FrancophonIA/ELRC3.0 huggingface dataset:
English: Other secondary endpoints included duration of MCyR, PFS, and overall survival.
Maltese: Punti aħħarija sekondarji oħra kienu jinkludu t-tul tal-MCyR, PFS, u s-sopravivenza globali.
English: The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group.
Maltese: 64 xahar fil-grupp ta' dasatinib u 52 xahar fil-grupp ta' imatinib.
English: (95% CI) CCyR (95% CI)
Maltese: MaHRb (95 % CI) CHRb (95 % CI) NELb (95 % CI) MCyRc (95 % CI) CCyR (95 % CI)
English: b Includes ventricular dysfunction, cardiac failure, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and ventricular failure.
Maltese: b Tinkludi disfunzjoni ventrikulari, insuffiċjenza tal-qalb, insuffiċjenza konġestiva tal-qalb, kardjomijopatija, kardjomijopatija konġestiva, disfunzjoni dijastolika, tnaqqis fil-porzjon ta' tfigħ 'il barra, u insuffiċjenza ventrikulari.
English: Pregnancy and breast-feeding
Maltese: Abort Disturbi fis-sistema riproduttiva u fis-sider
English: These effects occurred at doses that did not produce maternal toxicity, indicating that dasatinib is a selective reproductive toxicant from implantation through the completion of organogenesis.
Maltese: Dawn l-effetti seħħew f'dożi li ma pproduċewx tossiċità fl-omm u dan jindika li dasatinib huwa tossikant selettiv għas-sistema riproduttiva mill-impjantazzjoni sa tmiem l-organoġeneżi.
English: Benzoic acid and benzoates
Maltese: Aċidu benżojku u benżoati
English: • If a second dose is needed to complete the total prescribed dose, repeat steps 3 through 10.
Maltese: • Jekk tkun meħtieġa t-tieni doża biex tlesti d-doża preskritta totali, irrepeti passi 3 sa 10.
English: b Complete cytogenetic response (CCyR) is based on a single bone marrow cytogenetic evaluation.
Maltese: b Rispons ċitoġenetiku komplet (CCyR) hu bbażat fuq evalwazzjoni ċitoġenika waħda tal-mudullun.
English: At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Maltese: F'konċentrazzjonijiet li huma klimikament rilevanti ta' dasatinib, it-twaħħil ma' proteini tal-plażma kien bejn wieħed u ieħor 96 % fuq il-bażi ta' esperimenti in vitro.
English: a Results reported in recommended starting dose of 140 mg once daily (see section 4.2).
Maltese: a Riżultati rrappurtati fid-doża tal-bidu rakkomandata ta' 140 mg darba kuljum (ara sezzjoni 4.2).
English: Common side effects (may affect up to 1 in 10 people) Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, serious infection of the blood or tissues (including uncommon cases with fatal outcomes)
Maltese: Infezzjonijiet: pnewmonja, infezzjoni bil-virus herpes (inkluż ċitomegalovirus - CMV), infezzjoni fl-apparat tal-parti ta' fuq tas-sistema respiratorja, infezzjoni serja tad-demm jew tattessuti (inkluż każijiet mhux komuni ta' riżultat fatali)
English: Table 2: Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose
Maltese: Tabella 2: Żieda fid-doża għal pazjenti pedjatriċi b'Ph+ CML-CP Doża (doża massima kuljum) Doża tal-bidu
English: Headache
Maltese: Sukrożju
English: Twenty-one of these patients (1%) experienced a QTcF > 500 msec.
Maltese: Wieħed u għoxrin minn dawn il-pazjenti (1 %) esperjenzaw QTcF > 500 msec.
English: Haematologic response rateb (%) (95% CI)
Maltese: Rata ta' rispons ematoloġikub (%) (95% CI)
English: At 60 months, transformation to accelerated or blast phase occurred in fewer dasatinib-treated patients (n=8; 3%) compared with imatinib-treated patients (n=15; 5.8%).
