FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with BCR-ABL ≤ 10% at 3 months
Maltese: Pazjenti b'BCR-ABL ≤ 10 % wara 3 xhur
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets
Maltese: FARMAĊEWTIKA U KONTENUT 30 x 1 pillola miksijin b'rita
English: Daily Dose, mL (mg)
Maltese: Doża ta' kuljum, mL (mg)
English: Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year
Maltese: (%; stimi Kaplan-Meier) Ħielsa minn progressjoni sena sentejn Ġenerali sena sentejn
English: Summary of the safety profile The data described below reflect the exposure to SPRYCEL as single-agent therapy at all doses tested in clinical studies (N=2,900), including 324 adult patients with newly diagnosed chronic phase CML, 2,388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 188 paediatric patients.
Maltese: Id-dejta deskritta hawn taħt tirrifletti l-esponiment għal SPRYCEL bħala terapija b'aġent uniku biddożi kollha li ġew ittestjati fl-istudji kliniċi (N=2,900), inkluż 324 pazjent adult b'dijanjożi għallewwel darba ta' CML ta' fażi kronika, 2,388 pazjent adult b'CML kronika jew ta' fażi avvanzata reżistenti jew intolleranti għal imatinib jew b'Ph+ ALL, u 188 pazjent pedjatriku.
English: In the Phase II paediatric study, in patients receiving the tablet formulation, estimated 24-month PFS rate among the 51 patients with newly diagnosed CML-CP was 94.0% (82.6, 98.0), and 81.7% (61.4, 92.0) among the 29 patients with imatinib-resistant/intolerant CML-CP. After 24 months of follow-up, OS in newly diagnosed patients was 100%, and 96.6% in imatinib-resistant or intolerant patients.
Maltese: II, f'pazjenti li rċivew il-formulazzjoni tal-pillola, ir-rata ta' PFS ta' 24 xahar stmata fost il-51 pazjent b'CML-CP iddijanjostikata għall-ewwel darba kienet 94.0 % (82.6, 98.0), u 81.7 % (61.4, 92.0) fost id-29 pazjent b'CML-CP reżistenti/intolleranti għal imatinib.
English: In clinical studies in patients with advanced phase CML receiving the recommended dose of SPRYCEL (n=304), severe central nervous system (CNS) haemorrhage occurred in 1% of patients.
Maltese: Fi studji kliniċi f'pazjenti b'CML f'fażi avvanzata li kienu qegħdin jirċievu d-doża rakkomandata ta' SPRYCEL (n = 304), emorraġija severa tas-sistema nervuża ċentrali (CNS) ġrat f'1 % tal-pazjenti.
English: Haematologic response rateb (%) MaHR (95% CI)
Maltese: Rata ta' rispons ematoloġikab (%) MaHR (95 % CI)
English: SPRYCEL contains the active substance dasatinib.
Maltese: SPRYCEL fih is-sustanza attiva dasatinib.
English: Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 135.0 mg ta' lactose monohydrate.
English: Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma
Maltese: Komuni edema pulmonari*, pressjoni tad-demm pulmonari għolja*, infiltrazzjoni fil-pulmun, pnewmonite, sogħla
English: MCyR (95% CI) Newly diagnosed (N = 51)a
Maltese: MCyR (95 % CI) Iddijanjostikati għall-ewwel darba (N = 51)a
English: SPRYCEL 20 mg tablets dasatinib
Maltese: SPRYCEL 20 mg pilloli dasatinib
English: By 3 years 67%, p<.0055
Maltese: Sa 3 snin p < .0055
English: A total of 670 patients, of whom 497 were imatinib-resistant, were randomised to the dasatinib 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily group.
Maltese: Total ta' 670 pazjent, li minnhom 497 kienu reżistenti għal imanitib, ġew magħżula b'mod każwali għall-grupp ta' dasatinib 100 mg darba kuljum, 140 mg darba kuljum, 50 mg darbtejn kuljum, jew 70 mg darbtejn kuljum.
English: CCyRb within 24 months cCCyRa CCyRb within 36 months cCCyRa CCyRb within 48 months cCCyRa CCyRb within 60 months cCCyRa CCyRb Major molecular responsec
Maltese: CCyRb fi żmien 48 xahar cCCyRa CCyRb fi żmien 60 xahar cCCyRa
English: How to store SPRYCEL 6.
