FrancophonIA/ELRC3.0 huggingface dataset:
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: Madankollu,il-frekwenzi ta' ċitopenji dehru biċ-ċar li kienu jiddependu wkoll fuq l-istadju tal-marda, tant li l-frekwenzi ta' newtropinji tat-3 jew ir-4 grad (ANC < 1.0 x 109/L) u tromboċitpenji (għadd tal-plejtlets < 50 x 109/L) kienu bejn 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: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract
Maltese: Herpes zoster, herpes simplex, nasofarinġite, pulmonite1, sinużite, ċellulite,
English: CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4
Maltese: CPM (250 mg/m2/doża q12h x 4 dożi, iv): Jiem 3 u 4
English: 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 = 6mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2
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 =
English: In the adjuvant setting, imatinib 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: Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Maltese: Pakketti ta' 30x1 or 90x1 kapsuli iebsin f' ‘perforated unit dose blisters'.
English: • Mouth ulcers.
Maltese: Użu orali.
English: A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day imatinib 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 imatinib 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 >
English: MTX 15 mg intrathecal, days 1, 8, 15, 22;
Maltese: MTX 15 mg għal ġot-teka, jum 1, 8, 15, 22;
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 nnatura 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: Description of selected adverse reactions Hepatitis B reactivation
Maltese: Riattivazzjoni tal-epatite B
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 lmoffa azole inkluż ketoconazole, itraconazole, posaconazole, voriconazole; ċerti makrolidi bħal erythromycin, clarithromycin u telithromycin) jistgħu jnaqqsu l-metaboliżmu u b'hekk iżidu ilkonċentrazzjonijiet ta' imatinib.
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Maltese: CPM (250 mg/m2/doża q12h x 4 doI, IV): jiem 3 u 4
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: Iddoża kienet miżjuda għal 800 mg kuljum f'total ta' 103 pazjenti, 6 pazjenti kisbu rispons parzjali u f'21 ilmarda ġiet stabbli wara żieda fid-doża b'benefiċju kliniku globali ta' 26%.
English: RFS rates (%) 12 month 24 month Imatinib vs placebo
Maltese: RFS rates (%) 12-il xahar 24 xahar
English: In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of imatinib 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' imatinib kienet miżjuda għall 800 mg kuljum fil-pazjenti li kienu għaddejin tajjeb bid-dożi aktar baxxi ta' 400 mg u 600 mg kuljum.
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: 147), filwaqt li fil-popolazzjoni globali kienet 84 ġimgħat (95% C.I. 71-109).
English: • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor (PDGFR) gene re-arrangements.
Maltese: - Pazjenti adulti b'mard majelopisplatiku/majeloproliferattiv (myelodysplastic/myeloproliferative diseases (MDS/MPD)) assoċjat ma' bidla fl-arranġament tal-ġene tar-riċettur tal-fattur ta' tkabbir derivat minn plejtlets (platelet-derived growth factor receptor (PDGFR)).
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-mediċina kienet akkumulat b' 1.7-il darba wara dożi ripetuti ta' darba kuljum.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5;
Maltese: DEX 10 mg/m2 orali, jum 1-5; CP 200 mg/m2 i.v., jum 3-5;
English: Frequency categories are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenzi huma definiti bl-użu ta' din il-konvenzjoni li jmiss: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa
English: , Ελλάδα Τηλ: +30 210 72 79 099
Maltese: Τηλ: +30 210
English: Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT population)
Maltese: Figura 1 L-istimi Kaplan-Meier għall-endpoint primarju ta' sopravivenza mingħajr rikorrenza
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of
Maltese: Fl-istudju kliniku 38% tal-pazjenti kellhom ≥ 60 sena u 12% tal-pazjenti kellhom ≥ 70 sena.
English: • Itching.
Maltese: il xahar).
English: imatinib teva b.v. 100 mg hard capsules
Maltese: Imatinib Teva B.V. 100 mg kapsuli Imatinib
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase
Maltese: Krejatinina fid-demm tiżdied, creatine phosphokinase fid-demm jiżdied, lactate dehydrogenase jiżdied, alkaline phosphatise fid-demm jiżdied
English: - The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous.
Maltese: Crospovidone Magnesium stearate Silica colloidal, anhydrous
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, f'konċentrazzjonijiet simili għal dawk li jaffettwaw l-attività tas-CYP3A4.
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: ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
Maltese: ANC < 1.0 x 109/L u/jew plejtelets < 50 x 109/L
English: (1 h), days 1-3; Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Maltese: Daunorubicin 60 mg/m2 i.v. (siegħa), jum 1-3; Vincristine 1.3 mg/m2 i.v., jum 1, 8, 15, 21;
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: VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Maltese: VCR (1.5 mg/m2/kuljum, IV): jiem 1, 8, u 15
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-prodott mediċinali 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: Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Maltese: Pakketti li fihom 20x1, 60x1, 120x1 jew 180x1 pilloli miksija b'rita f' ‘perforated unit dose blisters'.
