FrancophonIA/ELRC3.0 huggingface dataset:
English: Hence the applicant used advanced models for PEC calculation in groundwater (FOCUS), as described in the CVMP guideline on environmental impact assessment for veterinary medicinal products (EMEA/CVMP/ERA/418282/2005-Rev.1).
Maltese: B'hekk, l-applikant uża mudelli avvanzati għall-kalkolazzjoni tal-PEC fl-ilma ta' taħt l-art (FOCUS), kif deskritti fil-linja gwida tas-CVMP dwar il-valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji (EMEA/CVMP/ERA/418282/2005-Rev.1).
English: The target species are treated by 20 mg/kg bw of amoxicillin and 5 mg/kg bw of clavulanic acid for 5 consecutive days.
Maltese: L-ispeċi fil-mira huma kkurati b'20 mg/kg bw ta' amoxicillin u b'5 mg/kg bw ta' clavulanic acid għal 5 ijiem konsekuttivi.
English: PECgroundwater (combination) was 98.67 μg/l.
Maltese: Il-(kombinazzjoni) talPECilma ta' taħt l-art kienet ta' 98.67 μg/l.
English: The PECsoil value 217 μg/kg was used in the subsequent assessment.
Maltese: Il-valur tal-PECħamrija ta' 217 μg/kg intuża fil-valutazzjoni sussegwenti.
English: The PECgroundwater for both compounds was above the trigger value 0.1 μg/l (PECgroundwater for amoxicillin was 95.40 μg/l and for clavulanic acid 3.27 μg/l).
Maltese: 40 μg/l u għal clavulanic acid kienet ta' 3.27 μg/l).
English: Terrestrial effects studies
Maltese: Studji dwar l-effetti terrestri
English: Aquatic environment
Maltese: L-ambjent akwatiku
English: A PECsurfacewater refined by FOCUS modelling and corrected as a sum of predicted surface water concentration of amoxicillin and clavulanic acid (combination) was calculated as 0.036 μg/l.
Maltese: PECilma tal-wiċċ raffinata mill-mudelli ta' FOCUS u kkoreġuta bħala somma tal-konċentrazzjoni prevista tal-ilma tal-wiċċ tal-(kombinazzjoni ta') amoxicillin u clavulanic acid ġiet ikkalkolata bħala 0.036 μg/l.
English: This value was subsequently used in calculations of RQs for aquatic organisms.
Maltese: Dan il-valur intuża sussegwentement fil-kalkoli tal-RQs għall-organiżmi akwatiċi.
English: The refined RQ of 0.7 is below the trigger value of 1, hence the product does not pose a risk for the aquatic environment - surface water.
Maltese: L-RQ raffinat ta' 0.7 huwa taħt il-valur ta' skattar ta' 1, b'hekk, il-prodott ma jikkawża ebda riskju għall-ambjent akwatiku - l-ilma tal-wiċċ.
English: • The studies on the degradation in soil of amoxicillin and clavulanic acid and the adsorption/desorption of amoxicillin in soil provided by the applicant are acceptable;
Maltese: • L-istudji dwar id-degradazzjoni fil-ħamrija minn amoxicillin u clavulanic acid u l-assorbiment/id deassorbiment ta' amoxicillin fil-ħamrija pprovduti mill-applikant huma aċċettabbli;
English: Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding lack of data on the degradation in soil of amoxicillin and clavulanic acid and the adsorption/desorption of amoxicillin in soil, due to which the environmental risk assessment (ERA) could not be completed.
Maltese: Matul il-proċedura deċentralizzata ġew identifikati riskji serji potenzjali mill-Pajjiżi l-Baxxi u mir-Renju Unit fir-rigward tan-nuqqas ta' dejta dwar id-degradazzjoni fil-ħamrija ta' amoxicillin u ta' clavulanic acid u l-assorbiment/id-deassorbiment ta' amoxicillin fil-ħamrija, li minħabba fihom ma setgħetx issir il-valutazzjoni tar-riskju ambjentali (ERA).
English: Quality, Target animal safety, User safety, Residues, Resistance and Efficacy were not assessed in this referral procedure.
Maltese: Il-kwalità, is-Ssigurtà tal-annimali fil-mira, is-Sigurtà tal-utenti, ir-Residwi, ir-Reżistenza u l-Effikaċja ma ġewx ivvalutati f'din il-proċedura ta' riferiment.
