FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of dexamethasone, a weak CYP3A4 inducer, with dasatinib is allowed; dasatinib AUC is predicted to decrease approximately 25% with concomitant use of dexamethasone, which is not likely to be clinically meaningful.
Maltese: L-użu konkomitanti ta' dexamethasone, induttur dgħajjef ta' CYP3A4, ma' dasatinib, ġie permess; l-AUC ta' dasatinib hija prevista li titnaqqas b'madwar 25 % bl-użu konkomitanti ta' dexamethasone, li aktarx ma jkunx klinikament sinifikanti.
English: Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate.
Maltese: Sustanzi attivi li jistgħu jżidu l-konċentrazzjoni ta' dasatinib fil-plażma Studji in vitro jindikaw li dasatinib huwa sottostat ta' CYP3A4.
English: At clinically relevant concentrations, binding of dasatinib to plasma proteins is approximately 96% on the basis of in vitro experiments.
Maltese: F'konċentrazzjonijiet klinikament rilevanti, it-twaħħil ta' dasatinib ma' proteini tal-plażma huwa bejn wieħed u ieħor ta' 96 % fuq il-bażi ta' esperimenti in vitro.
English: Gastrointestinal toxicity was dose-limiting in rats and monkeys, as the intestine was a consistent target organ.
Maltese: It-tossiċità gastrointestinali kienet ta' limitazzjoni għad-doża fil-firien u fix-xadini, minħabba li l-intestini kienu organu konsistentament fil-mira.
English: SPRYCEL is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
Maltese: SPRYCEL huwa indikat għat-trattament ta' pazjenti adulti li jkollhom dawn il-kundizzjonijiet: dijanjożi għall-ewwel darba ta' Philadelphia chromosome positive (Ph+) lewkemija majeloġena kronika (CML) fil-fażi kronika.
English: SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Maltese: SPRYCEL 50 mg pilloli miksija b'rita EU/1/06/363/005
English: To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg film-coated tablets and powder for oral suspension (10 mg/mL suspension upon constitution).
Maltese: Biex tikseb id-doża rakkomandata, SPRYCEL hu disponibbli bħala pilloli miksija b'rita ta' 20 mg, 50 mg, 70 mg, 80 mg, 100 mg u 140 mg u trab għal sospensjoni orali (10 mg/mL sospensjoni malkostituzzjoni).
English: b Progression was defined as increasing WBC count, loss of CHR or MCyR, ≥30% increase in Ph+ metaphases, confirmed AP/BP disease or death.
Maltese: b Il-progressjoni kienet definita bħala żieda fl-għadd ta' WBC, telf tas-CHR jew MCyR, ≥ 30 % żieda fil-metafażijiet Ph+, mard AP/BP ikkonfermat jew mewt.
English: SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
Maltese: SPRYCEL 100 mg: il-pillola miksija b'rita tvarja minn bajda għal offwajt, bikonvessa, ovali u b'“BMS 100” imnaqqxa fuq naħa waħda u “852” fuq in-naħa l-oħra.
English: PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy.
Maltese: Il-PFS kienet analizzata fuq il-prinċipju ta' intenzjoni ta' kura u l-pazjenti kienu segwiti għal avvenimenti li jinkludu terapija sussegwenti.
English: In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
Maltese: III dwar l-ottimizzazzjoni tad-doża li sar fuq pazjenti b'CML fil-fażi kronika b'reżistenza jew intolleranza għal terapija b'imatinib fil-passat (il-medjan ta' tul ta' żmien tal-kura kien ta' 30 xahar), l-inċidenza ta' effużjoni mill-plewra u insuffiċjenza konġestiva tal-qalb/disfunzjoni kardijaka kienet iktar baxxa f'pazjenti kkurati bi SPRYCEL 100 mg darba kuljum milli f'dawk kkurati bi SPRYCEL 70 mg darbtejn kuljum.
English: Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a MR4.5 despite dose interruptions or dose adjustment.
