FrancophonIA/ELRC3.0 huggingface dataset:
English: Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycinand telithromycin) could decrease metabolism and increase imatinib concentrations.
Maltese: Dawk is-sustanzi li jinibixxu l-attivita CYP3A4 tal-isoenzima ċitokromju P450 (eż. inibituri talprotease bħal indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; sustanzi kontra l-moffa azole inkluż ketoconazole, itraconazole, posaconazole, voriconazole; ċerti makrolidi bħal erythromycin, clarithromycin u telithromycin) jistgħu jnaqqsu l-metaboliżmu u b'hekk iżidu il-konċentrazzjonijiet ta' imatinib.
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Maltese: F'konċentrazzjonijiet ta' imatinib li kienu klinikament relevanti, l-irbit mal-proteini tal-plażma kien ta' xi 95% bażati fuq esperimenti li saru in vitro, l-aktar mal-albumina u ma' alpha acid glycoprotein, bi ftit li xejn irbit mal-lipoprotein.
English: Tumour haemorrhage/tumour necrosis* Immune system disorders Not known
Maltese: Emorraġija mit-tumur/nekrożi tat-tumur* Disturbi fis-sistema immuni Mhux magħruf
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Accord, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13antibody determination, should be completed.
Maltese: Jekk is-sejbiet tal-laboratorju jew kliniċi assoċjati ma' TMA iseħħu f'pazjent li jkun qed jirċievi Imatinib Accord, it-trattament għandu jitwaqqaf u għandha titlesta evalwazzjoni bir-reqqa għal TMA, inkluża l-attività ta' ADAMTS13 u ddeterminazzjoni ta' antikorpi kontra ADAMTS13.
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: fit-tnaqqis fid-demm fil-periferiji ta' ≥ 3 logarittmi fl-ammont ta' Brc-Abl transcripts (imkejla b'assaġġ PCR ta' transkrittażi inversa kwantitattiva f'ħin reali) fuq linja bażi standardizzata.
English: PVC/PVdC/Alu blisters
Maltese: Għall-folji tal-PVC/PVdC/Alu
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: MTX 15 mg intrathecal, day1;
Maltese: MTX 15 mg intrathecal, jum 1;
English: The recommended dose of Imatinib is 600 mg/day for adults patients with Ph+ ALL.
Maltese: Id-doża rakkomandata ta' Imatinib hija ta' 600 mg/jum għal pazjenti adulti b'Ph+ ALL.
English: Other medicines and Imatinib Accord
Maltese: Mediċini oħra u Imatinib Accord
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: Espożizzjoni kontinwa kuljum għal imatinib kmieni waqt il-proċess ta' trattament flimkien ma' kemoterapija lil pazjenti f'koorti 5 (n=50) tejbu s-sopravivenza ħielsa minn kull episodju (EFS) f'4 snin mqabbel mal-kontrolli storiċi (n=120), li ngħataw kemoterapija standard mingħajr imatinib (69.6% vs 31.6%, rispettivament).
English: (NEL) Return to chronic phase
Maltese: Ritorn għall-fażi kronika
English: Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Maltese: Imatinib u l-metabolu N-demethyl flimkien kienu jgħoddu għal xi 65% tar-radjuattivita fiċċirkolazzjoni (AUC(0-48h)).
English: Biotransformation
Maltese: Biokimika
English: Pericarditis*, cardiac tamponade* Vascular disorders4
Maltese: Perikardite*, tamponade kardijaku*
English: In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Maltese: F'testijiet in vitro imatinib inibixxa l-attivita tas-CYP2D6, isoenzima taċ-ċitokromju P450, f'konċentrazzjonijiet simili għal dawk li jaffettwaw l-attivita tas-CYP3A4.
English: Imatinib Accord is a treatment for adults for:
Maltese: Imatinib Accord huwa kura f'adulti għall-:
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), 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: Wieħed għandu joqgħod attent meta imatinib jittieħed ma' inibituri talprotease, sustanzi kontra l-moffa azole, ċerti makrolidi (ara sezzjoni 4.5), sottostrati ta' CYP3A4 b'tieqa terapewtika dejqa (eż. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) jew warfarin jew derivattivi oħrajn ta' coumarin (ara sezzjoni 4.5).
