FrancophonIA/ELRC3.0 huggingface dataset:
English: DFSP (at dose 800 mg)
Maltese: DFSP (doża ta' 800 mg)
English: Study 0102 38-month data Myeloid blast crisis (n = 260) % of patients (CI95 %)
Maltese: Studju 0102 Dejta ta' 38 xahar Majelojd blast crisis (n=260) % tal-pazjenti (CI95%)
English: Consolidation (de novo Ph+ ALL)
Maltese: Aċċertament (de novo Ph+ ALL)
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia
Maltese: Herpes zoster, herpes simplex, nasofarinġite, pulmonite
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Maltese: Majelojd blast crisis: 260 pazjent b'majelojde blast crisis kienu reklutati.
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Maltese: In-vitro, imatinib jinibixxi paracetamol O-glucuronidation b'valur Ki ta' 58.5 mikromol/l.
English: • The active substance is imatinib (as mesilate).
Maltese: • Is-sustanza attiva hi imatinib (bħala mesilate).
English: In study 0102 [ANC ≥ 1.5 x 10
Maltese: CHR: Fi studji 0102 [ANC ≥ 1.5 x 10
English: terfenadine, bortezomib, docetaxel and quinidine).
Maltese: diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel u quinidine).
English: Mean absolute bioavailability for imatinib is 98 %.
Maltese: Il-biodisponibiltà assoluta medja għal imatinib hija ta' 98%.
English: Consolidation therapy I, III, V
Maltese: Terapija t'aċċertament I, III, V
English: G-CSF (5 μg/kg, SC): days 34-43
Maltese: G-CSF (5 μg/kg, SC): jiem 34-43
English: HES/CEL (starting dose 100 mg)
Maltese: HES/CEL (doża talbidu 100 mg)
English: In 61 of these 117 patients FIP1L1-PDGFRα fusion kinase was identified.
Maltese: F'61 minn dawn il-117 pazjent FIP1L1-PDGFRα fusion kinase kien identifikat.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n = 10).
Maltese: Limfojd blast crisis: numru limitat ta' pazjenti kienu reklutati fi studji ta' fażi I (n=10).
English: You may require medical attention.
Maltese: Jista' jkun li jkollok bżonn attenzjoni medika.
English: Clinical studies in HES/CEL
Maltese: Provi Kliniċi f'HES/CEL
English: Methylprednisolone 40 mg intrathecal, day 1
Maltese: Methylprednisolone 40 mg intrathecal, jum 1
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Maltese: Is-sustanza attiva imatinib turi riskju ambjentali għall-organiżmi sedimentali.
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Maltese: PEG-ASP (2500 IUnitajiet/m², IM): jum 4
English: Bilirubin elevation was below 3 %.
Maltese: Iż-żieda fil-bilirubina kienet taħt 3%.
English: • Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Maltese: • Mard majelodisplastiku/majeloproliferattiv (MDS/MPD).
English: In GIST patients (study B2222), 6.8 % of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8 % of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Maltese: F'pazjenti b'GIST (studju B2222), żiediet ta' 6.8% tal-grad 3 jew 4 ALT (alanine aminotransferase) u żidiet ta' 4.8% ta' grad 3 jew 4 AST (aspartate aminotransferase) kienu evidenti.
English: Haematological response Complete haematological response (CHR)
Maltese: Rispons ematoloġiku Rispons ematoloġiku komplet (CHR)
English: Triple IT therapy (age-adjusted): days 1, 29
Maltese: Terapija IT tripla (aġġustata skont l-età): jiem 1, 29
English: When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
Maltese: Meta nqisu b'mod konservattiv li l-pazjenti b'data nieqsa kienu pazjenti li ma rrispondewx, is-CHR kien osservat f'20/23 (87%) pazjent, is-CCyR f'9/23 (39.1%) pazjent, u l-MR fi 11/23 (47.8%) pazjent, rispettivament.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Maltese: Sindrome ta' eritrodisasteżija palmoplantari*, keratożi lichenoid*, lichen planus*, nekrolisi tossika tal-epidermide*, raxx ikkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)*
English: • adult and paediatric patients with Ph+ CML in blast crisis.
