FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of teriflunomide with leflunomide is not recommended, as leflunomide is the parent compound of teriflunomide.
Maltese: Mhux irrakkomandat it-teħid flimkien ta' teriflunomide u leflunomide, peress li leflunomide huwa lkompost oriġinali ta' teriflunomide.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONI RIGWARD ILPROVVISTA
English: Preferred term
Maltese: Terminu preferut
English: # DEATHS / # Land Patient
Maltese: # MWIET / # Land Patient
English: % with MR4.5
Maltese: % b MR4.5
English: Clinically relevant interactions
Maltese: Interazzjonijiet klinikalment rilevanti
English: Film-coating Hypromellose Titanium dioxide (E171) Macrogol 400
Maltese: Hypromellose Titanium dioxide (E171) Macrogol 400
English: GROUP
Maltese: GRUPP
English: 140 mg once daily n = 304
Maltese: 140 mg darba kuljum n = 304
English: Prior imatinib (N = 46)b
Maltese: Qabel imatinib (N = 46)b
English: By 1 year 5%, p<.2394
Maltese: Sa sena 5%, p < .2394
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate
English: Durability of cCCyR
Maltese: Durabilità ta' cCCyR
English: 24 months 36 months 48 months 60 months p=0.0021
Maltese: 24 xahar 36 xahar 48 xahar 60 xahar p = 0.0021
English: Histamine-2 antagonists and proton pump inhibitors
Maltese: Antagonisti ta' Histamine-2 u inibituri tal-proton pump
English: i Gravitational oedema, localised oedema, oedema peripheral.
Maltese: i Edima gravitazzjonali, edima lokalizzata, edima periferali.
English: Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4.
Maltese: Dasatinib huwa sottostrat u inibitur ta'cytochrome P450 (CYP) 3A4.
English: Minimum of 7 years follow up
Maltese: Minimu ta' 7 snin ta' follow up
English: Minimum of 5 years follow up
Maltese: Minimu ta' 5 snin ta' follow up
English: CYP3A4 is a major enzyme responsible for the metabolism of dasatinib.
Maltese: CYP3A4 huwa enżima maġġuri responsabbli għall-metaboliżmu ta' dasatinib.
English: The mutations detected among the dasatinib-treated patients were T315I, F317I/L and V299L.
Maltese: Il-mutazzjonijiet osservati fost pazjenti kkurati b'dasatinib kienu T315I, F317I/L u V299L.
English: CTC grades: neutropaenia (Grade 3 ≥ 0.5- < 1.0 × 109/l, Grade 4 < 0.5 × 109/l); thrombocytopaenia (Grade 3 ≥ 25 - < 50 × 109/l, Grade 4 < 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 - < 80 g/l, Grade 4 < 65 g/l).
Maltese: Gradi CTC: newtropenja (Grad 3 ≥ 0.5- < 1.0 × 109/l, Grad 4 < 0.5 × 109/l); tromboċitopenja (Grad 3 ≥ 25 - < 50 × 109/l, Grad 4 < 25 × 109/l); anemija (emoglobina Grad 3 ≥ 65 - < 80 g/l, Grad 4 < 65 g/l).
English: Paediatric population (Ph+ CML-CP and Ph+ ALL)
Maltese: Popolazzjoni pedjatrika (Ph+ CML-CP u Ph+ ALL)
English: *Adjusted for Hasford Score and indicated statistical significance at a pre-defined nominal level of significance.
Maltese: *Aġġustat għal Punteġġ Hasford u rilevanza statistika indikata f'rilevanza definita minn qabel ta' livell nominali.
English: Accelerated (n= 174)
Maltese: Aċċellerata (n = 174)
English: Sulphur dioxide (E220)
Maltese: Diossidu tal-kubrit (E220)
English: Date of first authorisation: 20 November 2006 Date of latest renewal: 15 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2006 Data tal-aħħar tiġdid: 15 ta' Lulju 2016
English: % with MMR
Maltese: % b'MMR
English: Dasatinib had phototoxic potential in an in vitro neutral red uptake phototoxicity assay in mouse fibroblasts.