Maltese: Kif taħżen SPRYCEL 6.
English: This medicinal product contains 2.1 mg sodium per mL of SPRYCEL oral suspension.
Maltese: Dan il-prodott mediċinali fih 2.1 mg sodju għal kull mL ta' SPRYCEL sospensjoni orali.
English: By 4 years 34%, p<.0055
Maltese: Sa 4 snin p < .0055
English: The proportion of patients achieving BCR-ABL ratio of ≤0.0032% (4.5-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (44% versus 34%).
Maltese: 0032 % (tnaqqis 4.5-log) fi kwalunkwe żmien kien ogħla fil-grupp ta' SPRYCEL meta mqabbel mal-grupp ta' imatinib (44 % kontra 34 %).
English: d Excludes gastrointestinal bleeding and CNS bleeding; these adverse reactions are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively.
Maltese: d Jeskludi ħruġ ta' demm gastrointestinali u ħruġ ta' demm fis-SNĊ; dawn ir-reazzjonijiet avversi huma rrappurtati taħt is sistema tal-klassi tal-organi ta' disturbi gastrointestinali u s-sistema tal-klassi tal-organi ta' disturbi fis-sistema nervuża, rispettivament.
English: Dasatinib may be resumed at the original dose for mild/moderate adverse reactions (≤ grade 2) and resumed at a dose level reduction for severe adverse reactions (≥ grade 3) (see section 4.2).
Maltese: Dasatinib jista' jitkompla fid-doża oriġinali għal reazzjonijiet avversi ħfief/moderati (≤ grad 2) u jitkompla bi tnaqqis fil-livell ta' doża għal reazzjonijiet avversi severi (≥ grad 3) (ara sezzjoni 4.2).
English: Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Maltese: Rari xokk anafilattiku Disturbi fis-sistema endokrinarja
English: Dasatinib PK showed dose proportionality with a dose-related increase in exposure observed in paediatric patients.
Maltese: Il-PK ta' dasatinib uriet ilproporzjonalità tad-doża b'żieda relatata mad-doża f'esponiment osservat f'pazjenti pedjatriċi.
English: Each film-coated tablet contains 108 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 108 mg ta' lactose monohydrate.
English: Results are shown in Table 15.
Maltese: Tabella 15:
English: • 40 mg daily for patients taking SPRYCEL 140 mg tablet daily.
Maltese: • 40 mg kuljum għal pazjenti li jkunu qed jieħdu SPRYCEL 140 mg pillola kuljum.
English: 56 film-coated tablets 60 x 1 film-coated tablets 60 film-coated tablets
Maltese: 56 pillola miksijin b'rita 60 x 1 pillola miksijin b'rita 60 pillola miksijin b'rita
English: Cardiac adverse reactions
Maltese: Reazzjonijiet kardijaċi avversi
English: Table 7: Adverse reactions reported in ≥10% of paediatric patients with Ph+ ALL treated with SPRYCEL on a continuous dosing regimen in combination with chemotherapy (N=126)a
Maltese: Reazzjonijiet avversi rrappurtati f'≥10% tal-pazjenti pedjatriċi b'Ph+ ALL ikkurati b'SPRYCEL fuq reġimen tad-dożaġġ kontinwu flimkien ma' kimoterapija (N=126)a
English: Chronic phase CML - Resistance or intolerance to prior imatinib therapy
Maltese: CML fil-fażi kronika - Reżistenza jew intolleranza għal terapija b'imatinib fil-passat
English: After constitution The oral suspension is stable for 60 days.
Maltese: Is-sospensjoni orali hija stabbli għal 60 jum.
English: d Major molecular response criteria: Defined as BCR-ABL/control transcripts ≤0.1% by RQ-PCR in peripheral blood samples
Maltese: c Rispons molekulari maġġuri (fi kwalunkwe ħin) kien definit bħala proporzjonijiet ta' BCR-ABL ≤ 0.1 % minn RQ-PCR
English: After a minimum of 60 months follow-up the cumulative rate of grade 3 or 4 hypophosphataemia was 7%, grade 3 or 4 elevations of creatinine and bilirubin was 1% and grade 3 or 4 elevations of transaminases remained 1%.
