FrancophonIA/ELRC3.0 huggingface dataset:
English: 5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.
Maltese: 5.2 ml ta' ilma għall-injezzjonijiet jiġu injettati fil-kunjett billi tuża siringa u labra ta' daqs 21.
English: Each vial contains 3,750 U of pegaspargase.
Maltese: Kull kunjett fih 3,750 U ta' pegaspargase.
English: Hypersensitivity reactions to Oncaspar, including life-threatening anaphylaxis, angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnoea, pruritus and rash, can occur during therapy (see sections 4.3 and 4.4).
Maltese: Waqt it-terapija jistgħu jseħħu reazzjonijiet ta' sensittività eċċessiva għal Oncaspar, inkluż anafilassi ta' theddida għall-ħajja, anġjoedema, nefħa fix-xufftejn, nefħa fl-għajnejn, eritema, tnaqqis filpressjoni tad-demm, bronkospażmu, dispnea, ħakk u raxx (ara sezzjonijiet 4.3 u 4.4).
English: In these studies a total of 94 patients with ALL diagnosis with a history of prior clinical allergic reaction to native E. coli L-asparaginase were exposed to Oncaspar.
Maltese: F'dawn l-istudji, total ta' 94 pazjent b'dijanjosi ta' ALL, bi storja medika ta' reazzjoni allerġika klinika fil-passat għal native E. coli L-asparaginase ġew esposti għal Oncaspar.
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Maltese: Tel: +39 06 669081
English: Administration of Oncaspar before vincristine may increase the neurotoxicity of vincristine.
Maltese: L-għoti ta' Oncaspar qabel vincristine jista' jżid in-newrotossiċità ta' vincristine.
English: Alterations in endocrine pancreatic function are observed commonly and are expressed mainly in the form of abnormal glucose metabolism.
Maltese: Tibdil fil-funzjoni tal-frixa pankreatika endokrinali jiġi osservat b'mod komuni u jidher l-aktar filforma ta' metaboliżmu anormali tal-glucose.
English: The PEGylation does not change the enzymatic properties of L-asparaginase, but it influences the pharmacokinetics and immunogenicity of the enzyme.
Maltese: Il-pegilazzjoni ma tibdilx il proprjetajiet enzimatiċi ta' L-asparaginase, iżda tinfluwenza l-farmakokinetika u l-immunoġeniċità tal enzima.
English: No reproduction studies in animals with pegaspargase were performed but studies in animals with L-asparaginase have shown teratogenicity (see section 5.3).
Maltese: Ma sarux studji dwar ir-riproduzzjoni b'pegaspargase fl-annimali, iżda studji fl-annimali b'L-asparaginase urew teratoġeniċità (ara sezzjoni 5.3).
English: During treatment with Oncaspar
Maltese: Mediċini oħra u Oncaspar
English: White to off-white powder.
Maltese: Soluzzjoni ċara u bla kulur.
English: Adults >21 years
Maltese: Adulti li jkollhom >21 sena
English: A total of 239 patients were randomised, 237 of whom were treated with study drug (146 male and 91 female), of these, 119 patients (115 with a diagnosis of ALL) were treated with Oncaspar 2500 U/m2.
Maltese: Total ta' 239 pazjent ntgħażlu b'mod każwali, li minnhom 237 ġew ikkurati bil-mediċina tal-istudju (146 irġiel u 91 nisa), u minn dawn, 119-il pazjent (115 b'dijanjosi ta' ALL) ġew ikkurati b'Oncaspar 2,500 U/m2.
English: Reduced splenic weight might be a sign of potential immunosuppressant effect of the treatment.
Maltese: Tnaqqis fil-piż tal-milsa jista' jkun sinjal ta' effett immunosoppressiv potenzjali tal-kura.
English: A total of 166 patients were enrolled in this study; 54 patients were randomised to treatment with 2,500 U/m2 BSA Oncaspar and 111 patients were randomised to the investigational pegylated asparaginase product.
Maltese: Total ta' 166 pazjent ġew irreġistrati f'dan l-istudju; 54 pazjent intgħażlu b'mod każwali għal kura b'2,500 U/m2 BSA Oncaspar u 111-il pazjent intgħażlu b'mod każwali biex jirċievu l-prodott b'asparaginase pegilat investigazzjonali.
