FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal ewwel awtorizzazzjoni: 14 ta' Jannar, 2016
English: Treatment was administered during Induction (Day 7), and then every 2 weeks for a total of 30 weeks post-Induction therapy.
Maltese: It-trattament ingħata waqt l-Induzzjoni (Jum 7), u mbagħad kull ġimagħtejn għal total ta' 30 ġimgħa wara t-terapija tal-Induzzjoni.
English: Asparagine concentration fell to <3 µM when asparaginase activity was >0.1 U/mL.
Maltese: asparagine waqgħet għal <3 µM meta l-attività ta' asparaginase kienet >0.1 U/ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1070/001
Maltese: EU/1/15/1070/001
English: Les Laboratoires Servier Tél: + 33 (0)1 55 72 60 00
Maltese: Les Laboratoires Servier Tel: +33 (0)1 55 72 60 00
English: Patients with newly diagnosed ALL received a single IM injection of Oncaspar (2,500 U/m² BSA) or native asparaginase from E. coli (25,000 U/m² BSA) or from Erwinia (25,000 U/m² BSA).
Maltese: Oncaspar (2,500 U/m² BSA) jew native asparaginase minn E. coli (25,000 U/m² BSA) jew minn Erwinia (25,000 U/m² BSA).
English: The type of adverse reactions of Oncaspar is similar with that of native non-pegylated L-asparaginase (e.g., native E. coli asparaginase).
Maltese: It-tip tar-reazzjonijiet avversi ta' Oncaspar hu simili ma' dik ta' native non-pegylated L-asparaginase (eż., native E. coli asparaginase).
English: The volume of distribution at steady-state and clearance were estimated at 1.86 L/m2 and 0.169 L/m2 per day, respectively.
Maltese: Il-volum tad-distribuzzjoni fl-istat fiss u t-tneħħija kienu stmati li huma 1.86 l/m2 u 0.169 l/m2 kuljum, rispettivament.
English: Oncaspar should be discontinued in patients with serious hypersensitivity reactions (see sections 4.3 and 4.8).
Maltese: Oncaspar għandu jitwaqqaf f'pazjenti li jkollhom reazzjonijiet serji ta' sensittività eċċessiva (ara sezzjonijiet 4.3 u 4.8).
English: CL (L/day)
Maltese: CL (L/jum)
English: When there is a marked decrease in fibrinogen or antithrombin III (ATIII) deficiency, consider appropriate replacement therapy.
Maltese: Meta jkun hemm tnaqqis notevoli ta' fibrinogen jew defiċjenza ta' antithrombin III (ATIII), ikkunsidra terapija ta' sostituzzjoni xierqa.
English: Pegaspargase was not mutagenic in the Ames test using Salmonella typhimurium strains.
Maltese: Pegaspargase ma kienx mutaġeniku fit-test Ames bl-użu ta' razez ta' Salmonella typhimurium.
English: Neutralising antibodies reducing clinical efficacy were also recorded.
Maltese: Ġew osservati wkoll antikorpi newtralizzanti li tnaqqas leffikaċja klinika.
English: Not known: Confusional state
Maltese: Stat konfużjonali
English: - medicines which reduce the blood´s ability to clot such as anticoagulants (e.g., coumarin/warfarin and heparin), dipyridamol, acetylsalicylic acid or non-steroidal anti-inflammatory medicines (such as ibuprofen or naproxen).
Maltese: - mediċini li jnaqqsu l-kapaċità tad-demm li jagħqad bħal antikoagulanti (eż., coumarin/warfarin u heparin), dipyridamol, acetylsalicylic acid jew mediċini mhux sterojdi antiinfjammatorji (bħal ibuprofen jew naproxen).
English: - vincristine, another cancer medicine.
Maltese: - vincristine, mediċina oħra kontra l-kanċer.
English: The mechanism of action of L-asparaginase is the enzymatic cleavage of the amino acid L-asparagine into aspartic acid and ammonia.
Maltese: Il-mekkaniżmu ta' azzjoni ta' L-asparaginase hu l-qsim enzimatiku tal-amino acid L-asparagine f'aspartic acid u ammonia.
English: 7-Year EFS Rate, % (95% CI)
Maltese: Rata ta' EFS wara 7 Snin, % (95% CI)
English: Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962)
Maltese: Tabella 2: Rata ta' sopravivenza mingħajr avvenimenti wara 3, 5 u 7 snin (Studju CCG-1962)
English: Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase.
Maltese: Ma sarux studji bi pegaspargase dwar tossiċità riproduttiva.
