FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 20 mg, 50 mg, 70 mg, 80 mg, 100 mg jew 140 mg ta' dasatinib (bħala monoidrat).
English: Constitution in this way produces 90 mL (deliverable volume) of 10 mg/mL SPRYCEL oral suspension.
Maltese: Il-kostituzzjoni b'dan il-mod tipproduċi 90 mL (volum li jitwassal) ta' 10 mg/mL SPRYCEL sospensjoni orali.
English: Cytogenetic response within 12 months cCCyRa p< 0.007*
Maltese: Rispons ċitoġeniku fi żmien 12-il xahar cCCyRa p< 0.007*
English: Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic (n= 387)
Maltese: Tabella 11: Effikaċja fi studji kliniċi single-arm ta' fażi
English: The rates of MMR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (8% and 0.4%), 6 months (27% and 8%), 9 months (39% and 18%), 12 months (46% and 28%), 24 months (64% and 46%) , 36 months (67% and 55%), 48 months (73% and 60%) and 60 months (76% and 64%)were also consistent with the primary endpoint.
Maltese: Ir-rati ta' MMR fil-gruppi ta' kura ta' SPRYCEL u imatinib, rispettivament, fi żmien 3 xhur (8 % u 0.4 %), 6 xhur (27 % u 8 %), 9 xhur (39 % u 18 %), 12-il xahar (46 % u 28 %), 24 xahar (64 % u 46 %), 36 xahar (67 % u 55 %), 48 xahar (73 % u 60 %) u 60 xahar (76 % u 64 %) kienu wkoll konsistenti mal-punt aħħari primarju.
English: Efficacy results are presented in Tables 12 and 13.
Maltese: Ir-riżultati taleffikaċja huma ppreżentati f'Tabelli 12 u 13.
English: at least 45
Maltese: tal-inqas 45
English: c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (> 0%-35%).
Maltese: c Kriterji ta' respons ċitoġenetiċi: totali (0 % Ph+ metafażi) jew parzjali (> 0 %-35 %).
English: Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic
Maltese: Tabella 11: Effikaċja fi provi kliniċi single-arm ta' fażi
English: ______ Dasatinib 100 mg once daily --------- Imatinib 400 mg once daily
Maltese: ______ Dasatinib 100 mg darba kuljum 259 --------- Imatinib 400 mg darba kuljum
English: 20 to less than 30 kg
Maltese: 20 sa inqas minn 30 kg
English: 1 bottle of 33 g powder 1 bottle adapter 1 oral syringe
Maltese: Trab għal sospensjoni orali Kartuna ta' Barra: flixkun 1 ta' 33 g trab adapter tal-flixkun 1 siringa orali 1
English: The rates of cCCyR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (54% and 30%), 6 months (70% and 56%), 9 months (75% and 63%), 24 months (80% and 74%), 36 months (83% and 77%), 48 months (83% and 79%) and 60 months (83% and 79%) were consistent with the primary endpoint.
Maltese: Ir-rati ta' cCCyR fil-gruppi ta' kura ta' SPRYCEL u imatinib, rispettivament, fi żmien 3 xhur (54 % u 30 %), 6 xhur (70 % u 56 %), 9 xhur (75 % u 63 %), 24 xahar (80 % u 74 %), 36 xahar (83 % u 77 %), 48 xahar (83 % u 79 %) u 60 xahar (83 % u 79 %) kienu konsistenti mal-punt aħħari primarju.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli wara t-tqegħid fis-suq).
English: Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4).
Maltese: Wieħed u għoxrin pazjent (1 %) kellhom QTcF ta' > 500 msek (ara sezzjoni 4.4).
English: A total of 519 patients were randomised to a treatment group: 259 to SPRYCEL and 260 to imatinib.
Maltese: Total ta' 519-il pazjent intgħażlu b'mod każwali għal grupp ta' kura: 259 biex jirċievu SPRYCEL u 260 biex jirċievu imatinib.
English: a Numbers in bold font are the results of primary endpoints.
Maltese: a Numbri b'tipa skura huma r-riżultati ta' punti ta' tmiem primarji.
English: In severely hepatic-impaired subjects, the mean Cmax and AUC adjusted for the 70 mg dose were decreased by 43% and 28%, respectively, compared to subjects with normal hepatic function (see sections 4.2 and 4.4).