Maltese: Dasatinib kellu potenzjal fototossiku f'analiżi ta' neutral red uptake phototoxicity in vitro f'fibroblasti tal-ġrieden.
English: The active substance is dasatinib.
Maltese: Is-sustanza attiva hi dasatinib.
English: Figure 1: Kaplan-Meier estimate of time to major molecular response (MMR)
Maltese: Figura 1: Stima Kaplan-Meier tal-ħin għal rispons molekulari maġġuri (MMR)
English: f In the post-marketing setting, individual cases of Stevens-Johnson syndrome have been reported.
Maltese: f Fl-ambitu ta' wara t-tqegħid fis-suq, ġew irrapportati każijiet individwali tas-sindrome ta' Stevens-Johnson.
English: Dasatinib over imatinib
Maltese: Dasatinib fuq imatinib
English: CI = confidence interval; ULN = upper limit of normal range.
Maltese: CI = intervall ta' kunfidenza ULN = medda normali tal-limitu ta' fuq.
English: Lymphoid blast phase and Ph+ ALL (n= 168)c
Maltese: Fażi lymphoid blast u Ph+ ALL (n = 168)ċ
English: Outer Carton: sprycel 10 mg/mL
Maltese: Kartuna ta' Barra: sprycel 10 mg/mL
English: Time-to cCCyR Time-to MMR Durability of cCCyR
Maltese: Żmien għal cCCyR Żmien għal MMR Durabilità ta' cCCyR
English: Outer Carton: 2D barcode carrying the unique identifier included.
Maltese: Kartuna ta' Barra: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: BCR-ABL tyrosine kinase inhibitors have been associated with thrombotic microangiopathy (TMA), including individual case reports for SPRYCEL (see section 4.8).
Maltese: Inibituri tat-tyrosine kinase tal-BCR-ABL ġew assoċjati ma' mikroanġjopatija trombotika (TMA), inkluż rapporti ta' każijiet individwali għal SPRYCEL (ara sezzjoni 4.8).
English: Body Weight (kg)a
Maltese: Piż tal-Ġisem (kg)a
English: CHR (95% CI) 91% (88-94) 50% (42-58) 26% (18-35) 29% (17-44) 35% (21-50) NEL (95% CI)
Maltese: mhux applikabbli 64% (57-72) CHR (95 % CI) 91% (88-94) 50 % (42-58) 26 % (18-35) 29 % (17-44) 35 % (21-50) NEL (95 % CI)
English: 7 years
Maltese: 7 snin
English: MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients.
Maltese: MCyR inkiseb f'55 % tal-pazjenti reżistenti għal imatinib u fi 82 % ta' pazjenti intolleranti għal imatinib.
English: The time to MMR is displayed graphically in Figure 1.
Maltese: Iż-żmien għal MMR huwa muri grafikament f'Figura 1.
English: 1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
Maltese: 1 Waqqaf it-trattament sakemm ANC ≥ 1.0 x 109/L u platelets ≥ 50 x 109/L.
English: The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Maltese: Qalba tal-pillola: lactose monohydrate (ara sezzjoni 2 “SPRYCEL fih lactose”); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Kisja b'rita: hypromellose; titanium dioxide (E171); macrogol 400
English: At baseline, the distribution of Hasford Scores was similar in the SPRYCEL and imatinib treatment groups (low risk: 33% and 34%; intermediate risk 48% and 47%; high risk: 19% and 19%, respectively).
Maltese: Fil-linja bażi, id-distribuzzjoni tal-Punteġġi Hasford kienet simili fil-gruppi ta' kura ta' SPRYCEL u imatinib (riskju baxx: 33 % u 34 %; riskju intermedju 48 % u 47 %; riskju għoli: 19 % u 19 %, rispettivament).