English: - cytarabine, a medicine which can be used in cancer treatment, and could interfere with the effects of Oncaspar.
Maltese: - cytarabine, mediċina li tista' tintuża fil-kura tal-kanċer, u tista' tinterferixxi mal-effetti ta'
English: 5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap.
Maltese: 5 ml ta' soluzzjoni f'kunjett (ħġieġ ta' Tip I) b'tapp (lastku) u siġill (aluminju) b'għatu flip-off.
English: History of pancreatitis, including pancreatitis related to previous L-asparaginase therapy (see section 4.4).
Maltese: Storja medika ta' pankreatite, inkluża pankreatite relatata ma' terapija b'L-asparaginase fil-passat (ara sezzjoni 4.4).
English: Oncaspar contains sodium
Maltese: Oncaspar fih is-sodium
English: Elderly There are limited data available for patients older than 65 years.
Maltese: Hemm dejta limitata disponibbli għal pazjenti li jkollhom aktar minn 65 sena.
English: The plasma elimination half-life of Oncaspar was statistically significantly longer (5.7 days) than the plasma elimination half-lives of the native asparaginases from E. coli (1.3 days) and Erwinia (0.65 days).
Maltese: Il-half-life tal-eliminazzjoni ta' Oncaspar mill-plażma kienet itwal b'mod statistikament sinifikanti (5.7 jiem) mill-half-lives tal-eliminazzjoni mill-plażma tan-native asparaginases minn E. coli (1.3 jiem) u Erwinia (0.65 jiem).
English: Central nervous system effects
Maltese: Effetti fuq is-sistema nervuża ċentrali
English: Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
Maltese: Oncaspar hu indikat bħala komponent ta' terapija kombinata antineoplastika f'lewkimja limfoblastika akuta (ALL) f'pazjenti pedjatriċi mit-twelid sa 18-il sena, u f'pazjenti adulti.
English: Embryotoxicity studies with L-asparaginase have given evidence of teratogenic potential in rats treated from day 6 to 15 of gestation with a No Observed Effect Level (NOEL) for teratogenic effects at 300 U/kg intravenous.
Maltese: Studji dwar embrijotossiċità b'L-asparaginase taw evidenza ta' potenzjal teratoġeniku f'firien ikkurati minn jum 6 sa 15 tat-tqala b'Livell ta' Ebda Effett Osservat (No Observed Effect Level (NOEL)) għal effetti teratoġeniċi f'doża ta' 300 U/kg ġol-vini.
English: The One-year EFS was 98.0 [95%CI 92.3, 99.5]; the One-year OS was 100 [95% CI 100, 100] in this study.
Maltese: 92.3, 99.5]; l-OS ta' sena kienet 100 [95% CI 100, 100] f'dan l-istudju.
English: CSF asparagine decreased from a mean pre-treatment concentration of 3.1 µM to 1.7 µM on Day 4 ± 1 and 1.5 µM at 25 ± 1 days after administration of Oncaspar.
Maltese: CSF asparagine naqas minn konċentrazzjoni medja qabel il-kura ta' 3.1 µM għal 1.7 µM f'Jum 4 ± 1 u 1.5 µM f'25 ± 1 jiem wara l-għoti ta' Oncaspar.
English: Asparaginase facilitates the rapid conversion of asparagine and glutamine to aspartic acid and glutamic acid, with ammonia as the shared by-product of both reactions (see section 5.1).
Maltese: Asparaginase jiffaċilita l-konverżjoni rapida ta' asparagine u glutamine għal aspartic acid u glutamic acid, b'ammonia bħala l-prodott sekondarju komuni taż-żewġ reazzjonijiet (ara sezzjoni 5.1).
English: Haemorrhagic or necrotising pancreatitis occurs rarely.
Maltese: Pankreatite emorraġika jew nekrotizzanti sseħħ b'mod rari.
English: Infections and infestations Common: Infections, sepsis
Maltese: Infezzjonijiet, sepsis
English: PHARMACEUTICAL FORM Solution for injection/infusion.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni/infużjoni.