English: Each pack contains 1 glass vial with 3,750 U pegaspargase.
Maltese: Kull pakkett fih kunjett tal-ħġieġ 1 bi 3,750 U ta' pegaspargase.
English: Sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, water for injections.
Maltese: Sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, ilma għall-injezzjonijiet.
English: The mean plasma half-life of Oncaspar was 8 days in non-hypersensitive patients (AUC 10.35 U/ml/day), and 2.7 days in hypersensitive patients (AUC 3.52 U/ml/day).
Maltese: U/ml/jum), u 2.7 ijiem f'pazjenti b'sensittività eċċessiva (AUC 3.52 U/ml/jum).
English: Oncaspar efficacy and safety were evaluated on the basis of three clinical studies using Oncaspar solution for injection/infusion in the first line treatment of ALL: Study CCG-1962 in standard risk ALL patients; Study AALL07P4 in high risk ALL patients; Study DFCI 11-001 enrolled both standard and high-risk ALL patients.
Maltese: Studju CCG-1962 f'pazjenti b'ALL ta' riskju standard; Studju AALL07P4 f'pazjenti b'ALL ta' riskju għoli; fi Studju DFCI 11-001 kien hemm reġistrati pazjenti b'ALL kemm standard u kemm ta' riskju għoli.
English: Pharmacokinetic/pharmacodynamic nonclinical comparability between the two pharmaceutical forms of Oncaspar, solution for injection/infusion, and powder for solution, was demonstrated in dogs after single and repeated doses (500 U/kg), by the intravenous route.
Maltese: Il-komparabilità mhux klinika farmakokinetika/farmakodinamika bejn iż-żewġ forom farmaċewtiċi ta' Oncaspar, soluzzjoni għall-injezzjoni/infużjoni, u trab għal soluzzjoni, intweriet fil-klieb wara dożi waħidhom u ripetuti (500
English: Not known (frequency cannot be estimated from the available data) - Decreased number of white blood cells and platelets; - Palpitations; - Cysts in your pancreas, swelling of the salivary glands; - High levels of urea in your blood; antibodies against Oncaspar; high levels of ammonia in your blood; decreased blood sugar levels; - Sleepiness, confusion, mild twitching of the fingers.
Maltese: - Palpitazzjonijiet; - Ċesti fil-frixa, nefħa fil-glandoli tal-bżieq; - Livelli għoljin ta' urea fid-demm tiegħek; antikorpi kontra Oncaspar; livelli għoljin ta' ammonia fid-demm tiegħek; tnaqqis fil-livelli ta' zokkor fid-demm;
English: The Cmax and AUC of Oncaspar trended lower in males, subjects with larger BMI, and subjects >10 years.
Maltese: Is-Cmax u l-AUC ta' Oncaspar kellhom tendenzi aktar baxxi fl-irġiel, f'individwi b'BMI ogħla, u f'individwi >10 snin.
English: In general, incidence and type of adverse reactions Grade 3 and 4 were similar between the two treatment groups.
Maltese: B'mod ġenerali, l-inċidenza u ttip ta' reazzjonijiet avversi ta' Grad 3 u 4 kienu simili bejn iż-żewġ gruppi ta' kura.
English: History of serious haemorrhagic events with prior L-asparaginase therapy (see section 4.4).
Maltese: Storja medika ta' avvenimenti emorraġiċi b'terapija b'L-asparaginase fil-passat (ara sezzjoni 4.4). 4.4
English: During Induction, following a single IV dose of Oncaspar 2,500 U/m2, asparaginase activity ≥0.1 U/mL was sustained for up to 18 days post-dose in 95.3% of subjects.
Maltese: U/m2, l-attività ta' asparaginase ≥0.1 U/ml kienet sostnuta sa 18-il jum wara d-doża f'95.
English: In Study CCG-1962, mean asparaginase activity reached peak value of 1 U/mL on Day 5 after the injection.
Maltese: Fi Studju CCG-1962, l-attività ta' asparaginase medja laħqet valur massimu ta' 1 U/ml f'Jum 5 wara linjezzjoni.
English: Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura taħt 25°C.
English: Other hypersensitivity reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnoea, pruritus and rash (see sections 4.3 and 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva oħra jistgħu jinkludu anġjoedema, nefħa fix-xufftejn, nefħa fl-għajnejn, eritema, tnaqqis fil-pressjoni taddemm, bronkospażmu, qtugħ ta' nifs, ħakk u raxx (ara sezzjonijiet 4.3 u 4.8).
