FrancophonIA/ELRC3.0 huggingface dataset:
English: Hyper-CVAD regimen: CP 300 mg/m i.v.
Maltese: Reġimen iper-CVAD: CP 300 mg/m i.v. (3 h, q 12 h), jiem 1-3;
English: F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Maltese: Il-fertilità tal-grupp F1 ma kienetx affettwata, filwaqt li n-numru ta' feti li naqsu mill-piż żdied u numru iżgħar ta' feti baqgħu ħajjin b'doża ta' 45 mg/kg/jum.
English: Median time to treatment failure in responders was 122 weeks (95% C.I 106-147), while in the overall study population it was 84 weeks (95% C.I 71-109).
Maltese: Iż-żmien medjan medhan għall-falliment tal-kura f'dawk li wrew rispons kien ta' 122 ġimgħat (95% C.I. 106-147), filwaqt li fil-popolazzjoni globali kienet 84 ġimgħat (95% C.I. 71-109).
English: The results of subgroup analyses according to the United States National Institutes of Health (NIH) and the Armed Forces Institute of Pathology (AFIP) risk classifications are shown in Table 7.
Maltese: Ir-riżultati tal-analiżi tas-sottogrupp skond ilklassifikazzjonijiet tar-riskju tal-Istituti Nazzjonali tas-Saħħa ta' l-Istati Uniti (NIH) u tal-Istitut talPatoloġija tal-Forzi Armati (AFIP) tal-Istati Uniti huma murija f'Tabella 7.
English: Glivec 100 mg film-coated tablets EU/1/01/198/007
Maltese: Glivec 100 mg pilloli miksija b'rita EU/1/01/198/007
English: - The other ingredients are microcrystalline cellulose, crospovidone, magnesium stearate and anhydrous colloidal silica.
Maltese: - Is-sustanzi mhux attivi huma microcrystalline cellulose, crospovidone, magnesium stearate u anhydrous colloidal silica.
English: Packs containing 10, 30 or 90 film-coated tablets
Maltese: Pakketti li fihom 10, 30 jew 90 pillola miksija b'rita.
English: Maximal plasma concentrations of imatinib in patients are 2-4 mol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma ta' imatinib filpazjenti jvarjaw minn 2-4 µmol/l, u għaldaqstant huwa possibbli li jinibixxi l-metaboliżmu permezz ta' CYP2D6 u/ jew CYP3A4/5 ta' mediċini li jingħataw fl-istess ħin miegħu.
English: The daily dose was escalated to 800 mg in a total of 103 patients; 6 patients achieved a partial response and 21 stabilisation of their disease after dose escalation for an overall clinical benefit of 26%.
Maltese: Id-doża kienet miżjuda għal 800 mg kuljum f'total ta' 103 pazjenti, 6 pazjenti kisbu rispons parzjali u f'21 il-marda ġiet stabbli wara żieda fid-doża b'benefiċju kliniku globali ta' 26%.
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Maltese: Kien hemm żiediet żgħar għal moderati fil-livelli tat-transaminases u kien hemm xi tnaqqis żgħir fil-livelli tal-kolesterol, tattriglycerides, proteini totali, u ta' l-albumina fiż-żewġ speċi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glivec 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 bi Glivec 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: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Maltese: Ibda 6MP fl-1el ġurnata wara t-tmiem tal-irradjazzjoni kranjali.) Methotrexate (20 mg/m2/ġimgħa, PO): jiem 8, 15, 22, 29, 36, 43, 50
English: The median time of follow-up was 54 months (from date of randomisation to data cut-off), with a total of 83 months between the first patient randomised and the cut-off date.
Maltese: Iż-żmien medju sakemm reġgħu ġew iċċekkjati kien ta' 54 xahar (mid-data ta' randomizzazzjoni sad-data tattwaqqif), b'total ta' 83 xahar bejn l-ewwel pazjent randomizzat u d-data tat-twaqqif.
English: In Ph+ ALL patients, there is clinical experience of co-administering Glivec 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 ta' l-użu ta' ġlivec ma' kemoterapija (ara sezzjoni 5.1), iżda interazzjonijiet bejn mediċini ta' imatinib ma' reġimens kimoterapewtiċi għadhom ma ġewx iċċarati.
English: 8, hepatic necrosis
Maltese: .8 Effetti mhux mixtieqa
English: Each capsule of Glivec contains 50 mg imatinib (as mesilate).
Maltese: Kull kapsula ta' Glivec fiha 50 mg imatinib (bħal mesilate).
English: Days 2 and 3
Maltese: 6 dożi)iii: Jiem 2 u 3
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI
English: (24 h), day 1; Etoposide 250 mg/m i.v.
