FrancophonIA/ELRC3.0 huggingface dataset:
English: Increase in transaminases, blood bilirubin, blood alkaline phosphatase, blood cholesterol, blood triglyceride, very low density lipoprotein (VLDL), lipoprotein lipase activity, blood urea, ammonia, blood lactate dehydrogenase (LDH), Decrease in antithrombin III, blood fibrinogen, blood cholesterol, low density lipoprotein (LDL), total protein
Maltese: Żieda fit-transaminases, bilirubina fid-demm, alkaline phosphatase fiddemm, kolesterol fid-demm, triglycerides fid-demm, lipoproteina ta' densità baxxa ħafna (VLDL), attività ta' lipoprotein lipase, urea fiddemm, ammonia, lactate dehydrogenase fid-demm (LDH) Tnaqqis fl-antithrombin III, fibrinogen fid-demm, kolesterol fid-demm lipoproteina ta' densità baxxa (LDL), proteina totali
English: Pharmacokinetic parameters of Spectrila were determined in 7 adult patients after intravenous infusion of 5,000 U/m².
Maltese: Il-parametri farmakokinetiċi ta' Spectrila ġew stabbiliti f'7 pazjenti adulti wara infużjoni ġol-vini ta' 5,000 U/m².
English: Spectrila is used as part of a combination therapy.
Maltese: Spectrila jintuża bħala parti minn terapija kombinata.
English: Paediatric population Data on safety of Spectrila in infants < 1 year of age is limited.
Maltese: Popolazzjoni pedjatrika Dejta dwar is-sigurtà ta' Spectrila fi trabi li jkollhom < 1 sena hi limitata.
English: • nervousness (agitation) or somnolence (sleepiness)
Maltese: • nervożità (aġitazzjoni) jew sonnolenza (ngħas)
English: Acute pancreatitis has developed in less than 10 % of patients.
Maltese: Pankreatite akuta żviluppat f'inqas minn 10% tal-pazjenti.
English: Complete asparagine depletion in CSF Yesc
Maltese: Tnaqqis komplet ta' asparagine f'CSF
English: Hyperammonaemia
Maltese: Iperammonemija
English: • jaundice
Maltese: • suffejra
English: Contraceptives
Maltese: Kontraċettivi
English: Patients received asparaginase at a dose of 10,000 U/m², adjusted to the current age of the patient at the time of administration (< 6 months: 6,700 U/m²; 6 - 12 months: 7,500 U/m²; > 12 months: 10,000 U/m²) on days 15, 18, 22, 25, 29, and 33 of induction treatment.
Maltese: U/m², aġġustat għalletà kurrenti tal-pazjent fiż-żmien tal-għoti (< 6 xhur: 6,700 U/m²; 6 - 12-il xahar: 7,500 U/m²; > 12-il xahar: 10,000
English: Ischaemic stroke, reversible posterior leukoencephalopathy syndrome (RPLS), convulsion, disturbances in consciousness including coma
Maltese: Puplesija iskemika, sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS), konvulżjoni, disturbi fil-koxjenza li jinkludu koma
English: Volume of distribution
Maltese: Volum ta' distribuzzjoni
English: Spectrila is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Maltese: Spectrila normalment jintuża bħala parti minn protokolli ta' kimoterapija kombinata ma' sustanzi antineoplastiċi oħrajn (ara ukoll sezzjoni 4.5).
English: Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Maltese: Spectrila hu indikat bħala komponent ta' terapija kombinata antineoplastika għall-kura ta' lewkimja limfoblastika akuta (ALL) f'pazjenti pedjatriċi mit-twelid sa 18-il sena u adulti.
English: • coagulation disorders including symptomatic thrombosis related to the use of central venous catheters,
Maltese: • disturbi fil-koagulazzjoni li jinkludu trombożi sintomatika relatata mal-użu ta' kateters venużi ċentrali,
English: Hepatic parameters should be monitored when potentially hepatotoxic medicinal products are given concomitantly with asparaginase (see sections 4.4 and 4.8).
Maltese: Il-parametri tal-fwied għandhom jiġu mmonitorjati meta prodotti mediċinali potenzjalment epatotossiċi jingħataw fl-istess ħin ma' asparaginase (ara sezzjonijiet 4.4 u 4.8)
English: • inflammation of the salivary glands (parotitis)
Maltese: • infjammazzjoni tal-glandoli tal-bżieq (parotite)
English: *Produced in Escherichia coli cells by recombinant DNA technology.
