FrancophonIA/ELRC3.0 huggingface dataset:
English: Oval-shape, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “37” with score line on the other side.
Maltese: Pillola ovali, bikonvessi, ta' kulur isfar skur sa kanella, pillola miksija b' rita, immarkata bil-logo tal kumpanija fuq naħa waħda u ‘37' b' linja ta' punteġġ fuq in-naħa l-oħra.
English: The rate of haematological response was 70% with a duration of 2-3 months.
Maltese: Ir-rata ta' rispons ematoloġiku kienet ta' 70% b'tul ta' żmien ta' minn 2-3 xhur.
English: One blister contains either 8 or 10 capsules.
Maltese: Folja wahda fiha 8 jew 10 kapsuli.
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst
Maltese: Il-maġġoranza tal-pazjenti li kisbu CCyR żviluppaw is-CCyR
English: In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Maltese: Fi studju fuq il-fertilità, f'firien ta' sess maskili li ngħataw il- prodott mediċinali għal 70 jum qabel ma tgħammru, irriżulta li kien hemm tnaqqis fil-piż tat-testikoli u ta' l-epididimu u anke tnaqqis filperċentwal ta' sperma b'mobilità tajba, meta ntużat doża ta' 60 mg/kg, li hi bejn wieħed u ieħor ekwivalenti għall-ogħla doża klinika possibbli ta' 800 mg/jum, jekk wieħed iqis l-erja tas-superfiċje tal-ġisem.
English: 20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Maltese: fil-kontrolli storiċi. 20 minn 50 (40%) pazjent f'koorti 5 ngħataw trapjant ta' ċelluli stem ematopoetiċi.
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-esponiment pedjatriku medju flogħla doża rrakkomandata ta' 340 mg/m2.
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Maltese: Din kienet popolazzjoni ta' pazjenti li kienu diġà ħadu bosta trattamenti, billi 46% kien diġà kellhom BMT u 73% kienu ħadu kemoterapija li kienet tinkludi ħafna sustanzi, minn qabel.
English: 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: Hard capsule of size 1 with light orange cap and light orange body imprinted with “100 mg” in black ink.
Maltese: Kapsula iebsa ta' daqs 1 b' għatu oranġjo ċar u korp oranġjo ċar mmarkata b' "100 mg" bl-inka sewda.
English: Imatinib Actavis 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate).
Maltese: Imatinib Actavis 100 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 100 mg ta' imatinib (bħala mesilate).
English: 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: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Maltese: Meta imitanib kien kombinat ma' dożi għolja ta' kimoterapija f'pazjenti b'Ph+ ALL, tossiċità mumentanja tal-fwied dehret bħala żieda fil-livelli ta' transaminases u bilirubin fid-demm.
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Maltese: Hemm esperjenza limitata fit-tfal b'Ph+ ALL u esperjenza limitata ħafna fit-tfal b'MDS/MPD, DFSP u HES/CEL.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m2.
Maltese: Jekk iċ-ċitopenja ma tkunx relatata mal lewkimja, naqqas id-doża ta' imatinib għal 260 mg/m2.
English: ANC < 0.5 x 10
Maltese: Waqqaf imatinib sakemm ANC ≥ 1.5 x
English: Biochemistry
Maltese: Pożoloġija
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural 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 rappurtati (ara sezzjoni 4.8).
English: Weakness, pyrexia, anasarca, chills, rigors
Maltese: Dgħjufija, deni, anasarca, dehxiet, tregħid
English: How to take Imatinib Actavis
Maltese: X'fih Imatinib Actavis
English: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Maltese: Fiż-żewġ każijiet, l-aktar effett avvers relatat mal-mediċina li kien rappurtat (≥ 10%) kienu tqallih ħafif, rimettar, dijarrea, uġigħ addominali, għejja, majalġja, bugħawwieġ u raxx.
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Maltese: Il-kura b' imatinib twassal għal rispons mgħaġġel f'pazjenti pedjatriċi li kienu għadhom kif ġew dijanjostikati b'CML b'CHR ta' 78% wara 8 ġimgħat ta' terapija.
English: No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older.
Maltese: Fi provi kliniċi li fihom aktar minn 20% tal-pazjenti kellhom 65 sena jew aktar, ma deherx li kien hemm xi differenzi farmakokinetiċi sinifikanti li għandhom x'jaqsmu ma' l-età, f'pazjenti adulti.