Maltese: It-trasformazzjoni wara 60 xahar għal fażi aċċellerata jew fażi blast seħħet f'inqas pazjenti kkurati b'dasatinib (n = 8; 3 %) meta mqabbel ma' pazjenti kkurati b'imatinib (n = 15; 5.8 %).
English: Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4).
Maltese: Reazzjonijiet avversi ta' emorraġija relatati mal-mediċina, li jvarjaw minn tbenġil u epistassi sa emorragija gastrointestinali u fsada tas-CNS ta' grad 3 jew 4, ġew irrappurtati f'pazjenti li kienu qed jieħdu SPRYCEL (ara sezzjoni 4.4).
English: SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
Maltese: SPRYCEL huwa indikat għat-trattament ta' pazjenti pedjatriċi bi: dijanjożi għall-ewwel darba ta' Ph+ CML fil-fażi kronika (Ph+ CML-CP) jew Ph+ CML-CP reżistenti jew intolleranti għal terapija preċedenti inkluż imatinib. dijanjożi għall-ewwel darba ta' Ph+ ALL flimkien ma' kimoterapija.
English: When this rate was based on the 85 patients with evaluable Ig/TCR assessments, the estimate was 89.4%.
Maltese: Meta din ir-rata ġiet ibbażata fuq il-85 pazjent b'valutazzjonijiet evalwabbli ta' Ig/TCR, l-istima kienet ta' 89.4 %.
English: Sucrose
Maltese: CCyR
English: Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations.
Maltese: Barra minn hekk, dasatinib jinibixxi l-kinasi tal-familja SRC f'koncentrazzjoni subnanomolari.
English: Decreased appetite Fatigue a In the pivotal study, among 106 total patients, 24 patients received the powder for oral suspension at least once, 8 of whom received the powder for oral suspension formulation exclusively.
Maltese: Uġigħ ta' ras Tnaqqis fl-aptit Għeja a Fl-istudju pivotali, fost il-106 pazjenti totali, 24 pazjent irċivew it-trab għal sospensjoni orali tal-inqas darba, li 8 minnhom irċivew il-formulazzjoni ta' trab għal sospensjoni orali esklussivament.
English: Stevens-Johnson syndromef Musculoskeletal and connective tissue disorders Very common musculoskeletal paing
Maltese: Rari vaskulite lewkoċitoklastika, fibrożi tal-ġilda Mhux magħrufa sindrome ta' Stevens-Johnnsonf Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna uġigħ muskoloskeletrikug
English: SPRYCEL 140 mg film-coated tablets
Maltese: SPRYCEL 140 mg pilloli dasatinib
English: Phase III clinical studies in patients with CML in chronic, accelerated, or myeloid blast phase, and Ph+ ALL who were resistant or intolerant to imatinib
Maltese: III f'pazjenti b'CML fil-fażi kronika, aċċellerata, jew majelodje blast, u Ph+ ALL li kienu reżistenti jew intolleranti għal imatinib
English: In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults.
Maltese: Fl-istudji ta' CML pedjatrika, ir-rati ta' anormalitajiet tal-laboratorju kienu konsisenti mal-profil magħruf għal parametri tal-laboratorju fl-adulti.
English: After constitution, one bottle contains 99 mL of oral suspension.
Maltese: Wara l-kostituzzjoni, flixkun wieħed fih 99 mL ta' sospensjoni orali.
English: SPRYCEL film-coated tablets
Maltese: Komuni tnaqqis fil-piż, żieda fil-piż
English: SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Based on the Kaplan-Meier estimates, the proportion of patients treated with dasatinib 100 mg once daily who maintained MCyR for 18 months was 93% (95% CI: [88%-98%]).
Maltese: Ibbażat fuq l-istimi Kaplan-Meier, il-proporzjon ta' pazjenti kkurati b'dasatinib 100 mg darba kuljum li żammew MCyR għal 18-il xahar kien ta' 93 % (95 % CI: [88 %-98 %]).