English: * The active substance is a covalent conjugate of Escherichia coli-derived L-asparaginase with monomethoxypolyethylene glycol **One unit is defined as the quantity of enzyme required to liberate 1 µmol ammonia per minute at pH 7.3 and 37°C
Maltese: ** Unità waħda hi definita bħala l-kwantità ta' enzimi meħtieġa sabiex tillibera 1 μmol ta' ammonia kull minuta f'pH ta' 7.3 u temperatura ta' 37°C
English: 3-Year EFS Rate, % (95% CI)
Maltese: Rata ta' EFS wara 3 Snin, % (95% CI)
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other antineoplastic agents, ATC code: L01XX24
Maltese: Mediċini antineoplastiċi u immunomodulanti, mediċini antineoplastiċi oħrajn, Kodiċi ATC:
English: Native E. coli L-asparaginase (6,000 Units/m2 BSA intramuscular) was administered 3 times weekly for 9 doses during induction.
Maltese: Native E. coli L-asparaginase (6,000 Unità/m2 BSA ġol-muskoli) ingħata 3 darbiet fil-ġimgħa għal total ta' 9 dożi matul l-induzzjoni.
English: BSA during Induction, Consolidation, Delayed Intensification, and Interim Maintenance phases in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Münster therapy.
Maltese: Intensifikazzjoni Mdewma, u Manteniment Interim f'pazjenti b'ALL ta' riskju għoli li kienu qed jirċievu terapija Berlin-Frankfurt-Münster imtejba.
English: Note: Oncaspar (2,500 Units/m2 BSA intramuscular) was administered on Day 3 of the 4-week induction phase.
Maltese: Nota: Oncaspar (2,500 Unità/m2 BSA ġol-muskoli) ingħata f'Jum 3 tal-fażi ta' induzzjoni li damet 4 ġimgħat.
English: After reconstitution, 1 ml of solution contains 750 U pegaspargase (750 U/ml).
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni fih 750 U ta' pegaspargase (750 U/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 750 U of pegaspargase.
Maltese: ATTIVA(I) 1 ml fih 750 U ta' pegaspargase.
English: Depending on the severity of the symptoms, administration of antihistamines, corticosteroids and vasopressors may be indicated as counter-measure.
Maltese: Skont is-severità tas-sintomi, l għoti ta' antistamini, kortikosterojdi u vasopressors jistgħu jiġu indikati bħala kontromiżura.
English: Rare (may affect up to 1 in 1,000 people) - Liver failure.
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) - Insuffiċjenza tal-fwied.
English: The most common, severe adverse reactions with Oncaspar (graded 3 or 4) observed in studies DFCI 11-001 and AALL07P4 with a frequency of >5% included: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, febrile neutropenia, hyperglycaemia, lipase increased, and pancreatitis.
Maltese: L-aktar reazzjonijiet avversi severi komuni b'Oncaspar (ta' grad 3 jew 4) osservati fi studji DFCI 11-001 u AALL07P4 bi frekwenza ta' >5% inkludew: żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fil-bilirubina fid-demm, newtropenija bid-deni, ipergliċemija,
English: Oncaspar may cause central nervous system signs and symptoms manifesting as somnolence, confusion, convulsions.
Maltese: Oncaspar jista' jikkawża sinjali u sintomi fis-sistema nervuża ċentrali li jidhru bħala ngħas, konfużjoni, konvulżjonijiet.
English: 3 patients (27%) achieved complete remission, 1 patient (9%) had partial remission, 1 patient (9%) had haematologic improvement and 2 patients (18%) had therapeutic efficacy.
Maltese: Minn dawn, 3 pazjenti (27%) kisbu remissjoni kompleta, pazjent 1 (9%) kellu remissjoni parzjali, pazjent 1 (9%) kellu titjib ematoloġiku u 2 pazjenti (18%) kellhom effikaċja terapewtika.
English: The percentage of patients in the Oncaspar arm with evaluable Low End-Induction MRD (<0.001 detectable disease) at Day 32 was 87.9% (80/91).
Maltese: 001 marda traċċabbli) f'Jum 32 kien 87.9% (80/91).
English: Oncaspar pharmacokinetic properties were based on asparaginase activity measured by an enzymatic assay after IM (CCG-1962) and IV (AALL07P4, DFCI 11-001) administration.
Maltese: It-tagħrif farmakokinetiku ta' Oncaspar kien ibbażat fuq attività ta' asparaginase mkejla b'assaġġ enzimatiku wara l-għoti ġol-muskoli (CCG-1962) u ġol-vini (AALL07P4, DFCI 11-001).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection/infusion 1 vial of 5 ml.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni/infużjoni kunjett 1 ta' 5 ml.
English: Two patients in the Oncaspar arm had allergic reactions during Delayed Intensification (DI) DI #1 (Grade 1 allergic reaction and Grade 3 hives).