Maltese: Fost il-pazjenti kkurati b'dasatinib li kellhom effużjoni plewrali, 96 % kisbu cCCyR, 82 % kisbu MMR, u 50 % kisbu MR4.5 minkejja interruzzjonijiet tad-doża jew aġġustament tad-doża.
English: Rare epiphyses delayed fusion,h growth retardationh
Maltese: Rari abort Disturbi fis-sistema riproduttiva u fis-sider
English: Common appetite disturbancesa, hyperuricaemia Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia
Maltese: Mhux komuni sindrome tal-lisi tat-tumur, deidratazzjoni, ipoalbuminemija, iperkolesterolemija
English: Digestive problems: loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes
Maltese: Problemi fid-diġestjoni: telf ta' nutrijenti vitali bħal proteina mill-passaġġ diġestiv tiegħek, sadd fl-imsaren, fistla anali (ftuħ anormali mill-anus għall-ġilda ta' madwar l-anus), indeboliment tal-funzjoni tal-kliewi, dijabete
English: Following a single oral dose of [14C]-labelled dasatinib, approximately 89% of the dose was eliminated within 10 days, with 4% and
Maltese: Wara doża orali waħda ta' dasatinib ittikkettat b'[14C], bejn wieħed u ieħor 89 % tad-doża ġiet eliminata fi żmien 10t ijiem,
English: Shake bottle repeatedly for 30 seconds.
Maltese: Ħawwad il-flixkun għal ħafna drabi għal 30 sekond a.
English: SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Maltese: SPRYCEL 100 mg pilloli miksija b'rita EU/1/06/363/011
English: Abdominal pain Diarrhoea
Maltese: Uġigħ addominali Dijarea
English: Figure 4: Landmark plot for overall survival for dasatinib by BCR-ABL level (≤ 10% or > 10%) at 3 months in a phase 3 study of newly diagnosed patients with chronic phase CML
Maltese: Figura 4: Plott tal-punti sinifikanti għas-sopravivenza globali għal dasatinib skont il-livell ta' BCR-ABL (≤ 10% jew > 10%) wara 3 xhur fi studju ta' fażi 3 ta' pazjenti ddijanjostikati għall-Ewwel darba b'CML fil-fażi kronika
English: Myeloid blast phase (n= 74)c
Maltese: Fażi myeloid blast (n = 74)ċ
English: While the safety profile of SPRYCEL in elderly was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions such as fatigue, pleural effusion, dyspnoea, cough, lower gastrointestinal haemorrhage, and appetite disturbance and more likely to experience less frequently reported adverse reactions such as abdominal distention, dizziness, pericardial effusion, congestive heart failure, and weight decrease and should be monitored closely (see section 4.4).
Maltese: Filwaqt li l-profil tas-sigurtà ta' SPRYCEL fil-popolazzjoni tal-anzjani kien simili għal dak filpopolazzjoni aktar żagħżugħa, pazjenti li jkollhom 65 sena u aktar, għandhom possibbiltà akbar li jkollhom ir-reazzjonijiet avversi rrappurtati b'mod komuni bħal għeja, effużjoni plewrali, qtugħ ta' nifs, sogħla, emorraġija fil-parti ta' isfel tal-apparat gastrointestinali, u disturb fl-aptit u huma aktar probabbli li jesperjenzaw reazzjonijiet avversi rrappurtati b'mod anqas frekwenti bħal distensjoni addominali, sturdament, effużjoni perikardijaka, insuffiċjenza konġestiva tal-qalb, u tnaqqis fil-piż u għandhom jiġu mmonitorjati mill-qrib (ara sezzjoni 4.4).
English: The effect of hepatic impairment on the single-dose pharmacokinetics of dasatinib was assessed in 8 moderately hepatic-impaired subjects who received a 50 mg dose and 5 severely hepatic-impaired subjects who received a 20 mg dose compared to matched healthy subjects who received a 70 mg dose of dasatinib.