English: Amoxicillin is a semi-synthetic aminopenicillin with broad-spectrum bactericidal activity.
Maltese: Amoxicillin huwa aminopenicillin semi-sintetiku b'attività batteriċidjali bi spettru wiesa'.
English: STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names contains amoxicillin and clavulanic acid (in the form of the potassium salt) at a ratio 4:1 as active ingredients.
Maltese: STRENZEN 500/125 mg/g trab għal użu fl-ilma tax-xorb għall-ħnieżer u ismijiet assoċjati fihom amoxicillin u clavulanic acid (fil-forma tal-melħ tal-potassju) fi proporzjon ta' 4:1 bħala ingredjenti attivi.
English: Advanced models for PECs in groundwater with the lowest KOC value (40.4 ml/g) as the worst case confirm that predicted environmental concentrations in all scenarios were below the trigger value of 0.1 μg/l and the product does not pose any risk to groundwater.
Maltese: Il-mudelli avvanzati għall-PECs fl-ilma ta' taħt l-art bl-aktar valur baxx ta' KOC (40.4 ml/g) bħala lagħar każ jikkonfermaw li l-konċentrazzjonijiet ambjentali previsti fix-xenarji kollha kienu taħt il-valur ta' skattar ta' 0.1 μg/l u li l-prodott ma jikkawża ebda riskju għall-ilma ta' taħt l-art.
English: The risk quotients (RQs) calculated for terrestrial plants and earthworms were below the trigger value of 1 and the product can be considered as safe for terrestrial organisms.
Maltese: Il-kwozjenti tar-riskju (RQs) li ġew ikkalkolati għall-pjanti terrestri u l-ħniex kienu taħt il-valur ta' skattar ta' 1 u l-prodott jista' jitqies bħala sigur għall-organiżmi terrestri.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of STRENZEN 500/125 mg/g powder for use in drinking water for pigs due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the product.
Maltese: Dan ir-riferiment skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE sar minħabba tħassib li l-applikant ma weriex b'mod sodisfaċenti s-sigurtà ambjentali ta' STRENZEN 500/125 mg/g trab għal użu fl-ilma tax-xorb għall-ħnieżer minħabba nuqqas ta' dejta pivotali li mingħajrha mhuwiex possibbli li tinġibed konklużjoni dwar is-sigurtà ambjentali tal-prodott.
English: The applicant did not propose any risk mitigation measures, because they did not identify any environmental risks.
Maltese: L-applikant ma ppropona ebda miżura ta' mitigazzjoni tar-riskji, minħabba li ma ġie identifikat ebda riskju ambjentali.
English: Therefore, the CVMP recommended the granting of the marketing authorisation for the veterinary medicinal products referred to in annex I for which the valid Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in annex III.
Maltese: Għalhekk, is-CVMP irrakkomanda li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji msemmija fl-Anness I, li għalihom jibqa' japplika s-Sommarju tal-Karatteristiċi tal-Prodott validu, tikkettar u fuljett ta' tagħrif fir-rigward tal-verżjonijiet finali miksuba matul ilproċedura tal-grupp ta' Koordinazzjoni msemmija fl-Anness
English: Soil
Maltese: Anness
English: Route of administration
Maltese: Ir-Repubblika Ċeka
English: Based on the revised ERA and considering additional information from peer-reviewed scientific literature, no serious risk for the environment was identified and the risk can be properly managed by the proposed conditions for use of the product as per the currently proposed SPC.
Maltese: Fuq il-bażi tal-ERA riveduta u fid-dawl tal-informazzjoni addizzjonali mir-riċensjoni xjentifika riveduta mill-pari, ma ġie identifikat ebda riskju serju għall-ambjent u r-riskju jista' jiġi ġestit kif suppost millkundizzjonijiet proposti għall-użu tal-prodott skont l-SPC propost bħalissa.
English: 5 May 2009 EMEA/215198/2009
Maltese: 5 ta' Mejju 2009 EMEA/215198/2009
English: International Non-Proprietary Name (INN): Enrofloxacin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): Enrofloxacin
English: The Decentralised Procedure IE/V/0200/001/DC started on 19 January 2007.
Maltese: Il-Proċedura Deċentralizzata IE/V/0200/001/DC bdiet fid-19 ta' Jannar 2007.
