FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric patients: 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, nonrandomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Maltese: Fl-istudju I2301, total ta' 93 pazjent pedjatriċi, adolexxenti u adulti żgħażagħ (minn sena sa 22 sena) b'Ph+ ALL issieħbu fi prova f'fażi
English: Imatinib medac is also a treatment for children and adolescents with CML.
Maltese: Imatinib medac hu wkoll kura għat-tfal u adolexxenti għal:
English: Maintenance (8-week cycles) Cycles 6-12
Maltese: Ċikli 6-12
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
English: The age of the DFSP patients ranged from 23 to 75 years; DFSP was metastatic, locally recurrent following initial resective surgery and not considered amenable to further resective surgery at the time of study entry.
Maltese: L-etajiet tal-pazjenti kienu bejn 23 u 75 sena; DFSP kien metastatiku, reġa ħareġ fil-post wara li kien tneħħa b'operazzjoni, u kien meqjus li aħjar ma jerġax issir operazzjoni oħra ta' tneħħija fil-ħin tad-dħul fl-istudju.
English: The starting dose 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 tal-bidu hija 600 mg li għandha tittieħed bħala 6 kapsuli ta' 100 mg (jew 1 kapsula ta' 400 mg flimkien ma' 2 kapsuli ta' 100 mg) darba kuljum.
English: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Maltese: L-esperjenza bl-użu ta' imatinib f'pazjenti b'MDS/MPD assoċjat mal-arranġamenti mill-ġdid tal-ġene PDGFR hija ferm limitata (ara sezzjoni 5.1).
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Maltese: L-analiżi kkonfermat li l-espożizzjonijiet ta' imatinib f'pazjenti pedjatriċi mogħtija 260 mg/m² darba kuljum (mhux aktar minn 400 mg darba kuljum) jew 340 mg/m² darba kuljum (mhux aktar minn 600 mg darba kuljum) kienu l-istess bħal dawk f'pazjenti adulti li ngħataw 400 mg jew 600 mg imatinib darba kuljum.
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with 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 600 mg għall-massimu ta' 800 mg (li jingħataw f'dożi ta' 400 mg, darbtejn kuljum) f'pazjenti li jkollhom blast crisis għandha mnejn tiġi kkunsidrata fl-assenza ta' effetti avversi severi minħabba fil-mediċina u fl-assenza ta' newtropenija jew tromboċitopenija 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; meta ma jkunx hemm rispons ċitoġenetiku wara mill-inqas 12-il xahar ta' kura, jew meta jkun hemm telf ta' rispons ematoloġiku u/jew ċitoġenetiku li jkun(u) inkiseb(bu) qabel.
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intratumoural haemorrhages were reported (see section 4.8).
Maltese: Fl-istudju f'pazjenti b'GIST li ma jistax jitneħħa b'operazzjoni u/jew li huwa metastatiku, emorraġiji gastrointestinali u fit-tumur kienu rrappurtati (ara sezzjoni 4.8).
English: There are no controlled trials in paediatric patients with DFSP.
Maltese: M'hemmx provi kkontrollati fost pazjenti pedjatriċi b'DFSP.
English: The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Maltese: L-AUC medja tiżdied b'mod lineari ma' żieda fid-doża, u ż-żieda fl-AUC medja hija wkoll proporzjonali għad-doża f'dożi ta' bejn 25-1,000 mg ta' imatinib mill-ħalq.
English: Study ADE10 Induction therapy I
Maltese: 4.1 Indikazzjonijiet terapewtiċi
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 1 minn kull 100 persuna) jew rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna):
English: VCR (1.5 mg/m 2/day, IV): days 1, 8, and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
Maltese: DAUN (45 mg/m²/bolus kuljum, IV): jiem 1 u 2
English: What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.
Maltese: Imatinib kellu effett teratoġeniku fil-firien, meta ngħata fiż-żmien l-organoġenesi f'dożi ta' ≥ 100 mg/kg, li jiġu bejn wieħed u ieħor ekwivalenti għall-ogħla doża klinika ta' 800 mg/jum, jekk wieħed jikkunsidra l-erja tas-superfiċje tal-ġisem.
English: In the event of recurrence of ANC < 1.0 x10
Maltese: Fil-każ li l-ANC jerga' < 1.0 x 10
English: Description of selected adverse reactions:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni ħafna:
English: days 3-5;
Maltese: Ċiklu 5
English: The dose of 340 mg/m 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 (m'għandhiex taqbeż id-doża sħiħa ta' 600 mg).
