FrancophonIA/ELRC3.0 huggingface dataset:
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
Maltese: • pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati b'lewkimja majelojd kronika (CML) li huma posittivi (Ph+) għall-kromosoma ta' Filadelfja (bcr-abl) u li ma jkunux jistgħu jirċievu trapjant tal-mudullun bħala l-kura preferita.
English: The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Maltese: Id-doża ta' Imatinib Accord rakkomandata għal pazjenti adulti b'MDS/MPD hija 400 mg/jum.
English: Additionally Imatinib Accord 100 mg tablets are also available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Maltese: Barra minn hekk, Imatinib Accord 100 mg pilloli huma disponibbli wkoll f'folji ta' doża waħda perforati tal- PVC/PVdC/Alu f'pakketti b'daqs ta' 30x1, 60x1, 90x1, 120x1 jew 180x1 pillola miksija b'rita.
English: 5 patients responded, 3 completely and 2 partially.
Maltese: 5 pazjenti wrew rispons, 3 komplet u 2 parzjali.
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Maltese: Minbarra hekk, 24 pazjent ieħor b'MDS/MPD kienu rappurtati f'13-il pubblikazzjoni.
English: In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Maltese: F'dan l-istudju, 65 % tal-pazjenti kisbu rispons ċitoġenetiku maġġuri li kien komplet fi 53 % (ikkonfermat f'43 %) tal-pazjenti (Tabella 3).
English: As reported in a recent publication 21 of these 65 patients also achieved complete molecular remission with a median follow-up of 28 months (range 13-67 months).
Maltese: 21 minn dawn is-65 pazjent kisbu wkoll remissjoni kompleta molekulari b'follow-up medju ta' 28 xahar (medda 13-67 xahar).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittivita eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or < ULN if total bilirubin is > ULN)
Maltese: > ULN (jista' jkun normali jew < ULN il-bilirubin totali jkun > ULN)
English: The safety and efficacy of imatinib in children and adolescents with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Maltese: Is-sigurtà u l-effikaċja ta' imatinib fit-tfal u fl-adolexxenti b'MDS/MPD, DFSP u HES/CEL li għandhom inqas minn 18-il sena ma ġewx determinati waqt provi kliniċi.
English: Other adverse reactions were reported with lower or equal frequency.
Maltese: Ġew irrappurtati reazzjonijiet avversi oħra bi frekwenza aktar baxxa jew indaqs.
English: Hyperkalaemia, hypomagnesaemia Psychiatric disorders Common
Maltese: Iperkalimija, ipomagneżimja
English: MTX 12 mg intrathecal, day 1 Remission induction DEX 10 mg/ m2 oral, days 6-7, 13-16;
Maltese: DEX 10 mg/m2 orali, jiem 6-7, 13-16;
English: In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Imatinib Accord at reduced dose of 300 mg.
Maltese: Fil-każ li l-ANC jerġa' < 1.0 x 109/l u/jew il-plejtlets < 50 x 109/l, erġa' irrepeti Nru. 1 u erġa' ibda Imatinib Accord b'doża mnaqqsa ta' 300 mg.
English: Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Maltese: Żieda fid-dożi minn 400 mg għal 600 mg jew 800 mg f'pazjenti li jkollhom marda fil-fażi kronika, jew minn 600 mg għall-massimu ta' 800 mg (li jingħataw f'dożi ta' 400 mg, darbtejn kuljum) f'pazjenti li jkollhom fażi aċċellerata jew blast crisis għandha mnejn tiġi kkunsidrata fl-assenza ta' effetti avversi severi minħabba fil-mediċina u fl-assenza ta' newtropinja jew tromboċitopenja severi li ma jkunux relatati ma' lewkimja, f'dawn iċ-ċirkustanzi: meta jkun hemm avvanz tal-marda (ikun f'liema żmien ikun); meta ma jkunx hemm rispons ematoloġiku sodisfaċenti wara mill-inqas 3 xhur ta' kura; meta ma jkunx hemm rispons ċitoġenetiku wara mill-inqas 12-il xahar ta' kura, jew meta jkun hemm telf ta' rispons ematoloġiku u/jew ċitoġenetiku li jkun(u) inkiseb(bu) qabel.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose ofimatinibresulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Maltese: Meta ngħata trattament minn qabel b'numru ta' dożi ta' rifampicin 600 mg li mbagħad kien segwit b'doża waħda ta' imatinib 400 mg, dan irriżulta fi tnaqqis fis-Cmax u flAUC(0-∞) b'mill-inqas 54% u 74% tal-valuri rispettivi għal meta ma ngħatax rifampicin.
