FrancophonIA/ELRC3.0 huggingface dataset:
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: The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily.
Maltese: Il-pazjent pedjatriku rċieva doża 400 mg/m²/kuljum, u sussegwentement tiżdied għal 520 mg/m²/kuljum.
English: In an observational study in the CML paediatric population, a statistically significant decrease (but of uncertain clinical relevance) in median height standard deviation scores after 12 and 24 months of treatment was reported in two small subsets irrespective of pubertal status or gender.
Maltese: Fi studju ta' osservazzjoni fil-popolazzjoni pedjatrika b'CML, kien irrappurtat tnaqqis statistikament sinifikanti (imma ta' relevanza mhux ċerta klinikament) fil-punteġġi ta' devjazzjoni standard tat-tul medju wara 12 u 24 xahar ta' trattament f'żewġ sottogruppi żgħar irrispettivament mill-istat ta' pubertà jew sess.
English: MTX 15 mg intrathecal, day 1;
Maltese: MTX 12 mg intrathecal, jum 1
English: 9/l) and thrombocytopenias (platelet count < 50 x 10
Maltese: 9/l) u tromboċitpenji (għadd tal-plejtlits < 50 x 10
English: Active substances that may increase imatinib plasma concentrations 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 tal-isoenzima ċitokromju P450 (eż. inibituri talprotease bħal indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; antifungali azole li jinkludu ketoconazole, itraconazole, posaconazole, voriconazole; ċerti makrolidi bħal erythromycin, clarithromycin u telithromycin) jistgħu jnaqqsu l-metaboliżmu u b'hekk iżidu ilkonċentrazzjonijiet ta' imatinib.
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg, or from 800 mg to 600 mg, and in paediatric patients from 340 mg to 260 mg/m2/day.
Maltese: Fil-kbar id-doża għandha titnaqqas minn 400 mg għal 300 mg jew inkella minn 600 mg għal 400 mg, jew minn 800 mg għal 600 mg, u f'pazjenti pedjatriċi minn 340 mg għal 260 mg/m²/jum.
English: In clinical trials in CML, discontinuation of the investigational medicinal product for treatment-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-prodott mediċinali investigattiv minħabba reazzjonijiet avversi tal-kura 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: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Maltese: II, open label, f'ħafna ċentri (studju B2225) kien imwettaq b'12-il pazjent b'DFSP ikkurati b'imatinib 800 mg kuljum.
English: Induction therapy II
Maltese: Terapija ta' induzzjoni II
English: Liver dysfunction
Maltese: Indeboliment fil-funzjoni tal-organi
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 attività ta' Abl kinase.
English: Clinical studies in chronic myeloid leukaemia
Maltese: Studji kliniċi fil-lewkimja majelojde kronika
English: 9/l and platelets ≥ 75 x 10
Maltese: 9/l u l-plejtlits ≥ 75 x 10
English: DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Maltese: G-CSF = fattur stimulanti tal-kolonja granuloċite, VP-16 = etoposide, MTX = methotrexate, IV = minn ġol-vina, SC = minn taħt il-ġilda, IT = intrathecal, PO = orali, IM = intramuskulari, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= jew sa meta l-livell MTX ikun < 0.1 μM, q6h = kull 6 sigħat, Gy= Gray
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli):
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 l-epilessija li jinduċu l-enzimi (EIAEDs) bħal carbamazepine, oxcarbazepine u phenytoin.
English: oral, days 1-7, 15-21;
Maltese: Prednisone 60 mg/m² orali, jiem 1-7, 15-21;
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Maltese: Erba' pazjenti oħra instabu pożittivi għal FIP1L1-PDGFRα f'3 rapporti oħra li ġew ippubblikati.
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Maltese: MTX: methotrexate; 6-MP: 6-mercaptopurine VM26:
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 jimpedixxi wkoll lir-receptor tyrosine kinases għall-growth factor derivat mill-plejtlits (PDGF), PDGF-R, u l-istem cell factor(SCF), c-Kit, u b'hekk jimpedixxi effetti fil-livell ċellulari li jkunu assoċjati ma' PDGF u ma' SCF.