English: 340 mg/m daily is recommended for paediatric patients with chronic phase CML and accelerated phase CML (not to exceed the total dose of 800 mg).
Maltese: Doża ta' 340 mg/m² kuljum hija rakkomandata f'pazjenti pedjatriċi li jkollhom CML f'fażi kronika u CML fil-fażi aċċelerata (sabiex ma tinqabiżx id-doża totali ta' 800 mg).
English: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhoea.
Maltese: Tifel wieħed ta' 3 snin li kien espost għal doża waħda ta' 400 mg sofra minn rimettar, dijarea u anoreksja u tifel ieħor ta' 3 snin li kien espost għal doża ta' 980 mg sofra minn tnaqqis fl-għadd taċċelluli l-bojod u dijarea.
English: Adverse reactions and their frequencies are reported in Table 1.
Maltese: Reazzjonijiet avversi u l-frekwenzi tagħhom huma irrappurtati f'Tabella 1.
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: Il65 pazjenti kollha li kienu pożittivi għal FIP1L1-PDGFRα fusion kinase kisbu CHR li nżamm għal xhur (medda bejn 1+ sa 44+ xhur ċensurati fil-ħin meta ġew rrappurtati).
English: When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females.
Maltese: Meta firien tas-sess feminili ngħataw il-kura minn 14-il jum qabel ma tgħammru sas-6 jum tat-tqala, ma kien hemm l-ebda effett fuq it-tgħammir jew fuq in-numru ta' firien li ħarġu tqal.
English: There is very limited experience in children with MDS/MPD and DFSP.
Maltese: Hemm esperjenza limitata ħafna fi tfal b'MDS/MPD u DFSP.
English: The dose can be reduced if not tolerated (see sections 4.4, 4.8 and 5.2).
Maltese: Id-doża tista' titnaqqas jekk il-pazjent ma jkunx jiflaħ għaliha (ara sezzjonijiet 4.4, 4.8 u 5.2).
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 fi tfal b'MDS/MPD, DFSP u HES/CEL li jkollhom inqas minn 18il sena ma ġewx determinati s'issa fl-istudji kliniċi.
English: The milk/plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Maltese: Il-proporzjon fil-ħalib u l-plażma studjat f'pazjenta waħda kien iddeterminat li kien 0.5 għal imatinib u 0.9 għall-metabolit, li jissuġġerixxi distribuzzjoni ogħla tal-metabolit fil-ħalib.
English: • adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Maltese: • pazjenti adulti b'dermatofibrosarkoma protuberans (DFSP) li ma tistax titneħħa b'operazzjoni u pazjenti adulti b'DFSP rikurrenti u/jew metastatika li mhumiex eliġibbli għal operazzjoni.
English: MARKETING AUTHORISATION NUMBER (S) EU/1/13/876/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/876/001
English: 95 (37 %) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63 %) had not (“untreated patients”).
Maltese: 95 (37%) minnhom kienu diġà ħadu kemoterapija għall-kura tal-fażi aċċelerata jew tal-blast crisis (“pazjenti li kienu kkurati minn qabel”) filwaqt li 165 (63%) ma' kinux għamlu hekk (“pazjenti mhux ikkurati minn qabel”).
English: An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Maltese: Kien hemm rata ogħla ta' infezzjonijiet opportunistiċi meta imatinib ingħata fit-tul.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 10
Maltese: Jekk iċ-ċitopenija tippersisti għal 4 ġimgħat u għadha mhix relatata mallewkimja, waqqaf imatinib sakemm ANC ≥ 1 x 10
English: Induction-consolidation therapy i.v.
Maltese: Indikazzjonijiet terapewtiċi
English: Carriers of HBV who require treatment with imatinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Maltese: Portatuti tal-HBV li jeħtieġu l-kura b'imatinib għandhom jiġu mmonitorjati mill-qrib għal sinjali u għal sintomi tal-infezzjoni attiva tal-HBV waqt ilkura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: Metabolism of imatinib is mainly hepatic, and only 13 % of excretion is through the kidneys.
Maltese: Il-metaboliżmu ta' imatinib issir l-aktar permezz tal-fwied, u 13% biss tal-eskrezzjoni hija minn ġolkliewi.
English: Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Maltese: Dawk is-sustanzi li jistimolaw l-attività tas-CYP3A4 (eż. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone u Hypericum perforatum, ukoll mgħaruf bħala St.
English: 9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
Maltese: 9/l, imbagħad erġa ibda l-kura b'200 mg/m².