Maltese: (Delayed Intensification (DI)) DI #1 (reazzjoni allerġika ta' Grad 1 u ħorriqija ta' Grad 3).
English: Table 3: Pharmacokinetic Parameters After a Single IV Dose of Oncaspar 2,500 U/m2 BSA During Induction (N=47; Study AALL07P4)
Maltese: 2,500 U/m2 BSA Waqt l-Induzzjoni (N=47; Studju AALL07P4)
English: Each vial contains 3,750 Units (U)** of pegaspargase*.
Maltese: Kull kunjett fih 3,750 unità (U)** ta' pegaspargase*.
English: In case of contact, irrigate with plenty of water for at least 15 minutes.
Maltese: F'każ ta' kuntatt, xarrab b'ħafna ilma għal mill-inqas 15-il minuta.
English: One vial of 5 ml solution contains 3750 U.
Maltese: Kunjett wieħed ta' 5 ml ta' soluzzjoni fih 3750 U.
English: During Induction, plasma asparaginase activity ≥0.1 U/mL was sustained in 93.5% of subjects 18 days after administration.
Maltese: Waqt l-Induzzjoni, l-attività ta' asparaginase fil-plażma ≥0.1 U/ml kienet sostnuta fi 93.5% tal-individwi 18-il jum wara l-għoti.
English: Oncaspar should be discontinued in patients with serious thrombotic events.
Maltese: Oncaspar għandu jitwaqqaf f'pazjenti li jkollhom avvenimenti trombotiċi serji.
English: A dose-independent rise in serum transaminases, and serum bilirubin is commonly observed.
Maltese: Żieda tat-transaminases fis-serum li hi indipendenti mid doża, u bilirubina fis-serum jiġu osservati b'mod komuni.
English: Cases of encephalopathy (including reversible posterior leukoencephalopathy syndrome) have been reported (see section 4.8).
Maltese: Każijiet ta' enċefalopatija (inkluż is-sindrome ta' lewkoenċefalopatija riversibbli posterjuri) ġew irrappurtati (ara sezzjoni 4.8).
English: One vial of 5 ml solution contains 3750 units of pegaspargase.
Maltese: soluzzjoni ta' 5 ml fih 3750 unità ta' pegaspargase.
English: There may be an increased risk of hepatotoxicity in Philadelphia chromosome positive patients, for whom treatment with tyrosine kinase inhibitors (e.g., imatinib) is combined with L-asparaginase therapy.
Maltese: Jista' jkun hemm riskju akbar ta' epatotossiċità f'pazjenti pożittivi għall-kromożoma Philadelphia, li għalihom it-trattament b'inibituri ta' tyrosine kinase (eż., imatinib) huwa kkombinat ma' terapija b'Lasparaginase.
English: 5-Year EFS Rate, % (95% CI)
Maltese: Snin, % (95% CI)
English: Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Maltese: Oncaspar normalment jingħata bħala parti minn protokolli ta' kimoterapija kombinata ma' mediċini antineoplastiċi oħrajn (ara wkoll sezzjoni 4.5).
English: One ml of solution contains 750 Units (U)** of pegaspargase*.
Maltese: 1 ml ta' soluzzjoni fih 750 unità (U)** ta' pegaspargase*.
English: In Study AALL07P4, PK parameters after a single 2,500 U/m2 IV dose during Induction were calculated by noncompartmental PK analysis from sequential plasma samples and are depicted in Table 3 (see section 5.1).
Maltese: Fi Studju AALL07P4, il-parametri PK wara doża waħda ta' 2,500 U/m2 ġol-vini waqt l-Induzzjoni ġew ikkalkolati permezz ta' analiżi PK nonkompartamentali minn kampjuni sekwenzjali tal-plażma u huma murija f'Tabella 3 (ara sezzjoni 5.1).
English: Type I flint glass vial with chlorobutyl elastomer stopper, capped with a 20 mm aluminium flip-off seal, containing 3,750 U pegaspargase.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ taż-żnied ta' Tip I b'tapp tal-chlorobutyl elastomer, magħluq b'siġill flip-off tal aluminju ta' 20 mm, li jkun fih 3,750 U ta' pegaspargase.
English: Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Maltese: Oncaspar 750 U/ml soluzzjoni għall-injezzjoni/infużjoni pegaspargase
English: In single cases, haemorrhagic or necrotising pancreatitis with fatal outcome has been reported.
Maltese: F'każijiet individwali, ġiet irrappurtata pankreatite emorraġika jew nekrotizzanti b'riżultat fatali.
