FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual starting dose in treatment in CML in blast crisis is 600 mg, to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Maltese: Id-doża li normalment tibda biha hija il-kura ta' CML fi kriżi tal-blasts ta' 600 mg li tittieħed bħala 6 kapsuli ta' 100 mg (jew 1 kapsula ta' 400 mg flimkien ma' 2 kapsuli ta' 100 mg) darba kuljum.
English: Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Maltese: Methotrexate (5 g/m² fuq medda ta' 24 siegħa, IV): jiem 1 u 15 Leucovorin (75 mg/m² fis-36 siegħa, IV; 15 mg/m² IV jew PO q6h x
English: There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Maltese: Kien hemm żieda sinifikanti fl-ammont ta' imatinib esponut (is-Cmax intermedju u l-AUC għal imatinib għolew b'26% u 40% rispettivament) f'persuni f'saħħithom, meta imatinib ingħata flimkien ma' doża waħda ta' ketoconazole (sustanza li tinibixxi s-CYP3A4).
English: The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Maltese: It-23 pazjent imsieħba fir-reġistru ngħataw Imatinib medac f'doża medja kuljum ta' 264 mg (firxa: 100 sa 400 mg) għal tul medju ta' żmien ta' 7.2 snin (firxa minn 0.1 sa 12.7 snin).
English: Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n = 11) or CML in blast crisis or Ph+ acute leukaemias (n = 15) were enrolled in a dose-escalation phase I trial.
Maltese: B'kollox 26-il pazjent pedjatriku ta' età ta' < 18-il sena li jew kellhom CML filfażi l-kronika (n=11) jew kellhom CML fi blast crisis jew lewkimji akuti (n=15) b'Ph+ kienu reklutati fi prova ta' fażi I li fiha d-doża kienet tiżdied.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problem ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Maltese: Uġigħ fil-plewra, fibrożi fil-pulmun, pressjoni għolja fil-pulmun, emorraġija
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Maltese: • pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati pożittivi għall-lewkimja limfoblastika akuta b'kromosoma ta' Philadelphia (Ph+ ALL) integrata b'kimoterapija.
English: Imatinib
Maltese: Pabianice
English: The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Maltese: Il-qoxra tal-kapsula għal kapsula ta' 100 mg hija magħmula minn gelatine, iron oxide isfar (E172), titanium dioxide (E171) u iron oxide aħmar (E172).
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: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'imatinib f'kull sett tal-popolazzjoni pedjatrika fil-kromosoma Philadelphia (bcr-abl translocation)lewkimja majelojde kronika pożittiva (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
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 li kienu osservati f'popolazzjoni ta' 211 pazjenti li kienu għadhom kif ġew dijanjostikati Ph+ ALL f'erba' studji kliniċi mingħajr kontroll (AAU02, ADE04, AJP01 u AUS01) huma konsistenti mar-risżultati deskritti hawn fuq.
English: 8 g to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Maltese: 8 g sa10 g (doża waħda):
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: Skont analiżi tal-farmakokinetiċi tal-grupp ta' pazjenti b'CML, kien hemm effett żgħir tal-età fuq ilvolum ta' distribuzzjoni (żieda ta' 12% f'pazjenti li għandhom > 65 sena).
English: Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Maltese: Dożi ta' 400 mg jew 600 mg għandhom jingħataw darba kuljum, filwaqt li doża ta' 800 mg kuljum għandha tingħata bħala 400 mg darbtejn kuljum, filgħodu u filgħaxija.
English: Imatinib medac is a treatment for adults and children and adolescents for:
Maltese: Imatinib medac huwa kura għall-adulti u tfal u adolexxenti għall-:
English: Study AUS01
Maltese: L01XE01
English: Take the medicine pack with you.
Maltese: Ħu l-pakkett mediku miegħek.
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Maltese: Kien hemm żidiet żgħar għal moderati fil-livelli tat-transaminases u kien hemm xi tnaqqis żgħir fil-livelli tal-kolesterol, tattriglycerides, proteini totali, u tal-albumina fiż-żewġ speċi.
English: Dosing in paediatric patients at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Maltese: II. Dożi ta' 260 u 340 mg/m²/jum f'pazjenti pedjatriċi kisbu l-istess esponiment, rispettivament, bħalma jkun hemm fl-adulti b'dożi ta' 400 mg u 600 mg.
English: Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL.
Maltese: Meta wieħed iqis id-databażi limitata dwar is-sigurtà, l-episodji avversi rrappurtati sa issa fit-tfal huma konsistenti mal-profil magħruf tas-sigurtà f'pazjenti adulti b'Ph+ ALL.
English: Imatinib medac contains lactose.
Maltese: Imatinib fih il-lactose.