Maltese: F'pazjenti li jkollhom indeboliment sever tal-fwied, il-medja tas- Cmax u tal-AUC aġġustata għad-doża ta' 70 mg tnaqqsu bi 43 % u 28 %, rispettivament, meta mqabbla ma' persuni b'funzjoni normali tal-fwied (ara sezzjonijiet 4.2 u 4.4).
English: The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients.
Maltese: Il-farmakokinetiċi ta' dasatinib ġew evalwati f'229 adult b'saħħtu u f'84 pazjent.
English: Table 10: Dasatinib patients with BCR-ABL ≤ 10% and > 10% at 3 months
Maltese: Pazjenti fuq dasatinib b'BCR-ABL ≤ 10 % u > 10 % wara 3 xhur
English: A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Maltese: Total ta' 48 pazjent b'lymphoid blast CML irċevew dasatinib 70 mg darbtejn kuljum (42 reżistenti u 6 intolleranti għal imatinib).
English: Key efficacy endpoints were: complete cytogenetic response (CCyR), major cytogenetic response (MCyR) and major molecular response (MMR).
Maltese: Il-punti aħħarija tal-effikaċja ewlenin kienu: rispons ċitoġenetiku komplet (CCyR), rispons ċitoġeniku maġġuri (MCyR) u rispons molekulari maġġuri (MMR).
English: SPRYCEL tablets are not recommended for patients weighing less than 10 kg.
Maltese: SPRYCEL pilloli mhumiex rakkomandati għal pazjenti li jiżnu inqas minn 10 kg.
English: • 1 SPRYCEL oral suspension bottle containing a white to yellow opaque suspension.
Maltese: • Flixkun 1 ta' SPRYCEL sospensjoni orali li fih sospensjoni opaka bajda għal safra.
English: A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib).
Maltese: Total ta' 109 pazjent irċevew dasatinib 70 mg darbtejn kuljum (99 reżistenti u 10 intolleranti għal imatinib).
English: Common febrile neutropaenia Uncommon lymphadenopathy, lymphopaenia
Maltese: Mhux komuni limfodenopatija, limfopenija
English: Sucrose Carmellose sodium Simethicone emulsion consisting of: simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid.
Maltese: Sukrożju Carmellose sodium Simethicone emulsion li jikkonsisti minn: simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, gliċeridi, methylcellulose, xanthan gum, aċidu benżojku, aċidu sorbiku, aċidu sulfuriku. Aċidu tartariku Trisodium citrate anhydrous Benżoat tas-sodju (E211)
English: Seventeen patients had 2 separate adverse reactions, 6 had 3 adverse reactions, 18 had 4 to 8 adverse reactions and 5 had > 8 episodes of pleural effusions.
Maltese: Sbatax-il pazjent kellhom 2 reazzjonijiet avversi separati, 6 kellhom 3 reazzjonijiet avversi, 18 kellhom minn 4 sa 8 reazzjonijiet avversi u 5 kellhom > 8 episodji ta' effużjonijiet plewrali.
English: MEDIAN (95% CI)
Maltese: MEDJAN (95 % CI)
English: The proportion of patients achieving BCR-ABL ratio of ≤0.01% (4-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (54.1% versus 45%).
Maltese: Il-proporzjon ta' pazjenti li kisbu proporzjon BCR-ABL ta' ≤ 0.01 % (tnaqqis ta' 4-log) fi kwalunkwe żmien kien ogħla fil-grupp ta' SPRYCEL meta mqabbel mal-grupp ta' imatinib (54.1 % kontra 45 %).
English: In patients, dasatinib has a large apparent volume of distribution (2,505 L), coefficient of variation (CV% 93%), suggesting that the medicinal product is extensively distributed in the extravascular space.
Maltese: Fil-pazjenti, dasatinib għandu volum ta' distribuzzjoni apparenti kbir (2,505 L), koeffiċjent ta' varjazzjoni (CV% 93%), li jissuġġerixxi li l-prodott mediċinali huwa distribwit b'mod estensiv flispazju ekstravaskulari.
English: Pack size: 1 bottle
Maltese: Daqs tal-pakkett: flixkun 1
English: In these patients, CCyR and MMR were CCyR: 87.9% [95% CI: (71.8-96.6)] and MMR: 45.5% [95% CI: (28.1-63.6)] at 12 months.