English: (24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Maltese: 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: Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Maltese: F'analiżi in vitro għal klastoġeniċità (aberrazzjoni tal-kromosomi), li saret fuq ċelluli mammiferi (l-ovarju tal-ħamster Ċiniż) irriżulta li imatinib kellu effett tossiku fuq il-ġeni filpresenza ta' attivazzjoni metabolika f'konċentrazzjoni ta' 125 μg/ml.
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Maltese: Ma kien hemm l-ebda bidla fil-farmakokinetiċi ta' imatinib meta ngħataw dożi ripetuti, u kien hemm akkumulazjoni ta' 1.5-2.5-il darba fl-istat fiss meta d-doża ingħatat darba kuljum.
English: The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations.
Maltese: Id-doża li tkun ordnata għandha tingħata mill-ħalq, flimkien mal-ikel u tazza ilma kbira sabiex jitnaqqas ir-riskju li jkun hemm irritazzjonijiet gastro-intestinali.
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% mqabbel mal-44.8% fost il-kontrolli storiċi. 20 mill-50 (40%) pazjent f'koorti 5 ngħataw trapjant tal-mudullun ematopoetiku.
English: The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn trabi tat-twelid sa 14-il sena u imatinib ingħata f'doża ta'50 mg kuljum jew f'dożi li jvarjaw minn 400 sa 520 mg/m² kuljum.
English: Posology for Ph+ ALL in children
Maltese: Pożoloġija għall-Ph+ ALL fi tfal
English: Resume treatment with imatinib at 600 mg.
Maltese: Erġa ibda l-kura b'imatinib b'600 mg.
English: Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Maltese: Fl-unika prova klinika li saret s'issa, il-kura b'imatinib tkompliet sakemm kien hemm avvanz tal-marda (ara sezzjoni 5.1).
English: 2/day PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 8-28 Methotrexate (20 mg/m 2/week, PO): days 8, 15, 22
Maltese: Methotrexate (20 mg/m²/ġimgħa, PO): jiem 8, 15, 22 VP-16 (100 mg/m², IV): jiem 29-33
English: A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Maltese: 6 pazjenti oħra b'DFSP ikkurati b'imatinib kienu rrappurtati f'5 rapporti dwar każijiet, b'etajiet li jvarjaw minn 18-il xahar sa 49 sena.
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Maltese: Inħoloq reġistru ta' osservazzjoni (studju L2401) sabiex tinġabar data dwar is-sigurtà u l-effikaċja fuq medda ta' żmien fost pazjenti li jbatu minn neoplażmi majeloproliferattivi b'arranġament PGDFR- β u li kienu ttrattati bi Imatinib medac.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
Maltese: Kien hemm rapporti li saru wara li lprodott tqiegħed fis-suq dwar abborti spontanji u anomaliji konġenitali fi trabi minn nisa li ħadu Imatinib medac.
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Maltese: Ipokalemija, żieda fl-aptit, ipofosfatemija, nuqqas ta' aptit, deidrazzjoni, gotta, iperuriċemija, iperkalċemija, ipergliċemija, iponatremija
English: Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
Maltese: Il-funzjoni epatika għandha tiġi monitorata bir-reqqa meta imatinib jingħata flimkien ma' reġimens ta'kimoterapija li jkunu magħrufin li jistgħu jkunu marbuta ma' funzjoni mhux normali tal-fwied (ara sezzjoni 4.5 u 4.8).
English: • If you are being treated for Ph-positive ALL:
Maltese: Disturbi fil-fwied u fil-marrara Komuni:
English: VP-16 (100 mg/m2/day, IV): days 1-5
Maltese: 6-MP (75 mg/m²/kuljum, PO): jiem 1-56
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Maltese: • pazjenti adulti b'mard majelopisplatiku/majeloproliferattiv (MDS/MPD) assoċjat ma' tibdil filġene tar-riċettur tal-fattur ta' tkabbir li jkun ġej minn plejtlits (PDGFR).
English: Cataract, glaucoma, papilloedema
Maltese: Dardir, dijarea, rimettar, dispepsja, uġigħ fl-addome
English: There were no special safety findings in paediatric clinical trials.
Maltese: Ma kienx hemm sejbiet ta' sigurtà speċjali fi provi kliniċi pedjatriċi.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali li huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwlunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
Maltese: Madanakollu, studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3) u mhux magħruf ir-riskju potenzjali fuq il-fetu.
English: A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Maltese: II, fuq pazjenti li kellhom CML li kienet pożittiva għall-kromosoma ta' Philadelphia (Ph+), fil-fażi blast crisis tal-marda.
