FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59),
Maltese: Risponsijiet ematoloġiċi u ċitoġenetiċi inżammu għall-medja ta' 49 xahar (medda bejn 19 u 60) u 47 xahar (medda ta' 16-59), rispettivament.
English: 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: 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: DEX (6 mg/m2/day, PO): days 1-5; 29-33
Maltese: DEX (6 mg/m2/kuljum, PO): jiem 1-5; 29-33
English: Imatinib Actavis contains sodium
Maltese: Imatinib Actavis fih sodium
English: Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Maltese: Dawk is-sustanzi li jinibixxu l-attività CYP3A4 ta' l-isoenzima ċitokromju P450 (eż. inibituri tal protease bħal indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; sustanzi kontra l-moffa azole inkluż ketoconazole, itraconazole, posaconazole, voriconazole; ċerti makrolidi bħal erythromycin, clarithromycin u telithromycin) jistgħu jnaqqsu l-metaboliżmu u b'hekk iżidu il-konċentrazzjonijiet ta' imatinib.
English: Neutropenia, thrombocytopenia, anaemia
Maltese: Newtropenja, tromboċitopenja, anemija
English: No evidence of leukaemia (NEL)
Maltese: L-ebda evidenza ta' lewkimja (NEL)
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (platelet count < 50 x 109/L) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Maltese: 4-6 darbiet ogħla fil-blast crisis jew fil-fażi l-imgħaġġla (59-64% u 44-63% fil-każijiet ta' newtropinja u tromboċitopenja, rispettivament) meta mqabbla mal-frekwenzi li wieħed kien isib fil-każijiet ta' pazjenti li tkun għada kif ġiet dijanjostikata CML fil-fażi l-kronika (16.7% newtropinja u 8.9% tromboċitopenja).
English: Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
Maltese: proteini diversi imseħħbin jew produzzjoni kostituttiva ta' PDGF kienu implikati fil-patoġenesi ta' MDS/MPD, HES/CEL u DFSP.
English: Out of the 12 patients enrolled, 9 responded, one completely and 8 partially.
Maltese: Mit-12-il pazjent reklutat, 9 urew rispons, wieħed komplet u 8 parzjali.
English: Caution should be used when taking imatinib 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 4.5).
Maltese: Wieħed għandu joqgħod attent meta imatinib 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: Complete haematological response (CHR)
Maltese: Rispons ematoloġiku1 Rispons ematoloġiku komplet (CHR)
English: Muscular weakness, arthritis, rhabdomyolysis/myopathy
Maltese: Dgħjufija muskolari, artrite, rabdomijoliżi/mijopatija
English: Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Maltese: Il-kapsuli huma fornuti f'pakketti bil-folji tal-aluminju ta' 24, 48, 60, 96, 120 jew 180 kapsuli.
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44%) and 3 (33%) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77%.
Maltese: Minn 9 pazjenti b'CML fil-fażi kronika u mit-tagħrif ċitoġenetiku disponibbli, jirriżulta li 4 (44%) u 3 (33%) kellhom rispons ċitoġenetiku komplet u parzjali, rispettivament, għal rata ta' MCyR ta' 77%.
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs. 31.6%, respectively).
Maltese: Espożizzjoni kontinwa kuljum għal imatinib kmieni waqt il-proċess ta' trattament flimkien ma' kimoterapija lil pazjenti f'koorti 5 (n=50) tejbu s-sopravivenza ħielsa minn kull episodju (EFS) ta' 4 snin imqabbel mal-kontrolli storiċi (n=120), li ngħataw kimoterapija standard mingħajr imatinib (69.6% vs 31.6%,
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Actavis, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Maltese: Jekk is-sejbiet tal-laboratorju jew kliniċi assoċjati ma' TMA iseħħu f'pazjent li jkun qed jirċievi Imatinib Actavis, 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: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Maltese: G-CSF (5 μg/kg, SC): jiem 5-14 jew sa ANC > 1500 post nadir Terapija IT tripla (aġġustata skont l-età): jiem 1 u 15
English: The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Maltese: Il-clearance tal-mediċina ħielsa ta' imatinib hija probabli simili bejn pazjenti li jkollhom indeboliment tal-kliewi u dawk b'funzjoni tal-kliewi normali, peress li l-eliminazzjoni renali tirrappresenta mezz ta' eliminazzjoni minuri għal imatinib (ara sezzjonijiet 4.2 u 4.4).
English: - The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).
Maltese: Kontenut tal-kapsula: microcrystalline cellulose, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe u colloidal anhydrous).
