FrancophonIA/ELRC3.0 huggingface dataset:
English: In all clinical studies 38-40% of patients were  60 years of age and 10-12% of patients were  70 years of age.
Maltese: Fl-istudji kliniċi kollha 38-40% tal-pazjenti kellhom ≥ 60 sena u 10-12% tal-pazjenti kellhom ≥ 70 sena.
English: 9/l, platelets  100 x 10
Maltese: 9/l, plejtlets  100 x10
English: What Glivec contains - The active substance is imatinib mesilate.
Maltese: X'fih Glivec - Is-sustanza attiva hi imatinib mesilate.
English: Mean absolute bioavailability for imatinib is 98%.
Maltese: Il-firxa mal-ġisem assoluta medja għal imatinib hija ta' 98%.
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Maltese: F'konċentrazzjonijiet ta' imatinib li kienu klinikament relevanti, l-irbit mal-proteini tal-plażma kien ta' xi 95% bażati fuq esperimenti li saru in vitro, l-aktar ma' l-albumina u ma' alpha acid glycoprotein, bi ftit li xejn irbit mal-lipoprotein.
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Maltese: AST: li jkun ULN = il-limitu ta' fuq in-normal ta' l-instituzzjoni AST = aspartate aminotransferase
English: Stop Glivec until ANC  1.5 x 10
Maltese: Waqqaf Glivec sakemm l-ANC  1.5 x 10
English: Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Maltese: Imatinib u l-metabolu N-demethyl flimkien kienu jgħoddu għal xi 65% tar-radjuattività fiċċirkolazzjoni (AUC(0-48h)).
English: Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Maltese: Bħala rutina, kienu dejjem isiru testijiet ta' l-immunoistokimika b'anti-korpi Kit (A-4502, anti-serum poliklonali tal-fenek, 1;100; Korporazzjoni DAKO, Carpinteria, CA) skond analiżi permezz ta' metodu ta' kumpless magħmul minn avidin-biotin-peroxidase wara li jkun irkuprat l-antiġen.
English: Haematological response CHR rate n (%)
Maltese: Rispons ematoloġiku n (%) tar-rata ta'CHR
English: Glivec 400 mg tablets imatinib
Maltese: Glivec 400 mg pilloli imatinib
English: A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day Glivec 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity.
Maltese: Studju ieħor multiċentriku, open label, f'fażi III (SSG XVIII/AIO) qabbel 400 mg/kuljum Glivec matul trattament ta' 12-il xahar kontra 36 xahar ta' trattament f'pazjenti wara resezzjoni kirurġika ta' GIST u wieħed minn dawn li ġejjin: dijametru tat-tumur > 5 ċm u l-għadd mitotiku > 5/50 high power fields (HPF); jew dijametru tat-tumur > 10 cm u kwalunkwe għadd mitotiku jew tumur ta' kull daqs bl-għadd mitotiku > 10/50
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.
Maltese: Il-funzjoni tal-fwied (transaminases, bilirubin, alkaline phosphatase) għandha tiġi immonitorjata b'mod regolari f'pazjenti li jkunu qed jirċievu Glivec.
English: 9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Maltese: Kriterji ta' rispons ċitoġenetiku: sħaħ (0% ta' metafasijiet Ph+), parzjali (1-35%), minuri (36-65%) jew minimi (66-95%).
English: This inhibition has not been observed in vivo after the administration of Glivec 400 mg and paracetamol 1000 mg. Higher doses of Glivec and paracetamol have not been studied.
Maltese: Din linibizzjoni ma ġietx osservata in vivo wara l-għoti ta' Glivec 400 mg u paracetamol 1000 mg.
English: - The tablet coating is made of red iron oxide (E172), yellow iron oxide (E172), macrogol, talc and hypromellose.
Maltese: - Il-kisja tal-pillola hija magħmula minn iron oxide aħmar (E172), iron oxide isfar (E172), macrogol, talc u hypromellose.
English: 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 doI, IV): jiem 3 u 4 PEG-ASP (2500 IUnitajiet/m2, IM): jum 4
English: VCR (1.5 mg/m 2/day, IV): days 1, 29
Maltese: VCR (1.5 mg/m 2/kuljum, IV): jiem 1, 29
English: Infections and infestations Uncommon:
Maltese: Infezzjonijiet u infestazzjonijiet Mhux Komuni:
English: The pharmacokinetics of Glivec have been evaluated over a dosage range of 25 to 1,000 mg.