English: However, E255K and F317L were also detected prior to treatment.
Maltese: Madankollu, E255K u F317L ġew identifikati wkoll qabel it-trattament.
English: Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor.
Maltese: Dasatinib jinibixxi l-attività ta' kinase BCR-ABL u kinases tal-familja SRC flimkien ma' numru ta' kinases onkoġeniċi oħra magħżula li jinkludu c-KIT, ephrin (EPH) receptor kinases, u r-riċettur PDGFβ.
English: One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia.
Maltese: Każ wieħed kien fatali u kien assoċjat ma' Kriterji ta' Tossiċità Komuni (CTC) tromboċitopenja tar-4 grad.
English: The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients.
Maltese: Ilhalf-life terminali medju globali ta' dasatinib huwa bejn wieħed u ieħor 5-6 sigħat f'pazjenti.
English: Rare diabetes mellitus Psychiatric disorders
Maltese: Rari dijabete mellitus Disturbi psikjatriċi
English: • Store the constituted oral suspension in a refrigerator (2°C - 8°C).
Maltese: • Aħżen is-sospensjoni orali kkostitwita fi friġġ (2°C - 8°C).
English: 10 to less than 20
Maltese: 10 sa inqas minn 20
English: 70 mg at least 45 kg
Maltese: 70 mg tal-inqas 45 kg
English: The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8.
Maltese: Il-frekwenza ta' anormalitajiet ematoloġiċi ta' grad 3 u 4 qed jiġu ppreżentati f'Tabella 8.
English: ANC < 0.5 x 109/L and/or platelets < 10 x 109/L
Maltese: ANC < 0.5 x 109/L u/jew platelets < 10 x 109/L
English: There were 45 different BCR-ABL mutations in 38% of patients enrolled in this study.
Maltese: Kien hemm 45 mutazzjonijiet BCR-ABL differenti fi 38 % tal-pazjenti mniżżlin fl-istudju.
English: There was no difference in OS (HR 1.01, 95% CI: 0.58-1.73, p= 0.9800) and PFS (HR 1.00, 95% CI: 0.58-1.72, p = 0.9998) between dasatinib and imatinib.
Maltese: 0.58-1.73, p = 0.9800) u fil-PFS (HR 1.00, 95 % CI: 0.58-1.72, p = 0.9998) bejn dasatinib u imatinib.
English: Pulmonary arterial hypertension (PAH)
Maltese: Pressjoni għolja arterjali pulmonari (PAH)
English: Dasatinib was clastogenic in vitro to dividing Chinese Hamster Ovary (CHO) cells.
Maltese: Dasatinib kien klastoġeniku in vitro għal diviżjoni ta' ċelloli ovarji tal-Ovarju tal-Ħamster Ċiniż (CHO).
English: Among dasatinib-treated CML-CP paediatric patients previously exposed to imatinib, the mutations detected at the end of treatment were: T315A, E255K and F317L.
Maltese: Fost pazjenti pedjatriċi b'CML-CP ittrattati b'dasatinib li ġew esposti preċedentement għal imatinib, ilmutazzjonijiet identifikati fl-aħħar tat-trattament kienu: T315A, E255K u F317L.
English: Dasatinib activity in vitro in hERG and Purkinje fiber assays suggested a potential for prolongation of cardiac ventricular repolarisation (QT interval).
Maltese: L-attività in vitro ta' dasatinib f'analiżi hERG u Purkinje fiber issuġġeriet potenzjal għal titwil tar-ripolarizzazzjoni ventrikulari kardijaka (intervall QT).
English: Each mL of oral suspension contains approximately 291 mg of sucrose, 2.1 mg of sodium, 0.25 mg of sodium benzoate, 0.25 mg of benzoic acid, 0.017 mg of benzyl alcohol and <10 ppm of sulphur dioxide (E220).