English: The Rapporteur and Co-Rapporteur appointed were: Dr Anja Holm (Denmark) and Dr Boris Kolar (Slovenia), respectively.
Maltese: It-Tabiba Anja Holm (Danimarka) u t-Tabib Boris Kolar (Slovenja), rispettivament.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Maltese: GĦALL-UŻU VETERINARJU (CVMP)
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR
Maltese: OPINJONI WARA REFERENZA GĦALL-ARTIKOLU 33(4) GĦAL
English: Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Maltese: Enrofloxacin huwa sustanza sintetika antimikrobika b'medda wiesgħa, li tappartjeni għall-grupp ta' antibijotiċi tal-fluworokinolini (fluoroquinoline).
English: On 29 April 2008 Ireland, referred the matter to the EMEA under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that enrofloxacin may present a potential serious risk to the environment (risk to blue-green algae and to terrestrial plants).
Maltese: Fid-29 ta' April 2008, l-Irlanda rreferiet il-kwistjoni lill-EMEA skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, minħabba xi tħassib li tqajjem mill-Ġermanja, li enrofloxacin jista' jippreżenta riskju potenzjali gravi lill-ambjent (riskju għall-alka blu fl-aħdar u għall-pjanti tal-art).
English: The applicant, Universal Farma S.L., submitted an application for a decentralised procedure for Unisol 10% Oral Solution, indicated for chickens and turkeys and for oral administration via the drinking water.
Maltese: L-applikant, Universal Farma S.L., ippreżenta applikazzjoni għal proċedura deċentralizzata għal Unisol 10% Oral Solution, indikat għat-tiġieġ u d-dundjani u għall-amministrazzjoni orali permezz talilma tax-xorb.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Ireland and the Concerned Member States were Belgium, Czech Republic, Germany and Poland.
Maltese: L-applikazzjoni ġiet preżentata fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendat, fejn l-Istat Membru ta' Referenza kien l-Irlanda u l-Istati Membri Konċernati kienu l-Belġju, ir-Repubblika Ċeka, il-Ġermanja u l-Polonja.
English: • Identification of a potential serious risks to blue-green algae and terrestrial plants arising from the use of Unisol 10% Oral solution.
Maltese: • L-identifikazzjoni ta' riskji serji potenzjali għall-alka blu fl-aħdar u l-pjanti tal-art li huma kkawżati mill-użu tas-Unisol 10% Oral Solution.
English: During its 13-15 January 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion that the use of the product as recommended does not constitute a risk for the environment and therefore the points of disagreement raised by Germany should not prevent the granting of a Marketing Authorisation.
Maltese: Waqt il-laqgħa tat-13-15 ta' Jannar 2009, is-CVMP, fid-dawl tad-dejta globali disponibbli u ddiskussjoni xjentifika fi ħdan il-Kumitat, adotta b'kunsens opinjoni li l-użu tal-prodott kif inhu rakkomandat ma joħloqx riskju għall-ambjent u għalhekk il-punt li dwarhom ma ntlaħaqx qbil millĠermanja ma għandhomx jipprevjenu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: The final opinion was converted into a Decision by the European Commission on 5 May 2009.
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fil-5 ta' Mejju 2009.
English: Written explanations were provided by the Applicant on 17 November 2008.
Maltese: L-Applikant ipprovda spjegazzjonijiet bil-miktub fis-17 ta' Novembru 2008.
English: • Adequacy of the data available in respect to the environmental risk assessment for blue-green algae and terrestrial plants;
Maltese: • Kemm kienet xierqa d-dejta disponibbli rigward il-valutazzjoni tar-riskju ambjentali għallalka blu fl-aħdar u l-pjanti tal-art;
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredient.
Maltese: Ma ngħatat l-ebda kunsidrazzjoni jew konklużjoni rigward l-applikabilità tal-konklużjonijiet għal prodotti oħra b'liċenzja li fihom l-istess sustanza attiva.
English: On the basis of the grounds for referral, the points considered by the CVMP were:
Maltese: Abbażi tar-raġunijiet tar-referenza, il-punti kkunsidrati mis-CVMP kienu:
English: 3 Apparently normal language.
Maltese: Lingwa apparentement normali.