Maltese: Il-farmakokinetiċi ta' Glivec kienu stmati għal dożaġġ li jvarja minn 25 sa 1,000 mg.
English: Study 0109 40.5-month data Accelerated phase (n=235)
Maltese: Studju 0109 Dejta ta' 40.5 xahar Fażi aċċelerata (n=235)
English: A total of 1,106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Maltese: Total ta' 1,106 pazjenti tqassmu b'mod randomized, 553 f'kull fergħa ta' trattament.
English: 29.7 16/84 vs. 39/81 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5 * Full follow-up period; NE - Not estimable
Maltese: 39/81 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs.
English: With 7 years follow-up, there were 93 (16.8%) progression events in the Glivec arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Maltese: 37 (6.7%) li jinvolvu avvanz għall-Fażi aċċelerata/blast crisis, 31 (5.6%) telf ta' MCyR, 15 (2.7%) telf ta' CHR jew żieda fil-WBC, u 10 (1.8%) mwiet mhux relatati ma' CML.
English: In the adjuvant setting, Glivec was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.
Maltese: III, multiċentriku, double-blind, fuq perjodu twil ta' żmien u kkontrollat bi plaċebo (Z9001) li kien jinvolvi 773 pazjent.
English: Packs containing 20, 60, 120 or 180 film-coated tablets
Maltese: Pakketti li fihom 20, 60, 120 jew 180 pilloli miksija b'rita.
English: Glivec 400 mg film-coated tablets PVDC/alu blisters
Maltese: Glivec 400 mg pilloli miksija b'rita Folji ta' l-alu/PVDC
English: DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28 Methotrexate (20 mg/m2/week, PO): days 8, 15, 22
Maltese: DEX (6 mg/m 2/jum PO): jiem 1-5; 29-33 6-MP (75 mg/m 2/jum, PO): jiem 8-28 Methotrexate (20 mg/m 2/ġimgħa, PO): jiem 8, 15, 22
English: (1 h) day 1; Ara-C 60 mg/m i.v., days 22-25, 29-32
Maltese: CP 500 mg/m i.v.(1 h) jum 1; Ara-C 60 mg/m i.v., jiem 22-25, 29-32
English: Thirty-six (36) months of Glivec treatment significantly prolonged RFS compared to 12 months of Glivec treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 8, Figure 1).
Maltese: Sitta u tletin (36) xahar ta' kura bi Glivec tawlet b'mod sinifikanti l-RFS imqabbel mat-12-il xahar ta' trattament bi Glivec (bil-proporzjoni totali ta' periklu (HR) = 0.46 [0.32, 0.65], p<0.0001)
English: Glivec 50 mg hard capsules EU/1/01/198/001
Maltese: Glivec 50 mg kapsuli ibsin EU/1/01/198/001
English: Other medicines and Glivec
Maltese: Mediċini oħra u Glivec
English: VP-16 (100 mg/m2/day, IV): days 1-5 Ifosfamide (1.8 g/m2/day, IV): days 1-5 MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5
Maltese: Ifosfamide (1.8 g/m2/kuljum, IV): jiem 1-5 MESNA (360 mg/m2/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5
English: Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Maltese: Imatinib huwa sustanza li tinpedixxi l-enzima protein-tyrosine kinase li b'saħħa tinpedixxi lill-BcrAbl tyrosine kinase fil-livelli in vitro, ċellulari u in vivo.
English: Based on preliminary population pharmacokinetic analysis in GIST patients, there were three variables (albumin, WBC and bilirubin) found to have a statistically significant relationship with imatinib pharmacokinetics.
Maltese: Skond analiżi farmakokinetika preliminari tal-popolazzjoni f' pazjenti b'GIST, jidher li kien hemm tlett varjanti (albumina, WBC, u bilirubin) li kellhom relazzjoni mal-farmakokinetiċi ta' imatinib li kienet statistikament sinifikanti.
English: 9/l and platelets  75 x 10
Maltese: 9/l u l-plejtlets  75 x 10
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) Glivec daily.
Maltese: Il-pazjenti adulti rappurtati fil-publikazzjoni kienu kurati jew b'400 mg (4 każijiet) jew 800 mg (każ 1) Glivec kuljum.