English: The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib.
Maltese: Il-kondizzjoni kienet rappurtata bħala riversibbli meta ingħataw sterojdi b'mod sistemiku, miżuri ta' support ċirkolatorju, u interruzzjoni ta' imatinib b'mod temporanju.
English: Imatinib medac is also a treatment for adults for:
Maltese: Imatinib medac huwa wkoll kura f'adulti għall-:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in theagreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Severe elevation of transaminases (< 5 %) or bilirubin (< 1 %) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Maltese: Żieda qawwija fil-livelli tat-transaminases (<5%) jew tal-bilirubina (<1%) kienet evidenti f'pazjenti b'CML u s-soltu kienet kontrollata bi tnaqqis fid-doża jew inkella billi kien imwaqqaf għal ftit żmien it-trattament (it-tul medjan ta' dawn l-episodji kien ta' bejn wieħed u ieħor, ġimgħa).
English: This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Maltese: Dan l-istudju kien jinkludi 7 pazjenti b'MDS/MPD li kienu trattati b'imatinib 400 mg kuljum.
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Maltese: Iż-żieda tkun bejn 1.5-il-darba għal darbtejn akbar, li tikkorrispondi għal żieda ta' 1.5-il-darba fl-AGP tal-plasma, li miegħu imatinib jintrabat bil-qawwa.
English: Dose increases from 340 mg/m daily to 570 mg/m daily (not to exceed the total dose of 800 mg) 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: Żidiet fid-dożi minn 340 mg/m² kuljum għal 570 mg/m² kuljum (sabiex ma tinqabiżx id-doża totali ta' 800 mg) tista' titqies jekk ma jkunx hemm effetti avversi severi u newtropenija jew tromboċitopenija severi li ma jkunux relatati ma' lewkimja taħt dawn iċ-ċirkostanzi: avvanz tal-marda (ikun f'liema żmien ikun) meta ma jkunx hemm rispons ematoloġiku sodisfaċenti wara mill-inqas 3 xhur ta' kura; meta ma jkunx hemm rispons ċitoġenetiku wara mill-inqas 12-il xahar ta' kura, jew meta jkun hemm telf ta' rispons ematoloġiku u/jew ċitoġenetiku li jkun(u) inkiseb(bu) qabel.
English: Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Maltese: Il-profili farmakokinetiċi fil-plażma kienu analizzati fl-1 jum u jew fis-7 jum jew inkella fit-28 jum, sakemm ilkonċentrazzjonijiet fil-plażma kienu laħqu stat fiss.
English: Crospovidone (type A) Lactose monohydrate Magnesium stearate
Maltese: Imatinib medac 100 mg kapsuli ibsin Kontenut tal-kapsula Crospovidone (tip A) Lactose monohydrate Magnesium stearate
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Very common: Fluid retention and oedema, fatigue
Maltese: Il-fażi aċċelerata hi fażi intermedjarja bejn il-fażi kronika u l-bidu tal-kriżi tal-blasts; hi kkunsidrata bħala l-ewwel manifestazzjoni ta' reżistenza għat-terapija.
English: Triple IT therapy (age-adjusted): days 1 and 22 2/day, IV): days 22-26 2/day, IV): days 22-26 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir 2, q12h, IV): days 43, 44 2, IM): day 44
Maltese: Methotrexate (5 g/m² fuq medda ta' 24 siegħa, IV): jum 1 Leucovorin (75 mg/m² fis-36 siegħa, IV; 15 mg/m² IV jew PO q6h x 6 dożi)iii: Jiem 2 u 3
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR(I) RESPONSABBLI
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Maltese: Dan l-istudju kien jinkludi 14 pazjenti b'HES/CEL li kienu trattati b'imatinib minn 100 mg sa 1,000 mg kuljum.
English: The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Maltese: It-terapija fi studju B2225 damet medja ta' 6.2 xhur, l-aktar li damet kienet 24.3 xhur.
English: In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2).
Maltese: F'pazjenti li jkollhom il-fwied ma jaħdimx normali (ħafif, moderat jew sever), għadd taddemm periferiku u enzimi tal-fwied għandhom ikunu monitorati bir-reqqa (ara sezzjonijiet 4.2, 4.8, u 5.2).
English: Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
Maltese: Seħħet riattivazzjoni tal-epatite B f'pazjenti li huma portaturi kroniċi ta' dan il-virus wara li dawn ilpazjenti rċevew inibituri tat-tirożina kinażi BCR-ABL.