English: Increased hepatic enzymes
Maltese: Anemija emolitika
English: Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Maltese: Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x 6 dożi)iii: jiem 2 and 3
English: The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)-positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Maltese: imatinib f'kull sett tal-popolazzjoni pedjatrika fil-kromosoma Philadelphia (bcr-abl translocation)-lewkimja majelojd kronika pożittiva (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
Maltese: aANC < 0.5 x 109/L u/jew plejtelets < 10 x 109/L
English: Imatinib Teva B.V. 400 mg hard capsules Pack sizes of 30 or 90 hard capsules in blisters.
Maltese: Imatinib Teva B.V. 400 mg kapsuli iebsin Pakketti li fihom 30 jew 90 kapsuli iebsin f' folji.
English: (0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
Maltese: IDA 8 mg/m2 i.v. (0.5 h), jum 7, 8, 14, 15; CP 500 mg/m2 i.v. (siegħa) jum 1;
English: 6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
Maltese: 6+7 Uġigħ fl-addome u emorraġija gastro-intestinali dehru b'mod l-aktar komuni f'pazjenti b'GIST.
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 li għandhom minn 55 sena ‘l fuq, imatinib użat waħdu wassal għal rispons ematoloġiku komplet b'rata ogħla mill-kimoterapija (96.3% vs 50%; p=0.001).
English: then resume treatment at 300 mg.
Maltese: Jekk iċ-ċitopenja tippersisti għal ġimgħatejn,erġa naqqas għal 300 mg.
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Maltese: Ara-C 40 mg għal ġot-teka, jum 1, 8, 15, 22;
English: (3 weeks)
Maltese: (3 ġimgħat)
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Maltese: Tromboċitemija, limfopenja, dipressjoni tal-mudullun, eżinofolja,
English: - Each hard capsule of Imatinib Teva B.V. contains 400 mg imatinib (as mesilate).
Maltese: - Kull kapsula ta' Imatinib Teva B.V. fiha 400 mg imatinib (bħal mesilate).
English: then resume treatment at 200 mg/m2.
Maltese: 200 mg/m2.
English: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Maltese: Prednisone 60 mg/m2 orali, jum 1-7, 15-21;
English: Imatinib Teva B.V. 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets
Maltese: Imatinib Teva B.V. Pilloli miksija b'rita ta '400 mg huma disponibbli f'pakketti ta' daqs ta' 30x1 jew 90x1
English: In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56].
Maltese: F'analiżi ppjanata ta' grupp sekondarju permezz tat-tip ta' mutazzjoni, l-HR għar-RFS għal 36 xahar ta' trattament għal pazjenti b'mutazzjonijiet ta' exon 11 kien 0.35 [95% CI: 0.22, 0.56].
English: • Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Maltese: - Pazjenti adulti illi ġew iddijanjostikati għall-ewwel darba bil-lewkimja limfoblastika akuta b'kromosoma ta' Filadelfja (Ph+ ALL), integrata mal-kemoterapija.
English: • The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Maltese: • Il-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: The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 l/h, while for a patient weighing 100 kg the clearance will rise to 11.8 l/h.
Maltese: kg il-clearance medja mistennija tkun 8.5 l/siegħa, filwaqt li f'pazjent ta' 100 kg il-clearance titla' għal 11.8 l/siegħa.
English: The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients with Ph+ ALL.
Maltese: Id-doża rakkomandata ta' imatinib għal pazjenti adulti b'Ph+ALL hija ta' 600 mg/jum.
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 il-volum ta' distribuzzjoni (żieda ta' 12% f' pazjenti li għandhom > 65 sena).
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15
Maltese: Methotrexate (5 g/m2 fuq medda ta' 24 siegħa, IV): jiem 1 u 15
English: Imatinib significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the imatinib group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Maltese: Imatinib tawwal b'mod sinifikanti l-RFS, b'75% tal-pazjenti li ma reġax kellhom il-marda fit-38 xahar fil grupp ta' imatinib vs. 20 xahar fil-grupp bi plaċebo (CIs 95%, [30 - ma tistax tittieħed stima]; [14 - ma tistax tittieħed stima], rispettivament);
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 25234).
English: MTX 1.5 g/m2 i.v.
Maltese: MTX 1.5 g/m2 i.v. (24 siegħa), jum 1;
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis,
Maltese: Stomatite, ulċeri fil-ħalq, emorraġija gastro-intestinali7, tifwieq, melena, esofaġite, axxite, ulċera fl-istonku, rimettar tad-demm, kejlite, disfaġja,
English: The age of these patients ranged from 25 to 72 years.
Maltese: L-etajiet ta' dawn ilpazjenti kienu bejn 25 u 72 sena.
English: Etoposide 250 mg/m2 i.v.
