FrancophonIA/ELRC3.0 huggingface dataset:
English: Triple IT therapy (age-adjusted): day 1
Maltese: Terapija IT trippla (aġġustata skont l-età): jiem 1 u 15
English: The no observed effect level (NOEL) was 15 mg/kg/day.
Maltese: Illivell fejn ma jkunx osservat effett (NOEL) kien 15 mg/kg/jum.
English: Induction therapy I
Maltese: Terapija ta' induzzjoni I
English: - Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).
Maltese: Kull kapsula iebsa fiha 400 mg ta' imatinib (bħala mesilate).
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Maltese: Tlett pazjenti urew rispons ematoloġiku komplet (CHR) u pazjent wieħed kellu rispons ematoloġiku parzjali (PHR).
English: Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
Maltese: Seħħet riattivazzjoni tal-epatite B f'pazjenti li huma portaturi kroniċi ta' dan il-virus wara li dawn ilpazjenti rċevew inibituri ta' tyrosine kinase BCR-ABL.
English: The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.
Maltese: Jekk iddoża ta' kuljum tkun 800 mg, (8 kapsuli), għandek tieħu 4 kapsuli filgħodu u 4 kapsuli filgħaxija.
English: days 3-5;
Maltese: 4.2 u 5.2).
English: Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Maltese: L-użu fl-istess żmien, ta' imatinib ma' prodotti mediċinali li jinduċu is-CYP3A4 (ez., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, jew Hypericum perforatum, magħruf ukoll bħala St.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets Imatinib Teva 400 mg film-coated tablets
Maltese: Imatinib Teva 100 mg pilloli miksija b'rita Imatinib Teva 400 mg pilloli miksija b'rita
English: Your doctor has prescribed Imatinib Teva because you suffer from a serious condition.
Maltese: Imatinib Teva huwa mediċina li fih is-sustanza attiva imatinib.
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
Maltese: Fl-istudju f'pazjenti b' GIST li ma jistax jitneħħa b'operazzjoni u/jew li huwa metastatiku, emorraġiji gastrointestinali u fit-tumur kienu rappurtati (ara sezzjoni 4.8).
English: Imatinib Teva 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Maltese: Kull kapsula iebsa fiha 100 mg ta' imatinib (bħala mesilate).
English: Nervous system disorders Very common
Maltese: Stat konfużjonali Disturbi fis-sistema nervuża
English: Study AUS01 Induction-consolidation therapy
Maltese: Studju AUS01
English: 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
Maltese: Id-doża tal-bidu hija 600 mg li għandha tittieħed bħala pillola waħda ta' 400 mg u 2 pilloli ta'
English: MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Maltese: MTX (5 g/m2 fuq medda ta' 24 siegħa, IV): jum 1 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x 6
English: For doses other than 400 mg and 800 mg (see dose recommendation below) a 100 mg film-coated tablet is available.
Maltese: Għal dożi oħra minbarra 400 mg u 800 mg (ara d-dożaġġ rakkomandat hawn taħt) hemm disponibbli pillola ta' 100 mg.
English: ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l, then resume treatment at 300 mg.
Maltese: ≥ 20 x 109/l, imbagħad kompli bit-trattament b'doża ta' 300 mg.
English: Imatinib Teva 100 mg film-coated tablets
Maltese: Imatinib Teva 100 mg pilloli miksija b'rita
English: Other adverse reactions were reported with lower or equal frequency.
Maltese: Reazzjonijiet avversi oħrajn kienu rappurtati bl-istess frekwenza jew anqas.
English: - Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
Maltese: Kull pillola miksija b'rita fiha 400 mg ta' imatinib (bħala mesilate).
English: 20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Maltese: mill-50 (40 %) pazjent f'koorti 5 ingħataw trapjant ta' ċelloli staminali ematopoetiċi.