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, pankrejatite
English: Stop Imatinib Accord until ANC ≥ 1.5x109/l and platelets ≥ 75x109/l.
Maltese: Waqqaf Imatinib Accord sakemm lANC  1.5 x 109/l u l-plejtlets  75 x 109/l.
English: Doxorubicine 50 mg/ m2 i.v.
Maltese: Doxorubicine 50 mg/m2 i.v. (24 h), jum 4;
English: Do not take Imatinib Accord
Maltese: Tiħux Imatinib Accord
English: Posology for Ph+ ALL in children and adolescents
Maltese: Pożoloġija għall-Ph+ ALL fi tfal u adolexxenti
English: 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: Imatinib iżid is-Cmax intermedju u l-AUC ta' simvastatin (sustanza li fuqha jaħdem is-CYP3A4) b' 2- u bi 3.5-il darba, rispettivament, u dan jindika li imatinib jinibixxi is-CYP3A4.
English: Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic drugs (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: VCR (1.5 mg/m2/day, IV): days 1, 29
Maltese: VCR (1.5 mg/m2/kuljum, IV): jiem 1, 29
English: Haematological response Complete haematological response (CHR) No evidence of leukaemia
Maltese: Rispons ematoloġiku Rispons ematoloġiku kompletmplete haematological komplet (CHR)
English: In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
Maltese: Fi provi kliniċi b'CML, it-twaqqif tal-mediċina minħabba reazzjonijiet avversi tal-mediċina kienu osservati f'2.4% tal-pazjenti li jkunu għadhom kif ġew dijanjostikati, 4% tal-pazjenti fil-fażi kronika avvanzata wara li falliet terapija b'interferon, 4% tal-pazjenti fil-fażi aċċellerata wara li falliet terapija b'interferon u 5% tal-pazjenti bi blast crisis wara li falliet it-terapija b'interferon.
English: In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children and adolescents from 340 to 260 mg/m2/day.
Maltese: Fil-kbar id-doża għandha titnaqqas minn 400 mg għal 300 mg jew inkella minn 600 mg għal 400 mg, jew minn 800 mg għal 600 mg, u fit-tfal u fl-adolexxenti minn 340 għal 260 mg/m2/jum.
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: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Maltese: Tromboċitemija, limfopenja, dipressjoni tal-mudullun, eżinofolja, limfadenopatija
English: Paediatric chronic phase CML (at dose 340 mg/m2)
Maltese: CML fil-fażi kronika pedjatrika (doża tal-bidu 340 mg/m2)
English: CP 1.2 g/ m2 i.v.
Maltese: CP 1.2 g/m2 i.v. (3 h), jum 1;
English: The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily.
Maltese: Il-pazjent pedjatriku rċieva 400 mg/m2/kuljum, u wara kien miżjud għal 520 mg/m2/kuljum.
English: Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Maltese: Irritazzjoni ta' l-għajnejn, uġigħ fl-għajnejn, edema orbitali, emorraġija flisklera, emorraġija fir-retina, blefarite, edema makulari
English: Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Maltese: Imatinib ma kienx meqjus li kellu effett ġenotossiku meta ġie ttestjat f'assay ta' ċelluli ta' batterji in vitro (test Ames), u f'assay ta' ċelluli mammiferi in vitro (limfoma fil-ġurdien) u f'test in vivo fuq il mikronukleju fil-far.
English: Packs containing 10, 30, or 90 film-coated tablets.
Maltese: Pakketti fihom 10, 30, jew 90 pillola miksija b'rita.
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Maltese: Palpitazzjonijiet, takikardja, insuffiċjenza konġestiva tal-qalb3, edema filpulmun
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 fil-fażi kronika hi definita meta jiġu ssodisfati l-kriterji kollha li ġejjin: blasts < 15 % fid-demm u fil-mudullun, bażofils fid-demm fil-periferiji < 20 %, plejtelets > 100 x 109/l.
English: (0.5 h), days 7, 8, 14, 15; CP 500 mg/ m2 i.v.
Maltese: IDA 8 mg/m2 i.v. (0.5 h), jiem 7, 8, 14, 15; CP 500 mg/m2 i.v.(1 h) jum 1;
English: ANC < 1.0x109/l and/or platelets < 50 x 109/l
Maltese: ANC < 1.0 x 109/l u/jew plejtelets < 50 x 109/l
English: Similar findings were found based on a 18-months landmark analysis.