English: The percentage of patients in the Oncaspar treatment arm with evaluable minimal residual disease (MRD) negative status (<0.1% leukaemia cells in bone marrow) at Day 29 of Induction was 80% (40/50).
Maltese: 1% ċelloli ta' lewkimja fil-mudullun) f'Jum 29 tal-Induzzjoni kien 80% (40/50).
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 48 siegħa f'temperatura ta' 2°C-8°C.
English: In this study, 118 paediatric patients aged 1 to 9 years with previously untreated standard-risk ALL were randomised 1:1 to Oncaspar or native E. coli L-asparaginase as part of combination therapy.
Maltese: F'dan l-istudju, 118-il pazjent pedjatriku li kellhom bejn sena u 9 snin, li kellhom ALL ta' riskju standard li ma ġietx ikkurata fil-passat, intgħażlu b'mod każwali fi proporzjon ta' 1:1 għal Oncaspar jew native E. coli L-asparaginase bħala parti minn terapija kombinata.
English: Very common: Weight decreased, hypoalbuminaemia, alanine aminotransferase increased, aspartate aminotransferase increased, hypertriglyceridaemia, blood fibrinogen decreased, lipase increased, amylase increased, activated partial thromboplastin time prolonged, blood bilirubin increased
Maltese: >10%) inkludew: żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda filbilirubina fid-demm, titwil fil-ħin ta' thromboplastin parzjali attivat, ipertrigliċeridemija,
English: In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) may occur.
Maltese: F'każijiet rari, jista' jseħħ sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS).
English: No statistically significant differences in PK characteristics between male and female subjects were identified in this analysis.
Maltese: Ma ġew identifikati l-ebda differenzi statistikament sinifikanti fil-karatteristiċi PK bejn individwi rġiel u nisa f'din l-analiżi.
English: Study DFCI 11-001, conducted by the Dana-Farber Cancer Institute (DFCI), is an ongoing, active-controlled, randomised multicentre study of an intravenous investigational pegylated asparaginase product versus Oncaspar, in children and adolescents aged 1 to <22 years with newly diagnosed ALL treated with a DFCI ALL consortium therapeutic backbone.
Maltese: Institute) huwa studju multiċentriku kkontrollat b'mod attiv, li fih il-parteċipanti ntgħażlu b'mod każwali u li bħalissa għadu għaddej, ta' prodott ta' asparaginase pegilat investigazzjonali li jingħata ġol-vini kontra Oncaspar, fit-tfal u fl-adolexxenti ta' età bejn 1 u <22 sena li għadha kif saritilhom dijanjosi ta' ALL li qed tiġi kkurata b'sinsla terapewtika tal-konsorzju ALL tad-DFCI.
English: Oncaspar was given IM in a dose of 2,500 U/m² BSA on days 1 and 15 of induction.
Maltese: 2,500 U/m² BSA f'jiem 1 u 15 tal-induzzjoni.
English: How to store Oncaspar
Maltese: X'fih Oncaspar
English: Pancreatitis, including haemorrhagic or necrotising pancreatitis with fatal outcomes, have been reported in patients receiving Oncaspar (see section 4.8).
Maltese: Każijiet ta' pankreatite, inkluż pankreatite emorraġika jew nekrotizzanti b'riżultat fatali, ġew irrappurtati f'pazjenti li kienu qed jirċievu Oncaspar (ara sezzjoni 4.8).
English: The following adverse reactions have been reported in patients treated with Oncaspar along with other chemotherapy medicinal products: somnolence, confusion, dizziness, syncope, seizure.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrappurtati f'pazjenti kkurati b'Oncaspar flimkien ma' prodotti mediċinali oħra talkimoterapija: ngħas, konfużjoni, sturdament, sinkope, aċċessjoni.
English: Post-authorisation efficacy study (PAES): In order to further define the efficacy and safety of Oncaspar in adult patients with acute lymphoblastic leukaemia, the MAH should submit the results of a multicentre, open label single arm phase II trial evaluating the efficacy and toxicity of treatment regimens including Oncaspar in adults (aged 18-60) with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukaemia.