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: 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: Imatinib Actavis 100 mg hard capsules Al/PVC/Aclar blister.
Maltese: Imatinib Actavis 100 mg kapsuli iebsin Folji ta' l-aluminium/PVC/Aclar.
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Maltese: Riżultati simili dehru f'pazjenti b'glijomas malinni ikkurati b' imatinib waqt li kienu qed jieħdu prodotti mediċinali kontra lepilessija li jinduċu l-enzimi (EIAEDs) bħal carbamazepine, oxcarbazepine u phenytoin.
English: EU/1/13/825/020 10 capsules EU/1/13/825/021 30 capsules EU/1/13/825/022 60 capsules EU/1/13/825/023 90 capsules
Maltese: EU/1/13/825/020 10 kapsuli EU/1/13/825/021 30 kapsuli EU/1/13/825/022 60 kapsuli EU/1/13/825/023 90 kapsuli
English: 15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Maltese: 15 mg għal ġot-teka, jum 1, 8, 15, 22; Ara-C 40 mg għal ġot-teka, jum 1, 8, 15, 22; methylprednisolone 40 mg għal ġot-teka, jum 1, 8, 15,
English: VP-16 (100 mg/m2/day, IV): days 22-26
Maltese: VP-16 (100 mg/m2/kuljum, IV): jiem 22-26
English: Grade 3 and 4 neutropenia was seen in 7.5% and
Maltese: Newtropinja ta' grad 3 u grad 4 kienet evidenti f' 7.5% f' 2.7% tal-pazjenti,
English: In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
Maltese: Fi provi kliniċi b'CML, it-twaqqif tal-mediċina minħabba reazzjonijiet avversi tal-mediċina kienu osservati f'2.4% tal-pazjenti li jkunu għadhom kif ġew dijanjostikati, 4% tal-pazjenti fil-fażi kronika avvanzata wara li falliet terapija b'interferon, 4% tal-pazjenti fil-fażi aċċelerata wara li falliet terapija b'interferon u 5% tal-pazjenti bi blast crisis wara li falliet it-terapija b'interferon.
English: (1 h) day 1; AraC 60 mg/m2 i.v., days 22-25, 29-32
Maltese: Ara-C 60 mg/m2 i.v., jum 22-25, 29-32
English: Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Maltese: (SCF) kkodifikat bis-c-Kit proto-oncogene, id-discoidin domain receptors (DDR1 u DDR2), il-colony stimulating factor receptor (CSF-1R) u l-platelet-derived growth factor receptors alpha u beta
English: EU/1/13/825/015 10 tablets EU/1/13/825/016 30 tablets EU/1/13/825/017 60 tablets EU/1/13/825/018 90 tablets
Maltese: EU/1/13/825/015 10 pilloli EU/1/13/825/016 30 pilloli EU/1/13/825/017 60 pilloli EU/1/13/825/018 90 pilloli
English: 5.2 Pharmacokinetic properties
Maltese: .2 Propretajiet farmakokinetiku
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Maltese: Tlett pazjenti urew rispons ematoloġiku komplet (complete haematological response (CHR)) u pazjent kellu rispons ematoloġiku parzjali (partial haematological response (PHR)).
English: Due to the observational nature of this registry, haematologic, cytogenetic and molecular assessment data were available for 22, 9 and 17 of the 23 enrolled patients, respectively.
Maltese: osservazzjoni ta' dan il-reġistru, data ta' valutazzjoni ematoloġiċi, ċitoġenetiċi u molekulari, kienu disponibbli għal 22, 9 u 17 il-pazjent mit-23 pazjent irreġistrat, rispettivament.
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-Bcr-Abl tyrosine kinase fil-livelli in vitro, ċellulari u in vivo.
English: Imatinib Actavis 400 mg hard capsules Al/PVC-PVDC blister.
Maltese: Imatinib Actavis 400 mg kapsuli iebsin Folja ta' l-aluminium/PVC/PVDC.
English: Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8; prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28; MTX
Maltese: Daunorubicin 30 mg/m2 i.v., jum 1-3, 15-16; VCR 2 mg dosa totali i.v., jum 1, 8, 15, 22; CP 750 mg/m2 i.v., jum 1, 8; prednisone 60 mg/m2 orali, jum 1-7, 15-21;
English: This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Maltese: 7 pazjenti b'MDS/MPD li kienu trattati b'imatinib 400 mg kuljum.
English: In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Maltese: F'testijiet in vitro imatinib inibixxa l-attività tas-CYP2D6, isoenzima taċ-ċitokromju P450,
English: Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR and Abl kinase activity.