English: Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but < 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils ≥ 20%, platelets < 100 x 109/l unrelated to therapy.
Maltese: Il-fażi aċċellerata hi definita mill-preżenza ta' kwalunkwe wieħed milli ġej: blasts ≥15 % iżda < 30 % fid-demm jew fil-mudullun, blasts flimkien ma' promajeloċiti ≥30 % fid-demm jew filmudullun (sakemm ikun hemm< 30% blasts), bażofils fid-demm fil-perifiji ≥20 %, plejtelets < 100 x 109/l mhux relatati mat-terapija.
English: WBC < 10 x 109/l, platelet < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement
Maltese: 9/l, majeloċit+metamajeloċit < 5 % fid-demm, lebda blast u promajeloċit fid-demm, < 20 % bażofils, l-ebda involviment barra lmudullun
English: The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)-positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'imatinib f'kull sett tal-popolazzjoni pedjatrika fil-kromosoma Philadelphia (bcr-abl translocation)lewkimja majelojd kronika pożittiva (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Additionally Imatinib Accord 400 mg tablets are available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1or 90x1 film-coated tablets.
Maltese: Barraminhekk, Imatinib Accord 400 mg pilloli huma disponibbli f'folji ta' doża waħda perforati talPVC/PVdC/Alu f'pakketti b'daqs ta' 30x1, 60x1 jew 90x1 pillola miksija b'rita.
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Maltese: Meta imatanib kien kombinat ma' dożi għolja ta' kimoterapija f'pazjenti b'Ph+ ALL, tossiċità mumentanja tal-fwied dehret bħala żieda fil-livelli ta' transaminases u bilirubin fid-demm.
English: Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Maltese: Imatinib ingħata b'mod intermittenti b'koorti ta' 1-5, b'żieda fid-dewmien u bi tnedija bikrija ta' imatinib minn koorti għal koorti; koorti 1 jingħata l-anqas intensità u koorti 5 jingħata l-ogħla intensità ta' imatinib (l-iktar dewmien fi ġranet b'doża ta' imatinib kuljum b'mod kontinwu matul l-ewwel korsijiet ta' trattament b'kemotarapija).
English: For patients with reduction in Bcr-Abl transcripts of at least 3 logarithms at 12 months, the probability of remaining free from progression to accelerated phase/blast crisis was 99% at 84 months.
Maltese: Għal pazjenti bi tnaqqis fit-transcripts Bcr-Abl ta' mill-inqas 3 logarittmi wara 12-il xahar, il-probabbiltà li dawn jibqgħu ħielsa minn avvanz għal fażi aċċellerata/blast crisis kienet ta' 99 % wara 84 xahar.
English: If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Maltese: Jekk iċ-ċitopenja tippersisti għal ġimgħatejn, erġa' naqqas għal 200 mg/m2.
English: Imatinib Accord 400 mg film-coated tablets are supplied in packs containing 10, 30, or 90 tablets, but these may not all be available in your country.
Maltese: Imatinib Accord 400 mg pilloli miksija b'rita jiġu fornuti f'pakketti li fihom 10, 30, jew 90 pillola, imma dawn jistgħu ma jkunux kollha disponibbli fil-pajjiż tiegħek.
English: Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Maltese: Dożi ta' 400 mg jew 600 mg għandhom jingħataw darba kuljum, filwaqt li doża ta' kuljum ta' 800 mg għandha tingħata bħala 400 mg darbtejn kuljum, filgħodu u filgħaxija.
English: There was a significant increase in exposure to imatinib (the mean Cmaxand AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Maltese: Kien hemm żieda sinifikanti fl-ammont ta' imatinib esponut (is-Cmax intermedju u l-AUC għal imatinib għolew b'26% u 40% rispettivament) f'persuni f'saħħithom, meta imatinib ingħata flimkien ma' doża waħda ta' ketoconazole (sustanza li tinibixxi sCYP3A4).