Maltese: Kull mL ta' sospensjoni orali fih madwar 291 mg ta' sukrożju, 2.1 mg ta' sodju, 0.25 mg ta' benżoat tas-sodju, 0.25 mg ta' aċidu benżojku, 0.017 mg ta' alkoħol benżiliku u <10 ppm ta' diossidu tal-kubrit (E220).
English: At the maximum daily dose of 16 mL oral suspension, this is equivalent to 1.7% of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult.
Maltese: Bid-doża ta' kuljum massima ta' 16 mL sospensjoni orali, dan huwa ekwivalenti għal 1.7 % tat-teħid tad-dieta ta' kuljum massimu rakkomandat tal-WHO ta' 2 g sodju għal adult.
English: ANC < 0.5 x 109/L and/or platelets < 50 x 109/L
Maltese: ANC < 0.5 x 109/L u/jew platelets < 50 x 109/L
English: Excipients: contains sucrose, sodium, sodium benzoate, benzoic acid, benzyl alcohol and sulphur dioxide (E220).
Maltese: Eċċipjenti: fih sukrożju, sodju, sodium benzoate, aċidu benżojku, alkoħol benżiliku u diossidu talkubrit (E220).
English: SPRYCEL contains lactose
Maltese: SPRYCEL fih lactose
English: 5 to less than 10 kg
Maltese: 5 sa inqas minn 10 kg
English: The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%).
Maltese: It-tneħħija orali apparenti medja hija 363.8 L/hr (CV% 81.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE06
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastika, inibituri tal-proteina kinase, Kodiċi ATC:
English: Myeloid blast (n= 109)
Maltese: Majelojde blast (n = 109)
English: 30 to less than 45
Maltese: 30 sa inqas minn 45
English: By 5 years 42%, p<.0251
Maltese: Sa 5 snin p < .0251
English: • Paper towel
Maltese: • Karta xuga
English: Excipients: contains lactose monohydrate.
Maltese: Sustanzi mhux attivi: fih lactose monohydrate.
English: Time-to MMR
Maltese: Żmien għal MMR
English: In a paediatric pharmacokinetics study, dose-normalized dasatinib exposure (Cavg, Cmin and Cmax) appears similar between 21 patients with CP-CML and 16 patients with Ph+ ALL.
Maltese: Fi studju tal-farmakokinetika pedjatrika, l-esponiment ta' dasatinib normalizzat mid-doża (Cavg, Cmin u Cmax) jidher simili bejn 21 pazjent b'CP-CML u 16-il pazjent b'Ph+ ALL.
English: Treatment duration
Maltese: It-tul tat-trattament
English: Contains 0.29 g of sucrose per mL of oral suspension.
Maltese: Fih 0.29 g ta' sukrożju għal kull mL ta' sospensjoni orali.
English: Cumulative grade 3 or 4 cytopaenias among patients treated with 100 mg once daily were similar at 2 and 5 years including: neutropaenia (35% vs. 36%), thrombocytopaenia (23% vs. 24%) and anaemia (13% vs. 13%).
Maltese: Ċitopenji kumulattivi ta' grad 3 jew 4 fost pazjenti kkurati b'100 mg darba kuljum kienu simili wara sentejn u 5 snin inkluż: newtropenja (35 % vs. 36 %), tromboċitopenija (23 % vs. 24 %) u anemija (13 % vs. 13 %).
English: SPRYCEL 10 mg/mL powder for oral suspension
Maltese: SPRYCEL 10 mg/mL trab għal sospensjoni orali
English: Nine (12%) patients underwent therapeutic thoracentesis.
Maltese: Disa' (12 %) pazjenti għaddew minn toraċentesi terapewtika.
English: After a minimum of 60 months follow-up, the cumulative rates of neutropaenia, thrombocytopaenia, and anaemia were 29%, 22% and 13%, respectively.
Maltese: Wara minimu ta' 60 xahar ta' follow-up, ir-rati kumulattivi ta' newtropenija, tromboċitopenija, u anemija kienu ta' 29 %, 22 % u 13 %, rispettivament.