Maltese: L-effett ta' indeboliment tal-fwied fuq il-farmakokinetika ta' doża waħda ta' dasatinib, kien evalwat fi 8 pazjenti li kellhom indeboliment moderat tal-fwied li rċivew doża ta' 50 mg, u f'5 pazjenti li kellhom indeboliment sever tal-fwied li rċivew doża ta' 20 mg, meta mqabbla ma' persuni normali b'saħħithom li rċivew doża ta' 70 mg ta' dasatinib.
English: In the newly diagnosed chronic phase CML study, grade 3 or 4 hypophosphataemia was reported in 4% of SPRYCEL-treated patients, and grade 3 or 4 elevations of transaminases, creatinine, and bilirubin were reported in ≤ 1% of patients after a minimum of 12 months follow-up.
Maltese: Fl-istudju kliniku fuq pazjenti ddijanjostikati għall-ewwel darba b'CML fil-fażi kronika, kienet irrappurtata ipofosfatemija ta' grad 3 jew 4 f'4 % tal-pazjenti kkurati bi SPRYCEL u żidiet ta' grad 3 jew 4 ta' transaminases, kreatinina, u bilirubina kienu rrappurtati f'≤ 1 % tal-pazjenti wara minimu ta' 12-il xahar ta' follow-up.
English: In a supportive study, of 55 paediatric patients, 35 received SPRYCEL in combination with chemotherapy on a discontinuous dosing regimen (two weeks on treatment followed by one to two weeks off) and 20 received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Maltese: Fi studju ta' appoġġ, ta' 55 pazjent pedjatriku, 35 rċivew SPRYCEL flimkien ma' kimoterapija fuq reġimen ta' dożaġġ mhux kontinwu (ġimagħtejn fuq il-kura segwiti minn ġimgħa sa ġimagħtejn mingħajr kura) u 20 irċivew SPRYCEL flimkien ma' kimoterapija fuq reġimen tad-dożaġġ kontinwu.
English: SPRYCEL powder for oral suspension is also available for paediatric Ph+ CML-CP and Ph+ ALL patients, and adult CML-CP patients, who cannot swallow tablets.
Maltese: SPRYCEL trab għal sospensjoni orali huwa disponibbli wkoll għal Ph+ CML-CP pedjatrika u pazjenti b'Ph+ ALL, u pazjenti adulti b'CML-CP, li ma jistgħux jibilgħu pilloli sħaħ.
English: SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each, and in cartons containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: SPRYCEL 20 mg, 50 mg jew 70 mg pilloli miksija b'rita huma disponibbli f'kaxxa tal-kartun li jkun fiha 56 pillola miksija b'rita f'4 folji kalendarji ta' 14-il pillola miksija b'rita kull waħda, u f'kaxex talkartun li fihom 60 x 1 pillola miksija b'rita f'folji ta' doża waħda pperforati.
English: 120-mL high-density polyethylene bottle with polypropylene child-resistant closure containing 33 g of powder for oral suspension.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Flixkun ta' 120 mL ta' polietilen ta' densità għolja b'tapp tal-polypropylene reżistenti għat-tfal li fih 33 g ta' trab għal sospensjoni orali.
English: The once daily schedule demonstrated comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MaHR 0.8%; 95% confidence interval [-7.1% - 8.7%]); however, the 140 mg once daily regimen demonstrated improved safety and tolerability.
Maltese: L-iskeda ta' darba kuljum uriet effikaċja komparabbli (mhux inferjuri) ma l-iskeda ta' darbtejn kuljum fuq il-punt aħħari primarju ta l-effikaċja (differenza fil-MaHR 0.8 %; 95 % intervall ta' kunfidenza [-7.1 % - 8.7 %]); madankollu, il-kors ta' 140 mg darba kuljum wera sigurtà u tollerabbiltà mtejba.
English: • 20 mg daily for patients taking SPRYCEL 100 mg tablet daily.
Maltese: • 20 mg kuljum għal pazjenti li jkunu qed jieħdu SPRYCEL 100 mg pillola kuljum.
English: grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups.