English: July 2020
Maltese: Lulju 2020
English: Age groups
Maltese: Gruppi tal-età
English: CSF (N=17) Mean (SD)
Maltese: CSF (N=17) Medja (SD)
English: - The active substance is cerliponase alfa.
Maltese: - Is-sustanza attiva hi cerliponase alfa.
English: • Syringe: Braun and BD Luer-Lok
Maltese: Braun u BD Luer-Lok
English: • Extension Set with 0.2 micron filter: Impromediform GmbH
Maltese: • Sett ta' Estensjoni b'filtru ta' 0.2 micron: Impromediform GmbH
English: 200 (first 4 doses) 300 (subsequent doses)
Maltese: 200 (l-ewwel 4 dożi) 300 (dożi sussegwenti)
English: CLN2 patients with ventriculo-peritoneal shunts.
Maltese: Pazjenti b'CLN2 b'shunts ventrikulo-peritonjali.
English: Language
Maltese: Lingwa
English: Table 3: CLN2 Clinical Rating Scale
Maltese: Tabella 3: Skala ta' Klassifikazzjoni Klinika ta' CLN2
English: birth to < 6 months: 100 mg
Maltese: twelid sa < 6 xhur: 100 mg
English: Rash Urticaria
Maltese: Raxx Urtikarja
English: Rate of Decline (points/48 weeks)a Overall (n = 23)
Maltese: Rata ta' Tnaqqis (punti/48 ġimgħa)a
English: Brineura is compatible with disposable infusion components made of PVC, PVC (non-DEHP) polyethylene, polyethersulfone (PES), polypropylene (PP), and PTFE.
Maltese: Brineura huwa kompatibbli ma' komponenti ta' infużjoni li jintremew wara l-użu magħmula minn PVC, PVC (mhux DEHP) polyethylene, polyethersulfone (PES), polypropylene (PP), u PTFE.
English: Date of first authorisation: 30 May 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 30 ta' Mejju 2017
English: • Two single-use hypodermic syringe needles, (21 G, 25.4 mm).
Maltese: • Żewġ labar tas-siringi ipodermiċi li jintużaw darba biss, (21 G, 25.4 mm).
English: BIOMARIN PHARMACEUTICAL INC GALLI DRIVE FACILITY, 46 GALLI DRIVE, NOVATO,
Maltese: DRIVE FACILITY, 46 GALLI
English: CSF Pleocytosis Dropped head syndrome
Maltese: CSF Pleocytosis Sindrome ta' ras imwaqqa'
English: Brineura 150 mg solution for infusion cerliponase alfa
Maltese: Brineura 150 mg soluzzjoni għal infużjoni cerliponase alfa
English: Each vial contains 44 mg of sodium.
Maltese: Kull kunjett fih 44 mg ta' sodium.
English: Table 4: 0 to 6 Point Motor-Language CLN2 Clinical Rating Scale: Rate of Decline over 48 weeks (Intent to Treat (ITT) population)
Maltese: Tabella 4: 0 sa 6 Punteġġ Mutur-Lingwa tal-Iskala ta' Klassifikazzjoni Klinika ta' CLN2: Rata ta' Tnaqqis fuq 48 ġimgħa (Popolazzjoni b'Intenzjoni ta' Kura (ITT))
English: Cerliponase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Maltese: Cerliponase alfa huwa proteina u huwa mistenni li jkun metabolikament degradat permezz ta' idroliżi tal-peptide.
English: Pharmacotherapeutic group: other alimentary tract and metabolism products, enzymes, ATC code: A16AB17.
Maltese: Kategorija farmakoterapewtika: prodotti oħra tal-apparat alimentari u l-metaboliżmu, enzimi, Kodiċi ATC:
English: Anti-drug antibodies (ADAs) were detected in both serum and CSF in 79% and 21%, respectively, of patients treated with cerliponase alfa for up to 107 weeks.
Maltese: Antikorpi antimediċina (ADA) instabu kemm fis-serum kif ukoll fis-CSF f'79% u 21%, rispettivament, tal-pazjenti kkurati b'cerliponase alfa sa 107 ġimgħat.
English: Other medicines and Brineura
Maltese: Mediċini oħra u Brineura
English: MedDRA System organ class
Maltese: Sistema tal-klassifika tal-organi fid-database MedDRA
English: frequency convention defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra, skont il-konvenzjoni tal-frekwenza MedDRA, bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Brineura and flushing solution Sodium phosphate dibasic heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
Maltese: Sodium phosphate dibasic heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
English: • Two single-use syringes compatible with the pump equipment.