Maltese: MTX 1.5 g/m i.v. (24 h), jum 1; Etoposide 250 mg/m i.v. (1 h) jiem 4-5;
English: Glivec 100 mg hard capsules Each capsule contains 100 mg imatinib (as mesilate).
Maltese: Glivec 100 mg kapsuli ibsin Kull kapsula fiha 100 mg imatinib (bħala mesilate).
English: If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as one tablet once a day, 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Maltese: Jekk qed tieħu kura għal CML: Skond il-kundizzjoni tiegħek, id-doża li normalment tibda biha hija ta' jew 400 mg jew ta' 600 mg. 400 mg li tittieħed bħala pillola darba kuljum, 600 mg li tittieħed bħala pillola waħda ta' 400 mg flimkien ma' żewġ pilloli ta' 100 mg darba kuljum.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of Glivec resulted 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' Glivec 400 mg, dan irriżulta fi tnaqqis fis-Cmax u fl-AUC(0-∞) b'mill-inqas 54% u 74% tal-valuri rispettivi għal meta ma ngħatax rifampicin.
English: Methotrexate (5 g/m over 24 hours, IV): day 1
Maltese: Methotrexate (5 g/m fuq medda ta' 24 siegħa, IV): jum 1
English: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec.
Maltese: Każijiet ta' retenzjoni severa ta' fluwidi (effużjoni mill-plewra, edima, edima tal-pulmun, axxite, edima superfiċjali) kienu rapurtati f'madwar 2.5% tal-pazjenti b'CML li jkunu għadhom kif ġew dijanjostikati li jkunu qed jieħdu Glivec.
English: Palpitations, tachycardia, cardiac failure congestive
Maltese: Palpitazzjonijiet, takikardja, insuffiċjenza konġestiva tal-qalb
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
Maltese: F'CML, fil-fażi l-kronika, li kienet għada kif ġiet dijanjostikata, kien hemm newtropinja tar-4 grad (ANC < 0.5 x 10
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 mard li jkun f'fażi kronika, jew minn 600 mg għall-massimu ta' 800 mg (li jingħataw f'dożi ta' 400 mg, darbtejn kuljum) f'pazjenti li jkunu fil-fażi aċċelerata jew li jkollhom blast crisis għandha mnejn tiġi kkunsidrata flassenza 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: Table 3 Response in adult CML studies
Maltese: Tabella 3 Rispons f'adult bl-istudji CML
English: The dose is 800 mg per day (16 capsules), to be taken as 8 capsules in the morning and 8 capsules in the evening.
Maltese: Jekk id-doża ta' kuljum tkun 800 mg, (16 -il kapsula), għandek tieħu 8 kapsuli filgħodu u 8 kapsuli filgħaxija.
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: Skond analiżi tal-farmakokinetiċi tal-grupp ta' pazjenti b'CML, kien hemm effett żgħir ta' l-età fuq ilvolum ta' distribuzzjoni (żieda ta' 12% f' pazjenti li għandhom > 65 sena).
English: < 10 x 10
Maltese: WBC< 10 x 10
English: Glivec significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the Glivec group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - nonestimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Maltese: Glivec tawwal b'mod sinifikanti l-RFS, b'75% tal-pazjenti li ma reġax kellhom il-marda fit-38 xahar fil-grupp ta' Glivec vs. 20 xahar fil-grupp bi plaċebo (CIs 95%, [30 - ma tistax tittieħed stima]; [14ma tistax tittieħed stima], rispettivament);
English: 9/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC  1 x 109/l and platelets  20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Maltese: biss) RTC < 15% blasts fil-mudullun u fid-demm fil-periferiji, < 30% blasts+promajeloċiti fil-mudullun u fid-demm fil-periferiji, < 20% bażofils fid-demm fil-periferiji, l-ebda involviment 'l barra mill-mudullun ħlief għall-involviment tal-milsa u tal-fwied (għal 0102 u 0109 biss). BM = Mudullun, PB = demm fil-periferiji Kriterji għar-risponsijiet ċitoġenetiċi:
English: 9/l and/or platelets < 10 x 10
Maltese: 9/l u/jew plejtelets < 10 x 10
English: 9/l and platelets  75 x 109/l.
Maltese: 9/l u/jew plejtelets < 50 x 109/l
English: N Evt
Maltese: ULN
English: Chronic phase, Interferon failure: 532 adult patients were treated at a starting dose of 400 mg.
Maltese: Il-fażi kronika, meta Interferon ma ħadimx: 532 il-pazjent adult ġew kurati b'doża tal-bidu ta' 400 mg.