Maltese: Wara minimu ta' 60 xahar ta' follow-up ir-rata kumulattiva ta' ipofosfatemija ta' grad 3 jew 4 kienet ta' 7 %, żidiet ta' grad 3 jew 4 ta' kreatinina u bilirubina kienu ta' 1 % u żidiet ta' grad 3 jew 4 ta' transaminases baqgħu 1 %.
English: Step 4: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 60 days from the date of constitution).
Maltese: Pass 4: Ikteb id-data ta' skadenza tas-sospensjoni orali kkostitwita fuq it-tikketta tal-flixkun (id-data ta' skadenza tas-sospensjoni orali kkostitwita hija 60 jum mid-data tal-kostituzzjoni).
English: Each film-coated tablet contains 27 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 27 mg ta' lactose monohydrate.
English: CCyR (95% CI) Newly diagnosed (N = 51)a
Maltese: CCyR (95 % CI) Iddijanjostikati għall-ewwel darba (N = 51)a
English: Second dose (mL)
Maltese: It-tieni doża (mL)
English: By 2 years 19%, p<.0008
Maltese: Sa 2 snin p < .0008
English: Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Maltese: Għalhekk, wieħed għandu joqgħod attent meta dasatinib jingħata flimkien ma' sottostrat ta' CYP3A4 b'indiċi terawpetiku dejjaq, bħalma huma astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew alkolojdi tal-ergot (ergotamine, dihydroergotamine) (ara sezzjoni 4.5).
English: SPRYCEL 50 mg tablets dasatinib
Maltese: SPRYCEL 50 mg pilloli dasatinib
English: MCyR All patients Imatinib-resistant patients CCyR All patients Imatinib-resistant patients Major molecular response in patients achieving CCyRd (%) (95% CI)
Maltese: MCyR Il-pazjenti kollha Pazjenti reżistenti għal imatinib CCyR Il-pazjenti kollha Pazjenti reżistenti għal imatinib Rispons molekulari maġġuri f'pazjenti li kisbu CCyRd (%) (95 % CI)
English: The rates of MCyR at 2 years were similar whether patients had any baseline BCR-ABL mutation, P-loop mutation, or no mutation (63%, 61% and 62%, respectively).
Maltese: Ir-rati ta' MCyR wara sentejn kienu simili kemm jekk il-pazjenti kellhom xi mutazzjoni BCR-ABL tal-linja bażi, mutazzjoni P-loop, jew ebda mutazzjoni (63 %, 61 % u 62 %, rispettivament).
English: The pharmacokinetics of dasatinib have been evaluated in 104 paediatric patients with leukaemia or solid tumours (72 who received the tablet formulation and 32 who received the powder for oral suspension).
Maltese: Il-farmakokinetika ta' dasatinib ġiet evalwata f'104 pazjenti pedjatriċi b'lewkimja jew tumuri solidi (72 li rċivew il-formulazzjoni tal-pillola u 32 li rċivew it-trab għal sospensjoni orali).
English: A different spectrum of mutation was detected in the imatinib treatment arm. Dasatinib does not appear to be active against the T315I mutation, based on in vitro data.
Maltese: Ma jidhirx li dasatinib hu attiv kontra l-mutazzjoni T315I, ibbażat fuq dejta in vitro.
English: 2 Resume treatment at the original starting dose.
Maltese: 2 Erġa' ibda t-trattament bid-doża oriġinali talbidu.
English: An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib.
Maltese: Sar studju open-label, single-arm, f'aktar minn ċentru wieħed f'pazjenti intolleranti jew reżistenti għal imatinib.
English: A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Maltese: MCyR minn qabel għal imatinib kien miksub fi 28 % u 29 % talpazjenti fil-fergħat ta' dasatinib u imatinib, rispettivament.
English: The proportion of patients who maintained MCyR for 18 months was 90% (95% CI: [82%-98%]) for dasatinib (CCyR 94%, 95% CI: [87%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
Maltese: Il-proporzjon ta' pazjenti li żammew MCyR għal 18-il xahar kien 90 % (95 % CI: [82 %-98 %]) għal dasatinib (CCyR 94 %, 95 % CI: [87 %-100 %]) u 74 % (95 % CI: [49 %-100 %]) għal imatinib (CCyR 100 %).