English: Anti-asparaginase antibodies may be associated with low asparaginase activity levels due to potential neutralising activity of these antibodies.
Maltese: Antikorpi kontra asparaginase jistgħu jiġu assoċjati ma' livelli baxxi ta' attività ta' asparaginase minħabba l-attività newtralizzanti potenzjali ta' dawn l-antikorpi.
English: Serum amylase can rise during and also after the conclusion of Oncaspar therapy.
Maltese: Amylase fis-serum jista' jiżdied matul u wkoll wara l-konklużjoni tat-terapija b'Oncaspar.
English: CSF asparagine of 2.3 µM pre-treatment fell to 1.1 µM on Day 7 and 0.6 µM on Day 28 of Induction (see Clinical efficacy and safety).
Maltese: Asparagine fis-CSF ta' 2.3 µM qabel it-trattament waqa' għal 1.1 µM f'Jum 7 u 0.6 µM f'Jum 28 tal-Induzzjoni
English: A pilot study was conducted for newly diagnosed patients from 1 to <31 years of age with high risk B-precursor ALL (Study AALL07P4).
Maltese: Twettaq studju pilota li sar għal pazjenti li ġew iddijanjostikati għall-ewwel darba li kellhom minn sena sa <31 sena b'ALL prekursur B ta' riskju għoli (Studju AALL07P4).
English: Very common: Weight decreased, hypoalbuminaemia, alanine aminotransferase increased, aspartate aminotransferase increased,
Maltese: Tnaqqis fil-piż, ipoalbuminemija, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase,
English: E. coli
Maltese: CSF
English: Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving pegaspargase (see section 4.8).
Maltese: Avvenimenti trombotiċi serji, li jinkludu trombożi saġittali tas-sinus, jistgħu jseħħu f'pazjenti li jkunu qed jirċievu pegaspargase (ara sezzjoni 4.8).
English: Combination therapy with Oncaspar can result in central nervous system toxicity.
Maltese: It-terapija kombinata b'Oncaspar tista' tirriżulta f'tossiċità tas-sistema nervuża ċentrali.
English: Anti-leukaemic effect of L-asparaginase is related to a sustained L-asparagine depletion in blood and cerebrospinal fluid (CSF).
Maltese: Effett antilewkimiku ta' L-asparaginase hu relatat ma' tnaqqis sostnut ta' L-asparagine fid-demm u filfluwidu ċerebrospinali (CSF, cerebrospinal fluid).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The pharmacodynamic (PD) effect of Oncaspar was assessed after IM (Study CCG-1962) and IV administration (AALL07P4).
Maltese: ta' Oncaspar ġie evalwat wara l-għoti ġol-muskoli (Studju CCG-1962) u ġol-vini (AALL07P4).
English: In Study DFCI 11-001, assessments of asparaginase activity were performed following a single IV dose of Oncaspar 2,500 U/m2 BSA during Induction, and every two weeks during post-Induction (see section 5.1).
Maltese: Fi Studju DFCI 11-001, twettqu valutazzjonijiet tal-attività ta' asparaginase wara doża waħda ta' Oncaspar ġol-vini ta' 2,500 U/m2 BSA waqt l-Induzzjoni, u kull ġimagħtejn waqt il-perjodu ta' wara l-Induzzjoni (ara sezzjoni 5.1).
English: If symptoms of hyperammonaemia exist, ammonia levels should be monitored closely.
Maltese: Jekk hemm sintomi ta' iperammonaemija, il-livelli ta' ammonia għandhom jiġu mmonitorjati mill-qrib.
English: The recommended dose in patients with a body surface area (BSA) ≥0.6 m2 and who are ≤21 years of age is 2,500 U of pegaspargase (equivalent to 3.3 ml Oncaspar)/m2 body surface area every 14 days.
Maltese: Id-doża rakkomandata f'pazjenti b'erja tas-superfiċje tal-ġisem (BSA, body surface area) ta' ≥0.6 m2 u li jkollhom ≤21 sena hi ta' 2,500 U ta' pegaspargase (ekwivalenti għal 3.3 ml Oncaspar)/m² ta' erja tassuperfiċje tal-ġisem kull 14-il jum.
English: The primary determination of efficacy was based on demonstration of similar asparagine depletion (magnitude and duration) in the Oncaspar and native E. coli L-asparaginase arms.