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Maltese: L-AUC filplażma għal imatinib naqset b'73% meta mqabbla ma pazjenti li ma kienux qed jieħdu EIAED's.
English: Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
Maltese: Kienu rrappurtati 3 pazjenti b'HES u CEL b'assoċjazzjoni ma' riarranġamenti tal-ġene PDGFR fi 3 pubblikazzjonijiet.
English: In newly diagnosed chronic phase CML grade 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
Maltese: F'CML, fil-fażi l-kronika, li kienet għada kif ġiet dijanjostikata, kien hemm newtropinja tar-4 grad (ANC < 0.5 x 109/l) u tromboċitopenja (għadd tal-plejtlets < 10 x 109/l) f' 3.6% u f' < 1% tal-pazjenti, rispettivament.
English: The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Maltese: Din is-sutanza tinpedixxi b'mod selettiv ilproliferazzjoni u tistimola apoptożi f'linji ta' ċelluli li jkunu pożittivi għal Bcr-Abl kif ukoll f'ċelluli lewkimiċi friski li jinstabu f'pazjenti li jkollhom CML li tkun pożittiva għall-kromosoma ta' Filadelfja u f'pazjenti b'acute lymphoblastic leukaemia (ALL).
English: The dose of 340 mg/m2 daily is recommended for children and adolescents with Ph+ ALL (not to exceed the total dose of 600 mg).
Maltese: Hija rrakkomandata doża ta' 340 mg/m2 għal tfal u adolexxenti b'Ph+ ALL (m'għandhiex taqbeż id-doża sħiħa ta' 600 mg).
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1 x 109/1 and platelets ≥ 20 x 109/1, then resume treatment at 300 mg.
Maltese: Jekk iċ-ċitopenja tippersisti għal 4 ġimgħat u għada mhix relatata mallewkimja, waqqaf Imatinib Accord sakemm ANC  1 x 109/l u l-plejtlets  20 x 109/l, imbagħad erġa' ibda l-kura b'300 mg.
English: CHR rate n (%) [95% CI]
Maltese: Rispons ematoloġiku Rata CHR n (%)
English: When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8%) out of 11 achieving a complete haematological response.
Maltese: Meta terapija ta' sokkors b'imatinib ingħatat f'pazjenti li ma wrewx rispons jew li urew rispons fqir għallkimoterapija, irriżulta li 9 pazjenti (81.8%) minn 11 kisbu rispons ematoloġiku komplet.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Accord 400 mg film-coated tablets imatinib
Maltese: Imatinib Accord 400 mg pilloli miksija b'rita Imatinib
English: In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Maltese: Fi studju fuq il-fertilita, f'firien ta' sess maskili li ngħataw il-mediċina għal 70 jum qabel ma tgħammru, irriżulta li kien hemm tnaqqis fil-piż tat-testikoli u tal-epididimu u anke tnaqqis filperċentwal ta' sperma b'mobilita tajba, meta ntużat doża ta' 60 mg/kg, li hi bejn wieħed u ieħor ekwivalenti għall-ogħla doża klinika possibbli ta' 800 mg/jum, jekk wieħed iqis l-erja tas-superfiċje tal-ġisem.
English: Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
Maltese: Imatinib Accord 100 mg pilloli miksija b'rita Imatinib Accord 400 mg pilloli miksija b'rita
English: Joint swelling
Maltese: Polyethylene glycol
English: Imatinib Accord 400 mg tablets
Maltese: Imatinib Accord 400 mg pilloli miksija b'rita
English: Table 5 Chemotherapy regimen used in combination with imatinib in study I2301
Maltese: Reġim ta' kemoterapija użata flimkien ma' imatinib fl-istudju I2301
English: Using this approach, the estimated cumulative response rates for first-line treatment with Imatinib improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Maltese: Filwaqt li ntuża dan l-approċċ, ir-rati ta' risponsi kumulattivi stmati għall-kura tal-ewwel linja b'Imatinib tjiebu minn 12-il xahar ta' terapija għal 84 xahar ta' terapija kif ġej: CHR minn 96.4 % għal 98.4 % u CCyR minn 69.5 % għal 87.2 %, rispettivament.