English: Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
Maltese: Togħma ta' frotta ratba mħallta [li fiha alkoħol benżiliku, diossidu tal-kubrit (E220)] 6
English: SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 140 mg dasatinib (bħala monoidrat).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Maltese: U KWANTITATTIVA Flixkun wieħed ta' trab għal sospensjoni orali fih 990 mg ta' dasatinib (bħala monidrat).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fruttożjju, malassorbiment ta' glucosegalactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu dan il-prodott mediċinali.
English: The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).
Maltese: It-tul medjan tatterapija f'1,618-il pazjent adult b'CML fil-fażi kronika kien ta' 29 xahar (medda 0 sa 92.9 xhur).
English: In the Phase III clinical study in patients with newly diagnosed chronic phase CML, grade 3 or 4 fluid retention was reported in 13 patients (5%) in the dasatinib-treatment group and in 2 patients (1%) in the imatinib-treatment group after a minimum of 60 months follow-up (see section 4.8).
Maltese: III fuq pazjenti ddijanjostikati għall-ewwel darba b'CML fil-fażi kronika, żamma ta' fluwidu ta' grad 3 jew 4 kienet irrappurtata fi 13-il pazjent (5 %) fil-grupp ta' kura b'dasatinib u f'2 pazjenti (1 %) fil-grupp ta' kura b'imatinib wara minimu ta' 60 xahar ta' follow-up (ara sezzjoni 4.8).
English: SPRYCEL with food and drink Do not take SPRYCEL with grapefruit or grapefruit juice.
Maltese: SPRYCEL ma' ikel u xorb Tiħux SPRYCEL mal-grejpfrut jew mal-meraq tal-grejpfrut.
English: SPRYCEL contains benzoic acid and sodium benzoate SPRYCEL contains 0.25 mg benzoic acid in each mL of oral suspension and 0.25 mg sodium benzoate in each mL of oral suspension.
Maltese: SPRYCEL fih aċidu benżojku u benżoat tas-sodju SPRYCEL fih 0.25 mg aċidu benżojku f'kull mL ta' sospensjoni orali u 0.25 mg benżoat tas-sodju f'kull mL ta' sospensjoni orali.
English: 3 If recurrence of cytopaenia, repeat step 1 and resume treatment at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
Maltese: 3 F'każ ta' rikorrenza ta' ċitopenja, irrepeti numru 1 u erġa' ibda t-trattament b'doża mnaqqsa ta' 100 mg darba kuljum (it-tieni episodju) jew 80 mg darba kuljum (it-tielet episodju).
English: Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib intolerant or resistant chronic phase CML)a
Maltese: Tabella 6a: Reazzjonijiet avversi magħżula rrappurtati fi studju ta' ottimizzazzjoni tad-doża ta' fażi 3 (CML fil-fażi kronika intolleranti jew reżistenti għal imatinib)a Minimu ta' 2 snin ta' follow up
English: Table 2: Dose escalation for patients with Ph+CML-CP Dose (maximum dose per day) Starting dose
Maltese: Tabella 2: Żieda fid-doża għal pazjenti b'Ph+ CML-CP Doża (doża massima kull jum) Doża tal-bidu
English: Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received dasatinib in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Maltese: Mill-2,182 pazjent b'reżistenza jew intolleranza għal terapija b'imatinib fil-passat li rċivew dasatinib fl-istudji kliniċi, 15 (1 %) kellhom titwil tal-QTc rrappurtat bħala reazzjoni avversa.
English: Mix the SPRYCEL oral suspension in the closed bottle by shaking for 30 seconds.
Maltese: Ħallat is-SPRYCEL sospensjoni orali fil-flixkun magħluq billi tħawwad għal 30 sekonda.
English: c MCyR combines both complete (0% Ph+ metaphases) and partial (> 0%-35%) responses.