English: Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
Maltese: Kriterji ta' rispons molekulari maġġuri: fid-demm periferali tnaqqis ta' ≥ 3 logaritmi fl-ammont tat-traskritti Bcr-Abl (imkejjla b'assay ta' reverse transcriptase kwantitattiv li jinqara f'dak il-ħin stess) fuq linja bażika standardizzata.
English: 7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Maltese: 7, tifwieq, melena, esofaġite, axxite, ulċera fl-istonku, rimettar tad-demm, kejlite, disfaġja, pankrejatite
English: Paediatric chronic phase CML (at dose 340 mg/m
Maltese: CML fil-fażi kronika pedjatrika (doża tal-bidu 340 mg/m
English: (2 h, q 12 h), days 2-3 (total of 8 courses)
Maltese: jum 1, Ara-C 1 g/m i.v. (2 h, q 12 h), jiem 2-3 (total ta' 8 korsijiet)
English: Caution should be used when taking Glivec with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section
Maltese: Wieħed għandu joqgħod attent meta Glivec jittieħed ma' inibituri tal-protease, sustanzi kontra l-moffa azole, ċerti makrolidi (ara sezzjoni 4.5), sottostrati ta' CYP3A4 b'tieqa terapewtika dejqa (eż. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) jew warfarin jew derivattivi oħrajn ta' coumarin (ara sezzjoni 4.5).
English: % of patients
Maltese: % ta' pazjenti
English: The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Maltese: Iddoża totali kuljum fit-tfal ma tistax taqbeż it-800 mg b'CML u 600 mg b'Ph+ALL.
English: VM26 60 mg/m i.v.
Maltese: VM26 60 mg/m i.v. (1 h), jiem 1-5
English: Posology for MDS/MPD The recommended dose of Glivec is 400 mg/day for adult patients with MDS/MPD.
Maltese: Pożoloġija għal MDS/MPD Id-doża ta' Glivec rakkomandata għal pazjenti adulti b'MDS/MPD hija 400 mg/jum.
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Glivec, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed.
Maltese: Jekk is-sejbiet tal-laboratorju jew kliniċi assoċjati ma' TMA iseħħu f'pazjent li jkun qed jirċievi Glivec, it-trattament għandu jitwaqqaf u għandha titlesta evalwazzjoni bir-reqqa għal TMA, inkluża l-attività ta' ADAMTS13 u d-determinazzjoni ta' antikorpi kontra ADAMTS13.
English: Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Maltese: Riżultati simili dehru f'pazjenti b'glijomas malinni ikkurati bi Glivec waqt li kienu qed jieħdu mediċini kontra l-epilessija li jinduċu l-enzimi (EIAEDs) bħal carbamazepine, oxcarbazepine u phenytoin.
English: Pleural effusion
Maltese: Żieda fil-piż
English: PVDC/alu blisters Packs containing 60, 120 or 180 film-coated tablets
Maltese: Folji ta' l-alu/PVDC Pakketti li fihom 60, 120 jew 180 pilloli miksija b'rita.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Maltese: CML fil-fażi aċċelerata pedjatrika u blast crisis (doża tal-bidu 340 mg/m
English: MTX (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Maltese: MTX (5 g/m fuq medda ta' 24 siegħa, IV): jum 1 Leucovorin (75 mg/m fis-36 siegħa, IV; 15 mg/m
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Maltese: Imatinib jinpedixxi wkoll lir-receptor tyrosine kinases għall-growth factor derivat mill-plejtlets (PDGF), PDGF-R, u l-istem cell factor(SCF), c-Kit, u b'hekk jinpedixxi effetti fil-livell ċellulari li jkunu assoċjati ma' PDGF u ma' SCF.
English: VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Maltese: VCR (1.5 mg/m 2/kuljum, IV): jiem 1, 8, u 15
English: Glivec 100 mg tablets imatinib
Maltese: Glivec 100 mg pilloli imatinib
English: BLISTERS
Maltese: Baxx
English: (3 h, q 12 h), day 5
Maltese: Ara-C 2x 2 g/m i.v. (3 h, q 12 h), jum 5
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Maltese: Fi studju kontrollat (ADE10) ta' imatinib versus induzzjoni b'kimoterapija f'55 pazjent li kienu għadhom kif ġew dijanjostikati ta' etajiet minn 55 sena ‘l fuq. imatinib użat waħdu wassal għal rispons ematoloġiku komplet b'rata ogħla minn kimoterapija (96.3% vs 50%; p=0.001).