English: Imatinib Teva 400 mg film-coated tablets
Maltese: Imatinib Teva 400 mg pilloli miksija b'rita
English: (1 h), days 1-5
Maltese: h), jum 5
English: When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8%) out of 11 achieving a complete haematological response.
Maltese: Meta terapija ta' sokkors b'imatinib ingħatat f'pazjenti li ma wrewx rispons jew li urew rispons fqir għall-kimoterapija, irriżulta li 9 pazjenti (81.8%) minn 11 kisbu rispons ematoloġiku komplet.
English: Hypothyroidism
Maltese: pankrejatite
English: (24 h), day 4;
Maltese: (Ara sezzjoni 4).
English: When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females.
Maltese: Meta firien tas-sess feminili ngħataw il-kura minn 14-il jum qabel ma tgħammru sas-6 jum tat-tqala, ma kien hemm l-ebda effett fuq it-tgħammir jew fuq innumru ta' firien li ħarġu tqal.
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Maltese: Il-kura b'imatinib twassal għal rispons mgħaġġel f'pazjenti pedjatriċi li kienu għadhom kif ġew dijanjostikati b'CML b'CHR ta' 78% wara 8 ġimgħat ta' terapija.
English: Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
Maltese: Il-funzjoni epatika għandha tiġi monitorata bir-reqqa meta imatinib jingħata flimkien ma' reġimens ta'kimoterapija li jkunu magħrufin li jistgħu jkunu marbuta ma' funzjoni mhux normali tal fwied (ara sezzjoni 4.5 u 4.8).
English: Table 4 Chemotherapy regimen used in combination with imatinib
Maltese: Tabella 4 Reġimen ta' kimoterapija kombinata ma' imatinib
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Maltese: Methotrexate (5 g/m2 fuq medda ta' 24 siegħa, IV): jum 1 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Maltese: Din kienet popolazzjoni ta' pazjenti li kienu diġ ħadu bosta trattamenti, billi 46% kien diġ kellhom BMT u 73% kienu ħadu kemoterapija li kienet tinkludi ħafna sustanzi, minn qabel.
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
Maltese: • Nawsja, qtugħ ta' nifs, taħbit tal-qalb irregolari, awrina mċajpra, għeja u/jew skumdit fil-ġogi b'rabta ma' riżultati tal-laboratorju mhux normali (eż. potassju għoli, aċidu uriku u livelli ta' kalċju u livelli baxxi ta' fosfru fid-demm).
English: Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Maltese: Dawk is-sustanzi li jistimolaw l-attivita' tas-CYP3A4 (eż. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone u Hypericum perforatum, ukoll mgħaruf bħala St.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets imatinib
Maltese: Imatinib Teva 100 mg pilloli miksija b'rita imatinib
English: A total of 71 (12.8%) and 85 (15.4%) patients died in the imatinib and IFN+Ara-C groups, respectively.
Maltese: Total ta' 71 (12.8%) u 85 (15.
English: - Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' imatinib (bħala mesilate).
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Maltese: L-analiżi kkonfermat li l-espożizzjonijiet ta' imatinib f'pazjenti pedjatriċi mogħtija 260 mg/m2 darba kuljum (mhux aktar minn 400 mg darba kuljum) jew 340 mg/m2 darba kuljum (mhux aktar minn 600 mg darba kuljum) kienu l-istess bħal dawk f'pazjenti adulti li ngħataw 400 mg jew 600 mg imatinib darba kuljum.
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Maltese: esperti fil-mard tal-fwied u fil-kura tal-epatite B għandhom jiġu kkonsultati qabel ma tibda l-kura f'pazjenti b'seroloġija pożittiva għall-epatite B (inklużi dawk b'marda attiva) u għal dawk il-pazjenti li nstabu pożittivi għall-infezzjoni tal-HBV matul il-kura.