English: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Maltese: F'pazjenti adulti u pedjatriċi, l-effikaċja ta' imatinib titkejjel skond ir-rati globali ta' rispons ematoloġiku u ċitoġenetiku u sopravivenza mingħajr progressjoni ta' CML, skond ir-rati ta' rispons ematoloġiku u ċitoġenetiku f'Ph+ ALL, MDS/MPD, fuq rati ta' rispons ematoloġiku f'HES/CEL u rispons oġġettiv f'pazjenti adulti b'DFSP li ma tkunx tista' titneħħa b'operazzjoni u/jew li tkun metastatika.
English: Round, 9.2 mm in diameter, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Maltese: Pillola tonda, b' dijametru ta' 9.2mm, bikonvessi, bejn isfar skur u kannella, miksija b'rita, immarkata bil-logo tal-kumpanija fuq naħa waħda u "36" bil-linja ta' punteġġ fuq in-naħa l-oħra.
English: Hard capsule with orange opaque cap and body imprinted with 400 mg in black ink.
Maltese: Kapsula iebsa b' għatu u korp oranġjo opak immarkat b' 400 mg bl-inka sewda.
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 Actavis f'dawk il-pazjenti b'MDS/MPD assoċjat ma bidla fl-arranġament tal-ġene ta' PDGFR hija ferm limitata (ara sezzjoni 5.1).
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 kurati minn qabel”) filwaqt li 165 (63%) ma' kienux għamlu hekk (“pazjenti mhux ikkurati minn qabel”).
English: When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8%) out of 11 achieving a complete haematological response.
Maltese: Meta terapija taomplet b'rata ogħla mi f'55 pazjent li kienu għurewx rispons jew li urew rispons fqir għall-kimoterapija, irriżulta li 9 pazjenti (81.8%) minn 11 kisbu rispons ematoloġiku komplet.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5; MTX 15 mg intrathecal, day 1
Maltese: DEX 10 mg/m2 orali, jum 1-5; CP 200 mg/m2 i.v., jum 3-5;
English: This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Maltese: Dan jinkludi rapporti spontanji ta' każijiet kif ukoll avvenimenti avversi serji minn studji li għadhom għaddejjin, programmi ta' aċċess estiż, studji dwar il-farmakoloġija klinika u studji esploratorji f'indikazzjonijiet mhux approvati.
English: Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Maltese: irriżulta li, fil-53 mill-411 pazjent li setgħu jiġu evalwati għar-rispons, f'rata ta' rispons ematoloġiku ta' 30% (9% kompleti) u rata ta' rispons ċitoġenetiku maġġuri ta' 23%.
English: Table 2 Response in adult CML study
Maltese: Pożoloġija f'pazjenti adulti b'CML
English: Not known (frequency cannot be estimated from the available data): - Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli): - Il-kombinazzjoni ta' raxx qawwi u mifrux, tħossok ma tiflaħx, deni, livell għoli ta' ċerti ċelluli bojod tad-demm jew ġilda jew għajnejk sofor (sinjali ta 'suffejra) ma' qtugħ ta' nifs, uġigħ fis sider/skonfort, tnaqqis sever tal-awrina u tħossok bil-għatx eċċ (sinjali ta' reazzjoni allerġika marbuta mal-kura).
English: Joint swelling
Maltese: Mhux komuni
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-sigurta u l-effikaċija ta' imatinib fit-tfal b'MDS/MPD, DFSP u HES/CEL li huma anqas minn 18-il sena ma ġewx stabbiliti waqt provi kliniċi.
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 nonleukaemia-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' 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; meta ma jkunx hemm rispons ċitoġenetiku wara mill-inqas 12-il xahar ta' kura, jew meta jkun hemm telf ta'
English: Imatinib Actavis is indicated for the treatment of - 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: Dan l-effett kliniku kien assoċjat ma' tnaqqis akbar fil-bcr-abl transcripts fil-pazjenti kurati b'imatinib milli fil-fergħa tal-kimoterapija wara ġimgħatejn ta' terapija
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 200 mg/m2.
Maltese: Jekk iċ-ċitopenja tippersisti għal 4 ġimgħat u għada mhix relatata mal lewkimja, waqqaf imatinib sakemm ANC ≥ 1 x 109/L u l-plejtlets ≥ 20 x 10
English: Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL.
Maltese: Fuq bażi ta' tagħrif eżistenti, intwera li imatinib huwa effettiv u sigur meta jingħata f'dosa ta' 600 mg/jum konġunt ma kimoterapija matul il-fażi ta' induzzjoni, il-fażi tal-kimoterapija konsolidati u ta' manteniment (ara sezzjoni 5.1) għal pazjenti adulti b'Ph+ ALL li jkunu għadhom kif ġew iddijanjostikati.
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 sara sal-ġurnata tal-lum, kura b'imatinib baqgħet tingħata sakemm kien hemm progressjoni tal-marda (ara sezzjoni 5.1).