Maltese: c MCyR jgħaqqad flimkien responsi kemm sħaħ (0 % Ph+ metafażijiet) kif ukoll parzjali (> 0 %-35 %).
English: If cytopaenia recurs, repeat marrow aspirate/biopsy and resume treatment at a reduced dose.
Maltese: Jekk iċċitopenja terġa' sseħħ, irrepeti aspirate talmudullun/bijopsija u kompli ttrattament b'doża mnaqqsa.
English: At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Maltese: Mill-2,182 pazjent b'reżistenza jew intolleranza għal terapija b'imatinib fil-passat li rċivew SPRYCEL fl-istudji kliniċi, 15 (1 %) kellhom titwil talQTc li kien irrappurtat bħala reazzjoni avversa.
English: SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 80 mg dasatinib (bħala monoidrat).
English: One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension.
Maltese: Flixkun tal-plastik wieħed ta' 120 mL (b'għatu li ma jinfetaħx faċilment mit-tfal) fih 33 g ta' trab għal sospensjoni orali.
English: The rate of major molecular response (assessed in 41 patients with a CCyR) was 46% at 24 months.
Maltese: Ir-rata ta' rispons molekulari maġġuri (evalwata f'41 pazjent b'CCyR) kienet ta' 46 % wara 24 xahar.
English: Adults with accelerated and blast phase CML and Ph+ ALL (starting dose 140 mg once daily)
Maltese: Adulti b'CML u Ph+ ALL b'fażi aċċellerata u splussiva (doża tal-bidu 140 mg darbta kuljum)
English: A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the tablet, in section 4.2, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
Maltese: Simulazzjoni bbażata fuq il-mudell tal-PPK bassret li rrakkomandazzjoni tad-dożaġġ fuq livelli tal-piż tal-ġisem deskritta għall-pillola, f'sezzjoni 4.2, hija mistennija li tipprovdi esponiment simili għad-doża tal-pillola ta' 60 mg/m2.
English: Imatinib-resistant patients
Maltese: IL-PRODOTT MEDIĊINALI
English: Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5).
Maltese: Għalhekk, antagonist ta' H2 u inibituri tal-proton pump mhumiex rakkomandati u prodotti ta' aluminium hydroxide/magnesium hydroxide għandhom jittieħdu sa sagħtejn qabel, jew sagħtejn wara li jittieħed dasatinib (ara sezzjoni 4.5).
English: Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia.
Maltese: Ħafna majelosoppressjoni (li tinkludi anemija, newtropenija, tromboċitopenija)
English: Since dasatinib is associated with grade 3 or 4 myelosuppression (see section 4.4), patients who ingest more than the recommended dose should be closely monitored for myelosuppression and given appropriate supportive treatment.
Maltese: Billi dasatinib huwa assoċjat ma' majelosuppressjoni ta' grad 3 jew 4 (ara sezzjoni 4.4), il-pazjenti li jibilgħu aktar mid-doża rakkomandata għandhom jiġu mmonitorjati mill-qrib għal majelosuppressjoni u jingħataw trattament xieraq ta' sostenn.
English: • Do not take the syringe apart in order to avoid damaging it.
Maltese: • Iċċekkja biex tkun ċert li lpazjent ikun bela' d-doża kollha.
English: Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: Kartuna li fiha 60 x 1 pillola miksija b'rita f'folji ta' doża waħda perforati.
English: Data from healthy subjects administered a single 100 mg dose of dasatinib 30 minutes following a high-fat meal indicated a 14% increase in the mean AUC of dasatinib.
Maltese: Tagħrif minn individwi b'saħħithom mogħtija doża waħda ta' 100 mg ta' dasatinib 30 minuta wara ikla b'ammont kbir ta' xaħam indika żieda ta' 14 % fl-AUC medju ta' dasatinib.