Maltese: • pazjenti adulti u pedjatriċi b'Ph+ CML fi blast crisis.
English: Posology for HES/CEL in adult patients
Maltese: Pożoloġija għal HES/CEL f'pazjenti adulti
English: Imatinib medac 400 mg hard capsules EU/1/13/876/002
Maltese: Imatinib medac 400 mg kapsuli ibsin EU/1/13/876/002
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Maltese: Methotrexate (20 mg/m²/ġimgħa, PO): jiem 8, 15, 22, 29, 36, 43, 50
English: Imatinib medac 100 mg hard capsules EU/1/13/876/001
Maltese: Imatinib medac 100 mg kapsuli ibsin EU/1/13/876/001
English: 1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Maltese: 1800 mg sa 3200 mg (sa doża għolja ta' 3200 mg kuljum għal 6 ijiem): Dgħufija, majalġja, żieda filcreatine phosphokinase, żieda fil-bilirubina, uġigħ gastrointestinali.
English: Cytogenetic abnormalities were evaluated in 117 of the total population of 176 patients.
Maltese: Anormalitajiet ċitoġenetiċi kienu evalwati f'117 mill-popolazzjoni kollha ta' 176 pazjent.
English: • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Maltese: • Sindrome iperesinofilika (HES) u/jew Lewkimja esinofilika kronika (CEL).
English: • The other ingredients are crospovidone (type A), lactose monohydrate, magnesium stearate.
Maltese: • Is-sustanzi mhux attivi huma crospovidone (tip A), lactose monohydrate, magnesium stearate.
English: Consolidation therapy II, IV
Maltese: Terapija t'aċċertament II, IV
English: Clinical studies in MDS/MPD
Maltese: Provi kliniċi f'MDS/MPD
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Maltese: • pazjenti li jkollhom sindrome iperesinofilika avvanzata (HES) u/jew lewkimja kronika eżinofolika (CEL) b'tibdil FIP1L1-PDGFRα.
English: Clinical studies in DFSP
Maltese: Studji kliniċi f'DFSP
English: Imatinib is a small molecule protein 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: Imatinib hu inibitur molekulari żgħir ta' protein kinase b'potenzjal li jinibixxi l-attività ta' Bcr-Abl tyrosine kinase (TK), kif ukoll ta' riċetturi oħrajn ta' TKs: Kit, ir-riċettur tal-istem cell factor (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 (PDGFR-alpha u PDGFR-beta).
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Maltese: Imatinib ma fixkilx il-biotrasformazzjoni ta' 5-fluoruracil, iżda inibixxa l-metaboliżmu ta' paclitaxel billi inibixxa b'mod kompetittiv lill-CYP2C8 (Ki=34.7 µM).
English: DEX 10 mg/m oral, days 1-5;
Maltese: DEX 10 mg/m² orali, jiem 1-5;
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: Imatinib 400 mg darbtejn kuljum kellu effett li inibixxa il-metaboliżmu ta' metoprolol medjat b'CYP2D6, b'żieda tas-Cmax u l-AUC ta' metoprolol b'madwar 23% (90%CI [1.16-1.30]).
English: 60 hard capsules.
Maltese: 60 kapsula iebsa
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Maltese: It-translokazzjoni t17:22)[(q22:q13)], jew il-prodott tal-ġene tiegħu, instab filpazjenti kollha li wrew rispons għall-kura b'imatinib.
English: Study ADE04 Prephase
Maltese: Studju ADE04
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 µmol/l, rispettivament.
English: {2D barcode carrying the unique identifier included.}
Maltese: <Barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19 - 60) and 47 months (range 16-59), respectively.
Maltese: Risponsijiet ematoloġiċi u ċitoġenetiċi inżammu għall-medja ta' 49 xahar (medda bejn 19 u 60) u 47 xahar (medda 16-59), rispettivament.