English: In this population of patients who received 100 mg once daily, MCyR was achieved in 77% and CCyR in 67%.
Maltese: F'din il-popolazzjoni ta' pazjenti li rċivew 100 mg darba kuljum, MCyR inkiseb f'77 % u CCyR f'67 %.
English: The concomitant use of strong CYP3A4 inhibitors and grapefruit juice with SPRYCEL should be avoided (see section 4.5).
Maltese: L-użu konkomitanti ta' inibituri qawwija ta' CYP3A4 u meraq tal-grejpfrut ma' SPRYCEL għandu jiġi evitat (ara sezzjoni 4.5).
English: In vivo, in separate experiments using murine models of CML, dasatinib prevented the progression of chronic CML to blast phase and prolonged the survival of mice bearing patient-derived CML cell lines grown at various sites, including the central nervous system.
Maltese: In vivo, f'esperimenti separati bl-użu ta' mudelli tal-ġrieden ta' CML, dasatinib impedixxa l-iżvilupp ta' CML kronika għall-fażi splussiva u tawwal is-sopravivenza tal-ġrieden li kellhom linji ta' ċelloli b'CML meħudin minn pazjenti u mkabbra f'siti differenti, inkluża is-sistema nervuża ċentrali.
English: b CA180-034 study results in recommended starting dose of 100 mg once daily.
Maltese: b Riżultati tal-istudju CA180-034 fid-doża tal-bidu rakkomandata ta' 100 mg darba kuljum.
English: No clinically relevant age-related pharmacokinetic differences have been observed in these patients.
Maltese: Ma ġew osservati ebda differenzi farmakokinetiċi klinikament rilevanti relatati mal-età f'dawn ilpazjenti.
English: Grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% of patients with chronic phase CML (resistant or intolerant to imatinib), but elevations were reported with an increased frequency of 1 to 7% of patients with advanced phase CML and Ph+ ALL.
Maltese: Żidiet ta' grad 3 jew 4 ta' transaminażi jew bilirubin ġew irrappurtati f'1 % tal-pazjenti b'CML b'fażi kronika (reżistenti jew intolleranti għal imatinib) imma ż-żidiet kienu rapportati wkoll bi frekwenza ogħla ta' 1 sa 7 % ta' pazjenti b'CML fil-fażi avvanzata u Ph+ ALL.
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 0800 0752002 (+49 (0)89 121 42 350)
Maltese: KGaA Tel: + 0800 0752002 (+49 (0)89 121 42 350)
English: Imatinib-intolerant patients
Maltese: Pazjenti intolleranti għal Imatinib
English: Mean Tmax was observed between 0.5 and 6 hours and mean half-life ranged from 2 to 5 hours across all dose levels and age groups.
Maltese: It-Tmax medju ġie osservat bejn 0.5 u 6 sigħat u l- u n-nofs ħajja medja varjat minn sagħtejn sa 5 sigħat fil-livelli tad-doża u fil-gruppi tal-età kollha.
English: Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI: [85%-100%]) for dasatinib (CCyR 97%, 95% CI: [92%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
Maltese: Abbażi ta' l-istimi Kaplan-Meier, il-proporzjon ta' pazjenti li żammew MCyR għal sena kien 92 % (95 % CI: [85 %-100 %]) għal dasatinib (CCyR 97 %, 95 % CI: [92 %-100 %]) u 74 % (95 % CI: [49 %-100 %]) għal imatinib (CCyR 100 %).
English: The proportion of patients who maintained CCyR for 1 year was 97% (95% CI: [94%-99%]) and for 2 years was 90% (95% CI: [86%-95%]).
Maltese: Il-proporzjon ta' pazjenti li żammew CCyR għal sena kien 97 % (95 % CI: [94 %-99 %]) u għal sentejn kien ta' 90 % (95 % CI: [86 %-95 %]).
English: The median duration of dasatinib-related pleural effusion (all grades) was 283 days (~40 weeks).