Maltese: II, multiċentrika, open-label, b'parti waħda, li evalwat l-effikaċja u t-tossiċità ta' korsijiet ta' kura li jinkludu Oncaspar fl-adulti (età 18-60) b'lewkimja limfoblastika akuta negattiva għal kromożomi Philadelphia, li tkun ġiet iddjanjostikata għall-ewwel darba.
English: Fertility No studies investigating the effect of pegaspargase on fertility have been performed.
Maltese: Fertilità Ma twettqux studji li jinvestigaw l-effett ta' pegaspargase fuq il-fertilità.
English: Increased serum glutamic pyruvic transaminase activity also occurred in one out of four dogs.
Maltese: Żieda fl-attività ta' serum glutamic pyruvic transaminase seħħet ukoll f'wieħed minn erbat iklieb.
English: Common: Hepatotoxicity, fatty liver
Maltese: Komuni: Anemija, koagulopatija
English: Following overdose, increased liver enzymes, rash and hyperbilirubinaemia have been observed.
Maltese: Wara doża eċċessiva, ġew osservati żieda fl-enzimi tal-fwied, raxx u iperbilirubinemija.
English: For intravenous administration, the reconstituted solution should be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
Maltese: Għall-għoti ġol-vini, is-soluzzjoni rikostitwita għandha tiġi dilwita f'soluzzjoni għall-injezzjoni ta' 100 ml sodium chloride 9 mg/ml (0.9%) jew soluzzjoni ta' 5% glucose.
English: - if you ever had pancreatitis.
Maltese: żieda fil-lipase u pankreatite.
English: Rare (may affect up to 1 in 1,000 people) - Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome characterised by headache, confusion, seizures and visual loss which resolves after some time.
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) - Sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS), sindrome ikkaratterizzat minn uġigħ ta' ras, konfużjoni, aċċessjonijiet u t-telf tal-vista, li jgħaddi wara ċertu ħin.
English: Simultaneous vaccination with live vaccines may increase the risk of severe infections attributable to the immunosuppressive activity of pegaspargase, the presence of the underlying disease and combination chemotherapy (see section 4.4).
Maltese: Tilqim simultanju b'vaċċini ħajjin jista' jżid ir-riskju ta' infezzjonijiet severi attribwibbli għall-attività immunosoppressiva ta' pegaspargase, il-preżenza tal-marda sottostanti u l-kimoterapija kombinata (ara sezzjoni 4.4).
English: ALL patients hypersensitive to native E. coli L-asparaginase Six open-label studies evaluated Oncaspar in relapse/refractory haematological diseases.
Maltese: Pazjenti b'ALL b'sensittività eċċessiva għal native E. coli L-asparaginase Sitt studji open-label evalwaw Oncaspar f'mard ematoloġiku li jirkadi/refrattorju.
English: In addition, Oncaspar studies using the intramuscular route of administration (studies CCG-1962 and CCG-1991) were also considered to determine the safety profile (see section 5.1).
Maltese: CCG-1962 u CCG-1991) ukoll ġew ikkunsidrati biex jiġi ddeterminat il-profil tas sigurtà (ara sezzjoni 5.1).
English: Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110
Maltese: Tel: +353 (0)1 663 8110
English: Specific antibodies to pegaspargase have been detected; uncommonly they were associated with hypersensitivity reactions.
Maltese: Antikorpi speċifiċi għal pegaspargase ġew osservati; b'mod mhux komuni ġew assoċjati ma' reazzjonijiet ta' sensittività eċċessiva.
English: Powder for solution for injection/infusion.
Maltese: Trab għal soluzzjoni għall-injezzjoni/infużjoni.
English: In rabbits doses of 50 or 100 U/kg intravenous on days 8 and 9 of gestation induced viable fetuses with congenital malformations: no NOEL has been determined.
Maltese: Fil-fniek, dożi ta' 50 jew 100 U/kg ġol-vini f'jiem 8 u 9 tat-tqala, ikkawżaw feti vijabbli b'malformazzjonijiet konġenitali: l-ebda NOEL ma ġie stabbilit Malformazzjonijiet multipli u effetti embrijoletali ġew osservati b'dożi fil-medda terapewtika.
English: Hepatic effects Combination therapy with Oncaspar and hepatotoxic products can result in severe hepatic toxicity.
