FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib).
Maltese: Barra minn hekk, 46 pazjent b'Ph+ ALL irċevew dasatinib 70 mg darbtejn kuljum (44 reżistenti u 2 intolleranti għal imatinib).
English: A total of 43% of the patients in the dasatinib arm, and 82% in the imatinib arm had treatment failure, defined as disease progression or cross-over to the other treatment (lack of response, intolerance of study medicinal product, etc.).
Maltese: Total ta' 43 % tal-pazjenti fil-fergħa ta' dasatinib, u 82 % fil-fergħa ta' imatinib ma ħadimx ittrattament fuqhom, definit bħala progress tal-marda jew cross-over għat-trattament l-ieħor (nuqqas ta' rispons, intolleranza għall-prodott mediċinali li kien qed jiġi studjat, eċċ.).
English: BSA).
Maltese: għolja).
English: SPRYCEL contains benzyl alcohol
Maltese: SPRYCEL fih alkoħol benżiliku
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew talmediċini.
English: Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up.
Maltese: Effużjoni perikardijaka Edima pulmonari Emorraġija Fsada gastrointestinali a Riżultati tal-istudju ta' ottimizzazzjoni tad-doża ta' fażi 3 rrappurtati fil-popolazzjoni li ħadet id-doża tal-bidu rakkomandata ta' 140 mg darba kuljum (n = 304) fil-follow up finali ta' sentejn għall-istudju.
English: Outer Carton: sprycel 80 mg
Maltese: Sprycel 80 mg
English: In the Phase III newly diagnosed chronic phase CML study, the following grade 3 or 4 laboratory abnormalities were reported after a minimum of 12 months follow-up in patients taking SPRYCEL: neutropaenia (21%), thrombocytopaenia (19%), and anaemia (10%).
Maltese: III f'pazjenti ddijanjostikati għall-ewwel darba b'CML fil-fażi kronika, lanormalitajiet tal-laboratorju ta grad 3 jew 4, li ġejjin kienu rrappurtati wara minimu ta' 12-il xahar ta' follow-up f'pazjenti li kienu qed jieħdu SPRYCEL: newtropenija (21 %), tromboċitopenija (19 %), u anemija (10 %).
English: Response rate (95% CI)
Maltese: Rata ta' rispons (95 % CI)
English: A bioequivalence study evaluating the powder for oral suspension to the reference tablet formulation in 77 adult patients showed that the exposure for the powder for oral suspension was 19% less than that of reference tablets.
Maltese: Studju ta' bijoekwivalenza li evalwa t-trab għal sospensjoni orali għall-formulazzjoni tal-pillola ta' referenza f'77 pazjent adult wera li l-esponiment għat-trab għal sospensjoni orali kien 19 % inqas minn dak tal-pilloli ta' referenza.
English: Active substances that may decrease dasatinib plasma concentrations When dasatinib was administered following 8 daily evening administrations of 600 mg rifampicin, a potent CYP3A4 inducer, the AUC of dasatinib was decreased by 82%.
Maltese: Sustanzi attivi li jistgħu jnaqqsu l-konċentrazzjonijiet ta' dasatinib fil-plażma Meta dasatinib ngħata wara tmint ijiem ta' għoti kuljum ta' kull filgħaxija ta' 600 mg rifampicin, li jinduċi b'mod qawwi CYP3A4, l-AUC ta' dasatinib naqset bi 82 %.
English: Among imatinib-resistant patients, the estimated rate of PFS was 88% (95% CI: [84%-92%]) at 1 year and 75% (95% CI: [69%-81%]) at 2 years.
Maltese: Fost il-pazjenti reżistenti għal imatinib, ir-rati stmati ta' PFS kienu ta' 88 % (95 % CI: [84 %-92 %]) wara sena u 75 % (95 % CI: [69 %-81 %]) wara sentejn.
English: The cumulative rate of dasatinib-related pleural effusion (all grades) over time was 10% at 12 months, 14% at 24 months, 19% at 36 months, 24% at 48 months and 28% at 60 months.
