FrancophonIA/ELRC3.0 huggingface dataset:
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 publikazzjoni rappurtat dejta fuq żmien twil ta' follow-up minn 12 pazjenti b'MDS/MPD b'tibdil filġene PDGFR (5 pazjenti minn studju B2225).
English: The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold drug accumulation after repeated once-daily dosing.
Maltese: Meta ġew imqabbla l-AUC(0-24) fit-8 jum u fl-1 jum fl-livell ta' doża ta' 340 mg/m2/jum, instab li l-mediċina kienet akkumulat b' 1.7-il darba wara dożi ripetuti ta'
English: CP 500 mg/m2 i.v.
Maltese: CP 500 mg/m2 i.v.(1 h) jum 1; Ara-C 60 mg/m2 i.v., jiem
English: Pack sizes of 60 or 120, hard capsules in blisters.
Maltese: Daqsijiet tal-pakketti li fihom 60 jew 120 kapsuli ibsin ġo folji.
English: VCR (1.5 mg/m2/day, IV): days 1, 29 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 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
Maltese: Reġimen iper-CVAD: CP 300 mg/m2 i.v. (3 h, q 12 h), jiem 1-3; Vincristine 2 mg i.v., jiem 4, 11; Doxorubicine 50 mg/m i.v. (24 h), jum 4; DEX 40 mg/jum f'jiem 1-4 u 11-14, alternati b'MTX 1 g/m2 i.v. (24 h), jum 1, Ara-C 1 g/m2 i.v. (2 h, q 12 h), jiem 2-3 (total ta' 8 korsijiet)
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Maltese: Madankollu,il-frekwenzi ta' ċitopenji dehru biċ-ċar li kienu jiddependu wkoll fuq l-istadju tal-marda, tant li l-frekwenzi ta' newtropinji tat-3 jew ir-4 grad (ANC < 1.0 x 109/l) u tromboċitpenji (għadd tal-plejtlets < 50 x 109/l) kienu bejn 4-6 darbiet ogħla fil-blast crisis jew fil-fażi l-imgħaġġla (59-64% u 44-63% fil-każijiet ta' newtropinja u tromboċitopenja, rispettivament) meta mqabbla mal-frekwenzi li wieħed kien isib fil-każijiet ta' pazjenti li tkun għada kif ġiet dijanjostikata CML fil-fażi l-kronika (16.7% newtropinja u 8.9% tromboċitopenja).
English: There were no special safety findings in paediatric clinical trials.
Maltese: Ma kienx hemm riżultati ta' sigurtà speċjali fi provi kliniċi pedjatriċi.
English: (Best response rates)
Maltese: (3 ġimgħat)
English: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Maltese: Pressjoni għolja, ematoma, ematoma subdurali, kesħa periferali, pressjoni baxxa, fenomenu ta'Raynaud
English: 30 film-coated tablets 30x1 film-coated tablets 90 film-coated tablets 90x1 film-coated tablets
Maltese: 30 pillola miksija b'rita 30x1 pillola miksija b'rita 90 pillola miksija b'rita 90x1 pillola miksija b'rita
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,
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 ngħata 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: • Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
Maltese: • Pazjenti adulti u pedjatriċi jkunu għadhom kif ġew dijanjostikati b'lewkimja majelojd kronika (CML) li huma posittivi (Ph+) għall-kromosoma ta' Filadelfja (bcr-abl) u li ma jkunux jistgħu jirċievu trapjant tal-mudullun bħala l-kura preferita.
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 children (based on AUC) at 340 mg/m2/day.
Maltese: L-adenoma/karċinoma tal-kliewi, ilbużżieqa tal-awrina u papilloma tal-uretra, l-adenokarċinomi tal-imsaren, 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 (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 1.2-il darba l-esponiment ta' kuljum fit-tfal bażat (fuq l-AUC) b'340 mg/m2/jum.
English: Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Maltese: Daqsijiet tal-pakketti li fihom 20x1, 60x1, 120x1 jew 180x1 kapsuli ibsin ġo folji pperforati ta' doża waħda.
English: Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Maltese: Ginekomastja, funzjoni ħażina tal-erezzjoni, menorraġja, mestrwazzjoni irregolari, funzjoni sesswali ħażina, uġigħ fir-ras tal-beżżula, tkabbir tas-sider, edema fl-iskrotu
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Maltese: tat-triglycerides, proteini totali, u tal-albumina fiż-żewġ speċi.
English: Imatinib Teva 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Maltese: Imatinib Teva 400 mg kapsuli ibsin huma disponibbli f'pakketti għal daqsijiet ta' 30x1 jew 90x1 ta' kapsuli ibsin ġo folji perforati ta' doża waħda.