Maltese: *Prodott f'ċelluli ta' Escherichia coli minn teknoloġija ta' DNA rikombinanti.
English: Pharmacotherapeutic group: Antineoplastic agents; Other antineoplastic agents ATC code: L01XX02
Maltese: Mediċini antineoplastiċi; Mediċini antineoplastiċi oħrajn Kodiċi ATC:
English: Serum and urine glucose levels should be regularly monitored and managed as clinically indicated.
Maltese: Livelli ta' glucose fis-serum u fl-awrina għandhom jiġu mmonitorjati b'mod regolari u mmaniġġjati kif klinikament indikat.
English: In rare cases severe liver impairment has been described, including cholestasis, icterus, hepatic necrosis and hepatic failure with fatal outcome (see sections 4.8 and 4.5).
Maltese: F'każijiet rari, ġie deskritt indeboliment sever tal-fwied, li jinkludi kolestasi, icterus, nekrożi tal-fwied u insuffiċjenza tal-fwied b'riżultat fatali (ara sezzjonijiet 4.8 u 4.5).
English: Elderly Limited data are available for the treatment of patients older than 65 years of age.
Maltese: Dejta limitata hi disponnibli għall-kura f'pazjenti li għandhom aktar minn 65 sena hi limitata.
English: Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott. medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: In a clinical trial in children with newly diagnosed ALL (study MC-ASP.5/ALL), the following frequencies of allergic events were observed (table 2).
Maltese: Fi prova klinika fi tfal b'ALL (studju MC-ASP.5/ALL) iddijanjostikata għall-ewwel darba, ilfrekwenzi li ġejjin ta' avvenimenti allerġiċi ġew osservati (tabella 2).
English: Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.
Maltese: Kunjett tal-ħġieġ bla kulur ta' 20 ml (ħġieġ ta' Tip I) magħluq b'tapp tal-lastku butyl, siġill talaluminju u għatu flip-off tal-plastik, li jkun fih 10,000 unità ta' asparaginase.
English: Spectrila is available in packs containing 1 or 5 vials.
Maltese: Spectrila hu disponibbli f'pakketti li fihom 1 jew 5 kunjetti.
English: In an uncontrolled clinical trial (study MC-ASP.6/INF), 12 infants (median age [range] at time of first infusion: 6 months [0.5 - 12.2 months]) with de novo ALL were treated with Spectrila within the
Maltese: Fi prova klinika mhux ikkontrollata (studju MC-ASP.6/INF), 12-il tarbija (età medjana [medda] fiżżmien tal-ewwel infużjoni: 6 xhur [0.5 - 12.2 xhur]) b'de novo ALL kienu ġew ikkurati bi Spectrila fil-protokoll INTERFANT-06.
English: After reconstitution 1 ml contains 2,500 units of asparaginase.
Maltese: Wara r-rikostituzzjoni, 1 ml ikun fih 2,500 unità ta' asparaginase.
English: The primary toxicity of asparaginase results from immunologic reactions caused by exposure to the bacterial protein.
Maltese: It-tossiċità primarja ta' asparaginase tirriżulta minn reazzjonijiet immunoloġiċi kkawżati minn esponiment għall-proteina batterjali.
English: Table 2: Frequency of patients with allergic reactions (MC-ASP.5/ALL; Safety analysis set) Treatment group
Maltese: Tabella 2: Frekwenza ta' pazjenti b'reazzjonijiet allerġiċi (MC-ASP.5/ALL;
English: • cholestasis (blocked bile flow from the liver)
Maltese: • kolestasi (fluss imblukkat tal-bila mill-fwied)
English: Even those few patients with trough asparaginase serum activity levels of 10 - 100 U/l usually experienced complete asparagine depletion in serum and CSF.
Maltese: Anki dawk ftit pazjenti b'livelli minimi ta' attività ta' asparaginase fis-serum ta' asparaginase ta' 10 - 100 U/L, normalment kellhom tnaqqis komplet ta' asparagine fis-serum u fis-CSF.
English: Spectrila is given into a vein.
Maltese: Mediċini oħra u Spectrila
English: However, when asparaginase was given after cytarabine a synergistic effect was observed.
Maltese: Madankollu, meta asparaginase ingħata wara cytarabine, ġie osservat effett sinerġistiku.