English: EU/1/12/808/013 30 film-coated tablets EU/1/12/808/014 30 x 1 film-coated tablets EU/1/12/808/015 90 film-coated tablets EU/1/12/808/016 90 x 1 film-coated tablets EU/1/12/808/017 30 film-coated tablets EU/1/12/808/018 30 x 1 film-coated tablets EU/1/12/808/019 90 film-coated tablets EU/1/12/808/020 90 x 1 film-coated tablets
Maltese: EU/1/12/808/013 30 pillola miksija b'rita EU/1/12/808/014 30 x 1 pillola miksija b'rita EU/1/12/808/015 90 pillola miksija b'rita EU/1/12/808/016 90 x 1 pillola miksija b'rita EU/1/12/808/017 30 pillola miksija b'rita EU/1/12/808/018 30 x 1 pillola miksija b'rita EU/1/12/808/019 90 pillola miksija b'rita EU/1/12/808/020 90 x 1 pillola miksija b'rita
English: Rates of complete haematological response, major cytogenetic response and complete cytogenetic response on first-line treatment were estimated using the Kaplan-Meier approach, for which nonresponses were censored at the date of last examination.
Maltese: Ir-rati ta' rispons ematoloġiku komplet, rispons ċitoġenetiku maġġuri u rispons ċitoġenetiku komplet wara kura bit-terapija preferita kienu stmati bl-approċċ Kaplan-Meier, li bihom nuqqas ta' risponsijiet kienu ċensurati fil-jum ta' l-aħħar eżami.
English: Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Maltese: Daqsijiet tal-pakketti li fihom 30x1 jew 90x1 kapsuli ibsin ġo folji pperforati ta' doża waħda.
English: Carriers of HBV who require treatment with Imatinib Teva should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Maltese: Portatuti tal-HBV li jeħtieġu l-kura b'Imatinib Teva għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' infezzjoni attiva tal-HBV waqt il-kura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: Imatinib Teva 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Maltese: Imatinib Teva 400 mg kapsuli ibsin huma disponibbli f'pakketti għal daqsijiet ta' 30 jew 90 kapsula iebsa ġo folji.
English: Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Daqsijiet tal-pakketti li fihom 30x1 jew 90x1 pillola miksija b'rita ġo folji pperforati ta' doża waħda.
English: VCR 2 mg i.v., days 6, 13, 20;
Maltese: DEX 10 mg/m2 orali, jiem 1-5; VCR 2 mg i.v., jiem 6, 13, 20;
English: Relapsed/refractory Ph+ ALL
Maltese: Terapija t'induzzjoni (de novo Ph+ ALL)
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 (MDS/MPD) assoċjat ma' tibdil fil ġene tar-riċettur tal-fattur ta' tkabbir li jkun ġej minn plejtlets (PDGFR).
English: Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Maltese: Filwaqt li 96% (93%) tal-pazjenti b'CCyR (PCyR) kienu stmati li kienu ħielsa minn avvanz fit-12-il xahar għall-Fażi aċċelerata/blast crisis fl-84 xahar, 81% biss tal-pazjenti mingħajr MCyR fit-12-il xahar kienu ħielsa minn avvanz għal CML fl-84 xahar (p< 0.001 globali, p=0.25 bejn CCyR u PCyR).
English: How to take Imatinib Teva
Maltese: Imatinib Teva.
English: Haematological response1
Maltese: Induzzjoni tar-remissjoni
English: Of these 11 patients, 4 patients escalated up to 800 mg daily, 2 of whom regained a cytogenetic response (1 partial and 1 complete, the latter also achieving a molecular response), while of the 7 patients who did not escalate the dose, only one regained a complete cytogenetic response.
Maltese: Minn dawn il-11-il pazjent, 4 pazjenti laħqu 800 mg kuljum, li 2 minnhom reġgħu kisbu rispons ċitoġeniku (1 parzjali u 1 komplet, dan ta' l-aħħar kellu wkoll rispons molekulari), filwaqt li mis-7 pazjenti li ma żiedux iddoża, wieħed biss kiseb mill-ġdid rispons ċitoġenetiku komplet.