English: Active substances that may have their plasma concentration altered by Glivec Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Maltese: Imatinib iżid is-Cmax intermedju u l-AUC ta' simvastatin (sustanza li fuqa jaħdem is-CYP3A4) b' 2- u bi 3.5-il darba, rispettivament, u dan jindika li imatinib jinibixxi is-CYP3A4.
English: Liver dysfunction classification:
Maltese: Indeboliment fil-funzjoni ta' l-organi
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2 CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Maltese: CPM (250 mg/m2/doża q12h x 4 dożi, iv): Jiem 3 u 4 PEG-ASP (2500 IUnitajiet/m2, IM): jum 4
English: The 23 patients enrolled in this registry received Glivec at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Maltese: It-23 pazjent imsieħba fir-reġistru ngħataw Glivec f'doża medja kuljum ta' 264 mg (firxa: 100 sa 400 mg) għal tul medju ta' żmien ta' 7.2 snin (firxa minn 0.1 sa 12.7 snin).
English: 9/l) and thrombocytopenia (platelet count
Maltese: 9/l) u tromboċitpenji (għadd tal-plejtlets < 50 x 10
English: Each capsule of Glivec contains 100 mg imatinib (as mesilate).
Maltese: Kull kapsula ta' Glivec fiha 100 mg imatinib (bħal mesilate).
English: 9/l and/or platelets < 50 x10
Maltese: 9/l u/jew plejtelets < 50 x 10
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets
Maltese: 10 pilloli miksija b'rita 30 pilloli miksija b'rita 90 pilloli miksija b'rita
English: Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 10
Maltese: CML titqies li tkun fil-fażi kronika meta jintlaħqu dawn il-kriterji: blasts < 15% fiddemm u fil-mudullun, fid-demm periferiku il-bażofils < 20%, u l-plejtlets > 100 x 10
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Very common:
Maltese: Il-fażi l-kronika, li tkun għada kif ġiet dijanjostikata:
English: NIH Low
Maltese: U LUŻU
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of Glivec daily.
Maltese: Dan l-istudju kien jinkludi 14 pazjenti b'HES/CEL li kienu trattati b'Glivec minn 100 mg sa 1,000 mg kuljum.
English: (24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Maltese: Vincristine 2 mg i.v., jiem 4, 11; Doxorubicine 50 mg/m i.v. (24 h), jum 4; DEX 40 mg/jum f'jiem 1-4 u 11-14, alternati b'MTX 1 g/m i.v. (24 h),
English: This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Glivec.
Maltese: 4%) ta' pazjenti mietu fil-gruppi ta' Glivec u IFN + Ara-C, rispettivament.
English: The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).
Maltese: Il-qoxra tal-kapsula hija magħmula gelatin, iron oxide aħmar (E172), iron oxide isfar (E172) u titanium dioxide (E171).
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Maltese: Il-livell fejn ma jkunx osservat effett (NOEL) kien 15 mg/kg/jum. Ladenoma/karċinoma tal-kliewi, il-bużżieqa ta' l-awrina u papilloma ta' l-uretra, l-adenokarċinomi ta' l-imsaren, l-adenomi tal-glandoli paratajrojd, it-tumuri benini u malinni tal-mudullun tal-glandoli adrenali u tal-papillomi/karċinomi ta' l-istonku mingħajr il-glandoli dehru b'60 mg/kg/jum, li jiġu madwar 1.7-il darba jew darba 1 l-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 1.2-il darba l-esponiment ta' kuljum fit-tfal (bażat fuq l-AUC) b'340 mg/m2/jum.
English: Paediatric patients: 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' età ta' < 18-il sena li jew kellhom CML filfażi 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: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Maltese: 20 pilloli miksija b'rita 60 pilloli miksija b'rita 120 pilloli miksija b'rita 180 pilloli miksija b'rita
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-anqas 3 logarithms fit-12-il xahar, il-probabilità li l-pazjent jibqa ħieles minn avvanz għall-Fażi aċċelerata/blast crisis kienet 99% fl-84 xahar.
English: Ara-C 1,000 mg/m2/12 h i.v.
Maltese: Ara-C 1,000 mg/m2/12 h i.v.(3 h), jiem 1-4; Mitoxantrone 10 mg/m i.v. jiem 3-5;
English: In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Maltese: Il-kura kellha titwaqqaf għal kollox, minħabba abnormalitajiet fit-testijiet tal-laboratorju fuq il-funzjoni tal-fwied, f'inqas minn 1% tal-pazjenti b'CML.F'pazjenti b'GIST (studju B2222), żiediet ta' 6.8% tal-grad 3 jew 4 ALT (alanine aminotransferase) u żiediet ta' 4.8% ta' grad 3 jew 4 AST (aspartate aminotransferase) kienu evidenti.