English: When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11 % decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4 %) compared to fasting conditions.
Maltese: Meta ingħata fl-istess ħin ma' ikla li kien fiha ħafna xaħam, ir-rata li biha imatinib ġie assorbit tnaqqset b'ammont minimu (tnaqqis bi 11% fis-Cmax u titwil tat-tmax b'1.5 sigħat), bi tnaqqis żgħir fl-AUC (7.4%) meta mqabbla ma' dawk ta' pazjenti sajmin.
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Maltese: L-istess pubblikazzjoni rrappurtat dejta fuq żmien twil ta' follow-up minn 12 pazjenti b'MDS/MPD b'tibdil fil-ġene PDGFR (5 pazjenti minn studju B2225).
English: • Then continue with your normal schedule.
Maltese: • Imbagħad kompli bl-iskeda normali tiegħek.
English: Dyspnoea, epistaxis, cough
Maltese: Katarretti, glawkoma, papilledema
English: • Do not breast-feed during the treatment with Imatinib medac as there is limited information on the distribution of imatinib into the breast milk.
Maltese: • M'għandekx tredda' meta tkun qed tieħu Imatinib medac għax hemm informazzjoni limitata rigward id-distribuzzjoni ta' imatinib fil-ħalib tal-omm.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni:
English: Study AJP01 Induction therapy i.v.
Maltese: Studju AUS01 Terapija ta' induzzjoniaċċertament
English: Active substances that may have their plasma concentration altered by imatinib Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Maltese: Sustanzi attivi li jistgħu jkollhom il-konċentrazzjoni tagħhom fil-plażma mibdula minħabba f'imatinib Imatinib iżid is-Cmax medju u l-AUC ta' simvastatin (substrat ta' CYP3A4) b'2- u bi 3.5 darbiet, rispettivament, u dan jindika li imatinib jinibixxi is-CYP3A4.
English: Table 2 Response in adult CML study
Maltese: Tabella 2 Rispons f'adult bl-istudju CML
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Maltese: Il-funzjoni tal-fwied (transaminases, bilirubina, alkaline phosphatase) għandha tiġi mmonitorjata b'mod regolari f'pazjenti li jkunu qed jirċievu imatinib.
English: The rate of haematological response was 70 % with a duration of 2-3 months.
Maltese: Ir-rata ta' rispons ematoloġiku kienet ta' 70% b'tul ta' żmien ta' minn 2-3 xhur.
English: Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
Maltese: Kull kapsula iebsa ta' 400 mg ta' Imatinib medac fiha 400 mg ta' imatinib (bħala mesilate).
English: Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash
Maltese: Edema mad-dawra tal-għajnejn, dermatite/ekżema/raxx
English: The most commonly reported (≥ 10 %) treatment-related adverse reactions were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Maltese: Fiż-żewġ każijiet, l-aktar effett avvers relatat mal-mediċina li kien rappurtat (≥ 10%) kienu tqallih ħafif, rimettar, dijarrea, uġigħ addominali, għejja, majalġja, bugħawwieġ u raxx.
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
Maltese: F'CML, fil-fażi l-kronika, li kienet għadha kif ġiet dijanjostikata, kien hemm newtropenija tar-4 grad (ANC < 0.5 x 10
English: Posology for MDS/MPD in adult patients The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD.
Maltese: Id-doża ta' imatinib rakkomandata għal pazjenti adulti b'MDS/MPD hija 400 mg/jum.
English: (Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.)
Maltese: (Li wieħed jinnota, mill411 pazjent, 353 kienu kkurati f'programm ta' aċċess imwessa' mingħajr ma kienet miġbura dejta dwar ir-rispons ewlieni).
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 it-tossikoloġija fl-iżvilupp fuq firien ġuvenili, l-effetti fuq it-tkabbir, dewmien fil-ftuħ vaġinali u s-separazzjoni tal-prepuzju, ġew osservati f'madwar 0.3 darba sad-doppju talesponiment medju pedjatriku fl-ogħla doża rakkomandata ta' 340 mg/m².
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: (1 h), days 1-5
Maltese: /kuljum, IV): jiem 1-5
English: Cytogenetic response criteria:
Maltese: Disturbi psikjatriċi Komuni:
English: The rate of response was also higher in the patients treated at 600 mg (33 %) as compared to the patients treated at 400 mg (16 %, p = 0.0220).
Maltese: Ir-rata tar-rispons kienet ukoll ogħla fil-pazjenti li ħadu doża ta' 600 mg (33%) meta mqabbla malpazjenti li kienu ħadu doża ta' 400 mg (16%, p=0.0220).
English: The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2).
Maltese: Irrakkomandazzjoni tad-doża bħalissa hija bażata fuq numru żgħir ta' pazjenti pedjatriċi (ara sezzjonijiet 5.1 u 5.2).