Maltese: F'dawn il-pazjenti, CCyR u MMR kienu CCyR: 87.9 % [95 % CI: (71.8-96.6)] u MMR: 45.5 % [95 % CI: (28.1-63.6)] wara 12-il xahr.
English: Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Maltese: Mill-130 pazjent pedjatriku ttrattati bi SPRYCEL b'CML-CP, 2 (1.5 %) esperjenzaw reazzjonijiet avversi li wasslu għal twaqqif tal-kura.
English: The rate of major molecular response at 24 months was 45% (35% for imatinib-resistant patients and 74% for imatinib-intolerant patients).
Maltese: Ir-rata ta' rispons molekulari maġġuri wara 24 xahar kienet ta' 45 % (35 % għal pazjenti reżistenti għal imatinib u 74 % għal pazjenti intolleranti għal imatinib).
English: Adults with chronic phase CML (starting dose 100 mg once daily)
Maltese: Adulti b'CML ta' fażi kronika (doża tal-bidu 100 mg darba kuljum)
English: Outer Carton: sprycel 140 mg
Maltese: Sprycel 140 mg
English: • 12-mL oral syringe provided with the bottle.
Maltese: • Siringa orali ta' 12 mL ipprovduta mal-flixkun.
English: A total of 2,712 patients were evaluated in clinical studies; of these 23% were ≥ 65 years of age and 5% were ≥ 75 years of age.
Maltese: Total ta' 2,712-il pazjent kienu evalwati fl-istudji kliniċi; minn dawn 23 % kellhom ≥ 65 sena u 5 % kellhom ≥ 75 sena.
English: SPRYCEL 80 mg, SPRYCEL 100 mg and SPRYCEL 140 mg film-coated tablets Alu/Alu blisters (perforated unit dose blisters).
Maltese: SPRYCEL 80 mg, SPRYCEL 100 mg u SPRYCEL 140 mg pilloli miksija b'rita Folji tal-Alu/Alu (folji perforati ta' doża waħda).
English: 10 to less than 20 kg
Maltese: 10 sa inqas minn 20 kg
English: Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score.
Maltese: L-effikaċja ta' SPRYCEL intweriet b'mod konsistenti f'sottogruppi differenti, li jinkludu l-età, is-sess, u l-punteġġ Hasford fil-linja bażi.
English: Myeloid blast (n= 75)
Maltese: Majelojde blast (n = 75)
English: Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased
Maltese: Mhux komuni infart mijokardijaku, (li tinkludi riżultati fatali)*, elettrokardjogramm li juri titwil filQT*, perikardite, arritmija ventrikulari (li tinkludi takikardija ventrikulari), anġina pectoris, kardjomegalija, T wave abnormali fuq l-elettrokardjogramma, żieda fittroponin
English: The mean Cmax and AUC of dasatinib adjusted for the 70 mg dose were decreased by 47% and 8%, respectively, in subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
Maltese: Il-medja tas- Cmax u tal-AUC ta' dasatinib aġġustati għad-doża ta' 70 mg, tnaqqsu b'47 % u 8 %, rispettivament, f'pazjenti b'indeboliment moderat talfwied meta mqabbla ma' persuni b'funzjoni normali tal-fwied.
English: PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib treatment (see section 4.8).
Maltese: PAH (pressjoni għolja arterjali pulmonari pre-kapillari kkonfermata b'katiterizzazzjoni tal-parti lleminija tal-qalb) ġiet irrapportata f'assoċjazzjoni ma' kura b'dasatinib (ara sezzjoni 4.8).
English: SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side.
Maltese: SPRYCEL 80 mg: il-pillola miksija b'rita tvarja minn bajda għal offwajt, bikonvessa, triangulari b'“BMS 80” imnaqqxa fuq naħa waħda u “855” fuq in-naħa l-oħra.
English: In healthy subjects, the concomitant use of aluminium hydroxide/magnesium hydroxide antacids with SPRYCEL reduced the AUC of a single dose of SPRYCEL by 55% and the Cmax by 58%.
Maltese: F'individwi b'saħħithom, lużu tal-antaċidi aluminium hydroxide/magnesium hydroxide flimkien ma' SPRYCEL naqqas l-AUC ta' doża waħda ta' SPRYCEL b'55 % u Cmax bi 58 %.