English: 30 hard capsules.
Maltese: 30 kapsula iebsa
English: INFORMATION IN BRAILLE Imatinib medac 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Imatinib medac 100 mg
English: CPM (300 mg/m2, IV): days 29-33
Maltese: CPM (300 mg/m², IV): jiem 29-33
English: Imatinib medac 400 mg hard capsules Each hard capsule contains 50.072 mg lactose monohydrate.
Maltese: Imatinib medac 400 mg kapsuli ibsin Kull kapsula iebsa fiha 50.072 mg ta' lactose monohydrate.
English: Packs containing 60 hard capsules.
Maltese: Pakketti li fihom 60 kapsula iebsa.
English: The complete molecular response rate was 48 % (49 out of 102 evaluable patients).
Maltese: Ir-rata ta' rispons molekulari komplet kienet 48% (49 minn 102 pazjenti li setgħu jkunu evalwati).
English: Muscular weakness, arthritis, rhabdomyolysis/myopathy
Maltese: Dgħufija muskolari, artrite, rabdomijoliżi/mijopatija
English: Triple IT therapy (age-adjusted): day 1
Maltese: Terapija IT tripla (aġġustata skont l-età): jum 1
English: Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Maltese: Għandu jkun hemm kawtela meta imatinib jingħata ma' inibituri tal-familja CYP3A4.
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Maltese: 6-MP (75 mg/m²/kuljum, PO): jiem 11-56 (Miżmuma 6-MP matul is6-10 ijiem ta' irrdjazzjoni kranjali mibdija fl-1 ġurnata ta' Ċiklu 5.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Maltese: Ileus/imblukkar tal-imsaren*, titqib gastro-intestinali*, divertikulite*, ektażja
English: Additionally, partial cytogenetic response (PCyR) was observed in 16 % for a MCyR of 81 %.
Maltese: Minbarra hekk, rispons ċitoġenetiku parzjali (PCyR) kien evidenti f'16% għal MCyR ta' 81%.
English: DEX (6 mg/m 2/day, PO): days 1-5; 29-33
Maltese: DEX (6 mg/m²/kuljum, PO): jiem 1-5; 29-33
English: Posology for Ph+ ALL in adult patients
Maltese: Pożoloġija għall-Ph+ ALL f'pazjenti adulti
English: DEX (6 mg/m2/day, PO): days 1-7 and 15-21
Maltese: DEX (6 mg/m²/kuljum, PO): jiem 1-7 u 15-21
English: Imatinib medac contains lactose monohydrate
Maltese: Imatinib medac fih lactose monohydrate
English: In the clinical study 38 % of patients were ≥ 60 years of age and 12 % of patients were ≥ 70 years of age.
Maltese: Fl-istudju kliniku, 38% tal-pazjenti kellhom ≥ 60 sena u 12% tal-pazjenti kellhom ≥ 70 sena.
English: Ifosfamide (1.8 g/m2/day, IV): days 1-5
Maltese: Ifosfamide (1.8 g/m²/kuljum, IV): jiem 1-5
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Maltese: ARA-C (3 g/m²/doża q 12 h x 4, IV): jiem 2 u 3
English: The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Maltese: Id-doża rakkomandata ta' imatinib hija 600 mg/jum għal pazjenti adulti b'Ph+ ALL.
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Maltese: 162 pazjent ieħor b'HES/CEL, irrappurtati f'35 rapporti ta' każijiet u serje ta' każijiet li ġew ppubblikati irċevew imatinib b'dożi bejn 75 mg sa 800 mg kuljum.
English: In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Maltese: In vitro imatinib inibixxa l-attività tas-CYP2D6, isoenzima taċ-ċitokromju P450, f'konċentrazzjonijiet simili għal dawk li jaffettwaw l-attività tas-CYP3A4.