Maltese: It-tul ta' żmien medjan ta' effużjoni plewrali relatata ma' dasatinib (il-gradi kollha) kien ta' 283 ġurnata (~40 ġimgħa).
English: The safety profile of SPRYCEL administered as single-agent therapy in paediatric patients with Ph+ CML-CP was comparable to the safety profile in adults.
Maltese: Il-profil tas-sigurtà ta' SPRYCEL mogħti bħala terapija ta' aġent uniku fil-pazjenti pedjatriċi b'Ph+ CML-CP kien komparabbli mal-profil tas-sigurtà fl-adulti.
English: SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia 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' Philadelphia chromosome positive (Ph+) lewkemija majeloġena kronika fil-fażi kronika (Ph+ CML-CP) jew Ph+ CML-CP reżistenti jew intolleranti għal terapija preċedenti inkluż imatinib. dijanjożi għall-ewwel darba ta' lewkimja limfoblastika akuta (ALL) Ph+ flimkien ma' kimoterapija.
English: Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 94.5 mg ta' lactose monohydrate.
English: Uncommon neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome, hair disorder
Maltese: Mhux komuni dermatosi newtrofilika, sensittività għad-dawl, disturbi fil-pigmentazzjoni, pannikulite, ulċera fil-ġilda, kundizzjonijiet bullosi, disturbi fid-dwiefer, sindrome taleritrodisestesija palmar-plantar, disturb fix-xagħar
English: The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks).
Maltese: Iż-żmien medjan sal-ewwel okkorrenza ta' effużjoni plewrali ta' grad ≥ 3 relatata ma' dasatinib kien ta' 175 ġimgħa (medda: 114 sa 274 ġimgħa).
English: A total of 46 dasatinib-treated patients had recurrent pleural effusions.
Maltese: Total ta' 46 pazjent li ngħataw dasatinib kellhom effużjonijiet plewrali rikorrenti.
English: Treatment with dasatinib is associated with anaemia, neutropaenia and thrombocytopaenia.
Maltese: It-trattament b'dasatinib hu assoċjat ma' anemija, newtropenja u tromboċitopenja.
English: Outer Carton: sprycel 20 mg
Maltese: Sprycel 20 mg
English: Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder
Maltese: Komuni ħruġ ta' demm gastrointestinali*, kolite (li tinkludi kolite newtropenika), gastrite, infjammazzjoni fil-mukuża (li tinkludi mukożite/stomatite), dispepsja, nefħa addominali, stitikezza, disturb fit-tessut artab tal-ħalq
English: j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema mouth, orbital oedema, periorbital oedema, swelling face.
Maltese: j Edima konġuntivali, edima fl-għajnejn, nefħa fl-għajnejn, edima fil-kappell tal-għajnejn, edima fil-wiċċ, edima fixxufftejn, edima makulari, edima fil-ħalq, edima orbitali, edima periorbitali, nefħa fil-wiċċ.
English: Each film-coated tablet contains 67.5 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 67.5 mg ta' lactose monohydrate.
English: Outer Carton: sprycel 70 mg
Maltese: Sprycel 70 mg
English: SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets dasatinib
Maltese: SPRYCEL 20 mg pilloli miksija b'rita SPRYCEL 50 mg pilloli miksija b'rita SPRYCEL 70 mg pilloli miksija b'rita SPRYCEL 80 mg pilloli miksija b'rita SPRYCEL 100 mg pilloli miksija b'rita SPRYCEL 140 mg pilloli miksija b'rita dasatinib
English: Fluid retention adverse reactions were typically managed by supportive care measures that include diuretics and short courses of steroids (see sections 4.2 and 4.8).
Maltese: Reazzjonijiet avversi ta' akkumulazzjoni ta' fluwidi kienu tipikament ikkontrollati b'miżuri ta' kura t'appoġġ li jinkludu pilloli dijuretiċi u korsijiet qosra ta' sterojdi (ara sezzjonijiet 4.2 u 4.8).
English: Among imatinib-intolerant patients, the estimated rate of PFS was 98% (95% CI: [95%-100%]) at 1 year and 94% (95% CI: [88%-99%]) at 2 years.