Maltese: Ir-rata kumulattiva ta' effużjoni plewrali relatata ma' dasatinib (il-gradi kollha) maż-żmien kienet ta' 10 % wara 12-il xahar, 14 % wara 24 xahar, 19 % wara 36 xahar, 24 % wara 48 xahar u 28 % wara 60 xahar.
English: Of the 126 Ph+ ALL paediatric patients on a continuous dosing regimen, 2 (1.6%) experienced adverse reactions leading to treatment discontinuation.
Maltese: Fost il-126 pazjent pedjatriku b'Ph+ ALL fuq reġimen ta' dożaġġ kontinwu, 2 (1.6%) esperjenzaw reazzjonijiet avversi li wasslu għal interruzzjoni tal-kura.
English: Table 4: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Maltese: Tabella 4: Aġġustamenti fid-doża għal newtropenja u tromboċitopenja f'pazjenti pedjatriċi b'Ph+ CML-CP
English: SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
Maltese: SPRYCEL 70 mg pilloli miksija b'rita EU/1/06/363/006
English: Diarrhoea Fluid retention Superficial oedema Pleural effusion Generalised oedema Pericardial effusion Pulmonary hypertension Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported in recommended starting dose of 100 mg once daily (n=165) population
Maltese: Żamma ta' fluwidu Edima superfiċjali Effużjoni plewrali Edima ġeneralizzata Effużjoni perikardijaka Pressjoni għolja pulmonari Emorraġija Fsada gastrointestinali a Riżultati tal-istudju ta' ottimizzazzjoni tad-doża ta' fażi 3 rrappurtati fil-popolazzjoni (n = 165) b'doża tal-bidu rakkomandata ta' 100 mg darba kuljum
English: No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration > 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Maltese: Ma sarux studji kliniċi bi SPRYCEL f'pazjenti b'funzjoni renali imnaqqsa (l-istudju fuq pazjenti ddijanjostikati għall-ewwel darba b'CML fil-fażi kronika eskluda pazjenti b'konċentrazzjoni ta' kreatinina fis-serum ta' > 3 darbiet tal-ogħla limitu tal-medda normali, u studji fuq pazjenti b'CML filfażi kronika b'reżistenza jew intolleranza għal terapija b'imatinib fil-passat eskluda pazjenti b'konċentrazzjoni tal-kreatinina fis-serum > 1.5 darbiet l-ogħlalimitu tal-medda normali).
English: By 3 years 24%, p<.0013
Maltese: Sa 3 snin p < .0013
English: Unchanged dasatinib accounted for 0.1% and 19% of the dose in urine and faeces, respectively, with the remainder of the dose as metabolites.
Maltese: Dasatinib mhux mibdul ammonta għal 0.1 % u 19 % tad-doża fl-awrina u fl-ippurgar, rispettivament, bil-bqija tad-doża bħala metaboliti.
English: In clinical studies in patients with advanced phase CML or Ph+ ALL receiving SPRYCEL at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively.
Maltese: Fi studji kliniċi f'pazjenti b'CML f'fażi avvanzata jew b'Ph+ ALL li kienu qegħdin jirċievu SPRYCEL bid-doża rakkomandata (n = 304), retenzjoni tal-fluwidi ta' grad 3 jew 4 ġiet irrappurtata fi 8 % tal-pazjenti, inkluż effużjoni plewrali u perikardjali ta' grad 3 jew 4 rrappurtati f'7 % u f'1 % tal-pazjenti, rispettivament.
English: There were 33 newly diagnosed paediatric patients with CML-CP who received SPRYCEL powder for oral suspension at a dose of 72 mg/m2.
Maltese: Kien hemm 33 pazjent pedjatriku ddijanjostikati għall-ewwel darba b'CML-CP li rċivew SPRYCEL trabb għal sospensjoni orali b'doża ta' 72 mg/m2.
