FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 and 4 neutropenia was seen in 7.5% and 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients.
Maltese: Newtropinja ta' grad 3 u grad 4 kienet evidenti f'7.5% f' 2.7% tal-pazjenti, rispettivament, u tromboċitopenja ta' grad 3 f' 0.7% tal-pazjenti.
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs. 31.6%, respectively).
Maltese: Imatinib kmieni waqt il-proċess ta' kura flimkien ma' kimoterapija lil pazjenti f'koorti 5 (n=50) tejbet is-sopravivenza ħielsa minn kull episodju (EFS) f'4 snin meta mqabbel mal-kontrolli storiċi (n=120), li ngħataw kimoterapija standard mingħajr imatinib (69.6 % vs 31.6 %, rispettivament).
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 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: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Maltese: Kreatinina fid-demm tiżdied, creatine phosphokinase fid-demm jiżdied, lactate dehydrogenase jiżdied, alkaline phosphatise fid-demm jiżdied
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Maltese: Il-pazjenti kienu kurati b'imatinib 340 mg/m2/jum, mingħajr interuzzjonijiet jekk ma jkunx hemm tossiċità li tillimita d-doża.
English: A total of 1.106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Maltese: Total ta' 1,106 pazjenti tqassmu b'mod randomized, 553 f'kull fergħa ta' trattament.
English: The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.
Maltese: Il-linka tal-istampar hi magħmula minn shellac, iron oxide black (E172) u propylene glycol.
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Maltese: Riżultati simili dehru f'pazjenti b'glijomas malinni ikkurati b'imatinib waqt li kienu qed jieħdu mediċini kontra l-epilessija li jinduċu l-enzimi (EIAEDs) bħal carbamazepine, oxcarbazepine u phenytoin.
English: 9/l) and thrombocytopenias frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10 (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: 9/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: Film-coated tablet.
Maltese: • Żieda fil-piż.
English: Renal pain, haematuria, renal failure acute, urinary frequency increased
Maltese: Uġigħ renali, demm fl-awrina, insuffiċjenza renali akuta, żieda fil frekwenza tal-awrina
English: The tablets are approximately 20 mm long and 10 mm wide.
Maltese: Il-pilloli huma madwar 20 mm twal u 10 mm wiesgħa.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5;
Maltese: DEX 10 mg/m2 orali, jiem 1-5; CP 200 mg/m2 i.v., jiem 3-5;
English: Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Maltese: Cmax u l-AUC ta' metoprolol b'madwar 23% (90%CI [1.16-1.30]).
English: Other medicines and Imatinib Teva
Maltese: Mediċini oħra u Imatinib Teva
English: The patients were distributed in three main categories: haematological failure (29%), cytogenetic failure (35%), or intolerance to interferon (36%).
Maltese: Il-pazjenti ġew imqassma fi tliet kategoriji prinċipali: nuqqas ta' suċċess mill-aspett matolaġiku (29%), nuqqas ta' suċċess mill-aspett ċitoġenetiku (35%), jew inkella nuqqas ta' tolleranza għall- interferon (36%).
English: Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common
Maltese: Anemija emolitika, mikroanġjopatija trombotika
English: In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Maltese: 165 (29.8%) eventi fil-fergħa IFN+Ara-C, li minnhom 130 seħħew waqt il-kura preferita b'IFN+Ara-C.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
Maltese: DEX 10 mg/m2 orali, jiem 1-5; CP 200 mg/m2 i.v., jiem 3, 4, 5;
English: The tablet is debossed with “IT” and “4” at each side of the score line.
Maltese: Il-pillola hi mnaqqxa b'“IT” u “4” fuq kull naħa tas-sinjal imnaqqax.
English: • Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Maltese: • Pazjenti adulti li rkadew jew li jkollhom Ph+ ALL rifrattorja bħala monoterapija.
English: The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 l/h, while for a patient weighing 100 kg the clearance will rise to 11.8 l/h.
Maltese: 50 kg il-clearance medja mistennija tkun 8.5 l/siegħa, filwaqt li f'pazjent ta' 100 kg il-clearance titla' għal 11.8 l/siegħa.
English: a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
Maltese: a ANC < 0.5 x 109/l u/jew plejtlits < 10 x 109/l
English: With 7 years follow-up, there were 93 (16.8%) progression events in the imatinib arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Maltese: 37 (6.7%) li jinvolvu avvanz għall-Fażi aċċelerata/blast crisis, 31 (5.6%) telf ta' MCyR, 15 (2.7%) telf ta' CHR jew żieda fil-WBC, u 10 (1.8%) mwiet mhux relatati ma' CML.
English: The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
Maltese: Il-qoxra tal-kapsula hija magħmula minn gelatn, titanium oxide (E171), iron oxide yellow (E172), u iron oxide red (E172).