English: Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia,
Maltese: Spażmi fil-muskoli u bugħawwieġ, uġigħ muskoluskeletrali inklużi mijalġja9, artralġja, u uġigħ fl-għadam10
English: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Maltese: Fiż-żewġ każijiet, l-aktar effett avvers relatat mal-mediċina li kien rappurtat ( 10%) kienu tqallih ħafif, rimettar, dijarrea, uġigħ addominali, għejja, majalġja, bugħawwieġ u raxx.
English: Imatinib Accord 100 mg tablets
Maltese: Imatinib Accord 100 mg pilloli miksija b'rita
English: Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Maltese: Dawk is-sustanzi li jistimolaw l-attivita tas-CYP3A4 (eż. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone u Hypericum perforatum, ukoll magħruf bħala St.
English: Dosing in children and adolescents at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Maltese: II. Dożi fit-tfal u fl-adolexxenti ta' 260 u 340 mg/m2/jum kisbu l-istess esponiment, rispettivament, bħalma jkun hemm fl-adulti b'dożi ta' 400 mg u 600 mg.
English: The age of the DFSP patients ranged from 23 to 75 years; DFSP was metastatic, locally recurrent following initial resective surgery and not considered amenable to further resective surgery at the time of study entry.
Maltese: L-etajiet tal-pazjenti kienu bejn 23 u 75 sena; DFSP kien metastatiku, reġa' ħareġ fil-post wara li kien tneħħa b'operazzjoni, u kien meqjus li aħjar ma jerġax issir operazzjoni oħra ta' tneħħija fil-ħin tad-dħul fl-istudju.
English: (3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
Maltese: Ara-C 1,000 mg/m2/12 h i.v.(3 h), jiem 1-4; Mitoxantrone 10 mg/m2 i.v. jiem 3-5;
English: In paediatric CML patients the most frequent toxicities observed were grade3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Maltese: F'pazjenti pedjatriċi b'CML, l-aktar tossiċitajiet frekwenti kienu ċitopenji ta' grad 3 jew 4 li jinvolvu newtropenji, tromboċitopenji u anemija.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1x109/1 and platelets ≥ 20x109/1, then resume treatment at 200 mg/m2.
Maltese: Jekk iċ-ċitopenja tippersisti għal 4 ġimgħat u għada mhix relatata mallewkimja, waqqaf Imatinib Accord sakemm ANC  1 x 109/l u l-plejtlets  20 x 109/l, imbagħad erġa' ibda l-kura b'200 mg/m2.
English: Imatinib Accord 100 mg film-coated tablets are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Maltese: Imatinib Accord 100 mg pilloli miksija b'rita jiġu fornuti f'pakketti li fihom 20, 60, 120 jew 180 pillola, imma dawn jistgħu ma jkunux kollha disponibbli fil-pajjiż tiegħek.
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Maltese: Papilloma/karċinoma tal-glandola tal-prepuzju/klitoris dehru mat-30 mg/kg/jum ‘l quddiem, li jiġi madwar 0.5 jew 0.3-il darba tal-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 0.
English: In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Maltese: F'pazjenti b'Ph+ ALL, hemm esperjenza klinika tal-użu ta' imatinib ma' kimoterapija (ara sezzjoni 5.1), iżda interazzjonijiet bejn mediċini ta' imatinib ma' reġimens kimoterapewtiċi għadhom ma ġewx iċċarati.
English: Tablet core
Maltese: Induzzjoni tarremissjoni
English: Imatinib Accord is also a treatment for children and adolescents with CML.
Maltese: Imatinib Accord huwa wkoll kura għal tfal u adolexxenti b'CML.
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intratumoural haemorrhages were reported (see section 4.8).
Maltese: Fl-istudju f'pazjenti b' GIST li ma jistax jitneħħa b'operazzjoni u/jew li huwa metastatiku, emorraġiji gastrointestinali u fit-tumur kienu rappurtati (ara sezzjoni 4.8).
