' reazzjonijiet ta' sensittività eċċessiva, antiistamina mhux sedattiv, flimkien jew ma' prodott mediċinali antipiretiku, għandu jingħata 30-60 minuta qabel ma tinbeda l-infużjoni (ara sezzjoni 4.4.).
English: How to store Mepsevii
Maltese: X'inhu Mepsevii
English: Of the 12 patients enrolled in the UX003-CL301, 4 were male and 8 were female and ranged in ages from 8 to 25 years (median 14 years).
Maltese: Mit-12-il pazjent irreġistrati f'UX003-CL301, 4 kienu rġiel u 8 kienu nisa u l-età kienet tvarja minn 8 snin sa 25 sena (valur medjan 14-il sena).
English: Mepsevii must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique according to the steps described below.
Maltese: Mepsevii jrid jiġi dilwit b'soluzzjoni għall-injezzjonijiet ta' sodium chloride 9 mg/mL (0.9%) permezz ta' teknika asettika skont l-istadji deskritti hawn taħt.
English: The lowest rate administered to a patient in the clinical development program was 0.5 mL/hour during the first 30 minutes of infusion, followed by 1 mL/hour over the next 30 minutes, equalling 0.75 mL as the lowest total volume infused during the first hour.
Maltese: L-inqas rata mogħtija lillpazjent fil-programm ta' żvilupp kliniku kienet ta' 0.5 mL/siegħa matul l-ewwel 30 minuta talinfużjoni, segwita minn 1 mL/siegħa matul it-30 minuta suċċessivi, ugwali għal 0.75 mL bħala l-inqas volum totali infuż matul l-ewwel siegħa.
English: Vestronidase alfa is not expected to be eliminated through renal or faecal excretion.
Maltese: Vestronidase alfa mhux mistenni li jkun eliminat permezz ta' tneħħija renali jew mal-ippurgar.
English: The primary endpoint was the percent reduction in urinary GAG excretion (Dermatan Sulfate, DS) before and after 24 weeks of treatment with vestronidase alfa.
Maltese: Il-punt tat-tmiem primarju kien it-tnaqqis f'perċentwali fit-tneħħija ta' GAG fl-awrina (Dermatan Sulfate, DS) qabel u wara 24 ġimgħa ta' trattament b'vestronidase alfa.
English: Spinal or cervical cord compression is a known and serious complication of MPS VII.
Maltese: Kompressjoni tas-sinsla tad-dahar jew ċervikali hija komplikazzjoni magħrufa u serja tal-MPS VII.
English: MPS VII is an illness that runs in families, where the body does not produce enough of an enzyme called beta-glucuronidase.
Maltese: MPS VII hija marda li sseħħ f'xi familji, fejn il-ġisem ma jipproduċix biżżejjed enzima msejjaħ beta glucuronidase.
English: This event was assessed as possibly related to vestronidase alfa due to the temporal association with the infusion.
Maltese: Dan il-każ kien assessjat bħala possibilment relatat ma' vestronidase alfa minħabba l-assoċjazzjoni temporali mal-infużjoni.
English: Infusion Rate for Subsequent 3 Hours
Maltese: Infużjoni fit-3 Sigħat ta'
English: Due to the low infusion rate, additional sodium chloride 9 mg/mL (0.9%) solution for infusion may be added through a separate line (piggyback or Y tube) to maintain sufficient intravenous flow.
Maltese: Minħabba r-rata baxxa ta' infużjoni, soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/mL (0.9%) addizzjonali tista' tingħata minn ġo pajp separat (piggyback jew tubu tat-tip Y) biex jinżamm fluss suffiċjenti fil-vini.
English: Two other patients with baseline hepatosplenomegaly had reduction in liver volume (24% and 53%) and spleen volume (28% and 47%) after 36 weeks of treatment.
Maltese: titjib ta' 105 metri fil-6MWT. Żewġ pazjenti oħra b'epatosplenomegalija fil-linja bażi kellhom tnaqqis fil-volum tal-fwied (24% u 53%) u l-volum tal-milsa (28% u 47%) wara 36 ġimgħa ta' trattament.
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Sensittività eċċessiva li tista' tkun ta' periklu għall-ħajja (reazzjoni anafilattika) għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1 (ara sezzjoni 4.4.).
English: Total Mepsevii Volume (rounded) (mL)
Maltese: Il-Volum Totali tal-Infużjoni (mogħti fuq 4 sigħat)
English: The patient subsequently was re-challenged without recurrence and continued on vestronidase alfa treatment.
Maltese: Sussegwentament il-pazjent reġa' ngħata l-istess mediċina mingħajr rikorrenza u kompla bit-trattament ta' vestronidase alfa.
English: No human data are available on the effect of vestronidase alfa on fertility.
Maltese: M'hemmx dejta fil-bniedem dwar l-effett ta' vestronidase alfa fuq il-fertilità.
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa.