Maltese: Imatinib jinibixxi s-sinjalar u l-proliferazzjoni ta' ċelluli mmexxija minn PDGFR regolat ħażin u attivit ta' Abl kinase.
English: The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Maltese: L-OS stmata ta' 4 snin fost il-pazjenti f'koorti 5 kienet ta' 83.6% imqabbel ma' 44.8%
English: Pack sizes: The capsules are supplied in aluminium blister packs of 10, 30, 60, or 90 capsules.
Maltese: Il-kapsuli huma fornuti f'pakketti bil-folji tal-aluminium ta' 10, 30, 60 jew 90 kapsuli.
English: EU/1/13/825/008 10 tablets EU/1/13/825/009 20 tablets EU/1/13/825/010 30 tablets EU/1/13/825/011 60 tablets EU/1/13/825/012 90 tablets EU/1/13/825/013 120 tablets EU/1/13/825/014 180 tablets
Maltese: EU/1/13/825/008 10 pilloli EU/1/13/825/009 20 pilloli EU/1/13/825/010 30 pilloli EU/1/13/825/011 60 pilloli EU/1/13/825/012 90 pilloli EU/1/13/825/013 120 pilloli EU/1/13/825/014 180 pilloli
English: Pack containing either 30 or 90 capsules.
Maltese: Pakketi li fihom 30 jew 90 kapsuli.
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Maltese: Barra minn hekk, 24 pazjent ieħor b'MDS/MPD kienu rappurtati f'13-il publikazzjoni.
English: Imatinib Actavis 100 mg film-coated tablets Pack containing either 10, 20, 30, 60, 90, 120 or 180 film-coated tablets
Maltese: Imatinib Actavis 100 mg pilloli miksija b'rita Pakketti li fihom 10, 20, 30, 60, 90, 120 jew 180 pilloli miksija b'rita.
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Maltese: Kienu rrappurtati 5 pazjenti b'DFSP u b'assoċjazzjoni ma' riarranġamenti tal-ġene PDGFR fi 3 pubblikazzjonijiet.
English: Inductionconsolidation therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Stop imatinib until ANC ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Maltese: Waqqaf imatinib sakemm ANC ≥ 1.5 x 109/L u plejtlets ≥ 75 x 109/L.
English: Induction therapy I DEX 10 mg/m2 oral, days 1-5; VCR 2 mg i.v., days 6, 13, 20; daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Maltese: DEX 10 mg/m2 orali, jum 1-5; VCR 2 mg i.v., jum 6, 13, 20; daunorubicin 45 mg/m2 i.v., jum 6-7, 13-14
English: Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Maltese: Spażmi fil-muskoli u bugħawwieġ, uġigħ muskoluskeletrali inklużi mijalġja9, artralġja, u uġigħ fl-għadam10
English: Ara-C 75 mg/m2 i.v.
Maltese: Ara-C 75 mg/m2 i.v. (siegħa), jum 1-5;
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 at reduced dose of 260 mg/m2.
Maltese: Fil-każ li l-ANC jerga' < 1.0 x 109/L u/jew il-plejtlets < 50 x 109/L, erġa irrepeti Nru. 1 u erġa ibda imatinib b'doża mnaqqsa ta' 260 mg/m2.
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Maltese: Il-pazjenti kienu kurati b'imatinib 340 mg/m2/jum, mingħajr interuzzjonijiet jekk ma jkunx hemm tossiċita li tillimita d-doża.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-immaniggjar tar-riskju (RMP)
English: ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
Maltese: ANC < 1.0 x 109/L u/ jew plejtlets < 50 x 109/L
English: The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
Maltese: In-numru meħtieġa ta' pilloli għandhom jitpoġġew fil-volum xieraq ta' xorb (madwar 50 ml għall-pillola ta' 100 mg, u 200 ml għall-pillola ta' 400 mg) u jiġu mħawwda b'kuċċarina.
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Maltese: L-AUC talplażma għal dan il-metabolu kienet biss 16% ta' l-AUC għal imatinib.
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Maltese: MESNA (360 mg/m2/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5 G-CSF (5 μg/kg, SC): jiem 6-15 jew sa ANC > 1500 post nadir
English: 11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Maltese: 11 Każijiet fatali kienu rrappurtati f'pazjenti b'marda avanzata, infezzjonijiet severi, newtropenija severa u kondizzjonijiet serji oħra fl-istess waqt.