Maltese: III, żidiet ta' grad 3 jew 4 ta' transaminases jew bilirubin ġew irrappurtati f'≤ 1 % tal-pazjenti b'inċidenza baxxa simili fl-erba' gruppi ta' trattament.
English: Each pack also contains a low-density polyethylene press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe (polypropylene syringe barrel with high-density polyethylene syringe plunger rod) in a sealed plastic bag.
Maltese: Kull pakkett fih ukoll adapter tal-flixkun li jingħalaq (PIBA, press-in-bottle adapter) ta' polietilen ta' densità baxxa u siringa tad-dożaġġ orali ta' 12 mL (parti ewlenija tas-siringa tal-polypropylene b'kamin tal-planġer tas-siringa ta' polietilen ta' densità għolja) f'borża tal-plastik issiġillata.
English: These medicines are not to be used with SPRYCEL: ketoconazole, itraconazole - these are antifungal medicines erythromycin, clarithromycin, telithromycin - these are antibiotics ritonavir - this is an antiviral medicine phenytoin, carbamazepine, phenobarbital - these are treaments for epilepsy rifampicin - this is a treatment for tuberculosis famotidine, omeprazole - these are medicines that block stomach acids St. John's wort - a herbal preparation obtained without a prescription, used to treat depression and other conditions (also known as Hypericum perforatum)
Maltese: Dawn il-mediċini m'għandhomx jintużaw ma' SPRYCEL: ketoconazole, itraconazole - dawn huma mediċini antifungali erythromycin, clarithromycin, telithromycin - dawn huma antibijotiċi ritonavir - din hija mediċina antivirali phenytoin, carbamazepine, phenobarbital - dawn huma trattamenti kontra l- epilessija rifampicin - dan huwa trattament għat- tuberkolożi famotidine, omeprazole - dawn huma mediċini li jimblukkaw l-aċidi ta' l-istonku St.
English: Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Maltese: Għalhekk, f'pazjenti li qed jieħdu dasatinib, għandhom jingħażlu prodotti mediċinali alternattivi li għandhom anqas possibbilta' li jinduċu CYP3A4 (ara sezzjoni 4.5).
English: Tests may show: abnormal blood test results and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell) in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in the brain, irregularity of the electrical activity of the heart, enlarged heart, inflammation of the liver, protein in the urine, raised creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), raised troponin (an enzyme mainly found in the heart and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver)
Maltese: It-testijiet jistgħu juru: riżultati ta' testijiet tad-demm mhux normali u possibbilment funzjoni indebolita tal-kliewi kkawżata mill-prodotti eliminati tat-tumur li jkun qiegħed imut (sindromu ta' liżi tat-tumur), livelli baxxi ta' albumina fid-demm, livelli baxxi ta' limfoċiti (tip ta' ċelloli bojod tad-demm) fid-demm, livell għoli ta' kolesterol fid-demm, nodi limfatiċi minfuħin, fsada fil-moħħ, irregolarità tal-attività elettrika tal-qalb, qalb minfuħa, infjammazzjoni tal-fwied, proteina fl-awrina, fosfokinażi tal-kreatina miżjuda (enzima li tinstab prinċipalment fil-qalb, filmoħħ u fil-muskoli skeletali), żieda fit-troponin (enzima li tinstab prinċipalment fil-qalb u filmuskoli skeletali), żieda fil-gamma-glutamyltransferase (enzima li tinstab prinċipalment filfwied)
English: Tablet core
Maltese: Infjammazzjoni tal-pulmun
English: Concomitant use of dasatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
Maltese: L-għoti fl-istess ħin ta' dasatinib ma' prodotti mediċinali li jinduċu CYP3A4 (eż. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital jew preparazzjonijiet li ġejjin mill-ħxejjex li fihom Hypericum perforatum, magħruf ukoll bħala St.
