FrancophonIA/ELRC3.0 huggingface dataset:
English: • Program the pump alarms to sound at the most sensitive settings for pressure, rate, and volume limits.
Maltese: • Ipprogramma l-allarmi tal-pompa sabiex idoqqu fil-konfigurazzjonijiet l-iktar sensittivi għal-limiti ta' pressjoni, rata, u volum.
English: • A non-coring port needle with a gauge of 22 or smaller and a suggested length of 16 mm.
Maltese: • Labra tal-port mhux coring b'gejġ ta' 22 jew iżgħar u tul suġġerit ta' 16 mm.
English: • Port needle: Deltec GRIPPER Needles
Maltese: Labar Deltec GRIPPER
English: Convulsions
Maltese: Konvulżjonijiet
English: Do not administer Brineura if there are signs and symptoms of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.3 and 4.4).
Maltese: Brineura ma jridx jingħata sakemm ikun hemm sinjali ta' tnixxija tal-apparat, falliment tal-apparat, jew infezzjoni relatata mal-apparat ta' aċċess intraċerebroventrikulari akuti (ara sezzjoni 4.2 u 4.4).
English: Vial (type I glass) with a stopper (butyl rubber), a flip-off cap (polypropylene) and crimp seal (aluminium).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett (ħġieġ tat-tip I) b'tapp (gomma butyl), għatu flip-off (polypropylene) u siġill tat-tip crimp (aluminju).
English: Figure 2: CLN2 Score Mean Change from Baseline (Natural History Control Group vs Brineura treated patients, 300 mg every other week)
Maltese: Figura 2: Bidla Medja tal-Punteġġ CLN2 mil-Linja Bażi (Grupp ta' Kontroll ta' Storja Naturali vs pazjenti kkurati bi Brineura, 300 mg ġimgħa iva u ġimgħa le)
English: • A 0.2 µm inline filter is required.
Maltese: • Filtru inline ta' 0.2 μm huwa meħtieġ.
English: The inline filter should be placed as close as practically possible to the port needle.
Maltese: Il-filtru inline għandu jitqiegħed kemm prattikament possibbli qrib il-labra tal-port.
English: Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Maltese: Briunera jintuża għall-kura ta' pazjenti bil-marda ta' neuronal ceroid lipofuscinosis tat-tip 2 (CLN2), magħrufa wkoll bħala defiċjenza ta' tripeptidyl peptidase-1 (TPP1).
English: Healthcare professionals should be aware of the possible symptoms of anaphylaxis such as: generalized hives, pruritus or flushing, swollen lips, tongue, and/or uvula, dyspnoea, bronchospasm, stridor, hypoxemia, hypotonia, syncope, or incontinence.
Maltese: Professjonisti tal-kura tas-saħħa għandhom ikunu konxji mis-sintomi possibbli ta' anafilassi bħal: urtikarja ġeneralizzata, ħakk jew ħmura, xofftejn, ilsien, u/jew uvula minfuħin, dispnea, bronkospażmi, stridor, ipoksemija, ipotonija, sinkope, jew inkontinenza.
English: CSF protein increased ECG abnormalities CSF protein decreased
Maltese: Żieda fil-proteina fis-CSF ECG anormali Tnaqqis fil-proteina fis-CSF
English: Pack size of three vials: two 10 ml vials, each containing 150 mg of cerliponase alfa in 5 ml of solution; and one 10 ml vial, containing 5 ml flushing solution.
Maltese: Pakkett ta' tliet kunjetti: żewġ kunjetti ta' 10 ml, kull wieħed fih 150 mg ta' cerliponase alfa f'5 ml ta' soluzzjoni; u kunjett wieħed ta' 10 ml, li jkun fih 5 ml ta' soluzzjoni għat-tlaħliħ.