English: Very common: Headache Common:
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni:
English: Other medicines and Imatinib medac
Maltese: Mediċini oħra u Imatinib medac
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage
Maltese: Stomatite, ulċeri fil-ħalq, emorraġija gastro-intestinali
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: Minħabba n-natura ta' osservazzjoni ta' dan ir-reġistru, kien hemm disponibbli data ematoloġika, ċitoġenetika u molekulari għal 22, 9 u 17 mit-23 pazjent imsieħba, rispettivament.
English: Imatinib is a protein kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Maltese: Imatinib huwa sustanza li timpedixxi l-enzima protein kinase li b'saħħa timpedixxi lill-Bcr-Abl tyrosine kinase fil-livelli in vitro, ċellulari u in vivo.
English: Neutropenia and thrombocytopenia toxicity
Maltese: Tossiċità min newtropenija u tromboċitopenija
English: Common: Uncommon:
Maltese: Komuni ħafna:
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Maltese: Tromboċitemija, limfopenija, dipressjoni tal-mudullun, eżinofolja,
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;
English: The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Maltese: Id-doża totali kuljum fit-tfal u fl-adolexxenti ma tistax taqbeż it-800 mg b'CML u 600 mg b'Ph+ALL.
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: Intensification block 1 (9 weeks)
Maltese: Blokk 1 ta' intesifikazzjoni (9 ġimgħat)
English: Paediatric chronic phase CML (at dose 340 mg/m
Maltese: CML fil-fażi kronika pedjatrika (doża tal-bidu 340 mg/m²)
English: Intensification block 2 (9 weeks)
Maltese: Blokk 2 ta' intesifikazzjoni (9 ġimgħat)
English: Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Maltese: Kienu rrappurtati 5 pazjenti b'MDS/MPD b'assoċjazzjoni ma' riarranġamenti tal-ġene PDGFR f'4 pubblikazzjonijiet.
English: • Difficulty in sleeping (insomnia).
Maltese: • Diffikultà biex torqod (insomnja).
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/m²)
English: The overall survival is 65 months since diagnosis (range 25-234).
Maltese: Is-sopravivenza globali hija 65 xahar minn meta saret id-dijanjosi (medda 25-234).
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: L-istudju AIT07 kien studju f'fażi II/III multiċentriku, open-label, randomizzat li kien jinkludi 128 pazjent (1 sa< 18-il sena) ttrattati b'imatinib flimkien ma' kemoterapija.
English: In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Maltese: F'pazjenti b'indeboliment tal-kliewi, l-esponiment fil-plażma ta' imatinib jidher li jkunu ogħla minn dak f'pazjenti b'funzjoni tal-kliewi normali, probabbli minħabba livell għoli fil-plażma ta' alpha-acid glycoprotein (AGP), proteina li tintrabat ma' imatinib, f'dawn il-pazjenti.
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/m² i.v., jiem 6-7, 13-14
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 fil-401 pazjent li setgħu jiġu evalwati kienet bejn 4.9 u 9 xhur.
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Maltese: Krejatinina fid-demm tiżdied, creatine phosphokinase fid-demm jiżdied, lactate dehydrogenase jiżdied, alkaline phosphatise fid-demm jiżdied
English: Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Maltese: Imatinib medac 100 mg kapsuli ibsin Imatinib medac 400 mg kapsuli ibsin
English: The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Maltese: Il-farmakokinetiċi ta' imatinib kienu stmati għal dożaġġ li jvarja minn 25 sa 1,000 mg.
English: The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Maltese: Il-qoxra tal-kapsula għal kapsula ta' 400 mg tikkonsisti minn gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) u black iron oxide (E172).
English: • CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase.