English: Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 1.9%; 95% confidence interval [-6.8% - 10.6%]); however, the
Maltese: L-effikaċja nkisbet fil-gruppi kollha ta' trattament b'dasatinib, bl-iskeda ta' darba kuljum li turi effikaċja komparabbli (mhux inferjuri) għall-iskeda ta' darbtejn kuljum fuq il-punt aħħari primarju ta' l-effikaċja (differenza fil-MCyR 1.9 %; 95 % intervall ta' kunfidenza [-6.8 % - 10.6
English: The non-clinical safety profile of dasatinib was assessed in a battery of in vitro and in vivo studies in mice, rats, monkeys, and rabbits.
Maltese: Il-profil tas-sigurtà mhux kliniku ta' dasatinib ġie vvalutat f'sensiela ta' studji in vitro u in vivo fi ġrieden, firien, xadini, u fniek.
English: Rare pulmonary embolism, acute respiratory distress syndrome
Maltese: Rari emboliżmu pulmonari, sindrome ta' problema respiratorja akuta Mhux magħrufa mard interstizjali tal-pulmun Disturbi gastro-intestinali
English: What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
Maltese: SPRYCEL 20 mg: il-pillola miksija b'rita tvarja minn bajda għal offwajt, bikonvessa, tonda b'“BMS” imnaqqxa fuq naħa u “527” fuq in-naħa l-oħra.
English: Table 4: Dose reduction for concomitant use of strong CYP3A4 inhibitors in paediatric patients
Maltese: Tabella 4: Tnaqqis fid-doża għal użu konkomitanti ta' inibituri qawwija ta' CYP3A4 f'pazjenti pedjatriċi
English: Dose reduction for concomitant use of strong CYP3A4 inhibitors
Maltese: Prodotti mediċinali oħra li jistimolaw l-attività ta' CYP3A4
English: Special handling instructions for SPRYCEL
Maltese: SPRYCEL sospensjoni orali jittieħed darba kuljum.
English: One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Maltese: Flixkun wieħed ta' trab għal sospensjoni orali fih 990 mg ta' dasatinib (bħala monidrat).
English: Dasatinib and its metabolites are minimally excreted via the kidney.
Maltese: Dasatinib u l-metaboliti tiegħu jitneħħew minimament permezz tal-kilwa.
English: In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, the median duration of treatment was 14 months for accelerated phase CML, 3 months for myeloid blast CML, 4 months for lymphoid blast CML and 3 months for Ph+ ALL.
Maltese: III f'pazjenti b'CML ta' fażi avanzata u Ph+ ALL, ilmedjan tat-tul ta' żmien tal-kura kien ta' 14-il xahar għal CML fil-fażi aċċellerata, 3 xhur għal CML bi blast majelodje, 4 xhur għal CML bi blast limfojde u 3 xhur għal Ph+ ALL.
English: In clinical studies, treatment with SPRYCEL in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient.
Maltese: Fl-istudji kliniċi, kura b'SPRYCEL f'adulti b'Ph+ CML-CP, CML aċċellerata, majelojd jew tal-fażi lymphoid blast (fażi avvanzata), jew Ph+ ALL u pazjenti pedjatriċi b'Ph+ CML-CP tkompliet salprogressjoni tal-marda jew sakemm ma baqgħetx tiġi ttollerata mill-pazjent.
English: SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water.
Maltese: SPRYCEL trab għal sospensjoni orali fih madwar 0.29 g/mL ta' sukrożju mal-kostituzzjoni mal-ilma.
English: See section 4.2 for the recommended starting dose.
Maltese: Ara sezzjoni 4.2 għad-doża rakkomandata tal-bidu.
English: These reduced doses of SPRYCEL are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.
Maltese: Dawn id-dożi mnaqqsa ta' SPRYCEL huma previsti li jaġġustaw l-erja taħt il-kurva (AUC) għallmedda osservata mingħajr inibituri ta' CYP3A4; madankollu, m'hemmx dejta klinika disponibbli b'dawn l-aġġustamenti fid-doża f'pazjenti li jirċievu inibituri qawwija ta' CYP3A4.
English: Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL).