Maltese: Terapija kombinata b'Oncaspar u prodotti epatotossiċi oħra tista' tirriżulta f'tossiċità severa tal-fwied.
English: Aseptic technique must be used.
Maltese: It-teknika assetika trid tintuża.
English: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenaemia can occur in patients receiving pegaspargase.
Maltese: Żieda fil-ħin ta' prothrombin (PT), żieda fil-ħin ta' thromboplastin parzjali (PTT), u ipofibrinogenemija jistgħu jseħħu f'pazjenti li jkunu qed jirċievu pegaspargase.
English: Since an indirect interaction between the oral contraceptives and pegaspargase cannot be ruled out, the use of oral contraception is not considered an acceptable method of contraception (see sections 4.5 and 4.6).
Maltese: Billi interazzjoni indiretta bejn il-kontraċettivi orali u pegaspargase ma tistax tiġi eskluża, l-użu tal-kontraċettivi orali mhumiex ikkunsidrati bħala metodu aċċettabbli ta' kontraċezzjoni (ara sezzjonijiet 4.5 u 4.6).
English: Very common: Embolism** Common: Thrombosis*** Not known: Cerebrovascular accident, haemorrhage, superior sagittal sinus thrombosis *Adverse reactions observed with other asparaginases in the class **Cases of pulmonary embolism, venous thrombosis, venous thrombosis limb, and thrombophlebitis superficial were observed in DFCI 11-001 ***Legend: CNS thrombosis
Maltese: *Reazzjonijiet avversi osservati b'asparaginases oħrajn fil-klassi **Każijiet ta' emboliżmu fil-pulmun, trombożi fil-vini, membru bi trombożi fil-vini, u tromboflebite superfiċjali ġew osservati f'DFCI 11-001 ***Tifsira:
English: As your doctor will administer the medicine, it is very unlikely you will be given more than you need.
Maltese: Billi t-tabib tiegħek se jagħti l-mediċina, hu improbabbli ħafna li inti se tingħata mediċina aktar milli jkollok bżonn.
English: Oncaspar is used to treat acute lymphoblastic leukaemia (ALL) in children from birth to 18 years and adults.
Maltese: Oncaspar jintuża biex jikkura lewkimja limfoblastika akuta (ALL) fit-tfal mit-twelid sa 18-il sena u fladulti.
English: Hypersensitivity reactions to pegaspargase, including life-threatening anaphylaxis, can occur during therapy, including in patients with known hypersensitivity to E. coli derived asparaginase formulations.
Maltese: Reazzjonijiet ta' sensittività eċċessiva għal pegaspargase, li jinkludu anafilassi ta' theddida għall-ħajja, jistgħu jseħħu matul it-terapija, inkluż f'pazjenti b'sensittività eċċessiva magħrufa għal formulazjonijiet ta' asparaginase miksuba minn E. coli.
English: Pegaspargase may cause myelosuppression, either directly or indirectly (by altering myelosuppressive effects of other agents such as methotrexate or 6-mercaptopurine).
Maltese: Pegaspargase jista' jikkawża majelosoppressjoni, jew direttament jew indirettament (billi jibdel leffetti ta' majelosoppressjoni ta' aġenti oħra bħal methotrexate jew 6-mercaptopurine).
English: Musculoskeletal and connective tissue disorders Common: Pain in extremities
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi
English: First-Line (ALL patients non-hypersensitive to native E. coli L-asparaginase) The safety and efficacy of Oncaspar was evaluated in an open-label, multicentre, randomised, active-controlled study (StudyCCG-1962).
Maltese: Is-sigurtà u l-effikaċja ta' Oncaspar ġew evalwati fi studju open-label, multiċentriku, li fih ilparteċipanti ntgħażlu b'mod każwali, ikkontrollat b'mod attiv (Studju CCG-1962).
English: In Study CCG-1962, PD effect of Oncaspar was assessed through serial measurements of asparagine in serum (n=57) and CSF (n=50) of newly diagnosed paediatric patients with standard-risk ALL who received three intramuscular doses of Oncaspar (2,500 Units/m2 BSA), one each during induction and two during delayed intensification treatment phases.