English: Not evaluable / not known
Maltese: Mhux evalwabbli/mhux magħruf
English: Due to the inhibition of protein synthesis (decreased synthesis of factors II, V, VII, VIII, and IX, proteins C and S, antithrombin III [AT III]) caused by asparaginase, coagulation disorders can occur which can manifest either as thrombosis, disseminated intravascular coagulation (DIC), or bleeding.
Maltese: II, V, VII, VIII, u IX, proteini C u S, antithrombin III [AT III]) ikkawżat minn asparaginase, disturbi tal-koagulazzjoni jistgħu jseħħu li jistgħu jidhru bħala trombożi, koagulazzjoni intravaskulari mifruxa (DIC), jew emorraġija.
English: Trough serum activity levels were measured in 12 infants (age from birth to 1 year) with de novo ALL (study MC-ASP.6/INF).
Maltese: Il-minimu tal-livelli tal-attività fis-serum tkejlu fi 12-il tarbija (età mit-twelid sa sena) b'de novo ALL (studju MC-ASP.6/INF).
English: Aggressive alkalinisation of the urine and use of allopurinol can prevent urate nephropathy.
Maltese: Alkalinizzazzjoni aggressiva tal-awrina u l-użu ta' allopurinol jistgħu jipprevjenu nefropatija urate.
English: In a clinical trial in children with de novo ALL (study MC-ASP.4/ALL) it was shown that immediately after the end of infusion of asparaginase mean asparagine concentrations in serum dropped from the pre-dose concentrations of about 40 µM to below the lower limit of quantification of the bioanalytical method (< 0.5 µM).
Maltese: Fi prova klinika fi tfal b'de novo ALL (studju MC-ASP.4/ALL), intwera li immedjatament wara ttmiem tal-infużjoni ta' asparaginase, il-medja tal-konċentrazzjonijiet ta' asparagine fis-serum niżlet mill-konċentrazzjonijiet ta' qabel id-doża ta' madwar 40 µM għal taħt il-limitu t'isfel ta' kwantifikazzjoni tal-metodu bijoanalitiku (< 0.5 µM).
English: Median trough serum asparaginase activities were measured in 81 children/adolescents with de novo ALL three days after infusion of asparaginase (just before the next dose had to be given) during induction treatment and ranged from 168 to 184 U/l (study MC-ASP.5/ALL).
Maltese: Il-medjan tal-inqas livell ta' attivitajiet ta' asparaginase fis-serum tkejjel f'81 tifel/tifla/adolexxenti b'de novo ALL, tlett ijiem wara l-infużjoni ta' asparaginase (eżatt qabel ma kellha tingħata d-doża li jmiss) matul il-kura ta' induzzjoni, u varjaw minn 168 sa 184 U/l (studju MC-ASP.5/ALL).
English: However, in rare cases severe hypertriglyceridaemia (triglycerides > 1,000 mg/dl) has been reported which increases the risk of development of acute pancreatitis.
Maltese: Madankollu, f'każijiet rari, ġiet irrappurtata ipertrigliċeridemija severa (triglycerides ta' > 1,000 mg/dl), li żżid ir-riskju ta' żvilupp ta' pankreatite akuta.
English: • Vincristine (used to treat certain types of cancer) since the simultaneous use of vincristine and asparaginase may increase the risk of certain side effects.
Maltese: • Vincristine (jintuża għall-kura ta' ċerti tipi ta' kanċer) billi l-użu fl-istess ħin ta' vincristine u asparaginase jista' jżid ir-riskju ta' ċerti effetti sekondarji.
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase (see section 4.8).
Maltese: Is-sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS) jista' jseħħ b'mod rari matul il-kura bi kwalunkwe asparaginase (ara sezzjoni 4.8).
English: Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity of medicinal products metabolised by the liver or bound to plasma proteins and altered pharmacokinetics and pharmacodynamics of medicines bound to plasma proteins.
Maltese: Asparaginase jista' jżid it-tossiċità ta' prodotti mediċinali oħrajn permezz tal-effett tiegħu fuq ilfunzjoni tal-fwied, eż. żieda fl-epatotossiċità b'mediċini potenzjalment epatotossiċi, żieda fit-tossiċità ta' prodotti mediċinali metabolizzati mill-fwied jew marbuta ma' proteini tal-plażma u farmakokinetika u farmakodinamika mibdulin ta' mediċini marbuta ma' proteini tal-plażma.
English: The following life-threatening situations could arise during treatment with Spectrila:
Maltese: Għid lit-tabib tiegħek immedjatament u waqqaf it-teħid ta' Spectrila jekk ikollok:
English: This regimen has been shown to reduce the gastrointestinal and haematological effects of methotrexate.