English: 2/day, IV): days 1, 8 and 15 2/day bolus, IV): days 1 and 2 2/dose q12h x 4 doses, iv): Days 3 and 4 2, IM): day 4 G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 2/day, PO): days 1-7 and 15-21
Maltese: MESNA (360 mg/m²/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5 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: Colitis, ileus, inflammatory bowel disease
Maltese: Kolite, iljus, marda tal-infjammazzjoni tal-imsaren
English: Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Maltese: Kull kapsula iebsa ta' 100 mg ta' Imatinib medac fiha 100 mg ta' imatinib (bħala mesilate).
English: Maximal plasma concentrations of imatinib in patients are 2-4 μmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered medicinal products is possible.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma ta' imatinib filpazjenti jvarjaw minn 2-4 µmol/l, u għaldaqstant huwa possibbli li jinibixxi l-metaboliżmu permezz ta' CYP2D6 u/jew CYP3A4/5 ta' prodotti mediċinali li jingħataw fl-istess ħin miegħu.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in paediatric patients (based on AUC) at 340 mg/m2/day.
Maltese: Ladenoma/karċinoma tal-kliewi, il-bużżieqa tal-awrina u papilloma tal-uretra, l-adenokarċinomi talimsaren, l-adenomi tal-glandoli paratajrojd, it-tumuri benini u malinni tal-mudullun tal-glandoli adrenali u tal-papillomi/karċinomi tal-istonku mingħajr il-glandoli dehru b'60 mg/kg/jum, li jiġu madwar 1.7-il darba jew darba 1 l-esponiment ta' kuljum fil-bniedem (ibbażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 1.2-il darba l-esponiment ta' kuljum f'pazjenti pedjatriċi (ibbażat fuq l-AUC) b'340 mg/m²/jum.
English: In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Maltese: F'pazjenti pedjatriċi b'CML, l-aktar tossiċitajiet frekwenti kienu ċitopenji ta' grad 3 jew 4 li jinvolvu newtropenji, tromboċitopenji u anemija.
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1 % of CML patients.
Maltese: Il-kura kellha titwaqqaf għal kollox, minħabba abnormalitajiet fit-testijiet tal-laboratorju fuq il-funzjoni tal-fwied, f'inqas minn 1% tal-pazjenti b'CML.
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: Start 6-MP the 1st day after cranial irradiation completion.)
Maltese: MP fl-1el ġurnata wara t-tmiem tal-irradjazzjoni kranjali.)
English: This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Maltese: Dan jinkludi rapporti spontanji ta' każijiet kif ukoll avvenimenti avversi serji minn studji li għadhom għaddejjin, programmi ta' aċċess estiż, studji dwar ilfarmakoloġija klinika u studji esploratorji f'indikazzjonijiet mhux approvati.
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Maltese: Kienu rrappurtati ħames5 pazjenti b'DFSP u b'assoċjazzjoni ma' riarranġamenti tal-ġene PDGFR fi 3 pubblikazzjonijiet.
English: The no observed effect level (NOEL) was 15 mg/kg/day.
Maltese: Il-livell fejn ma jkunx osservat effett (NOEL) kien 15 mg/kg/jum.
English: 10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Maltese: 8) Xi każijiet fatali ta' insuffiċjenza epatika u ta' nekrożi epatika kienu rrappurtati.
English: The age of these patients ranged from 2 to 79 years.
Maltese: L-etajiet ta' dawn ilpazjenti kienu bejn 2 u 79 sena.
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Maltese: Każijiet kliniċi ta' ipertirojdiżmu kienu rrappurtati f'pazjenti li tneħħietilhom it-tirojde li jkunu qed jirċievu terapija b'levothyroxine waqt il-kura b'imatinib (ara sezzjoni 4.5).
English: Biotransformation
Maltese: Modifika tal-pożoloġija
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 diġà ħadu bosta trattamenti, billi 46% kien diġà kellhom BMT u 73% kienu ħadu kemoterapija li kienet tinkludi ħafna sustanzi, minn qabel.
English: Therapeutic indication
Maltese: Terapija ta' induzzjoni
English: • If you are being treated for DFSP:
Maltese: • Jekk qed tirċievi kura għal DFSP:
English: The remaining circulating radioactivity consisted of a number of minor metabolites.
Maltese: Ir-radjuattività l-oħra fiċ-ċirkolazzjoni kienet minħabba numru ta'metaboli minuri.
English: Weakness, pyrexia, anasarca, chills, rigors
Maltese: Dgħufija, deni, anasarca, dehxiet, tregħid
English: 9/l) and thrombocytopenia (platelet count < 10 x 10
Maltese: 9/l) u tromboċitopenija (għadd tal-plejtlits
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in paediatric patients (based on AUC) at 340 mg/m2/day.