English: OTHER
Maltese: NIH
English: Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR and Abl kinase activity.
Maltese: Imatinib jinibixxi s-sinjalar u lproliferazzjoni ta' ċelluli mmexxija minn PDGFR regolat ħażin u attività ta' Abl kinase.
English: Glivec 50 mg capsules imatinib
Maltese: Glivec 50 mg kapsuli imatinib
English: • the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Maltese: • għall-kura awżiljari ta' pazjenti adulti li huma f'riskju sinifikanti li jirkadu wara t-tneħħija b'operazzjoni ta' GIST pożittiv għal Kit (CD 117).
English: Glivec 100 mg capsules imatinib
Maltese: Glivec 100 mg kapsuli imatinib
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 800 mg daily.
Maltese: II, open label, f'ħafna ċentri (studju B2225) kien imwettaq b'12-il pazjent b'DFSP kurata b'Glivec 800 mg kuljum.
English: 0.59 (0.17; 2.10) 100 vs. 94.8 97.8 vs. 89.5
Maltese: 0.59 (0.17; 2.10) 100 vs. 94.
English: In this retrospective analysis, the superiority of Glivec over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Glivec patients and 63 (19.4%) IFN+Ara-C patients had died.
Maltese: 001); fi żmien 42 xahar, 47 (8.5%) pazjenti fuq Glivec u 63 (19.4%) pazjenti fuq IFN+Ara-C kienu mietu.
English: Ara-C 75 mg/m i.v.
Maltese: Ara-C 75 mg/m i.v. (1 h), jiem 1-5;
English: Patients were treated with Glivec 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Maltese: Il-pazjenti kienu kurati b'Glivec 340 mg/m2/jum, mingħajr interuzzjonijiet jekk ma jkunx hemm tossiċita li tillimita d-doża.
English: Partial 1 Haematological response criteria (all responses to be confirmed after  4 weeks): CHR: Study 0110 [WBC < 10 x 10 9/l, platelets < 450 x 10
Maltese: CHR: Studju 0110 [WBC < 10 x 10 9/l, plejtlets < 450 x10
English: Glivec 400 mg film-coated tablets EU/1/01/198/009
Maltese: Glivec 400 mg pilloli miksija b'rita EU/1/01/198/009
English: The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Maltese: Il-ħin medjan għall-avvanz fil-popolazzjoni globali ta' 411 pazjent b' Ph+ ALL li jirkadi/rifrattorju kienet bejn 2.6 u 3.1 xhur, u s-sopravivenza medja globali fil401 pazjent li setgħu jiġu evalwati kienet bejn 4.9 u 9 xhur.
English: In addition, thirty-six (36) months of Glivec treatment significantly prolonged overall survival (OS) compared to 12 months of Glivec treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 8, Figure 2).
Maltese: Barra minn hekk, sitta u tletin (36) xahar ta' trattament bi Glivec tawwal b'mod qawwi s-sopravivenza sħiħa (OS) mqabbel mat-12-il xahar ta' trattament bi Glivec (HR = 0.45 [0.22, 0.89], p=0.0187) (Tabella 8, Figura 2).
English: The printing ink is composed of red iron oxide (E172), shellac, soya lecithin.
Maltese: L-inka ta' l-istampar hija magħmula minn iron oxide aħmar (E172), shellac, soya lecithin.
English: Continuous daily exposure to Glivec early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without Glivec (69.6% vs. 31.6%, respectively).
Maltese: Espożizzjoni kontinwa kuljum għal Glivec kmieni waqt il-proċess ta' trattament flimkien ma' kemoterapija lil pazjenti f'koorti 5 (n=50) tejbu s-sopravivenza ħielsa minn kull episodju (EFS) f'4 snin mqabbel malkontrolli storiċi (n=120), li ngħataw kemoterapija standard mingħajr Glivec (69.6% vs 31.6%, rispettivament).
English: In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
Maltese: F'żewġ studji kliniċi (studju B2222 u studju b'grupp intern S0033), id-doża ta' Glivec kienet miżjuda għall 800 mg kuljum fil-pazjenti li kienu għaddejin tajjeb bid-dożi aktar baxxi ta' 400 mg u 600 mg kuljum.
English: In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Maltese: B'kuntrast, kien hemm 165 (29.8%) eventi fil-fergħa IFN+Ara-C, li minnhom 130 seħħew waqt il-kura preferita b'IFN+Ara-C.