Maltese: • CML fil-fażi kronika wara l-falliment ta' terapija b'interferon alfa, jew fil-fażi aċċellerata.
English: • adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Maltese: • pazjenti adulti li rkadew jew li jkollhom Ph+ ALL rifrattorja bħala monoterapija.
English: Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Maltese: Irritazzjoni tal-għajnejn, uġigħ fl-għajnejn, edema orbitali, emorraġija flisklera, emorraġija fir-retina, blefarite, edema makulari
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Maltese: 18 Gy f'10 frazzjonijiet għal pazjenti li huma CNS3 waqt id-dijanjosi VCR (1.5 mg/m²/kuljum, IV): jiem 1, 29
English: Out of the 12 patients enrolled, 9 responded, one completely and 8 partially.
Maltese: Mit-12-il pazjent reklutat, 9 wrew rispons, wieħed komplet u 8 parzjali.
English: (1 h), days 28-31, 35-38, 42-45;
Maltese: Ara-C 75 mg/m² i.v. (1 h), jiem 28-31, 35-38, 42-45; 6-MP 60 mg/m² orali, jiem 26-46
English: Pharmacokinetics of imatinib
Maltese: Il-farmakokinetiċi ta' imatinib
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 rrappurtati fil-pubblikazzjoni kienu kkurati jew b'400 mg (4 każijiet) jew 800 mg (każ 1) imatinib kuljum.
English: Plasma pharmacokinetics
Maltese: Farmakokinetiċi tal-plażma
English: (n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Maltese: Il-pazjenti ġew ikkurati b'dożi ta' imatinib ta' 260 mg/m²/jum (n=5), 340 mg/m²/jum (n=9), 440 mg/m²/jum (n=7), u 570 mg/m²/jum (n=5).
English: Laboratory test abnormalities
Maltese: Anormalitajiet fit-testijiet tal-laboratorju
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: *, interstitial lung disease*
Maltese: *, marda tal-interstizju tal-pulmun*
English: • Chronic renal failure.
Maltese: • Insuffiċjenza kronika tal-kliewi.
English: In GIST the investigational medicinal product was discontinued for imatinib-related adverse reactions in 4 % of patients.
Maltese: F'GIST, il-prodott mediċinali investigattiv kellu jitwaqqaf minħabba reazzjonijiet avversi relatati ma' imatinib f'4% tal-pazjenti.
English: 5, pharyngolaryngeal pain, pharyngitis
Maltese: 5, uġigħ fil-farinġi u fil-larinġi, farinġite
English: No evidence of leukaemia (NEL) Return to chronic phase (RTC) Major cytogenetic response Complete (Confirmed
Maltese: Ritorn għall-fażi l-kronika (RTC)
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p < 0.001; OS p < 0.0001) in two studies (AJP01 and AUS01).
Maltese: OS p<0.0001) f'żewġ studji (AJP01 u AUS01).
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation,
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, iperpigmentazzjoni tal-ġilda, joħorġu l-imsiemer
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Maltese: • Lewkimja limfoblastika akuta pożittiva għall-kromosoma ta' Philadelphia (Ph-pożittiva
English: There are no controlled trials in paediatric patients with MDS/MPD.
Maltese: M'hemmx provi kkontrollati fost pazjenti pedjatriċi b'MDS/MPD.
English: MTX 1.5 g/m i.v.
Maltese: MTX 1.5 g/m² i.v. (24 h), jum 1;
English: BM = bone marrow, PB = peripheral blood
Maltese: BM = Mudullun, PB = demm fil-periferiji ² Kriterji għar-risponsijiet ċitoġenetiċi:
English: Five (5) patients responded, 3 completely and 2 partially.
Maltese: Ħames (5) pazjenti wrew rispons, 3 komplet u 2 parzjali.
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% tal-AUC għal imatinib.
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: NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ medac GmbH
English: How to store Imatinib medac
Maltese: Tiħux Imatinib medac:
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-firien.