English: Lymphoid blast phase CML and Ph+ ALL
Maltese: Fażi ta' CML ta' limfojde blast u Ph+ ALL
English: The other ingredients are: sucrose, carmellose sodium, simethicone emulsion (consisting of simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid), tartaric acid, trisodium citrate anhydrous, sodium benzoate (E211), silica hydrophobic colloidal, mixed berry flavour (containing: benzyl alcohol, sulphur dioxide) (see section 2 "What you need to know before you take SPRYCEL").
Maltese: Is-sustanzi mhux attivi l-oħra huma: sukrożju, carmellose sodium, emulsjoni ta' simethicone (li tikkonsisti minn simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, gliċeridi, methylcellulose, xanthan gum, aċidu benżojku, aċidu sorbiku, aċidu sulfuriku, aċidu tartariku, trisodium citrate anhydrous, benżoat tas-sodju (E211), silica hydrophobic colloidal, togħma ta' frotta ratba mħallta (li fiha alkoħol benżiliku, diossidu tal-kubrit) (ara sezzjoni 2 "X'għandek tku taf qabel ma tieħu SPRYCEL").
English: 2 year n/a 60% (50-70) 41% (21-60) 10% (0-28) 24% (2-47) Cytogenetic responsec (%)
Maltese: sentejn mhux applikabbli 60% (50-70) 41% (21-60) 10% (0-28) 24% (2-47) Rispons ċitoġenetikuc (%) MCyR (95 % CI) CCyR (95 %
English: In rats, dasatinib inhibited platelet aggregation in vitro and prolonged cuticle bleeding time in vivo, but did not invoke spontaneous haemorrhage.
Maltese: Fil-firien, dasatinib inibixxa laggregazzjoni tal-platelets in vitro u tawwal il-ħin tal-fsada ta' l-epiderme in vivo, iżda ma wassalx għal emorraġija spontanja.
English: In patients with chronic phase CML (n=548), 5 patients (1%) receiving dasatinib had grade 3 or 4 haemorrhage.
Maltese: F'pazjenti b'CML fil-fażi kronika (n = 548), 5 pazjenti (1 %) li kienu qed jirċievu dasatinib kellhom emorraġija ta' grad 3 jew 4.
English: In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding.
Maltese: F'pazjenti b'CML b'reżistenza jew intolleranza għal terapija b'imatinib fil-passat, ċitopeniji (tromboċitopenija, newtropenija, u anemija) instabu b'mod konsistenti.
English: MCyR (0%-35%) combines both complete and partial responses.
Maltese: MCyR (0 %-35 %) jikkombina kemm respons sħiħ kif ukoll parzjali.
English: Eighty-two patients received dasatinib tablets exclusively and 24 patients received dasatinib powder for oral suspension at least once, 8 of whom received dasatinib powder for oral suspension exclusively.
Maltese: Tnejn u tmenin pazjent irċivew dasatinib pilloli esklussivament u 24 pazjent irċivew dasatinib trab għal sospensjoni orali tal-inqas darba, li 8 minnhom irċivew dasatinib trab għal sospensjoni orali esklussivament.
English: Baseline characteristics were well balanced between the two treatment groups with respect to age (median age was 46 years for the SPRYCEL group and 49 years for the imatinib group with 10% and 11% of patients 65 years of age or older, respectively), gender (women 44% and 37%, respectively), and race (Caucasian 51% and 55%; Asian 42% and 37%, respectively).
Maltese: Il-karatteristiċi tal-linja bażi kienu bbilanċjati tajjeb bejn iż-żewġ grupp ta' kura fir-rigward tal-età (il-medjan tal-età kien ta' 46 sena għall-grupp ta' SPRYCEL u 49 sena għallgrupp ta' imatinib b'10 % u 11 % tal-pazjenti li kellhom 65 sena jew aktar, rispettivament), sess (nisa 44 % u 37 %, rispettivament), u razza (Kawkasi 51 % u 55 %; Asjatiċi 42 % u 37 %, rispettivament).
English: All patients n=167
Maltese: Il-pazjenti kollha n = 167
English: SPRYCEL 70 mg tablets dasatinib
Maltese: SPRYCEL 70 mg pilloli dasatinib
English: ANC: absolute neutrophil count
Maltese: ANC: għadd assolut ta' newtrofili
English: Based on the Kaplan-Meier estimates, 95% (95% CI: [92%-98%]) of the patients maintained MCyR for 1 year and 88% (95% CI: [83%-93%]) maintained MCyR for 2 years.