English: White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Maltese: Pillola miksija b'rita trijangulari, tvarja minn bajda għal offwajt, ibbuzzata fuq iż-żewġ naħat, b'“BMS 80” imnaqqxa fuq naħa waħda u “855” fuq in-naħa l-oħra.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Maltese: 3. GĦAMLA FARMAĊEWTIKA Pillola miksija b'rita (pillola).
English: If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose.
Maltese: Jekk iċċitopenja ma tkunx relatata mallewkimja, waqqaf it-trattament sakemm ANC ≥1.0 × 109/L u platelets ≥75 × 109/L u kompli bid-doża oriġinali tal-bidu jew b'doża mnaqqsa.
English: Skin, hair, eye, general: convulsion, inflammation of the optic nerve that may cause a complete or partial loss of vision, blue-purple mottling of the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, inflammation of the skin blood vessels, skin fibrosis
Maltese: Ġilda, xagħar, għajn, ġenerali: konvulżjoni, infjammazzjoni tan-nerv ottiku li jista' jikkawża telf komplet jew parzjali tal-vista, tbajja' blu-vjola tal-ġilda, funzjoni abnormalment għolja tattirojde, infjammazzjoni tal-glandola tat-tirojde, atassja (kundizzjoni assoċjata ma' nuqqas ta' koordinazzjoni muskolari), diffikultà fil-mixi, korriment, infjammazzjoni tal-vini fil-ġilda, fibrożi tal-ġilda
English: SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 70 mg dasatinib (bħala monoidrat).
English: Patients with risk factors (e.g. hypertension, hyperlipidaemia, diabetes) or a history of cardiac disease (e.g. prior percutaneous coronary intervention, documented coronary artery disease) should be monitored carefully for clinical signs or symptoms consistent with cardiac dysfunction such as chest pain, shortness of breath, and diaphoresis.
Maltese: Pazjenti b'fatturi ta' riskju (eż. pressjoni għolja, iperlipidemija, dijabete) jew passat mediku ta' mard kardijaku (eż. intervent koronarju perkutaneju fil-passat, mard dokumentat tal-arterja koronarja) għandhom jiġu mmonitorjati b'attenzjoni għal sinjali jew sintomi kliniċi li jkunu konsistenti ma' disfunzjoni kardijaka bħal uġigħ fis-sider, qtugħ ta' nifs, u dijaforesi.
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
Maltese: SPRYCEL 140 mg pilloli miksija b'rita dasatinib
English: k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to cardiac disease, perinephric effusion, post procedural oedema, visceral oedema.
Maltese: k Ammont eċċessiv ta' fluwidu, żamma ta' fluwidu, edima gastrointestinali, edima ġeneralizzata, edima, edima minħabba mard tal-qalb, effużjoni perinefrika, edima wara proċedura, edima vixxerali.
English: Based on the patient population PK analysis, variability in dasatinib exposure was estimated to be mainly due to inter-occasion variability in bioavailability (44% CV) and, to a lesser extent, due to inter-individual variability in bioavailability and inter-individual variability in clearance (30% and 32% CV, respectively).
Maltese: Abbażi tal-analiżi tal-PK tal-popolazzjoni, il-varjabbiltà fl-esponiment ta' dasatinib ġiet stmata li kienet prinċipalment minħabba l-varjabbiltà interokkażjonali fil-bijodisponibbiltà (44% CV) u, sa livell inqas, minħabba l-varjabbiltà interindividwali fil-bijodisponibbiltà u l-varjabbiltà interindividwali fit-tneħħija (30% u 32% CV, rispettivament).
English: Uncommon anxiety, confusional state, affect lability, libido decreased Nervous system disorders
Maltese: Mhux komuni ansjetà, stat ta' konfużjoni, daħk/tbissim/biki patoloġiku, tnaqqis fil-libido Disturbi fis-sistema nervuża
English: Blood and lymphatic system disorders
Maltese: Rispons molekulari maġġuric
English: The backbone chemotherapy regimen was the same as used in the AIEOP-BFM ALL 2000 trial (chemotherapeutic standard multi-agent chemotherapy protocol).