English: No studies have been performed to evaluate dasatinib interaction with other protein-bound medicinal products.
Maltese: Ma surux studji li jevalwaw l-interazzjoni ta' dasatinib ma' prodotti mediċinali oħra mwaħħlin mal-proteini.
English: In 865 patients with leukaemia treated with dasatinib in Phase II clinical studies, the mean changes from baseline in QTc interval using Fridericia's method (QTcF) were 4 - 6 msec; the upper 95% confidence intervals for all mean changes from baseline were < 7 msec (see section 4.8).
Maltese: II, il-bidliet medji mil-linja bażi fl-intervall QTc bl-użu tal-metodu Fridericia (QTcF) kienu 4 - 6 msec; l-intervalli ta' kunfidenza ta' aktar minn 95 % għall-bidliet medji kollha mil-linja bażi kienu < 7 msec (ara sezzjoni 4.8).
English: Durability of response and estimated survival rates provide additional evidence of dasatinib clinical benefit.
Maltese: Id-durabilità tar-rispons u r-rati stmati ta' sopravivenza jipprovdu evidenza addizzjonali tal-benefiċċju kliniku ta' dasatinib.
English: SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: SPRYCEL 80 mg, 100 mg jew 140 mg pilloli miksija b'rita huma disponibbli f'kaxxi tal-kartun li fihom 30 x 1 pillola miksija b'rita f'folji perforati b'doża waħda.
English: 2 If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose.
Maltese: 2 Jekk iċ-ċitopenja ma tkunx relatata mallewkimja, waqqaf it-trattament sakemm ANC ≥ 1.0 x 109/L u platelets ≥ 20 x 109/L u erġa' ibda bid-doża oriġinali tal-bidu.
English: Therefore, CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving dasatinib (see section 4.4).
Maltese: Għalhekk, sottostrati ta' CYP3A4 magħrufa li għandhom indiċi terawpetiku dejjaq (eż. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew alkalojdi tal-ergot [ergotamine, dihydroergotamine]) għandhom jingħataw b'kawtela lill-pazjenti li qed jirċievu dasatinib (ara sezzjoni 4.4).
English: Prior complete haematologic response (CHR) to imatinib was
Maltese: Rispons ematoloġiku komplet (CHR) (CML kronika):
English: One patient (< 1%) in each group experienced a QTcF > 500 msec.
Maltese: Pazjent wieħed (< 1 %) f'kull grupp kellu QTcF ta' > 500 msek.
English: Outer Carton: sprycel 100 mg
Maltese: Sprycel 100 mg
English: Outer Carton: sprycel 50 mg
Maltese: Sprycel 50 mg
English: The MRD negativity rates at the end of induction and consolidation as measured by flow cytometry were 66.0% and 84.0%, respectively.
Maltese: Ir-rati ta' negattività ta' MRD fl-aħħar tal-induzzjoni u l-konsolidazzjoni kif imkejla minn ċitometrija tal-fluss kienu 66.0 % u 84.0
English: b Haematologic response criteria (all responses confirmed after 4 weeks): Major haematologic response (MaHR) = complete haematologic response (CHR) + no evidence of leukaemia (NEL).
Maltese: Rispons ematoloġiku maġġuri (MaHR) = rispons ematoloġiku komplet (CHR) + l-ebda evidenza ta' lewkimja (NEL).
English: NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and
Maltese: NEL: l-istess kriterji bħal fil-każ ta' CHR iżda ANC ≥ 500/mm3 u < 1,000/mm3, jew plejtlits ≥ 20,000/mm3 u
English: SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Maltese: SPRYCEL 80 mg pilloli miksija b'rita EU/1/06/363/013
English: SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
Maltese: SPRYCEL 70 mg: il-pillola miksija b'rita tvarja minn bajda għal offwajt, bikonvessa, tonda b'“BMS” imnaqqxa fuq naħa u “524” fuq in-naħa l-oħra.