Maltese: Instabu sejbiet simili abbażi ta' analiżi landmark ta' 18-il xahar.
English: Depending on your condition the usual starting dose is either 400 mg or 600 mg: - 400 mg to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once a day - 600 mg to be taken as 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.
Maltese: Jekk qed tieħu kura għal CML Skont il-kundizzjoni tiegħek, id-doża li normalment tibda biha hija ta' jew 400 mg jew ta' 600 mg: 400 mg li tittieħed bħala 4 pilloli ta' 100 mg jew pillola 1 ta' 400 mg darba kuljum 600 mg li tittieħed bħala 6 pilloli ta' 100 mg jew pillola 1 ta' 400 mg flimkien ma' 2 pilloli darba kuljum
English: Major response n (%) [95% CI]
Maltese: (23.3 %)* [95 % CI]
English: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
Maltese: 20 pillola miksija b'rita 60 pillola miksija b'rita 120 pillola miksija b'rita 180 pillola miksija b'rita 30x1 pillola miksija b'rita 60x1 pillola miksija b'rita 90x1 pillola miksija b'rita 120x1 pillola miksija b'rita 180x1 pillola miksija b'rita
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, pulmonite1, sinużite, ċellulite, infezzjoni tan-naħa ta' fuq tal-passaġġ respiratorju, influwenza, infezzjoni talpassaġġ tal-awrina, gastro-enteretite, sepsi
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accord to 260 mg/m2.
Maltese: Jekk iċ-ċitopenja ma tkunx relatata mallewkimja, naqqas id-doża ta' Imatinib Accord għal 260 mg/m2.
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: B'kuntrast, kien hemm 165 (29.8 %) avveniment fil-fergħa IFN+Ara-C, li minnhom 130 seħħew matul il-kura tal-ewwel linja b'IFN+Ara-C.
English: • For PVC/PVdC/Alu blisters Do not store above 30C.
Maltese: • Għall-folji tal-PVC/PVdC/Alu Taħżinx f'temperatura 'l fuq minn 30°C.
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 < 1.0x109/1) and thrombocytopenias (platelet count < 50x109/1) 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 tat3 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: Partial Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): 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: 9/l, l-ebda blast fid demm, blasts BM < 5 % u l-ebda mard barra l-mudullun] NEL L-istess kriterji bħal ta' CHR iżda ANC > 1 x 109/l u plejtelets > 20 x 109/l (0102 u 0109 biss) RTC < 15 % blasts BM u PB, < 30 % blasts+promajeloċiti BM u PB, < 20 % bażofils PB, l-ebda involviment barra l-mudullun ħlief għall-involviment tal-milsa u tal-fwied.
English: aANC < 0.5x109/1 and/or platelets < 10 x 109/1
Maltese: aANC < 0.5 x 109/l u/jew plejtelets < 10 x 109/l
English: • Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Maltese: • pazjenti adulti li jkunu għadhom kif ġew dijanjostikati posittivi għall-lewkimja limfoblastika akuta b'kromosoma ta' Filadelfja (Ph+ ALL) integrata b'kimoterapija.
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: 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' mediċini li jingħataw fl-istess ħin miegħu.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Maltese: Il-pazjenti adulti rappurtati fil-pubblikazzjoni kienu kurati jew b'400 mg (4 każijiet) jew 800 mg (każ 1) imatinib kuljum.
English: MTX 1.5 g/ m2 i.v.
Maltese: MTX 1.5 g/m2 i.v. (24 h), jum 1;
English: Alu/Alu blisters
Maltese: Folji Alu/Alu
English: Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Rari
English: There is limited experience in children and adolescents with Ph-positive ALL and very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
Maltese: Hemm esperjenza limitata bl-użu fit-tfal u fl-adolexxenti b'MDS/MPD, DFSP u HES/CEL.
English: Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Maltese: Lewkimja limfoblastika akuta pożittiva għall-kromosoma ta' Filadelfja (Ph-pożittiva ALL).
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets
Maltese: 10 pilloli miksija b'rita 30 pillola miksija b'rita 90 pillola miksija b'rita 30x1 pillola miksija b'rita 60x1 pillola miksija b'rita 90x1 pillola miksija b'rita
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: The estimated rate of progression-free survival at 84 months was 81.2% in the Imatinib arm and 60.6% in the control arm (p<0.001).