Maltese: Intwera li dan il-kors inaqqas l-effetti gastrointestinali u ematoloġiċi ta' methotrexate.
English: The primary endpoint was the rate of patients with complete asparagine depletion in serum (defined as asparagine serum levels below the lower limit of quantification (< 0.5 µM) at all time points measured from day 12 up to day 33) during induction treatment.
Maltese: Il-punt aħħari primarju kienet ir-rata ta' pazjenti bi tnaqqis komplet ta' asparagine fis-serum (definit bħala livelli ta' asparagine fis-serum taħt il-limitu ta' kwantifikazzjoni (< 0.5 µM) fil-punti kollha ta' ħin imkejla minn jum 12 sa jum 33) matul il-kura ta' induzzjoni.
English: Dyslipidemia
Maltese: Dislipidemija
English: Very common Oedema, fatigue
Maltese: Komuni ħafna Edema, għeja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1072/001
English: The following adverse reactions, listed in table 1, have been accumulated from clinical trials with Spectrila in 125 children with newly diagnosed acute lymphoblastic leukaemia as well as postmarketing experience with other E. coli-derived asparaginase preparations in children and adults.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati f'tabella 1, ġew akkumulati mill-provi kliniċi b'Spectrila f'125 tifel/tifla b'lewkimja limfoblastika akuta li tkun għadha kif ġiet iddijanjostikata, kif ukoll minn esperjenza wara t-tqegħid fis-suq bi preparazzjonijiet oħrajn ta' asparaginase miksuba minn E. coli fit-tfal u adulti.
English: Myelosuppressive agents
Maltese: Mediċini majelsoppressivi
English: One vial contains 10,000 units of asparaginase.
Maltese: Kull kunjett fih 10,000 unità ta' asparaginase.
English: Treatment with asparaginase should be interrupted if patients develop severe hepatic impairment (bilirubin > 3 times the upper limit of normal [ULN]; transaminases > 10 times ULN), severe hypertriglyceridaemia, hyperglycaemia or coagulation disorder (e.g. sinus vein thrombosis, severe bleeding).
Maltese: Il-kura b'asparaginase għandha tiġi interrotta jekk il-pazjenti jiżviluppaw indeboliment sever tal-fwied (bilirubina ta' > 3 darbiet tal-limitu ta' fuq tan-normal [ULN]; transaminases ta' > 10 darbiet talULN), ipertrigliċeridemija severa, ipergliċemija jew disturb tal-koagulazzjoni (eż. trombożi tal-vini tas-sinus, emorraġija severa).
English: • high blood levels of uric acid (hyperuricaemia)
Maltese: • livelli għoljin ta' uric acid fid-demm (iperuriċemija)
English: Low asparaginase activity levels are often accompanied by the appearance of anti-asparaginase antibodies.
Maltese: Livelli ta' attività baxxa ta' asparaginase ikunu akkumpanjati ta' spiss mid-dehra ta' antikorpi anti-asparaginase.
English: Median (range) maximum serum concentrations of asparaginase activity were 2,324 U/l (1,6254,819 U/l).
Maltese: Il-medjan (medda) tal-konċentrazzjonijiet massimi fis-serum tal-attività ta' asparaginase kien ta' 2,324 U/L (1,625 - 4,819 U/L) Il-massimu (Cmax) tal-attività ta' asparaginase fis-serum intlaħaq b'dewmien ta' madwar sagħtejn wara t-tmiem tal-infużjoni.
English: Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Maltese: Spectrila 10,000 U trab għall-konċentrat għal soluzzjoni għall-infużjoni Asparaginase
English: After administration of asparaginase, close monitoring of bilirubin, hepatic transaminases, of blood/urinary glucose, coagulation parameters (PTT, PT, antithrombin III, fibrinogen, and D-dimer), amylase, lipase, triglycerides, and cholesterol is recommended.
Maltese: Wara l-għoti ta' asparaginase, monitoraġġ mill-qrib tal-bilirubina, transaminases tal-fwied, glucose fid-demm/awrina, parametri tal-koagulazzjoni (PTT, PT, antithrombin III, fibrinogen, u D-dimer), amylase, lipase, triglycerides u tal-kolesterol hu rakommandat.
English: In case of occurrence of allergic symptoms, administration of Spectrila should be discontinued immediately (see section 4.4).