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Maltese: Is-sustanza attiva imatinib turi riskju ambjentali għal organiżmi li jgħixu fis-sedimenti.
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Maltese: L-AUC tal-plażma għal dan il-metabolit kienet biss ta' 16% tal-AUC għal imatinib.
English: Complete (Confirmed3) [95% CI]
Maltese: 3) [CI ta' 95%]
English: 9/l.
Maltese: 9 mm.
English: In an observational study in the CML paediatric population, a statistically significant decrease (but of uncertain clinical relevance) in median height standard deviation scores after 12 and 24 months of treatment was reported in two small subsets irrespective of pubertal status or gender.
Maltese: Fi studju ta' osservazzjoni fil-popolazzjoni pedjatrika b'CML, kien irrappurtat tnaqqis statistikament sinifikanti(imma ta' relevanza mhux ċerta klinikament) fil-punteġġi ta' devjazzjoni standard tat-tul medju wara 12 u 24 xahar ta' trattament f'żewġ sottogruppi żgħar irrispettivament mill-istat ta' pubertà jew sess.
English: DEX (6 mg/m2/day PO): days 1-5; 29-33
Maltese: DEX (6 mg/m2/jum PO): jiem 1-5; 29-33
English: There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Maltese: 89.9% kienu kawkasi u 4.7% kienu pazjenti suwed.
English: The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Maltese: Id-doża totali kuljum fit-tfal ma tistax taqbeż it-800 mg b'CML u 600 mg b'Ph+ALL.
English: Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Maltese: Kapsuli oranġjo mhux trasparenti b'immarkar ta' 7630 iswed fuq il-korp tal-kapsula u mmarkar iswed ta' TEVA fuq l-għatu tal-kapsula.
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Maltese: Stomatite, ulċeri fil-ħalq, emorraġija gastro-intestinali7, tifwieq, melena, esofaġite, axxite, ulċera fl-istonku, rimettar tad-demm, kejlite, disfaġja,
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis
Maltese: 12 Gy fi 8 frazzjonijiet għall-pazjenti kollha li huma CNS1 u CNS2 waqt id-dijanjosi
English: Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Maltese: Spażmi fil-muskoli u bugħawwieġ, uġigħ muskoluskeletrali inklużi mijalġja9, artralġja, u uġigħ fl-għadam
English: ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
Maltese: ANC < 1.0 x 109/l u/jew plejtelets < 50 x 109/l
English: Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
Maltese: Kriterji ta' rispons molekulari maġġuri: fid-demm periferali tnaqqis ta' ≥ 3 logaritmi fl-ammont ta' traskritti Bcr-Abl (imkejjla b'assay ta' reverse transcriptase kwantitattiv li jinqara f'dak il-ħin stess) fuq linja bażi standardizzata.
English: Patients were treated at doses of imatinib 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: Ilpazjenti ġew ikkurati b'dożi ta' imatinib ta' 260 mg/m2/jum (n=5), 340 mg/m2/jum (n=9),
English: 9/l and platelets ≥ 20 x 109/l, then resume treatment at 200 mg/m2.
Maltese: ≥ 20 x 109/l, imbagħad kompli bit-trattament b'200 mg/m2.
English: Chronic phase CML, MDS/MPD (starting dose 400 mg) HES/CEL (at dose 400 mg)
Maltese: CML fil-fażi kronika, MDS/MPD (doża tal-bidu 400
English: What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Maltese: Imatinib Teva 100 mg kapsuli ibsin huma kapsuli oranġjo mhux trasparenti b'immarkar iswed ta' 7629
English: (0.5 h), days 7, 8, 14, 15;
Maltese: IDA 8 mg/m2 i.v. (0.5 h), jiem 7, 8, 14, 15;
English: CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/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 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Maltese: CHR: Studju 0110 [WBC < 10 x 109/l, plejtlits < 450 x 109/l, majeloċita+metamajeloċita < 5% fid demm, l-ebda blasts u promajeloċiti fid-demm, bażofili < 20%, l-ebda involviment 'l barra mill mudullun] u fi studji 0102 u 0109 [ANC ≥ 1.5 x 109/l, plejtlits ≥ 100 x 109/l, l-ebda blasts fiddemm, blasts BM < 5% u l-ebda mard barra l-mudullun]
English: The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Maltese: Il-ħin medjan għall-avvanz fil-popolazzjoni globali ta' 411 pazjent b' Ph+ ALL li jirkadi/rifrattorju kienet bejn 2.6 u 3.1 xhur, u s-sopravivenza medja globali fil-401 pazjent li setgħu jiġu evalwati kienet bejn 4.9 u 9 xhur.
