FrancophonIA/ELRC3.0 huggingface dataset:
English: No additional studies in patients were needed as Docefrez is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: Ma kinux meħtieġa studji addizzjonali f'pazjenti minħabba li Docefrez jingħata b'infużjoni u fih l-istess sustanza attiva bħall-mediċina ta' referenza, Taxotere.
English: For more information about treatment with Docefrez, read the Package Leaflet (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar kura b'Docefrez, aqra lFuljett ta' Tagħrif (parti wkoll mill-EPAR).
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Maltese: Għalhekk, l-opinjoni tas-CHMP kienet li, bħal f'Taxotere, il-benefiċċju huwa akbar mir-riskju identifikat.
English: Docefrez is a powder and solvent that is made up to a solution for infusion (drip into a vein).
Maltese: Docefrez huwa trab u solvent li jsir soluzzjoni għal infużjoni (drip fil-vina).
English: • breast cancer.
Maltese: • kanċer tal-pulmun ta' ċelloli mhux żgħar.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' wkoll jintuża ma' mediċini oħrajn kontra l-kanċer ((doxorubicin, cyclophosphamide, trastuzumab jew capecitabine) f'pazjenti li jkunu għadhom ma ngħatawx kura għall-kanċer tagħhom jew wara li trattamenti oħrajn ma jkunux irnexxew, skont it-tip u l-istadju tal-kanċer tassider li jkun qed jiġi kkurat;
English: Docefrez should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Docefrez għandu jintuża f'taqsimiet tal-kura speċjalizzati fl-għoti ta' kimoterapija (l-użu ta' mediċina għall-kura tal-kanċer) taħt superviżjoni ta' tabib ikkwalifikat fl-għoti ta' kimoterapija.
English: How has Docefrez been studied?
Maltese: Kif ġie studjat Docefrez?
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Maltese: • adenokarċinoma gastrika (tip ta' kanċer tal-istonku) f'pazjenti li jkunu għadhom ma ngħataw ebda kura għall-kanċer tagħhom.
English: At-risk : Events
Maltese: F'riskju : Episodji
English: Glivec vs placebo
Maltese: Glivec vs plaċebo
English: -- (1) Imatinib 12 MO:
Maltese: -- (1) Imatinib 12 XA:
English: 9/l (0102 and 0109
Maltese: 9/l (0102 u 0109
English: 4 cycles
Maltese: 4 ċikli
English: All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Maltese: Id-dożi kollha (n=147) 400 mg (n=73) 600 mg (n=74)
English: Date of first authorisation: 07 November 2001 Date of latest renewal: 07 November 2006
Maltese: Data tal-aħħar tiġdid: 07 Novembru 2006
English: Prednisolone 60 mg/m 2/day oral
Maltese: Prednisolone 60 mg/m 2/jum orali
English: Acute respiratory failure
Maltese: Insuffiċjenza respiratorja akuta
English: Overall hazard ratio (95%CI)*
Maltese: Proporzjon globali ta' periklu (95%CI)*
English: Glivec 100 mg hard capsules Packs containing 24, 48, 96, 120 and 180 capsules.
Maltese: Glivec 100 mg kapsuli ibsin Pakketti li fihom 24, 48, 96, 120 u 180 kapsula.
English: In vitro, Glivec inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Maltese: In-vitro, Glivec jinibixxi paracetamol O-glucuronidation b'valur Ki ta' 58.5 mikromol/l.
English: Hazard ratio 0.46 (95% Cl, 0.32-0.65)
Maltese: Proporzjon ta' periklu 0.46 (95% Cl, 0.32-0.65)
English: Hazard ratio 0.45 (95% Cl, 0.22-0.89)
Maltese: Proporzjon ta' periklu 0.45 (95% Cl, 0.22-0.89)
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Glivec and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Maltese: Fl-84 xahar is-sopravivenza globali hija stmata 86.4% (83, 90) vs 83.3% (80, 87) filgruppi randomised Glivec u IFN + Ara-C, rispettivament (p=0.073, test log-rank).
English: 6-MP 60 mg/m oral, days 26-46
Maltese: 6-MP 60 mg/m orali, jiem 26-46
English: 24 hard capsules 48 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
Maltese: 24 kapsula iebsa 48 kapsula iebsa 96 kapsula iebsa 120 kapsula iebsa 180 kapsula iebsa
English: 9/l) were observed in 3.6% and < 1% of patients, respectively.
Maltese: 9/l) f' 3.6% u f' < 1% tal-pazjenti, rispettivament.