Maltese: • Żewġ siringi li jintużaw darba biss kompatibbli mal-pompa.
English: A length of 150 to 206 cm (not to exceed 400 cm) and an inner diameter of 0.1 cm is recommended.
Maltese: Tul ta' 150 sa 206 cm (li ma taqbiżx 400 cm) u li għandhom dijametru intern ta'
English: Intracerebroventricular access devices shown to be compatible with Brineura and flushing solution and used in Brineura clinical studies include CodmanHOLTER RICKHAM and HOLTER SALMON-RICKHAM Reservoirs, Codman Ventricular Catheter, and Medtronic CSF-Ventricular Reservoir (with catheter).
Maltese: Apparati ta' aċċess intraċerebroventrikulari murija bħala kompatibbli ma' Brineura u s-soluzzjoni għat-tlaħliħ u użati fi studji kliniċi ta' Brineura jinkludu Codman HOLTER RICKHAM u HOLTER SALMON-RICKHAM Reservoirs, Codman Ventricular Catheter, u Medtronic CSF-Ventricular
English: Table 1: Dose and volume of Brineura
Maltese: Tabella 1: Doża u volum ta' Brineura
English: Volume of Brineura solution (ml)
Maltese: Volum ta' soluzzjoni ta' Brineura (ml)
English: A total of 24 patients, aged 3 to 8 years, were treated with Brineura 300 mg every other week.
Maltese: Total ta' 24 pazjent, minn età ta' 3 snin sa 8 snin, ġew ikkurati bi Brineura 300 mg ġimgħa iva u ġimgħa le.
English: Brineura 150 mg solution for infusion
Maltese: Brineura 150 mg soluzzjoni għal infużjoni
English: Device issue:
Maltese: Problemi bl-apparat:
English: In cardiac normal patients, regular 12-lead ECG evaluations should be performed every 6 months.
Maltese: F'pazjenti bi stat kardijaku normali, evalwazzjonijiet bi 12-lead ECG regolari għandhom isiru kull 6 xhur.
English: Figure 1: Infusion System Set Up
Maltese: Figura 1: Set Up tas-Sistema għall-Infużjoni
English: Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Maltese: Magnesium chloride hexahydrate Calcium chloride dihydrate Ilma għall-injezzjonijiet
English: LOT:
Maltese: Lott:
English: The mean baseline CLN2 score was 3.5 (standard deviation (SD) 1.20) with a range from 1 to 6; no patients with advanced disease progression were studied (inclusion criteria: mild to moderate progression of CLN2 disease).
Maltese: 3.5 (standard deviation (SD) 1.20) b'medda minn 1 sa 6; ebda pazjent bi progressjoni avvanzata tal marda ma kien studjat (kriterji ta' inklużjoni: progressjoni tal-mard ta' CLN2 minn ħafifa sa moderata).
English: Vertical bars represent standard error of the mean Solid line: 190-201 and 190-202 clinical studies Dash line: 190-901 Natural history control group
Maltese: Linja solida: studji kliniċi 190-201 u 190-202 Linja mkissra:
English: Tmax*, hr
Maltese: *, hr
English: Store upright in a freezer (-25°C to -15°C).
Maltese: Aħżen wieqaf fil-friża (-25°C sa -15°C).
English: 3 Grossly normal gait.
Maltese: Mixja ferm normali.
English: Intelligible and grossly age-appropriate.
Maltese: Tinftiehem u ġeneralment adattat għall-età.
English: The most common manifestations included pyrexia with vomiting, pleocytosis, or irritability, which are inconsistent with classic immune mediated hypersensitivity.
Maltese: L-iktar manifestazzjonijiet komuni inkludew deni ma' rimettar, pleocytosis, jew irritabilità, li huma inkonsistenti ma' sensittività eċċessiva medjata mill-immunità klassika.
English: There is limited data in patients older than 8 years of age.
Maltese: Hemm data limitata f'pazjenti ikbar minn 8 snin.
English: Findings from studies 190-201 and 190-202 were compared with a natural history control group that included patients that satisfied the inclusion criteria for studies 190-201 and 190-202.