English: Monitor patients less than 3 years of age for respiratory symptoms.
Maltese: Immonitorja l-pazjenti ta' inqas minn 3 snin għal sintomi respiratorji.
English: This medicinal product contains lactose monohydrate.
Maltese: Dan il-prodott mediċinali fih lactose monohydrate.
English: Time-to cCCyR
Maltese: Żmien għal cCCyR
English: The rate of MMR at any time in each risk group determined by Hasford score was higher in the SPRYCEL group compared with the imatinib group (low risk: 90% and 69%; intermediate risk: 71% and 65%; high risk: 67% and 54%, respectively).
Maltese: Ir-rata ta' MMR fi kwalunkwe żmien f'kull grupp ta' riskju stabbilit mill-iskor ta' Hasford kienet ogħla fil-grupp ta' SPRYCEL meta mqabbel mal-grupp ta' imatinib (riskju baxx: 90 % u 69 %; riskju intermedju: 71 % u 65 %; riskju għoli: 67 % u 54 %, rispettivamemt).
English: 12 months p< 0.00003*
Maltese: 12-il xahar p< 0.00003*
English: Pharmacokinetics of the tablet formulation of dasatinib were evaluated for 72 paediatric patients with relapsed or refractory leukaemia or solid tumours at oral doses ranging from 60 to 120 mg/m2 once daily and 50 to 110 mg/m2 twice daily.
Maltese: Il-farmakokinetika tal-formulazzjoni tal-pillola ta' dasatinib ġiet evalwata għal 72 pazjent pedjatriku b'lewkimja rikaduta jew refrattarja jew tumuri solidi b'dożi orali li jvarjaw minn 60 sa 120 mg/m2 darba kuljum u 50 sa 110 mg/m2 tdarbtejn kuljum.
English: After a minimum of 60 months follow-up the cumulative rate of permanent discontinuation due to grade 3 or 4 myelosuppression was 2.3%.
Maltese: Wara minimu ta' 60 xahar ta' follow-up ir-rata kumulattiva ta' twaqqif permanenti minħabba majelosoppressjoni ta' grad 3 jew 4 kienet ta' 2.3 %.
English: The geometric means of dosenormalized dasatinib Cmax, AUC (0-T), and AUC (INF) appeared to be similar between children and adolescents at different dose levels.
Maltese: Il-medji ġeometriċi ta' dasatinib Cmax, AUC (0-T), u AUC (INF) normalizzat mid-doża dehru li huma simili bejn it-tfal u ladolexxenti bil-livelli tad-doża differenti.
English: In the newly diagnosed chronic phase CML study after a minimum of 60 months follow-up, dasatinib-related fluid retention adverse reactions included pleural effusion (28%), superficial oedema (14%), pulmonary hypertension (5%), generalised oedema (4%), and pericardial effusion (4%).
Maltese: Fl-istudju dwar CML fil-fażi kronika li tkun għadha kif ġiet iddijanjostikata wara minimu ta' 60 xahar ta' follow-up, reazzjonijiet avversi ta' żamma ta' fluwidu relatati ma' dasatinib kienu jinkludu effużjoni plewrali (28 %), edima superfiċjali (14 %), pressjoni għolja pulmonari (5 %), edima ġeneralizzata (4 %), u effużjoni perikardijaka (4 %).
English: The rate of major molecular response (defined as BCR-ABL/control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
Maltese: Ir-rata ta' rispons molekulari maġġuri (definit bħala BCR-ABL/transcripts ta' kontroll ≤ 0.1 % b'RQ-PCR f'kampjuni periferali tad-demm) qabel il-crossover kienet 29 % għal dasatinib u 12 % għal imatinib.
English: Powder Store below 25°C.
Maltese: Trab Aħżen taħt 25°C.
English: In the overall population of 2,712 SPRYCEL-treated adult subjects, 520 (19%) experienced adverse reactions leading to treatment discontinuation.