Maltese: Kull kunjett ta' konċentrat ta' 5 mL fih 10 mg ta' vestronidase alfa.
English: Mepsevii 2 mg/mL concentrate for solution for infusion.
Maltese: IL-PRODOTT MEDIĊINALI Mepsevii 2 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: Each mL of concentrate contains 2 mg vestronidase alfa*.
Maltese: Kull mL tal-konċentrat fih 2 mg ta' vestronidase alfa*.
English: Anaphylactoid reaction Very common
Maltese: Reazzjoni anafilattojda Komuni ħafna
English: In order to obtain long-term data on effectiveness and safety of treatment with Mepsevii and to characterize the entire mucopolysaccharidosis VII, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a Disease Monitoring Program of patients with mucopolysaccharidosis VII.
Maltese: Sabiex tinkiseb dejta fit-tul dwar l-effettività u s-sigurtà tat-trattament b'Mepsevii u biex tiġi kkaratterizzata l-mucopolysaccharidosis VII sħiħa, inkluża l-varjabbiltà tal-manifestazzjoni klinika, il-progressjoni u l-istorja naturali, l-MAH huwa mitlub li jissottometti r-riżultati ta' studju bbażat fuq sors adegwat ta' dejta li ġejja minn Programm ta' Monitoraġġ tal-Mard ta' pazjenti b'mapopolysaccharidosis VII.
English: Adverse reactions are presented by System Organ Class and frequency.
Maltese: Ir-reazzjonijiet avversi huma ppreżentati skont is-Sistema tal-Klassifika tal-Orgni u l-frekwenza.
English: Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
Maltese: polysorbate 20, u ilma għall-injezzjonijiet (għas-sodium, ara sezzjoni 2 taħt “Mepsevii għandu s-sodium”).
English: Vestronidase alfa is a recombinant form of human GUS and is intended to provide exogenous GUS enzyme for uptake into cellular lysosomes and subsequent catabolism of accumulated GAGs in affected tissues.
Maltese: Vestronidase alfa hu forma rikombinanti ta' GUS uman u hu intenzjonat li jipprovdi l-enzima GUS
English: Mepsevii is supplied as a concentrate for solution for infusion (sterile concentrate).
Maltese: Mepsevii jiġi bħala konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: Excretion
Maltese: Deskrizzjoni
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation of the total clearance (CL) was 0.079 ± 0.045 L/h/kg (range: 0.038 to 0.20 L/h/kg); the mean ± standard deviation of the elimination half-life (t1/2) was 2.6 ± 0.6 hours (range: 0.9 to 3.6 hours).
Maltese: Wara dożaġġ repetut ta' 4 mg/kg, ġimgħa iva u ġimgħa, le f'pazjenti b'MPS VII, il-medja ± standard deviation tat-tneħħija totali (total clearance CL) kien 0.079 ± 0.045
English: Take this into account if you are on a controlled sodium diet.
Maltese: Ħu dan f'konsiderazzjoni jekk qiegħed fuq dieta ta' sodium ikkontrollat.
English: - This enzyme helps to break down sugars in the body called mucopolysaccharides.
Maltese: - Dan l-enzima jgħin sabiex jitkissru tipi ta' zokkor fil-ġisem imsejħa mukopolisakkaridi.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Animal studies with vestronidase alfa do not indicate any impact on male or female fertility (see section 5.3).
Maltese: Studji f'annimali b'vestronidase alfa ma jindikaw l-ebda effett fuq il-fertilità fl-irġiel jew fin-nisa (ara sezzjoni 5.3).
English: Consider rapid sodium chloride 9 mg/mL (0.9%) solution for infusion for decreased blood pressure and oxygen for hypoxia.
Maltese: Ikkonsidra infużjoni rapida ta' soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/mL (0.9%) għal tnaqqis fil-pressjoni u ossiġnu għall-ipoksja.
English: Contents of the pack and other information What Mepsevii contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Mepsevii
English: It is recommended that premedication with non-sedating antihistamines with or without antipyretics be administered 30-60 minutes prior to the start of the infusion (see section 4.2).
Maltese: tingħata 30-60 minuta qabel ma tinbeda l-infużjoni (ara sezzjoni 4.2).
English: - Your doctor or nurse will give Mepsevii to you by an infusion (drip) into a vein.
Maltese: - It-tabib jew infermier tiegħek ser jagħtik Mepsevii permezz ta' infużjoni (drip) ġo vina.
English: Vestronidase alfa, at the exposure observed in humans, is not expected to cross the blood-brain-barrier and therefore it is not likely to impact the neurological manifestations of the disease.
Maltese: Vestronidase alfa, fl-esponiment osservat fil-bniedem, mhux mistenni li jaqbeż il-barriera bejn id demm u l-moħħ u għaldaqstant mhuwiex mistenni li jaffettwa l-manifestazzjonijiet newroloġiċi tal marda.