Maltese: Etoposide 250 mg/m2 i.v. (siegħa) days 4-5;
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction,
Maltese: Arritmija, fibrillazzjoni atrijali, attakk tal-qalb, infart mijokardijaku, anġina pectoris, effużjoni perikardjali
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.
Maltese: Espożizzjoni kontinwa kuljum għal Imatinib kmieni waqt ilproċess ta' trattament flimkien ma' kemoterapija lil pazjenti f'koorti 5 (n=50) tejbu s-sopravivenza ħielsa minn kull episodju (EFS) f'4 snin mqabbel mal-kontrolli storiċi (n=120), li ngħataw kemoterapija standard mingħajr Imatinib (69.6% vs 31.6%, rispettivament).
English: Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Pakketti li fihom 30x1 or 90x1 pilloli miksija b'rita f' ‘perforated unit dose blisters'.
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively.
Maltese: Il-valuri Ki fil-mikrosomi tal-fwied tal-bniedem kienu 27, 7.5 u 7.9
English: 2-3 (total of 8 courses)
Maltese: (total ta' 8 korsijiet)
English: The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies (AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
Maltese: Ir-riżultati osservati f'popolazzjoni ta' 211-il pazjent li għadhom kif ġew iddijanjostikati b'Ph+ ALL f'erba' studji kliniċi mux ikontrollati (AAU02, ADE04, AJP01 u AUS01) huma konsistenti mar-riżultati deskritti hawn fuq.
English: CP 1.2 g/m2 i.v.
Maltese: CP 1.2 g/m2 i.v. (3 siegħat), jum 1;
English: In GIST the study drug was discontinued for drug-related adverse reactions in 4% of
Maltese: F'GIST, l-istudju kellu jitwaqqaf minħabba reazzjonijiet avversi tal- prodott mediċinali f'4% tal-pazjenti.
English: 4.2 Posology and method of administration
Maltese: Metodu ta 'amministrazzjoni
English: In adult patients, Imatinib Teva B.V. is intended for use in the most advanced phase of the disease (blast crisis).
Maltese: F'pazjenti adulti, Imatinib Teva B.V. huwa maħsub għall-użu fil-fażi l-aktar avvanzata tal-marda (blast crisis).
English: Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
Maltese: Imatinib Teva B.V. 100 mg kapsuli iebsin huma disponibbli f'pakketti ta' 60 jew 120 kapsuli iebsin f'folji.
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 ta' l-użu ta' imatinib ma' kemoterapija (ara sezzjoni 5.1), iżda interazzjonijiet bejn mediċini ta' imatinib ma' reġimens kimoterapewtiċi għadhom ma ġewx iċċarati.
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Maltese: Il- blast crisis hija definita bħala blasts ta ≥ 30% fid-demm jew fil-mudullun jew mard estramedullari minbarra lhepatosplenomegalija.
English: Haemolytic anaemia Metabolism and nutrition disorders Common:
Maltese: limfadenopatija Anemija emolitika Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: In children and adolescents, Imatinib Teva B.V. can be used in different phases of the disease (chronic, accelerated phase and blast crisis).
Maltese: Fit-tfal u adolexxenti, Imatinib Teva B.V. jista' jintuża fil-fażijiet differenti tal-marda (kronika, fażi aċċelerata u blast crisis).
English: In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
Maltese: Fl-istudju dwar l-effett tossiku fil-minorenni, effetti fuq it-tkabbir, dewmien fil-ftuħ vaġinali u s-separazzjoni talprepuzju kienu osservati f'madwar 0.3 sa darbtejn l-esponiment pedjatriku medju fl-ogħla doża rrakkomandata ta' 340 mg/m2.
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
Maltese: Sindrome ta' eritrodisasteżija palmoplantari*, keratożi lichenoid*, lichen planus*, nekrolisi tossika tal-epidermide*, raxx ikkawżat millmediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)* Disturbi muskolu-skelettriċi u tat-tessuti konnettivi
English: PLIVA Croatia Ltd. Prilaz baruna Filipovica 25
Maltese: • CML fil fażi kronika pedjatrika
English: 2/dose q3h, x 8 doses/day, IV): days 1-5
Maltese: MESNA (360 mg/m2/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to
Maltese: Il-65 pazjenti kollha li kienu posittivi għal FIP1L1PDGFRα fusion kinase kisbu CHR li nżamm għal xhur (medda bejn 1+ sa 44+ xhur ċensurati fil-ħin meta ġew rappurtati).
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% talvaluri rispettivi għal meta ma ngħatax rifampicin.
English: Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Maltese: Imatinib Teva B.V. 100 mg kapsuli iebsin huma disponibbli f'pakketti ta' daqs ta' 20x1, 60x1, 120x1 jew
English: Caution should be taken when administering imatinib with inhibitors of the CYP3A4
Maltese: il darba, rispettivament, u dan jindika li imatinib jinibixxi is-CYP3A4.
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.