Maltese: Id-determinazzjoni primarja tal-effikaċja kienet ibbażata fuq id-dimostrazzjoni ta' tnaqqis simili ta' asparagine (kobor u tul ta' żmien) fil-partijiet tal-istudju dwar Oncaspar u native E. coli
English: Tel: + 34 91 748 96 30
Maltese: Laboratorios Servier S.L. Tel: +34 91 748 96 30
English: Oncaspar contains pegaspargase, which is an enzyme (asparaginase) that breaks down asparagine, an important building block of proteins without which cells cannot survive.
Maltese: Oncaspar fih pegaspargase, li hi enzima (asparaginase) li tkisser asparagine, komponent importanti tal proteini li mingħajrha, iċ-ċelluli ma jistgħux jgħixu.
English: 2 years.
Maltese: il minuta.
English: In Study AALL07P4, the PD effect of Oncaspar was assessed in 47 evaluable subjects with high risk B-precursor ALL who received IV doses of Oncaspar 2,500 U/m2 BSA during the Induction and
Maltese: Fi Studju AALL07P4, l-effett PD ta' Oncaspar ġie evalwat f'47 individwu evalwabbli b'ALL prekursur B ta' riskju għoli li ngħataw dożi ġol-vini ta' Oncaspar 2,500 U/m2 BSA matul il fażijiet ta' Induzzjoni u Konsolidazzjoni.
English: Intravenous infusion of Oncaspar is usually given over a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
Maltese: Infużjoni ġol-vini ta' Oncaspar normalment tingħata fuq perjodu ta' minn siegħa sa sagħtejn f'100 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew 5% soluzzjoni ta' glucose.
English: White blood cell (WBC) criteria were: a) Age 1-10 years: WBC ≥50,000/μL; b) Age 10-30 years: Any WBC; c) Prior steroid therapy: Any WBC.
Maltese: Il-kriterji taċ-ċelluli tad-demm bojod (white blood cells, WBC)) kienu: a) Età 1-10 snin:
English: Chemical and physical in-use stability of the diluted solution has been demonstrated for 48 hours at 2°C-8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni dilwita ntweriet għal 48 siegħa f'temperatura ta' 2-8°C.
English: During the maintenance phase, 19 patients were evaluated, with 17 patients (89%) achieving complete remission, and 1 patient (5%) with therapeutic efficacy.
Maltese: Matul il-fażi ta' manteniment, 19-il pazjent ġew evalwati, bi 17-il pazjent (89%) li kisbu remissjoni kompleta, u pazjent 1 (5%) b'effikaċja terapewtika.
English: A reduction in serum asparagine concentration was evident by the 4th day after the first Induction dose and reached an apparent nadir by the 10th day after the dose.
Maltese: Tnaqqis fil-konċentrazzjoni ta' asparagine fis-serum kien evidenti sa Jum 4 wara l-ewwel doża tal-Induzzjoni u laħaq minimu apparenti sa Jum 10 wara d-doża.
English: The other ingredients are: disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) (see section 2 “Oncaspar contains sodium”).
Maltese: Is-sustanzi l-oħra huma: disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH) (ara sezzjoni 2 “Oncaspar fih is-sodium”).
English: Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 U of pegaspargase (equivalent to 2.67 ml Oncaspar)/m2 body surface area every 14 days.
Maltese: Sakemm ma tingħatax riċetta mod ieħor, il-pożoloġija rakkomandata fl-adulti li jkollhom >21 sena hi ta' 2,000 U ta' pegaspargase (ekwivalenti għal 2.67 ml Oncaspar)/m2 ta' erja tas-superfiċje tal-ġisem kull 14-il jum.
English: When glucocorticoids (e.g., prednisone) and pegaspargase are given at the same time, alterations in coagulation parameters (e.g., fall in fibrinogen and antithrombin III deficiency, ATIII) can be more pronounced.
Maltese: Meta glukokortikojdi (eż., prednisone) u pegaspargase jingħataw fl-istess ħin, it-tibdil fil-parametri tal-koagulazzjoni (eż., tnaqqis fil-fibrinogen u d-defiċjenza ta' antithrombin III, ATIII) jista' jkun aktar notevoli.
English: Overall, in the group receiving Oncaspar, the rate of all grade hypersensitivity was 5.8%, anaphylactic reactions was 19.2%, and pancreatitis 7.7%.
Maltese: B'kollox, fil-grupp li kien qed jirċievi Oncaspar, ir-rata tal-gradi kollha ta' sensittività eċċessiva kienet 5.8%, reazzjonijiet anafilattiċi kienu 19.2%, u pankreatite kienet 7.7%. Newtropenija bid-deni ta' Grad 3 jew ogħla kienet