English: In this multicenter, historically-controlled Phase II study of dasatinib added to standard chemotherapy, 106 paediatric patients with newly diagnosed Ph+ ALL, of whom 104 patients had confirmed Ph+ ALL, received dasatinib at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to
Maltese: II multiċentriku, ikkontrollat storikament ta' dasatinib miżjud ma' kimoterapija standard, 106 pazjenti pedjatriċi b'Ph+ ALL li kienet għadha kif ġiet dijanjostikata, li minnhom 104 pazjenti kellhom Ph+ ALL ikkonfermata, irċivew dasatinib b'doża ta' kuljum ta' 60 mg/m2 fuq reġimen tad-dożaġġ kontinwu sa 24 xahar, flimkien ma' kimoterapija.
English: See section 4.4 for further information on patients with chronic phase CML and advanced phase CML or Ph+ ALL.
Maltese: Ara sezzjoni 4.4 għal aktar informazzjoni dwar pazjenti b'CML fil-fażi kronika u CML f'fażi avvanzata jew Ph+ ALL.
English: Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations
Maltese: Komuni insuffiċjenza konġestiva tal-qalb/disfunzjoni kardijaka*ċ, tnixxija ta' likwidu millperikardju*, arritmija (li tinkludi takikardija), palpitazzjonijiet
English: Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflammation of the skin, persistent noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia, flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema Pain: pain in joints, muscular weakness, chest pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle spasm
Maltese: Ġilda, xagħar, għajnejn, ġenerali: tingiż tal-ġilda, ħakk, ġilda xotta, akne, infjammazzjoni talġilda, ħsejjes persistenti fil-widnejn, telf ta' xagħar, għaraq eċċessiv, disturb fil-vista (inkluż vista mċajpra u vista ddisturbata), għajnejn xotti, tbenġil, dipressjoni, nuqqas ta' rqad, fwawar, sturdament, kontużjoni (tbenġil), anoreksja, ngħas, edema ġeneralizzata Uġigħ: uġigħ fil-ġogi, dgħufija muskolari, uġigħ fis-sider, uġigħ madwar is-saqajn u l-idejn, kesħa, ebusija fil-muskoli u fil-ġogi, spażmu fil-muskoli
English: The proportion of patients who had PFS at 2 years was 86% (95% CI: [78%-93%]) for dasatinib and 65% (95% CI: [43%-87%]) for imatinib.
Maltese: Il-proporzjon ta' pazjenti li kellhom PFS wara sentejn kien ta' 86 % (95 % CI: [78 %-93 %]) għal dasatinib u 65 % (95 % CI: [43 %-87 %]) għal imatinib.
English: By 4 years 73%, p<.0021
Maltese: Sa 4 snin p < .0021
English: The median duration of therapy in 1,094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months).
Maltese: Ittul medjan tat-terapija f'1,094 pazjent adult b'CML fil-fażi avvanzata jew Ph+ ALL kien ta' 6.2 xhur (medda 0 sa 93.2 xhur).
English: SPRYCEL is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, and lymphoid blast CML in adults who are not benefiting from prior therapies.
Maltese: SPRYCEL jintuża wkoll biex jikkura l-lewkimja limfoblastika akuta (ALL) b'Philadelphia chromosome positive (Ph+) fl-adulti, adolexxenti u tfal ta' mill-inqas età ta' sena, u b'lymphoid blast CML f'adulti li ma jkunux qegħdin jibbenefikaw minn terapiji precedenti.
English: c CA180-035 study results in recommended starting dose of 140 mg once daily.
Maltese: ċ Riżultati tal-istudju CA180-035 fid-doża tal-bidu rakkomandata ta' 140 mg darba kuljum.
English: Uncommon blood creatine phosphokinase increased, gamma-glutamyltransferase increased Injury, poisoning, and procedural complications
Maltese: Mhux komuni żieda tal-creatine phosphokinase fid-demm, żieda fil-gamma-glutamyltransferase Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS 140” debossed on one side and “857” on the other side.