Maltese: Huwa ta' min jinnota li responsi ematoloġiċi maġġuri (MaHR) intlaħaqu minnufih (ħafna minnhom fi żmien 35 jum mill-ewwel għoti ta' dasatinib għal pazjenti b'lymphoid blast CML, u fi żmien 55 jum għall-pazjenti b'Ph+ ALL).
English: Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib.
Maltese: Tnejn u erbgħin fil-mija tal-pazjenti reżistenti għal imatinib mingħajr MCyR preċedenti għal imatinib (n = 188) laħqu MCyR b'dasatinib.
English: 3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
Maltese: 3 Jekk platelets < 25 x 109/L u/jew ikun hemm rikorrenza ta' ANC ta' < 0.5 x 109/L għal > 7 ġranet, irrepeti numru 1 u erġa' ibda ttrattament b'doża mnaqqsa ta' 80 mg darba kuljum għat-tieni episodju.
English: Febrile neutropaenia Nausea
Maltese: SPRYCEL fih sukrożju
English: In animal studies, the fertility of male and female rats was not affected by treatment with dasatinib (see section 5.3).
Maltese: Fi studji f'annimali, il-fertilità tal-firien irġiel u nisa ma ġietx affettwata mit-trattament b'dasatinib (ara sezzjoni 5.3).
English: LIST OF EXCIPIENTS
Maltese: Doża oriġinali
English: Teл.
Maltese: XHUR
English: 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 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: SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side.
Maltese: SPRYCEL 50 mg: il-pillola miksija b'rita tvarja minn bajda għal offwajt, bikonvessa, ovali b'“BMS” imnaqqxa fuq naħa u “528” fuq in-naħa l-oħra.
English: If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected.
Maltese: Jekk ikun possibbli, għandha tintgħażel medikazzjoni konkomitanti blebda potenzjal tal-inibizzjoni tal-enzima jew b'wieħed minimu.
English: In rats, minimal to mild decreases in erythrocyte parameters were accompanied by bone marrow changes; similar changes occurred in monkeys at a lower incidence.
Maltese: Fil-firien, tnaqqis minimu għal ħafif f'parametri eritroċiti kien akkompanjat b'bidliet fil-mudullun; tibdil simili seħħ f'xadini f'inċidenza iktar baxxa.
English: The following adverse reactions, excluding laboratory abnormalities, were reported in patients treated with SPRYCEL used as single-agent therapy in clinical studies and post-marketing experience (Table 5).
Maltese: Ir-reazzjonijiet avversi li ġejjin, li jeskludu anormalitajiet tal-laboratorju, kienu rrappurtati f'pazjenti kkurati b'SPRYCEL li ntuża bħala terapija b'aġent uniku fl-istudji kliniċi u mill-esperjenza ta' wara ta' wara t-tqegħid fis-suq (Tabella 5).
English: After 60 months of follow-up, median time to cCCyR was 3.1 months in the SPRYCEL group and 5.8 months in the imatinib group in patients with a confirmed CCyR.
Maltese: Wara 60 xahar ta' follow-up, iż-żmien medjan għal cCCyR kien ta' 3.1 xhur fil-grupp ta' SPRYCEL u 5.8 xhur fil-grupp ta' imatinib f'pazjenti b'CCyRa kkonfermat.
English: In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 27 months.
Maltese: Fl-istudju ta' Fażi I, ir-responsi ematoloġiċi u ċitoġenetiċi ġew osservati f'kull fażi ta' CML u f'Ph+ ALL fl-ewwel 84 pazjent li ngħataw it-trattament u li kienu segwiti għal 27 xahar.
English: Table 13: Long term efficacy of SPRYCEL in phase 3 dose optimisation study: imatinib resistant or intolerant chronic phase CML patientsa Minimum follow-up period
Maltese: Tabella 13: Effikaċja fit-tul ta' SPRYCEL fi studju ta' ottimizzazzjoni tad-doża ta' fażi 3: pazjenti b'CML fil-fażi kronika reżistenti jew intolleranti għal imatinib a Perjodu minimu ta' follow-up sena sentejn