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 posittivi għall-lewkimja limfoblastika akuta b'kromosoma ta' Filadelfja (Ph+ ALL) integrata b'kimoterapija.
English: Tumour lysis syndrome
Maltese: Sindromu tad-diżintegrazzjoni tat-tumur
English: - If you are being treated for CML:
Maltese: - Jekk qed tieħu kura għal CML:
English: Haematological response1 Complete haematological response (CHR) No evidence of leukaemia (NEL)
Maltese: Rispons ematoloġiku1 Rispons ematoloġiku komplut (CHR) L-ebda evidenza ta' lewkimja (NEL)
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 drugs is possible.
Maltese: 2-4 µmol/l, u għaldaqstant huwa possibbli li jinibixxi l-metaboliżmu permezz ta' CYP2D6 u/ jew CYP3A4/5 ta' mediċini li jingħataw fl-istess ħin miegħu.
English: Periorbital oedema, dermatitis/eczema/rash
Maltese: Edema mad-dawra tal-għajnejn, dermatite/ekżema/raxx
English: Cytogenetic response Major response n (%) [95% CI]
Maltese: Rispons ematoloġiku n (%) tar-rata ta'CHR [CI ta' 95%]
English: The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Maltese: L-OS stmat f'4 snin fost il-pazjenti f'koorti 5 kien ta' 83.6 % meta mqabbel mal-44.8 % fil-kontrolli storiċi. 20
English: In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Maltese: ANC < 1.0 x109/l u/jew plejtlits < 50 x 109/l, irrepeti stadju 1 u erġa' ibda b'imatinib f'doża ridotta ta'
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Maltese: Raxx bil-ponot, kontużjoni, żieda fl-għaraq, urtikarja, ekkimożi, titbenġel malajr, ipotrikożi, ipopigmentazzjoni tal-ġilda, dermatite esfoljattiva, onikoklażi, follikulite, tikkek ħomor fil-ġilda, psorajiżi, purpura,
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin,
Maltese: (acetaminophen, aciclovir, allopurinol, amphoteracin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V), kienu biss erythromycin (IC50 50 µM) u fluconazole (IC50 118
English: Ara-C 75 mg/m2 i.v.
Maltese: Ara-C 75 mg/m2 i.v. (1 h), jiem 1-5;
English: This inhibition has not been observed in vivo after the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Maltese: Din l-inibizzjoni ma ġietx osservata in vivo wara l-għoti ta' imatinib 400 mg u paracetamol 1000 mg.
English: Paediatric chronic phase CML (at dose 340 mg/m2)
Maltese: (f'doża ta'340 mg/m2)
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p<0.001; OS p<0.0001) in two studies (AJP01 and AUS01).
Maltese: OS p<0.0001) f'żewġ studji (AJP01 u AUS01).
English: Stop imatinib until ANC ≥ 1.5 x 109/l and platelets ≥ 75 x 109/l.
Maltese: Waqqaf imatinib sakemm l-ANC ≥ 1.5 x 109/l u lplejtlits ≥ 75 x 109/l.
English: Imatinib Teva is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Maltese: - Mard majelodisplastiku/majeloproliferattiv (MDS/MPD).
English: • Blood clots in small blood vessels (thrombotic microangiopathy).
Maltese: • Emboli fil-vini ż-żgħar (mikroanġjopatija trombotika).
English: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Maltese: Fi studju kontrollat (ADE10) ta' imatinib versus induzzjoni b'kimoterapija f'55 pazjent li kienu għadhom kif ġew dijanjostikati ta' etajiet minn 55 sena ‘l fuq. imatinib użat waħdu wassal għal rispons ematoloġiku komplet b'rata ogħla minn kimoterapija (96.3% vs 50%; p=0.001).
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Maltese: Il-funzjoni tal-fwied (transaminases, bilirubin, alkaline phosphatase) għandha tiġi mmonitorjata b'mod regolari f'pazjenti li jkunu qed jirċievu imatinib.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Maltese: Is-sigurtà u l-effikaċja ta' imatinib fit-tfal b'MDS/MPD, DFSP u HES/CEL li għandhom inqas minn 18-il sena ma ġewx determinati waqt provi kliniċi.
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Maltese: CP 1 g/m2 i.v. (1 h), jiem 26, 46; Ara-C 75 mg/m2 i.v. (1 h), jiem 28-31, 35-38, 42-45; 6-MP 60 mg/m2 orali, jiem
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Maltese: Il-65 pazjenti kollha li kienu posittivi għal FIP1L1-PDGFRα fusion kinase kisbu CHR li nżamm għal xhur (medda bejn 1+ sa 44+ xhur ċensurati fil-ħin meta ġew rappurtati).