Maltese: SPRYCEL 140 mg: il-pillola miksija b'rita tvarja minn bajda għal offwajt, bikonvessa, tonda u b'“BMS 140” imnaqqxa fuq naħa waħda u “857” fuq in-naħa l-oħra.
English: • 20 mg daily for patients taking SPRYCEL 70 mg tablet daily.
Maltese: • 20 mg kuljum għal pazjenti li jkunu qed jieħdu SPRYCEL 70 mg pillola kuljum.
English: For storage conditions after constitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-kostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: c Includes brain natriuretic peptide increased, ventricular dysfunction, left ventricular dysfunction, right ventricular dysfunction, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased and ventricular failure, left ventricular failure, right ventricular failure, and ventricular hypokinesia.
Maltese: c Jinkludi żieda fil-peptide natrijuretiku fil-moħħ, disfunzjoni ventrikulari, disfunzjoni fil-ventrikolu tax-xellug, disfunzjoni fil-ventrikolu tal-lemin, insuffiċjenza kardijaka, insuffiċjenza akuta tal-qalb, insuffiċjenza kronika tal-qalb, attakk konġestiv tal-qalb, kardjomijopatija, kardjomijopatija konġestiva, disfunzjoni dijastolika, tnaqqis fil-porzjon ta' tfigħ ‘il barra ventrikulari u insuffiċjenza ventrikulari, insuffiċjenza tal-ventrikolu tax-xellug, insuffiċjenza tal-ventrikolu tallemin, u ipokinesija ventrikolari.
English: Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Maltese: Tabella 3: Aġġustamenti fid-doża għal newtropenja u tromboċitopenjaj f'pazjenti pedjatriċi b'Ph+ CML-CP
English: In a study of 14 healthy subjects, administration of a single 100-mg dose of SPRYCEL 22 hours following a 4-day, 40-mg omeprazole dose at steady state reduced the AUC of dasatinib by 43% and the Cmax of dasatinib by 42%.
Maltese: Fi studju ta' 14-il individwu b'saħħtu, l-għoti ta' doża waħda ta' 100 mg ta' SPRYCEL 22 siegħa wara doża ta' omeprazole ta' 40 mg għal 4 ijiem fl-istat fiss, naqqset l-AUC ta' dasatinib b'43 % u s- Cmax ta' dasatinib bi 42 %.
English: Fluid retention Superficial oedema Pleural effusion Generalised oedema Congestive heart failure /cardiac dysfunctionb
Maltese: Dijarea Żamma ta' fluwidu Edima superfiċjali Effużjoni plewrali Edima ġeneralizzata Insuffiċjenza konġestiva talqalb /disfunzjoni tal-qalbb
English: CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Maltese: CHR: WBC ≤ ULN istituzzjonali, ANC ≥ 1,000/mm3, plejtlits ≥ 100,000/mm3, l-ebda blast jew promajeloċiti fiddemm periferali, blasts fil-mudullun ≤ 5 %, < 5 % majeloċiti flimkien ma' metamajeloċiti fid-demm periferali, basofili fid-demm periferali < 20 %, u l-ebda involviment extramedullari.
English: Uncommon hypersensitivity (including erythema nodosum)
Maltese: Mhux komuni sensittività eċċessiva (li tinkludi eritema nodosum)
English: These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signalling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
Maltese: Dawn l-istudji mhux kliniċi juru li dasatinib jista' jegħleb ir-reżistenza għal imatinib li jirriżulta minn espressjoni żejda ta' BCR-ABL, mutazzjonijiet fid-domain tal-kinase BCR-ABL, attivazzjoni ta' passaġġi tas-senjalazzoni alternattivi li jinvolvu l-kinasi tal-familja SRC (LYN, HCK), u espressjoni żejda tal-ġene tar-reżistenza għal ħafna mediċini.
English: n/a
Maltese: NUMRU(I)
English: In addition to imatinib, 35% of patients had received prior cytotoxic chemotherapy, 65% had received prior interferon, and 10% had received a prior stem cell transplant.