Maltese: Filpopolazzjoni globali ta' 2,712-il pazjent ittrattati b'SPRYCEL, 520 (19 %) esperjenzaw reazzjonijiet avversi li wasslu għal twaqqif tal-kura.
English: No additional patients were reported to have QTcF > 500 msec after a minimum of 60 months follow-up.
Maltese: L-ebda pazjenti addizzjonali ma ġie rrappurtat li kellu QTcF > 500 msec wara minimu ta' 60 xahar ta' follow-up.
English: The estimated 60-month survival rates for dasatinib and imatinib-treated patients were 90.9% (CI: 86.6% - 93.8%) and 89.6% (CI: 85.2% - 92.8%), respectively.
Maltese: Ir-rati stmati ta' sopravivenza wara 60 xahar għal pazjenti kkurati b'dasatinib u imatinib kienu ta' 90.9 % (CI: 86.6 % - 93.8 %) u 89.6 % (CI: 85.2 % - 92.8 %), rispettivament.
English: Lymphoid blast (n= 33)
Maltese: Limfojde blast (n = 33)
English: In vitro data indicate a potential risk for interaction with CYP2C8 substrates, such as glitazones.
Maltese: Tagħrif in vitro jindika riskju potenzjali għal interazzjoni ma' sottostrati ta' CYP2C8, bħalma huma glitazones.
English: Laboratory test abnormalities Haematology
Maltese: Anormalitajiet tat-testijiet tal-laboratorju Ematoloġija
English: Table 8: CTC grades 3/4 haematological laboratory abnormalities in clinical studies in patients with resistance or intolerance to prior imatinib therapya
Maltese: Tabella 8: CTC anormalitajiet ematoloġiċi tal-laboratorju ta' gradi 3/4 fi studji kliniċi f'pazjenti b'reżistenza jew intolleranza għal terapija b'imatiniba
English: NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and ≤ 100,000/mm3.
Maltese: NEL: l-istess kriterji bħal ta' CHR iżda ANC ≥ 500/mm3 u < 1,000/mm3, jew platelets ≥ 20,000/mm3 u ≤ 100,000/mm3.
English: Step 2: Immediately invert the bottle and shake vigorously for no less than 60 seconds to obtain a uniform suspension.
Maltese: Pass 2: Eqleb il-flixkun rasu 'l isfel immedjatament u ħawwad sew għal mhux inqas minn 60 sekonda biex tikseb sospensjoni uniformi.
English: SPRYCEL 10 mg/mL powder for oral suspension dasatinib
Maltese: SPRYCEL 10 mg/mL trab għal sospensjoni orali dasatinib
English: If laboratory or clinical findings associated with TMA occur in a patient receiving SPRYCEL, treatment with SPRYCEL should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Maltese: Jekk iseħħu sejbiet laboratorji jew kliniċi assoċjati ma' TMA f'pazjent li jirċievi SPRYCEL, il-kura b'SPRYCEL għandha titwaqqaf u għandha tintemm evalwazzjoni bir-reqqa għal TMA, inkluż attività ta' ADAMTS13 u determinazzjoni ta' antikorp kontra ADAMTS13.
English: Lymphoid blast (n= 48)
Maltese: Limfojde blast (n = 48)
English: Percent (%) of patients
Maltese: Perċentwal (%) ta' pazjenti
English: Hazard ratio (HR) within 12 months (99.99% CI)
Maltese: Proporzjon ta' periklu (HR) fi żmien 12 xahar (99.99 % CI)
English: Congestive heart failure/cardiac dysfunction and pulmonary oedema were reported in < 2% of patients.
Maltese: Insuffiċjenza konġestiva talqalb/disfunzjoni tal-qalb u edima pulmonari kienu rrappurtati f'< 2 % tal-pazjenti.
English: By 5 years 76%, p<.0022
Maltese: Sa 5 snin p < .0022
English: In a study in healthy subjects, a single 100 mg dose of dasatinib increased AUC and Cmax exposure to simvastatin, a known CYP3A4 substrate, by 20 and 37% respectively.