English: Biochemistry
Maltese: Bijokimika
English: Pharmacotherapeutic group: protein kinase inhibitor, ATC code: L01XE01
Maltese: Kategorija farmakoterapewtika: sustanza li timpedixxi l-enzima protein kinase, Kodiċi ATC:
English: i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22;
Maltese: Daunorubicin 30 mg/m² i.v., jiem 1-3, 15-16; VCR 2 mg doża totali i.v., jiem 1, 8, 15, 22;
English: G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Maltese: G-CSF (5 μg/kg, SC): jiem 4-13 jew sa ANC > 1500 postnadir
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate.
Maltese: Imatinib medac 100 mg kapsuli ibsin Kull kapsula iebsa fiha 12.518 mg ta' lactose monohydrate.
English: (24 h), days 1, 15;
Maltese: (24 h), jum 4;
English: Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Maltese: Methylprednisolone 40 mg intrathecal, jiem 1, 8, 15, 22
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Maltese: Ara-C 40 mg intrathecal, jiem 1, 8, 15, 22;
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance (see section 4.5).
Maltese: Minn fost għadd ta' medikazzjonijiet li jistgħu jingħataw fl-istess ħin (acetaminophen, aciclovir, allopurinol, amphoteracin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V), kienu biss erythromycin (IC50 50 µM) u fluconazole (IC50 118 µM) li inibixxew il-metaboliżmu ta' imatinib b'mod li seta' kellu xi rilevanza klinika (ara sezzjoni 4.5).
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Maltese: Titjib kien irrappurtat fis-sistemi kardijaċi, nervużi, ġilda/tessut ta' taħt il-ġilda, respiratorju/toraċiku/medjastinali/muskoluskeletrali/connective tissue/vaskulari, u gastro-intestinali.
English: Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Maltese: Imatinib kombinat ma' induzzjoni b'kemoterapija (ara Tabella 3) wassal għal rata ta' rispons ematoloġiku komplet ta' 93% (147 minn 158 pazjenti li setgħu jkunu evalwati) u f'rata ta' rispons citoġenetika maġġuri ta' 90% (19 minn 21 pazjenti li setgħu jkunu evalwati).
English: Chronic phase CML, MDS/MPD (starting dose 400 mg)
Maltese: CML fil-fażi kronika, MDS/MPD (doża tal-bidu 400 mg) HES/CEL (b'doża ta' 400 mg)
English: Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Maltese: CML fil-fażi aċċelerata u blast crisis u Ph+ ALL (doża tal-bidu 600 mg)
English: 1200 mg to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Maltese: 1200 mg sa 1600 mg (tul ta' żmien ivarja minn jum 1 sa 10 ijiem): Nawsja, rimettar, dijarea, raxx, eritema, edima, nefħa, għejja, spażmi fil-muskoli, tromboċitopenija, panċitopenija, uġigħ fl-addome, uġigħ ta' ras, nuqqas t'aptit.
English: Clinical studies in Ph+ ALL
Maltese: Provi kliniċi f'Ph+ ALL
English: 9/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' newtropenija u tromboċitopenija, rispettivament) meta mqabbla mal-frekwenzi li wieħed kien isib filkażijiet ta' pazjenti li tkun għadha kif ġiet dijanjostikata CML fil-fażi l-kronika (16.7% newtropenija u 8.9% tromboċitopenija).
English: Grade 3 and 4 neutropenia was seen in 7.5 % and 2.7 % of patients, respectively, and grade 3 thrombocytopenia in 0.7 % of patients.
Maltese: Newtropenija ta' grad 3 u grad 4 kienet evidenti f'7.5% f'2.7% tal-pazjenti, rispettivament, u tromboċitopenija ta' grad 3 f'0.7% tal-pazjenti.
English: Induction therapy (de novo Ph+ ALL)
Maltese: Studju AAU02 Terapija t'aċċertament (de novo Ph+ ALL)
English: Renal pain, haematuria, renal failure acute, urinary frequency increased
Maltese: Uġigħ renali, demm fl-awrina, insuffiċjenza renali akuta, żieda fil-frekwenza tal-awrina
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Maltese: Ir-riżultati in vitro wrew li imatinib jinibixxi b'mod kompetittiv lis-sustanzi markaturi li fuqhom jaħdmu l-enzimi CYP2C9, CYP2D6 u CYP3A4/5.