Maltese: Papilloma/karċinoma tal-glandola tal-prepuzju/klitoris dehru mat-30 mg/kg/jum 'il quddiem, li jiġi madwar 0.5 jew 0.3-il darba tal-esponiment ta' kuljum fil-bniedem (ibbażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 0.
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Maltese: Meta imitanib kien kombinat ma' dożi għolja ta' kimoterapija f'pazjenti b'Ph+ ALL, tossiċità mumentanja tal-fwied dehret bħala żieda fil-livelli ta' transaminases u bilirubina fid-demm.
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Maltese: Minħabba l-possibbiltà li jista' jkun hemm sindrome tal-lisi tat-tumur (TLS), huwa rrakkomandat li ssir korrezzjoni tad-deidrazzjoni klinikament sinifikanti u li jkun hemm kura tal-livelli għoljin talaċidu uriku qabel ma jingħata imatinib (ara sezzjoni 4.8).
English: Haematological adverse reactions
Maltese: Effetti emataloġiċi avversi
English: In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥ 30 mg/kg/day.
Maltese: Fi studju dwar l-effett kanċeroġenu fil-firien li dam sentejn,meta imatinib ingħata b'15, 30 u 60 mg/kg/jum wassal għal tnaqqis statistikament sinifikanti fit-tul tal-ħajja tal-firien maskili b'60 mg/kg/jum u fil-firien femminili b'≥30 mg/kg/jum.
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 (eż., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, jew Hypericum perforatum, magħruf ukoll bħala St.
English: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Maltese: Emigranja, ngħas, sinkope, newropatija periferali, tixkil fil-memorja, xjatika, sindrome tas-sieq irrekwieta, tregħid, emorraġija ċerebrali
English: In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Maltese: Fi studju fuq il-fertilità, f'firien ta' sess maskili li ngħataw il-mediċina għal 70 jum qabel ma tgħammru, irriżulta li kien hemm tnaqqis fil-piż tat-testikoli u tal-epididimu u anke tnaqqis filperċentwal ta' sperma b'mobilità tajba, meta ntużat doża ta' 60 mg/kg, li hi bejn wieħed u ieħor ekwivalenti għall-ogħla doża klinika possibbli ta' 800 mg/jum, jekk wieħed iqis l-erja tas-superfiċje tal-ġisem.
English: Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30 % (9 % complete) and a major cytogenetic response rate of 23 %.
Maltese: Meta imatinib intuża waħdu f'pazjenti b'Ph+ ALL li jirkadi/rifrattorju, irriżulta li, fil-53 mill-411 pazjent li setgħu jiġu evalwati għar-rispons, f'rata ta' rispons ematoloġiku ta' 30% (9% kompleti) u rata ta' rispons ċitoġenetiku maġġuri ta' 23%.
English: The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn 3 xhur sa 4 snin u imatinib ingħata f'doża ta' 50 mg kuljum jew f'dożi li jvarjaw minn 92.5 sa 340 mg/m² kuljum.
English: Dose adjustments for neutropenia and thrombocytopenia:
Maltese: Tibdil fid-doża meta jkun hemm newtropenija u tromboċitopenija:
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Maltese: Il-pazjenti kienu kkurati b'imatinib 340 mg/m²/jum, mingħajr interuzzjonijiet jekk ma jkunx hemm tossiċita li tillimita d-doża.
English: Imatinib medac 100 mg hard capsules Capsule content
Maltese: Imatinib medac 100 mg kapsuli ibsin imatinib
English: Consolidation therapy DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
Maltese: Reġimen iper-CVAD: CP 300 mg/m² i.v. (3 h, q 12 h), jiem 1-3; Doxorubicine 50 mg/m² i.v.
English: CP 1 g/m i.v.
Maltese: CP 1.2 g/m² i.v. (3 h), jum 1;
English: Imatinib medac 400 mg hard capsules
Maltese: Imatinib medac 400 mg kapsuli ibsin imatinib
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg capsule (not divisible) is available.
Maltese: Għal dożi ta' 400 mg u aktar (ara r-rakkomandazzjoni dwar id-dożaġġ hawn taħt) kapsula ta' 400 mg (li ma tinqasamx) hi disponibbli.
English: Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
Maltese: DEX 10 mg/m² orali, jiem 6-7, 13-16; VCR 1 mg i.v., jiem 7, 14;
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Rari:
English: • Mouth ulcers.
Maltese: • Ulċeri fil-ħalq.
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Maltese: Tliet pazjenti urew rispons ematoloġiku komplet (CHR) u pazjent wieħed kellu rispons ematoloġiku parzjali (PHR).