English: Patients with MPS VII receiving vestronidase alfa should be monitored for signs and symptoms of spinal cord compression or neck instability including neck or back pain, weakness of limbs, changes in reflexes or urinary and faecal incontinence.
Maltese: Pazjenti b'MPS VII li qed jirċievu vestronidase alfa għandhom jiġu mmonitorjati għal sinjali u sintomi ta' kompressjoni tas-sinsla tad-dahar jew instabbiltà fl-għonq inkluż uġigħ flgħonq jew fid-dahar, dgħufija tar-riġlejn u d-dirgħajn, tibdil fir-riflessi jew inkontinenza tal-awrina u tal-ippurgar.
English: Each mL of sterile concentrate contains 2 mg vestronidase alfa.
Maltese: Kull mL ta' konċentrat sterili fih 2 mg ta' vestronidase alfa.
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi awtorizzazzjoni għat-Tqegħid fis-Suq taħt ċirkustanzi eċċezzjonali u skont lArtikolu 14(8) tar-Regolament (KE) Nru 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, ilmiżuri li gejjin:
English: Because it is a recombinant human protein and its enzyme action is within the lysosome, vestronidase alfa is not expected to interact with other medicinal products.
Maltese: Billi huwa proteina umana rikombinanti u l-azzjoni tiegħu ta' enzima hija fil-liżożomi, vestronidase alfa mhux mistenni li jagħmel interazzjonijiet ma' prodotti mediċinali oħra.
English: - The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium chloride, histidine, polysorbate 20, and water for injections (for sodium, see section 2 under “Mepsevii contains sodium”).
Maltese: - Is-sustanzi l-oħra huma: sodium dihydrogen phosphate dihydrate, sodium chloride, histidine,
English: The total infusion volume is based on the total Mepsevii dose and volume (refer to Table 2).
Maltese: Il-volum totali tal-infużjoni hu bbażat fuq id-doża u l-volum totali ta' Mepsevii (irreferi għal Tabella 2).
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity in rats, repeated dose toxicity in MPS VII mice and juvenile monkeys, fertility and embryo-foetal development in rats or rabbits, and pre- and postnatal development in rats.
Maltese: Tagħrif mhux kliniku ma juri l-ebda periklu speċjali għall-bniedem ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn doża waħda fil-firien, effett tossiku minn dożi repetuti fi ġrieden u xadini ġovanili b'MPS VII, il-fertilità u l-iżvilupp embrijo-fetali fir-firien u l-fniek, u liżvilupp ta' qabel u wara t-twelid fil-firien.
English: - If you have ever had a severe allergic reaction to vestronidase alfa or any of the other ingredients of this medicine (listed in section 6).
Maltese: - Jekk qatt kellek reazzjoni allerġika severa għal vestronidase alfa jew kwalunkwe ingredjent ieħor ta' din il-mediċina (elenkati f'sezzjoni 6).
English: Other symptoms to look out for
Maltese: Sintomi oħra li trid toqgħod attent għalihom
English: Due to lack of human data, vestronidase alfa should only be administered to a breast-feeding woman if the potential benefit of vestronidase alfa to the mother and the benefit of breast-feeding to the infant outweighs the potential theoretical risks to the infant.
Maltese: Minħabba fin-nuqqas ta' dejta fil-bniedem, vestronidase alfa għandu jingħata lil mara li qed tredda' biss jekk il-benefiċċju potenzjali ta' vestronidase alfa għall-omm u l-benefiċċju tattreddigħ għat-tarbija jisbqu r-riskji teoretiċi potenzjali għat-tarbija.
English: Total Number of Mepsevii Vials
Maltese: OĦRA, JEKK MEĦTIEĠA
English: Primary Endpoint
Maltese: ANNESS III
English: For each vial dosed, including the corresponding diluent volume, the sodium intake is 35.5 mg sodium.
Maltese: Għal kull kunjett li jingħata, inkluż ilvolum korrispondenti ta' dilwent, it-teħid ta' sodium huwa ta' 35.5 mg ta' sodium.
English: The diluted solution for infusion should be administered to patients using a low-protein binding infusion bag and set (a non di (2-ethylhexyl) phthalate [DEHP] bag could be used) and the application of an infusion set equipped with an in-line, low-protein binding 0.2 μm filter is recommended.
Maltese: Is-soluzzjoni dilwita għall-infużjoni għandha tkun mogħtija lill-pazjenti permezz ta' borża u sett tal-infużjoni b'livell baxx ta' proteini li jorbtu (borża li ma fihiex di (2-ethylhexyl) phthalate [DEHP] tista' tintuża) u l-użu ta' sett tal-infużjoni mgħammar b'filtru fil-pajp, b'livell baxx ta' proteini li jorbtu ta' 0.2 μm huwa rrakkomandat.
English: Gently rock the infusion bag to ensure proper distribution of Mepsevii.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: Further information on Eylea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Wet AMD
Maltese: AMD imxarrba