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: Flistudju dwar l-effett tossiku fil-minorenni, effetti fuq it-tkabbir, dewmien fil-ftuħ vaġinali u sseparazzjoni tal-prepuzju kienu osservati f'madwar 0.3 sa darbtejn l-espożizzjoni pedjatrika medja flogħla doża rrakkomandata ta' 340 mg/m2.
English: Major cytogenetic response2
Maltese: 2Kriterji għar-risponsijiet ċitoġenetiċi:
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Maltese: L-AUC fil-plażma għal imatinib naqset b'73% meta mqabbla ma pazjenti li ma kienux qed jieħdu EIAED's.
English: Imatinib Teva 100 mg hard capsules imatinib
Maltese: Imatinib Teva 100 mg kapsuli iebsin imatinib
English: - The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous.
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol,, crospovidone u magnesium stearate u silica kollojdali anidru.
English: Imatinib Teva 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
Maltese: Imatinib Teva 100 mg kapsuli ibsin huma disponibbli f'pakketti għal daqsijiet ta' 60 jew 120 kapsula iebsa ġo folji.
English: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non-randomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Maltese: III open-label, multiċentrika, b'koorti sekwenzjali, mhux randomizzata, u ngħataw kura b'imatinib (340 mg/m2/kuljum) flimkien ma' kemoterapija intensiva wara terapija ta' induzzjoni.
English: AST: any
Maltese: AST:
English: (24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
Maltese: MTX 500 mg/m2 i.v. (24 h), jiem 1, 15; 6-MP 25 mg/m2 orali, jiem 1-20
English: 305, 74770 Opava-Komarov Czech Republic
Maltese: Ostravska 29, c.p. 305, 74770
English: Dosing in children 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 kisbu l-istess esponiment, rispettivament, bħalma jkun hemm fl-adulti b'dożi ta' 400 mg u 600 mg.
English: Imatinib Teva 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Maltese: Imatinib Teva 100 mg kapsuli ibsin huma disponibbli f'pakketti għal daqsijiet ta' 20x1, 60x1, 120x1 jew 180x1 ta' kapsuli ibsin ġo folji perforati ta' doża waħda.
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-bijotrasformazzjoni ta' 5-fluoruracil, iżda impedixxa l-metaboliżmu ta' paclitaxel billi impedixxa b'mod kompetittiv lill
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 children (based on AUC) at 340 mg/m2/day.
Maltese: Papilloma/karċinoma tal-glandola tal-prepuzju/klitoris dehru mat-30 mg/kg/jum 'l quddiem, li jiġi madwar 0.5 jew 0.3-il darba tal-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 0.
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Maltese: Palpitazzjonijiet, takikardja, insuffiċjenza konġestiva tal-qalb
English: Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Maltese: Imatinib Teva 100 mg pilloli miksija b'rita huma disponibbli f'pakketti għal daqsijiet ta' 20x1, 60x1, 120x1 jew 180x1 ta' pilloli miksija b'rita ġo folji perforati ta' doża waħda.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Teva should not be resumed.
Maltese: Jekk antikorp kontra ADAMTS13 jiġi elevat flimkien ma' attività baxxa ta' ADAMTS13, it-trattament b'Imatinib Teva m'għandux jinbeda mill ġdid.
English: Imatinib Teva 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
Maltese: Imatinib Teva 400 mg pilloli miksija b'rita Daqsijiet tal-pakketti li fihom 30 jew 90 pillola miksija b'rita ġo folji.
English: Partial
Maltese: Ġelatin
English: Imatinib Teva 100 mg hard capsules For doses of 400 mg and above (see dose recommendation below) a 400 mg hard capsule is available.
Maltese: Għal dożi ta' 400 mg jew aktar (ara d-dożaġġ rakkomandat hawn taħt) teżisti kapsula iebsa ta' 400 mg.
English: Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Maltese: Żieda fid-dożi minn 400 mg għal 600 mg jew 800 mg, f'pazjenti li jkollhom marda li tkun f'fażi kronika, jew minn 600 mg għall-massimu ta' 800 mg (li jingħataw f'dożi ta' 400 mg, darbtejn kuljum) f'pazjenti li jkunu fil-fażi aċċelerata jew li jkollhom blast crisis għandha mnejn tiġi kkunsidrata fl-assenza ta' effetti avversi severi minħabba fil-mediċina u fl-assenza ta' newtropinja jew tromboċitopenja severi li ma jkunux relatati ma' lewkimja, f'dawn iċ-ċirkustanzi: meta jkun hemm avvanz tal-marda (ikun f'liema żmien ikun); meta ma jkunx hemm rispons ematoloġiku sodisfaċenti wara mill-inqas 3 xhur ta' kura;
English: Clinical studies in HES/CEL
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Infomazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: (Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.)