English: EU/1/01/198/002 24 capsules EU/1/01/198/003 48 capsules EU/1/01/198/004 96 capsules EU/1/01/198/005 120 capsules EU/1/01/198/006 180 capsules
Maltese: EU/1/01/198/002 24 kapsuli EU/1/01/198/003 48 kapsuli EU/1/01/198/004 96 kapsuli EU/1/01/198/005 120 kapsuli EU/1/01/198/006 180 kapsuli
English: Table 8 12-month and 36-month Glivec treatment (SSGXVIII/AIO Trial)
Maltese: Tabella 8 Trattament ta' 12-il xahar u 36 xahar bi Glivec (Prova SSGXVIII/AIO)
English: EU/1/01/198/009 10 tablets EU/1/01/198/010 30 tablets EU/1/01/198/013 90 tablets
Maltese: EU/1/01/198/009 10 pilloli EU/1/01/198/010 30 pilloli EU/1/01/198/013 90 pilloli
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 = 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: Vincristine 1.3 mg/m i.v., days 1, 8, 15, 21;
Maltese: Vincristine 1.3 mg/m i.v., jiem 1, 8, 15, 21;
English: Confusional state Nervous system disorders Very common:
Maltese: Stat konfużjonali Disturbi fis-sistema nervuża Komuni ħafna:
English: Daunorubicin 30 mg/m i.v., days 1-3, 15-16;
Maltese: Daunorubicin 30 mg/m i.v., jiem 1-3, 15-16;
English: - Chronic myeloid leukaemia (CML).
Maltese: Lewkimja majelojd kronika (CML).
English: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Maltese: Mard majelodisplastiku/majeloproliferattiv (MDS/MPD).
English: Posology for GIST
Maltese: Pożoloġija għal GIST
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Glivec (see section 4.8).
Maltese: Inibituri ta' tyrosine kinase (TKIs - tyrosine kinase inhibitors) BCR-ABL ġew assoċjati ma' mikroanġjopatija trombotika (TMA - thrombotic microangiopathy), inklużi rapporti ta' każijiet individwali għal Glivec (ara sezzjoni 4.8).
English: Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Maltese: Leucovorin (75 mg/m fis-36 siegħa, IV; 15 mg/m
English: 6-MP 25 mg/m oral, days 1-20
Maltese: 6-MP 25 mg/m orali, jiem 1-20
English: IDA 9 mg/m oral, days 1-28;
Maltese: IDA 9 mg/m orali, jiem 1-28;
English: MTX 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: MTX 15 mg intrathecal, jiem 1, 8, 15, 22; Ara-C 40 mg intrathecal, jiem 1, 8, 15, 22; Methylprednisolone 40 mg intrathecal, jiem 1, 8, 15, 22
English: EU/1/01/198/007 20 tablets (PVC/alu blisters) EU/1/01/198/008 60 tablets (PVC/alu blisters) EU/1/01/198/011 120 tablets (PVC/alu blisters) EU/1/01/198/012 180 tablets (PVC/alu blisters) EU/1/01/198/014 60 tablets (PVDC/alu blisters) EU/1/01/198/015 120 tablets (PVDC/alu blisters) EU/1/01/198/016 180 tablets (PVDC/alu blisters)
Maltese: EU/1/01/198/007 20 pilloli (Folji ta' l-alu/PVC) EU/1/01/198/008 60 pilloli (Folji ta' l-alu/PVC) EU/1/01/198/011 120 pilloli (Folji ta' l-alu/PVC) EU/1/01/198/012 180 pilloli (Folji ta' l-alu/PVC) EU/1/01/198/014 60 pilloli (Folji ta' l-alu/PVDC) EU/1/01/198/015 120 pilloli (Folji ta' l-alu/PVDC)
English: At one year the overall RFS was significantly better for Glivec (97.7%) vs. placebo (82.3%), (p<0.0001).
Maltese: Wara sena l-RFS globali kien aħjar b'mod sinifikanti għal Glivec (97.7%) vs. plaċebo (82.3%), (p<0.0001).
English: IV or PO q6h x 6 doses)iii:
Maltese: IV jew PO q6h x 6
English: VP-16 (100 mg/m 2, IV): days 29-33
Maltese: VP-16 (100 mg/m 2, IV): jiem 29-33
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 <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: Mean absolute bioavailability for the capsule formulation is 98%.
Maltese: Il-biodisponibiltà assoluta medja għall-formulazzjoni f'għamla ta' kapsula hija ta' 98%.
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 ilbiotrasformazzjoni ta' 5-fluoruracil, iżda inibixxa l-metaboliżmu ta' paclitaxel billi inibixxa b'mod kompetittiv lill-CYP2C8 (Ki=34.7 µM).