English: Each film-coated tablet contains 0.75 mg lecithin (soya) (E322) For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija b'rita fiha 0.75 mg leċitin (soya) (E322)
English: There are no controlled trials in paediatric patients with DFSP.
Maltese: M'hemm l-ebda provi kkontrollati fost pazjenti pedjatriċi b'DFSP.
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Maltese: Ipotirojdiżmu Każijiet kliniċi ta' ipertajrojdiżmu kienu rapurtati f'pazjenti li tneħħietilhom it-tajrojd li jkunu qed jirċievu terapija b'levothyroxine waqt il-kura b'imatinib (ara sezzjoni 4.5).
English: - If you are being treated for MDS/MPD:
Maltese: - Jekk qed tiġi ikkurat għall-MDS/MPD:
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 taċ ċelluli l-bojod u dijarea.
English: - Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Maltese: - Infjammazzjoni f'daqqa tal-ġilda u ħmura (sinjali ta' infezzjoni fil-ġilda msejħa ċellulite).
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
Maltese: DEX 10 mg/m2 orali, jum 1-5; CP 200 mg/m2 i.v., jum 3, 4, 5;
English: Cerebral oedema*
Maltese: Edima ċerebrali*
English: DEX 10 mg/m2 oral, days 1-5; vindesine 3 mg/m2 i.v., day 1; MTX 1.5 g/m2 i.v.
Maltese: DEX 10 mg/m2 orali, jum 1-5; vindesine 3 mg/m2 i.v., jum 1; MTX 1.5 g/m2 i.v. (24 siegħa), jum 1; etoposide 250 mg/m2 i.v. (siegħa) days 45; Ara- C 2x 2 g/m2 i.v. (3 siegħat, q 12-il siegħa), jum 5
English: (3 h), days 1-4; mitoxantrone 10 mg/m2 i.v.
Maltese: Ara-C 1,000 mg/m2 /12 siegħa i.v.(3 siegħa), jum 1-4; mitoxantrone 10 mg/m2 i.v. jum 3-5;
English: For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available.
Maltese: Għal dożi ta' 400 mg u 800 mg (ara d-dożaġġ rakkomandat hawn fuq) teżisti pillola ta' 100 mg li tista'
English: The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2).
Maltese: Ir-rakkomandazzjoni tad-doża bħalissa hija bażata fuq numru żgħir ta' pazjenti pedjatriċi (ara sezzjonijiet 5.1 u 5.2).
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: Sopravivenza ħielsa mill-marda (Disease-free survival (DFS)) u sopravivenza totali (overall survival (OS))qabżu sena b'mod fiss u kienu superjuri għall-kontroll storiku (DFS p<0.
English: Round, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Maltese: Pillola tonda, bikonvessi, ta' kulur isfar skur sa kanella, pillola miksija b' rita, immarkata bil-logo tal kumpanija fuq naħa waħda u ‘36' b' linja ta' punteġġ fuq in-naħa l-oħra.
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 kurati b'imatinib kienu rappurtati f'5 rapporti dwar każijiet, b'etajiet li jvarjaw minn 18-il xahar sa 49 sena.
English: Active substances that may have their plasma concentration altered by imatinib Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Maltese: Sustanzi attivi li jistgħu jkollhom il-konċentrazzjoni tagħhom fil-plażma mibdula minħabba f' imatinib Imatinib iżid is-Cmax intermedju u l-AUC ta' simvastatin (sustanza li fuqa jaħdem is-CYP3A4) b' 2- u bi 3.5-il darba, rispettivament, u dan jindika li imatinib jinibixxi is-CYP3A4.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Trombożi/emboliżmu* Disturbi respiratorji, toraċiċi u medjastinali
English: Renal failure chronic
Maltese: Insuffiċjenza kronika tal-kliewi
English: - Mouth ulcers.
Maltese: - Ulċeri fil-ħalq.
English: This clinical effect was associated with a higher reduction in bcrabl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Maltese: Dan l-effett kliniku kien assoċjat ma' tnaqqis akbar fil-bcr-abl transcripts fil-pazjenti kurati b'imatinib milli fil-fergħa tal-kimoterapija wara ġimgħatejn ta' terapija (p=0.02).
English: The starting dose is 600 mg to be taken as 6 tablets once a day.
Maltese: Id-doża tal-bidu tas-soltu hi 600mg li ttieħed bhala 6 pilloli darba kuljum.
English: Paediatric chronic phase CML (at dose 340 mg/m2)
Maltese: 4-il darba l-esponiment fit-tfal (bażat fuq l-AUC) b'340 mg/m2/jum.