Maltese: Fi Studju CCG-1962, l-effett PD ta' Oncaspar ġie evalwat permezz ta' kejl serjali ta' asparagine fisserum (n=57) u fis-CSF (n=50) ta' pazjenti pedjatriċi li ġew iddijanjostikati għall-ewwel darba b'ALL
English: Coagulation parameters should be monitored at baseline and periodically during and after treatment, particularly when other medicinal products with anticoagulant effects are used simultaneously, such as acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (see section 4.5), or when concomitant chemotherapy regimen including methotrexate, daunorubicin, corticosteroids is administered.
Maltese: Il-parametri tal-koagulazzjoni għandhom jiġu mmonitorjati fil-linja bażi u perjodikament matul u wara l-kura, partikularment meta prodotti mediċinali oħrajn b'effetti kontra l-koagulazzjoni jintużaw fl-istess ħin, bħal acetylsalicylic acid u prodotti mediċinali antiinfjammatorji mhux sterojdi (ara sezzjoni 4.5), jew meta jingħata kors ta' kimoterapija fl-istess ħin li jinkludi methotrexate, daunorubicin, u kortikosterojdi.
English: Children with a body surface area <0.6 m2 should receive 82.5 U of pegaspargase (equivalent to 0.1 ml Oncaspar)/kg body weight every 14 days.
Maltese: U ta' pegaspargase (ekwivalenti għal 0.1 ml ta' Oncaspar)/kg ta' piż tal-ġisem kull 14-il jum.
English: If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours.
Maltese: Jekk l-użu immedjat ma jkunx possibbli, is-soluzzjoni dilwita tista' tinħażen f'temperatura ta' 2-8°C għal sa 48 siegħa.
English: Overall, from five studies analysed based on 65 ALL patients exposed to Oncaspar using the highest therapeutic response during the entire study, complete remission was observed in 30 patients (46%), partial remission in 7 patients (11%) and haematological improvement in 1 patient (2%).
Maltese: B'kollox, minn ħames studji analizzati, ibbażat fuq 65 pazjent b'ALL esposti għal Oncaspar bl-użu tal-ogħla rispons terapewtiku matul l-istudju kollu, remissjoni kompleta ġiet osservata fi 30 pazjent (46%), remissjoni parzjali f'7 pazjenti (11%) u t-titjib ematoloġiku f' pazjent 1 (2%).
English: The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, and water for injections (see section 2 “Oncaspar contains sodium”).
Maltese: Is-sustanzi l-oħra huma: sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, u ilma għall-injezzjonijiet (ara sezzjoni 2 “Oncaspar fih is-sodium”).
English: - Keep this leaflet.
Maltese: - jekk ikollok id-deni.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Pankreatite nekrotizzanti, pankreatite emorraġika
English: Due to the risk of hyperbilirubinaemia, it is recommended to monitor bilirubin levels at baseline and prior to each dose.
Maltese: Minħabba r-riskju ta' iperbilirubinemija, huwa rakkomandat li jiġu mmonitorjati l-livelli tal-bilirubina fil-linja bażi u qabel kull doża.
English: The diluted solution can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose.
Maltese: Is-soluzzjoni dilwita tista' tingħata flimkien ma' infużjoni li tkun diġà għaddejja ta' jew sodium chloride 9 mg/ml jew 5% glucose.
English: In Study CCG-1962, the most common adverse reactions were infections, including two life-threatening infections (1 patient in each arm).
Maltese: Fi Studju CCG-1962, l-aktar reazzjonijiet avversi komuni kienu infezzjonijiet, li jinkludu żewġ infezzjonijiet ta' theddida għall-ħajja (pazjent 1 f'kull parti tal-istudju).
English: Very common (may affect more than 1 in 10 people) - Inflammation or other disorders of the pancreas (pancreatitis) causing severe stomach pain which may spread to your back, vomiting, increase in blood sugar levels; - Serious allergic reactions with symptoms such as rash, itching, swelling, hives, shortness of breath, fast heart beat and drop in blood pressure; - Severe infection with very high fever; - Blood clots.
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni) - Infjammazzjoni jew disturbi oħrajn tal-frixa (pankreatite) li jikkawżaw uġigħ qawwi fl-istonku li jista' jinfirex għal dahrek, rimettar, żieda fil-livelli taz-zokkor fid-demm; - Reazzjonijiet allerġiċi serji b'sintomi bħal raxx, ħakk, nefħa, urtikarja, qtugħ ta' nifs, taħbit ta'