English: Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after  4 weeks): WBC < 10 x 10
Maltese: Rispons Maġġuri fl-84 xahar (%) * p<0.001, test ezatt ta' Fischer ** perċentwali tar-rispons molekulari huma bbażati fuq il-kampjuni disponibbli Kriterji ta' rispons ematoloġiku (ir-risponsijiet kollha jridu jkunu konfermati wara ≥ 4 ġimgħat):
English: 9/l and platelets  20 x 10
Maltese: 9/l u plejtlets  20 x 10
English: CP 500 mg/m i.v.
Maltese: CP 200 mg/m i.v., jiem 3-5;
English: Using this approach, the estimated cumulative response rates for first-line treatment with Glivec 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: B'dan l-approċċ, ir-rati kumulativi stmati għall-kura preferita bi Glivec 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: Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Maltese: Għalhekk, huwa rakkomandat li tintuża kawtela meta Glivec jingħata flimkien ma' sustanzi li fuqhom jaġixxi isCYP3A4 u li għandhom medda terapewtika li hi żgħira (ez., cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel u quinidine).
English: - Gastrointestinal stromal tumours (GIST).
Maltese: (sinjali ta' disturbi gastrointestinali).
English: VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
Maltese: Daunorubicin 45 mg/m i.v., jiem 6-7, 13-14
English: Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Maltese: Ittumuri riedu jkunu jistgħu jitkejjlu f'mill-inqas sit wieħed tal-marda u l-karatterizzazzjoni kellha tkun ibbażata fuq il-kriterji tas-Southwestern Oncology Group (SWOG).
English: Glivec 50 mg hard capsules Glivec 100 mg hard capsules
Maltese: Glivec 50 mg kapsuli ibsin Glivec 100 mg kapsuli ibsin
English: repeat step 1 and resume Glivec at reduced dose of 260 mg/m
Maltese: Jekk iċ-ċitopenja ma tkunx relatata mallewkimja, naqqas id-doża ta' Glivec għal 260 mg/m
English: Fungal infection
Maltese: Infezzjoni tal-fungu
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST 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 b'MDS/MPD, DFSP, GIST u HES/CEL li għandhom inqas minn 18-il sena ma ġewx determinati waqt provi kliniċi.
English: 9/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC  1 x 10
Maltese: 9/l, l-ebda blasts fid-demm, blasts fil-mudullun < 5% u l-ebda mard barra l-mudullun] NEL L-istess kriterji bħal ta' CHR imma ANC  1 x 10
English: In vitro, imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumour (GIST) cells, which express an activating kit mutation.
Maltese: In vitro, imatinib jinibixxi l-proliferazzjoni u jistimola lapoptożi fiċ-ċelluli tat-tumur stromali gastro-intestinali (GIST), liema ċelluli jkunu jesprimu mutazzjoni kit li tattiva.
English: Glivec 100 mg film-coated tablets PVC/alu blisters
Maltese: Glivec 100 mg pilloli miksija b'rita Folji ta' l-alu/PVC
English: Methotrexate (5 g/m over 24 hours, IV): days 1 and 15
Maltese: Methotrexate (5 g/m fuq medda ta' 24 siegħa, IV): jiem 1 u 15
English: • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Maltese: • għall-kura ta' pazjenti adulti li jkollhom tumuri li jkunu pożittivi għal Kit (CD 117) u li ma jkunux jistgħu jitneħħew b'operazzjoni u/jew tumuri malinni u metastatiċi fl-istroma tassistema gastro-intestinali (GIST: Gastrointestinal Stromal Tumours).
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Maltese: II (studju B2225) kien imwettaq billi Glivec kien ittestjat f'popolazzjonijiet diversi ta' pazjenti li jsofru minn mard li jheddu l-ħajja assoċjati ma' Abl, Kit jew PDGFR proteini tyrosine kinases.
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Maltese: • pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati posittivi għall-lewkimja limfoblastika akuta b'kromosoma ta' Filadelfja (Ph+ ALL) integrata b'kimoterapija.
English: - The other ingredients are microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate and anhydrous colloidal silica.
Maltese: - Is-sustanzi mhux attivi huma microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate u anhydrous colloidal silica.
English: Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets
Maltese: Glivec 100 mg pilloli miksija b'rita Glivec 400 mg pilloli miksija b'rita