English: • Chronic myeloid leukaemia (CML) in blast crisis.
Maltese: • Lewkimja majelojde kronika (CML) fi kriżi tal-blasts.
English: Continuous daily exposure to imatinib 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 imatinib (69.6 % vs. 31.6 %, respectively).
Maltese: Espożizzjoni kontinwa kuljum għal imatinib 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 imatinib (69.6% vs 31.6%, rispettivament).
English: MTX 15 mg intrathecal, days 1, 8, 15, 22;
Maltese: MTX 15 mg intrathecal, jiem 1, 8, 15, 22;
English: Packs containing 30 hard capsules.
Maltese: Pakketti li fihom 30 kapsula iebsa.
English: (≥ 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 <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Maltese: Arritmija, fibrillazzjoni atrijali, attakk tal-qalb, infart mijokardijaku, anġina pectoris, effużjoni perikardjali
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
Maltese: Wieħed għandu joqgħod attent meta imatinib jittieħed ma' inibituri tal-protease, antifungali azole, ċerti makrolidi (ara sezzjoni 4.5), substrati 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: VCR (1.5 mg/m 2/day, IV): days 1, 29
Maltese: VCR (1.5 mg/m²/kuljum, IV): jiem 1, 29
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: 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: 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 postnadir Terapija IT tripla (aġġustata skont l-età): jiem 1 u 15
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: Attivazzjoni kostituttiva tar-riċettur PDGF jew Abl protein tyrosine kinases bħala konsegwenza tal-fużjoni ma' proteini diversi imseħħbin jew produzzjoni kostituttiva ta' PDGF kienu implikati fil-patoġenesi ta' MDS/MPD, HES/CEL u DFSP.
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
Maltese: Dermatożi newtrofilika bid-deni akuta (sindrome ta' Sweet), telf ta' kulur fid-dwiefer, edima anġionewrotika, raxx bl-infafet, eritema multiforme, vaskulite lewkoklastika, sindrome ta' Stevens-Johnson, pustulożi ekżantematuża mifruxa akuta (AGEP)
English: UNIQUE IDENTIFIER - 2D BARCODE {2D barcode carrying the unique identifier included.}
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Imatinib medac 400 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Maltese: Imatinib medac 400 mg kapsuli ibsin Folji tal-PA-Aluminju/PVC/Aluminju.
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 mal-albumina u ma' alpha acid glycoprotein, bi ftit li xejn irbit mal-lipoprotein.
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: Imatinib medac 100 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Maltese: Imatinib medac 100 mg kapsuli ibsin Folji tal-PA-Aluminju/PVC/Aluminju.
English: 9/l and platelets ≥ 20 x 10
Maltese: 9/l u plejtlits ≥ 20 x 10
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Maltese: Yellow iron oxide (E172) Titanium dioxide (E171)
English: Cranial irradiation (Block 5 only)
Maltese: Irradjazzjoni kranjali (Blokk 5 biss)
English: Imatinib medac 400 mg capsules are supplied in packs containing 30 capsules in blisters.
Maltese: Imatinib medac 400 mg kapsuli jiġu f'pakketti li jkun fihom 30 kapsula fil-folji.
English: Palpitations, tachycardia, cardiac failure congestive 3, pulmonary oedema
Maltese: Palpitazzjonijiet, takikardja, insuffiċjenza konġestiva tal-qalb 3, edema fil pulmun
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 tirrappreżenta mezz ta' eliminazzjoni minuri għal imatinib (ara sezzjonijiet 4.2 u 4.4).
English: Stop imatinib until ANC ≥ 1.5 x 10
Maltese: Waqqaf imatinib sakemm l-ANC ≥ 1.5 x 10
English: Table 4 Chemotherapy regimen used in combination with imatinib in study I2301
Maltese: Tabella 4 Reġim ta' kemoterapija użata flimkien ma' imatinib fl-istudju I2301