English: Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Maltese: Terapija IT tripla (aġġustata skont l-età): jiem 1 u 22 VP-16 (100 mg/m2/kuljum, IV): jiem 22-26
English: 9/l, platelet < 450 x 10
Maltese: 9/l, plejtlet < 450 x 10
English: Table 7 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Maltese: Tabella 7 Sommarju tal-prova Z9001 tal-analiżi ta' RFS permezz tal-klassifikazzjonijiet tarriskju NIH u AFIP
English: (2) Imatinib 36 MO: │││ Censored observations
Maltese: (2) Imatinib 36 XA:
English: 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.7 vs. 46.6 AFIP Very Low 20.7 0/52 vs. 2/63
Maltese: 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.
English: Intermediate 25.7 4/75 vs. 6/78
Maltese: 7 4/75 vs. 6/78
English: They are supplied in packs containing 30 capsules.
Maltese: Jiġu f'pakketti li jkun fihom 30 kapsula.
English: Table 6 Best tumour response in trial STIB2222 (GIST)
Maltese: L-aqwa rispons tat-tumur fil-prova STIB2222 (GIST)
English: Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)
Maltese: CML fil-fażi kronika, MDS/MPD u GIST (doża tal-bidu 400 mg) HES/CEL (b'doża ta' 400 mg)
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: Imatinib hu inibitur molekulari żgħir ta' protein-tyrosine 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: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common:
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)*, psewdoporfirja* Disturbi muskolu-skelettriċi u tat-tessuti konnettivi Komuni ħafna:
English: MTX 15 mg intrathecal, day 1;
Maltese: MTX 15 mg intrathecal, jum 1;
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code: L01XE01
Maltese: Kategorija farmakoterapewtika: sustanza li tinpedixxi l-enzima protein-tyrosine kinase, Kodiċi ATC:
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.
Maltese: • pazjenti li jkollhom sindrome ipereżinofilika avvanzata (HES) u/jew lewkimja kronika eżinofolika (CEL) b'tibdil FIP1L1-PDGFR.
English: Glivec 50 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Maltese: Glivec 50 mg kapsuli ibsin Kontenut tal-kapsula: Cellulose microcrystalline Crospovidone
English: 0.16 (0.03; 0.70) 97.9 vs. 90.8 97.9 vs. 73.3
Maltese: 16 (0.03; 0.70) 97.9 vs. 90.
English: 3, pulmonary oedema
Maltese: 3, edema fil pulmun
English: Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common:
Maltese: Anemija emolitika, mikroanġjopatija trombotika Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni:
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.
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 relevanza klinika.
English: days 2, 3, 16, and 17
Maltese: 6 dożi)iii: jiem 2, 3, 16, u 17
English: Patients were treated at doses of Glivec of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Maltese: 340 mg/m2/jum (n=9), 440 mg/m2/jum (n=7), u 570 mg/m2/jum (n=5).
English: Similar findings were found based on a 18-months landmark analysis.
Maltese: Sejbiet simili kienu evidenti minn analiżi landmark ta' 18-il xahar.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common:
Maltese: Ileus/imblukkar tal-imsaren*, titqib gastro-intestinali*, divertikulite*, ektażja vaskulari tal-antrum tal-istonku (GAVE)* Disturbi fil-fwied u fil-marrara Komuni:
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m i.v., days 1, 8; Prednisone 60 mg/m oral, days 1-7, 15-21;
Maltese: VCR 2 mg doża totali i.v., jiem 1, 8, 15, 22; CP 750 mg/m i.v., jiem 1, 8; Prednisone 60 mg/m orali, jiem 1-7, 15-21;
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to Glivec treatment.
Maltese: It-translokazzjoni t17:22)[(q22:q13)], jew il-prodott tal-ġene tiegħu, instab fil-pazjenti kollha li wrew rispons għall-kura b'Glivec.
English: (0.5 h), days 7, 8, 14, 15;
Maltese: IDA 8 mg/m i.v. (0.5 h), jiem 7, 8, 14, 15;
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' 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: Triple IT therapy (age-adjusted): day 1 ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Maltese: Terapija IT tripla (aġġustata skont l-età): jum 1 ARA-C (3 g/m2/doża q 12 h x 4, IV): jiem 2 u 3 G-CSF (5 μg/kg, SC): jiem 4-13 jew sa ANC > 1500 postnadir
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received Glivec at doses from 75 mg to 800 mg daily.
Maltese: 162 pazjent ieħor b'HES/CEL, rappurtati f'35 rapporti ta' każijiet u serje ta' każijiet li ġew publikati irċevew Glivec b'dożi bejn 75 mg sa 800 mg kuljum.