Maltese: Fi studju ta' individwi b'saħħithom, doża waħda ta' 100 mg ta' dasatinib żiedet lespożizzjoni tal-AUC u Cmax għal simvastatin, sottostrat magħruf ta' CYP3A4, b'20 u 37 % rispettivament.
English: The minimal residual disease (MRD) negativity rate assessed by Ig/TCR rearrangement was 71.7% by the end of consolidation in all treated patients.
Maltese: Ir-rata tan-negattività tal-marda residwali minima (MRD, minimal residual disease), ivvalutata minn arranġament mill-ġdid ta' Ig/TCR kienet ta' 71.7 % sal-aħħar tal-konsolidazzjoni fil-pazjenti kollha li ġew ikkurati.
English: CI) CHRb
Maltese: CHRb CI)
English: A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
Maltese: Total ta' 174 pazjenti rċevew dasatinib 70 mg darbtejn kuljum (161 reżistenti u 13 intolleranti għal imatinib).
English: Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM.
Maltese: Dasatinib hu inibitur subnanomolari qawwi tal-kinase BCR-ABL b'potenza f'konċentrazzjoni ta' 0.6-0.8 nM.
English: e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash, heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin eruption, urticaria vesiculosa, and vasculitic rash.
Maltese: e Jinkludi eruzzjoni minħabba l-mediċina, eritema, eritema multiforme, eritrosi, raxx bil-qxur, eritema ġeneralizzata, raxx ġenitali, raxx minħabba s-sħana, milia, milijaria, psorjasi pustulari, raxx, raxx eritematuż, raxx follikulari, raxx ġeneralizzat, raxx makulari, raxx makulo-papulari, raxx papulari, raxx pruritiku, raxx bil-ponot, raxx vesikulari, qxur filġilda, irritazzjoni tal-ġilda eruzzjoni tossika tal-ġilda, urtikarja vesiculosa, u raxx vaskulitiku.
English: For the recommended paediatric dosage, SPRYCEL oral suspension contains 1.17 grams sucrose per 40 mg dasatinib and 4.37 grams sucrose per 150 mg dasatinib.
Maltese: Għad-dożaġġ pedjatriku rrakkomandat, SPRYCEL sospensjoni orali fih 1.17-il gramma sukrożju għal kull 40 mg dasatinib u 4.37 gramma sukrożju għal kull 150 mg dasatinib.
English: * For additional details, see section "Description of selected adverse reactions"
Maltese: * Għal aktar dettalji, ara sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: Imatinib-resistant patients n=124
Maltese: Pazjenti reżistenti għal imatinib n = 124
English: SPRYCEL contains sulphur dioxide (E220) May rarely cause severe hypersensitivity reactions and bronchospasm.
Maltese: SPRYCEL fih diossidu tal-kubrit (E220) F'każijiet rari jista' jikkawża reazzjonijiet ta' sensittività eċċessiva severi u bronkospażmu.
English: Pharmacodynamics
Maltese: Farmakodinamiċi
English: SPRYCEL contains 0.017 mg benzyl alcohol in each mL of oral suspension.
Maltese: SPRYCEL fih 0.017 mg alkoħol benżiliku f'kull mL ta' sospensjoni orali.
English: Among 188 patients in paediatric studies, the median duration of therapy was 26.3 months (range 0 to 99.6 months).
Maltese: Fost 188 pazjent fl-istudji pedjatriċi, it-tul medjan tat-terapija kien ta' 26.3 xhur (medda 0 sa 99.6 xhur).
English: b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage.
Maltese: b Jinkludi emorraġija fis-sistema nervuża ċentrali, ematoma ċerebrali, emorraġija ċerebrali, ematoma extradural, emorraġija intrakranjali, puplesija emorraġika, emorraġija subaraknodji, ematoma subdurali, u emorraġija subdurali.