English: INFORMATION IN BRAILLE
Maltese: ISTRUZZJONIJIET DWAR L-UŻU INFORMAZZJONI BIL-BRAILLE
English: Each vial contains 44 mg of sodium in 5 ml of solution.
Maltese: Kull kunjett fih 44 mg ta' sodium f'kull 5 ml ta' soluzzjoni.
English: 2 Independent gait, as defined by ability to walk without support for 10 steps.
Maltese: Mixja indipendenti, definita bħala l-kapaċità li timxi mingħajr appoġġ għal 10 passi.
English: The activated proteolytic enzyme (rhTPP1) cleaves tripeptides from the N-terminus of the target protein with no known substrate specificity.
Maltese: L-enzima proteolitika attivata (rhTPP1) taqsam tripeptides mill-N-terminus tal-proteina mmirata blebda speċifiċità għas-sottostrat magħrufa.
English: Chemical and physical in-use stability has been demonstrated for up to 12 hours at room temperature (19-25°C).
Maltese: Stabbiltà kimika u fiżika waqt l-użu ntweriet għal sa 12-il siegħa f'temperatura ambjentali (19-25°C).
English: Cerliponase alfa is taken up by target cells and translocated to the lysosomes through the Cation Independent Mannose-6-Phosphate Receptor (CI-MPR, also known as M6P/IGF2 receptor).
Maltese: Phosphate Receptor (CI-MPR, magħrufa wkoll bħala riċettur M6P/IGF2).
English: Each ml of solution for infusion contains 30 mg of cerliponase alfa.
Maltese: Kull ml ta' soluzzjoni għal infużjoni fiha 30 mg ta' cerliponase alfa.
English: CSF samples should routinely be sent for testing to detect subclinical device infections (see section 4.2).
Maltese: Kampjuni ta' CSF għandhom jintbagħtu regolarment għall-ittestjar sabiex jiġu maqbuda infezzjonijiet tal-apparat sottokliniku (ara sezzjoni 4.2).
English: In study 190-201, the mean rate of decline in patients treated with Brineura at 300 mg every other week was 0.40 points per 48 weeks.
Maltese: Fi studju 190-201, ir-rata medja ta' tnaqqis f'pazjenti kkurati Brineura bi 300 mg ġimgħa iva u ġimgħa le kienet ta' 0.40 punt għal kull 48 ġimgħa.
English: The large CSF to plasma ratios in Cmax and AUC0-t (approximately 1000 and 400, respectively) suggest that the majority of administered cerliponase alfa remains localized within the CNS.
Maltese: Il-proporzjonijiet kbar ta' CSF għal plażma fis-Cmax u AUC0-t (madwar 1000 u 400, rispettivament) jissuġġerixxu li l-maġġoranza tas-cerliponase alfa mogħti tibqa' lokalizzata fis-CNS.
English: Brineura is administered to the cerebrospinal fluid (CSF) by infusion via a surgically implanted reservoir and catheter (intracerebroventricular access device).
Maltese: Brineura jingħata fil-fluwidu ċerebrospinali (CSF) b'infużjoni permezz ta' riżerva impjantata b'mod kirurġiku u kateter (apparat ta' aċċess intraċerebroventrikulari).
English: In study 190-201, 20 out of 23 (87%) patients receiving Brineura for 48 weeks did not have an unreversed 2 point decline in the untreated patient population (p=0.0002, binomial test assuming p0= 0.50).
Maltese: Brineura għal 48 ġimgħa ma kellhomx tnaqqis ta' 2 punti unreversed mistenni fil-popolazzjoni ta' pazjenti mhux ikkurati (p=0.0002, test binomjali fejn jitqies p0=0.50).
English: The estimated volume of distribution of cerliponase alfa following intracerebroventricular infusion of 300 mg (Vz = 435 ml) exceeds the typical CSF volume (100 ml), suggesting distribution to tissues outside the CSF.
Maltese: (Vz = 435 ml) jaqbeż il-volum ta' CSF tipiku (100 ml), li jissuġġerixxi distribuzzjoni fit-tessuti barra s-CSF.