English: Study 0110 37-month data Chronic phase, IFN failure (n=532)
Maltese: Studju 0110 Dejta ta' 37 xahar Fażi Kronika, meta IFN ma ħadimx (n=532)
English: Pharmacokinetics of Glivec
Maltese: Il-farmakokinetiċi ta' Glivec
English: CPM (300 mg/m 2/day, IV): days 22-26 MESNA (150 mg/m 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m 2, q12h, IV): days 43, 44 L-ASP (6000 IUnits/m 2, IM): day 44
Maltese: CPM (300 mg/m 2/kuljum, IV): jiem 22-26 MESNA (150 mg/m 2/kuljum, IV): jiem 22-26 G-CSF (5 μg/kg, SC): jiem 27-36 jew sa ANC > 1500 postnadir ARA-C (3 g/m 2, q12h, IV): jiem 43, 44 L-ASP (6000 IUnitajiet/m 2, IM): jum 44
English: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Maltese: Lewkimja limfoblastika akuta posittiva għall-kromosoma ta' Filadelfja (Ph-posittiva ALL).
English: days 2 and 3
Maltese: dożi)iii: jiem 2 and 3
English: Glivec 100 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Maltese: Glivec 100 mg kapsuli ibsin Il-kontenut tal-kapsula: Cellulose microcrystalline Crospovidone
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 DEX (6 mg/m2/day, PO): days 1-7 and 15-21
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 DEX (6 mg/m2/kuljum, PO): jiem 1-7 u 15-21
English: 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: G-CSF (5 μg/kg, SC): jiem 6-15 jew sa ANC > 1500 postnadir IT Methotrexate (aġġustata skont l-età): jum 1 BISS Terapija IT tripla (aġġustata skont l-età): jum 8, 15
English: Complete CyR n (%) Partial CyR n (%)
Maltese: Rispons ċitoġenetiku n (%) Rispons maġġuri [95% CI] n (%) ta' CyR sħaħ n (%) ta' CyR parzjali
English: 1200 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 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: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Maltese: L-istima tas-sopravivenza KaplanMeier wara 36-xahar ta' follow-up hija 68%.
English: Glivec 100 mg hard capsules EU/1/01/198/002-006
Maltese: Glivec 100 mg kapsuli ibsin EU/1/01/198/002-006
English: Tumour haemorrhage/tumour necrosis* Immune system disorders Not known:
Maltese: Emorraġija mit-tumur/nekrożi tat-tumur* Disturbi fis-sistema immuni Mhux magħruf:
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)
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: Imatinib in combination with chemotherapy induction (see Table 4) 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 4) 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: RFS rates (%) 12 month 24 month
Maltese: Rati ta' RFS (%) 12-il xahar 24 xahar
English: 12 months 24 months 36 months 48 months 60 months Survival 36 months 48 months 60 months
Maltese: 12-il xahar 24 xahar 36 xahar 48 xahar 60 xahar Sopravivenza 36 xahar 48 xahar 60 xahar
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 talprotease 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: In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Maltese: F'testijiet in vitro Glivec inibixxa l-attività tas-CYP2D6, isoenzima taċ-ċitokromju P450, f'konċentrazzjonijiet simili għal dawk li jaffettwaw l-attività tas-CYP3A4.
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Maltese: Sindrome ipereżinofilika (HES) u/jew Lewkimja eżinofilika kronika (CEL).
English: The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL.
Maltese: Id-doża rakkomandata ta' Glivec hija 600 mg/jum għal pazjenti adulti b'Ph+ ALL.
English: VCR 1.3 g/m2 i.v., day 1; Prednisolone 60 mg/m oral, days 1-5
Maltese: VCR 1.3 g/m i.v., jum 1; Prednisolone 60 mg/m orali, jiem 1-5
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 (popolazzjoni ITT)
English: 9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC  1.5 x 10
Maltese: 9/l, majeloċita+metamajeloċita < 5% fiddemm, l-ebda blasts u promajeloċiti fid-demm, bażofils < 20%, l-ebda involviment 'l barra mill-mudullun] u fi studji 0102 u 0109 [ANC  1.5 x 10
English: Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare:
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Rari:
English: DEX 10 mg/m oral, days 1-5;
Maltese: DEX 10 mg/m oralii, jiem 1-5;
English: DEX (6 mg/m2/day, PO): days 1-5; 29-33 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: DEX (6 mg/m2/kuljum, PO): jiem 1-5; 29-33 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: DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
Maltese: DEX (6 mg/m2/kuljum, PO): jiem 1-5; 29-33 6-MP (75 mg/m2/kuljum, PO): jiem 1-56 Methotrexate (20 mg/m2/ġimgħa, PO): jiem 1, 8, 15, 22, 29, 36, 43, 50