Maltese: Abbażi ta' l-estimi Kaplan-Meier, 95 % (95 % CI: [92 %-98 %]) tal-pazjenti żammew MCyR għal sena u 88 % (95 % CI: [83 %-93 %]) żammew MCyR għal sentejn.
English: Use the oral syringe included in the package.
Maltese: Uża s-siringa orali inkluża fil-pakkett.
English: c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (>0%-35%).
Maltese: c Kriterji tar-rispons ċitoġeniku: sħiħ (0 % Ph+ metafażijiet) jew parzjali (> 0 %-35 %).
English: MaHRb
Maltese: MaHRb CI)
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Maltese: l Nefħa fil-parti ġenitali, edima fis-sit tal-inċiżjoni, edima ġenitali, edima fil-pene, nefħa fil-pene, edima fl-iskrotum, nefħa fil-ġilda, nefħa fit-testikoli, nefħa vulvovaġinali.
English: Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Maltese: Komuni ħafna majelosoppressjoni (li tinkludi anemija, newtropenija, tromboċitopenija)
English: Paediatric patients with CML
Maltese: Pazjenti pedjatriċi b'CML
English: Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Maltese: Rari ipertirojdiżmu, tirojdite Disturbi fil-metaboliżmu u n-nutrizzjoni
English: These 6 cases included cases of epiphyses delayed fusion, osteopaenia, growth retardation, and gynecomastia (see section 5.1).
Maltese: Dawn is-6 każijiet inkludew każijiet ta' fużjoni mdewma ta' epifiżijiet, osteopenja, diżabilità fit-tkabbir u ginekomastja (ara sezzjoni 5.1).
English: In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%).
Maltese: F'analiżi addizzjonali, kienu aktar il-pazjenti kkurati b'dasatinib (84 %) li kisbu rispons molekulari bikri (definit bħala livelli ta' BCR-ABL ta' 10 % wara 3 xhur) meta mqabbla ma' pazjenti kkurati b'imatinb (64 %).
English: Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a
Maltese: Tabella 1: Dożaġġ ta' SPRYCEL pilloli għal pazjenti pedjatriċi b'Ph+ CML-CP jew Ph+ ALL Piż tal-ġisem (kg)a
English: Most resistant patients (72%) had received > 600 mg imatinib.
Maltese: Il-pazjenti l-aktar reżistenti (72 %) kienu rċevew > 600 mg imatinib.
English: MMR (95% CI) Newly diagnosed (N = 51)a
Maltese: MMR (95 % CI) Iddijanjostikati għall-ewwel darba (N = 51)a
English: Very common skin rashe Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis
Maltese: Komuni alopeċja, dermatite (li tinkludi ekżema), ħakk, akne, ġilda xotta, urtikarja, iperidrosi
English: The concomitant use of dasatinib and a histamine-2 (H2) antagonist (e.g. famotidine), proton pump inhibitor (e.g. omeprazole), or aluminium hydroxide/magnesium hydroxide may reduce the exposure to dasatinib.
Maltese: L-għoti fl-istess ħin ta' dasatinib ma' antagonist ta' histamine-2 (H2) (eż. famotidine), inibituri talproton pump (eż. omeprazole), jew aluminium hydroxide/magnesium hydroxide jista' jnaqqas lespożizzjoni ta' dasatinib.
English: Total prescribed dose (mL)
Maltese: Doża totali preskritta (mL)
English: The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that of the adult population, regardless of formulation, with the exception of no reported pericardial effusion, pleural effusion, pulmonary oedema, or pulmonary hypertension in the paediatric population.
Maltese: Il-profil tas-sigurtà globali ta' SPRYCEL fil-popolazzjoni pedjatrika b'Ph+ CML-CP kien simili għal dak tal-popolazzjoni adulta, irrispettivament mill-formulazzjoni, bl-eċċezzjoni li l-ebda effużoni perikardijaka, effużjoni plewrali, edema pulmonari jew ipertensjoni pulmonari ma ġew irrappurtati filpopolazzjoni pedjatrika.
English: A total of 387 patients received dasatinib 70 mg twice daily (288 resistant and 99 intolerant).