Maltese: Fost il-pazjenti intolleranti għal imatinib, irrata stmata ta' PFS kienet ta' 98 % (95 % CI: [95 %-100 %]) wara sena u 94 % (95 % CI: [88 %-99 %]) wara sentejn.
English: There is limited experience with the use of SPRYCEL in this age group.
Maltese: Hemm esperjenza limitata fuq l-użu ta' SPRYCEL f'dan il-grupp t'età.
English: Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Maltese: Ph+ lewkimja limfoblastika akuta (ALL) u lymphoid blast CML b'reżistenza jew intolleranza għal terapija li tkun saret qabel.
English: The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated.
Maltese: L-effett tal-waqfien tattrattament fuq l-eżitu fit-tul tal-marda wara li ntlaħaq rispons ċitoġeniku jew molekulari [li jinkludi respons ċitoġenetiku komplet (CCyR), rispons molekulari maġġuri (MMR) u MR4.5] ma ġiex investigat.
English: Concomitant use of dasatinib and medicinal products or substances that potently inhibit CYP3A4 (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice) may increase exposure to dasatinib.
Maltese: L-użu ta' dasatinib flimkien ma' prodotti mediċinali jew sustanzi li b'mod qawwi jinibixxu CYP3A4 (eż. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, meraq tal-grejpfrut) jista' jżid l-espożizzjoni għal dasatinib.
English: Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Maltese: Bi trattament u follow-up itwal (medjan ta' 24 xahar), inkiseb MCyR fi 53 % tal-pazjenti ttrattati b'dasatinib (CCyR f'44 %) u 33 % tal-pazjenti ttrattati b'imatinib (CCyR fi 18 %) qabel il- crossover.
English: ANC: absolute neutrophil count *lower tablet dose not available
Maltese: ANC: għadd assolut ta' newtrofili *doża ta' pilloli aktar baxxa mhijiex disponibbli
English: SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets Alu/Alu blisters (calendar blisters or perforated unit dose blisters).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih SPRYCEL 20 mg, SPRYCEL 50 mg u SPRYCEL 70 mg pilloli miksija b'rita Folji tal-Alu/Alu (folji indikati bil-ġranet jew folji perforati ta' doża waħda).
English: In paediatric trials of SPRYCEL in imatinib-resistant/intolerant Ph+ CML-CP paediatric patients and treatment-naive Ph+ CML-CP paediatric patients after at least 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 6 (4.6%) patients, one of which was severe in intensity (Growth Retardation Grade 3).
Maltese: Fi provi pedjatriċi ta' SPRYCEL f'pazjenti pedjatriċi b'Ph+ CML-CP reżistenti/intolleranti għal imatinib u f'pazjenti pedjatriċi b'Ph+ CML-CP li qatt ma kienu rċivew kura qabel wara tal-inqas sentejn ta' kura, ġew irrappurtati avvenimenti avversi relatati mal-kura bi tkabbir u żvilupp tal-għadam f'6 (4.6%) pazjenti, li wieħed minnhom kien sever fl-intensità (Dewmien fit-Tkabbir ta' Grad 3).
English: OUTER CARTON AND LABEL FOR BOTTLE PACK OUTER CARTON FOR BLISTER PACK
Maltese: IL-KARTUNA TA' BARRA T-TIKKETTA GĦALL-PAKKETT TAL-FLIXKUN
English: In the 2,712 adult patients with either chronic phase CML, advanced phase CML or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months).
Maltese: Fl-2,712-il pazjent adulti b'jew CML f'fażi kronika, avvanzata jew Ph+ ALL, it-tul medjan tat-terapija kien ta' 19.2 xhur (medda 0 sa 93.2 xhur).
English: This medicine is used to treat chronic myeloid leukaemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adolescents and children from at least one year of age.
Maltese: Din il-mediċina tintuża biex tikkura l-lewkimja kronika talmajelojd (CML) u l-lewkimja limfoblastika akuta (ALL) b'Philadelphia chromosome positive (Ph+) fl-adulti u tfal ta' mill-inqas età ta' sena.
English: Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis
Maltese: Mhux komuni rabdomijolosi, osteonekrożi, infjammazzjoni tal-muskoli, tendonite, artrite
English: SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
Maltese: SPRYCEL 140 mg pilloli miksija b'rita EU/1/06/363/015