English: MTX 500 mg/m2 i.v.
Maltese: VM26 60 mg/m2 i.v. (siegħa), jum 1-5
English: The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
Maltese: dawn il-pazjenti kienet minn 2 sa 16-il sena u imatinib ingħata f'doża ta' 300 mg/m2 kuljum jew f'dożi li jvarjaw minn 200 sa 400 mg kuljum.
English: Handling of opened capsules by women of child-bearing potential Since studies in animals have shown reproductive toxicity, and the potential risk for the human foetus is unknown, women of child-bearing potential who open capsules should be advised to handle the contents with caution and avoid skin-eye contact or inhalation (see section 4.6).
Maltese: Peress li studji fl-annimali jindikaw tossiċità fis-sistema riproduttiva, u ir riskju potenzjali għall-fetu uman ma huwiex magħruf, nisa li jistgħu joħorġu tqal li jiftħu il-kapsuli għandhom jingħataw parir biex joqogħdu attenti meta jimmanipulaw il-kapsuli u jevitaw kuntatt malgħajnejn u l-ġilda jew tħejid man-nifs (ara sezzjoni 4.6).
English: No patient developed grade 4 thrombocytopenia.
Maltese: L-ebda pazjent ma żviluppa tromboċitopenja tar-4 grad.
English: 10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
Maltese: 10 pilloli miksija b'rita 30 pilloli miksija b'rita 60 pilloli miksija b'rita 90 pilloli miksija b'rita
English: Oval-shape, 18.6x6.6 mm, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “37” with score line on the other side.
Maltese: Imatinib Actavis 400 mg pilloli miksija b'rita Pillola ovali, 18.6 x 6.6mm, bikonvessi, bejn isfar skur u kannella, miksija b'rita ,immarkata bil-logo tal-kumpanija fuq naħa waħda u "37" bil-linja ta' punteġġ fuq in-naħa l-oħra.
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: bħalma jkun hemm fl-adulti b'dożi ta' 400 mg u 600 mg.
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 ta' bejn 23 u 75 sena; DFSP kien metastatiku, reġa ħareġ fil-post wara li kien tneħħa b'operazzjoni, u kien meqjus li aħjar ma terġax issir operazzjoni oħra ta' tneħħija, fil-ħin tad-dħul fl-istudju.
English: The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.
Maltese: Id-doża hija 800 mg kuljum (8 kapsuli), li għandha tittieħed bħala 4 kapsuli filgħodu u 4 kapsuli filgħaxija.
English: Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Maltese: Leżjonijiet mhux neoplastiċi li ma kienux identifikati fi studji ta' qabel l-użu kliniku kienu s-sistema kardjovaskolari, il-pankreas, l-organi endokrini u s-snien.
English: In adult patients, Imatinib Actavis is intended for use in the most advanced phase of the disease (blast crisis).
Maltese: F'pazjenti adulti, Imatinib Actavis huwa maħsub għall-użu fil-fażi l-aktar avvanzata tal-marda (blast crisis).
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Maltese: Katarretti, glawkoma, papilledema
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Maltese: Minħabba l-possibbiltà li jista' jkun hemm sindrome tad-diżintegrazzjoni tat-tumur (TLS), huwa rrakkomandat li ssir korrezzjoni tad-deidrazzjoni klinikament sinifikanti u li jkun hemm kura tal-livelli għoljin tal-aċidu uriku qabel ma jingħata imatinib (ara sezzjoni 4.8).
English: Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Maltese: Imatinib jista' jżid il-konċentrazzjoni fil-plażma ta' mediċini oħrajn li jiġu metabolizzati permezz tas-CYP3A4 (ez., triazolo-benzodiazepines, sustanzi bħal dihydropyridine li jibblokkaw ilkanali li minnhom jgħaddi l-kalċju għal ġoċ-ċelluli, xi tipi ta' sustanzi li jinibixxu lill-HMG-CoA reductase, jiġifieri l-istatins, eċċ.).
English: The rate of response was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Maltese: Ir-rata tar-rispons kienet ukoll ogħla fil-pazjenti li ħadu doża ta' 600 mg (33%) meta mqabbla mal-pazjenti li kienu ħadu doża ta' 400 mg (16%, p=0.0220).
English: Each film-coated tablet contains 0.19 mg lecithin (soya) (E322) Imatinib Actavis 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate).
Maltese: Doża ta' 340 mg/m2 kuljum hija rakkomandata fi tfal li jkollhom CML f'fażi kronika u CML fil-fażi lavvanzata (sabiex ma tinqabiżx id-doża totali ta' 800 mg).