Maltese: Ir-reġimen ta' kimoterapija ewlieni kien l-istess bħal dak li ntuża fil-prova AIEOP-BFM ALL (protokoll ta' kimoterapija b'aktar minn aġent wieħed standard kimoterapewtiku).
English: (95% CI) MCyRc
Maltese: MCyRc CI)
English: Grade
Maltese: Dijarea
English: PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure.
Maltese: PAH (pressjoni għolja pulmonari pre-kapillari kkonfermata b'katiterizzazzjoni tal-parti l-leminija talqalb) ġiet irrapportata f'assoċjazzjoni ma' espożizzjoni għal dasatinib.
English: For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation (see Summary of Product Characteristics for SPRYCEL powder for oral suspension).
Maltese: Għal pazjenti li jkunu qed jieħdu SPRYCEL 60 mg jew 40 mg kuljum, ikkunsidra l-interruzzjoni taddoża ta' SPRYCEL sakemm l-inibitur ta' CYP3A4 jitwaqqaf, jew il-qlib għal doża aktar baxxa bilformulazzjoni ta' trab għal sospensjoni orali (ara s-Sommarju tal-Karatteristiċi tal-Prodott għal SPRYCEL trab għal sospensjoni orali).
English: In the study in chronic phase CML, the primary endpoint was MCyR in imatinib-resistant patients.
Maltese: Fl-istudju ta' CML fil-fażi kronika, il-punt aħħari primarju kien l-MCyR f'pazjenti reżistenti għal imatinib.
English: SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 20 mg dasatinib (bħala monoidrat).
English: EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
Maltese: EU/1/06/363/011 - 30 x 1 pillola miksijin b'rita (folji b'doża waħda)
English: Dasatinib did not affect male or female fertility in a conventional rat fertility and early embryonic development study, but induced embryolethality at dose levels approximating human clinical exposures.
Maltese: Dasatinib ma affettwax il-fertilità ta' l-irġiel jew tan-nisa fi studju konvenzjonali dwar il-fertilità talfirien u dwar l-iżvilupp embrijoniku bikri, iżda wassal għal embrijoletalità f'livelli ta' dożi li joqorbu għall-espożizzjonijiet kliniċi umani.
English: Rare side effects (may affect up to 1 in 1,000 people) Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) Qalb u pulmun: tkabbir tal-ventrikula tal-lemin fil-qalb, infjammazzjoni tal-muskolu tal-qalb, ġbir ta' kundizzjonijiet li jirriżultaw minn imblokk tal-provvista tad-demm għall-muskolu talqalb (sindromu koronarju akut), waqfien tal-qalb (waqfien tal-fluss tad-demm mill-qalb), mard tal-arterji koronarji (tal-qalb), infjammazzjoni tat-tessut li jiksi l-qalb u l-pulmun, emboli, emboli fil-pulmun
English: Dasatinib exposure variability is higher under fasted conditions (47% CV) compared to light-fat meal (39% CV) and high-fat meal (32% CV) conditions.
Maltese: Il-varjabbiltà talesponiment ta' dasatinib hija ogħla taħt kondizzjonijiet ta' stat sajjem (47% CV) meta mqabbel ma' kondizzjonijiet ta' ikla bi ftit xaħam (39% CV) u ikla b'ħafna xaħam (32% CV).
English: EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle)
Maltese: EU/1/06/363/013 - 30 x 1 pillola miksijin b'rita (folji b'doża waħda)
English: The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL is 140 mg once daily (see section 4.4).
Maltese: Id-doża tal-bidu rakkomandata għal CML aċċellerata, majelojd jew tal-fażi lymphoid blast (fażi avanzata) jew Ph+ ALL hija ta' 140 mg darba kuljum (ara sezzjoni 4.4).
English: HAZARD RATIO (95% CI)
Maltese: PROPORZJON TA' PERIKLU (95 % CI)