English: Connect a separate empty sterile syringe (no larger than 3 ml) to the port needle.
Maltese: Qabbad siringa sterili vojta separata (mhux ikbar minn 3 ml) mal-labra tal-port.
English: Prime the infusion components with Brineura.
Maltese: 3. Ipprajmja l-komponenti tal-infużjoni bi Brineura.
English: Transport and distribute frozen (-85°C to -15°C).
Maltese: Ittrasporta and ddistribwixxi ffriżat (-85°C sa -15°C).
English: Intracerebroventricular Infusion of Brineura
Maltese: Infużjoni intraċerebroventrikulari ta' Brineura
English: Common Common Not known Very common a Propionibacterium acnes, staphylococcus epidermis b Atonic seizures, clonic convulsion, drop attacks, epilepsy, generalised tonic-clonic seizure, myoclonic epilepsy, partial seizures, petit mal epilepsy, seizure, seizure cluster, and status epilepticus c Pyrexia includes combined preferred terms “Pyrexia” and “Increased body temperature” d Catheter flow obstruction e Device dislocation did not occur in clinical trials f Dislodgement of infusion needle
Maltese: Tabella 2: Frekwenza ta' reazzjonijiet avversi bi Brineura a Propionibacterium acnes, staphylococcus epidermis b Aċċessjonijiet atoniċi, konvulżjonijiet kloniċi, attakki ta' waqgħa (drop attacks), epilessija, aċċessjonijiet toniċi-kloniċi ġeneralizzati, epilessija mijoklonika, aċċessjonijiet parzjali, epilessija petit mal, aċċessjoni, aċċessjonijiet raggruppati
English: Excipients with known effect:
Maltese: Effetti sekondarji komuni:
English: A total of 15 patients out of 23 (65%) had no overall decline in CLN2 score, irrespective of baseline score, and 2 of these 15 patients increased their score by one point during the treatment period.
Maltese: Total ta' 15-il pazjent minn 23 (65%) ma kellhom l-ebda tnaqqis globali fil-punteġġ CLN2, irrispettivament mill-punteġġ fil-linja bażi, u 2 minn dawn il-15-il pazjent żiedu l-punteġġ tagħhom minn punt wieħed matul il-perjodu ta' kura.
English: The inline filter may be integral to the infusion set.
Maltese: Il-filtru inline jista' jkun integrali għas-sett tal-infużjoni.
English: There was no apparent effect of serum or CSF ADA on the plasma or CSF pharmacokinetics, respectively.
Maltese: Ma kien hemm ebda effett apparenti ta' ADA fis-serum jew fis-CSF fuq il-farmakokinetika tal-plażma jew CSF, rispettivament.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of cerliponase alfa.
Maltese: Konsegwentement, indeboliment tal-funzjoni tal-fwied mhux mistenni li jaffettwa lfarmakokinetika ta' cerliponase alfa.
English: The safety and efficacy of Brineura were assessed in an open label, dose escalation clinical study (190-201) and an ongoing long term extension study (190-202) in patients with CLN2 disease compared to untreated patients with CLN2 disease from a natural history database (natural history control group).
Maltese: Is-sigurtà u l-effikaċja ta' Brineura ġew evalwati fi studju kliniku open label, b'żieda fid-doża (190201) u studju ta' estensjoni fit-tul, li għaddej (190-202) f'pazjenti b'mard ta' CLN2 mqabbla ma' pazjenti mhux ikkurati b'mard ta' CLN2 minn database ta' storja naturali (grupp ta' kontroll ta' storja naturali).
English: Study 190-203 is an ongoing open label clinical study evaluating the safety and efficacy in patients from birth to 18 years of age.
Maltese: Studju 190-203 huwa studju kliniku li għaddej open label li qed jevalwa s-sigurtà u l-effikaċja f'pazjenti mit-twelid sa 18-il sena.