Maltese: (Għal nota, mill-411 pazjent, 353 kienu kurati f'programm ta' aċċess imwessa' mingħajr ma kienet miġbura dejta dwar ir-rispons ewlieni).
English: For doses other than 400 mg and 800 mg (see dose recommendation below) a 100 mg hard capsule is available.
Maltese: Għal dożi oħra minbarra 400 mg u 800 mg (ara d-dożaġġ rakkomandat hawn taħt) hemm disponibbli kapsula iebsa ta' 100 mg.
English: The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Maltese: Hija rrakkomandata doża ta' 340 mg/m2 għal tfal b'Ph+ ALL (ma għandhiex taqbeż id-doża totali ta' 600 mg).
English: 20x1 film-coated tablets 60 film-coated tablets 60x1 film-coated tablets 120 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
Maltese: 20x1 pillola miksija b'rita 60 pillola miksija b'rita 60x1 pillola miksija b'rita 120 pillola miksija b'rita 120x1 pillola miksija b'rita 180x1 pillola miksija b'rita
English: Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Imatinib Teva 400 mg pilloli miksija b'rita huma disponibbli f'pakketti għal daqsijiet ta' 30x1 jew 90x1 ta' pilloli miksija b'rita ġo folji perforati ta' doża waħda.
English: These effects were not seen at doses ≤ 30 mg/kg.
Maltese: Dawn l-effetti ma dehrux b'dożi ta' ≤ 30 mg/kg.
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/l) and thrombocytopenia (platelet count < 10 x 109/l) were observed in 3.6% and < 1% of patients, respectively.
Maltese: F'CML, fil-fażi l-kronika, li kienet għada kif ġiet dijanjostikata, kien hemm newtropinja tar-4 grad (ANC < 0.5 x 109/l) u tromboċitopenja (għadd tal plejtlets < 10 x 109/l) f'3.6% u f' < 1% tal-pazjenti, rispettivament.
English: Study 0109 40.5-month data Accelerated phase (n=235)
Maltese: Studju 0109 Dejta ta' 40.5 xahar
English: Imatinib Teva 100 mg hard capsules
Maltese: Imatinib Teva 100 mg kapsuli ibsin
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Maltese: 8, 15, 22; Ara-C 40 mg intrathecal, jiem 1, 8, 15, 22; Methylprednisolone 40 mg intrathecal, jiem 1, 8, 15, 22
English: EU/1/12/808/021 20 x 1 hard capsules EU/1/12/808/022 60 hard capsules EU/1/12/808/023 60 x 1 hard capsules EU/1/12/808/024 120 hard capsules EU/1/12/808/025 120 x 1 hard capsules EU/1/12/808/026 180 x 1 hard capsules EU/1/12/808/027 20 x 1 hard capsules EU/1/12/808/028 60 hard capsules EU/1/12/808/029 60 x 1 hard capsules EU/1/12/808/030 120 hard capsules EU/1/12/808/031 120 x 1 hard capsules EU/1/12/808/032 180 x 1 hard capsules
Maltese: EU/1/12/808/021 20 x 1 pillola iebsa EU/1/12/808/022 60 pillola iebsa EU/1/12/808/023 60 x 1 pillola iebsa EU/1/12/808/024 120 pillola iebsa EU/1/12/808/025 120 x 1 pillola iebsa EU/1/12/808/026 180 x 1 pillola iebsa EU/1/12/808/027 20 x 1 pillola iebsa EU/1/12/808/028 60 pillola iebsa EU/1/12/808/029 60 x 1 iebsa EU/1/12/808/030 120 pillola iebsa EU/1/12/808/031 120 x 1 pillola iebsa EU/1/12/808/012 180 x 1 pillola iebsa
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 il-volum ta' distribuzzjoni (żieda ta' 12% f' pazjenti li għandhom > 65 sena).
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
English: In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Maltese: F'pazjenti b'Ph+ ALL, hemm esperjenza klinika tal-użu ta' ġlivec ma' kemoterapija (ara sezzjoni 5.1),
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir
Maltese: MESNA (360 mg/m2/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5
English: EU/1/12/808/033 30 hard capsules EU/1/12/808/034 30 x 1 hard capsules EU/1/12/808/035 90 hard capsules EU/1/12/808/036 90 x 1 hard capsules EU/1/12/808/037 30 hard capsules EU/1/12/808/038 30 x 1 hard capsules EU/1/12/808/039 90 hard capsules EU/1/12/808/040 90 x 1 hard capsules
Maltese: EU/1/12/808/033 30 pillola iebsa EU/1/12/808/034 30 x 1 pillola iebsa EU/1/12/808/035 90 pillola iebsa EU/1/12/808/036 90 x 1 pillola iebsa EU/1/12/808/037 30 pillola iebsa EU/1/12/808/038 30 x 1 pillola iebsa EU/1/12/808/039 90 pillola iebsa EU/1/12/808/040 90 x pillola iebsa
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-far 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: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides, 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 4.5).