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
Maltese: L-età ta' dawn ilpazjenti kienet minn sentejn sa 16-il sena u imatinib ingħata f'doża ta' 300 mg/m2 kuljum jew f'dożi li jvarjaw minn 200 sa 400 mg kuljum.
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Maltese: Ma kien hemm l-ebda bidla fil-farmakokinetiċi ta' imatinib meta ngħataw dożi ripetuti, u kien hemm akkumulazjoni ta' 1.5-2.5-il darba fl-istat fiss meta d-doża ngħatat darba kuljum.
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Maltese: Kriterji ta' rispons ċitoġenetiku: sħiħ (0% ta' metafasijiet Ph+), parzjali (1-35%), minuri (36-65%) jew minimu (66-95%).
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia,
Maltese: Ipokalimija, żieda fl-aptit, ipofosfatemija, nuqqas ta' aptit, deidrazzjoni,
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 6-15 jew sa ANC > 1500 post nadir
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Maltese: Inħoloq reġistru ta' osservazzjoni (studju L2401) sabiex tinġabar data dwar is-sigurtà u l-effikaċja fuq medda ta' żmien fost pazjenti li jbatu minn neoplażmi majeloproliferattivi b'arranġament PGDFR- β u li kienu ttrattati bi Imatinib.
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Maltese: Hemm esperjenza limitata fi tfal li jsofru minn Ph-posittiva ALL u esperjenza limitata ħafna fi tfal b'MDS/MPD, DFSP u HES/CEL.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m2.
Maltese: naqqas id-doża ta' imatinib għal 260 mg/m2.
English: Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Maltese: Skont ġabra ta' analiżi farmakokinetika fost il-popolazzjoni ta' pazjenti pedjatriċi b'disturbi ematoloġiċi (CML, Ph+ALL, jew disturbi ematoloġiċi oħrajn ikkurati b'imatinib), l-eliminazzjoni ta' imatinib tiżdied skont l-erja tas-superfiċje tal-ġisem (BSA).
English: This time-toevent endpoint is strongly affected by the high crossover rate from IFN+Ara-C to imatinib.
Maltese: Meta l-livelli jinżlu, imatinib jista' imbagħad jitkompla b'doża ta' kuljum imnaqqsa.
English: Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Maltese: Imatinib jista' jżid il-konċentrazzjoni fil-plażma ta' mediċini oħrajn li jiġu metabolizzati permezz tas-CYP3A4 (ez., triazolo-benzodiazepines, sustanzi bħal dihydropyridine li jibblokkaw il-kanali li minnhom jgħaddi l-kalċju għal ġoċ-ċelluli, xi tipi ta' sustanzi li jinibixxu lill-HMG-CoA reductase, jiġifieri l-istatins, eċċ.).
English: 235 adult patients with accelerated phase disease were enrolled.
Maltese: 235 pazjent bil-marda fil-fażi aċċelerata ġew reklutati.
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'
English: Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Maltese: dożi)iii: jiem 2 and 3 Terapija IT trippla (aġġustata skont l-età): jiem 1, 29
English: Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Maltese: Il-profili farmakokinetiċi fil-plażma kienu analizzati fl-1 jum u jew fis-7 jum jew inkella fit-28 jum, sakemm il konċentrazzjonijiet fil-plażma kienu laħqu stat fiss.
English: Clinical studies in DFSP
Maltese: Espożizzjoni kontinwa kuljum għal
English: Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Maltese: Żieda qawwija fil-livelli ta' transaminases (<5%) jew ta' bilirubin (<1%) kienet evidenti f'pazjenti b'CML u s-soltu kienet kontrollata bi tnaqqis fid-doża jew inkella billi kien imwaqqaf għal ftit żmien ittrattament (it-tul medjan ta' dawn l-episodji kien ta' bejn wieħed u ieħor, ġimgħa).
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Maltese: • Rikorrenza (riattivazzjoni) tal-infezzjoni tal-epatite B meta kellek l-epatite B fil-passat (infezzjoni fil-fwied).