English: Haemolytic anaemia, thrombotic microangiopathy
Maltese: Anemija emolitika, mikroanġjopatija trombotika Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Maltese: B'kollox 26-il pazjent pedjatriku ta' eta ta' < 18-il sena li jew kellhom CML fil-fażi l-kronika (n=11) jew kellhom CML fi blast crisis jew lewkimji akuti (n=15) b'Ph+ kienu reklutati fi prova ta' fażi I li fiha d-doża kienet tiżdied.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets imatinib
Maltese: Imatinib Accord 100 mg pilloli miksija b'rita Imatinib
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Maltese: CPM (250 mg/m2/doża q12h x 4 doI, IV): jiem 3 u 4
English: Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12% increase in patients > 65 years old).
Maltese: Skont analiżi tal-farmakokinetiċi tal-grupp ta' pazjenti b'CML, kien hemm effett żgħir tal-eta fuq ilvolum ta' distribuzzjoni (żieda ta' 12% f' pazjenti li għandhom > 65 sena).
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Maltese: Ma kien hemm l-ebda bidla fil-farmakokinetiċi ta' imatinib meta ngħataw dożi ripetuti, u kien hemm akkumulazzjoni ta' 1.5-2.5-il darba fl-istat fiss meta d-doża ingħatat darba kuljum.
English: If you are being treated for Ph-positive ALL The starting dose is 600 mg to be taken as 6 tablets of 100 mg or one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Maltese: Id-doża tal-bidu hija ta' 600 mg li għandha tittieħed bħala 6 pilloli ta' 100 mg jew pillola waħda ta' 400 mg flimkien ma' 2 pilloli ta' 100 mg darba kuljum.
English: Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
Maltese: Kull pillola miksija b'rita fiha 100 mg imatinib (bħala mesilate)
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the
Maltese: 6-MP (75 mg/m2/kuljum, PO): jiem 11-56 (Miżmuma 6-MP matul is6-10 ijiem ta' irrdjazzjoni kranjali mibdija fl-1 ġurnata ta' Ċiklu 5.
English: DEX 10 mg/ m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3-5; MTX 15mg intrathecal, day 1
Maltese: DEX 10 mg/m2 orali, jiem 1-5; CP 200 mg/m2 i.v., jiem 3-5;
English: Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Maltese: Ginekomastja, funzjoni ħażina ta' l-erezzjoni, menorraġja, mestrwazzjoni irregolari, funzjoni sesswali ħażina, uġigħ fir-ras tal-beżżula, tkabbir tassider, edema fl-iskrotu
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
Maltese: • Nawsja, qtugħ ta' nifs, taħbit tal-qalb irregolari, awrina mċajpra, għeja u/jew skumdità fil-ġogi b'rabta ma' riżultati tal-laboratorju mhux normali (eż. potassju għoli, aċidu uriku u livelli ta' kalċju u livelli baxxi ta' fosfru fid-demm).
English: 235 adult patients with accelerated phase disease were enrolled.
Maltese: Ġew irreġistrati 235 pazjent adult b'marda fil-fażi aċċellerata.
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Maltese: • pazjenti adulti u pedjatriċi b'mard majelopisplatiku/majeloproliferattiv (MDS/MPD) assoċjat ma' tibdil fil-ġene tar-riċettur tal-fattur ta' tkabbir li jkun ġej minn plejtlets (PDGFR).
English: For PVC/PVdC/Alu blisters Do not store above 30C.
Maltese: Għall-folji tal-PVC/PVdC/Alu Taħżinx f'temperatura 'l fuq minn 30C.
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Maltese: Tlett pazjenti wrew rispons ematoloġiku komplet (CHR) u pazjent wieħed kellu rispons ematoloġiku parzjali (PHR).
English: • Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
Maltese: • Uża madwar 50 ml għal kull pillola ta' 100 mg jew 200 ml għal kull pillola ta' 400 mg.
English: Imatinib Accord 400 mg film-coated tablets are brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side.
Maltese: Imatinib Accord 400 mg pilloli miksija b'rita huma pilloli oranġjo fil-kannella, tondi, bikonvessi, miksija b'rita, imnaqqxa b'‘IM' fuq naħa waħda u b'‘T2' fuq kull naħa tas-sinjal minn fejn il-pillola tinqasam u lixxi fuq in-naħa l-oħra.
English: IFN+Ara-C n=553
Maltese: IFN+Ara