Maltese: pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) jew. warfarin jew derivattivi oħrajn ta' coumarin.
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: irriżulta li kien hemm tnaqqis fil-piż tat-testikoli u tal-epididimu u anke tnaqqis fil-perċentwal ta' sperma b'mobilit 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: (3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
Maltese: Ara-C 1,000 mg/m2/12 h i.v.(3 h), jiem 1-4; Mitoxantrone 10 mg/m2 i.v. jiem 3-5;
English: In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Maltese: Minbarra hekk, 24 pazjent ieħor b'MDS/MPD kienu rappurtati f'13-il publikazzjoni.
English: Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or < ULN if total bilirubin is > ULN)
Maltese: >ULN (jista' jkun normali jew < ULN jekk il-bilrubin totali jkun > ULN)
English: The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
Maltese: Numru ta' pilloli li jkun hemm bżonn jittieħdu għandhom jitqegħedu f'volum xieraq tax-xarba (bejn wieħed u ieħor 50 ml għall-pillola ta' 100 mg, u 200 ml għall-pillola ta' 400 mg) u mħawwda b'kuċċarina.
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: Irrata tar-rispons kienet ukoll ogħla fil-pazjenti li ħadu doża ta' 600 mg (33%) meta mqabbla mal-pazjenti li kienu ħadu doża ta' 400 mg (16%, p=0.0220).
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Maltese: Herpes zoster, herpes simplex, nasofarinġite, pulmonite
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 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): jiem 1 u 15 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x
English: EU/1/12/808/001 20 x 1 film-coated tablets EU/1/12/808/002 60 film-coated tablets EU/1/12/808/003 60 x 1 film-coated tablets EU/1/12/808/004 120 film-coated tablets EU/1/12/808/005 120 x 1 film-coated tablets EU/1/12/808/006 180 x 1 film-coated tablets EU/1/12/808/007 20 x 1 film-coated tablets EU/1/12/808/008 60 film-coated tablets EU/1/12/808/009 60 x 1 film-coated tablets EU/1/12/808/010 120 film-coated tablets EU/1/12/808/011 120 x 1 film-coated tablets EU/1/12/808/012 180 x 1 film-coated tablets
Maltese: EU/1/12/808/001 20 x 1 pillola miksija b'rita EU/1/12/808/002 60 pillola miksija b'rita EU/1/12/808/003 60 x 1 pillola miksija b'rita EU/1/12/808/004 120 pillola miksija b'rita EU/1/12/808/005 120 x 1 pillola miksija b'rita EU/1/12/808/006 180 x 1 pillola miksija b'rita EU/1/12/808/007 20 x 1 pillola miksija b'rita EU/1/12/808/008 60 pillola miksija b'rita EU/1/12/808/009 60 x 1 pillola miksija b'rita EU/1/12/808/010 120 pillola miksija b'rita EU/1/12/808/011 120 x 1 pillola miksija b'rita EU/1/12/808/012 180 x 1 pillola miksija b'rita
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF- mediated cellular events.
Maltese: Imatinib jinpedixxi wkoll lir-receptor tyrosine kinases għall-growth factor derivat mill-plejtlets
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib
Maltese: Imatinib Teva 400 mg pilloli miksija b'rita imatinib
English: Resume treatment with imatinib at 600 mg.
Maltese: Erġa ibda l-kura b'imatinib b'600 mg. 3.
English: (1 h), days 1-3; Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Maltese: CP 1.2 g/m2 i.v. (3 h), jum 1; Daunorubicin 60 mg/m2 i.v. (1 h), jiem 1-3; Vincristine 1.3 mg/m2 i.v., jiem 1, 8, 15,
English: Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Maltese: Imatinib ingħata b'mod intermittenti b'koorti ta' 1-5, b'żieda fiddewmien u bi tnedija bikrija ta' Imatinib minn koorti għal koorti; koorti 1 jirċievi l-inqas intensità u koorti 5 jirċievi l-ogħla intensità ta' imatinib (l-ikbar dewmien f'jiem b'doża ta' Imatinib kuljum b'mod kontinwu matul l-ewwel korsijiet ta' kura b'kimoterapija).
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) jew rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000):