Maltese: Total ta' 387 pazjent rċevew dasatinib 70 mg darbtejn kuljum (288 reżistenti u 99 intolleranti għal imatinib).
English: Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Maltese: infezzjoni bil-virus tal-herpes (inkluż ċitomegalovirus - CMV), infezzjoni fl enterokolite, sepsis (inkluż każijiet mhux komuni b'riżultat fatali)
English: 30 to less than 45 kg
Maltese: 30 sa inqas minn 45 kg
English: Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Maltese: Dasatinib ma kienx mutaġeniku f'analiżi ta' ċelloli batterjali in vitro (Ames test) u ma kienx ġenotossiku fi studju mikronukleju fuq il-firien in vivo .
English: Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified)
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna infezzjoni (li tinkludi infezzjoni batterika, virali, fungali, mhux speċifikata)
English: An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy.
Maltese: Sar studju open-label, single-arm, f'aktar minn ċentru wieħed fuq pazjenti b'lymphoid blast phase CML jew Ph+ ALL li kienu reżistenti jew intolleranti għal terapija b'imatinib preċedenti.
English: Additionally, 34 (47%) received diuretics, 23 (32%) received corticosteroids, and 20 (27%) received both corticosteroids and diuretics.
Maltese: Barra minn hekk, 34 (47 %) irċevew dijuretiċi, 23 (32 %) irċevew kortikosterojdi, u 20 (27 %) irċevew kemm kortikosterojdi kif ukoll dijuretiċi.
English: This medicinal product contains 2.1 mg sodium (main component of cooking/table salt) per mL of SPRYCEL oral suspension.
Maltese: Dan il-prodott mediċinali fih 2.1 mg sodju (komponent ewlieni ta' melħ tat-tisjir) għal kull mL ta' SPRYCEL sospensjoni orali.
English: Patients with BCR-ABL > 10% at 3 months
Maltese: Pazjenti b'BCR-ABL > 10 % wara 3 xhur
English: CHR Cytogenetic responsec (%) (95% CI)
Maltese: CHR Rispons Ċitoġenikuc (%) (95 % CI)
English: Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in adults
Maltese: Tabella 3: Aġġustamenti fid-doża għal newtropenja u tromboċitopenja fl-adulti
English: The 140 mg once daily regimen showed a comparable efficacy profile to the 70 mg twice daily regimen but a more favourable safety profile.
Maltese: Il-kors ta' 140 mg darba kuljum wera profil ta' effikaċja komparabbli mal-kors ta' 70 mg darbtejn kuljum iżda profil tas-sigurtà aktar favorevoli.
English: Among dasatinib-treated patients with drug-related pleural effusion (n=73), 45 (62%) had dose interruptions and 30 (41%) had dose reductions.
Maltese: Fost ilpazjenti kkurati b'dasatinib li kellhom effużjoni plewrali relatata mal-mediċina (n = 73), 45 (62 %) kellhom interruzzjonijiet tad-doża u 30 (41 %) kellhom tnaqqis fid-doża.
English: Table 1: Dosage of SPRYCEL powder for oral suspension for patients with Ph+ CML-CP and paediatric patients with Ph+ ALL (10 mg/mL suspension upon constitution) Body weight (kg)
Maltese: Tabella 1: Dożaġġ ta' SPRYCEL trab għal sospensjoni orali għal pazjenti b'Ph+ CML-CP u pazjenti pedjatriċi b'Ph+ ALL (10 mg/mL sospensjoni mal-kostituzzjoni) Piż tal-ġisem (kg)
English: Each film-coated tablet contains 189 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 189 mg ta' lactose monohydrate.
English: Store upright.
Maltese: Mhux applikabbli.
English: They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
Maltese: Ilpazjenti ntgħażlu b'mod każwali (2:1) biex jingħataw jew dasatinib (70 mg darbtejn kuljum) jew imatinib (400 mg darbtejn kuljum).
English: In the subset of 130 chronic phase CML SPRYCEL-treated paediatric patients, the median duration of therapy was 42.3 months (range 0.1 to 99.6 months).
Maltese: Fil-kategorija ta' 130 pazjent pedjatriku b'CML fil-fażi kronika ttrattati b'SPRYCEL, it-tul medjan tat-terapija kien ta' 42.3 xhur (medda 0.1 sa 99.6 xhur).
English: at least 45 kg
Maltese: tal-inqas 45 kg