Maltese: Sejbiet minn studji 190-201 u 190-202 tqabblu ma' grupp ta' kontroll ta' storja naturali li kien jinkludi pazjenti li ssodisfaw il-kriterji ta' inklużjoni għal studji 190-201 u 190-202.
English: - The other ingredients of Brineura and the flushing solution are: sodium phosphate dibasic heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections (see section 2 “Brineura contains sodium”)
Maltese: - Is-sustanzi mhux attivi l-oħra ta' Brineura u s-soluzzjoni għat-tlaħliħ huma: sodium phosphate dibasic heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, and ilma għall injezzjonijiet (ara sezzjoni 2 “Brineura fih sodium”)
English: MedDRA Preferred term
Maltese: Terminoloġija preferuta MedDRA Frekwenza
English: Each domain encompasses scores of 3 (grossly normal) to 0 (profoundly impaired), for a total possible score of 6, with unit decrements representing milestone events in the loss of previously attained functions of ambulation and speech.
Maltese: Kull qasam jinkludi punteġġi ta' 3 (ġeneralment normali) sa 0 (profondament indebolit), għal punteġġ totali possibbli ta' 6, ma' tnaqqis ta' unità li jirrappreżentaw avvenimenti ta' mira importanti fil-telf ta' funzjonijiet li nkisbu qabel ta' ambulazzjoni u diskors.
English: Withdraw Brineura
Maltese: Iġbed Brineura
English: Cerliponase alfa plasma pharmacokinetics were assessed in 13 patients, and a median Tmax of 12.0 hours (since start of infusion), a mean Cmax of 1.39 µg/ml, and mean AUC0-t of 24.1 µg-hour/ml were characterized.
Maltese: Tmax medjan ta' 12.0 sigħat (sa mill-bidu tal-infużjoni), Cmax medju ta 1.39 µg/ml, u l-medja AUC0-t ta' 24.1 µg siegħa/ml kienu kkaratterizzati.
English: Intracerebroventricular use.
Maltese: Għal użu intraċerebroventrikulari.
English: Overall, 23 (96%) subjects who received cerliponase alfa experienced an event that mapped to the Convulsions Standardized MedDRA Query.
Maltese: B'mod ġenerali, 23 (96%) individwu li rċivew cerliponase alfa esperjenzaw avveniment li ġie mmappjat għall-Convulsions Standardized MedDRA Query.
English: Each vial of Brineura contains 150 mg cerliponase alfa in 5 ml of solution (30 mg/ml)
Maltese: Kull kunjett ta' Brineura fih 150 mg cerliponase alfa f'5 ml ta' soluzzjoni (30 mg/ml)
English: The pharmacokinetic parameters in CSF were assessed in 17 patients and are summarized in Table 5 below.
Maltese: Il-parametri farmakokinetiċi fis-CSF ġew ivvalutati fi 17-il pazjent u huma mqassra fitTabella 5 hawn taħt.
English: • Do not return CSF to the intracerebroventricular access device.
Maltese: • Tirritornax CSF lura fl-apparat ta' aċċess intraċerebroventrikulari.
English: 1 year to < 2 years: 200 mg (first 4 doses), 300 mg (all other doses) ≥ 2 years: 300 mg
Maltese: 6 xhur sa < sena: 150 mg sena sa < sentejn: 200 mg (l-ewwel 4 dożi), 300 mg (dożi sussegwenti) > sentejn:
English: • Extension Set: Fresenius Injectomat® line, Alaris CC Extension set, Vygon Lectro-Cath Extension tube
Maltese: • Sett ta' Estensjoni: linja Fresenius Injectomat®, Sett ta' Estensjoni Alaris CC, Tubu ta'
English: Label the infusion line for “Intracerebroventricular infusion only”.
Maltese: Immarka l-linja tal-infużjoni bi “Għal infużjoni intraċerebroventrikulari biss”.
English: No prominent ataxia, no pathologic falls.
Maltese: L-ebda atassja prominenti, l-ebda waqa' patoloġika.
English: Total convulsion events with a temporal relationship to cerliponase alfa administration was 17% and were mild to moderate, grade 1 to 2 in severity.
Maltese: cerliponase alfa kienu ta' 17% u kienu ħfief għal moderati, grad 1 sa 2 fis-severità.
English: 2 years
Maltese: 2 punti.