English: days 3-5;
Maltese: Intermedju 25.
English: The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Maltese: L-esperjenza bl-użu ta' Glivec f'pazjenti b'MDS/MPD assoċjat mal-arranġamenti mill-ġdid tal-ġene PDGFR hija ferm limitata (ara sezzjoni 5.1).
English: Muscle spasm and cramps, musculoskeletal pain including myalgia arthralgia, bone pain10
Maltese: Spażmi fil-muskoli u bugħawwieġ, uġigħ muskoluskeletrali inklużi mijalġja artralġja, u uġigħ fl-għadam
English: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Maltese: III open-label, multiċentrika, b'koorti sekwenzjali, mhux randomizzata, u ngħataw trattament b'Glivec (340 mg/m2/kuljum) flimkien ma' kemoterapija intensiva wara terapija ta' induzzjoni.
English: Study AAU02
Maltese: ANNESS II
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Glivec should not be resumed.
Maltese: Jekk antikorp kontra ADAMTS13 jiġi elevat flimkien ma' attività baxxa ta' ADAMTS13, it-trattament bi Glivec m'għandux jinbeda mill-ġdid.
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Maltese: Hemm esperjenza limitata ħafna fi tfal b'MDS/MPD, DFSP, GIST u HES/CEL.
English: They are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Maltese: Jiġu f'pakketti ta' 20, 60, 120 jew 180 pillola, iżda jista' jkun li mhux il-pakketti kollha jkunu disponibbli f'pajjiżek.
English: 95 (37%) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63%) had not (“untreated patients”).
Maltese: 95 (37%) minnhom kienu diġà ħadu kemoterapija għall-kura tal-fażi aċċelerata jew tal-blast crisis (“pazjenti li kienu kurati minn qabel”) filwaqt li 165 (63%) ma' kienux għamlu hekk (“pazjenti mhux ikkurati minn qabel”).
English: Glivec is a medicine containing an active substance called imatinib.
Maltese: Glivec huwa mediċina li fih is-sustanza attiva imatinib.
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Maltese: Din kienet popolazzjoni ta' pazjenti li kienu diġà ħadu bosta trattamenti, billi 46% kien diġà kellhom BMT u 73% kienu ħadu kemoterapija li kienet tinkludi ħafna sustanzi, minn qabel.
English: The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn 3 xhur sa 4 snin u imatinib ingħata f'doża ta' 50 mg kuljum jew f'dożi li jvarjaw minn 92.5 sa 340 mg/m kuljum.
English: Glivec 50 mg hard capsules Each capsule contains 50 mg imatinib (as mesilate).
Maltese: Glivec 50 mg kapsuli ibsin Kull kapsula fiha 50 mg ta' imatinib (bħala mesilate).
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-fertilità, 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 ta' l-epididimu u anke tnaqqis filperċentwal ta' sperma b'mobilità 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: Glivec treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Maltese: Il-kura bi Glivec twassal għal rispons mgħaġġel f'pazjenti pedjatriċi li kienu għadhom kif ġew dijanjostikati b'CML b'CHR ta' 78% wara 8 ġimgħat ta' terapija.
English: Each capsule contains 100 mg of imatinib (as mesilate).
Maltese: Kull kapsula fiha 100 mg ta' imatinib (bħala mesilate).
English: Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Maltese: Peress li żieda filvaskularità u tendenza ta' fsada hija parti naturali mill-proċess kliniku ta' GIST, prattiċi standard u proċeduri ta' monitoraġġ u maniġġjar ta' fsada fil-pazjenti kollha għandhom jintużaw.
English: Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Maltese: L-użu fl-istess żmien, ta' imatinib ma' prodotti mediċinali li jinduċu is-CYP3A4 (ez., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, jew Hypericum perforatum, magħruf ukoll bħala St.
English: Glivec 100 mg hard capsules imatinib
Maltese: Glivec 100 mg kapsuli ibsin imatinib
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 imitanib 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: The most commonly reported ( 10%) drugrelated 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: • Use about 50 ml for each 100 mg tablet.
Maltese: • Uża madwar 50 ml għal kull pillola ta' 100 mg.
English: This study included 7 patients with MDS/MPD who were treated with Glivec 400 mg daily.
Maltese: Dan l-istudju kien jinkludi 7 pazjenti b'MDS/MPD li kienu trattati b'Glivec 400 mg kuljum.
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 Glivec, potentially increasing the risk of therapeutic failure.
Maltese: Dawk is-sustanzi li jistimolaw l-attività tas-CYP3A4 (eż. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone u Hypericum perforatum, ukoll mgħaruf bħala St.