English: In the ongoing study 190-202 (as of 03 June 2016), the rate of decline in patients treated with Brineura compared to the natural history control group (N=42 patients) continues to show durability of the treatment effect (see Figure 2).
Maltese: Fl-istudju li għaddej 190-202 (mit-3 ta' Ġunju 2016), ir-rata ta' tnaqqis f'pazjenti kkurati bi Brineura meta mqabbla mal-grupp ta' kontroll ta' storja naturali (N=42 pazjent) ikompli juri durabilità tal-effett tal-kura (ara l-Figura 2).
English: 6.7 (first 4 doses) 10 (subsequent doses)
Maltese: 6.7 (l-ewwel 4 dożi)
English: Cerliponase alfa is a recombinant human protein and systemic exposure is limited due to intracerebroventricular administration, therefore interactions between cerliponase alfa and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni. Cerliponase alfa huwa proteina tal-bniedem rekombinanti u esponiment sistemiku huwa limitat minħabba għoti intraċerebroventrikulari, għaldaqstant interazzjonijiet bejn cerliponase alfa u prodotti mediċinali metabolizzati minn enzimi ta' ċitokroma P450 mhux komuni li jseħħu.
English: Brineura contains sodium:
Maltese: Brineura fih is-sodium.
English: The most commonly reported convulsion events include seizure, epilepsy and generalized tonic-clonic seizure.
Maltese: L-avvenimenti konvulżivi irrapportati bl-iktar mod komuni jinkludu aċċessjonijiet, epilessija u aċċessjonijiet toniċi-kloniċi ġeneralizzati.
English: Hypersensitivity reactions were reported in 14 out of 24 patients (58%) treated with Brineura.
Maltese: Reazzjonijiet ta' sensittività eċċessiva kienu rrappurtati f'14 minn 24 pazjent (58%) ikkurati bi
English: Flushing solution for Brineura Intracerebroventricular use
Maltese: Għall-użu intraċerebroventrikulari
English: All pharmacokinetic parameters were similar following the initial infusion on Day 1 and following infusions at Week 5 and Week 13, indicating no apparent accumulation or time dependent PK of cerliponase alfa in CSF or plasma when administered at of dose of 300 mg once every other week.
Maltese: Il-parametri farmakokinetiċi kollha kienu simili wara l-infużjoni tal-bidu f'Jum 1 u wara infużjonijiet f'Ġimgħa 5 u Ġimgħa 13, li ma jindikaw l-ebda akkumulazzjoni apparenti jew PK dipendenti fuq il ħin ta' cerliponase alfa fis-CSF jew plażma meta jingħata f'doża ta' 300 mg darba ġimgħa iva u ġimgħa le.
English: Results from the natural history control group demonstrate CLN2 disease is a rapidly progressive neurodegenerative disease with predictable decline in motor and language function with an estimated mean rate of decline in the CLN2 score of 2 points per 48 weeks.
Maltese: Riżultati mill-grupp ta' kontroll ta' storja naturali juru li l-marda ta' CLN2 hija marda newrodeġenerattiva li tipprogressa malajr bi tnaqqis prevedibbli fil-funzjoni tal-mutur u tal-lingwa b'rata medja stmata ta' tnaqqis fil punteġġ CLN2 ta' 2 punti għal kull 48 ġimgħa.
English: Cerliponase alfa is a recombinant form of human tripeptidyl peptidase-1 (rhTPP1).
Maltese: magħrufa wkoll bħala defiċjenza ta' tripeptidyl peptidase 1 (TPP1).
English: of all convulsion events were considered related to cerliponase alfa and ranged from mild to severe, CTCAE grade 1-4.
Maltese: B'kollox, 6% tal avvenimenti kollha konvulżivi kienu kkunsidrati relatati ma' cerliponase alfa u varjaw minn ħfief għal severi, CTCAE grad 1-4.