Maltese: Barra imatinib, 35 % tal-pazjenti kienu rċevew kimoterapija ċitotossika qabel, 65 % kienu ħadu interferon qabel, u 10 % kienu għamlu trapjant taċċelloli stemma qabel.
English: The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups.
Maltese: 84 % - 92.4 %) kemm għal għall-gruppi ta' kura ta' dasatinib u imatinib.
English: In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Maltese: Fl-istudji kliniċi f'pazjenti adulti b'CML u Ph+ ALL, kienet permessa żieda fid-doża sa 140 mg darba kuljum (CML ta' fażi kronika) jew 180 mg darba kuljum (CML ta' fażi avanzata jew Ph+ ALL) f'pazjenti li ma kellhomx respons ematoloġiku jew ċitoġenetiku fid-doża tal-bidu rakkomandata.
English: • Review total prescribed dose and determine number of milliliters (mL) you will need.
Maltese: • Irrevedi d-doża preskritta totali u ddetermina n-numru ta' millimetri (mL) li ser teħtieġ.
English: EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle)
Maltese: EU/1/06/363/004 - 56 pillola miksijin b'rita (folji) EU/1/06/363/007 - 60 x 1 pillola miksijin b'rita (folji b'doża waħda)
English: A reaction with fever, blisters on the skin, and ulceration of the mucous membranes Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots
Maltese: Reazzjoni bid-deni, infafet fuq il-ġilda, u ulċerazzjoni tal-membrani mukużi Mard tal-kliewi b'sintomi li jinkludu edima u riżultati ta' testijiet tal-laboratorju anormali bħal proteina fl-awrina u livell baxx ta' proteina fid-demm Ħsara fil-vini/arterji tad-demm magħrufa bħala mikroanġjopatija trombotika (TMA), inkluż tnaqqis fl-għadd ta' ċelloli ħomor tad-demm, tnaqqis fil-plejtlits, u formazzjoni ta' emboli
English: Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia
Maltese: Rari inċident ċerebrovaskulari, attakk iskemiku temporanju, konvulżjoni, nevrite ottika, isVII paraliżi tan-nervituri, dimenzja, atassja Disturbi fl-għajnejn
English: Elimination is predominantly in the faeces, mostly as metabolites.
Maltese: Eliminazzjoni sseħħ b'mod predominanti fl-ippurgar, l-aktar bħala metaboliti.
English: EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle)
Maltese: EU/1/06/363/005 - 56 pillola miksijin b'rita (folji) EU/1/06/363/008 - 60 x 1 pillola miksijin b'rita (folji b'doża waħda)
English: May rarely cause severe hypersensitivity reactions and bronchospasm.
Maltese: F'każijiet rari jista' jikkawża reazzjonijiet ta' sensittività eċċessiva severi u bronkospażmu.
English: Add 77.0 mL of purified water all at once to the bottle and close tightly with closure.
Maltese: Żid 77.0 mL ta' ilma purifikat f'daqqa mal-flixkun u agħlqu sew bit-tapp.
English: EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle)
Maltese: EU/1/06/363/006 - 56 pillola miksijin b'rita (folji) EU/1/06/363/009 - 60 x 1 pillola miksijin b'rita (folji b'doża waħda)
English: Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI: [85%-97%]) for dasatinib and 73% (95% CI: [54%-91%]) for imatinib.
Maltese: Abbażi tal- estimi Kaplan-Meier, il-proporzjon ta' pazjenti li kellhom sopravivenza ħielsa millprogressjoni (PFS) għal sena kien ta' 91 % (95 % CI: [85 %-97 %]) għal dasatinib u 73 % (95 % CI: [54 %-91 %]) għal imatinib.
English: In the study in advanced phase CML and Ph+ ALL, the primary endpoint was MaHR.
Maltese: Fl-istudju ta' CML fil-fażi avanzata u Ph+ ALL, il-punt aħħari primarju kien MaHR.