English: Using this approach, the estimated cumulative response rates for first-line treatment with imatinib improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Maltese: B'dan l-approċċ, ir-rati kumulativi stmati għall-kura preferita bi imatinib tjiebu minn 12-il xahar ta' terapija għal 84 xahar ta' terapija kif ġej: CHR minn 96.4% għal 98.4% u CCyR minn 69.5% għal 87.2% rispettivament.
English: Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Maltese: Irritazzjoni tal-għajnejn, uġigħ fl-għajnejn, edema orbitali, emorraġija fl isklera, emorraġija fir-retina, blefarite, edema makulari
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Maltese: Ir-rabta tal-proteina fil-plażma tal-metabolit li hu N-demethylated huwa simili għal dak tal-kompost ġenitur.
English: In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Maltese: F' dan l-istudju 65% tal-pazjenti kellhom rispons ċitoġenetiku maġġuri li kien komplet f' 53% (43% konfermati) tal-pazjenti (Tabella 3).
English: 1.5 x 109/l and platelets ≥ 75 x 109/l.
Maltese: ANC ≥ 1.5 x 109/l u lplejtlets ≥ 75 x 109/l.
English: Table3 Response in adult CML study
Maltese: Tabella 3 Rispons f'adult bl-istudji CML
English: Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
Maltese: L-età medjana kienet ta' 51 sena (minn 18-70 sena), b' 21.9% tal-pazjenti jkollhom ≥ 60 sena. 59% kienu rġiel filwaqt li 41% kienu nisa;
English: In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
Maltese: F'GIST, l-istudju kellu jitwaqqaf minħabba reazzjonijiet avversi tal-mediċina f'4% tal-pazjenti.
English: What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg hard capsules are non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Maltese: Imatinib Teva 400 mg kapsuli ibsin huma kapsuli oranġjo mhux trasparenti b'immarkar iswed ta' 7630
English: 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 pazjent pedjatriku ta' età ta' < 18-il sena li jew kellhom CML fil-fażi 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 ddoża kienet tiżdied.
English: Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 109/l.
Maltese: CML titqies li tkun fil-fażi kronika meta jintlaħqu dawn il-kriterji: blasts < 15% fiddemm u fil-mudullun, fid-demm periferiku il-bażofils < 20%, u l-plejtlets > 100 x 109/l.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara EXP.
English: Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Maltese: Daqsijiet tal-pakketti li fihom 20x1, 60x1, 120x1 jew 180x1 pillola miksija b'rita ġo folji pperforati ta' doża waħda.
English: - If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 1 capsule once a day, 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.
Maltese: - Jekk qed tieħu kura għal CML: Skont il-kondizzjoni tiegħek, id-doża li normalment tibda biha hija ta' 400 mg jew ta' 600 mg: 400 mg għandha tittieħed bħala pillola waħda darba kuljum, 600 mg għandha tittieħed bħala pillola waħda ta' 400 mg u 2 pilloli ta' 100 mg jew bħala pillola u nofs ta' 400 mg darba kuljum
English: BM = bone marrow, PB = peripheral blood 2 Cytogenetic response criteria:
Maltese: BM = Mudullun, PB = demm fil-periferiji
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-database limitata dwar is-sigurtà, l-avvenimenti avversi rrapportati s'issa fit-tfal huma konsistenti mal-profil magħruf tas-sigurtà f'pazjenti adulti b'Ph+ ALL.
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Maltese: Daunorubicin 30 mg/m2 i.v., jiem 1-3, 15-16; VCR 2 mg doża totali i.v., jiem 1, 8, 15, 22; CP 750 mg/m2 i.v., jiem
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 (Cmax u lAUC medju 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: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Maltese: 1, 8; Prednisone 60 mg/m2 orali, jiem 1-7, 15-21;
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Maltese: CPM (250 mg/m2/doża q12h x 4 dożi, IV): jiem 3 u 4
English: CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Maltese: CPM (250 mg/m2/doża q12h x 4 dożi, iv): Jiem 3 u 4
English: Imatinib Teva 400 mg hard capsules imatinib
Maltese: Imatinib Teva 400 mg kapsuli ibsin imatinib
English: Daunorubicin 60 mg/m2 i.v.
Maltese: 260 mg/m2.
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Maltese: infezzjoni tal-passaġġ tal-awrina, gastro-enteretite, sepsis
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Maltese: Meta ngħata trattament minn qabel b'numru ta' dożi ta' rifampicin 600 mg li mbagħad kien segwit b'doża waħda ta' imatinib 400 mg, dan irriżulta fi tnaqqis fis-Cmax u fl-AUC(0-∞) b'mill-inqas 54% u 74% tal-valuri rispettivi għal meta ma ngħatax rifampicin.
English: Imatinib Teva 400 mg hard capsules
Maltese: Imatinib Teva 400 mg kapsuli ibsin