English: Clinical and laboratory monitoring
Maltese: Monitoraġġ kliniku u tal-laboratorju
English: The pump must be programmable to deliver the medicinal product at a constant rate of 2.5 ml/hr.
Maltese: Il-pompa għandha tkun programmabbli li tagħti l prodott mediċinali b'rata kostanti ta' 2.5 ml/hr.
English: Cerliponase alfa is a proteolytic inactive proenzyme (zymogen) that is activated in the lysosome.
Maltese: Cerliponase alfa hu forma rikombinanti ta tripeptidyl peptidase-1 umana (rhTPP1). Cerliponase alfa hu proenzima inattiva (zymogen) proteolitika li hija attivata fil-liżożomi.
English: Fertility
Maltese: Anafilassi
English: Attach the infusion set to the port needle (see Figure 1).
Maltese: Qabbad is-sett tal-infużjoni mal-labra tal-port (ara Figura 1).
English: Solution for infusion.
Maltese: Soluzzjoni għal infużjoni.
English: CSF samples should routinely be sent for infection monitoring (see section 4.4).
Maltese: għandhom jintbagħtu regolarment għall-monitoraġġ ta' infezzjoni (ara sezzjoni 4.4).
English: *Cerliponase alfa is produced in mammalian Chinese Hamster Ovary cells.
Maltese: *Cerliponase alfa huwa prodott fiċ-ċelluli mammiferi tal-Ovarji tal-Ħamster Ċiniż. Eċċipjenti b'effett magħruf:
English: Thus, the non-clinical development is inconclusive with respect to the clinical safety of cerliponase alfa.
Maltese: Għalhekk, l-iżvilupp mhux kliniku jkun inkonklussiv fir-rigward tas-sigurtà klinika ta cerliponase alfa.
English: Brineura and the flushing solution must only be administered by the intracerebroventricular route.
Maltese: Brineura u s-soluzzjoni għat-tlaħliħ (flushing solution) għandhom jingħataw biss permezz tar-rotta intraċerebroventrikulari.
English: Genotoxicity, carcinogenicity and reproductive toxicity investigations have not been performed.
Maltese: Ma twettqux investigazzjonijiet dwar il-ġenotossiċità, il-karċinoġeniċità u t-tossiċità riproduttiva.
English: Very common Common Common Not known
Maltese: Komuni ħafna Komuni ħafna Komuni ħafna
English: Do not dilute Brineura.
Maltese: Tiddilwix Brineura.
English: In patients less than 3 years of age the recommended dose is in accordance with the posology used in the ongoing clinical study 190-203, see section 5.1.
Maltese: F'pazjenti f'età ta' inqas minn 3 snin, id-doża rakkomandata hija konformi mal-pożoloġija użata fl-istudju kliniku li għaddej 190-203, ara sezzjoni 5
English: In clinical studies, antibiotics were administered, the intracerebroventricular access device was replaced, and Brineura treatment was continued.
Maltese: Fl-istudji kliniċi, ingħataw antibijotiċi, l-apparat ta' aċċess intraċerebroventrikulari ġie ssostitwit, u l-kura bi Brineura tkompliet.
English: When compared to the expected rate of decline based on natural history, the study results are statistically significant (p < 0.0001) (see Table 4).
Maltese: Meta mqabbel mar-rata mistennija ta' tnaqqis ibbażata fuq l-istorja naturali, ir-riżultati tal-istudju huma statistikament sinifikanti (p <0.
English: The pharmacokinetics of cerliponase alfa were evaluated in patients with CLN2 disease who received intracerebroventricular infusions of 300 mg over approximately 4.5 hours once every other week.
Maltese: .2 Tagħrif farmakokinetiku Il-farmakokinetika ta' cerliponase alfa ġiet evalwata f'pazjenti b'mard ta' CLN2 li rċevew infużjonijiet intraċerebroventrikulari ta' 300 mg iktar minn madwar 4.5 sigħat darba ġimgħa iva u ġimgħa le.