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,
English: ANC = absolute neutrophil count a occurring after at least 1 month of treatment
Maltese: ANC = l-għadd assolut tan-newtrofils (absolute neutrophil count)
English: 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.
Maltese: 9/l 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.
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Maltese: 9%), 9/9 (100%) u 11/17 (64.7%), rispettivament.
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' żamma severa ta' fluwidi (effużjoni mill-plewra, edima, edima tal-pulmun, axxite, edima superfiċjali) kienu rrappurtati f'madwar 2.5% tal-pazjenti b'CML li jkunu għadhom kif ġew dijanjostikati li jkunu qed jieħdu imatinib.
English: • Itching.
Maltese: • Tinfaraġ.
English: The dose of
Maltese: U KWANTITATTIVA
English: The in vitro results showed that CYP3A4 was the major human P450 enzyme catalysing the biotransformation of imatinib.
Maltese: Ir-riżultati in vitro wrew li CYP3A4 kienet l-enzima prinċipali fil-bniedem tat-tip P450 li tikkatalizza l-biotransformazzjoni ta' imatinib.
English: 9/l, then resume treatment at 300 mg.
Maltese: Jekk iċ-ċitopenija tippersisti għal ġimagħtejn,erġa naqqas għal 300 mg.
English: VP-16 (100 mg/m 2, IV): days 29-33
Maltese: VP-16 (100 mg/m²/kuljum, IV): jiem 22-26
English: The plasma AUC for imatinib decreased by 73 % compared to patients not on EIAEDs.
Maltese: L-AUC fil-plażma għal imatinib naqset b'73% meta mqabbla ma pazjenti li ma kinux qed jieħdu EIAED's.
English: Pleural effusion
Maltese: Bijotrasformazzjoni
English: Population pharmacokinetics
Maltese: Farmakokinetiċi tal-popolazzjoni
English: This inhibition has not been observed in vivo after the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Maltese: Din linibizzjoni ma ġietx osservata in vivo wara l-għoti ta' imatinib 400 mg u paracetamol 1000 mg.
English: Capsule shell
Maltese: Qoxra tal-kapsula Gelatin
English: The no observed effect level (NOEL) was 30 mg/kg/day.
Maltese: Il-livell fejn ma jkunx osservat effett (NOEL) kien 30 mg/kg/jum.
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-bilirubina totali
English: The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of
Maltese: Jekk id-doża ta' kuljum tkun 800 mg għandek tieħu 1 kapsula ta' 400 mg filgħodu u 1 kapsula ta' 400 mg filgħaxija.
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' kemoterapija (ara sezzjoni 5.1), iżda interazzjonijiet bejn mediċini ta' imatinib ma' reġimens kimoterapewtiċi għadhom ma ġewx iċċarati.
English: The age of these patients ranged from 25 to 72 years.
Maltese: L-etajiet ta' dawn il-pazjenti kienu bejn 25 u 72 sena.
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib 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 imatinib 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: 4) Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Maltese: 4) Fwawar kienu l-aktar komuni f'pazjenti b'GIST u fsada (ematoma, emorraġija) kienet l-aktar komuni f'pazjenti b'GIST u pazjenti b'CML trasformat (CML-AP u CML-BC).
English: Imatinib medac inhibits the
Maltese: Kif taħżen Imatinib medac
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Maltese: • Infjammazzjoni f'daqqa tal-ġilda u ħmura (sinjali ta' infezzjoni fil-ġilda msejħa ċellulite).
English: Name and address of the manufacturers responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib 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' imatinib 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: 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 accumulation after repeated once-daily dosing.
Maltese: Meta ġew imqabbla l-AUC(024) fit-8 jum u fl-1 jum fl-livell ta' doża ta' 340 mg/m²/jum, instab li l-mediċina kienet akkumulat b'1.7-il darba wara dożi ripetuti ta' darba kuljum.
English: 9/l and/or platelets < 50 x 10
Maltese: 9/l plejtlits < 50 x 10