Maltese: Fil-każ tal-okkorrenza ta' sintomi allerġiċi, l-għoti ta' Spectrila għandu jitwaqqaf immedjatament (ara sezzjoni 4.4).
English: This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Maltese: Dan jista' jippromwovi tendenza għal emorraġija (antikoagulanti) jew trombożi (glukokortikojdi).
English: Most frequently (very common) observed side effects of Spectrila include hypersensitivity reactions, hyperglycaemia, hypoalbuminaemia, nausea, vomiting, diarrhoea, abdominal pain, oedema, fatigue, and change in laboratory parameters (e.g. transaminases, bilirubin, blood lipids, coagulation parameters).
Maltese: L-effetti sekondarji osservati b'mod l-aktar frekwenti (komuni ħafna) ta' Spectrila jinkludu reazzjonijiet ta' sensittività eċċessiva, ipergliċemija, ipoalbuminaemija, dardir, rimettar, dijarea, uġigħ addominali, edema, għeja, u bidla fil-parametri tal-laboratorju (eż. parametri ta' transaminases, bilirubina, lipidi fid-demm, u tal-koagulazzjoni).
English: Efficacy and safety of Spectrila have not been established in Philadelphia chromosome-positive patients.
Maltese: L-effikaċja u s-sigurtà ta' Spectrila ma ġewx determinati f'pazjenti bi kromożomi Philadelphia pożittivi.
English: Immediately after the end of infusion of asparaginase, serum levels of glutamine declined by a maximum of 50 % from pre-dose levels of about 400 µM but rapidly returned to normal values within a few hours.
Maltese: Immedjatament wara t-tmiem tal-infużjoni ta' asparaginase, il-livelli ta' glutamine fis-serum naqsu b'massimu ta' 50% mil-livelli ta' qabel id-doża ta' madwar 400 µM, iżda reġgħu lura malajr għallvaluri normali fi żmien ftit sigħat.
English: • pseudocysts of the pancreas (collections of fluid after acute inflammation of the pancreas)
Maltese: • psewdoċisti tal-frixa (akkumulazzjoni ta' fluwidu wara infjammazzjoni akuta tal-frixa)
English: Hepatic failure with potentially fatal outcome, hepatic necrosis, cholestasis, jaundice
Maltese: Insuffiċjenza tal-fwied b'riżultat potenzjalment fatali, nekrożi tal-fwied, kolestasi, suffejra,
English: • Medicines that reduce the ability of blood to clot, such as anticoagulants (e.g. warfarin and heparin), dipyridamole, acetylsalicylic acid or medicines to treat pain and inflammation, since using these medicines with asparaginase may increase the risk of bleeding.
Maltese: • Mediċini li jnaqqsu l-kapaċità tad-demm li jagħqad, bħal antikoagulanti (eż. warfarin u eparina), dipyridamole, acetylsalicylic acid jew mediċini biex jikkuraw uġigħ u infjammazzjoni, billi lużu ta' dawn il-mediċini jista' jżid ir-riskju ta' emorraġija.
English: Rare Diabetic ketoacidosis
Maltese: Ketoaċidożi dijabetika
English: Most serious side effects of Spectrila include severe hypersensitivity reactions such as anaphylactic shock (rare), thromboembolic events (common), acute pancreatitis (common), and severe hepatotoxicity, e.g. jaundice, hepatic necrosis, hepatic failure (rare).
Maltese: Il-biċċa l-kbira tal-effetti sekondarji serji ta' Spectrila jinkludu reazzjonijiet severi ta' sensittività eċċessiva bħal xokk anafilattiku (rari), avvenimenti tromboemboliċi (komuni), pankreatite akuta (komuni), u epatotossiċità severa, eż. suffejra, nekrożi tal-fwied, insuffiċjenza tal-fwied (rari).
English: In the study in children/adolescents aged 1 - 18 years with de novo ALL (study MC-ASP.5/ALL), by day 33 of induction treatment 10 patients in the Spectrila group (10.3 %) and 9 in the reference group (8.9 %) were measured positive for anti-asparaginase antibodies at least at one time point.
Maltese: Fl-istudju fit-tfal/adolexxenti li kellhom minn sena sa 18-il sena b'de novo ALL (studju MCASP.5/ALL), sa jum 33 ta' kura ta' induzzjoni, 10 pazjenti fil-grupp ta' Spectrila (10.3%) u 9 filgrupp ta' referenza (8.9%) kellhom kejl pożittiv għal antikorpi anti-asparaginase f'mill-inqas f'punt ta' ħin wieħed, Proporzjon komparabbli ta' pazjenti fiż-żewġ gruppi żviluppa antikorpi anti-asparaginase qabel il-bidu tal-fażi ta' kura wara l-induzzjoni (Spectrila 54.6% vs. E. coli-asparaginase ta' referenza 52.5%).