English: All 23 patients completed study 190-201 and continued to the ongoing extension study 190-202 treated with Brineura at 300 mg every other week to a maximum of 124 weeks.
Maltese: It-23 pazjent kollha temmew l-istudju 190-201 u komplew għall-istudju ta' estensjoni li għaddej 190-202 ikkurati bi Brineura 300 mg ġimgħa iva u ġimgħa le għal massimu ta' 124 ġimgħa.
English: Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of solution.
Maltese: Kull kunjett ta' Brineura fih 150 mg ta' cerliponase alfa* f'5 ml ta' soluzzjoni.
English: Signs of problems with the device include swelling, redness of the scalp, fluid leaking from device and bulging of the scalp.
Maltese: Sinjali ta' problemi bl-apparat jinkludu: nefħa, ħmura tal-qorriegħa, tnixxija ta' fluwidu, u mbuzzar talqorriegħa.
English: Table 5: Pharmacokinetic properties following first Intracerebroventricular infusion (approximately 4 hours in duration) of 300 mg cerliponase alfa in CSF
Maltese: madwar 4 sigħat) ta' 300 mg cerliponase alfa fis-CSF
English: Attach the syringe containing the calculated volume of flushing solution to the infusion components (see section 6.6).
Maltese: Qabbad is-siringa li fiha l-volum ikkalkulat ta' soluzzjoni għat-tlaħliħ għall-komponenti tal-infużjoni (ara sezzjoni 6.6).
English: The recommended dose is 300 mg cerliponase alfa administered once every other week by intracerebroventricular infusion.
Maltese: Id-doża rakkomandata hi ta' 300 mg cerloponase alfa mogħtija darba ġimgħa iva u ġimgħa le b'infużjoni intraċerebroventrikulari.
English: Withdraw 0.5 ml to 1 ml of CSF to check patency of the intracerebroventricular access device.
Maltese: 1 ml ta' CSF sabiex tiċċekkja li m'hemmx ostakolu għall-apparat ta' aċċess intraċerebroventrikulari.
English: Continuation of long-term treatment should be subject to regular clinical evaluation whether the benefits are considered to outweigh the potential risks to individual patients.
Maltese: It-tkomplija ta' kura fit-tul għandha tkun suġġetta għal evalwazzjoni klinika regolari jekk il-benefiċċji huma meqjusa li jisbqu r-riskji potenzjali għal pazjenti individwali.
English: Intracerebroventricular access device-related infections, including sub-clinical infections and meningitis, have been observed in patients treated with Brineura.
Maltese: Kienu osservati infezzjonijiet relatati mal-apparat ta' aċċess intraċerebroventrikulari, inkluż infezzjonijiet sottokliniċi u meninġite f'pazjenti kkurati bi Brineura.
English: The medicine is slowly pumped through the implanted device.
Maltese: Il-mediċina hija mogħtija bil-mod permezz tal-apparat impjantat.
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 approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Post-authorisation efficacy study (PAES): Study 190-203.
Maltese: Studju 190-203.
English: Device-related infectiona Meningitis
Maltese: Infezzjoni relatata mal-apparata
English: Rating
Maltese: Klassifika
English: Device leakage Device occlusiond Device dislocatione Needle issuef
Maltese: Vireg vertikali jirrappreżentaw l-istandard error tal-medja
English: Drug-specific neutralizing antibodies (NAb) capable of inhibiting receptor-mediated cellular uptake of cerliponase alfa were not detected in the CSF.
Maltese: Antikorpi newtralizzanti speċifiċi għall-mediċina (NAb) kapaċi jinibixxu assorbiment ċellulari medjat mir-riċettur ta'
English: • One empty sterile single-use syringe (for collection of CSF to check patency).