Maltese: Ir-rata stmata ta' sopravivenza mingħajr avvanz wara 84 xahar kienet ta' 81.2 % fil-fergħa b'Imatinib u ta' 60.6 % fil-fergħa ta' kontroll (p<0.
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, tidbenġel malajr, ipotrikożi, ipopigmentazzjoni tal-ġilda, dermatite esfoljattiva, onikoklażi, follikulite, tikkek ħomor fil-ġilda, psorajiżi, purpura, iperpigmentazzjoni tal-ġilda, joħorġu l-imsiemer
English: F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Maltese: Il-fertilita tal-grupp F1 ma kienetx affettwata, filwaqt li n-numru ta' feti li naqsu mill-piż żdied u numru iżgħar ta' feti baqgħu ħajjin b'doża ta' 45 mg/kg/jum.
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
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: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Maltese: L-AUC talplażma għal dan il-metabolu kienet biss 16% tal-AUC għal imatinib.
English: 2 Headache was the most common in GIST patients.
Maltese: Imbagħad kompli bl-iskeda normali tiegħek.
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Maltese: 18 Gy f'10 frazzjonijiet għal pazjenti li huma CNS3 waqt id-dijanjosi VCR (1.5 mg/m2/kuljum, IV): jiem 1, 29
English: Thisinhibition has not been observed in vivoafter the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Maltese: Din linibizzjoni ma ġietx osservata in vivo wara l-għoti ta' imatinib 400 mg u paracetamol 1000 mg.
English: • Chronic renal failure
Maltese: • Indeboliment kroniku tal-kliewi
English: Imatinib Accord is a medicine containing an active substance called imatinib.
Maltese: Imatinib Accord huwa mediċina li fih is-sustanza attiva imatinib.
English: In this retrospective analysis, the superiority of Imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Maltese: 001); f'42 xahar, 47 (8.5 %) pazjent ta' Imatinib u 63 (19.4 %) pazjent ta' IFN+Ara-C kienu mietu.
English: In the event of recurrence of ANC < 1.0 x 109/1 and/or platelets < 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2.
Maltese: Fil-każ li l-ANC jerġa' < 1.0 x 109/1 u/jew il-plejtlets < 50 x 109/l, erġa' irrepeti Nru. 1 u erġa' ibda Imatinib Accord b'doża mnaqqsa ta' 260 mg/m2.
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: 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' darba kuljum.
English: The dose is 800 mg per day (to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.
Maltese: Jekk id-doża ta' kuljum tkun ta' 800 mg, (8 pilloli ta' 100 mg jew 2 pilloli ta' 400 mg), għandek tieħu 4 pilloli ta' 100 mg jew pillola 1 ta' 400 mg filgħaxija.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Accord should not be resumed.
Maltese: Jekk antikorp kontra ADAMTS13 jiġi elevat flimkien ma' attività baxxa ta' ADAMTS13, it-trattament bi Imatinib Accord m'għandux jinbeda millġdid.
English: Adverse reactions and their frequencies are reported in Table 1.
Maltese: Reazzjonijiet avversi u l-frekwenzi tagħhom huma rrappurtati f'Tabella 1.
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, nonrandomized 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 trattament b'imatinib (340 mg/m2/kuljum) flimkien ma' kemoterapija intensiva wara terapija ta' induzzjoni.
English: This phase III study in adult patients compared treatment with either single-agent Imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Maltese: III f'pazjenti adulti qabbel il-kura ma' jew aġent waħdieni ta' Imatinib jew ma' taħlita ta' interferon-alfa (IFN) flimkien ma' cytarabine (Ara-C).
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: Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Maltese: Għalhekk, huwa rakkomandat li tintuża kawtela meta imatinib jingħata flimkien ma' sustanzi li fuqhom jaġixxi isCYP3A4 u li għandhom medda terapewtika li hi żgħira (eż., cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel u quinidine).
English: Ara-C 75 mg/ m2 i.v.
Maltese: Ara-C 75 mg/m2 i.v. (1 h), jiem 1-5;
English: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Maltese: Prednisone 60 mg/m2 orali, jiem 1-7, 15-21;