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Maltese: Tibdil fid-doża ma jidrux li huma neċessarji meta imatinib jingħata flimkien ma' sottostrati ta' CYP2D6, madankollu hija konsiljata lattenzjoni għal sottostrati ta' CYP2D6 b'medda terapewtika dejqa bħal metoprolol.
English: Chronic phase, Interferon failure
Maltese: Il-fażi kronika, meta Interferon ma ħadimx
English: The adverse reactions were similar in all indications, with two exceptions.
Maltese: Ir-reazzjonijiet avversi kienu simili fl-indikazzjonijiet kollha, bl-eċċezzjoni ta' tnejn.
English: Nederland Teva Nederland B.V. Tel: +31 8000228400
Maltese: Tel: +31 8000228400
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 lbijotrasformazzjoni ta' imatinib.
English: Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Maltese: Dejta dwar is-sigurtà minn dan l-istudju jidher li hi skont il-profil ta' sigurtà ta' imatinib f'pazjenti b'Ph+ ALL.
English: Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Maltese: Peress li żieda fil-vaskularit u tendenza ta' fsada hija parti naturali mill-proċess kliniku ta' GIST, prattiċi standard u proċeduri ta' monitoraġġ u maniġġjar ta' fsada fil-pazjenti kollha għandhom jintużaw.
English: Oral use.
Maltese: darba kuljum.
English: A complete haematological response was achieved in 95% of patients.
Maltese: Rispons ematoloġiku sħiħ ntlaħaq f' 95% tal-pazjenti.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
Maltese: Vindesine 3 mg/m2 i.v., jum 1; MTX 1.5 g/m2 i.v. (24 h), jum 1; Etoposide 250 mg/m2 i.v. (1 h) jiem 4-5; Ara-C 2x 2 g/m2 i.v. (3 h, q 12
English: Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but < 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils ≥ 20%, platelets < 100 x 109/l unrelated to therapy.
Maltese: RTC < 15% blasts fil-mudullun u fid-demm fil-periferiji, < 30% blasts+promajeloċiti filmudullun 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 (għal 0102 u 0109 biss)
English: Capsule content Mannitol
Maltese: Il-qalba tal-pillola Mannitol
English: There is very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Maltese: MDS/MPD, HES/CEL u DFSP.
English: One of these intermediates was also positive in the mouse lymphoma assay.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: In the study in patients with unresectable and/or metastatic GIST, 7 (5%) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
Maltese: Fl-istudju f'pazjenti b' GIST li ma jistax jitneħħa b'operazzjoni u/jew li huwa metastatiku 7 (5%) tal-pazjenti ħassew CTC grad 3/4 fsada GI (3 pazjenti), fsada fit-tumur (3 pazjenti) jew it-tnejn (pazjent 1).
English: The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib.
Maltese: Il-kondizzjoni kienet rappurtata bħala riversibbli meta ingħataw sterojdi b'mod sistemiku, miżuri ta' support ċirkolatorju, u interruzzjoni ta'imatinib b'mod temporanju.
English: Pack sizes of 60 or 120 film-coated tablets in blisters.
Maltese: Daqsijiet tal-pakketti li fihom 60 jew 120 pillola miksija b'rita ġo folji.
English: The dose is 800 mg per day (2 capsules), to be taken as 1 capsule in the morning and a second capsule in the evening.
Maltese: Jekk iddoża ta' kuljum tkun 800 mg, (2 kapsuli), għandek tieħu kapsula waħda filgħodu u t-tieni kapsula filgħaxija.
English: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Maltese: Ħakk, edema fil-wiċċ, ġilda xotta, ħmura, alopeċja, tgħereq ħafna matul il-lejl, reazzjoni ta' fotosensittività
English: Pharmacokinetics of imatinib
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month.
Maltese: Dan ma rriżultax meta ddożi li ntużaw kienu ta' ≤ 20 mg/kg.