Maltese: • Siringa waħda sterili vojta li tintuża darba biss (għall-ġbir ta' CSF biex jiċċekkjaw li m'hemmx ostakolu).
English: Sodium content
Maltese: sodium baxx.
English: In order to evaluate the long-term safety of cerliponase alfa, including the occurrence of serious hypersensitivity reactions and anaphylaxis, the MAH should submit the results of a study based on adequate source of data deriving from a registry of patients with neuronal ceroid lipfuscinosis Type 2 (CLN2).
Maltese: Sabiex tiġi evalwata s-sigurtà fit-tul ta' cerliponase alfa, inkluża l-okkorrenza ta' reazzjonijiet serji ta' sensittività eċċessiva u anafilassi, l-MAH għandu jissottometti r-riżultati bbażati fuq sors xieraq ta' tagħrif derivat minn reġistru ta' pazjenti b'neuronal ceroid lipfuscinosis tat-tip 2 (CLN2).
English: MRI volumetry measurements show attenuated rate of loss.
Maltese: Kejl tal-volumetrija b'MRI juri rata ta' telf attenwata.
English: Median Min, Max 95% CI Limits a Patient rate of decline per 48 weeks: (baseline CLN2 score - last CLN2 score) / (time elapsed in units of 48 weeks) b p-value based on 1-sample T-test comparing rate of decline to the value 2 c Positive estimates indicate clinical decline; negative estimates indicate clinical improvement
Maltese: Effett tal-kura f'pazjenti li qed jirċievu Brineura kienet evalwata bl-użu tal-iskala ta' klassifikazzjoni klinika ta' CLN2, u r-riżultati ġew imqabbla maż-2 punti għal kull 48 ġimgħa ta' tnaqqis fil-grupp ta'
English: Using aseptic technique, withdraw the volume of Brineura solution per required dose (see Table 1 in section 4.2) into the sterile syringe labelled “Brineura”.
Maltese: Brineura skont id-doża meħtieġa (ara t-Tabella 1 f'sezzjoni 4.2) fis-siringa sterili mmarkata
English: Thaw Brineura and flushing solution
Maltese: Kif jidher Brineura u l-kontenut tal-pakkett
English: *Tmax expressed as time since start of ~4 hour infusion and presented as median [min, max], and occurred at the first sampling timepoint post infusion
Maltese: *Tmax espress bħala ħin sa mill-bidu ta' infużjoni ta' ~4 sigħat u ppreżentat bħala medjan [min, max], u seħħew fl-ewwel timepoint tat-teħid ta' kampjuni wara l-infużjoni
English: For instructions on preparation of Brineura and flushing solution before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar il-preparazzjoni qabel l-għoti ta' Brineura u s-soluzzjoni għat-tlaħliħ, ara sezzjoni 6.6.
English: Abdominal pain Oral mucosal blistering Tongue blistering Gastrointestinal disorder
Maltese: Infafet fil-mukosa tal-ħalq Infafet fuq l-ilsien Disturbi gastro-intestinali
English: Tabulated list of adverse reactions Adverse reactions observed are listed below, by system organ class and frequency, following the MedDRA
Maltese: Ir-reazzjonijiet avversi osservati huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi u lfrekwenza.
English: Convulsion eventsb Headache
Maltese: Avvenimenti konvulżivib Uġigħ ta' ras
English: Label one unused sterile syringe “Brineura” and attach a syringe needle.
Maltese: L-apparati ta' aċċess kienu mibdula u l-pazjenti komplew il-kura b'Brineura.
English: Vomiting
Maltese: Mutur
English: The most frequent (>20%) adverse reactions observed during Brineura clinical trials include pyrexia, low CSF protein, ECG abnormalities, vomiting, upper respiratory tract infections, and hypersensitivity.
Maltese: CSF, anormalitajiet fl-ECG, rimettar, infezzjonijiet fl-apparat respiratorju, u sensittività eċċessiva.