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Maltese: Rispons maġġuri jiġbor flimkien kemm ir-risponsijiet kompleti kif ukoll dawk parzjali: kompleti (0% ta' metafasijiet Ph+), parzjali (1-35%).
English: Return to chronic phase (RTC) Major cytogenetic response2
Maltese: Ritorn għall-fażi l-kronika (RTC) Rispons ċitoġenetiku maġġuri2
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Maltese: Raxx bil-ponot, kontużjoni, żieda fl-għaraq, urtikarja, ekkimożi, tidbenġel malajr, ipotrikożi, ipopigmentazzjoni tal-ġilda, dermatite esfoljattiva, onikoklażi, follikulite, tikkek ħomor fil-ġilda, psorajiżi, purpura,
English: CPM (300 mg/m2/day, IV): days 22-26
Maltese: CPM (300 mg/m2/kuljum, IV): jiem 22-26
English: This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kapsula iebsa, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Maltese: Id-doża ta' imatinib rakkomandata hija ta' 600 mg/jum f' pazjenti adulti f' blast crisis.
English: Intensification block 2 (9 weeks)
Maltese: Blokk 2 ta' intensifikazzjoni
English: Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Maltese: Imatinib ma kienx meqjus li kellu effett ġenotossiku meta gie ttestjat f'assay ta' ċelluli ta' batterji in vitro (test Ames), u f'assay ta' ċelluli mammiferi in vitro (limfoma fil-ġurdien) u f'test in vivo fuq ilmikronukleju fil-far.
English: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Maltese: Id-doża hija 800 mg kuljum (8 pilloli), li għandha tittieħed bħala 4 pilloli filgħodu u 4 pilloli filgħaxija.
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Maltese: Qoxra tal-kapsula: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Maltese: Palpitazzjonijiet, takikardja, insuffiċjenza konġestiva tal-qalb3, edema fil pulmun
English: In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
Maltese: F'GIST, il-mediċina tal-istudju kellha titwaqqaf minħabba reazzjonijiet avversi tal-mediċina f'4% tal-pazjenti.
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Maltese: Tromboċitemija, limfopenja, dipressjoni tal-mudullun, eżinofolja,
English: 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients.
Maltese: rispettivament, u tromboċitopenja ta' grad 3 f' 0.7% tal-pazjenti.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Maltese: Il-pazjenti adulti rappurtati fil-publikazzjoni kienu kurati jew b'400 mg (4 każijiet) jew 800 mg (każ 1) imatinib kuljum.
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Maltese: Il-65 pazjent kollha li kienu posittivi għal FIP1L1-PDGFRα fusion kinase kisbu CHR li nżamm sostnut għal xhur (medda ta' bejn 1+ sa 44+ xhur ċensurati fil-ħin meta ġew rappurtati).
English: 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 function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Maltese: Il-funzjoni tal-fwied (transaminases, bilirubin, alkaline phosphatase) għandha tiġi immonitorjata b'mod regolari f'pazjenti li jkunu qed jirċievu imatinib.
English: (0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
Maltese: IDA 8 mg/m i.v. (0.5 h), jum 7, 8, 14, 15; CP 500 mg/m i.v. (siegħa) jum 1;
English: The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold drug accumulation after repeated once-daily dosing.
Maltese: Meta ġew imqabbla l-AUC(0-24) fit-8 jum u fl-1 jum fl-livell ta' doża ta' 340 mg/m2/jum, instab li l- prodott mediċinali kien akkumulat b' 1.7-il darba wara dożi ripetuti ta' darba kuljum.
English: Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Maltese: AUC ta' metoprolol b'madwar 23% (90%CI [1.16-1.30]).
English: Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Maltese: II/III, multiċentriku, open-label, randomised li kien jinkludi 128 pazjent (1 sa< 18-il sena) ttrattati b'imatinib flimkien ma' kimoterapija.
English: Dyspnoea, epistaxis, cough
Maltese: Qtugħ ta' nifs, epistassi, sogħla
English: and platelets ≥ 75 x 109/L.
Maltese: 109/L u plejtlets ≥ 75 x 109/L.
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 imatinib.
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 imatinib.
English: Table 4 Chemotherapy regimen used in combination with imatinib in study I2301
Maltese: Tabella 4 Kors ta' kimoterapija użat flimkien ma' imatinib fl-istudju I2301
English: Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Maltese: Uġigħ fil-plewra, fibrożi fil-pulmun, pressjoni għolja fil-pulmun, emorraġija fil-pulmun
English: Fluid retention
Maltese: Retenzjoni ta' fluwidi
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).