English: How to store Spectrila
Maltese: X'fih Spectrila
English: • The medicine also contains sucrose.
Maltese: • Il-mediċina fiha wkoll is-sucrose.
English: • Keep this leaflet.
Maltese: • kundizzjonijiet ipergliċemiċi.
English: Evidence from published data with asparaginase renders the mutagenic, clastogenic and carcinogenic potential of asparaginase negligible.
Maltese: Evidenza minn dejta ppubblikata b'asparaginase tirrendi l-potenzjal mutaġeniku, klastoġeniku u karċinoġeniku ta' asparaginase bħala negliġibbli.
English: In contrast to normal cells, lymphoblastic tumour cells have a very limited capacity for synthesising asparagine because of a significantly reduced expression of asparagine synthetase.
Maltese: B'kuntrast ma' ċelluli normali, iċċelluli limfoblastiċi tat-tumur għandhom kapaċità limitata ħafna biex jissintetizzaw lil asparagine minħabba espressjoni mnaqqsa b'mod sinifikanti ta' asparagine synthetase.
English: • hepatotoxicity,
Maltese: • anafilassi,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001 (1 vial)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1072/001 (1 kunjett)
English: Hypersensitivity reactions range from transient flushing or rash and urticaria to bronchospasm, angioedema and anaphylaxis.
Maltese: Reazzjonijiet ta' sensittività eċċessiva jvarjaw minn fwawar jew raxx u urtikarja temporanji, għal bronkospażmu, anġjoedema u anafilassi.
English: Study in children/adolescents aged 1 - 18 years with de novo ALL Efficacy and safety of Spectrila was compared to a native E. coli-asparaginase (reference medicinal product) in a randomised double-blinded clinical trial (study MC-ASP.5/ALL; based on ALL treatment protocol DCOG ALL10) in 199 children/adolescents aged 1 - 18 years with de novo ALL.
Maltese: L-effikaċja u s-sigurtà ta' Spectrila tqabblu ma' E. coli-asparaginase nattiv (prodott mediċinali ta' referenza) fi prova klinika double-blinded, li fiha l-parteċipanti ntgħażlu b'mod każwali (studju MCASP.5/ALL; ibbażat fuq il-protokoll tal-kura ALL, DCOG ALL10) li saret fuq 199 tifel/tifla/adolexxenti li kellhom 1 - 18-il sena b'de novo ALL.
English: Hypothyroidism
Maltese: FARMAĊEWTIKU
English: Headaches
Maltese: Pożoloġija
English: After repeated administration of asparaginase at a dose of 5,000 U/m² every third day, trough asparaginase activity levels in serum ranged from 108 to 510 U/l.
Maltese: Wara l-għoti ripetut ta' asparaginase f'doża ta' 5,000 U/m² kull tielet jum, il-livelli minimi tal-attività ta' asparaginase fis-serum kienu jvarjaw minn 108 sa 510
English: Decreased protein synthesis can predominantly lead to liver impairment, acute pancreatitis, decreased insulin production with hyperglycaemia, decreased production of clotting factors (especially fibrinogen and antithrombin III) leading to coagulation disorders (thrombosis, bleeding), and decreased production of lipoproteins resulting in hypertriglyceridaemia.
Maltese: It-tnaqqis fis-sintesi tal-proteini jista' jwassal b'mod predominanti għal indeboliment tal-fwied, pankreatite akuta, tnaqqis fil-produzzjoni tal-insulina flimkien ma' ipergliċemija, tnaqqis fil-produzzjoni ta' fatturi tat-tagħqid (speċjalment fibrinogen u antithrombin III) li jwassal għal disturbi tal-koagulazzjoni (trombożi, emorraġija), u tnaqqis fil-produzzjoni ta' lipoproteini li jirriżulta f'ipertrigliċeridemija.
English: These events are usually transient.
Maltese: Dawn l-avvenimenti normalment ikunu temporanji.
English: In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) has been observed during therapy with asparaginase-containing regimens.
Maltese: F'każijiet rari, sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS) ġie osservat matul korsijiet ta' terapija li kien fihom asparaginase.